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CEPI launches COVAX Marketplace to match buyers and sellers of critical manufacturing supplies and speed up global access to COVID-19 vaccines through COVAX

The Coalition for Epidemic Preparedness Innovations (CEPI) and COVAX partners are launching an innovative ‘marketplace’ to accelerate the global production of COVID-19 vaccine doses for COVAX by matching suppliers of critical inputs with vaccine manufacturers who urgently need them to produce vaccines for fair and equitable distribution through COVAX. This initiative is a key deliverable of the COVAX Manufacturing Task Force, which is co-led by COVAX and industry partners [1].

In the past year unprecedented efforts by vaccine manufacturers and suppliers of vaccine components have aimed to triple previous annual vaccine output, scaling up to produce an estimated 11 billion doses of COVID-19 vaccine by the end of 2021 [2,3]. As a result of this historic scaling up, bottlenecks are affecting the global supply chain leading to acute shortages of vital supplies which are preventing COVID-19 vaccine manufacturers from operating at full capacity. This is delaying vaccine production and contributing to inequity.

The new COVAX Marketplace announced today is designed to address short-term bottlenecks by facilitating access to supplies needed to produce COVID-19 vaccines intended for distribution through COVAX. It will provide a secure platform for vaccine manufacturers and suppliers of critical inputs to confidentially indicate their needs or available supplies to CEPI, in its role as facilitator. CEPI will identify matching offers and requests and connect potential matches, prioritising based on objective criteria including whether the manufacturer has a COVAX advance purchase agreement and WHO EUL in place, as well as dose volumes and delivery timings. Future versions of the Marketplace may include supplies required to manufacture other lifesaving therapies and vaccines which are also being affected by current global supply shortages.

The Marketplace is expected to improve the free flow of critical COVID-19 vaccine supplies by:

Providing suppliers with a platform to allocate and reallocate unused materials.

Mobilizing idle stock from vaccines and candidates that fail prior to gaining regulatory approval – as well as from those that might scale down their production in the future.

Mobilizing potential surplus stock from manufacturers with non-vaccine activities.

Vaccine manufacturing processes are highly complex and expanding manufacturing capacity requires managing intricate cross-border supply chains frequently involving more than 100 components. Participants will be able to offer and request any materials required for vaccine production through the COVAX Marketplace, but it will initially focus on six categories of supplies which have been identified as critical: bioreactor bags, single use assemblies, cell culture media, filters, lipids, vials and stoppers.

Towards a scalable Marketplace platform

The COVAX Marketplace launching today is an initial version which aims to respond quickly to immediate market needs and bottlenecks. It will launch with approximately 10 – 15 participants, comprising COVAX vaccine manufacturers and suppliers of the key materials which have been identified as being most urgently needed. In parallel, in consultation with stakeholders CEPI is urgently exploring extending the Marketplace to include additional participants such as vaccine manufacturers with unused inputs – including those with failed products – Contract Development and Manufacturing Organizations (CDMOs), and pharmaceutical companies not currently involved in COVID-19 vaccine production. This would provide a platform to resolve supply bottlenecks which could extend beyond COVID-19 vaccines to other lifesaving therapies and vaccines which are being impacted by the current supply situation.

Prospective participants in the Marketplace are encouraged to visit the COVAX Marketplace webpage and submit an expression of interest at marketplace@cepi.net.

Dr Richard Hatchett, CEPI CEO, said: “Vaccine manufacturers have described the ways in which shortages of critical supplies have limited the speed and scale at which vaccines can be produced, which means many vaccine production lines haven’t been operating at full capacity. Optimizing the use of scarce resources that may otherwise be sitting idle – by matching buyers and sellers around the globe – could contribute to improving the global supply of vaccines through COVAX. The pandemic has led to extraordinary innovation in vaccine development and production, and the COVAX Marketplace is an example of how we must continue to look beyond business as usual to find pragmatic solutions to fixable problems – such as supply chain bottlenecks – so that we can urgently unlock more COVID-19 vaccine doses for COVAX.”

