Langzaam maar zeker wordt hopen vertrouwen: na de jaarwisseling hebben we misschien wel de beschikking over de eerste coronavaccins. Hoera! Die vaccins moeten vervolgens zo snel mogelijk de juiste arm in. Dat is geen sinecure, dat vergt een nationaal vaccinatieplan, zo merkten we vorige week al op. We waren dan ook blij verrast toen minister De Jonge vrijdagmiddag de Nederlandse COVID-vaccinatiestrategie de ether in slingerde. We legden het plan langs de meetlat: is dit het felbegeerde integrale plan om de giga vaccinatie-uitdaging in goede banen te leiden? Spoiler alert: HollandBIO is er nog niet helemaal gerust op.
In zijn COVID-vaccinatiestrategie pleit het kabinet voor een wendbare Nederlandse aanpak en strategie. Er zijn, in samenwerking met verschillende partijen, meerdere scenario’s in voorbereiding. Check tot zover. Het kabinet wil waar mogelijk gebruik maken van bestaande structuren, én via kleinschalige distributie prioritaire groepen voorzien van een vaccin. Dat klinkt in eerste instantie handig en veilig. Maar is het wel realistisch? Een pandemie en bestaande structuren staan op gespannen voet, leerden we van het contactonderzoek, het inkoop-, en het testbeleid. Maar corona en kleinschalig, dat is helemaal een contradictio in terminis.
Reken maar even met ons mee. De door de Gezondheidsraad aangewezen prioritaire doelgroep bestaat in totaal uit maar liefst 6,5 miljoen mensen, die, afhankelijk van welke vaccins als eerste beschikbaar zijn, waarschijnlijk tweemaal een prik moeten krijgen. Dat maakt 13 miljoen vaccinaties.Ter vergelijking, in 2019 ontvingen zo’n 3,1 miljoen mensen uit diezelfde doelgroep de griepvaccinatie. Dat is één prik, met één vaccin, en ook dat is elk jaar weer een fikse opgave. Het getal 13 miljoen zou dus al voldoende moeten zijn om deze deelvaccinatiecampagne als grootschalig te bestempelen. Tel daar een paar pandemie-eigen complicerende factoren bij op. Het moet namelijk wel een beetje snel, want we willen liever vandaag dan morgen terug naar normaal of op z’n minst normaler. Met het oog op de schaarste, komen de vaccins daarbij zeker het eerste jaar van verschillende leveranciers, in verschillendedeelleveringen van verschillende omvang. Die vaccins hebben een verschillend, nog onbekend, profiel voor verschillende (deel)doelgroepen, en moeten, al dan niet via distributiecentra, vervoerd worden naar uiteenlopende (zorg)locaties, onder verschillende condities. Dat levert al met al een duizelingwekkend logistiek plaatje op, met een schier oneindig aantal mogelijke scenario’s, combinaties en leveringen. En last but not least, één persoon moet hetzelfde vaccin twee keer krijgen, en mogelijke bijwerkingen en liefst effectiviteit moeten nauwgezet geregistreerd worden. Ga er maar aan staan, kleinschalig binnen je reguliere structuren, naast je reguliere takenpakket.
We geven toe, het is onrealistisch om te verwachten dat de vaccinatiestrategie pasklaar zou zijn. We begrijpen dat cruciale gegevens – en de vaccins zelf – nog ontbreken, wat maakt dat we varen in dichte mist. Maar inzetten op kleinschalig en regulier is dat zeer zeker ook. Hoeveel en welke menskracht, hoeveel en welke middelen en hoeveel en welke distributiecentra maakt het kabinet vrij om dit huzarenstuk in goede banen te leiden? En hoe? De vaccinatiestrategie licht een tipje van de sluier op hoe het kabinet in de wedstrijd zit, maar veel van onze vragen blijven vooralsnog onbeantwoord.
Met een kleine steek van jaloezie kijken we naar de plannen van Duitsland, waar centraal aangestuurde distributiecentra worden klaargestoomd, benodigdheden worden ingekocht en mobiele teams worden ingesteld om de vaccinaties naar de arm van bestemming te begeleiden. Om pas later, als er vaccins in overvloed zijn en de coronavaccinatie daadwerkelijk business as usual is, ingebed te worden in de reguliere – zo je wil kleinschalige – infrastructuur. Deutsche Gründlichkeit, kortom.
https://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svg00HollandBIOhttps://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svgHollandBIO2020-11-24 12:08:092023-09-27 16:30:22Op naar de arm (deel II): kabinet publiceert Nederlandse COVID-vaccinatiestrategie← #nieuws
CureVac N.V. (Nasdaq: CVAC), a biopharmaceutical company developing a new class of transformative medicines based onmessenger ribonucleic acid (mRNA), and Wacker Chemie AG announced today that they had signed a contract for the manufacturing of CureVac’s COVID-19 vaccine candidate CVnCoV. Under the terms of the initial agreement, WACKER will ramp up GMP (Good Manufacturing Practice) production of the mRNA drug substance for CVnCoV at its biotech site in Amsterdam in the first half of 2021.Preparationsfor the start of production, technology transfers and test runs are already underway.It is planned to produce more than 100 million doses of the CureVac vaccine per year at WACKER’sAmsterdam site.There is also further potential for expansion at the site in order to meet rising demand in the future.
WACKER’s CEO Rudolf Staudigl said: “We are proud and highly motivated to make a contribution to the fight against the spread of the coronavirus pandemic together with CureVac.” As a CDMO (Contract Development and Manufacturing Organization), Wacker Biotech bundles WACKER Group’s biopharmaceutical activities. Its Amsterdam site has been producing vaccines for clinical development and commercial supply for 20 years. The portfolio ranges from conventionallive and killed vaccines to protein-based, polysaccharide and glycoconjugate vaccines. In recent months, WACKER has invested in the site to extend production to includemRNA-based vaccines. This new classof vaccines expands the broad vaccine portfolio Wacker Biotech offers to its customers.
Dr. Florian von der Mülbe, Chief Production Officer of CureVac, added:“With WACKER, we have found a committed and highly experienced partner for the production of our vaccine candidate in the Netherlands.”CureVac is building an integrated European vaccine manufacturing network with several CDMO partners. With this strategy, the company will significantly increase the manufacturing capacity already existing within CureVac for CVnCoV up to several hundred million doses per year and will manage potential supply chain risks by working with several partners for each of the key manufacturing process steps.
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced that the European Commission (EC) has granted marketing authorization for OXLUMO™ (lumasiran), an RNAi therapeutic, for the treatment of primary hyperoxaluria type 1 (PH1) in all age groups.
PH1 is an ultra-rare orphan disease characterized by excessive oxalate production, which can lead to life threatening end-stage renal disease (ESRD) and other systemic complications. Heterogeneity in disease manifestation often contributes to delays in diagnosis – particularly in adult PH1 patients, with a median time from symptoms onset to diagnosis of approximately six years. Untreated PH1 leads to progressive kidney damage; patients with advanced kidney disease require intensive dialysis to help filter waste products, including oxalate, from their blood until they are able and eligible to receive a dual or sequential liver/kidney transplant, an invasive procedure associated with a high risk of morbidity and mortality, and life-long immunosuppression.
“Prior to now there have been no approved treatment options for PH1 in Europe, so this is a potentially life-changing milestone for people diagnosed with this ultra-rare, debilitating disease – many of whom are infants and children – and their families. Lumasiran will address the urgent unmet need that exists for patients with PH1 and its approval today marks our continued commitment to rare disease communities,” said John Maraganore, Ph.D., Chief Executive Officer, Alnylam Pharmaceuticals. “Alnylam has taken lumasiran from identification of compound to regulatory approval in just six years and we will progress with the same sense of urgency as we work with national reimbursement bodies across Europe to bring lumasiran to patients.”
