Abivax SA, of Paris, said it published a review in Drug Discovery Today on the mechanism of action for ABX-464, in development for inflammatory diseases. The review summarizes the multiple effects of ABX-464 in dampening inflammatory processes through the down-regulation of several critical pro-inflammatory cytokines and cells, like TNF-alpha, IL-6, MCP-1, IL-17 and Th17-positive cells, emphasizing the drug’s potential as an efficient and long-term effective therapy for the treatment of inflammatory diseases.
Adamas Pharmaceuticals Inc., of Emeryville, Calif., said it closed the settlement of patent litigation with Osmotica Pharmaceutical US LLC, a subsidiary of Osmotica Pharmaceuticals Inc., of Bridgewater, N.J., and completed the acquisition of the global rights to Osmolex ER (amantadine extended release), approved for treating Parkinson’s disease and drug-induced extrapyramidal reactions in adults.
Akston Biosciences Inc., of Beverly, Mass., and Lakepharma, a U.S.-based CRDMO, said they established a partnership under which Lakepharma will manufacture Akston’s adjuvanted COVID-19 vaccine candidate, AKS-452, which is set to begin phase I/II testing later this month. AKS-452 is a COVID-19-specific Fc fusion protein vaccine engineered to induce or boost a Th1/Th2 mixed immune response in patients against the receptor binding domain of the SARS-CoV-2 coronavirus spike protein.
Allergy Therapeutics plc, of Worthing, U.K., said an ex vivo biomarker study of blood samples from peanut allergy patients was initiated at Imperial College London to confirm the hypoallergic potential and immune response of the company’s virus like particle-based peanut allergy vaccine candidate. The study will use human samples and functional and molecular biomarkers to help the company establish the starting dose for its phase I study. Allergy Therapeutics expects to submit an IND for that study to the FDA in 2021.
Bavarian Nordic A/S, of Copenhagen, Denmark, announced it has entered contracts with three European governments for the supply of the Imvanex smallpox vaccine. The combined value of the contracts is €11 million (US$13.5 million), which will be revenue recognized during the first half of 2021, when deliveries are expected to occur.
Dicerna Pharmaceuticals Inc., of Lexington, Mass., announced that Novo Nordisk A/S, of Bagsværd, Denmark, nominated its first candidate under the existing agreement between the companies for the discovery and development of therapies using Dicerna’s GalXC RNAi platform technology. The first development candidate selected will be evaluated for the treatment of liver-related cardiometabolic diseases and triggers a $2.5 million milestone payment to Dicerna. Under the agreement, which closed in December 2019, Dicerna is eligible to receive $25 million annually for each of the first three years contingent on delivering RNAi molecules. The deal encompasses the exploration of more than 30 liver cell targets.
Emergex Vaccines Holding Ltd., of Abingdon, U.K., signed a collaboration and development agreement with the Institute of Technology on Immunobiologicals (Bio-Manguinhos) of the Oswaldo Cruz Foundation (Fiocruz) in Brazil to develop a COVID-19 vaccine using Emergex’s next-generation synthetic T-cell vaccine technology. The parties will work together to progress certain immunotherapeutic programs, including a COVID-19 vaccine candidate, through a regulatory pathway in Brazil. Emergex will support the performance of clinical trials, and manufacture, market, promote and distribute certain infectious diseases vaccines within the National Health Service of Brazil.
Endo International plc, of Dublin, announced that its subsidiary, Endo Ventures Ltd., entered definitive agreements with Radius Health Inc., of Waltham, Mass., to register, commercialize and distribute abaloparatide on an exclusive basis in Canada. Endo obtained the rights to abaloparatide-subcutaneous injection (abaloparatide-SC) and abaloparatide-transdermal patch (abaloparatide-TD). Paladin Labs Inc., an operating company of Endo, will be responsible for all commercial activities related to abaloparatide, a parathyroid hormone-related protein analogue under investigation for osteoporosis, and plans to file a new drug submission with Health Canada for abaloparatide-SC by the first quarter of 2022.
Evotec SE, of Hamburg, Germany, received a $6 million milestone payment from Bristol Myers Squibb Co., of New York, as part of the companies' induced pluripotent stem cell-based neuroscience partnership, following the latter’s decision to add another drug discovery project to the partnership's portfolio. Evotec and BMS, the successor in interest to Celgene Corp., initiated the collaboration in 2016 to identify disease-modifying treatments for neurodegenerative diseases.
