Sanofi’s global vaccines unit Sanofi Pasteur will partner with Translate Bio to develop mRNA vaccines for up to five undisclosed infectious disease pathogens, through a collaboration that the mRNA therapeutics developer said today could generate for it up to $805 million-plus.
During the collaboration’s initial three-year research term, Translate Bio said, it will join Sanofi Pasteur in jointly conducting R&D activities to advance mRNA vaccines. Sanofi Pasteur agreed to pay for all costs during the research term and receive exclusive worldwide commercialization rights.
In return, Sanofi Pasteur agreed to pay Translate Bio $45 million upfront, and up to $760 million in payments tied to achieving development, regulatory, and sales-related milestones across several vaccine targets, as well as option exercise fees if Sanofi Pasteur exercises its option related to development of vaccines for additional pathogens.
Translate Bio said it is also eligible to receive tiered royalty payments associated with worldwide sales of the developed vaccines.
Under the collaboration with Sanofi Pasteur, Translate Bio will be responsible for clinical manufacture and will be entitled to additional payments under a separate supply agreement to be established.
“We believe mRNA technology has significant potential for rapid and versatile manufacturing, reduced industrialization costs for multiple vaccines, and the improved breadth of immune response for infectious disease vaccines,” John Shiver, SVP, R&D, Sanofi Pasteur, said in a statement. “The Translate Bio platform may allow us to further address medical needs worldwide, including those not readily accessible using conventional vaccine strategies.”
Sales, Clinical Setbacks
Sanofi is looking to broaden Sanofi Pasteur’s R&D efforts following a 0.9% year-over-year dip in sales during the first quarter, to €711 million ($839 million). While sales grew 8.3% for all of 2017, to €5.101 billion ($6.020 billion), they only inched up 1.2% during Q4, to €1.385 billion ($1.635 billion).
The vaccine unit is looking to bounce back from setbacks: Sanofi took a fourth-quarter charge for its pioneering Dengue vaccine Dengvaxia® to reflect reduced sales after long-term clinical trial data showed the vaccine could increase the severity of the disease in people who were not previously infected.
And in December 2017, Sanofi halted development of its Clostridium difficile candidate after the Independent Data Monitoring Committee for the Phase III Cdiffense™ clinical trial (NCT01887912) concluded that the vaccine was unlikely to meet the study’s primary endpoint of efficacy in adults ages 50 years-plus who are at risk for C. difficile infection and received at least one injection of the vaccine.
Translate Bio says its mRNA therapeutic platform (MRT) is designed to develop product candidates that deliver mRNA carrying instructions to produce intracellular, transmembrane, and secreted proteins for therapeutic benefit.
The company reasons that it can apply the MRT platform to a broad range of diseases caused by insufficient protein production or where production of proteins can modify disease—including diseases that affect the lung, liver, eye, central nervous system, lymphatic system, and circulatory system.
mRNA Platform “Potential”
“We believe that this partnership validates the potential of our mRNA platform, and also enables us to apply our mRNA technology beyond the current therapeutic applications that we are pursuing in cystic fibrosis and ornithine transcarbamylase deficiency, ultimately advancing our goal of delivering innovative medicines to patients,” added Translate Bio CEO Ronald Renaud.
Translate Bio emerged in January 2017 under the name RaNA Therapeutics when it acquired the MRT mRNA therapy platform from Shire—whose subsidiaries developed the technology—for an undisclosed price. At the time, the group of Shire MRT employees who had focused on developing the technology since 2008 joined RaNA to continue advancing the platform in cystic fibrosis and urea cycle disorders.
On April 12, Translate Bio said it won FDA clearance to begin a first-in-humans Phase I/II trial to assess the mRNA candidate MRT5005 in cystic fibrosis, with dosing of patients expected to begin “in mid-2018.”
The randomized, double-blind, placebo-controlled trial is designed to enroll at least 32 adult patients with cystic fibrosis who have at least one Class I or Class II mutation. The trial’s primary endpoint will be the safety and tolerability of single and multiple escalating doses of MRT5005 administered by nebulization.
Translate Bio’s deal with Sanofi is subject to customary closing conditions, including the expiration of the applicable waiting period under the Hart–Scott–Rodino Antitrust Improvements Act of 1976 in the U.S.
Researchers are genetically engineering plants to produce the sex pheromones of insects, which then frustrate the pests’ attempts to mate.
“Sexy plants” are on the way to replacing many harmful pesticides, scientists say, by producing the sex pheromones of insects which then frustrate pests’ attempts to mate.
Scientists have already genetically engineered a plant to produce the sex pheromones of moths and are now optimising that, as well as working on new pheromones such as those of the mealybugs that plague citrus growers.
Sex pheromones are already used to protect some higher-value crops, such as tomatoes and berries. But the complex molecules are currently produced by chemical synthesis, which is expensive.
The new work uses a plant as a bio-factory, powered by the sun. Other researchers are also working on brewing sex pheromones using genetically modified yeast, a process already widely used to make, for example, insulin for diabetic patients.
Existing pesticides often harm both pests and beneficial insects, such as bees. Some are now pervasive in the environment around the world and are partly to blame for crashing insect populations. The world’s most widely used insecticides, neonicotinoids, were banned from outdoor use by the European Union in April. In contrast, pheromones are specific to each species and, being used in tiny amounts in fields, do not contaminate the wider area.
“For many species, pheromone manufacturing is difficult and expensive,” said Nicola Patron, at the Earlham Institute, UK, which has received three years of European funding for the new project, along with scientists in Spain, Germany and Slovenia. “Bioengineering can provide viable alternatives to manufacturing, expanding the use of pheromones that will be much kinder to our environment.”
A pilot project called SexyPlant created a genetically modified tobacco plant that produces and releases the sex pheromones of the cotton bollworm and navel orangeworm, both larvae of moths. This is now being improved to give bigger yields. The same plant has already been engineered by others to produce ebola antibodies and polio vaccine.
In the new work, the pheromone will first be harvested from the plant and put in traps or dispensers to prevent pests mating. But in future, plants producing the pheromones could be planted alongside the crops they protect. This will prevent females finding mates and laying their eggs on crops, which the larvae then destroy, but will not affect the insects away from the field.
Patron and her colleagues are also isolating pheromones from citrus mealybugs, chosen because they are particularly complex molecules. “If we can do these, we can probably do most things,” said Patron.