Lumasiran is an RNAi therapeutic targeting the hydroxyacid oxidase 1 (HAO1) mRNA that encodes glycolate oxidase (GO) – an enzyme upstream of the disease-causing defect in PH1. By degrading the HAO1mRNA and reducing the synthesis of GO, lumasiran stops the production of oxalate – the toxic metabolite that directly contributes to the clinical manifestations of PH1.
“PH1 affects patients of all ages. It is particularly devastating when infants are born with the condition and develop kidney failure within the first few months of life. PH1 patients develop kidney stones from the overproduction of oxalate, and in many we see a progressive decline in kidney function, which can ultimately lead to life-threatening end-stage kidney disease. Until recently the only treatment options available have been combined liver and kidney transplantation, with vitamin B6 slowing down kidney failure in a limited number of sensitive patients,” said Sally-Anne Hulton, M.D., Consultant Paediatric Nephrologist, Birmingham Women’s and Children’s Hospital NHS Trust, UK. “For the first time, lumasiran provides those of us treating PH1 children and adults with a new therapeutic option to tackle the root cause of this disease and prevent the production of oxalate. The data show meaningful and sustained reductions in urinary and plasma oxalate with an encouraging safety and tolerability profile, providing us with hope for improving care for these patients.”
“In line with our Patient Access Philosophy, Alnylam is committed to being as innovative commercially as we have been scientifically,” said Brendan Martin, Acting Head of CEMEA, Alnylam. “While the ability to enter into innovative agreements varies by country and local regulations, we intend to work with health authorities across Europe to achieve responsible and sustainable access arrangements for lumasiran that address the diverse patient population affected by PH1, which ranges from infants to adults, and we will adapt to the local context. Our goal is to ensure that all patients in need have access to lumasiran while minimizing budget uncertainty for health services.”
The approval in the European Union is based on efficacy and safety findings from both the ILLUMINATE-A and ILLUMINATE-B Phase 3 studies of lumasiran. In the ILLUMINATE-A study conducted in adults and children six years or older, lumasiran achieved the primary endpoint with a 53 percent mean reduction in urinary oxalate relative to placebo and showed a 65 percent mean reduction in urinary oxalate relative to baseline. Eighty-four percent of patients achieved normal1 or near-normal2 levels of urinary oxalate and more than half of patients (52 percent) reached normalization, compared to zero percent in the placebo group. Findings from the ILLUMINATE-A pivotal study were presented in June 2020 at the virtual European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) International Congress. In the ILLUMINATE-B Phase 3 study, the efficacy results and safety profile of lumasiran in infants and children under the age of six years were found to be similar to those observed in ILLUMINATE-A. Results from the ILLUMINATE-B pediatric study were presented on October 22 at the virtual American Society of Nephrology (ASN) Annual Congress.
Lumasiran was granted Priority Medicines (PRIME) designation by the EMA as well as Orphan Designation in the European Union. Lumasiran was also granted an Accelerated Assessment by the EMA, which is awarded to medicines deemed to be of major public health interest and therapeutic innovation and is designed to bring new treatments to patients more quickly. This approval in the European Union follows the positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in October 2020. Alnylam has filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA). The FDA has granted a Priority Review for the NDA and has set an action date of December 3, 2020 under the Prescription Drug User Fee Act (PDUFA).
https://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svg00HollandBIOhttps://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svgHollandBIO2020-11-23 19:04:362020-11-23 19:04:37Alnylam Receives Approval for OXLUMO™ (lumasiran) in the European Union for the Treatment of Primary Hyperoxaluria Type 1 in All Age Groups← #nieuws
The European Commission has granted a marketing authorization for Supemtek®, a quadrivalent (four-strain) recombinant influenza vaccine, for the prevention of influenza in adults aged 18 years and older. Supemtek is the first and only recombinant influenza vaccine now approved in the European Union.
Supemtek is produced using recombinant technology, which allows an exact match to the key component of the influenza strains recommended by the World Health Organization, avoiding the risk of viral mutations. Supemtek also contains three times more antigen than both egg-based and cell-based standard-dose vaccines. This increased amount of antigen and the use of recombinant technology provide improved protection against influenza, particularly in those aged 50 and older. In comparison with a standard-dose egg-based quadrivalent influenza vaccine, Supemtek reduced the risk of influenza by an additional 30% for adults aged 50 years and older1,2.
The authorization is based on clinical data demonstrating safety, immunogenicity and efficacy of Supemtek in two Phase 3 randomized controlled trials1,2 involving more than 10,000 patients in total. Specifically, the relative efficacy of Supemtek was demonstrated in a Phase 3 multicenter (40 outpatient centers in the US, involving more than 9,000 adults), randomized controlled efficacy trial1,2.
“In the context of the COVID-19 pandemic, preventing influenza remains a public health priority,” said Thomas Triomphe, Head of Sanofi Pasteur. “Today’s approval of Supemtek supports our strong commitment in advancing influenza vaccine technology. With Supemtek, we provide European health authorities with an additional innovative solution that has demonstrated increased ability to prevent influenza and its potentially severe complications, as well as the burden this causes on healthcare systems.”
Each year, influenza-associated deaths range from 290,000 to 650,0003,4 globally, and the burden on hospitals is around 10 million of influenza-related hospitalizations5. Recent data also show that influenza can multiply the risk of heart attack by up to 10 times, and the risk of stroke by up to 8 times, in the week after influenza infection6 – demonstrating that the burden of influenza goes beyond its well-known respiratory complications.
The first European launches are expected for the 2022/2023 influenza season, with a possibility of accelerating the availability of doses as early as the 2021/2022 season in certain countries. Outside of the EU, Supemtek is also approved in the U.S. under the tradename Flublok Quadrivalent®.
https://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svg00HollandBIOhttps://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svgHollandBIO2020-11-23 19:01:312020-11-23 19:01:32European Commission approves Supemtek® (quadrivalent recombinant influenza vaccine) for the prevention of influenza in adults aged 18 years and older← #nieuws
Positive high-level results from an interim analysis of clinical trials of AZD1222 in the UK and Brazil showed the vaccine was highly effective in preventing COVID-19, the primary endpoint, and no hospitalisations or severe cases of the disease were reported in participants receiving the vaccine. There were a total of 131 COVID-19 cases in the interim analysis.
One dosing regimen (n=2,741) showed vaccine efficacy of 90% when AZD1222 was given as a half dose, followed by a full dose at least one month apart, and another dosing regimen (n=8,895) showed 62% efficacy when given as two full doses at least one month apart. The combined analysis from both dosing regimens (n=11,636) resulted in an average efficacy of 70%. All results were statistically significant (p<=0.0001). More data will continue to accumulate and additional analysis will be conducted, refining the efficacy reading and establishing the duration of protection.
An independent Data Safety Monitoring Board determined that the analysis met its primary endpoint showing protection from COVID-19 occurring 14 days or more after receiving two doses of the vaccine. No serious safety events related to the vaccine have been confirmed. AZD1222 was well tolerated across both dosing regimens.
AstraZeneca will now immediately prepare regulatory submission of the data to authorities around the world that have a framework in place for conditional or early approval. The Company will seek an Emergency Use Listing from the World Health Organization for an accelerated pathway to vaccine availability in low-income countries. In parallel, the full analysis of the interim results is being submitted for publication in a peer-reviewed journal.
Professor Andrew Pollard, Chief Investigator of the Oxford Vaccine Trial at Oxford, said: “These findings show that we have an effective vaccine that will save many lives. Excitingly, we’ve found that one of our dosing regimens may be around 90% effective and if this dosing regime is used, more people could be vaccinated with planned vaccine supply. Today’s announcement is only possible thanks to the many volunteers in our trial, and the hard working and talented team of researchers based around the world.”
Pascal Soriot, Chief Executive Officer, said: “Today marks an important milestone in our fight against the pandemic. This vaccine’s efficacy and safety confirm that it will be highly effective against COVID-19 and will have an immediate impact on this public health emergency. Furthermore, the vaccine’s simple supply chain and our no-profit pledge and commitment to broad, equitable and timely access means it will be affordable and globally available, supplying hundreds of millions of doses on approval.”
