Biopharma and life sciences companies from across the globe provide updates on their business and pipelines.
Belgium-based UCB and Microsoft announced a new multi-year, strategic collaboration that combines Microsoft’s computational services, cloud, and artificial intelligence capabilities with UCB’s drug discovery and development technology.
The collaboration builds on the work UCB and Microsoft have already embarked on around COVID-19. As part of the COVID Moonshot project, UCB’s medicinal and computational chemists contributed compound designs to create an orally bioavailable anti-viral for COVID-19 - with the most potent series of compounds coming from UCB designs. The companies hope the combination of AI and UCB’s technology will accelerate the iteration cycles required to explore a vast chemical space to test many hypotheses and identify more effective molecules. The companies have four strategic objectives under the new collaboration – improving a patient’s overall journey; increasing the impact of treatments through a deeper understanding of the biological causes of the disease; providing better research data-driven insights to enable the faster discovery of therapeutic molecules; and accelerating clinical development timelines.
“We are delighted to be collaborating with Microsoft to uncover new insights to better understand a patient’s condition, as well as the science, and to enable an enhanced patient experience,” said Jean-Christophe Tellier, chief executive officer of UCB said in a statement. “By amplifying the power of scientific innovation through digital transformation, we hope to have a better understanding of what makes a patient’s journey unique so that we can provide personalized and differentiated medicine in a sustainable way.”
In other news around the globe:
SIRION – Germany’s SIRON Biotech GmbH forged a collaboration with Sanofi to develop improved tissue-selective adeno-associated virus (AAV) vectors to realize effective gene therapy treatments for disorders affecting major human organs. The goal of this collaboration is to develop new and modified AAV capsids that exhibit a safe product profile with improved specificity and higher gene delivery efficiency. AAV vectors with improved efficacy can enable quickly entering into clinical trials with efficient, safe low doses and scalable therapeutic candidates and can expand the impact of gene therapies, SIRION CEO Christian Thirion said.
MaxiVAX – Switzerland-based MaxiVAX SA, a privately-held company, and Germany’s Minaris Regenerative Medicine GmbH, entered into a manufacturing agreement for MVX-ONCO-2, a cell-based immunotherapy for the treatment of cancers such as chordoma, head and neck and other solid tumors. To induce an efficient anti-tumor response against the patients’ own tumor cells, the encapsulated GM-CSF secreting cells are implanted subcutaneously at the site of tumor-cell vaccination. Minaris will be responsible for the GMP manufacturing, freezing and shipping of the MVX-ONCO-2 capsules, which will be delivered to clinical sites. The autologous patients’ tumor cells will be processed at the clinical sites. The manufacturing agreement includes process development for scale-up and technology transfer with the goal of supplying Phase II and Phase III clinical studies initially in the EU and eventually in the United States.
NovalGen – U.K. cancer company NovalGen Ltd. and Netherlands-based HALIX BV entered into a partnership that will have HALIX provide manufacturing of clinical supply of NovalGen’s therapies. NovalGen’s innovative platform technology has been successfully deployed at HALIX to manufacture clinical trial material for NovalGen’s first clinical program. The company’s asset, NVG-111, is a Receptor Tyrosine Kinase Like Orphan Like Receptor 1 (ROR1) targeting bispecific antibody T cell engager for the treatment of hematologic malignancies and solid tumors, is expected to enter the clinic in the first half of 2021. HALIX has supported NovalGen with the successful completion of GMP manufacture of NVG-111 from drug substance up to drug product and final release.
Pre Diagnostics AS – Based in Norway, Pre Diagnostics AS announced its PreADx immunoassay for early detection of Alzheimer’s disease has successfully completed a clinical evaluation. PreADx takes an intracellular approach and measures the clearance of beta-amyloid peptides by analyzing a patient’s monocytes. The company is now planning to further optimize the assay in advance of CE marking in the second quarter of 2021.
Solentim – Cell therapy workflow company Solentim, which is based in the U.K., opened a new office in Shanghai. Solentim China is a joint venture with its longstanding distribution partner Trio Biotech Co, and will enhance support for customers and expand commercial activity across the region, the company said.
ERS Genomics – Ireland’s ERS Genomics Limited and South Korea’s G+FLAS Life Sciences, Inc. announced a non-exclusive license agreement that grants G+FLAS access to ERS Genomics’ CRISPR/Cas9 patent portfolio. ERS Genomics was formed to provide broad access to the foundational CRISPR/Cas9 intellectual property co-owned by Emmanuelle Charpentier. G+FLAS supports research organizations by providing CRISPR-related biological research services, tools, and reagents. Financial details of the agreement are not disclosed.
Protalix Biotherapeutics – Israel-based Protalix and Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., announced positive topline results from the BRIGHT Phase III clinical trial evaluating pegunigalsidase alfa (PRX–102) for the potential treatment of Fabry disease. PRX–102 is the company’s plant cell-expressed recombinant, PEGylated, cross-linked α–galactosidase–A product candidate. Topline results indicate that 2 mg/kg of PRX–102 administered by intravenous infusion every four weeks was found to be well tolerated among treated patients, and stable clinical presentation was maintained in adult Fabry patients.
Beijing Tide – China’s Beijing Tide Pharmaceutical Co., Ltd. and Graviton Bioscience Corporation signed a licensing agreement for TDI01 that provides rights to Graviton in all territories excluding China. TDI01 is a targeted inhibitor of Rho/Rho containing protein kinase 2 (ROCK2). A Phase I clinical trial of the drug candidate in idiopathic pulmonary fibrosis is currently ongoing in the United States. Graviton expects to develop this novel therapeutic for the treatment of various serious diseases, including exploration of TDI01’s ability to penetrate the central nervous system, and the translation of efficacy demonstrated in certain preclinical cancer models as well as models of certain viral diseases. In 2020, an Investigational New Drug application for evaluation of TDI01 in fibrosis was cleared by the FDA, and a clinical trial application for the treatment of fibrosis was filed and accepted by the Center for Drug Evaluation of the People’s Republic of China. The aggregate amount of upfront, development, regulatory and sales milestone payments is up to $517.5 million.
Capitainer – Sweden’s Capitainer announced that the company’s qDBS dried blood spot card, tailored for measuring Phosphatidylethanol (PEth), an alcohol biomarker with multiple clinical and forensic applications, has been evaluated in a scientific study. The study demonstrates that blood sampling by the qDBS card, fortified with an inhibitor of the enzyme forming PEth, enables accurate and legally secure analysis of PEth.
NeonMind – Canada’s NeonMind Biosciences Inc. purchased GMP grade psilocybin from Psygen Labs Inc. for its planned Phase II clinical trial expected to begin in Canada later this year. Psygen is a Calgary-based company specializing in the synthetic manufacture of psychedelic medicines. NeonMind plans to study the use of psilocybin alone and in combination with psychotherapy as a treatment for obesity.
