Betterlife Pharma Inc., of Vancouver, British Columbia, signed an agreement with List Biological Laboratories Inc., of Campbell, Calif., for the manufacture of its interferon alpha 2b for the treatment of COVID-19. List Labs will provide manufacturing services from its biological development and cGMP manufacturing facility. Terms were not disclosed.
Biontech SE, of Mainz, Germany, signed a share purchase agreement with Novartis AG, of Basel, Switzerland, to acquire its GMP-certified manufacturing facility in Marburg, Germany. The manufacturing site will expand Biontech’s COVID-19 vaccine production capacity by up to 750 million doses per year, or over 60 million doses per month, once fully operational. The transaction is expected to close in the fourth quarter of 2020. Terms were not disclosed.
Boehringer Ingelheim GmbH, of Ingelheim, Germany, and Mirati Therapeutics Inc., of San Diego, disclosed a collaboration to evaluate the combination of BI-1701963, a SOS1 pan-KRAS inhibitor blocking KRAS independent of mutation type, and MRTX-849, a KRAS G12C selective inhibitor in patients with solid tumors that harbor the KRAS G12C mutation. The collaboration will investigate the potential of that combination to provide more effective and durable responses for patients with lung and colorectal cancers who currently have limited treatment options. Under the terms of the nonexclusive deal, Mirati will be the sponsor of the trial and the firms will jointly share the costs of and oversee clinical development for the combined therapy.
Bristol Myers Squibb Co., of New York, said its wholly owned subsidiary, Celgene, and Dr. Reddy’s Laboratories Ltd., of Hyderabad, India (DRL), have settled their litigation related to patents for Celgene’s Revlimid (lenalidomide). As part of the settlement, the parties will file consent judgments with the U.S. District Court for the District of New Jersey that enjoin DRL from marketing generic lenalidomide before the expiration of the patents-in-suit, except as provided for in the settlement. Celgene has agreed to provide DRL with a license to Celgene’s patents required to manufacture and sell certain volume-limited amounts of generic lenalidomide in the U.S. beginning sometime after the March 2022 volume-limited license date. The specific volume-limited license date and percentages agreed upon with DRL were not disclosed and are confidential. In addition, Celgene has agreed to provide DRL with a license to Celgene’s patents required to manufacture and sell an unlimited quantity of generic lenalidomide in the U.S. beginning no earlier than Jan. 31, 2026.
Cebina GmbH, of Vienna, disclosed positive results in its collaborative COVID-19 drug repurposing project, demonstrating that a common allergy nasal spray medication containing azelastine has potent efficacy against SARS-CoV-2 in a human 3D nasal tissue model. Azelastine, a generic antihistamine medication, has previously been identified as a potential anti-COVID-19 drug by Cebina in collaboration with Robert Konrat, a structural biologist at the University of Vienna, who applied a computational prediction approach. Ferenc Jakab and his group at the Szentágothai Research Center at the University of Pécs in Hungary provided experimental confirmation. The activity of azelastine was demonstrated in an experimental reconstituted human nasal tissue model and was evident at a lower dose than present in commercially available products, Cebina said.
Dogma Therapeutics Inc., of Cambridge, Mass., reached an agreement for the acquisition of its oral PCSK9 program by Astrazeneca plc, of Cambridge, U.K. Dogma will receive up-front as well as downstream payments linked to global regulatory and commercial milestones. Exact terms were not disclosed.
Dyadic International Inc., of Jupiter, Fla., and Jiangsu Hengrui Medicine Co. Ltd., of Lianyungang, China, disclosed a collaboration to apply Dyadic's C1 technology to the development of selected Hengrui biologic drugs. The deal highlights the ability of Dyadic to produce cell lines at higher expression levels and lower cost, the companies said. Terms were not disclosed.
Eisai Co. Ltd., of Tokyo, said it established a pharmaceutical sales subsidiary in Ho Chi Minh City, the Socialist Republic of Vietnam, which will be named Eisai Vietnam Co. Ltd.