The pooled analysis included data from the COV002 Phase II/III trial in the UK and COV003 Phase III trial in Brazil. Over 23,000 participants are being assessed following two doses of either a half-dose/full-dose regimen or a regimen of two full doses of AZD1222 or a comparator, meningococcal conjugate vaccine called MenACWY or saline. The global trials are evaluating participants aged 18 years or over from diverse racial and geographic groups who are healthy or have stable underlying medical conditions.
Clinical trials are also being conducted in the US, Japan, Russia, South Africa, Kenya and Latin America with planned trials in other European and Asian countries. In total, the Company expects to enrol up to 60,000 participants globally.
The Company is making rapid progress in manufacturing with a capacity of up to 3 billion doses of the vaccine in 2021 on a rolling basis, pending regulatory approval. The vaccine can be stored, transported and handled at normal refrigerated conditions (2-8 degrees Celsius/ 36-46 degrees Fahrenheit) for at least six months and administered within existing healthcare settings.
AstraZeneca continues to engage with governments, multilateral organisations and collaborators around the world to ensure broad and equitable access to the vaccine at no profit for the duration of the pandemic.
Mymetics SA, a subsidiary of Mymetics Corporation (OTCQB: MYMX), a pioneer and leader in the research and development of virosome-based vaccines against life threatening and life disabling diseases, and Insel Gruppe AG, of which the Inselspital, Bern University Hospital, are part of, announced that they have been awarded a grant from the Swiss Innovation Agency (Innosuisse). The grant will allow Mymetics in collaboration with the Department of Pneumology at the Inselspital, Bern University Hospital and the Department of Biomedical Research DBMR of Bern University to start a preclinical study which will investigate Mymetics’ virosome-based Covid-19 nasal vaccine candidate for safety and tolerance, and its capacity to elicit protective respiratory immunity to block nasal infection and virus spreading to the lungs and brain.
https://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svg00HollandBIOhttps://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svgHollandBIO2020-11-23 18:44:352020-11-23 18:44:36Mymetics to advance Preclinical Studies for Virosome-based Covid-19 Vaccine through Innosuisse grant← #nieuws
Pharvaris, a clinical-stage company focused on the discovery and development of novel oral bradykinin-B2-receptor antagonists for the treatment of hereditary angioedema (HAE) and other bradykinin-B2-receptor-mediated indications, announced the close of its oversubscribed $80 million Series C financing bringing its total venture funding to over $160 million to date. Viking Global Investors and General Atlantic co-led the financing, with participation by Cormorant Asset Management. Current investors Foresite Capital, Bain Capital Life Sciences, venBio Partners, and Venrock Healthcare Capital Partners also participated in the round.
“Our team is committed to developing and delivering differentiated products to patients – the oversubscription of our Series C highlights broad enthusiasm for our vision for HAE and beyond,” said Berndt Modig, Chief Executive Officer and co-founder of Pharvaris. “The backing from this prominent group of investors will enable us to develop our pipeline of compounds for the treatment of HAE and other bradykinin-B2-receptor-mediated indications. We expect to complete our Phase 1 assessments in healthy volunteers at the end of the year and anticipate announcing top-line data in 2021.”
The proceeds from the Series C financing will fund the clinical advancement of Pharvaris’ pipeline of novel oral bradykinin-B2-receptor antagonists for the treatment of HAE, including both on-demand treatment and prophylactic prevention. Pharvaris’ first product candidate, PHVS416 (PHA121 in soft capsules), is a potent, orally available bradykinin B2-receptor antagonist designed to block the effects of bradykinin during HAE attacks. Initiation of RAPIDe-1, a multi-center Phase 2 placebo-controlled on-demand study of PHVS416 in HAE patients, is expected in 2021. Pharvaris is also developing an orally available extended-release product containing PHA121 specifically for prophylaxis in HAE patients.
Brett Zbar, M.D., Managing Director and Global Head of General Atlantic’s Life Sciences sector, stated, “As I saw during my previous tenure as a director, Pharvaris has a demonstrated track record of executing against its development strategy for PHA121, underscored by the promising clinical data presented at ACAAI last week. We strongly believe in Pharvaris’ mission and are excited to back Berndt and the team as we put further momentum behind General Atlantic’s Life Sciences strategy.”
https://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svg00HollandBIOhttps://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svgHollandBIO2020-11-23 18:41:012020-11-23 18:41:02Pharvaris Announces $80 Million Series C Financing to Advance Novel Oral Bradykinin-B2-Receptor Antagonists for the Treatment of HAE← #nieuws
Pharming Group N.V. (Euronext Amsterdam: PHARM) maakt bekend dat het zich heeft gecommitteerd tot het bouwen van een nieuwe productiefaciliteit ter uitbreiding van de verwerkingscapaciteit van het hoofdproduct RUCONEST® (recombinant C1-esteraseremmer (rhC1INH)).
De zogeheten downstream-productie omvat de zuivering, filtratie en concentratie van het startmateriaal. De bouw start medio 2021 op het Pivot Park in Oss. Pivot Park is ook de locatie van BioConnection B.V., de fill & finish-partner van Pharming, waarin een minderheidsbelang wordt gehouden.
Op Pivot Park betrekt Pharming een nieuw, duurzaam gebouw van vijf bouwlagen met een totale vloeroppervlakte van circa 4.000 m². Het gebouw is specifiek voor Pharming ontworpen en is prominent gesitueerd op het terrein. Het is het eerste nieuwe gebouw op de campus en CEO Drees hoopt dat er nog veel meer zullen volgen. De komst van Pharming naar Pivot Park zorgt voor tenminste zo’n veertig nieuwe arbeidsplaatsen in Oss.
Sijmen de Vries, Chief Executive Officer van Pharming, zegt: “Met een groeiende vraag naar RUCONEST® voor de behandeling van erfelijk angio-oedeem en een toenemende behoefte aan rhC1INH voor onze klinische onderzoeken bij nieuwe, grote indicaties, blijven we investeren in de uitbreiding van onze interne verwerkingscapaciteit als onderdeel van onze lange-termijn groeistrategie. We kijken uit naar de start van bouw van de nieuwe fabriek medio 2021.”
Brigitte Drees, directeur van Pivot Park, zegt: “Pharming is een aanwinst voor onze campus. Enerzijds omdat het bedrijf een gevestigde naam is in de farmaceutische industrie. Anderzijds omdat het openstaat voor open innovatie en kennisdeling, net als de ruim zestig bedrijven die hier al gevestigd zijn. Reken maar dat Pharming zich in onze community snel thuis zal voelen. Én dat we het bedrijf goed zullen faciliteren in zijn ontwikkeling.”
https://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svg00HollandBIOhttps://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svgHollandBIO2020-11-23 18:38:082020-11-23 18:38:09Pharming gaat nieuwe downstream-productiefaciliteit voor RUCONEST® bouwen op Pivot Park in Oss← #nieuws
Immunicum AB (publ) (IMMU.ST) announced that it has entered into an agreement with Van Herk Investments B.V. to acquire all of the shares in DCprime B.V., a Dutch clinical stage company developing cancer relapse vaccines aimed to reduce tumor recurrence (the “Transaction”). Merging the complementary allogeneic dendritic cell biology approaches of both companies will enable Immunicum to further build and strengthen its position as a leader in cell-based cancer immunotherapies. Payment in the Transaction is effectuated through an issue in kind of 73,909,635 new shares in Immunicum representing 44 percent of the shares in Immunicum on a fully diluted basis. DCprime’s current majority shareholder, Van Herk Investments B.V., a leading European life science investor, will thereby become a significant shareholder of the combined entity. The issuance of the shares is subject to approval by an Extraordinary General Meeting (EGM) to be held on December 18th, 2020.
