Abveris Inc., of Canton, Mass., signed an agreement with Immunitas Therapeutics Inc., of Cambridge, Mass., for the discovery of monoclonal antibodies to expand the Immunitas therapeutic pipeline. Abveris will utilize its DiversimAb mouse model in combination with its next-generation B-cell screening platform, powered by the Berkeley Lights Beacon, to discover monoclonal antibodies for use as research reagents and therapeutics for immuno-oncology. Terms were not disclosed.
Aegle Therapeutics Corp., of Boston, was awarded a grant by the U.S. Department of Defense to fund the continued development of the company's product candidate AGLE-102. The grant will support clinical manufacturing and the completion of a phase I study in burn patients. AGLE-102 consists of allogeneic mesenchymal stem cell-derived extracellular vesicles.
Almirall SA, of Barcelona, Spain, and the University of Dundee in the U.K. formed a research collaboration agreement with the aim to identify and develop a novel class of medicines that target and degrade disease-causing proteins. The company aims to develop drugs for severe skin diseases with a high level of unmet medical need. The pair will work with novel biological targets defined by Almirall.
Ampio Pharmaceuticals Inc., of Englewood, Colo., disclosed the publication of a scientific manuscript on Ampion effects on peripheral blood monocytes (PBMC) in a preprint report, “Ampion suppresses cytokine release by modulating select inflammatory transcription factor activity in stimulated PBMC.” Ampion reduces pro-inflammatory cytokine release by activating the immunoregulatory transcription factors PPARγ and AhR. Ampio said the publication adds to the growing evidence of the important anti-inflammatory activities of Ampion in various inflammation-related conditions, including the dysregulated immune response observed in severe COVID-19-infected patients.
Betterlife Pharma Inc., of Vancouver, British Columbia, is teaming up with Virtrial LLC, of Scottsdale, Ariz., to conduct patient monitoring for imminent COVID-19 clinical trials in Australia to test the efficacy of AP-003, an interferon alpha 2b formulation. Virtrial’s platform enables Betterlife to empower selected clinical research sites to perform virtual visits – a combination of secure video, audio, chat and messaging, which can be used on any device.
Cellgenix GmbH, of Freiburg, Germany, completed the second phase of its facility expansion. The company has reconstructed and expanded the production facility for cytokines and implemented an automated filling and freeze-drying line. The move increases the company’s bulkware production footprint so that finished product capacity for cytokines is substantially increased.
Chromadex Corp., of Los Angeles, highlighted a new study in Nature Immunology that found nicotinamide riboside (NR) helped energize tumor-infiltrating T cells in samples extracted from mice. In a preclinical mouse model, NR was shown to improve T-cell function, an important component of immunotherapies such as PD-1 and PD-L1 inhibitors, the company noted. The findings lend further data to the potential role of NR in supporting healthy mitochondrial function.
Cytovia Therapeutics Inc., of New York, said it entered a research and licensing agreement with the French National Institute of Health and Medical Research (INSERM) to develop natural killer (NK) engager bispecific antibodies and induced pluripotent stem cell (iPSC) chimeric antigen receptor (CAR) NK cell therapy targeting CD38, a marker of multiple myeloma. Cytovia is licensing INSERM's CD38 antibody and CAR patent, then applying its NK engager bispecific antibody and iPSC CAR NK technology platforms. The research agreement will include evaluation of the therapeutic candidates at the Hôpital Saint-Louis’ Research Institute.
Evotec SE, of Hamburg, Germany, said it received $6 million from New York-based Bristol Myers Squibb Co. (BMS) following the decision to expand their joint portfolio with another drug discovery project. Evotec and Celgene Corp., now owned by BMS, initiated the collaboration in 2016 to identify disease-modifying treatments for a range of neurodegenerative diseases. The project has “direct relevance to Alzheimer’s disease,” according to Evotec.
Gilead Sciences Inc., of Foster City, Calif., and the European Commission said they signed a joint procurement agreement to enable rapid and equitable access to Veklury (remdesivir) to treat COVID-19 in adult and adolescent patients with pneumonia requiring supplemental oxygen in the European Union (EU). The agreement enables participating countries in the EU and the European Economic Area and the U.K. to purchase Veklury for both real-time demand and stockpiling needs, coordinated by the European Commission. The agreement covers purchases of Veklury for six months and has the option to be extended.