Elicio Therapeutics Inc., of Cambridge, Mass., and the Moffitt Cancer Center said they will characterize combination therapies pairing Elicio’s CD19 amphiphile and a universal FITC amphiphile with CD19 CAR T cells. The Moffit team has evaluated CD19+ malignancies in mice with a normal immune system and normal lymph nodes, an advantage over more common mouse models conducted in immunosuppressed mice, according to Elicio. Positive results would set the stage for clinical trials combining AMP-CD19 with marketed CD19 CAR T cells to increase response rate and durability, the company added.
Eli Lilly and Co., of Indianapolis, and Amgen Inc., of Thousand Oaks, Calif., are collaborating to manufacture Lilly's neutralizing antibody therapies for the prevention and/or treatment of COVID-19. Together the companies expect to be able to produce many millions of doses next year.
Fresh data from Exithera Pharmaceuticals Inc., of Westborough, Mass., described the pharmacodynamic, pharmacokinetic and safety profile of EP-7041, a parenteral and selective small-molecule factor XIa inhibitor, in Critical Care Explorations. Those data demonstrate that EP-7041 can inhibit thrombosis while minimizing the risk of unwanted bleeding, according to the company. By preferentially inhibiting thrombosis but not normal hemostasis, EP-7041 holds the promise of preventing circuit and vascular thromboembolism with substantially less inhibition of the local hemostasis required for bleeding control in trauma or surgical procedures, the company added, potentially enabling safer use of extracorporeal membrane oxygenation or other interventions employing vascular circuits such as cardiac surgery and ventricular assist devices in critically ill patients.
Expanding their existing collaboration, Genscript Biotech Corp., of Piscataway, N.J., has licensed global rights to develop and commercialize a bispecific antibody from the single-domain antibody fused to a monoclonal Ab platform for treating cancer to Remd Biotherapeutics Inc., of Camarillo, Calif. Remd will pay Genscript service fees, certain commercialization milestones and a specified percentage royalty based global sale revenue of the pertaining product after launch. This is an expansion of their April 2019 collaboration for developing multiple novel bispecific antibody candidates.
Hepion Pharmaceuticals Inc., of Edison, N.J., said a study of its CRV-431 conducted by the U.S. NIH’s National Institute of Allergy and Infectious Diseases demonstrated positive antiviral activity against SARS-CoV-2. The in vitro study tested CRV-431 at concentrations of 0.0032 to 10 µM and a positive control compound, a protease inhibitor, at 0.032 to 100 µg/ml in Caco-2 cells infected with SARS-CoV-2. CRV-431 treatment inhibited production of infectious virus in these cells with almost five times greater potency than the positive control compound in the study, the company said. The concentration of CRV-431 required to inhibit virus production by 90% (IC90) was 1.5 µM vs. 7.3 µM for the positive control compound, Hepion added.
Immunoprecise Antibodies Ltd., of Vancouver, British Columbia, will transform its previously tested SARS-CoV-2 neutralizing antibodies into bispecific and multispecific antibodies using Vancouver, British Columbia- based Zymeworks Inc.’s platforms. The candidates will be tested using SARS-CoV-2 spike protein provided by the National Research Council Canada prior to preclinical manufacturing at the council for animal studies. Zymeworks’ platform enables transformation of monospecific antibodies into bispecific and multispecific antibodies, allowing simultaneous binding to several different disease targets.
Papyrus Therapeutics Inc., of West Chester, Pa., and Oxford Biomedica plc, of Oxford, U.K., are collaborating to develop a CAR T product. Oxford will contribute the CAR T-cell therapy, which is already in preclinical development, while Papyrus will add PYTX-002, a gene replacement therapy that can confer cellular pharmacy properties on a CAR T.
Passage Bio Inc., of Philadelphia, published preclinical data on its gene therapy, PBFT-02, in the Annals of Clinical and Translational Neurology. PBFT-02, which is being developed for patients with frontotemporal dementia caused by mutations in the granulin gene, produced elevated levels of progranulin in the brain and cerebral spinal fluid in a mouse model of progranulin deficiency. The treatment also reduced lysosomal storage lesions, normalized lysosomal enzyme expression and corrected microgliosis.
