CureVac Bids to Develop First mRNA Coronavirus Vaccine

Labiotech | February 03, 2020

RNA vaccine developer CureVac will receive a grant of up to €8.3M from a global partnership to develop an mRNA vaccine against the new coronavirus strain from China. The agreement follows on from an existing collaboration launched in 2019, when the Coalition for Epidemic Preparedness Innovations, or CEPI, granted CureVac €30M to develop facilities that can ‘print’ mRNA vaccines. The aim of the new grant is to help CureVac’s preclinical-stage mRNA vaccine for the coronavirus strain to reach clinical trials as quickly as possible.

Spotlight

Biotechnology, described as “the manipulation of microorganisms to perform certain processes,” is developing very quickly, but public opinion and acceptance of it may not be evolving as fast. In fact the more we hear about biotechnology, the more it seems we hear an outcry against it. However, this opposition may be less pervasive than we think, or may only need a better education around the topic. While public opinion informs many things from policy to law, it is very important we make sure these opinions are formed by informed citizens, and not based in emotions such as fear.


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INDUSTRIAL IMPACT

Cantargia to hold webcast briefing on recently announced rights issue

Cantargia AB | July 05, 2022

Cantargia AB issued an invitation to attend a webcast on its recently announced fully covered rights issue. The text of the invitation is as follows Cantargia invites you to register for and attend an online briefing on Cantargia's recently announced fully covered rights issue intended to raise approximately SEK 250 million in additional capital. Cantargia's lead asset, nadunolimab has shown very promising efficacy results in phase IIa studies in over 70 PDAC patients as well as 30 NSCLC patients, as shared recently with scientific and clinical colleagues at the American Society for Clinical Oncology (ASCO) Annual Meeting 2022. As described in Cantargia's announcement of June 21, 2022, the principal and immediate reasons for raising primary proceeds are to enable Cantargia to build on the positive data obtained in PDAC and NSCLC and progress the late-stage clinical development of nadunolimab. About Cantargia Cantargia AB is a biotechnology company that develops antibody-based treatments for life-threatening diseases and has established a platform based on the protein IL1RAP, involved in a number of cancer forms and inflammatory diseases. The lead project, the antibody nadunolimab is being studied clinically in combination with chemotherapy or immune therapy in a series of clinical studies – CANFOUR, CIRIFOUR, CAPAFOUR, CESTAFOUR and TRIFOUR – with a primary focus on non-small cell lung cancer and pancreatic cancer. Positive interim data from the combination with chemotherapy indicate stronger efficacy than would be expected from chemotherapy alone. Cantargia's second project, the antibody CAN10, blocks signaling via IL1RAP in a different manner than nadunolimab and addresses treatment of serious autoimmune/inflammatory diseases, with initial focus on systemic sclerosis and myocarditis.

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DIAGNOSTICS

VeriSIM Life and Total Brain Announce Strategic Collaboration Agreement Applying AI to Develop New Drugs for Neurological Disorders