Thomas Cueni, Director General of the International Federation of Pharmaceutical Manufacturers (IFPMA), said: “Today, over 3 billion doses of effective and safe vaccines have been made and administered. But to vaccinate the world’s adult population by the end of the year, we must achieve the estimated production of 11 billion doses of COVID-19 vaccines. To do this, it is essential to optimize production, as well urgently increase dose sharing and remove trade barriers. A delay in the delivery of a bioreactor plastic bag can halt a whole production line and delay a batch of thousands of litres for weeks, if not months. To alert the international community to the challenges associated with this historic scaling up of vaccine production, in March 2021 we joined the Chatham House Summit on COVID-19 Vaccine Manufacturing Supply Chain. One of the recommendations, strongly endorsed by industrialised, developing world vaccine manufacturers and biotech companies, was to find a practical solution to removing the inevitable bottlenecks for raw materials and components. We are delighted to have been able to contribute to the creation of this platform to facilitate matching supplies with buyers, thereby ensuring manufacturing supplies for COVID-19 vaccines. Speed is of the essence to achieve vaccine equity. This marketplace will hopefully make an important contribution towards the global endeavour of achieving the 11 billion doses target this year.”

Sai Prasad, President of Developing Country Vaccine Manufacturers’ Network, said: “Within a year and a half into this pandemic we now have several safe and effective vaccines with demonstrated evidence in real world settings. Industry from both developing and developed world have shown leadership in product development and large-scale manufacturing, resulting in more than 3 billion doses manufactured. While this is a successful outcome for most infectious diseases, it is clearly not enough to address the global public health crisis caused by this pandemic. We now need to scale up at a rapid speed to reach a production capacity of more than 10 billion doses annually. With the complexities involved with vaccine manufacturing requiring specialized human resources, facilities, raw materials, consumables etc, we need to enable the entire supply and distribution chain to rise up to this challenge.  The COVAX Marketplace will enable partnerships focused on removing bottlenecks, increasing capacities and attaining our goal of vaccinating the world.”

Kevin D. Ott, Executive Director of Bio-Process Systems Alliance (BPSA), said: “BPSA’s 64 Members applaud CEPI and its partners for launching the COVAX Marketplace. It’s been said that ‘rocky roads lead to beautiful places’: the Marketplace is an exceptional and timely effort to match marketplace needs with available supplies, helping to smooth that road to global immunization with the tools and technologies needed to make the world safe again.”

[1] The COVAX Manufacturing Taskforce is spearheaded by the co-leads of COVAX – CEPI, Gavi, UNICEF and WHO – working in partnership with the Bill & Melinda Gates Foundation, and organizations representing vaccine manufacturers: International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), Developing Countries Vaccine Manufacturers’ Network (DCVMN), and Biotechnology Innovation Organization (BIO).

[2] Towards Vaccinating the World: Landscape of current COVID-19 supply chain and manufacturing capacity, potential challenges, initial responses, and possible ‘solution space’ – a discussion paper, 9 March 2021

[3] COVID-19 vaccine briefing. Science based forecasts for the short and long term, 28 June 2021
Source: CEPI (Press release)

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Khondrion announces publication in PLOS ONE of new research showing normalisation of prostate cancer stem cell mPGES-1 overexpression and inhibition of cancer spheroid growth by sonlicromanol’s active metabolite

Khondrion, a clinical-stage biopharmaceutical company discovering and developing therapies targeting mitochondrial disease, today announces the publication of new research in PLOS ONE examining the in vivo active metabolite of sonlicromanol, as a selective inhibitor of microsomal prostaglandin E synthase-1 (mPGES-1)-mediated PGE2 synthesis in prostate cancer stem cells and its potential as a novel treatment approach for prostate cancer and other cancers with high mPGES-1 expression.

