Aurobindo Pharma Ltd., of Hyderabad, Indian, and Covaxx, part of United Biomedical Inc., of New York, signed a licensing deal to develop, commercialize and manufacture UB-612, the first of what are dubbed Multitope Peptide-based vaccines to fight COVID-19, for India and the United Nations Children's Fund agency. Covaxx is conducting a phase I trial with the candidate. Aurobindo obtained the exclusive rights to develop, manufacture and sell Covaxx’s UB-612 vaccine in India and to the children’s fund as well as non-exclusive rights in other select emerging and developing markets. Aurobindo will manufacture the finished doses and has the capacity of making 220 million doses in multi-dose presentation. The firm is building additional facilities to have a total capacity of nearly 480 million doses by June 2021. Terms were not disclosed.
Beigene Ltd., of Beijing, said three of its oncology medicines have been included in the updated National Reimbursement Drug List by the China National Healthcare Security Administration, which means expanded access to the drugs. Included are Beigene’s internally developed anti-PD-1 antibody tislelizumab, the BTK inhibitor Brukinsa (zanubrutinib), and Xgeva (120 mg denosumab) from its collaboration with Amgen Inc., of Thousand Oaks, Calif.
Biontech SE, of Mainz, Germany, and Pfizer Inc., of New York, disclosed a second agreement with the U.S. government to supply an additional 100 million doses of the companies’ COVID-19 vaccine from production facilities in the U.S. The pact brings the total number of doses to be delivered to the U.S. to 200 million. The companies expect to deliver the full 200 million doses to Operation Warp Speed by July 31, 2021. The government will pay $1.95 billion for the added 100 million doses.
Bridgebio LLC, of Palo Alto, Calif., and the University of California San Francisco disclosed a partnership to drive the advancement of academic innovations in genetically driven diseases. Following a six-month pilot collaboration, the new agreement establishes a three-year alliance with Bridgebio with the goal of identifying early translational research to accelerate into clinical development and potential commercialization, the company said. The partnership is designed to foster close collaboration between the two entities that build on their respective strengths and will initially be structured to enable sponsored research agreements.
Chiesi Farmaceutici S.p.A., of Parma, Italy, said the first patient has been treated in the expanded access program in the U.S. for pegunigalsidase alfa, in development for the treatment of Fabry disease. Treatment was begun at the Lysosomal & Rare Disorders Research & Treatment Center in Fairfax, Va. The program is open to patients with a clinical diagnosis of Fabry disease who, in the opinion of the treating physician, have no comparable or satisfactory alternative treatment options with currently available FDA-approved therapies. Other eligibility criteria apply. Patients participating receive infusions of pegunigalsidase alfa every two weeks at 1mg/kg body weight. Information related to adverse events and other limited data will be collected from participants, Chiesi said.
Elevar Therapeutics Inc., of Salt Lake City, signed an agreement with Inceptua SA, of Luxembourg, for the distribution and commercialization of Apealea (paclitaxel micellar) in Europe. Apealea has been authorized by European regulatory authorities for use in the European Economic Area in combination with carboplatin for the treatment of adult patients with first relapse of platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer. Under the terms, Inceptua will have exclusive rights to distribute and commercialize Apealea in Europe. The rights do not extend to the Nordic countries (Denmark, Finland, Norway, Sweden, Iceland). Uppsala, Sweden-based Oasmia Pharmaceutical AB, which developed the drug delivery technology for Apealea, signed a global strategic partnership with Elevar in March for the commercialization of Apealea, under which Oasmia will be eligible for potential milestone payments of up to $678 million and double-digit royalties on sales.
IMV Inc., of Dartmouth, Nova Scotia, provided an update on the development of its vaccine candidate, DPX-COVID-19, for the prevention of COVID-19 infection. The company has successfully completed preclinical safety, GLP toxicology as well as immunogenicity and challenge studies confirming a favorable safety profile and potential for the long duration of antibody titers and protection against the virus. More supporting evidence favoring DPX-COVID-19 includes T cell response and “natural” immunity in convalescent plasma against the targeted epitope peptides in the DPX-COVID-19 formulation, IMV said.
Novadip Biosciences SA, of Mont-Saint-Guibert, Belgium, will receive €9.4 million (U.S.$11.45 million) of nondilutive funding from the Walloon Region Government, of which €5.7 million will be used to support its autologous cell therapy NVD-003 and €3.7 million is dedicated to the allogeneic program NVD-X3.