Goldfinch Bio Inc., of Cambridge, Mass., said a new data analysis demonstrates the benefit of continuous proteinuria reduction on kidney survival in patients with focal segmental glomerulosclerosis (FSGS) and underscores the utility of proteinuria as a clinically meaningful endpoint in FSGS. The analysis revealed that a greater reduction in proteinuria was associated with both a slower rate of decline in estimated glomerular filtration rate (eGFR), a measure of kidney function, and a decreased likelihood of progression to end-stage kidney disease or death, the company said. In preclinical studies, Goldfinch added, treatment with lead product candidate GFB-887 significantly reduced proteinuria in models of both FSGS and diabetic nephropathy.
ILC Therapeutics Ltd., of Scotland, U.K., said its synthetic interferon, Alfacyte, is 15 to 20 times more effective at preventing the spread of SARS-CoV-2 in cell culture than other commercially available interferons such as interferon-alpha 2 and interferon-beta 1a. COVID-19 tries to slow down the body’s innate interferon response to viral infection and Alfacyte is designed to help accelerate the response and prevent disease progression, the company said. Independent research at the University of St. Andrews demonstrated the effectiveness of Alfacyte in vitro against SARS-CoV-2, Goldfinch added.
IMV Inc., of Dartmouth, Nova Scotia, said it has been selected for additional funding by the Canadian government, bringing total support to $10 million for clinical development and manufacturing of its vaccine, DPX-COVID-19. In consultation with Health Canada, IMV said it decided to combine its original phase I and II studies into a single trial to accelerate development and the timeline. DPX-COVID-19 is a synthetic, targeted vaccine composed of multiple peptides of the spike protein of the coronavirus.
Intec Pharma Inc., of Jerusalem, said it entered a new research collaboration agreement with MSD, the tradename of Merck & Co. Inc., of Kenilworth, N.J. Details of the agreement are confidential, according to Intec, a clinical-stage biopharmaceutical company developing drugs based on its oral drug delivery system designed to improve the efficacy and safety of existing drugs and drugs in development by using a gastric retention and release mechanism.
Johnson & Johnson, of New Brunswick, N.J., said the European Commission, acting on behalf of the European Union (EU) Member States, has approved an advance purchase agreement in which the Janssen Pharmaceutical Companies will supply 200 million doses of its COVID-19 vaccine candidate following approval or authorization from regulators. The EU Member States also have the option to secure up to 200 million additional doses. Separate to the agreement, as part of J&J’s larger commitment to respond to the COVID-19 pandemic, it revealed plans to allocate up to 500 million vaccine doses toward international efforts to ensure access for lower-income countries.
Kineta Chronic Pain LLC, a subsidiary of Seattle-based Kineta Inc., said it will extend and expand its research collaboration with Genentech, a member of the Roche Group, of Basel, Switzerland, to continue development of α9/α10 nicotinic acetylcholine receptor (nAChR) antagonists and advance KCP-506, a potentially first-in-class α9α10 nAChR antagonist in development for the treatment of chronic neuropathic pain, through phase I trials. Kineta receives an undisclosed payment from Genentech to extend the collaboration.
Knopp Biosciences LLC, of Pittsburgh, said it entered the second year of research funded by the U.S. NIH to utilize its Kv7 platform to discover and develop non-opioid therapies for the treatment of chronic pain. The company has developed a discovery platform of molecules directed to a non-opioid biological target linked to chronic pain caused by damage to nerves. The drug target is a cellular membrane potassium channel called Kv7.2/7.3, which regulates the flow of electrically charged ions required to modulate the excitability of cells. The grant funding up to $8 million is contingent upon the attainment of milestones over a five-year period.
Eli Lilly and Co., of Indianapolis, and the Bill & Melinda Gates Foundation, as part of the COVID-19 Therapeutics Accelerator, said they entered an agreement to facilitate access to future Lilly therapeutic antibodies under development for the prevention and treatment of COVID-19 to benefit low- and middle-income countries. Commercial manufacturing will start in April 2021 at the Fujifilm Diosynth Biotechnologies facility in Denmark, where the Therapeutics Accelerator has reserved manufacturing capacity.
Marinomed Biotech AG, of Vienna, which is developing treatment for autoimmune gastritis together with the Medical University of Vienna, said that using its Marinosolv technology platform, its research focus will be on an anti-inflammatory treatment rather than treating only the deficiency symptoms of the condition. Anti-inflammatory drugs will be applied locally in the stomach in order to act predominantly in affected areas.