Sonlicromanol (KH176) is Khondrion’s wholly-owned investigational lead asset, currently in phase IIb development as a potentially disease-modifying treatment for mitochondrial disease. The Company has previously demonstrated the ability of sonlicromanol’s active metabolite to selectively inhibit mPGES-1, a key enzyme involved in the production of prostaglandin E2. This prostaglandin, known to induce and propagate the inflammation response, was found in significantly increased levels in cells derived from mitochondrial disease patients. Importantly, the aggressiveness of cancers, like prostate cancer, has also been found in independent studies to be associated with elevated expression of mPGES-1.

The new research, authored by Khondrion, details the effects of selective mPGES-1 targeting by sonlicromanol’s active metabolite, and examines its potential to decrease the aggressiveness of prostate cancer by inhibiting mPGES-1 expression.

The research team found that inhibition of mPGES-1 by sonlicromanol’s metabolite was able to considerably reduce spheroid growth in the human prostate cancer cell line DU145, potentially offering a novel approach in treating prostate cancer and other malignancies with high expression of mPGES-1. Sonlicromanol’s active metabolite was found to reduce the constitutively high mPGES-1 levels. The growth of spheroids in a physiological relevant 3D environment for tumour cells was reduced and the prostate cancer stem cell population was selectively decreased. These findings are of particular interest as they further strengthen earlier research indicating the potential of sonlicromanol [human plasma exposure at steady-state: active metabolite = ½ KH176] as a treatment for patients with high mPGES-1 expression and signal its potential as an anti-tumour drug, based on its ability to decrease the size of cancer stem cell-formed spheroids.

Dr. Herma Renkema, Chief Early Development Officer at Khondrion and co-author of the paper, said: “These are significant findings that build on our earlier research into the anti-inflammatory effect of sonlicromanol and its potential as a disease-modifying drug for patients with mitochondrial disease. That research led us to explore the potential of this compound beyond mitochondrial disease, given what we know about its mode of action. Inhibition of mPGES-1 expression is an approach currently being investigated to identify new therapeutic avenues for prostate cancer, which is the most frequently diagnosed cancer in the Western world and the leading cause of cancer-related death in men over 65 years of age. Our research provides compelling evidence to support further studies investigating the potential of sonlicromanol as an anti-tumour drug in prostate and other human cancers.”

A link to the study – Jiang, X., Renkema, H., Smeitink, J., Beyrath J. Sonlicromanol’s active metabolite KH176m normalizes prostate cancer stem cell mPGES-1 overexpression and inhibits cancer spheroid growth. PLoS ONE 16(7): e0254315 (2021) – can be found here: https://doi.org/10.1371/journal.pone.0254315

Source: Khondrion (Press release)

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Kamer wil stille pandemie van antibioticaresistentie bestrijden

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Mooi nieuws! Unaniem spoort de Tweede Kamer de regering aan om de ontwikkeling van nieuwe antibiotica te ondersteunen. Deze motie volgt op het recent verschenen Access to Medicine Foundation-rapport “Biotechs are saving the world form superbugs. Can they also save themselves?”. Ook nu is er namelijk al sprake van een wereldwijde “stille pandemie” van resistente infecties die globaal jaarlijks aan circa 700.000 mensen het leven kost.

De ontwikkeling van nieuwe, levensreddende antibiotica ligt voor een groot deel in de handen van kleine, innovatieve biotech bedrijven. De route die hun nieuwe producten van lab naar praktijk moeten afleggen is veelal een financiële lijdensweg – als die producten de eindstreep al halen. Juist om resistentie te voorkomen worden nieuwe antibiotica namelijk slechts spaarzaam ingezet. Daardoor hebben steeds meer bedrijven moeite om het hoofd boven water te houden.

