Affiris AG, of Vienna, said preclinical findings about its monoclonal antibody (MAb), C6-17, targeting Huntington's disease (HD), published in Neurobiology of Disease, showed effective binding with mutant huntingtin protein (mutHTT) and the ability to deplete the protein from cell culture supernatants. Using cell-based assays, Affiris also showed that extracellular secretion of mutHTT into cell culture media and its subsequent uptake in recipient HeLa cells can be blocked almost entirely by C6-17. Immunohistochemical stainings of post-mortem HD brain tissue confirmed specificity of the MAb to human mutHTT aggregates.
AGC Biologics A/S, of Soborg, Denmark, said it will partner with Novavax Inc., of Gaithersburg, Md., on large-scale GMP production of Matrix-M, the adjuvant component of Novavax' coronavirus vaccine candidate, NVX-CoV2373, which is in the phase I portion of a phase I/II trial.
Alivamab Discovery Services LLC, of San Diego, said it formed a discovery partnership with Tanabe Research Laboratories USA Inc., an independent subsidiary of Mitsubishi Tanabe Pharma Corp., of Osaka, Japan, to generate and deliver therapeutic antibody candidates using its Alivamab Mouse discovery platform.
Amryt Pharma plc, of London, said it inked an agreement giving Swixx Biopharma AG, of Baar, Switzerland, exclusive distribution rights to Myalepta (metreleptin) in the EU territories of Bulgaria, Croatia, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Poland, Romania, Slovakia and Slovenia. In addition, Swixx will distribute Myalepta in the West Balkan countries of Albania, Bosnia and Herzegovina, Kosovo, Montenegro, North Macedonia and Serbia. Financial terms were not disclosed. Myalepta, acquired in 2019 in Amryt’s all-stock takeover of Aegerion Pharmaceuticals Inc., is approved by the EMA to treat, in conjunction with diet, complications of leptin deficiency in individuals with generalized and partial lipodystrophy.
Avectas Ltd., of Dublin, said it agreed to collaborate with The Simon Laboratory at the University of California, Davis, which will characterize cells engineered with the company’s nonviral Solupore cell engineering platform. The collaboration will involve the transfer of Avectas technology to The Simon Laboratory, where researchers plan to engineer immune cells and study the delivery of cargoes such as DNA, mRNA, proteins and gene editing tools to cells while retaining cell viability and functionality, with the goal of developing autologous and allogeneic cell therapies.
CB Therapeutics Inc., of San Diego, said it achieved biosynthesis of N,N-dimethyltryptamine (DMT) and related tryptamine-based compounds in yeast and filed a patent on their biosynthetic production process for DMT and related analogues. Analysis of raw analytical DMT samples showed the biosynthetic process to be more efficient, of higher purity and less expensive than existing chemical and biosynthetic techniques, plant extractions or other production methods, enabling trials of related compounds as therapeutics.
Celmatix Inc., of New York, said it achieved the first milestone in its five-year, multitarget alliance with Evotec SE, of Hamburg, Germany. The milestone was triggered when Evotec collaborator Bayer AG, of Leverkusen, Germany, advanced an initial drug program focused on a Celmatix-identified target from Evotec. The polycystic ovary syndrome collaboration with Bayer, formed in January 2020, leverages the Celmatix-Evotec alliance, aimed at developing preclinical programs for prevalent, underserved conditions that affect women’s reproductive health.
Distributed Bio LLC, of South San Francisco, said it formed a comprehensive research partnership with Mediar Therapeutics Inc., of Cambridge, Mass., which is developing candidates to halt or reverse fibrosis. Distributed Bio will use its Superhuman2.0 antibody discovery platform to identify lead antibodies for Mediar programs. The company’s Superhuman2.0 antibody library encompasses 76 billion sequence-unique antibodies.
Eleva GmbH, of Freiburg, Germany, said it is exploring the potential of one of its drug candidates for first-in-line therapy of COVID-19. The compound, factor H, is part of the complement system, which is believed to affect the severity of the course of COVID-19. Eleva has developed factor H previously for a different indication and taken it through preclinical stages. The company is now looking to accelerate the COVID-19-specific evaluation with a pharmaceutical partner.
Ervaxx Ltd., of London, said, it rebranded as Enara Bio Ltd. to reflect the company’s expanded discovery and development strategy beyond an initial focus on endogenous retroviral antigens for the development of cancer vaccines. Enara, derived from an Arabic word that means illumination and enlightenment, was selected to illustrate the company’s mission to explore genomic dark matter as a source of cancer‐specific T‐cell antigens and to recognize its T-cell receptor research capabilities.
Katana Pharmaceuticals Inc., of San Francisco, said it received the first payment from a March of Dimes innovative challenge grant of up to $1.05 million to develop a non-opioid treatment for neonatal abstinence syndrome.