VeriSIM Life | May 30, 2022

VeriSIM Life (VeriSIM), the leading artificial intelligence (AI)-enabled, unique R&D decisions de-risker for breakthrough drug development, today announced that it has entered into a partnership agreement with Total Brain www.totalbrain.com, an applied, integrative neuroscience company, to create breakthrough neurodata-driven actionable insights for developing novel drugs to treat a wide range of neurological disorders. The partnership will pioneer the integration of Total Brain’s proprietary mental health and brain performance database with VeriSIM Life’s BIOiSIM™ AI-enabled drug development decision engine to enable new psychiatric and neurological therapies. The Total Brain platform helps more than one million individuals improve overall mental health and brain performance using several semi-quantitative functional methods. The company’s data sets represent the world’s largest standardized brain database encompassing human electrical brain function, brain structure and blood flow, inclusive of full genetic assessments. We are excited to partner with Total Brain to combine the power of their high-dimensional data with our drug prediction engine to open new doors for drug discovery specifically addressing neurological conditions – something that has never been explored this way before, Using this first-ever combined computational/data capability, pharmaceutical partners will be able to more efficiently and effectively develop new drugs to treat illnesses like depression, anxiety, bipolar disorder, Alzheimer’s, Parkinson’s, schizophrenia, epilepsy, anorexia, ADHD and PTSD.” Dr. Jo Varshney, CEO of VeriSIM Life. With this partnership, the BIOiSIM platform will utilize its Translational Index to discover novel drug candidates with other capabilities such as: Evaluate efficacy and side effects of existing drugs and novel drug candidates used to treat various neurological conditions in specific patient subpopulations with differing genetic, biomarker and demographic profiles Develop highly differentiated patient stratification strategies Help biotechnology companies develop genetics prediction products related to neurological diseases Develop companion diagnostics tracking essential biomarker data during the development of new drugs treating neurological diseases VeriSIM Life’s exceptional AI platform and their understanding of complex biological interactions between drugs and living systems, including the central nervous system, makes them an ideal partner for exploring this exciting new approach to drug discovery.” Matthew Mund, CEO of Total Brain. The collaboration between Total Brain and VeriSIM has the potential to accelerate the pace of drug development, reduce costs and minimize failed drug discovery for neurological diseases, We are on the precipice of a new era in drug development. We are excited by the growing role that Total Brain’s proprietary data is playing in the future of biopharma.” Evian Gordon, Chief Medical Officer, Total Brain. About Total Brain (ASX: TTB): Total Brain Limited is a San Francisco and Sydney-based applied, integrative neuroscience company that has developed and offers Total Brain, a SaaS-based mental health platform powered by the world’s largest standardized brain database. Its SaaS platform has helped more than one million registered users to-date scientifically measure and optimize their brain capacities while managing the risk of common mental conditions. Benefits for providers include improved patient outcomes, tracking of evidence-based outcomes across the continuum of care, and a reduction in clinician fatigue. Benefits for employers and payers include better mental healthcare access, lower costs, and higher productivity. About VeriSIM Life VeriSIM Life has developed a sophisticated computational platform that leverages advanced AI and ML techniques to improve drug discovery and development by significantly reducing the time and money it takes to bring a drug to market. BIOiSIM™ is a first-in-class 'virtual drug development engine' that offers unprecedented value for the drug development industry by narrowing down the number of drug compounds that offer anticipated value for the treatment or cure of specific illnesses or diseases. The program reduces the time and cost of drug discovery and development and dramatically reduces the need for animal testing that, in the vast majority of cases, does not translate to humans.

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MEDICAL

Pfizer Completes Acquisition of ReViral

Pfizer | June 10, 2022

Pfizer Inc. (NYSE: PFE) today announced the successful completion of its acquisition of ReViral, a privately held, clinical-stage biopharmaceutical company focused on discovering, developing, and commercializing novel antiviral therapeutics that target respiratory syncytial virus (RSV). ReViral brings to Pfizer a portfolio of promising therapeutic candidates, including sisunatovir, an orally administered inhibitor designed to block fusion of the RSV virus to the host cell. Sisunatovir has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA). It significantly reduced viral load in a phase 2 RSV human challenge study in healthy adults and is currently in phase 2 clinical development in infants. The development program for sisunatovir is expected to continue in both adult and pediatric populations. A second program is focused on the inhibition of RSV replication targeting the viral N protein. The lead candidate in this program is currently in phase 1 clinical development. We are excited to bring ReViral’s promising investigational treatments for RSV into our anti-infective pipeline at Pfizer. This acquisition further demonstrates our commitment to advancing pioneering science – both through our in-house expertise and our work with leading, innovative companies – with the goal of delivering new breakthroughs to patients suffering from serious infectious diseases, We believe these therapeutic candidates – and the scientific expertise that has advanced their development – will complement our ongoing work to help combat RSV infections, and we look forward to welcoming our new colleagues to further support these endeavors.” Mikael Dolsten, M.D., Ph.D., Chief Scientific Officer and President, Worldwide Research, Development and Medical of Pfizer. RSV is a respiratory pathogen, which can lead to severe and life-threatening lower respiratory tract infections (LRTIs) in high-risk populations, including young children, immunocompromised individuals, and older adults. It is estimated to cause infections in approximately 64 million people, resulting in about 160,000 deaths, globally each year. Currently, treatment options for RSV are limited, with care management focused primarily on supportive measures for people with the illness. About Pfizer: At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world.