She said crop plants were not themselves being engineered to produce pheromones, so no GM material would be in the final produce. Pheromones harvested from the plants could be used in fields quite soon, but putting pheromone-producing plants in fields is 10-15 years away, Patron said, because of the long regulatory process for GM plants.
Other scientists, at the Technical University of Denmark (DTU), are exploring using engineered yeast cells to produce pheromones. “We aim to produce pheromones by fermentation and it will make the pheromones affordable for the protection of row crops, like maize and soybean,” said Irina Borodina at DTU.
One of the pests her group is targeting is the fall armyworm, which poses a major threat to food security in Africa and elsewhere. “African farmers have tried to treat this pest with insecticides, but it has become resistant,” said Borodina. “So there is an urgent need for a solution because otherwise people will starve.”
Different approaches are welcomed by Patron, whose group is also exploring the potential of fungi to produce pheromones: “At this stage of biomanufacturing, there is not one perfect solution and it definitely makes sense we try it across different types of organisms and see what is going to work.”
Chris Hartfield, at the National Farmers’ Union in England, said: “Looking for alternative ways of effectively controlling the many crop pests farmers face is at the heart of the integrated pest management approach taken by farmers and growers. Using pheromones and other biopesticides, where available, is an important part of that approach.
“Farmers are in the job of producing safe, traceable and affordable food, so the critical thing for them is to have an effective crop protection toolbox available to combat pests today,” he said. “If they lose a pesticide from that toolbox, food production could be severely impacted if the effective alternative is several years away at the end of a research project.”
https://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svg00hollandbiohttps://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svghollandbio2018-06-07 17:33:362018-06-12 17:37:55‘Sexy plants’ on track to replace harmful pesticides to protect crops← #nieuws
The two pharma giants report data which showed clinical improvement in median radiologic progression-free survival (rPFS) with Lynparza (olaparib) in combination with abiraterone compared to abiraterone monotherapy, a standard of care, in metastatic castration-resistant prostate cancer (mCRPC).
Lynparza is being jointly developed and commercialised by AstraZeneca and MSD.
Phase II trial
The results of Study 08, a randomised, double-blinded, multi-centre Phase II trial, comparing Lynparza in combination with abiraterone (n=71) to abiraterone monotherapy (n=71) in patients with previously-treated mCRPC, regardless of homologous recombination repair (HRR) mutation status, were presented at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, US, 1-5 June 2018 as a “Best of ASCO presentation” and were published online today in the Lancet Oncology. The primary endpoint was rPFS. Secondary endpoints included time to second progression or death (PFS2), overall survival (OS) and health-related quality of life.
“A previous trial demonstrated improvements in response rates with Lynparza monotherapy in metastatic castration-resistant patients with HRR mutations. The Study 08 combination data suggests that regardless of their mutation status, men with metastatic castration-resistant prostate cancer may potentially benefit from Lynparza in combination with abiraterone,” says Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca.
https://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svg00hollandbiohttps://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svghollandbio2018-06-07 13:38:162018-06-12 13:40:23AstraZeneca and MSD present new results about Lynparza← #nieuws
Pfizer is planning to invest $600 million in biotechnology and other emerging growth companies through its venture investment group.
Pfizer Ventures will dedicate 25 percent of the funds to neuroscience, seeking out promising early-stage neuroscience companies to support “a broad array of early research and product development opportunities”.
“By changing the way we invest in neuroscience, we hope to support an energised community of biotech entrepreneurs who are progressing the understanding of the molecular mechanisms of neurologic diseases and help advance potential treatments for people with neurological conditions,” said Denis Patrick, vice president, Pfizer Worldwide Research and Development, and managing partner of Pfizer Ventures.
Initial areas of interest include neuro-degeneration, neuro-inflammation and neuro-metabolic disorders, and other areas where rapidly advancing science could lead to breakthroughs for patients, the group said.
Beyond neuroscience, Pfizer Ventures will continue to invest across a range of therapeutic areas of interest to Pfizer, such as oncology, inflammation and immunology, rare disease, internal medicine and vaccines.
The drugs giant also announced expansion of its venture capital team “to leverage expertise across venture capital investing, business development, drug discovery and clinical development”.
The new organisation marries R&D Innovate, Pfizer’s R&D equity investment vehicle, with Pfizer Venture Investments.
Biogen has acquired an exclusive option to TMS’ Phase II acute stroke candidate TMS-007 and backup compounds through a deal that could generate up to $357 million-plus for the Japanese biotech and is intended to reinforce the buyer’s commitment to stroke drugs by adding a potentially long-acting treatment to its acute neurology portfolio.
TMS-007 is a small-molecule plasminogen activator with a novel mechanism of action associated with breaking down blood clots, as well as an apparent ability to inhibit local inflammation at the site of thrombosis. Biogen reasons that the combination could position TMS-007 as a best-in-class thrombolytic for patients with acute ischemic stroke (AIS), with the potential for a more extended treatment window than current thrombolytic agents.
TMS-007 is now under study in Japan in a Phase IIa trial (JapicCTI-183842) in which the first patient was enrolled in December 2017 and dosed in February. The double-blind, placebo-controlled study is designed to investigate the safety and efficacy of a single IV administration of TMS-007 in approximately 60 to 90 patients with AIS up to 12 hours after stroke onset.
In a Phase I study (JapicCTI-142654) completed in 2015, TMS-007 has shown an acceptable safety profile and has also reduced the area of dead tissue resulting from failure of blood supply or infarct volume in experimental rodent and primate embolic and thrombotic stroke models.
Biogen has agreed to pay TMS $4 million upfront, $18 million upon exercising the exclusive option, and up to $335 million in payments tied to achieving development and commercialization milestones, plus royalties.
Based in Fuchu-shi, Tokyo, TMS is a privately held biotech that was founded in 2005 to develop therapeutics based on novel discoveries to modulate the fibrinolytic system. Those discoveries were identified by a team of scientists at Tokyo University of Agriculture and Technology (TUAT) led by Keiji Hasumi, Ph.D., who serves as the company’s CEO.
Complementing Phase III-Ready Stroke Candidate
Michael Ehlers, M.D., Ph.D., Biogen EVP, research and development, said in a statement that TMS-007 complemented the company’s broader efforts in stroke, led by its Phase III-ready candidate BIIB093 (glibenclamide IV), designed to target prevention and treatment of edema in one of the most severe types of stroke, large hemispheric infarction (LHI).
