A2 Biotherapeutics Inc., of Agoura Hills, Calif., said it entered an agreement with Merck & Co. Inc., of Kenilworth, N.J., in which A2 will continue research and preclinical development of its undisclosed Tmod cell therapy candidate, with the parties to co-fund A2's clinical development and allogeneic manufacturing activities through phase I. Merck will assist with preclinical development and has the option to exclusively develop, manufacture and commercialize the candidate following phase I. Under the terms, A2 will receive an up-front payment, and will be eligible for opt-in and milestone payments, plus royalties on sales of any approved product. A2 will also receive from Merck an equity investment and reimbursement of certain expenses. Merck has the option to designate a new Tmod program with increased economic terms. A2's Tmod engineered T cells are designed to combine a potent activating mechanism to kill tumor cells with a blocking mechanism that protects normal cells from harm by exploiting the loss of genetic material in tumors.
Abivax SA, of Paris, said its ongoing phase IIb/III miR-AGE study of ABX-464, a drug designed to up-regulate miR124, in high-risk COVID-19 patients was declared a research national priority by the French government steering committee therapeutic clinical trials and other research (CAPNET). That committee, advised by the REACTing Scientific Council, has been created by the French government to identify the most promising and impactful COVID-19 clinical trials in order to help investigators focus their patient recruitment and to foster the swift availability of high-level study results. Clinical trials declared research national priority and their sponsors have access to an accelerated regulatory review and approval process conducted by the French regulatory authorities (ANSM) and the French Ethics committee. The designation also incentivizes clinical investigators to prioritize enrollment of their patients in those clinical trials and may provide institutional financing of those studies.
Amgen Inc., of Thousand Oaks, Calif., and Medicines Development for Global Health (MDGH), a nonprofit biopharma company, said they entered a license agreement for AMG-634, a PDE4 inhibitor in development for tuberculosis and erythema nodosum leprosum (ENL), an inflammatory cutaneous and systemic complication of leprosy. The compound is in phase II development with studies led by the Aurum Institute NPC (TB study) and The Leprosy Mission Nepal (ENL study). Amgen had acquired AMG-634 (formerly CC-11050) as part of its acquisition of Otezla (apremilast) from Celgene in 2019 as part of the latter’s acquisition by Bristol Myers Squibb Co., of New York. Under the terms of the agreement, MDGH will assume full responsibility for the further development and commercialization of AMG-634.
Arbor Biotechnologies Inc., of Cambridge, Mass., and Swiss manufacturer Lonza entered a license agreement in which Arbor will provide Lonza access to its next-generation CRISPR-based gene editing technology for use in Lonza’s bioproduction products and services. Financial terms were not disclosed.
Bioinvent International AB, of Lund, Sweden, said that New York-based Pfizer Inc. has selected antibodies directed at a previously selected target under the companies' cancer immunotherapy research collaboration and license agreement. The agreement, which the companies entered in December 2016, covers developing antibodies from Bioinvent's discovery platform targeting tumor-associated myeloid cells. The selection triggered a $3 million payment to Bioinvent, which is also eligible for further milestone payments from development of the antibodies, and potential selection and development of further antibodies directed at the same target.
Following a six-month pilot collaboration, Bridgebio Pharma Inc., of San Francisco, and the University of California, San Francisco have created a three-year alliance to identify early translational research to accelerate into clinical development and commercialization. The partnership is designed to enable sponsored research agreements for certain labs working between the school and Bridgebio. The collaborations could lead to the creation of Bridgebio affiliates to support clinical development, the company said.
Celcuity Inc., of Minneapolis, said it will collaborate with Massachusetts General Hospital and Puma Biotechnology Inc., of Los Angeles, to conduct a phase II trial evaluating the efficacy and safety of Puma's Nerlynx (neratinib) and Cambridge, U.K.-based Astrazeneca plc’s Faslodex (fulvestrant) in previously treated metastatic HR-positive, HER2-negative breast cancer patients selected with Celcuity's Celsignia HER2 Activity Test. Massachusetts General Hospital is the sponsor. Celcuity said it expects interim results 12 to 15 months after the protocol is activated and final results 12 to 15 months later. Celcuity also said it expects enrollment to begin in the second quarter of 2021.