The main objective of the combination is to establish a unified company built on decades of combined immuno-oncology and cell therapy expertise in the field of allogeneic dendritic cell biology. Moving forward, Immunicum’s scientific focus will continue to be on triggering immune responses against established tumors via intratumoral immune priming and expanded to include the reduction of tumor recurrence via relapse vaccination. To date Immunicum has established clinical proof of concept for its lead program, ilixadencel, which has been tested in a range of solid tumors. DCprime has produced equally encouraging clinical results for blood-borne tumors including interim data from its ongoing Phase II study in Acute Myeloid Leukemia (AML), which will be provided in an oral presentation at the upcoming ASH 2020 conference. Together, the companies will advance a synergistic pipeline spanning both large and orphan indications in solid as well as blood-borne tumors, with two programs in Phase II clinical development and multiple near-term value inflection points as well as a portfolio of preclinical programs and research capabilities to fuel future pipeline expansion. Importantly, the combined process development and manufacturing expertise and specialized in-house research and development facilities will support the shared goal of becoming a leader in the development of cell-based immunotherapies.
The newly combined company will maintain its corporate headquarters in Stockholm, Sweden and consolidate research, process development and future manufacturing efforts at the location in Leiden, the Netherlands. Immunicum’s shares will continue to trade on the Nasdaq Stockholm.
Following the closing of the transaction, Erik Manting, Ph.D., currently CEO of DCprime, will join Immunicum’s leadership team as Chief Business Officer and deputy CEO. Jeroen Rovers, MD, Ph.D., currently Chief Medical Officer at DCprime, will have the role of the Managing Director of DCprime in the combination. Erik Manting brings several years of research experience in immunology as well as 15 years in commercial and management roles in banking. Jeroen Rovers brings 15 years of industry experience in a variety of medical roles, including CMO at Kiadis Pharma.
In addition, Immunicum will call for an EGM in order for the shareholders to resolve upon the proposed elections of Andrea van Elsas, Ph.D. and Dharminder Chahal to the Board of Directors of Immunicum. Andrea van Elsas is currently a venture partner at Third Rock Ventures, and his scientific career includes leading the anti-PD1 program that became leading immunotherapy, pembrolizumab (Keytruda®). Dharminder Chahal is CEO and co-founder of an oncology diagnostics company, SkylineDx, and investment manager to Van Herk. Van Herk is a leading European investor in life science having made a number of successful investments including Zealand Pharma, Ablynx, Crucell and Galapagos. Van Herk is also the largest shareholder in Swedish listed biotech company, BioInvent, where Dharminder Chahal serves as a board member.
By way of the Transaction, Immunicum will acquire all outstanding shares in DCprime. Payment in the Transaction is effectuated through an issue in kind of 73,909,635 new shares in Immunicum to Van Herk. The share purchase agreement has been entered into with Van Herk Investment B.V. and has been adhered to by Van Herk Royalty B.V., which is a company within the Van Herk Group and the current shareholder of the shares in DCprime. Before closing the shares will be transferred to Van Herk Investments B.V. Further, prior to the closing of the Transaction, Van Herk will acquire the minority shareholders’ shares in DCprime and such minority shareholders will consequently partly be paid in cash and partly in Immunicum shares. As a result of the Transaction, Van Herk will be the largest shareholder in Immunicum, holding approximately 43 percent of the total outstanding shares after the Transaction. Customary lock-up provisions covering a period of twelve months have been put in place between Immunicum, Van Herk and DCprime minority shareholders receiving issued shares.
Van Herk Investments, together with Immunicum’s largest shareholder, Fourth Swedish National Pension Fund (AP4), have expressed their support to the new, combined entity. In addition, Van Herk Investments, Immunicum’s largest shareholder following the Transaction, intends to invest up to SEK 82.5 million in the company.
Closing of the Transaction is conditional upon approval of issuance of the shares by the EGM, with a two-thirds majority requirement for the approval of both the votes cast and the shares represented at the EGM,1 approval and publication of the prospectus, and Van Herk’s acquisition of the minority shareholders’ shares in DCprime. The closing of the Transaction is expected to take place at the end of December 2020.
Immunicum’s assessment is that the current funds available for the combined entity will be sufficient to finance operations into the beginning of 2022 based on immediate financial benefit from the companies’ operational synergies. Immunicum will further propose to the EGM the approval of a mandate for the Board of Directors to resolve to issue shares in a directed issue of up to 20 percent of the outstanding shares after the Transaction to facilitate financing activities.
“As announced in the recent corporate and clinical update from September, one of Immunicum’s main goals is to expand the Company’s pipeline with the vision of becoming a leading cell therapy company. As such, joining forces with DCprime, an innovative company with extensive expertise in allogeneic dendritic cell biology, stands as an exciting opportunity with great potential for Immunicum that will build additional value for the Company, our shareholders and future patients,” stated Sven Rohmann, MD, Ph.D., Chief Executive Officer of Immunicum. “Together, we can pursue the treatment of both solid tumor and blood-borne tumors by intratumoral priming as well as systemic boosting using the next-generation of allogeneic, off-the-shelf cell-based therapies. Our teams and our technologies are complementary and would significantly increase the potential of our pipeline and deliver more value-inflection points and potential partnering opportunities.”
“DCprime has established a strong position in cell-based cancer therapy with a Phase II asset in blood-borne tumors. By integrating with the Immunicum team, we look forward to the continued advancement of our unique relapse vaccine approach in parallel to the ongoing clinical progress of Immunicum’s lead candidate, ilixadencel,” stated Erik Manting, Ph.D., Chief Executive Officer of DCprime. “From a corporate perspective, DCprime’s and Immunicum’s lean and focused organizations and excellent teams are the perfect match to drive the development of the combined pipeline products and identify additional novel therapeutic solutions to address unmet medical needs in the field of cancer therapy.”
“This transaction is a transformative milestone for Immunicum as it will bring additional value to the company and enable it to further establish itself as a leader in the development of cell-based immuno-oncology treatments,”said Michael Oredsson, Chairman of the Board at Immunicum. “Together, we will have world class competence with in-house process development and manufacturing expertise and specialized research and development facilitiesas well as strengthened ownership by the addition of Van Herk, a renowned and committed life science investor known for their success stories in Galapagos and Zealand Pharma, BioInvent, Galapagos and successful trade sale exits in Ablynx (Sanofi), Crucell (J&J), among others.”
“The combination of Immunicum and DCprime creates a well-positioned company with a broad pipeline with two programs in the clinical phase as well as several preclinical opportunities,” said Dharminder Chahal, Chairman of the Board at DCprime and representative for Van Herk. “We look forward to supporting Immunicum as the company further advances its innovative immuno-oncology projects.”
https://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svg00HollandBIOhttps://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svgHollandBIO2020-11-23 18:36:132020-11-23 18:36:14Immunicum AB and DCprime Combine Forces to Establish Leader in Cell-Based Cancer Immunotherapies← #nieuws
Catalyze is thrilled to announce that we have been selected once again to receive the prestigious FD Gazelle 2020 award. The FD Gazellen is awarded by Het Financieele Dagblad to companies that meet certain selected criteria, in recognition of their rapid, successful growth. Being elected a FD Gazelle 2020, Catalyze is recognized as one of the fastest growing companies in the Netherlands.
Catalyze is proud to receive this award, as it signifies our increasing capacity to supply our unique blend of services to our academic and business partners in the life sciences, but also in agriculture, food and bioeconomy. At Catalyze we push hard and are fully dedicated to support the latest groundbreaking scientific innovations. With our continued growth, we are able to contribute to the success of an ever-increasing number of impactful projects. For this, we thank all of our fantastic partners, clients and most importantly, our colleagues.
“This is a great recognition for our company. Our client base continues to grow and as Catalyze we continue to expand our service offering and expertise to better serve their needs. I am very thankful to our ambitious team that works hard every day to make a difference. This is a great acknowledgement.” – Theodoor Rutgers, founder and director.