Biogen plans a Phase III study assessing BIIB093 in severe cerebral edema following LHI (CHARM; NCT02864953). The study had yet to recruit patients as of March 22, the date of the most recent update on ClinicalTrials.gov.
According to Biogen, clinical proof-of-concept studies have shown the potential of BIIB093 to reduce brain swelling, disability, and the risk of death in LHI patients. Preclinical studies have shown BIIB093 to block SUR1-TRPM4 channels that mediate stroke related brain swelling.
“By growing our acute neurology portfolio, we aim to make new advances in a disease that in the past decades has seen limited therapeutic innovation,” Dr. Ehlers stated.
During Biogen’s most recent conference call with analysts on April 24, CEO Michel Vounatsos said BIIB093 is one of several late-stage candidates Biogen hopes to launch in the early 2020s, while CFO Jeff Capello said the company was committed to pipeline growth.
“Our premium is on adding to the pipeline, given our commercial footprint and our manufacturing footprint, and trying to bring in assets that are closer to being market ready. So there’s certainly a preference to kind of look at those types of transactions,” Capello said. “As we go along, we’ll continue to add to the pipeline with mid-stage assets and lower-stage assets where they fill in.”
Traditional insecticides are killers: they not only kill pests, they also endanger bees and other beneficial insects, as well as affecting biodiversity in soils, lakes, rivers and seas. A team from the Technical University of Munich (TUM) has now developed an alternative: A biodegradable agent that keeps pests at bay without poisoning them.
“It’s not just about the bees, it’s about the survival of humanity,” says Professor Thomas Brück, who heads the Werner Siemens Chair of Synthetic Biotechnology at TU Munich. “Without the bees that pollinate a wide variety of plants, not only would our supermarket shelves be quite bare, but within a short time, it would no longer be possible to supply the world’s population with food.”
Synthetically produced insecticides endanger not only bees but also beetles, butterflies and grasshoppers. They affect biodiversity in soils, lakes, rivers and seas. Their use has consequently been highly controversial for many years.
Repelling instead of poisoning
Brück and his team have now found an alternative: The insect repellent they have developed is biodegradable and ecologically harmless. Sprayed on plants, it works much like mosquito repellent used by bathers in the summer, spreading a smell that keeps away unwanted insects.
“With our approach, we are opening the door to a fundamental change in crop protection,” says Brück. “Instead of spraying poison, which inevitably also endangers useful species, we deliberately merely aggravate the pests.”
Bacteria as chemical factories
The Munich researchers were inspired by the tobacco plant, which produces cembratrienol in its leaves, CBTol for short. The plant uses this molecule to protect itself from pests.
Using synthetic biotechnology tools, Professor Brück’s team isolated the sections of the tobacco plant genome responsible for the formation of the CBTol molecules. They then built these into the genome of coli bacteria. Fed with wheat bran, a by-product from grain mills, the genetically modified bacteria now produce the desired active agent.
Efficiency in small and large scales
“The key challenge during production was to separate the active ingredients from the nutrient solution at the end of the process,” explains Mirjana Minceva, Professor of Biothermodynamics at the TUM Weihenstephan Campus.
The solution was centrifugal separation chromatography: a highly efficient process that works equally well on an industrial scale, but hitherto, had never been used to separate products from fermentation processes.
Equally effective against bacteria
Initial investigations indicate that the CBTol spray is non-toxic to insects, yet still protects against aphids. Since it is biodegradable, it does not accumulate.
In addition, the bioactivity tests showed that cembratrienol has an antibacterial effect on gram-positive bacteria. It can thus be used as a disinfectant spray that acts specifically against pathogens such as Staphylococcus aureus (MRSA pathogen), Streptococcus pneumoniae (pneumonia pathogen) or Listeria monocytogenes (listeriosis pathogen).
Publication
Wolfgang Mischko, Max Hirte, Simon Roehrer, Hannes Engelhardt, Norbert Mehlmer, Mirjana Minceva and Thomas BrückModular Biomanufacturing for a Sustainable Production of Terpenoid-based Insect DeterrentsGreen chemistry, May 14, 2018
MDxHealth announced a worldwide licensing agreement with Philips for the rights to manufacture and market Philips’ recently validated prognostic biomarker for prostate cancer, phosphodiesterase-4D7 (“PDE4D7”), as a prognostic test. The test is based on technology which was jointly developed by Philips Research and The University of Glasgow.
The agreement enables MDxHealth to prepare the launch of its InformMDx(TM) test for prostate cancer, a tissue-based test utilising PDE4D7 that can stratify patients according to their risk of disease progression and the development of secondary tumors. The Company anticipates that InformMDx will provide actionable information to help clinicians guide post-biopsy treatment decisions at the time of diagnosis, as well as post-surgical treatment decisions following prostatectomy. In the US alone, over 150,000 patients per year could benefit from the InformMDx test.
PDE4D7 has recently been validated in a 503 patient study published in the journal European Urology Focus which confirmed, based on 10-15 years of follow-up data, the independent prognostic and incremental value of PDE4D7 compared to the established clinical risk metric (https://www.eu-focus.europeanurology.com).
21.265 Nederlandse ondernemers – waarvan 97% mkb’er is – haalden afgelopen jaar een voordeel van bijna 1,2 miljard euro uit de innovatie- en onderzoeksregeling Wet Bevordering Speur- en Ontwikkelingswerk (WBSO). Via deze regeling kunnen ondernemers meer onderzoek doen naar nieuwe innovaties en kunnen ideeën sneller worden ontwikkeld tot succesvolle producten en diensten. Deze resultaten staan in de jaarrapportage 2017 die staatssecretaris Mona Keijzer van Economische Zaken en Klimaat (EZK) vandaag heeft gepubliceerd.
Staatssecretaris Keijzer (EZK): “Nederlandse bedrijven hebben in 2017 hun uitgaven voor onderzoek en ontwikkeling op peil gehouden. Dat is belangrijk, omdat de sterke economische groei er voor zorgt dat bedrijven zich vooral moeten richten op de toenemende vraag en productie. Het overgrote aandeel mkb’ers in deze groep laat zien dat zij niet alleen het fundament van onze economie zijn, maar ook een belangrijke bijdrage leveren aan vernieuwing in vele sectoren als de bouw, de verpakkingsindustrie of data-toepassingen. Onderzoek en ontwikkeling blijft de basis voor onze internationale concurrentiepositie.”