Galapagos NV, of Mechelen, Belgium, and Selvita SA, of Krakow, Poland, announced that the strategic transaction in which Selvita acquired the contract research organization Fidelta d.o.o., of Zagreb, Croatia, from Galapagos has been completed. Selvita acquired 100% of the outstanding shares in Fidelta for an enterprise value of €31.2 million (US$37 million) plus the customary adjustments for net cash and working capital. Fidelta has competences in inflammation, fibrosis and anti-infectives and currently has 181 employees. The transaction is expected to almost double Selvita’s revenues, and the CRO will continue to operate under the Fidelta name.
Hemogenyx Pharmaceuticals plc, of London, entered a master translational research services agreement with the University of Pennsylvania, with the goal of advancing its CAR T cells (HEMO-CAR-T) through clinical trials. As part of the agreement, the company will retain the university to conduct translational research activities in support of the research being performed under an existing sponsored research agreement from August 2020.
Immunitybio Inc., of Culver City, Calif., announced the results of a detailed computer-based molecular dynamics simulation, conducted in collaboration with Microsoft Corp., of Redmond, Wash., that allowed visualization of the behavior of the SARS-CoV-2 spike protein. The simulations indicate that the spike protein of the virus has evolved to be a nearly ideal fit for the ACE2 receptor and showed the precise shape of the portion of the protein that binds to ACE2. The simulation may be useful in the creation of molecules that mimic ACE2, to which the virus would bind instead of living cells, and provides information that could be used to create therapies that change the shape of the spike receptor binding domain region. Microsoft and Nantkwest Inc., of El Segundo, Calif., provided the computing resources for the simulation. The findings are available on Biorxiv and are undergoing peer-review for publication.
Innate Pharma SA, of Marseille, France, said its decision to progress NKp46-based NK cell engager IPH-6101/SAR-443579 into IND-enabling studies triggered a €7 million (US$8.61 million) milestone payment from partner Sanofi SA, of Paris. Preclinical models from the collaboration’s first research program showed IPH-6101/SAR-443579 had antitumor activity, encouraging pharmacokinetic, pharmacodynamic and safety data in preliminary nonhuman primate studies and positive manufacturability properties. Sanofi is responsible for all future development, manufacturing and commercialization.
Moderna Inc., of Cambridge, Mass., said Israel’s Ministry of Health secured 6 million doses of the mRNA COVID-19 vaccine. Israel is the third country to authorize Moderna the vaccine’s importation. The first two were the U.S. and Canada. The company said similar authorizations are being reviewed in the EU Singapore, Switzerland and the U.K.
Morphic Therapeutic Inc., of Waltham, Mass., said it expanded its collaboration with Janssen Pharmaceuticals Inc., a unit of New Brunswick, N.J.-based Johnson & Johnson, initiating work that includes activating antibodies against a third integrin target. Morphic will receive a milestone payment and any new product candidates will be subject to milestones and royalties. Integrins are receptors expressed on the surface of most human cells. Integrin signaling controls a range of cellular processes, including cell survival, cell cycle progression, immune system activation, cell differentiation and cell migration, according to Morphic, which focuses on autoimmune diseases, fibrosis and immuno-oncology.
Motif Bio plc, of London, said it is working to complete a reverse takeover process with a U.K.-based candidate. The company said that its board expects to further update shareholders in the second half of January. Following its reclassification as an AIM Rule 15 cash shell in January 2020, according to Jonathan Gold, president and chief business officer, the company is required to acquire constituting a reverse takeover by Jan. 28. Should it fail, the company's admission to trading on AIM, a submarket of the London Stock Exchange, may be canceled, Gold added.
Phoenix Pharmalabs Inc., of Salt Lake City, said it completed a license agreement with the University of Bath in England for exclusive rights to a portfolio of 25 nociceptin compounds. Specific terms were not disclosed. One of the compounds, formerly known as BU-10038, has properties much like those of the company’s lead compound, PPL-103, and has been renamed PPL-138. It will be developed as a non-addictive treatment for chronic pain. PPL-103 is an agonist that partially stimulates mu, kappa and delta pain receptors in the brain. PPL-138 is a partial nociceptin/mu agonist.
Qpex Biopharma Inc., of San Diego, said it exercised a $15 million option from the U.S. Biomedical Advanced Research and Development Authority to support advancement of its anti-infective portfolio into the clinic. The company is developing three programs focused on treating extended-spectrum beta-lactamase and carbapenemase-producing pathogens, including Acinetobacter spp., Pseudomonas aeruginosa and Enterobacteriaceae, which the CDC considers serious or urgent antimicrobial resistance threats.