Volgens de Access to Medicines Foundation zijn er nieuwe marktprikkels nodig om een medische catastrofe te voorkomen. Bijvoorbeeld in de vorm van abonnementsmodellen of beloningen voor het bereiken van mijlpalen, waaronder het bereiken van de markt (zogeheten market entry rewards). Volgens het rapport zou Nederland ook van de aanpak in Zweden en het VK kunnen leren. Genoeg te doen dus!

HollandBIO is daarom ontzettend blij dat de Kamer de regering oproept om werk te maken van de ontwikkeling van nieuwe antibiotica. Zij vraagt de regering de bijdragen vanuit de overheid voor nieuwe vormen van antibiotica op zo’n wijze te construeren dat de slaagkans wordt vergroot en ook om zich op Europees niveau in te zetten voor vernieuwende vormen van investeringen in en onderzoek naar nieuwe antibioticavarianten.

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Viewpoint Molecular Targeting® Partners with Industry Leader Pepscan to Accelerate Peptide Discovery Program

Viewpoint Molecular Targeting, Inc. (“Viewpoint” or the “Company”), a radiopharmaceutical company developing precision lead-212-based α-particle oncology therapeutics and complementary diagnostic imaging agents, announced it has entered into a collaborative partnership with Netherlands-based Pepscan Therapeutics B.V. (“Pepscan”), the all-in-one peptide service provider with proprietary peptide constraining technologies.

“Pepscan is clearly a world leader in peptide discovery and lead optimization, and we are delighted to have taken the first step on this journey,” commented Michael K Schultz PhD, Chief Science Officer and Co-Founder of Viewpoint. “In our diligence, the Pepscan team is technically and professionally the strongest we’ve had the pleasure to work with. We are particularly excited to see how their CLIPS™ innovative scaffold technology results in superior synthetic peptide candidates for us to develop.”

Peptide-based radiopharmaceuticals have recently emerged as an exciting therapeutic and diagnostic platform in the areas of neuroendocrine tumors, prostate cancer, and other solid tumors. Pepscan’s world-leading libraries of CLIPS™ (Chemical Linkage of Peptides onto Scaffolds) constrained peptides combined with its screening technologies and deep knowledge of the discovery process will result in optimal ligands which bind cancer-specific cellular targets with high affinity and selectivity. In post-discovery the candidates can be modified with Viewpoint’s proprietary linker and chelator technology which is specific for the lead-212 therapeutic isotope and lead-203 imaging isotope. This allows Viewpoint’s in-house scientists to optimize the pharmacokinetic “tuning” of the peptides to ensure high tumor uptake and reduced healthy organ uptake.

“We are excited to join Viewpoint’s journey and enabling them to reach life-improving breakthroughs. Ultimately, the success of our peptide discovery and optimization for radiopharmaceuticals lies in the technical strength, expertise, and understanding of the team that transitions our candidates to a clinically-relevant radiopharmaceutical drug.” says Pepscan’s Director of Peptide Discovery Michael Goldflam. “Given Viewpoint’s track-record in translating its two lead products through development to clinic-ready status, we have great confidence that the Viewpoint team will achieve success based on our discovery results.”

This collaborative partnership agreement provides an avenue for both Viewpoint and Pepscan to focus on their world-leading expertise and technologies in order to accelerate the process from discovery phase to clinic-ready radiopharmaceuticals. The terms of the agreement are to remain confidential.

Source: Pepscan (Press release)

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Het effect van “Verder met Vaccineren”

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Wat heeft het “Verder met Vaccineren”-beleid opgebracht? In deze voortgangsbrief belicht staatssecretaris Blokhuis de resultaten. De trendbreuk rond de -voorheen- dalende vaccinatiegraad geeft reden tot feest, al gaat bij HollandBIO de champagne pas écht open als het volgend kabinet doorpakt op de recente adviezen voor een verbeterd Nederlands vaccinatiestelsel.