2017 in cijfers
Via de WBSO kunnen bedrijven een deel van de loonkosten en andere uitgaven voor onderzoek en ontwikkeling verlagen. In 2017 kende de Rijksdienst voor Ondernemend Nederland, die de WBSO namens het ministerie van EZK uitvoert, in totaal 135.900 projecten toe. Dit aantal projecten staat gelijk aan circa 83.000 hoogwaardige arbeidsplaatsen in de Research & Development. Bij deze projecten was verreweg het grootste deel (96%) een ontwikkelingstraject voor een nieuw product, productieproces of programmatuur, in 4% van de projecten ging het om een technisch-wetenschappelijk onderzoek.
De cijfers over afgelopen jaar laten zien dat Amsterdam (met 1.923 bedrijven), de omgeving Eindhoven (1.726 bedrijven) en Utrecht (1.534 bedrijven) het meest gebruik maken van de regeling. In de provincies Noord-Brabant, Zuid-Holland en Noord-Holland geven bedrijven het meeste uit aan R&D.
Betere oogst en slimme hijskraan
Eén van de bedrijven die succesvol gebruik maakt van de innovatieregeling is Dacom, dat via data-apparatuur telers helpt hun gewassen te optimaliseren. Door sensoren te combineren met satellietbeelden en internetapplicaties wordt het gebruik van water, bestrijdingsmiddelen en meststoffen beter op elkaar afgestemd. Zo wordt de oogst verbeterd, het gebruik van de hoeveelheid hulpstoffen verminderd en duurzaamheid gestimuleerd. Met de recente WBSO-bijdrage onderzoekt het bedrijf nu het gebruik van deze technologie op de lange afstand.
Lagerwey bedacht met hulp van de WBSO een hijskraan die meeklimt in de opbouw van windmolens. Omdat de masthoogte van deze turbines steeds verder toeneemt moeten kranen ook steeds hoger worden. Doordat de nieuwe hijskraan zichzelf vasthoudt en zodoende niet veel ruimte nodig heeft kan zo op meer plekken makkelijker gebouwd worden. Daarbij blijft de ondergrond beschikbaar voor bijvoorbeeld akkerbouw. Die combinatie zorgt voor tijd- en milieuwinst en lagere kosten.
The average time to bring a new drug to market is 12 years—assuming it makes it through the rigorous regulatory hurdles. Any technology or methodology that can expedite the drug development process or increase the likelihood of FDA approval is advantageous to both companies and patients. Now, a new study from investigators at Coyne Scientific provides a unique look at a novel strategy—clinical trials in a dish (CTiD)—that bridges preclinical testing and clinical trials. Findings from the new study were published recently in SLAS Discovery, in an article entitled “Clinical Trials in a Dish: A Perspective on the Coming Revolution in Drug Development.”
“The pharmaceutical industry is facing unprecedented challenges as the cost of developing new drugs has reached unsustainable levels, fueled in large parts by a high attrition rate in clinical development,” the authors wrote. “Strategies to bridge studies between preclinical testing and clinical trials are needed to reduce the knowledge gap and allow earlier decisions to be made on the continuation or discontinuation of further development of drugs.”
This new CTiD platform allows pharmaceutical companies to test, at the population level, novel drugs on patient cells before moving into actual clinical trials. Because current preclinical strategies don’t follow this principle, CTiD offers the potential to impact drug discovery and development significantly.
Recent demonstrations have shown various human induced pluripotent stem cell-derived (hiPSCs) cell types (cardiac, neuronal, hepatic) recapitulate a specific individual’s drug response (rather than that of a generic human being) and have opened new avenues that support the concept of screening for cell-based safety and toxicity at the level of a population.
“The discovery and development of human induced pluripotent stem cells (hiPSCs) have opened up new avenues that support the concept of screening for cell-based safety and toxicity at the level of a population,” the authors penned. The researchers continued, stating that CTiD “allows testing medical therapies for safety or efficacy on cells collected from a representative sample of human patients, before moving into actual clinical trials. It can be applied to the development of drugs for specific populations, and it allows predicting not only the magnitude of effects but also the incidence of patients in a population who will benefit or be harmed by these drugs. This, in turn, can lead to the selection of safer drugs to move into clinical development, resulting in a reduction in attrition.”
The concept of CTiD is to satisfy, in an in vitro setting, the defining biological truth that establishes the need for a multipatient clinical trial, which is that drug responses vary by human. CTiD studies are efficient, allow the study of a range of clinical doses, and can be executed at a fraction of the cost outside of the rigid and heavily regulated clinical testing environment.
CTiD studies are poised to revolutionize thinking about practical, immediate, and near-term applications in the field of drug discovery and development. CTiD can lead to insights that cannot be obtained so early and economically in drug development by any other approach. Although still requiring improvements and enhancements, CTiD offers to refine the selection of drugs to move into clinical development, leading to reduced attrition and enabling safe drugs that address unmet medical needs to reach patients more quickly.
https://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svg00hollandbiohttps://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svghollandbio2018-06-05 17:59:002018-06-12 18:03:47Speeding Drug Development with Clinical Trials in a Dish← #nieuws
Glycostem and MolMed signed a binding term sheet for the development and manufacturing of new NK cells–based allogeneic CAR (Chimeric Antigen Receptors). The Master Agreement will be finalized by September 30th, 2018.
According to the agreement, Glycostem and MolMed will collaborate on an exclusive base in developing and manufacturing engineered NK cells targeted to three tumor antigens: Glycostem will be responsible for the final product GMP manufacturing and release, while MolMed will have exclusive rights for the exploitation of the resulting products and Glycostem will receive upfront payments, milestones and royalties on the developed products.
Troels Jordansen, Glycostem CEO, commented: “We are very proud to be teaming up with one of the most innovative cellular therapy companies around and jointly develop mold-breaking products for the help of doctors and patients. The synergy between MolMed and Glycostem is tangible and we are confident it could lead to exciting results in the short term. This is also the initiation of Glycostem’s in-house development program in our new state-of-the-art facility in the Netherlands. It is out of the same facility that we expect to have GMP approval for our closed-system production system by the end of 2018. This will allow us to expand our clinical trial program and enter pivotal for oNKord early 2019.”
https://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svg00hollandbiohttps://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svghollandbio2018-06-05 15:47:582018-06-05 16:03:36Glycostem and MolMed collaborate on allogenic CAR-NK therapies
Sanofi Pasteur and Translate Bio Launch mRNA Vaccine Partnership
Gezondheid, InnovatieklimaatSanofi’s global vaccines unit Sanofi Pasteur will partner with Translate Bio to develop mRNA vaccines for up to five undisclosed infectious disease pathogens, through a collaboration that the mRNA therapeutics developer said today could generate for it up to $805 million-plus.