Kymab Ltd., of Cambridge, U.K., said the U.S. Patent Trial and Appeal Board (PTAB) rejected an inter partes review attempt by Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., to invalidate a fifth Kymab patent (U.S. patent No. 10,165,763) that is part of a series covering genetically modified mice with chimeric human/mouse antibody genes used to produce human antibody therapeutics as well as the therapeutic antibodies themselves. Other so-called “Bradley patents” were previously upheld by the PTAB against opposition from Regeneron.
Kymera Therapeutics Inc., of Cambridge, Mass., said it initiated enrollment in a non-interventional trial assessing the role of IRAK4 expression in diseased and normal skin and blood and its relationship to inflammatory biomarkers and disease stage in individuals with hidradenitis suppurativa (HS) and atopic dermatitis (AD). The trial will enroll up to 30 people with mild, moderate and severe HS and up to 10 with AD. Kymera is developing orally administered IRAK4 degraders to treat Toll-like receptor/interleukin-1 receptor-driven autoimmune and autoinflammatory diseases and plans to advance its lead candidate into the clinic in the first half of 2021.
Lupin Ltd., of Mumbai, said it inked distribution agreements for Namuscla (mexiletine) to treat myotonia in adults with non-dystrophic myotonic disorders. Exeltis Healthcare SL, of Guadalajara, Spain, will commercialize the drug in Spain and Portugal, Cresco Pharma BV, of Meerssen, the Netherlands, will commercialize it in that country and Macure Pharma ApS, of Copenhagen, in the Nordic countries. Lupin will continue to commercialize Namuscla in Germany and the U.K. and expects to launch the product in 2020 in Austria and France. Financial terms were not disclosed.
Novellusdx Ltd., of Berkeley, Calif., said it entered an exclusive worldwide license agreement with Plexxikon Inc., also of Berkeley, Calif., for PLX-8394, a clinical-stage oncology drug candidate that targets the BRAF protein. PLX-8394 is completing a phase I/II trial in patients with advanced, unresectable solid tumors. Plexxikon granted Novellus rights to research, develop, manufacture and exclusively commercialize PLX-8394 worldwide. Plexxikon will receive an undisclosed up-front payment, additional developmental milestones and royalty payments. PLX-8394 is an oral small-molecule inhibitor of the oncogenic BRAF serine/threonine-protein kinase, which accelerates BRAF-mutant cancers by activating the RAS/MAPK pathway.
After reviewing positive preliminary data, Octapharma USA, of Hoboken, N.J., said it will extend funding from an investigator-initiated study for treating COVID-19 symptoms, specifically for those with hypoxia and are at highest risk of requiring mechanical ventilation. The randomized open-label study is evaluating the standard of care (SOC) plus intravenous immunoglobulin compared to SOC alone in the treatment of COVID-19 infection, specifically in preventing mechanical ventilation in COVID-19 patients requiring high-flow oxygen. Twenty adults are enrolled.
Pharmabcine Inc., of Daejeon, South Korea, said it entered a license agreement with Wincal Biopharm, a wholly owned U.S. subsidiary of Pharmabcine, so Wincal can expand the commercial value of Pharmabcine’s existing and future assets through R&D efforts. Under the agreement, Wincal will use Pharmabcine’s assets to develop new platforms designed to enhance biological activities of traditional antibody therapeutics to target broader disease areas.
Pluristem Therapeutics Inc., of Haifa, Israel, said it has been selected as a member of the CRISPR-IL consortium, a group funded by the Israeli Innovation Authority. CRISPR-IL brings those with life science and computer science experience from academia, medicine and business to develop artificial intelligence based end-to-end genome-editing solutions. The multispecies genome editing products for human, plant and animal DNA have applications in the pharma, agriculture and aquaculture industries.
Swift Biosciences Inc., of Ann Arbor, Mich., and Arbor Biosciences, also of Ann Arbor, a division of Chiral Technologies, said they agreed to partner to offer a complete workflow for RNA-Seq library preparation and targeted enrichment of the SARS-CoV-2 genome. An enabling offering for epidemiological research and public health surveillance, the partnership uses Swift's Adaptase technology within the Swift RNA Library Kits combined with Mybaits technology from Arbor Biosciences for hybridization-based target enrichment of the virus for whole genome sequencing.
Tenax Therapeutics Inc., of Morrisville, N.C., said it regained compliance with the minimum bid price requirement for continued listing on Nasdaq. Tenax shares (NASDAQ:TENX) rose 13% to close June 2 at $1.64 on upbeat results from a phase II trial testing chronic administration of the calcium sensitizer in patients with pulmonary hypertension associated with heart failure and preserved ejection fraction. Shares closed June 3 at $1.50, down 14 cents.
Tetra Bio-Pharma Inc., of Ontario, Canada, and Altus Formulation Inc., of Mirabel, Canada, jointly launched Tallc Corp. Inc., of Quebec, to develop TA-A001, an endocannabinoid CB2 receptor activator with anti-inflammatory analgesic properties, as an intravenous analgesic alternative to opioid medications and nonsteroidal anti-inflammatory drugs. The companies also said Tallc will develop TA-A001 as a topical micellar eye drop for ocular pain and dry eye disease.