Moderna Inc., of Cambridge, Mass., said it entered an agreement for a commitment of up to $56 million from the U.S. Defense Advanced Research Projects Agency (DARPA) to fund development of a mobile manufacturing protype leveraging the company’s existing manufacturing technology that is capable of rapidly producing vaccines and therapeutics. The agreement builds on a previous assistance grant with DARPA established in 2013. In separate news, Moderna said it regained all rights to respiratory syncytial virus (RSV) vaccine mRNA-1172 from Merck & Co. Inc., of Kenilworth, N.J., including rights to develop RSV vaccines for adult populations. mRNA-1172, which uses a Merck lipid nanoparticle for delivery, entered phase I development in 2019. Under the terms of the agreement, Merck will complete the phase I study and transition the program to Moderna, which now has consolidated all global commercial rights to all development candidates in its core prophylactic vaccines modality. Among its RSV candidates, Merck decided to focus its efforts on RSV infections through its antibody program that is currently in phase II development. Moderna and Merck will continue their ongoing collaboration in cancer vaccines.
Nordic Nanovector ASA, of Oslo, Norway, said its preclinical study investigating the ability of Betalutin (177Lu-lilotomab satetraxetan) to reverse rituximab-resistance in disease models of non-Hodgkins lymphoma has been published in the October 2020 issue of The Journal of Nuclear Medicine. The study found that Betalutin, an anti-CD37 radioimmunoconjugate, acted synergistically with rituximab to suppress tumor growth in a rituximab-resistant xenograft NHL mouse model. The median survival time of mice treated with this combination doubled when compared to survival of mice given Betalutin monotherapy and was five times longer than for mice given rituximab monotherapy.
Oblique Therapeutics AB, of Stockholm, said that together with collaborators at Sahlgrenska University Hospital and Karolinska Institutet it was granted SEK5 million (US$563,859) by Vinnova, the Swedish government’s innovation agency, to develop neutralizing antibodies against SARS-CoV-2 and to use its Abiprot platform to develop antibodies swiftly against future pandemics. Using the Abiprot antibody discovery platform, Oblique and collaborators showed earlier in 2020 that potential epitopes for neutralizing antibodies can be identified within days from a single patient nasal swab.
Privately held Oligomerix Inc., of New York, said it relocated its headquarters to White Plains, N.Y., to accommodate growth and continue the expansion of R&D operations at its lab facilities, located at the Ullmann Research Center for Health Sciences in the Albert Einstein College of Medicine. The company is developing small-molecule therapeutics targeting tau to treat Alzheimer’s disease and related neurodegenerative disorders.
Recombinetics Inc., of Eagan, Minn., said that it merged with Makana Therapeutics Inc., of Boston, which will operate as a subsidiary to address the shortage of organs for transplant. Recombinetics said both companies have expertise and strong intellectual property positions in clinical organ transplantation, genetic engineering, reproductive technology and xenotransplantation and plan to focus on and commercialize a pipeline of transplantable cells, tissues and organs for human use, with kidneys for human patients as the first initiative.
Redhill Biopharma Ltd., of Tel Aviv, Israel, said it gained the rights to Movantik (naloxegol) in Israel from Astrazeneca plc, of Cambridge, U.K., giving it global rights to the opioid receptor mu antagonist outside Europe and Canada. Movantik is approved in Israel under the brand name Moventig to treat opioid-induced constipation but is not yet commercialized, and Redhill is evaluating the potential for a local commercialization partnership.
Rentschler Biopharma SE, of Laupheim, Germany, said it reached an agreement to serve as contract development and manufacturing organization partner for Biontech SE, of Mainz, Germany. Initially, Rentschler will be responsible for key aspects of cGMP drug substance manufacturing for BNT-162b2, the mRNA-based vaccine against SARS-CoV-2 in development by Biontech and Pfizer Inc., of New York, that has moved into a global phase III trial. Under the agreement, Rentschler assumed responsibility for downstream processing to provide highly purified drug substance. In addition to large-scale production services for the COVID-19 vaccine, the agreement provides for small-batch manufacturing of other Biontech RNA programs for use in clinical trials. Financial terms were not disclosed.
Santen Pharmaceutical Co. Ltd., of Osaka, Japan, and non-profit Orbis International, of New York, agreed to a 10-year partnership to tackle the burden of eye diseases in low- and middle-income countries, especially in Asia. The organizations will seek to accelerate the growth of quality eye care systems by building the capacity of eye care professionals, developing digital technology and increasing awareness of the importance of eye health. These activities will supplement the digital glaucoma educational initiative for ophthalmologists in China that Santen and Orbis formed in June 2020.
Seattle Genetics Inc., of Bothell, Wash., said it rebranded as Seagen Inc. to reflect its expansion into global markets. The company’s common shares will continue to trade on Nasdaq under the ticker SGEN.