Staatssecretaris Blokhuis zette zich de afgelopen beleidstermijn samen met “zijn” vaccinatiealliantie en de denktank desinformatie in voor het Nederlandse vaccinatiebeleid. Gewapend met een actieplan is het hem gelukt om de dalende trend in de vaccinatiegraad te keren: een mooi resultaat! Hij stelde daarnaast diverse nieuwe vaccinatieprogramma’s in, waaronder bijvoorbeeld de maternale kinkhoestvaccinatie en een uitbreiding van de HPV-vaccinatie naar jongens. Ook kijkt hij positief aan tegen de invoer van een gordelroosvaccinatie voor ouderen, en was hij eerder positief over de invoer van een rotavirusvaccinatie in risicogroepen, waar recent een aangepast GR-advies over uitkwam.

Tot HollandBIO’s grote genoegen merkte Blokhuis ook op dat het vaak lang duurt voordat nieuwe vaccins een arm bereiken. Diverse vraagstukken over de in- en uitvoer spelen daarbij een rol – en gaven Blokhuis aanleiding een verkenning naar de bestendigheid van het Nederlandse vaccinatiestelsel uit de zetten bij de Raad voor Volksgezondheid en Samenleving. Nu de resultaten van de verkenning, en het advies van het Zorginstituut over de vaccinatiezorg voor medische risicogroepen bekend zijn, laat Blokhuis de broodnodige verbeteringen aan het stelsel aan zijn opvolger over.

Hoewel er onder leiding van Blokhuis mooie stappen gezet zijn, gaat het dak er bij HollandBIO pas echt af als het ons lukt om ook het vaccinatiestelsel duurzaam te verbeteren. Essentieel daarvoor is een overkoepelende visie, met breed gedragen doelen, een bijpassende strategie en een goed gecoördineerde, gezamenlijke uitvoering. Blokhuis laat daarmee een bijzonder relevante en actuele uitdaging achter voor zijn opvolger. Wie pakt de handschoen op?

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MIMETAS and Roche enter into a collaboration to develop human disease models for drug development

MIMETAS, a leader in organ-on-chip-based disease models and technology, and Roche, a world-leading pharmaceutical company, announced today that they have entered into a collaboration to develop human disease models to characterize novel compounds in inflammatory bowel disease (IBD) and hepatitis B virus infections (HBV). Under the terms of the agreement, MIMETAS is eligible to receive an upfront payment and milestone payments from Roche.

MIMETAS will be responsible for developing tissue-based disease models and assays in the OrganoPlate, its proprietary organ-on-chip platform that increases predictability of biomarkers and reduces animal use in scientific testing. Roche will gain access to technology, disease models, and scientific results. Roche will also receive an option to exclusively license specific disease models and assays for use in drug discovery.

“This exciting collaboration enables our research and early development group to apply state-of-the-art organ-on-a-chip technology in the modeling of IBD and HBV. These models have the potential to improve our understanding of disease biology and transform our drug discovery process,” said James Sabry, Global Head, Roche Pharma Partnering.

“The collaboration with Roche leverages our ongoing focus on developing predictive, phenotypic models, preceded by numerous successful projects over the last eight years,” said Jos Joore, CEO of MIMETAS. “We will leverage our disease modeling expertise in our world-leading OrganoPlate platform to gain novel insights in IBD and HBV. Working together with the outstanding Roche team, we hope to make a difference in the lives of patients.”

Source: MIMETAS (Press release)

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Orchard Therapeutics and Pharming Group Announce Collaboration to Develop and Commercialize ex vivo autologous HSC Gene Therapy for Hereditary Angioedema

Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, and Pharming Group N.V. (Euronext Amsterdam: PHARM/Nasdaq: PHAR), a global, commercial stage biopharmaceutical company, announced a strategic collaboration to research, develop, manufacture and commercialize OTL-105, a newly disclosed investigational ex vivo autologous hematopoietic stem cell (HSC) gene therapy for the treatment of hereditary angioedema (HAE), a life-threatening rare disorder that causes recurring swelling attacks in the face, throat, extremities and abdomen.