Recce Pharmaceuticals Ltd., of Sydney, said two of its synthetic anti-infective candidates, RECCE-327 and RECCE-529 demonstrated dose-dependent activity in-vivo against SARS-CoV-2 virus in Syrian golden hamsters, a well-accepted model of infection. The results for both candidates demonstrated a positive reduction in COVID-19 viral load compared to the placebo group. "We are certainly encouraged by these in-vivo results and will continue to investigate the potential of Recce’s anti-infectives in larger animal models," said the company's non-executive chairman John Prendergast.
Soligenix Inc., of Princeton, N.J., said the National Institute of Allergy and Infectious Diseases awarded it a $1.5 million SBIR grant to support the manufacture, formulation and characterization of its COVID-19 and Ebola virus disease vaccine candidates in conjunction with the company's Covaccine HT adjuvant.
Tonix Pharmaceuticals Holding Corp., of Chatham, N.J., said it has completed the purchase of about 44 acres in Hamilton, Montana, for the construction of a vaccine development and commercial scale manufacturing facility. The move followed the company's purchase in September 2020 of a 40,000 square foot facility in Massachusetts to house its new Advanced Development Center for accelerated development and manufacturing of vaccines for clinical trials. "The COVID-19 pandemic exposed weaknesses in the U.S. domestic vaccine development and manufacturing capabilities," said Tonix president and CEO Seth Lederman. "Tonix seeks to be a leader in the re-domestication of American vaccine development and production," he said. The company's lead vaccine, TNX-1800, is based on a horsepox vector.
United Therapeutics Corp., of Silver Springs, Md., agreed to purchase a rare pediatric disease priority review voucher (PRV) for $105 million from New York-based Ymabs Therapeutics Inc. The PRV was granted in conjunction with the FDA approval Danyelza (naxitamab-gqgk) for the treatment of refractory/relapsed high-risk neuroblastoma and will be used by United with an upcoming NDA for Tyvaso DPI, previously referred to as Treprostinil Technosphere, an investigational drug-device combination product comprised of a dry powder formulation of treprostinil and a small, portable, dry powder inhaler. Under the terms of Ymabs license agreement with Memorial Sloan Kettering Cancer Center, the company is entitled to retain 60% of the net proceeds from monetization of the PRV, and the remaining 40% will be paid to MSK.
Vincera Pharma Inc., of Santa Clara, Calif., announced the completion of its business combination with Lifesci Acquisition Corp. At the beginning of October, Vincera signed an exclusive license agreement with Bayer AG, of Leverkusen, Germany, to develop and commercialize its early-stage oncology portfolio. The new combined company began trading shares of its common stock under the ticker symbol VINC on Dec. 24 on the Nasdaq Capital Market. On Dec. 28, company shares fell 4.4% to $18.70.
Yumanity Therapeutics Inc., of Boston, said its reverse merger with Proteostasis Therapeutics Inc. closed on Dec. 22, following the approval of Proteostasis shareholders. Its lead candidate is YTX-7739, currently in phase I development for the treatment of Parkinson’s disease. The combined company, retaining the Yumanity name, now trades on the Nasdaq Capital Market under the symbol YMTX. Shares fell 14% on Dec. 28 to $16.92.
Zai Lab Ltd., of Shanghai, and Cambridge, Mass.-based Cullinan Oncology Inc. announced a license agreement for the development, manufacturing and commercialization of the small molecule irreversible EGFR inhibitor CLN-081 in Greater China. Cullinan Pearl, a Cullinan subsidiary, will receive a $20 million up-front payment, with the potential to receive up to an additional $211 million in development, regulatory and sales-based milestone payments. Cullinan Pearl is also eligible to receive high-single-digit to low-teen tiered royalties based on annual net sales of CLN-081 in Greater China, the companies said. Zai Lab obtained exclusive rights to develop, manufacture and commercialize CLN-081 in Greater China. CLN-081 is currently in a phase I/IIa dose escalation and expansion trial evaluating oral, twice-daily administration of various doses in patients with non-small cell lung cancer harboring EGFR Ex20ins mutations who have had at least one prior treatment with platinum-based chemotherapy or another approved standard therapy.