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DIAGNOSTICS

Exothera announces industrial scale AAV manufacturing collaboration with LogicBio Therapeutics and Polyplus

Exothera | June 15, 2022

Exothera SA today announced a collaboration with LogicBio® Therapeutics and Polyplus-transfection® SA. for the development of a highly scalable AAV manufacturing platform with a capacity from 200 L to 2,000 L. Adeno-associated viruses (AAV) are non-enveloped, non-pathogenic viruses largely used as drug delivery vectors for biotherapeutics, like gene therapies and vaccines. Although the application of AAV is spreading rapidly, the industry is struggling to find cost-effective manufacturing strategies to reach clinical and commercial scales. The collaboration among Exothera, LogicBio, and Polyplus aims to focus on the scale-up of a transient transfection-based AAV serotype 8 (AAV8) manufactured in suspension cell culture. The consortium selected the Allegro™ stirred tank Single-Use Bioreactor (from Pall) as a suspension culture device due to its scalability and single-use features. The project aims to assess reproducibility and comparability between the different scales of suspension bioreactors, up to 2,000 L bioreactor scale. Exothera will provide state-of-the-art production space, process development expertise and access to the latest enabling technologies. LogicBio will support the initiative with its mAAVRx™ plasmid technology and its AAV expertise. Polyplus will provide transfection reagent expertise with FectoVIR®-AAV for a smooth scaled-up GMP-eligible process development. Exothera's team is proud to work with the experienced teams at biotech companies like LogicBio and Polyplus. The success of AAV-based therapeutics requires a change in the manufacturing paradigm and through this collaboration, we aim to enable a new approach to consistently scale AAV manufacturing." Hanna Lesch, Chief Technology Officer at Exothera: " We are excited to collaborate with Exothera, an emerging leader in the CDMO industry and with Polyplus, a long-time transfection partner, for implementing an AAV manufacturing process at 200L scale and above. We believe our proprietary mAAVRx™ plasmid technology could dramatically help to improve manufacturing yields and consequently reduce AAV manufacturing costs. We are hopeful that the work done under this collaboration will be an important step forward in making gene therapy products accessible for a greater number of patients.". Matthias Hebben, Global Vice President, Technology Development at LogicBio. We are delighted to scale up AAV Viral vector Manufacturing processes to larger bioreactor volumes with innovators in the industry like Exothera and LogicBio. At Polyplus we aim to improve gene-therapy viral vector manufacturing economics by increasing titers in the upstream processes using novel transfection reagents like FectoVIR®-AAV. The collaboration will use a combination of state-of-the-art manufacturing technologies, innovative plasmid technologies and scalable transfection reagents which will make gene-therapy viral vector therapies affordable". Roel Gordijn, Chief commercial Officer at Polyplus. Exothera specializes in the industrialization of vaccine and gene therapy processes. It has recently performed successful viral vector manufacturing scale-up studies in adherent and suspension cell systems helping its clients to reach the clinical trial scale. Additionally, the team is operating and continuously improving its own GMP manufacturing platform, exoREADY, for viral vector-based gene therapies and vaccine production. About Exothera SA Exothera is a viral vector CDMO (contract manufacturing and development organization) using standard and innovative bioproduction platforms to rapidly deliver affordable viral vector-based vaccines and cell and gene therapies. As a Univercells company, Exothera capitalizes on novel manufacturing technologies and best-in-class bioprocessing expertise to provide custom-made process optimization and GMP clinical and commercial production of viral vectors. Based on its extensive technology expertise, Exothera selects technologies to optimally answer customer needs for cost-effective and agile viral vector manufacturing and provides QC services and analytical development. About LogicBio® Therapeutics LogicBio® Therapeutics is a clinical-stage genetic medicine company pioneering genome editing and gene delivery platforms to address rare and serious diseases from infancy through adulthood. The company's genome editing platform, GeneRide®, is a new approach to precise gene insertion harnessing a cell's natural DNA repair process potentially leading to durable therapeutic protein expression levels. The company's gene delivery platform, sAAVy™, is an adeno-associated virus (AAV) capsid engineering platform designed to optimize gene delivery for treatments in a broad range of indications and tissues. The company's proprietary system, mAAVRx™, aims to overcome some of the current limitations of AAV manufacturing by optimizing the transfection process to improve yields and product quality. The company is based in Lexington, MA.

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Spotlight

Biotechnology, described as “the manipulation of microorganisms to perform certain processes,” is developing very quickly, but public opinion and acceptance of it may not be evolving as fast. In fact the more we hear about biotechnology, the more it seems we hear an outcry against it. However, this opposition may be less pervasive than we think, or may only need a better education around the topic. While public opinion informs many things from policy to law, it is very important we make sure these opinions are formed by informed citizens, and not based in emotions such as fear.

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