As an organization, we look forward to continuing this exciting journey being at the forefront of our field, where we make a real difference and together, make positive and sustainable impact!
https://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svg00HollandBIOhttps://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svgHollandBIO2020-11-23 18:27:392020-11-23 18:27:40Catalyze to receive FD Gazelle 2020 award
Op naar de arm (deel II): kabinet publiceert Nederlandse COVID-vaccinatiestrategie
Gezondheid op maat, Hollandbio, Gezondheid, UitgelichtLangzaam maar zeker wordt hopen vertrouwen: na de jaarwisseling hebben we misschien wel de beschikking over de eerste coronavaccins. Hoera! Die vaccins moeten vervolgens zo snel mogelijk de juiste arm in. Dat is geen sinecure, dat vergt een nationaal vaccinatieplan, zo merkten we vorige week al op. We waren dan ook blij verrast toen minister De Jonge vrijdagmiddag de Nederlandse COVID-vaccinatiestrategie de ether in slingerde. We legden het plan langs de meetlat: is dit het felbegeerde integrale plan om de giga vaccinatie-uitdaging in goede banen te leiden? Spoiler alert: HollandBIO is er nog niet helemaal gerust op.
In zijn COVID-vaccinatiestrategie pleit het kabinet voor een wendbare Nederlandse aanpak en strategie. Er zijn, in samenwerking met verschillende partijen, meerdere scenario’s in voorbereiding. Check tot zover. Het kabinet wil waar mogelijk gebruik maken van bestaande structuren, én via kleinschalige distributie prioritaire groepen voorzien van een vaccin. Dat klinkt in eerste instantie handig en veilig. Maar is het wel realistisch? Een pandemie en bestaande structuren staan op gespannen voet, leerden we van het contactonderzoek, het inkoop-, en het testbeleid. Maar corona en kleinschalig, dat is helemaal een contradictio in terminis.
Reken maar even met ons mee. De door de Gezondheidsraad aangewezen prioritaire doelgroep bestaat in totaal uit maar liefst 6,5 miljoen mensen, die, afhankelijk van welke vaccins als eerste beschikbaar zijn, waarschijnlijk tweemaal een prik moeten krijgen. Dat maakt 13 miljoen vaccinaties.Ter vergelijking, in 2019 ontvingen zo’n 3,1 miljoen mensen uit diezelfde doelgroep de griepvaccinatie. Dat is één prik, met één vaccin, en ook dat is elk jaar weer een fikse opgave. Het getal 13 miljoen zou dus al voldoende moeten zijn om deze deelvaccinatiecampagne als grootschalig te bestempelen. Tel daar een paar pandemie-eigen complicerende factoren bij op. Het moet namelijk wel een beetje snel, want we willen liever vandaag dan morgen terug naar normaal of op z’n minst normaler. Met het oog op de schaarste, komen de vaccins daarbij zeker het eerste jaar van verschillende leveranciers, in verschillendedeelleveringen van verschillende omvang. Die vaccins hebben een verschillend, nog onbekend, profiel voor verschillende (deel)doelgroepen, en moeten, al dan niet via distributiecentra, vervoerd worden naar uiteenlopende (zorg)locaties, onder verschillende condities. Dat levert al met al een duizelingwekkend logistiek plaatje op, met een schier oneindig aantal mogelijke scenario’s, combinaties en leveringen. En last but not least, één persoon moet hetzelfde vaccin twee keer krijgen, en mogelijke bijwerkingen en liefst effectiviteit moeten nauwgezet geregistreerd worden. Ga er maar aan staan, kleinschalig binnen je reguliere structuren, naast je reguliere takenpakket.
We geven toe, het is onrealistisch om te verwachten dat de vaccinatiestrategie pasklaar zou zijn. We begrijpen dat cruciale gegevens – en de vaccins zelf – nog ontbreken, wat maakt dat we varen in dichte mist. Maar inzetten op kleinschalig en regulier is dat zeer zeker ook. Hoeveel en welke menskracht, hoeveel en welke middelen en hoeveel en welke distributiecentra maakt het kabinet vrij om dit huzarenstuk in goede banen te leiden? En hoe? De vaccinatiestrategie licht een tipje van de sluier op hoe het kabinet in de wedstrijd zit, maar veel van onze vragen blijven vooralsnog onbeantwoord.
Met een kleine steek van jaloezie kijken we naar de plannen van Duitsland, waar centraal aangestuurde distributiecentra worden klaargestoomd, benodigdheden worden ingekocht en mobiele teams worden ingesteld om de vaccinaties naar de arm van bestemming te begeleiden. Om pas later, als er vaccins in overvloed zijn en de coronavaccinatie daadwerkelijk business as usual is, ingebed te worden in de reguliere – zo je wil kleinschalige – infrastructuur. Deutsche Gründlichkeit, kortom.
CureVac and WACKER Sign Manufacturing Contract forCureVac’s COVID-19 Vaccine Candidate:CVnCoV
InnovatieklimaatCureVac N.V. (Nasdaq: CVAC), a biopharmaceutical company developing a new class of transformative medicines based onmessenger ribonucleic acid (mRNA), and Wacker Chemie AG announced today that they had signed a contract for the manufacturing of CureVac’s COVID-19 vaccine candidate CVnCoV. Under the terms of the initial agreement, WACKER will ramp up GMP (Good Manufacturing Practice) production of the mRNA drug substance for CVnCoV at its biotech site in Amsterdam in the first half of 2021.Preparationsfor the start of production, technology transfers and test runs are already underway.It is planned to produce more than 100 million doses of the CureVac vaccine per year at WACKER’sAmsterdam site.There is also further potential for expansion at the site in order to meet rising demand in the future.
WACKER’s CEO Rudolf Staudigl said: “We are proud and highly motivated to make a contribution to the fight against the spread of the coronavirus pandemic together with CureVac.” As a CDMO (Contract Development and Manufacturing Organization), Wacker Biotech bundles WACKER Group’s biopharmaceutical activities. Its Amsterdam site has been producing vaccines for clinical development and commercial supply for 20 years. The portfolio ranges from conventionallive and killed vaccines to protein-based, polysaccharide and glycoconjugate vaccines. In recent months, WACKER has invested in the site to extend production to includemRNA-based vaccines. This new classof vaccines expands the broad vaccine portfolio Wacker Biotech offers to its customers.
Dr. Florian von der Mülbe, Chief Production Officer of CureVac, added:“With WACKER, we have found a committed and highly experienced partner for the production of our vaccine candidate in the Netherlands.”CureVac is building an integrated European vaccine manufacturing network with several CDMO partners. With this strategy, the company will significantly increase the manufacturing capacity already existing within CureVac for CVnCoV up to several hundred million doses per year and will manage potential supply chain risks by working with several partners for each of the key manufacturing process steps.
Source: Wacker (Press release)
Alnylam Receives Approval for OXLUMO™ (lumasiran) in the European Union for the Treatment of Primary Hyperoxaluria Type 1 in All Age Groups
GezondheidAlnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced that the European Commission (EC) has granted marketing authorization for OXLUMO™ (lumasiran), an RNAi therapeutic, for the treatment of primary hyperoxaluria type 1 (PH1) in all age groups.
PH1 is an ultra-rare orphan disease characterized by excessive oxalate production, which can lead to life threatening end-stage renal disease (ESRD) and other systemic complications. Heterogeneity in disease manifestation often contributes to delays in diagnosis – particularly in adult PH1 patients, with a median time from symptoms onset to diagnosis of approximately six years. Untreated PH1 leads to progressive kidney damage; patients with advanced kidney disease require intensive dialysis to help filter waste products, including oxalate, from their blood until they are able and eligible to receive a dual or sequential liver/kidney transplant, an invasive procedure associated with a high risk of morbidity and mortality, and life-long immunosuppression.
“Prior to now there have been no approved treatment options for PH1 in Europe, so this is a potentially life-changing milestone for people diagnosed with this ultra-rare, debilitating disease – many of whom are infants and children – and their families. Lumasiran will address the urgent unmet need that exists for patients with PH1 and its approval today marks our continued commitment to rare disease communities,” said John Maraganore, Ph.D., Chief Executive Officer, Alnylam Pharmaceuticals. “Alnylam has taken lumasiran from identification of compound to regulatory approval in just six years and we will progress with the same sense of urgency as we work with national reimbursement bodies across Europe to bring lumasiran to patients.”