OTL-105 is an investigational HSC gene therapy designed to increase C1 esterase inhibitor (C1-INH) in HAE patient serum to prevent hereditary angioedema attacks. OTL-105 inserts one or more functional copies of the SERPING1 gene into patients own HSCs ex vivo which are then transplanted back into the patient for potential durable C1-INH production. In preclinical studies, to date, OTL-105 demonstrated high levels of SERPING1 gene expression via lentiviral-mediated transduction in multiple cell lines and primary human CD34+ HSCs. Furthermore, the program achieved production of functional C1-INH protein, as measured by a clinically validated assay.

Under the terms of the collaboration, Pharming has been granted worldwide rights to OTL-105 and will be responsible for clinical development, regulatory filings, and commercialization of the investigational gene therapy, including associated costs. Orchard will lead the completion of IND-enabling activities and oversee manufacturing of OTL-105 during pre-clinical and clinical development, which will be funded by Pharming. In addition, both companies will explore the application of non-toxic conditioning regimen for use with OTL-105 administration.

Orchard will receive an upfront payment of $17.5 million comprising $10 million in cash and a $7.5 million equity investment from Pharming at a premium to Orchard’s recent share price. Orchard is also eligible to receive up to $189.5 million in development, regulatory and sales milestones as well as mid-single to low double-digit royalty payments on future worldwide sales.

“Given the combination of our expertise in HSC gene therapy with Pharming’s long-standing legacy and experience, we have the potential to reinvent the treatment paradigm for HAE by providing people living with this life-threatening disorder a sustained therapy with a single administration,” said Bobby Gaspar, M.D., Ph.D., chief executive officer of Orchard Therapeutics. “This collaboration demonstrates the promise of the HSC gene therapy platform and how it can be applied to new therapeutic areas with larger patient populations. We believe the HSC gene therapy pipeline we are building could continue to be a source of future partnerships in areas where the biology supports our approach.”

“Pharming has been committed to the HAE community for more than two decades,” said Sijmen de Vries M.D., MBA, chief executive officer of Pharming. “We have partnered with Orchard Therapeutics, a leader in the development of autologous HSC gene therapy, to develop a potentially curative treatment for HAE. Based on Pharming’s experience in HAE, we believe that HSC gene therapy has the potential for the highest probability of success. This confidence is based on the durability of effect and safety observed in approved treatments from Orchard’s HSC gene therapy portfolio and positive clinical data in several other programs. This a significant first step in developing a potentially transformative one-time treatment for HAE.”

“Great progress has been made in HAE treatment over the last 15 years. However, HAE remains a severe, debilitating disease with an ongoing burden of angioedema attacks or chronic medication use,” said Dr. Marc Riedl, professor of medicine and clinical director of the U.S. Hereditary Angioedema Association Center at the University of California, San Diego. “This promising work toward treatment with the potential for durable long-term clinical benefit is encouraging and signifies an ongoing commitment to the HAE community. I look forward to these efforts to identify and carefully advance a potential cure for HAE.”

The HAE market is expected to generate ~$2 billion in sales in 2021, currently growing at 8% per annum. This represents a significant commercial opportunity for Pharming Group and Orchard Therapeutics.

Source: Orchard Therapeutics (Press release)

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Zorginstituut: Nederlands vaccinatiebeleid moet beter, meer regie nodig

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Naast de Raad voor Volksgezondheid en Samenleving (RVS) concludeert nu ook het Zorginstituut (ZIN) dat het vaccinatiebeleid en de vaccinatiezorg in Nederland versnipperd zijn en beter moeten. Het Zorginstituut pleit daarom voor meer duidelijkheid over regie en verantwoordelijkheid. Een oproep die HollandBIO in bredere zin steunt: laten we gezamenlijk werk maken van visie op het overkoepelende Nederlandse vaccinatiebeleid!