During the collaboration’s initial three-year research term, Translate Bio said, it will join Sanofi Pasteur in jointly conducting R&D activities to advance mRNA vaccines. Sanofi Pasteur agreed to pay for all costs during the research term and receive exclusive worldwide commercialization rights.
In return, Sanofi Pasteur agreed to pay Translate Bio $45 million upfront, and up to $760 million in payments tied to achieving development, regulatory, and sales-related milestones across several vaccine targets, as well as option exercise fees if Sanofi Pasteur exercises its option related to development of vaccines for additional pathogens.
Translate Bio said it is also eligible to receive tiered royalty payments associated with worldwide sales of the developed vaccines.
Under the collaboration with Sanofi Pasteur, Translate Bio will be responsible for clinical manufacture and will be entitled to additional payments under a separate supply agreement to be established.
“We believe mRNA technology has significant potential for rapid and versatile manufacturing, reduced industrialization costs for multiple vaccines, and the improved breadth of immune response for infectious disease vaccines,” John Shiver, SVP, R&D, Sanofi Pasteur, said in a statement. “The Translate Bio platform may allow us to further address medical needs worldwide, including those not readily accessible using conventional vaccine strategies.”
Sales, Clinical Setbacks
Sanofi is looking to broaden Sanofi Pasteur’s R&D efforts following a 0.9% year-over-year dip in sales during the first quarter, to €711 million ($839 million). While sales grew 8.3% for all of 2017, to €5.101 billion ($6.020 billion), they only inched up 1.2% during Q4, to €1.385 billion ($1.635 billion).
The vaccine unit is looking to bounce back from setbacks: Sanofi took a fourth-quarter charge for its pioneering Dengue vaccine Dengvaxia® to reflect reduced sales after long-term clinical trial data showed the vaccine could increase the severity of the disease in people who were not previously infected.
And in December 2017, Sanofi halted development of its Clostridium difficile candidate after the Independent Data Monitoring Committee for the Phase III Cdiffense™ clinical trial (NCT01887912) concluded that the vaccine was unlikely to meet the study’s primary endpoint of efficacy in adults ages 50 years-plus who are at risk for C. difficile infection and received at least one injection of the vaccine.
Translate Bio says its mRNA therapeutic platform (MRT) is designed to develop product candidates that deliver mRNA carrying instructions to produce intracellular, transmembrane, and secreted proteins for therapeutic benefit.
The company reasons that it can apply the MRT platform to a broad range of diseases caused by insufficient protein production or where production of proteins can modify disease—including diseases that affect the lung, liver, eye, central nervous system, lymphatic system, and circulatory system.
mRNA Platform “Potential”
“We believe that this partnership validates the potential of our mRNA platform, and also enables us to apply our mRNA technology beyond the current therapeutic applications that we are pursuing in cystic fibrosis and ornithine transcarbamylase deficiency, ultimately advancing our goal of delivering innovative medicines to patients,” added Translate Bio CEO Ronald Renaud.
Translate Bio emerged in January 2017 under the name RaNA Therapeutics when it acquired the MRT mRNA therapy platform from Shire—whose subsidiaries developed the technology—for an undisclosed price. At the time, the group of Shire MRT employees who had focused on developing the technology since 2008 joined RaNA to continue advancing the platform in cystic fibrosis and urea cycle disorders.
On April 12, Translate Bio said it won FDA clearance to begin a first-in-humans Phase I/II trial to assess the mRNA candidate MRT5005 in cystic fibrosis, with dosing of patients expected to begin “in mid-2018.”
The randomized, double-blind, placebo-controlled trial is designed to enroll at least 32 adult patients with cystic fibrosis who have at least one Class I or Class II mutation. The trial’s primary endpoint will be the safety and tolerability of single and multiple escalating doses of MRT5005 administered by nebulization.
Translate Bio’s deal with Sanofi is subject to customary closing conditions, including the expiration of the applicable waiting period under the Hart–Scott–Rodino Antitrust Improvements Act of 1976 in the U.S.
Source: GEN
‘Sexy plants’ on track to replace harmful pesticides to protect crops
Voedsel en materialenResearchers are genetically engineering plants to produce the sex pheromones of insects, which then frustrate the pests’ attempts to mate.
“Sexy plants” are on the way to replacing many harmful pesticides, scientists say, by producing the sex pheromones of insects which then frustrate pests’ attempts to mate.
Scientists have already genetically engineered a plant to produce the sex pheromones of moths and are now optimising that, as well as working on new pheromones such as those of the mealybugs that plague citrus growers.
Sex pheromones are already used to protect some higher-value crops, such as tomatoes and berries. But the complex molecules are currently produced by chemical synthesis, which is expensive.
The new work uses a plant as a bio-factory, powered by the sun. Other researchers are also working on brewing sex pheromones using genetically modified yeast, a process already widely used to make, for example, insulin for diabetic patients.
Existing pesticides often harm both pests and beneficial insects, such as bees. Some are now pervasive in the environment around the world and are partly to blame for crashing insect populations. The world’s most widely used insecticides, neonicotinoids, were banned from outdoor use by the European Union in April. In contrast, pheromones are specific to each species and, being used in tiny amounts in fields, do not contaminate the wider area.
“For many species, pheromone manufacturing is difficult and expensive,” said Nicola Patron, at the Earlham Institute, UK, which has received three years of European funding for the new project, along with scientists in Spain, Germany and Slovenia. “Bioengineering can provide viable alternatives to manufacturing, expanding the use of pheromones that will be much kinder to our environment.”
A pilot project called SexyPlant created a genetically modified tobacco plant that produces and releases the sex pheromones of the cotton bollworm and navel orangeworm, both larvae of moths. This is now being improved to give bigger yields. The same plant has already been engineered by others to produce ebola antibodies and polio vaccine.
In the new work, the pheromone will first be harvested from the plant and put in traps or dispensers to prevent pests mating. But in future, plants producing the pheromones could be planted alongside the crops they protect. This will prevent females finding mates and laying their eggs on crops, which the larvae then destroy, but will not affect the insects away from the field.
Patron and her colleagues are also isolating pheromones from citrus mealybugs, chosen because they are particularly complex molecules. “If we can do these, we can probably do most things,” said Patron.