Lumasiran is an RNAi therapeutic targeting the hydroxyacid oxidase 1 (HAO1) mRNA that encodes glycolate oxidase (GO) – an enzyme upstream of the disease-causing defect in PH1. By degrading the HAO1mRNA and reducing the synthesis of GO, lumasiran stops the production of oxalate – the toxic metabolite that directly contributes to the clinical manifestations of PH1.
“PH1 affects patients of all ages. It is particularly devastating when infants are born with the condition and develop kidney failure within the first few months of life. PH1 patients develop kidney stones from the overproduction of oxalate, and in many we see a progressive decline in kidney function, which can ultimately lead to life-threatening end-stage kidney disease. Until recently the only treatment options available have been combined liver and kidney transplantation, with vitamin B6 slowing down kidney failure in a limited number of sensitive patients,” said Sally-Anne Hulton, M.D., Consultant Paediatric Nephrologist, Birmingham Women’s and Children’s Hospital NHS Trust, UK. “For the first time, lumasiran provides those of us treating PH1 children and adults with a new therapeutic option to tackle the root cause of this disease and prevent the production of oxalate. The data show meaningful and sustained reductions in urinary and plasma oxalate with an encouraging safety and tolerability profile, providing us with hope for improving care for these patients.”
“In line with our Patient Access Philosophy, Alnylam is committed to being as innovative commercially as we have been scientifically,” said Brendan Martin, Acting Head of CEMEA, Alnylam. “While the ability to enter into innovative agreements varies by country and local regulations, we intend to work with health authorities across Europe to achieve responsible and sustainable access arrangements for lumasiran that address the diverse patient population affected by PH1, which ranges from infants to adults, and we will adapt to the local context. Our goal is to ensure that all patients in need have access to lumasiran while minimizing budget uncertainty for health services.”
The approval in the European Union is based on efficacy and safety findings from both the ILLUMINATE-A and ILLUMINATE-B Phase 3 studies of lumasiran. In the ILLUMINATE-A study conducted in adults and children six years or older, lumasiran achieved the primary endpoint with a 53 percent mean reduction in urinary oxalate relative to placebo and showed a 65 percent mean reduction in urinary oxalate relative to baseline. Eighty-four percent of patients achieved normal1 or near-normal2 levels of urinary oxalate and more than half of patients (52 percent) reached normalization, compared to zero percent in the placebo group. Findings from the ILLUMINATE-A pivotal study were presented in June 2020 at the virtual European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) International Congress. In the ILLUMINATE-B Phase 3 study, the efficacy results and safety profile of lumasiran in infants and children under the age of six years were found to be similar to those observed in ILLUMINATE-A. Results from the ILLUMINATE-B pediatric study were presented on October 22 at the virtual American Society of Nephrology (ASN) Annual Congress.
Lumasiran was granted Priority Medicines (PRIME) designation by the EMA as well as Orphan Designation in the European Union. Lumasiran was also granted an Accelerated Assessment by the EMA, which is awarded to medicines deemed to be of major public health interest and therapeutic innovation and is designed to bring new treatments to patients more quickly. This approval in the European Union follows the positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in October 2020. Alnylam has filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA). The FDA has granted a Priority Review for the NDA and has set an action date of December 3, 2020 under the Prescription Drug User Fee Act (PDUFA).
Source: Alnylam (Press release)
European Commission approves Supemtek® (quadrivalent recombinant influenza vaccine) for the prevention of influenza in adults aged 18 years and older
GezondheidThe European Commission has granted a marketing authorization for Supemtek®, a quadrivalent (four-strain) recombinant influenza vaccine, for the prevention of influenza in adults aged 18 years and older. Supemtek is the first and only recombinant influenza vaccine now approved in the European Union.
Supemtek is produced using recombinant technology, which allows an exact match to the key component of the influenza strains recommended by the World Health Organization, avoiding the risk of viral mutations. Supemtek also contains three times more antigen than both egg-based and cell-based standard-dose vaccines. This increased amount of antigen and the use of recombinant technology provide improved protection against influenza, particularly in those aged 50 and older. In comparison with a standard-dose egg-based quadrivalent influenza vaccine, Supemtek reduced the risk of influenza by an additional 30% for adults aged 50 years and older1,2.
The authorization is based on clinical data demonstrating safety, immunogenicity and efficacy of Supemtek in two Phase 3 randomized controlled trials1,2 involving more than 10,000 patients in total. Specifically, the relative efficacy of Supemtek was demonstrated in a Phase 3 multicenter (40 outpatient centers in the US, involving more than 9,000 adults), randomized controlled efficacy trial1,2.
“In the context of the COVID-19 pandemic, preventing influenza remains a public health priority,” said Thomas Triomphe, Head of Sanofi Pasteur. “Today’s approval of Supemtek supports our strong commitment in advancing influenza vaccine technology. With Supemtek, we provide European health authorities with an additional innovative solution that has demonstrated increased ability to prevent influenza and its potentially severe complications, as well as the burden this causes on healthcare systems.”
Each year, influenza-associated deaths range from 290,000 to 650,0003,4 globally, and the burden on hospitals is around 10 million of influenza-related hospitalizations5. Recent data also show that influenza can multiply the risk of heart attack by up to 10 times, and the risk of stroke by up to 8 times, in the week after influenza infection6 – demonstrating that the burden of influenza goes beyond its well-known respiratory complications.
The first European launches are expected for the 2022/2023 influenza season, with a possibility of accelerating the availability of doses as early as the 2021/2022 season in certain countries. Outside of the EU, Supemtek is also approved in the U.S. under the tradename Flublok Quadrivalent®.
Source: Sanofi (Press release)
AZD1222 vaccine met primary efficacy endpoint in preventing COVID-19
GezondheidPositive high-level results from an interim analysis of clinical trials of AZD1222 in the UK and Brazil showed the vaccine was highly effective in preventing COVID-19, the primary endpoint, and no hospitalisations or severe cases of the disease were reported in participants receiving the vaccine. There were a total of 131 COVID-19 cases in the interim analysis.
One dosing regimen (n=2,741) showed vaccine efficacy of 90% when AZD1222 was given as a half dose, followed by a full dose at least one month apart, and another dosing regimen (n=8,895) showed 62% efficacy when given as two full doses at least one month apart. The combined analysis from both dosing regimens (n=11,636) resulted in an average efficacy of 70%. All results were statistically significant (p<=0.0001). More data will continue to accumulate and additional analysis will be conducted, refining the efficacy reading and establishing the duration of protection.
An independent Data Safety Monitoring Board determined that the analysis met its primary endpoint showing protection from COVID-19 occurring 14 days or more after receiving two doses of the vaccine. No serious safety events related to the vaccine have been confirmed. AZD1222 was well tolerated across both dosing regimens.
AstraZeneca will now immediately prepare regulatory submission of the data to authorities around the world that have a framework in place for conditional or early approval. The Company will seek an Emergency Use Listing from the World Health Organization for an accelerated pathway to vaccine availability in low-income countries. In parallel, the full analysis of the interim results is being submitted for publication in a peer-reviewed journal.
Professor Andrew Pollard, Chief Investigator of the Oxford Vaccine Trial at Oxford, said: “These findings show that we have an effective vaccine that will save many lives. Excitingly, we’ve found that one of our dosing regimens may be around 90% effective and if this dosing regime is used, more people could be vaccinated with planned vaccine supply. Today’s announcement is only possible thanks to the many volunteers in our trial, and the hard working and talented team of researchers based around the world.”