Volgens het Zorginstituut staat een gebrek aan regie en verantwoordelijkheid aan de basis van alle knelpunten die zij signaleert binnen de vaccinatiezorg voor medische risicogroepen. Zo weten behandelaren en patiënten lang niet altijd van het bestaan en hebben zij onvoldoende kennis van deze zorg. Of is de bekostiging en vergoeding van vaccinatie voor medische doelgroepen onduidelijk. Ook is er per regio een andere invulling, met soms de medisch specialist en in andere gevallen de huisarts of de GGD als primair verantwoordelijke. Met een rol als “procesarchitect” wil het Zorginstituut deze kluwen aan knelpunten uiteenhalen en toekomstige verbeteringen realiseren voor de vaccinaties die binnen de Zorgverzekeringswet vallen, of zouden moeten vallen.

HollandBIO is allereerst buitengewoon blij met alle erkenning van de problematiek rond het Nederlandse vaccinatielandschap. Alle eerdere adviezen, verkenningen en loketten ten spijt, bereiken beschikbare vaccins blijkbaar nog steeds niet altijd tijdig de juiste arm, en laat Nederland nog altijd gezondheidswinst liggen. Daar moet snel verandering in komen.

Hoog tijd om op basis van de gesignaleerde knelpunten werk te maken van de Nederlandse ambitie om in de strijd tegen infectieziekten zoveel mogelijk gezondheidswinst te realiseren met behulp van vaccinaties. Waar ZIN pleit voor meer regie en verantwoordelijkheid voor vaccinaties van medische risicogroepen, trekt HollandBIO -ook in navolging van het RVS-advies– deze oproep graag breder. Wat ons betreft is een overkoepelende visie, met breed gedragen doelen, een bijpassende strategie en een goed gecoördineerde, gezamenlijke uitvoering nodig. Laten we als veldpartijen niet de formatie en beleidsreactie afwachten, maar kijken of we hier alvast een gezamenlijke basis voor kunnen leggen!

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BioConnection ontvangt GMP-certificaat en productielicentie van Inspectie Gezondheidszorg en Jeugd (IGJ) voor nieuwe productielijn steriele geneesmiddelen

BioConnection B.V., een onafhankelijke CMO (loonfabrikant) gespecialiseerd in de productie van steriele geneesmiddelen voor (bio)farmaceutische bedrijven, heeft toestemming ontvangen van de Inspectie Gezondheidszorg en Jeugd (IGJ) om op zijn nieuwe productielijn steriele producten voor menselijke gebruik te produceren. De ontvangst van deze productielicentie en GMP-certificaat (Good Manufacturing Practice) betekent het startsein om de lijn in productie te nemen en op grote schaal flacons af te vullen. Daarmee kan BioConnection een belangrijke bijdrage leveren om te voorzien in het wereldwijde tekort aan productie- en afvulcapaciteit voor bijvoorbeeld vaccins.

BioConnection kondigde in april 2019 aan 12 miljoen euro te investeren in een nieuwe productielijn om de jaarlijkse productiecapaciteit aanzienlijk te verhogen en daarmee in te spelen op de groeiende vraag van klanten en de toekomstige groei van het bedrijf te waarborgen. De bouw startte in december 2019. Na een zeer voorspoedig verlopen bouwproces is de lijn nu GMP gecertificeerd.

Internationale eisen van EMA en US-FDA

De nieuwe productielijn heeft een jaarlijkse productiecapaciteit van ongeveer 40 miljoen flacons voor vloeistoffen en ongeveer vier miljoen flacons voor gevriesdroogde producten. De productielijn is gebouwd volgens de internationale eisen van EMA en US-FDA en is voorzien van een volledig geautomatiseerde vullijn (Groninger, Duitsland) gekoppeld aan een volledig geautomatiseerde vriesdroger van 10 m2 (HOF, Duitsland). 