Sorrento Therapeutics Inc., of San Diego, said it discovered a small molecule termed Salicyn-30 that demonstrated a 3- to 4-log reduction in SARS-CoV-2 virus infection in an in vitro virus infection experiment. Sorrento screened a collection of salicylanilide compounds of interest from a library of molecules developed upon a chemical scaffolding known as salicylanilides. In preliminary preclinical experiments, comparative data suggested Salicyn-30 may be more effective than another salicylanilide, niclosamide, a small molecule previously used to treat tapeworm infection that is in a phase I program against COVID-19. Sorrento plans to assess Salicyn-30 as a stand-alone therapy to reduce viral load in individuals with severe COVID-19 infection and, in parallel, to examine its potential synergy in combination with antibodies in its portfolio.
Sumitomo Chemical Co. Ltd., of Tokyo, and Sumitomo Dainippon Pharma Co. Ltd., of Osaka, said they established S-Racmo Co. Ltd. as a joint venture to develop production methods and to manufacture products for the regenerative medicine and cell therapy field. S-Racmo, which will conduct business as a contract development and manufacturing organization, will use a manufacturing facility for regenerative medicine and cell therapy owned by Sumitomo and will construct a second facility on the premises of Sumitomo Dainippon’s Central Research Laboratories. In addition, Sumitomo Dainippon initiated negotiations with privately held Corneagen Inc., of Seattle, to manufacture its corneal endothelial cells to treat corneal diseases so that S-Racmo can assume these operations in Japan.
Translate Bio Inc., of Lexington, Mass., said it plans to present preclinical data at the virtual 34th Annual North American Cystic Fibrosis Conference showing that the design of mRNA sequences encoding rationally engineered cystic fibrosis transmembrane conductance regulator, or CFTR, protein produced highly active ion channels and enhanced protein expression compared to a reference sequence encoding the native protein in vitro.
Treefrog Therapeutics SAS, of Bordeaux, France, and Invetech Pty Ltd., of Melbourne, Australia, said they formed a strategic partnership to develop a GMP-compliant device for high-throughput stem cell encapsulation. The companies began to collaborate on the project in 2019 and delivered a beta encapsulation system in April 2020 with a throughput of 1,000 stem cell capsules per second. The new partnership is designed to secure GMP compliance and further enhance the functionality, yield and processing conditions of the encapsulation device, with the goal of reaching the market by year-end 2022.
Urovant Sciences Ltd., of Basel, Switzerland, said it inked a five-year U.S. co-promotion agreement with Sunovion Pharmaceuticals Inc., of Marlborough, Mass., to promote vibegron in the primary care segment following FDA approval. Sunovion agreed to deploy its multispecialty sales force to bring the beta 3 adrenoceptor agonist to primary care physicians, targeting this segment through March 31, 2026. In exchange, Sunovion is set to receive a mid-single-digit repayment fee based on net vibegron sales beginning on April 1, 2023. In March, the FDA accepted the NDA for vibegron to treat overactive bladder and assigned a PDUFA date of Dec. 26. The vibegron co-promotion agreement is separate from the exclusive three-year agreement between Urovant and Sunovion for services related to wholesale trade and retail distribution, contract operations and select account management activities for vibegron. Sunovion is a subsidiary of Sumitomo Dainippon Pharma Co. Ltd., of Osaka, Japan, which also is a majority shareholder of Urovant.
Vincera Pharma Inc., of Santa Clara, said it inked an exclusive license agreement with Bayer AG, of Leverkusen, Germany, to develop and commercialize an early stage oncology portfolio. Vincera agreed to in-license VIP-152 (formerly BAY-1251152), a selective positive transcription elongation factor b (PTEFb)/cyclin-dependent kinase 9 (CDK9) inhibitor to treat cancer. Additionally, Vincera will receive assets and license technology for a preclinical bioconjugation platform to address the limitations of small-molecule and antibody-drug conjugates in oncology. The preclinical assets include VIP-236, a small-molecule drug conjugate targeting advanced and metastatic cancer; VIP-943 (formerly BAY-943) and VIP-924 (formerly BAY-924), antibody-drug conjugates targeting hematologic tumors; and VIP217, an oral PTEFb/CDK9 inhibitor in discovery. Vincera agreed to pay Bayer an up-front license fee and development and commercial sales milestone payments as well as an annual royalty in the single- to low-double-digit percentage range on net sales.
Willow Biosciences Inc., of Vancouver, British Columbia, said it agreed to partner with researchers at the University of Lethbridge and the University of Calgary to study the therapeutic potential of non-psychoactive cannabinoids on intestinal inflammation, abdominal pain and depression. The studies, financially supported by Alberta Innovates, will involve laboratory testing in preclinical disease models. Willow will provide four non-plant-derived cannabinoids for use in the research, which is set to begin in the fourth quarter of 2020.