Pascal Soriot, Chief Executive Officer, said: “Today marks an important milestone in our fight against the pandemic. This vaccine’s efficacy and safety confirm that it will be highly effective against COVID-19 and will have an immediate impact on this public health emergency. Furthermore, the vaccine’s simple supply chain and our no-profit pledge and commitment to broad, equitable and timely access means it will be affordable and globally available, supplying hundreds of millions of doses on approval.”
The pooled analysis included data from the COV002 Phase II/III trial in the UK and COV003 Phase III trial in Brazil. Over 23,000 participants are being assessed following two doses of either a half-dose/full-dose regimen or a regimen of two full doses of AZD1222 or a comparator, meningococcal conjugate vaccine called MenACWY or saline. The global trials are evaluating participants aged 18 years or over from diverse racial and geographic groups who are healthy or have stable underlying medical conditions.
Clinical trials are also being conducted in the US, Japan, Russia, South Africa, Kenya and Latin America with planned trials in other European and Asian countries. In total, the Company expects to enrol up to 60,000 participants globally.
The Company is making rapid progress in manufacturing with a capacity of up to 3 billion doses of the vaccine in 2021 on a rolling basis, pending regulatory approval. The vaccine can be stored, transported and handled at normal refrigerated conditions (2-8 degrees Celsius/ 36-46 degrees Fahrenheit) for at least six months and administered within existing healthcare settings.
AstraZeneca continues to engage with governments, multilateral organisations and collaborators around the world to ensure broad and equitable access to the vaccine at no profit for the duration of the pandemic.
Source: AstraZeneca (Press release)
Mymetics to advance Preclinical Studies for Virosome-based Covid-19 Vaccine through Innosuisse grant
GezondheidMymetics SA, a subsidiary of Mymetics Corporation (OTCQB: MYMX), a pioneer and leader in the research and development of virosome-based vaccines against life threatening and life disabling diseases, and Insel Gruppe AG, of which the Inselspital, Bern University Hospital, are part of, announced that they have been awarded a grant from the Swiss Innovation Agency (Innosuisse). The grant will allow Mymetics in collaboration with the Department of Pneumology at the Inselspital, Bern University Hospital and the Department of Biomedical Research DBMR of Bern University to start a preclinical study which will investigate Mymetics’ virosome-based Covid-19 nasal vaccine candidate for safety and tolerance, and its capacity to elicit protective respiratory immunity to block nasal infection and virus spreading to the lungs and brain.
Source: Mymetics (Press release)
Pharvaris Announces $80 Million Series C Financing to Advance Novel Oral Bradykinin-B2-Receptor Antagonists for the Treatment of HAE
InnovatieklimaatPharvaris, a clinical-stage company focused on the discovery and development of novel oral bradykinin-B2-receptor antagonists for the treatment of hereditary angioedema (HAE) and other bradykinin-B2-receptor-mediated indications, announced the close of its oversubscribed $80 million Series C financing bringing its total venture funding to over $160 million to date. Viking Global Investors and General Atlantic co-led the financing, with participation by Cormorant Asset Management. Current investors Foresite Capital, Bain Capital Life Sciences, venBio Partners, and Venrock Healthcare Capital Partners also participated in the round.
“Our team is committed to developing and delivering differentiated products to patients – the oversubscription of our Series C highlights broad enthusiasm for our vision for HAE and beyond,” said Berndt Modig, Chief Executive Officer and co-founder of Pharvaris. “The backing from this prominent group of investors will enable us to develop our pipeline of compounds for the treatment of HAE and other bradykinin-B2-receptor-mediated indications. We expect to complete our Phase 1 assessments in healthy volunteers at the end of the year and anticipate announcing top-line data in 2021.”
The proceeds from the Series C financing will fund the clinical advancement of Pharvaris’ pipeline of novel oral bradykinin-B2-receptor antagonists for the treatment of HAE, including both on-demand treatment and prophylactic prevention. Pharvaris’ first product candidate, PHVS416 (PHA121 in soft capsules), is a potent, orally available bradykinin B2-receptor antagonist designed to block the effects of bradykinin during HAE attacks. Initiation of RAPIDe-1, a multi-center Phase 2 placebo-controlled on-demand study of PHVS416 in HAE patients, is expected in 2021. Pharvaris is also developing an orally available extended-release product containing PHA121 specifically for prophylaxis in HAE patients.
Brett Zbar, M.D., Managing Director and Global Head of General Atlantic’s Life Sciences sector, stated, “As I saw during my previous tenure as a director, Pharvaris has a demonstrated track record of executing against its development strategy for PHA121, underscored by the promising clinical data presented at ACAAI last week. We strongly believe in Pharvaris’ mission and are excited to back Berndt and the team as we put further momentum behind General Atlantic’s Life Sciences strategy.”
Source: Pharvaris & LSP
Pharming gaat nieuwe downstream-productiefaciliteit voor RUCONEST® bouwen op Pivot Park in Oss
InnovatieklimaatPharming Group N.V. (Euronext Amsterdam: PHARM) maakt bekend dat het zich heeft gecommitteerd tot het bouwen van een nieuwe productiefaciliteit ter uitbreiding van de verwerkingscapaciteit van het hoofdproduct RUCONEST® (recombinant C1-esteraseremmer (rhC1INH)).
De zogeheten downstream-productie omvat de zuivering, filtratie en concentratie van het startmateriaal. De bouw start medio 2021 op het Pivot Park in Oss. Pivot Park is ook de locatie van BioConnection B.V., de fill & finish-partner van Pharming, waarin een minderheidsbelang wordt gehouden.
Op Pivot Park betrekt Pharming een nieuw, duurzaam gebouw van vijf bouwlagen met een totale vloeroppervlakte van circa 4.000 m². Het gebouw is specifiek voor Pharming ontworpen en is prominent gesitueerd op het terrein. Het is het eerste nieuwe gebouw op de campus en CEO Drees hoopt dat er nog veel meer zullen volgen. De komst van Pharming naar Pivot Park zorgt voor tenminste zo’n veertig nieuwe arbeidsplaatsen in Oss.
Sijmen de Vries, Chief Executive Officer van Pharming, zegt: “Met een groeiende vraag naar RUCONEST® voor de behandeling van erfelijk angio-oedeem en een toenemende behoefte aan rhC1INH voor onze klinische onderzoeken bij nieuwe, grote indicaties, blijven we investeren in de uitbreiding van onze interne verwerkingscapaciteit als onderdeel van onze lange-termijn groeistrategie. We kijken uit naar de start van bouw van de nieuwe fabriek medio 2021.”
Brigitte Drees, directeur van Pivot Park, zegt: “Pharming is een aanwinst voor onze campus. Enerzijds omdat het bedrijf een gevestigde naam is in de farmaceutische industrie. Anderzijds omdat het openstaat voor open innovatie en kennisdeling, net als de ruim zestig bedrijven die hier al gevestigd zijn. Reken maar dat Pharming zich in onze community snel thuis zal voelen. Én dat we het bedrijf goed zullen faciliteren in zijn ontwikkeling.”
Source: Pharming Group & Pivot Park
Read more: Brabants Dagblad
Immunicum AB and DCprime Combine Forces to Establish Leader in Cell-Based Cancer Immunotherapies
InnovatieklimaatImmunicum AB (publ) (IMMU.ST) announced that it has entered into an agreement with Van Herk Investments B.V. to acquire all of the shares in DCprime B.V., a Dutch clinical stage company developing cancer relapse vaccines aimed to reduce tumor recurrence (the “Transaction”). Merging the complementary allogeneic dendritic cell biology approaches of both companies will enable Immunicum to further build and strengthen its position as a leader in cell-based cancer immunotherapies. Payment in the Transaction is effectuated through an issue in kind of 73,909,635 new shares in Immunicum representing 44 percent of the shares in Immunicum on a fully diluted basis. DCprime’s current majority shareholder, Van Herk Investments B.V., a leading European life science investor, will thereby become a significant shareholder of the combined entity. The issuance of the shares is subject to approval by an Extraordinary General Meeting (EGM) to be held on December 18th, 2020.