Door de uitbreiding beschikt BioConnection nu in totaal over vier productielijnen met verschillende schaalgrootte. Hierdoor kan het klanten bedienen van enkele flacons tot meer dan honderdduizend flacons per productie batch en is het bedrijf in staat om klanten te ondersteunen van de klinische onderzoeksfase tot aan producties op commerciële schaal. 

“De goedkeuring van IGJ laat onze expertise zien op het gebied van de productie van steriele geneesmiddelen. We hebben anderhalf jaar gewerkt aan de uitbreiding en nu kunnen we daadwerkelijk van start met het afvullen van de eerste batches op grote schaal voor onze klanten”, zegt Alexander Willemse, CEO bij BioConnection. “We zijn enorm trots op deze uitbreiding en de betekenis daarvan voor de Nederlandse maakindustrie. Vanuit Oss kunnen we nu een belangrijke bijdrage leveren om het wereldwijde tekort aan productiecapaciteit van steriele geneesmiddelen te verkleinen.”

Bron: BioConnection (Persbericht)

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Immunicum Announces Enrollment of First Patient in Phase I ALISON Study Evaluating Cancer Relapse Vaccine Candidate DCP-001 in Ovarian Cancer

Immunicum AB (publ) announced that the first patient has been enrolled in the Phase I ALISON clinical study evaluating DCP-001, the Company’s lead cancer relapse vaccine candidate, in High-Grade Serous Ovarian Cancer (HGSOC) patients following primary standard of care treatment. The ALISON study is carried out by Professor Hans Nijman and his research group in Groningen, the Netherlands, and investigates the ability of DCP-001 to trigger the immune system to control cancer cells that may have remained in the body after surgery and treatment with chemotherapy in order to prevent or reduce tumor reccurence. This is the first study using Immunicum’s cancer relapse vaccine approach to target a solid tumor indication and will evaluate the safety, feasibility and immunogenicity of DCP-001.

“The start of the Phase I ALISON study with the first patient enrolled marks an important milestone in our clinical development strategy, as ovarian cancer is a completely new indication for Immunicum and the study is the first evaluation of DCP-001 in a solid tumor indication,” commented Jeroen Rovers, Chief Medical Officer at Immunicum. “Other immunotherapies such as checkpoint inhibitors have shown relatively low responses in ovarian cancer. This study builds on our promising preclinical data showing significant reduction in tumor growth following DCP-001 administration and will further evaluate the immunogenicity of our cancer relapse vaccine candidate in patients with solid tumors for the first time.”

Hans W Nijman, MD, PhD, Principal Investigator of the ALISON study and Professor at University Medical Center in Groningen, the Netherlands, added: “Tumors tend to develop ways that allow them to evade the body’s immune response against them, hence making the tumors resistant to many therapies. Immunicum’s relapse vaccine candidate contains allogeneic dendritic cells that can boost various key elements of the immune system against multiple tumor antigens, potentially making it a vital component in the fight against tumor recurrence and clinical relapse in ovarian cancer patients.”

The Phase I ALISON study is a single-center, open-label study evaluating safety and efficacy of DCP-001 in High-Grade Serous Ovarian Cancer (HGSOC) patients. HGSOC is a unique type of epithelial cancer that is characterized by the loss of function of the tumor suppressor protein, p53, which can lead to chemotherapy resistance and disease relapse. The vaccination regimen with DCP-001 will be scheduled after standard of care treatment, which includes chemotherapy either before or after debulking surgery, and will start 6 weeks following the last cycle of chemotherapy. Patients will receive 4 bi-weekly vaccinations with 25 million cells per DCP-001 vaccination and 2 additional booster vaccinations with 10 million cells per vaccination. Patient follow-ups will be conducted for 24 months. The primary endpoint of the study is change from baseline of DCP-001 vaccine antigen-specific T cells in peripheral blood after treatment. Key secondary endpoints include safety and tolerability after repeated DCP-001 dosing as well as recurrence free survival (RFS) and overall survival (OS) during the follow-up period.

Source: Immunicum (Press release)