She said crop plants were not themselves being engineered to produce pheromones, so no GM material would be in the final produce. Pheromones harvested from the plants could be used in fields quite soon, but putting pheromone-producing plants in fields is 10-15 years away, Patron said, because of the long regulatory process for GM plants.
Other scientists, at the Technical University of Denmark (DTU), are exploring using engineered yeast cells to produce pheromones. “We aim to produce pheromones by fermentation and it will make the pheromones affordable for the protection of row crops, like maize and soybean,” said Irina Borodina at DTU.
One of the pests her group is targeting is the fall armyworm, which poses a major threat to food security in Africa and elsewhere. “African farmers have tried to treat this pest with insecticides, but it has become resistant,” said Borodina. “So there is an urgent need for a solution because otherwise people will starve.”
Different approaches are welcomed by Patron, whose group is also exploring the potential of fungi to produce pheromones: “At this stage of biomanufacturing, there is not one perfect solution and it definitely makes sense we try it across different types of organisms and see what is going to work.”
Chris Hartfield, at the National Farmers’ Union in England, said: “Looking for alternative ways of effectively controlling the many crop pests farmers face is at the heart of the integrated pest management approach taken by farmers and growers. Using pheromones and other biopesticides, where available, is an important part of that approach.
“Farmers are in the job of producing safe, traceable and affordable food, so the critical thing for them is to have an effective crop protection toolbox available to combat pests today,” he said. “If they lose a pesticide from that toolbox, food production could be severely impacted if the effective alternative is several years away at the end of a research project.”
Source: The Guardian
AstraZeneca and MSD present new results about Lynparza
GezondheidThe two pharma giants report data which showed clinical improvement in median radiologic progression-free survival (rPFS) with Lynparza (olaparib) in combination with abiraterone compared to abiraterone monotherapy, a standard of care, in metastatic castration-resistant prostate cancer (mCRPC).
Lynparza is being jointly developed and commercialised by AstraZeneca and MSD.
Phase II trial
The results of Study 08, a randomised, double-blinded, multi-centre Phase II trial, comparing Lynparza in combination with abiraterone (n=71) to abiraterone monotherapy (n=71) in patients with previously-treated mCRPC, regardless of homologous recombination repair (HRR) mutation status, were presented at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, US, 1-5 June 2018 as a “Best of ASCO presentation” and were published online today in the Lancet Oncology. The primary endpoint was rPFS. Secondary endpoints included time to second progression or death (PFS2), overall survival (OS) and health-related quality of life.
“A previous trial demonstrated improvements in response rates with Lynparza monotherapy in metastatic castration-resistant patients with HRR mutations. The Study 08 combination data suggests that regardless of their mutation status, men with metastatic castration-resistant prostate cancer may potentially benefit from Lynparza in combination with abiraterone,” says Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca.
Source: Nordic
Pfizer unveils $600m investment in venture capital arm
InnovatieklimaatPfizer is planning to invest $600 million in biotechnology and other emerging growth companies through its venture investment group.
Pfizer Ventures will dedicate 25 percent of the funds to neuroscience, seeking out promising early-stage neuroscience companies to support “a broad array of early research and product development opportunities”.
“By changing the way we invest in neuroscience, we hope to support an energised community of biotech entrepreneurs who are progressing the understanding of the molecular mechanisms of neurologic diseases and help advance potential treatments for people with neurological conditions,” said Denis Patrick, vice president, Pfizer Worldwide Research and Development, and managing partner of Pfizer Ventures.
Initial areas of interest include neuro-degeneration, neuro-inflammation and neuro-metabolic disorders, and other areas where rapidly advancing science could lead to breakthroughs for patients, the group said.
Beyond neuroscience, Pfizer Ventures will continue to invest across a range of therapeutic areas of interest to Pfizer, such as oncology, inflammation and immunology, rare disease, internal medicine and vaccines.
The drugs giant also announced expansion of its venture capital team “to leverage expertise across venture capital investing, business development, drug discovery and clinical development”.
The new organisation marries R&D Innovate, Pfizer’s R&D equity investment vehicle, with Pfizer Venture Investments.
Source: PharmaTimes
Biogen Buys Option to TMS’ Phase II Stroke Candidate
Gezondheid, InnovatieklimaatBiogen has acquired an exclusive option to TMS’ Phase II acute stroke candidate TMS-007 and backup compounds through a deal that could generate up to $357 million-plus for the Japanese biotech and is intended to reinforce the buyer’s commitment to stroke drugs by adding a potentially long-acting treatment to its acute neurology portfolio.
TMS-007 is a small-molecule plasminogen activator with a novel mechanism of action associated with breaking down blood clots, as well as an apparent ability to inhibit local inflammation at the site of thrombosis. Biogen reasons that the combination could position TMS-007 as a best-in-class thrombolytic for patients with acute ischemic stroke (AIS), with the potential for a more extended treatment window than current thrombolytic agents.
TMS-007 is now under study in Japan in a Phase IIa trial (JapicCTI-183842) in which the first patient was enrolled in December 2017 and dosed in February. The double-blind, placebo-controlled study is designed to investigate the safety and efficacy of a single IV administration of TMS-007 in approximately 60 to 90 patients with AIS up to 12 hours after stroke onset.
In a Phase I study (JapicCTI-142654) completed in 2015, TMS-007 has shown an acceptable safety profile and has also reduced the area of dead tissue resulting from failure of blood supply or infarct volume in experimental rodent and primate embolic and thrombotic stroke models.
Biogen has agreed to pay TMS $4 million upfront, $18 million upon exercising the exclusive option, and up to $335 million in payments tied to achieving development and commercialization milestones, plus royalties.
Based in Fuchu-shi, Tokyo, TMS is a privately held biotech that was founded in 2005 to develop therapeutics based on novel discoveries to modulate the fibrinolytic system. Those discoveries were identified by a team of scientists at Tokyo University of Agriculture and Technology (TUAT) led by Keiji Hasumi, Ph.D., who serves as the company’s CEO.
Complementing Phase III-Ready Stroke Candidate
Michael Ehlers, M.D., Ph.D., Biogen EVP, research and development, said in a statement that TMS-007 complemented the company’s broader efforts in stroke, led by its Phase III-ready candidate BIIB093 (glibenclamide IV), designed to target prevention and treatment of edema in one of the most severe types of stroke, large hemispheric infarction (LHI).
Biogen plans a Phase III study assessing BIIB093 in severe cerebral edema following LHI (CHARM; NCT02864953). The study had yet to recruit patients as of March 22, the date of the most recent update on ClinicalTrials.gov.