Precision Biosciences Inc., of Durham, N.C., and Les Laboratoires Servier SAS, of Paris, said they added two hematological cancer targets beyond CD19 and two solid tumor targets to their CAR T development and commercial license agreement, extending the relationship beyond development of PBCAR-0191, Precision’s allogeneic CAR T candidate, and related programs. In the expanded agreement, Precision will conduct early stage R&D, including IND filing through manufacturing of initial material for a phase II study. Servier may opt in for late-stage development and commercialization, with Precision retaining a 50-50 co-development and co-promotion option for licensed candidates in the U.S. Precision expects to receive milestone payments in 2020 and 2021 related to the new targets and is eligible for option fees and clinical, regulatory and sales milestones in addition to product royalties.
Raziel Therapeutics Ltd., of Rehovot, Israel, licensed rights to RZL-012, which is being developed for submental fullness, commonly referred as a double-chin, in mainland China, Hong Kong, Macau and Taiwan to Tianjin Juvestar Biotech Co. Ltd., of Tianjin, China. Juvestar was incubated and invested in by the venture capital arm of Shanghai Fosun Pharmaceutical Co. Ltd., of Shanghai. Raziel is eligible for up-front and R&D milestone payments of $27 million and sales milestone payments of up to $47 million, as well as tiered royalty payments on future net sales. Juvestar will be responsible for conducting clinical studies, marketing and sales in its territory. Raziel will be responsible for manufacturing RZL-012.
Samsung Biologics Co. Ltd., of Incheon, South Korea, and Panolos Bioscience Inc., of South Korea, signed a services agreement for Samsung to provide cell line development, process development and nonclinical and clinical material manufacturing of Panolos' PB-101, an Fc-fusion protein intended to treat solid tumors.
Santen Pharmaceutical Co. Ltd., of Osaka, Japan, is acquiring the outstanding shares of Eyevance Pharmaceuticals Holdings Inc., of Fort Worth, Texas, from Eyevance Holdings LLC for $225 million. Santen gains access to Eyevance's topical ophthalmic products targeting the ocular surface and anterior segment, although Visovanq (vancomycin ophthalmic ointment) and Nexagon (ophthalmic gel for persistent corneal epithelial defects) were carved out of the deal.
Summit Therapeutics plc, of Oxford, U.K., said the U.K. court had approved its redomiciliation to Delaware where Summit Therapeutics Inc. will become the holding company of Summit Therapeutics plc and its subsidiaries. The redomiciliation is expected to be complete on Sept. 18, at which point Summit's American depositary shares will stop trading after the market closes. Shares of common stock of Summit Therapeutics Inc. are scheduled to begin trading on Sept. 21, using the same ticker symbol, SMMT.
Tiziana Life Sciences plc, of London, said it agreed to a collaborative study assessing nasally administered foralumab, alone or in combination with orally administered dexamethasone, in individuals in Brazil with COVID-19. The study, in partnership with scientists at Harvard Medical School and at Brazil’s Santa Casa de Misericórdia de Santos Hospital, is expected to start around the end of September, with data potentially available before the end of 2020.
Vaccinex Inc., of Rochester, N.Y., and Merck & Co. Inc., of Kenilworth, N.J., are collaborating to test Vaccinex's anti-semaphorin 4D pepinemab with Merck's anti-PD-1, Keytruda (pembrolizumab), in patients with advanced, recurrent or metastatic head and neck squamous cell carcinoma. The study, which will measure objective response rate, progression-free survival and overall survival, will include a dose-escalation phase, followed by an expansion phase in 65 patients.
Wigen Biomedicine Technology Co. Ltd., of Shanghai, will transfer its 50% interest in four of its self-developed drug projects, WJ1024/WJ1075, WJ-05129, APL-1898 and WJ-13404, to Junshi Biosciences Co. Ltd., of Shanghai. Junshi will be granted worldwide exclusive rights for production and commercialization. Junshi and Wigen will facilitate preclinical research, and Junshi is responsible for clinical trial applications. Junshi will pay Wigen an up-front ¥36 million (US$5.32 million). Wigen is also eligible to receive milestone payments up to ¥436 million (US$64.45 million) in aggregate, based on the R&D and commercialization progress, and 50% of net profits.