The main objective of the combination is to establish a unified company built on decades of combined immuno-oncology and cell therapy expertise in the field of allogeneic dendritic cell biology. Moving forward, Immunicum’s scientific focus will continue to be on triggering immune responses against established tumors via intratumoral immune priming and expanded to include the reduction of tumor recurrence via relapse vaccination. To date Immunicum has established clinical proof of concept for its lead program, ilixadencel, which has been tested in a range of solid tumors. DCprime has produced equally encouraging clinical results for blood-borne tumors including interim data from its ongoing Phase II study in Acute Myeloid Leukemia (AML), which will be provided in an oral presentation at the upcoming ASH 2020 conference. Together, the companies will advance a synergistic pipeline spanning both large and orphan indications in solid as well as blood-borne tumors, with two programs in Phase II clinical development and multiple near-term value inflection points as well as a portfolio of preclinical programs and research capabilities to fuel future pipeline expansion. Importantly, the combined process development and manufacturing expertise and specialized in-house research and development facilities will support the shared goal of becoming a leader in the development of cell-based immunotherapies.
The newly combined company will maintain its corporate headquarters in Stockholm, Sweden and consolidate research, process development and future manufacturing efforts at the location in Leiden, the Netherlands. Immunicum’s shares will continue to trade on the Nasdaq Stockholm.
Following the closing of the transaction, Erik Manting, Ph.D., currently CEO of DCprime, will join Immunicum’s leadership team as Chief Business Officer and deputy CEO. Jeroen Rovers, MD, Ph.D., currently Chief Medical Officer at DCprime, will have the role of the Managing Director of DCprime in the combination. Erik Manting brings several years of research experience in immunology as well as 15 years in commercial and management roles in banking. Jeroen Rovers brings 15 years of industry experience in a variety of medical roles, including CMO at Kiadis Pharma.
In addition, Immunicum will call for an EGM in order for the shareholders to resolve upon the proposed elections of Andrea van Elsas, Ph.D. and Dharminder Chahal to the Board of Directors of Immunicum. Andrea van Elsas is currently a venture partner at Third Rock Ventures, and his scientific career includes leading the anti-PD1 program that became leading immunotherapy, pembrolizumab (Keytruda®). Dharminder Chahal is CEO and co-founder of an oncology diagnostics company, SkylineDx, and investment manager to Van Herk. Van Herk is a leading European investor in life science having made a number of successful investments including Zealand Pharma, Ablynx, Crucell and Galapagos. Van Herk is also the largest shareholder in Swedish listed biotech company, BioInvent, where Dharminder Chahal serves as a board member.
By way of the Transaction, Immunicum will acquire all outstanding shares in DCprime. Payment in the Transaction is effectuated through an issue in kind of 73,909,635 new shares in Immunicum to Van Herk. The share purchase agreement has been entered into with Van Herk Investment B.V. and has been adhered to by Van Herk Royalty B.V., which is a company within the Van Herk Group and the current shareholder of the shares in DCprime. Before closing the shares will be transferred to Van Herk Investments B.V. Further, prior to the closing of the Transaction, Van Herk will acquire the minority shareholders’ shares in DCprime and such minority shareholders will consequently partly be paid in cash and partly in Immunicum shares. As a result of the Transaction, Van Herk will be the largest shareholder in Immunicum, holding approximately 43 percent of the total outstanding shares after the Transaction. Customary lock-up provisions covering a period of twelve months have been put in place between Immunicum, Van Herk and DCprime minority shareholders receiving issued shares.
Van Herk Investments, together with Immunicum’s largest shareholder, Fourth Swedish National Pension Fund (AP4), have expressed their support to the new, combined entity. In addition, Van Herk Investments, Immunicum’s largest shareholder following the Transaction, intends to invest up to SEK 82.5 million in the company.
Closing of the Transaction is conditional upon approval of issuance of the shares by the EGM, with a two-thirds majority requirement for the approval of both the votes cast and the shares represented at the EGM,1 approval and publication of the prospectus, and Van Herk’s acquisition of the minority shareholders’ shares in DCprime. The closing of the Transaction is expected to take place at the end of December 2020.
Immunicum’s assessment is that the current funds available for the combined entity will be sufficient to finance operations into the beginning of 2022 based on immediate financial benefit from the companies’ operational synergies. Immunicum will further propose to the EGM the approval of a mandate for the Board of Directors to resolve to issue shares in a directed issue of up to 20 percent of the outstanding shares after the Transaction to facilitate financing activities.
“As announced in the recent corporate and clinical update from September, one of Immunicum’s main goals is to expand the Company’s pipeline with the vision of becoming a leading cell therapy company. As such, joining forces with DCprime, an innovative company with extensive expertise in allogeneic dendritic cell biology, stands as an exciting opportunity with great potential for Immunicum that will build additional value for the Company, our shareholders and future patients,” stated Sven Rohmann, MD, Ph.D., Chief Executive Officer of Immunicum. “Together, we can pursue the treatment of both solid tumor and blood-borne tumors by intratumoral priming as well as systemic boosting using the next-generation of allogeneic, off-the-shelf cell-based therapies. Our teams and our technologies are complementary and would significantly increase the potential of our pipeline and deliver more value-inflection points and potential partnering opportunities.”
“DCprime has established a strong position in cell-based cancer therapy with a Phase II asset in blood-borne tumors. By integrating with the Immunicum team, we look forward to the continued advancement of our unique relapse vaccine approach in parallel to the ongoing clinical progress of Immunicum’s lead candidate, ilixadencel,” stated Erik Manting, Ph.D., Chief Executive Officer of DCprime. “From a corporate perspective, DCprime’s and Immunicum’s lean and focused organizations and excellent teams are the perfect match to drive the development of the combined pipeline products and identify additional novel therapeutic solutions to address unmet medical needs in the field of cancer therapy.”
“This transaction is a transformative milestone for Immunicum as it will bring additional value to the company and enable it to further establish itself as a leader in the development of cell-based immuno-oncology treatments,” said Michael Oredsson, Chairman of the Board at Immunicum. “Together, we will have world class competence with in-house process development and manufacturing expertise and specialized research and development facilities as well as strengthened ownership by the addition of Van Herk, a renowned and committed life science investor known for their success stories in Galapagos and Zealand Pharma, BioInvent, Galapagos and successful trade sale exits in Ablynx (Sanofi), Crucell (J&J), among others.”
“The combination of Immunicum and DCprime creates a well-positioned company with a broad pipeline with two programs in the clinical phase as well as several preclinical opportunities,” said Dharminder Chahal, Chairman of the Board at DCprime and representative for Van Herk. “We look forward to supporting Immunicum as the company further advances its innovative immuno-oncology projects.”
Source: Immunicum (Press release)
Catalyze to receive FD Gazelle 2020 award
InnovatieklimaatCatalyze is thrilled to announce that we have been selected once again to receive the prestigious FD Gazelle 2020 award. The FD Gazellen is awarded by Het Financieele Dagblad to companies that meet certain selected criteria, in recognition of their rapid, successful growth. Being elected a FD Gazelle 2020, Catalyze is recognized as one of the fastest growing companies in the Netherlands.
Catalyze is proud to receive this award, as it signifies our increasing capacity to supply our unique blend of services to our academic and business partners in the life sciences, but also in agriculture, food and bioeconomy. At Catalyze we push hard and are fully dedicated to support the latest groundbreaking scientific innovations. With our continued growth, we are able to contribute to the success of an ever-increasing number of impactful projects. For this, we thank all of our fantastic partners, clients and most importantly, our colleagues.
“This is a great recognition for our company. Our client base continues to grow and as Catalyze we continue to expand our service offering and expertise to better serve their needs. I am very thankful to our ambitious team that works hard every day to make a difference. This is a great acknowledgement.” – Theodoor Rutgers, founder and director.
As an organization, we look forward to continuing this exciting journey being at the forefront of our field, where we make a real difference and together, make positive and sustainable impact!
Source: Catalyze (Press release)