According to Biogen, clinical proof-of-concept studies have shown the potential of BIIB093 to reduce brain swelling, disability, and the risk of death in LHI patients. Preclinical studies have shown BIIB093 to block SUR1-TRPM4 channels that mediate stroke related brain swelling.
“By growing our acute neurology portfolio, we aim to make new advances in a disease that in the past decades has seen limited therapeutic innovation,” Dr. Ehlers stated.
During Biogen’s most recent conference call with analysts on April 24, CEO Michel Vounatsos said BIIB093 is one of several late-stage candidates Biogen hopes to launch in the early 2020s, while CFO Jeff Capello said the company was committed to pipeline growth.
“Our premium is on adding to the pipeline, given our commercial footprint and our manufacturing footprint, and trying to bring in assets that are closer to being market ready. So there’s certainly a preference to kind of look at those types of transactions,” Capello said. “As we go along, we’ll continue to add to the pipeline with mid-stage assets and lower-stage assets where they fill in.”
Source: GEN
Organic insect deterrent for agriculture
Voedsel en materialenTraditional insecticides are killers: they not only kill pests, they also endanger bees and other beneficial insects, as well as affecting biodiversity in soils, lakes, rivers and seas. A team from the Technical University of Munich (TUM) has now developed an alternative: A biodegradable agent that keeps pests at bay without poisoning them.
“It’s not just about the bees, it’s about the survival of humanity,” says Professor Thomas Brück, who heads the Werner Siemens Chair of Synthetic Biotechnology at TU Munich. “Without the bees that pollinate a wide variety of plants, not only would our supermarket shelves be quite bare, but within a short time, it would no longer be possible to supply the world’s population with food.”
Synthetically produced insecticides endanger not only bees but also beetles, butterflies and grasshoppers. They affect biodiversity in soils, lakes, rivers and seas. Their use has consequently been highly controversial for many years.
Repelling instead of poisoning
Brück and his team have now found an alternative: The insect repellent they have developed is biodegradable and ecologically harmless. Sprayed on plants, it works much like mosquito repellent used by bathers in the summer, spreading a smell that keeps away unwanted insects.
“With our approach, we are opening the door to a fundamental change in crop protection,” says Brück. “Instead of spraying poison, which inevitably also endangers useful species, we deliberately merely aggravate the pests.”
Bacteria as chemical factories
The Munich researchers were inspired by the tobacco plant, which produces cembratrienol in its leaves, CBTol for short. The plant uses this molecule to protect itself from pests.
Using synthetic biotechnology tools, Professor Brück’s team isolated the sections of the tobacco plant genome responsible for the formation of the CBTol molecules. They then built these into the genome of coli bacteria. Fed with wheat bran, a by-product from grain mills, the genetically modified bacteria now produce the desired active agent.
Efficiency in small and large scales
“The key challenge during production was to separate the active ingredients from the nutrient solution at the end of the process,” explains Mirjana Minceva, Professor of Biothermodynamics at the TUM Weihenstephan Campus.
The solution was centrifugal separation chromatography: a highly efficient process that works equally well on an industrial scale, but hitherto, had never been used to separate products from fermentation processes.
Equally effective against bacteria
Initial investigations indicate that the CBTol spray is non-toxic to insects, yet still protects against aphids. Since it is biodegradable, it does not accumulate.
In addition, the bioactivity tests showed that cembratrienol has an antibacterial effect on gram-positive bacteria. It can thus be used as a disinfectant spray that acts specifically against pathogens such as Staphylococcus aureus (MRSA pathogen), Streptococcus pneumoniae (pneumonia pathogen) or Listeria monocytogenes (listeriosis pathogen).
Publication
Wolfgang Mischko, Max Hirte, Simon Roehrer, Hannes Engelhardt, Norbert Mehlmer, Mirjana Minceva and Thomas BrückModular Biomanufacturing for a Sustainable Production of Terpenoid-based Insect DeterrentsGreen chemistry, May 14, 2018
Source: Technical University of Munich
MDxHealth licensing agreement with Philips facilitates launch InformMDx(TM)
Gezondheid, InnovatieklimaatMDxHealth announced a worldwide licensing agreement with Philips for the rights to manufacture and market Philips’ recently validated prognostic biomarker for prostate cancer, phosphodiesterase-4D7 (“PDE4D7”), as a prognostic test. The test is based on technology which was jointly developed by Philips Research and The University of Glasgow.
The agreement enables MDxHealth to prepare the launch of its InformMDx(TM) test for prostate cancer, a tissue-based test utilising PDE4D7 that can stratify patients according to their risk of disease progression and the development of secondary tumors. The Company anticipates that InformMDx will provide actionable information to help clinicians guide post-biopsy treatment decisions at the time of diagnosis, as well as post-surgical treatment decisions following prostatectomy. In the US alone, over 150,000 patients per year could benefit from the InformMDx test.
PDE4D7 has recently been validated in a 503 patient study published in the journal European Urology Focus which confirmed, based on 10-15 years of follow-up data, the independent prognostic and incremental value of PDE4D7 compared to the established clinical risk metric (https://www.eu-focus.europeanurology.com).
Source: MDxHealth
MKB profiteert volop van innovatieregeling WBSO
Innovatieklimaat21.265 Nederlandse ondernemers – waarvan 97% mkb’er is – haalden afgelopen jaar een voordeel van bijna 1,2 miljard euro uit de innovatie- en onderzoeksregeling Wet Bevordering Speur- en Ontwikkelingswerk (WBSO). Via deze regeling kunnen ondernemers meer onderzoek doen naar nieuwe innovaties en kunnen ideeën sneller worden ontwikkeld tot succesvolle producten en diensten. Deze resultaten staan in de jaarrapportage 2017 die staatssecretaris Mona Keijzer van Economische Zaken en Klimaat (EZK) vandaag heeft gepubliceerd.
Staatssecretaris Keijzer (EZK): “Nederlandse bedrijven hebben in 2017 hun uitgaven voor onderzoek en ontwikkeling op peil gehouden. Dat is belangrijk, omdat de sterke economische groei er voor zorgt dat bedrijven zich vooral moeten richten op de toenemende vraag en productie. Het overgrote aandeel mkb’ers in deze groep laat zien dat zij niet alleen het fundament van onze economie zijn, maar ook een belangrijke bijdrage leveren aan vernieuwing in vele sectoren als de bouw, de verpakkingsindustrie of data-toepassingen. Onderzoek en ontwikkeling blijft de basis voor onze internationale concurrentiepositie.”