Cocrystal Pharma Inc., of Bothell, Wash., said it selected CDI-45205, a broad-spectrum protease inhibitor, as the lead compound for further development against coronaviruses including SARS-CoV-2.
CDI-45205 was obtained by an exclusive license from Kansas State University Research Foundation in April. The agreement also provides Cocrystal with an exclusive, royalty-bearing license to develop and commercialize therapeutic, diagnostic and prophylactic products against coronaviruses, caliciviruses and picornaviruses based on antivirals discovered by Kansas State.
Compugen Ltd., of Holon, Israel, said it hit the first preclinical milestone in its collaboration with Astrazeneca plc, of Cambridge, U.K., triggering a $2 million payday for Compugen. Astrazeneca is developing bispecific and multispecific antibody products based on one of Compugen's pipeline programs and is responsible for all research, development and commercial activities. Compugen received a $10 million up-front payment and is eligible to receive up to $200 million in development, regulatory and commercial milestones for the first product as well as tiered royalties on future product sales.
Cytokinetics Inc., of South San Francisco, said Les Laboratoires Servier, of Paris, and Institut de Recherches Internationales Servier terminated the sublicense agreement between Amgen Inc., of Thousand Oaks, Calif., and Servier to develop and commercialize omecamtiv mecarbil in Europe and the Commonwealth of Independent States, including Russia. The termination is effective March 18, 2021, when all development, commercialization and other rights regarding omecamtiv mecarbil revert to Amgen. Amgen terminated the collaboration and option agreement between Amgen and Cytokinetics effective May 20, 2021. All worldwide rights related to the development and commercialization of omecamtiv mecarbil return to Cytokinetics on that date. Omecamtiv mecarbil is a cardiac myosin activator for treating heart failure with reduced ejection fraction.
A second monoclonal antibody against the COVID-19 spike protein from Halberd Corp., of Jackson Center, Pa., produced a stronger affinity for the SARS-CoV-2 antigen than its initial antibody, the company said. In vitro experiments show the antibodies demonstrated a high degree of affinity and lysis for infected cells, the company added, and in vivo studies are getting underway to demonstrate their efficacy in diagnosing COVID-19 as well as preventing viral replication and multi-organ system damage associated with COVID-19.
Helix Biopharma Corp., of Richmond Hill, Ontario, said it closed the transaction with Caiac Fund Management AG for the company's remaining holdings in its Polish subsidiary, Helix Immuno-Oncology SA, for gross proceeds of PLN6.7 million (US$1.81 million). In November, Helix reached a definitive agreement with Caiac to buy Helix’s remaining holdings in the subsidiary, which is developing CAR T therapies.
Hyundai Bioscience Co. Ltd., of Seoul, South Korea, said it is developing Poly-COV01, an injectable for treating severe cases of COVID-19, and is planning an efficacy study. Poly-COV01 was developed for patients who cannot ingest drugs orally or through nasal inhalation. The active pharmaceutical ingredient is niclosamide, which was developed to have an effective drug concentration level in the blood that inhibits virus proliferation by 100% by controlling the number of administrations, the company added.
Jaguar Health Inc., of San Francisco, said it agreed to a royalty financing transaction with a secured lender, selling for $6 million a royalty interest entitling the lender to receive twice that amount in future royalties of Mytesi (crofelemer) and Jaguar’s lechlemer plant-based drug candidate, along with certain up-front license fees and milestone payments from licensees and/or distributors. Interest on the royalty repayment amount was set at 10% per year until paid in full. Proceeds from the deal will be used to support regulatory activities associated with Jaguar’s development pipeline, including continued funding of the pivotal phase III trial of Mytesi by wholly owned subsidiary Napo Pharmaceuticals Inc. for prophylaxis of diarrhea in adults receiving targeted cancer therapy. The plant-based chloride ion channel modulating antidiarrheal medicine is approved for symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS receiving antiretroviral therapy. The royalty financing transaction follows a similar $6 million arrangement that Jaguar concluded in October 2020 with an affiliate of the lender.