Revitope Oncology Inc., of Cambridge, Mass., said it will collaborate with Janssen Biotech Inc., a unit of New Brunswick, N.J.-based Johnson & Johnson, to conduct a feasibility study in the evaluation of Revitope's T-cell engager technology platform to develop next-generation bispecific antibody therapies. Revitope's platform exploits co-expressed tumor antigens to enable the development of specific cancer drugs by combining a pair of tumor-targeted antibodies with a shared silent T-cell engaging domain that become active only when they encounter cancer cells co-expressing both antigens
Rhythm Pharmaceuticals Inc., of Boston, said it entered a definitive agreement to sell its rare pediatric disease priority review voucher for $100 million up front. The voucher was granted to Rhythm by the FDA with the approval of Imcivree (setmelanotide) for chronic weight management in adult and pediatric patients 6 and older with obesity due to proopiomelanocortin, proprotein convertase subtilisin/kexin type 1 or leptin receptor deficiency confirmed by genetic testing.
Sosei Group Corp., of Tokyo, said it will regain the worldwide rights to its muscarinic agonist programs, licensed to Allergan plc in April 2016, which was acquired by North Chicago-based Abbvie Inc. in May 2020. The decision to return rights was based on business decisions regarding Abbvie's pipeline strategy and not on any efficacy, safety or other data related to the collaboration programs, Sosei noted. The company will conduct a full internal review to determine a strategy for the further development and re-partnering of the program.
Spinogenix Inc., of San Diego, said it will be collaborating with Rita Sattler at the Barrow Neurological Institute and Justin Ichida at the USC Keck School of Medicine on a grant awarded from the U.S. Department of Defense’s Congressionally Directed Medical Research Programs to evaluate its lead development candidate in amyotrophic lateral sclerosis (ALS). The grant will be used to study the effects of Spinogenix’s compound in human induced pluripotent stem cells from patients with ALS and from healthy volunteers. Additional experiments will be conducted in animal models of ALS.
Symvivo Corp., of Burnaby, British Columbia, signed a research collaboration with Merck & Co. Inc., of Kenilworth, N.J. Under the terms, Merck receives an option to take an exclusive license to Symvivo’s bacTRL platform technology for use in advancing delivery of oral vaccines. Financial details were not disclosed.
Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, disclosed the completion of its sale of a portfolio of select prescription products to Greifswald, Germany-based Cheplapharm Arzneimittel GmbH for $562 million. The portfolio includes 16 prescription pharmaceutical products sold predominantly in Europe. The divestment agreement was first made known in September.
Tonix Pharmaceuticals Holding Corp., of Chatham, N.J., signed a second research collaboration agreement with Massachusetts General Hospital to develop TNX-1500, a humanized monoclonal antibody that targets the CD40-ligand (also known as CD154, T-BAM or 5c8 antigen1) for the prevention and treatment of organ transplant rejection. The new collaboration will focus on kidney transplantation, while an earlier collaboration with MGH is focused on heart transplantation. Researchers will study TNX-1500 in a variety of models including nonhuman primates.
Vigeneron GmbH, of Munich, disclosed a global collaboration and licensing agreement with Biogen Inc., of Cambridge, Mass., to develop and commercialize gene therapy products based on adeno-associated virus (AAV) vectors to treat inherited eye diseases. The companies will use Vigeneron’s vgAAV, novel engineered AAV capsids, to transduce retinal cells via intravitreal injections. Vigeneron will receive an up-front payment and R&D funding for the mutually agreed workplan. Vigeneron will be eligible to receive development, regulatory and commercial milestone payments, and will also be eligible to receive tiered royalties.
Xbrane Biopharma AB, of Solna, Sweden, has re-negotiated a pre-existing license agreement of certain intellectual property rights, mainly patent US7871815B2, with Vaxiion Therapeutics Inc., of San Diego. The re-negotiated agreement gives Xbrane full nonexclusive rights to the intellectual property (IP) and entitles Vaxiion to a low single-digit-million SEK up-front payment as well as low single-digit royalties on sales income generated by Xbrane from pharmaceutical products produced, through February 2024. After that, Xbrane can continue to utilize the Vaxiion IP for all its products without any further royalty payments to Vaxiion.
Y-Biologics Inc., of Daejeon, South Korea, and 3D Medicines Inc., of Shanghai, signed a license agreement granting 3D Medicines exclusive rights to develop, manufacture and commercialize YBL-013, a T-cell bispecific engager based on ALiCE platform technology, in the territory of greater China. Y-Biologics will receive an up-front fee of $2 million and is eligible to receive up to $85 million in additional development, regulatory, commercialization and sales milestone payments as well as up to double-digit royalties on net sales. The parties will share IND costs. YBL-013 targets CD3 on T cells and PD-L1 on cancer cells.