2017 in cijfers
Via de WBSO kunnen bedrijven een deel van de loonkosten en andere uitgaven voor onderzoek en ontwikkeling verlagen. In 2017 kende de Rijksdienst voor Ondernemend Nederland, die de WBSO namens het ministerie van EZK uitvoert, in totaal 135.900 projecten toe. Dit aantal projecten staat gelijk aan circa 83.000 hoogwaardige arbeidsplaatsen in de Research & Development. Bij deze projecten was verreweg het grootste deel (96%) een ontwikkelingstraject voor een nieuw product, productieproces of programmatuur, in 4% van de projecten ging het om een technisch-wetenschappelijk onderzoek.
De cijfers over afgelopen jaar laten zien dat Amsterdam (met 1.923 bedrijven), de omgeving Eindhoven (1.726 bedrijven) en Utrecht (1.534 bedrijven) het meest gebruik maken van de regeling. In de provincies Noord-Brabant, Zuid-Holland en Noord-Holland geven bedrijven het meeste uit aan R&D.
Betere oogst en slimme hijskraan
Eén van de bedrijven die succesvol gebruik maakt van de innovatieregeling is Dacom, dat via data-apparatuur telers helpt hun gewassen te optimaliseren. Door sensoren te combineren met satellietbeelden en internetapplicaties wordt het gebruik van water, bestrijdingsmiddelen en meststoffen beter op elkaar afgestemd. Zo wordt de oogst verbeterd, het gebruik van de hoeveelheid hulpstoffen verminderd en duurzaamheid gestimuleerd. Met de recente WBSO-bijdrage onderzoekt het bedrijf nu het gebruik van deze technologie op de lange afstand.
Lagerwey bedacht met hulp van de WBSO een hijskraan die meeklimt in de opbouw van windmolens. Omdat de masthoogte van deze turbines steeds verder toeneemt moeten kranen ook steeds hoger worden. Doordat de nieuwe hijskraan zichzelf vasthoudt en zodoende niet veel ruimte nodig heeft kan zo op meer plekken makkelijker gebouwd worden. Daarbij blijft de ondergrond beschikbaar voor bijvoorbeeld akkerbouw. Die combinatie zorgt voor tijd- en milieuwinst en lagere kosten.
Bron: Rijksoverheid
Speeding Drug Development with Clinical Trials in a Dish
GezondheidThe average time to bring a new drug to market is 12 years—assuming it makes it through the rigorous regulatory hurdles. Any technology or methodology that can expedite the drug development process or increase the likelihood of FDA approval is advantageous to both companies and patients. Now, a new study from investigators at Coyne Scientific provides a unique look at a novel strategy—clinical trials in a dish (CTiD)—that bridges preclinical testing and clinical trials. Findings from the new study were published recently in SLAS Discovery, in an article entitled “Clinical Trials in a Dish: A Perspective on the Coming Revolution in Drug Development.”
“The pharmaceutical industry is facing unprecedented challenges as the cost of developing new drugs has reached unsustainable levels, fueled in large parts by a high attrition rate in clinical development,” the authors wrote. “Strategies to bridge studies between preclinical testing and clinical trials are needed to reduce the knowledge gap and allow earlier decisions to be made on the continuation or discontinuation of further development of drugs.”
This new CTiD platform allows pharmaceutical companies to test, at the population level, novel drugs on patient cells before moving into actual clinical trials. Because current preclinical strategies don’t follow this principle, CTiD offers the potential to impact drug discovery and development significantly.
Recent demonstrations have shown various human induced pluripotent stem cell-derived (hiPSCs) cell types (cardiac, neuronal, hepatic) recapitulate a specific individual’s drug response (rather than that of a generic human being) and have opened new avenues that support the concept of screening for cell-based safety and toxicity at the level of a population.
“The discovery and development of human induced pluripotent stem cells (hiPSCs) have opened up new avenues that support the concept of screening for cell-based safety and toxicity at the level of a population,” the authors penned. The researchers continued, stating that CTiD “allows testing medical therapies for safety or efficacy on cells collected from a representative sample of human patients, before moving into actual clinical trials. It can be applied to the development of drugs for specific populations, and it allows predicting not only the magnitude of effects but also the incidence of patients in a population who will benefit or be harmed by these drugs. This, in turn, can lead to the selection of safer drugs to move into clinical development, resulting in a reduction in attrition.”
The concept of CTiD is to satisfy, in an in vitro setting, the defining biological truth that establishes the need for a multipatient clinical trial, which is that drug responses vary by human. CTiD studies are efficient, allow the study of a range of clinical doses, and can be executed at a fraction of the cost outside of the rigid and heavily regulated clinical testing environment.
CTiD studies are poised to revolutionize thinking about practical, immediate, and near-term applications in the field of drug discovery and development. CTiD can lead to insights that cannot be obtained so early and economically in drug development by any other approach. Although still requiring improvements and enhancements, CTiD offers to refine the selection of drugs to move into clinical development, leading to reduced attrition and enabling safe drugs that address unmet medical needs to reach patients more quickly.
Source: GEN
Glycostem and MolMed collaborate on allogenic CAR-NK therapies
Gezondheid, InnovatieklimaatGlycostem and MolMed signed a binding term sheet for the development and manufacturing of new NK cells–based allogeneic CAR (Chimeric Antigen Receptors). The Master Agreement will be finalized by September 30th, 2018.
According to the agreement, Glycostem and MolMed will collaborate on an exclusive base in developing and manufacturing engineered NK cells targeted to three tumor antigens: Glycostem will be responsible for the final product GMP manufacturing and release, while MolMed will have exclusive rights for the exploitation of the resulting products and Glycostem will receive upfront payments, milestones and royalties on the developed products.
Troels Jordansen, Glycostem CEO, commented: “We are very proud to be teaming up with one of the most innovative cellular therapy companies around and jointly develop mold-breaking products for the help of doctors and patients. The synergy between MolMed and Glycostem is tangible and we are confident it could lead to exciting results in the short term. This is also the initiation of Glycostem’s in-house development program in our new state-of-the-art facility in the Netherlands. It is out of the same facility that we expect to have GMP approval for our closed-system production system by the end of 2018. This will allow us to expand our clinical trial program and enter pivotal for oNKord early 2019.”
Source: PivotPark