Merck & Co. Inc., of Kenilworth, N.J., said it reached agreement with the U.S. government to support the development, manufacture and initial distribution of CD24-IgFc, renamed MK-7110, upon FDA approval or emergency use authorization to treat people with severe and critical COVID-19 infection. Under the agreement, Merck will receive up to approximately $356 million to manufacture and supply approximately 60,000 to 100,000 doses to the U.S. government through June 30, 2021, under provisions of Operation Warp Speed. Merck also is expanding its manufacturing capacity to increase the supply of MK-7110, which the pharma gained through its November acquisition of privately held Oncoimmune Ltd.
Contract research organization Open Orphan plc, of London, said drug development company Prep Biopharm Ltd., also of London and 62.6% owned by Open Orphan, completed a 12-week toxicology study of its pan-viral prophylactic asset, PREP-001. The animal model study provided safety data needed to move PREP-001 into longer duration dosing in the clinic. Prep intends to move forward with a real-world field trial to validate efficacy of the synthetic RNA viral mimic, delivered as a nasal spray, against circulating respiratory viruses, including COVID-19, influenza and the common cold.
Pfizer Inc., of New York, and Biontech SE, of Mainz, Germany, said they reached a second agreement with the U.S. government to supply 100 million additional doses of their mRNA-based COVID-19 vaccine, BNT-162b2, from production facilities in the U.S., raising the number of doses for U.S. delivery to 200 million. Under terms of the second agreement, the companies will deliver at least 70 million additional doses by June 30, 2021, with the remaining 30 million doses to be delivered no later than July 31, 2021. Consistent with the original agreement in July 2020, the U.S. government agreed to pay $1.95 billion for the additional doses. The government retained an option to acquire up to 400 million additional doses of the vaccine.
Recce Pharmaceuticals Ltd., of Sydney, said in vivo studies confirmed activity of RECCE-327 and RECCE-529 against SARS-CoV-2 virus in Syrian golden hamsters. The study consisted of five groups of eight hamsters, each group tested with a low or high dose of the candidates or with placebo control of saline nasal wash. Results for both agents showed positive reduction in COVID-19 viral load vs. placebo.
Regenxbio Inc., of Rockville, Md., said it agreed to sell a portion of royalty rights due from Novartis Gene Therapies, a unit of Novartis AG, of Basel, Switzerland, from net sales of the spinal muscular atrophy drug Zolgensma (onasemnogene abeparvovec) to entities managed by Healthcare Royalty Management LLC (HCR) for a single payment of $200 million. In exchange, HCR is set to receive a portion of Regenxbio royalties from Zolgensma received in the fourth quarter of 2020, up to 1.3 times the royalty purchase price until Nov. 7, 2024, or, if that cap is not met, up to 1.5 times the purchase price thereafter. If either cap is met, royalty rights would revert to Regenxbio, which licensed the AAV9 vector used in Zolgensma.
Tonix Pharmaceuticals Holding Corp., of Chatham, N.J., said it completed the purchase of a site of approximately 44 acres in Hamilton, Mont., to construct a vaccine development and commercial-scale manufacturing facility. In September, Tonix completed the purchase of a 40,000-square-foot facility in Massachusetts to house its vaccine advanced development center. Both facilities are expected to support development and production of the company’s modified horsepox vaccines; TNX-1800, a potential COVID-19 vaccine; and TNX-801, a potential smallpox and monkeypox vaccine.
Vincera Pharma Inc., of Santa Clara, Calif., said it completed its business combination with the special purpose acquisition vehicle Lifesci Acquisition Corp. in a deal disclosed in September. The combined company, Vincera Pharma Inc., is set to begin trading on Nasdaq on Dec. 24, under the ticker VINC. Proceeds from the transaction totaled approximately $62 million.