Absci Corp., of Vancouver, Wash., said it acquired artificial intelligence (AI) deep learning company Denovium Inc., of San Diego. Absci intends to integrate the Denovium Engine into its drug discovery and manufacturing cell line development capabilities to gain synergies that may improve predictability of relevant variants and cell line characteristics for new projects. Financial terms were not disclosed.
Adagene Inc., of San Francisco, said it completed its component of a collaboration with Richard Childs, chief of the laboratory of transplantation immunotherapy at the U.S. NIH’s National Heart, Lung and Blood Institute, discovering antibodies that Child’s lab converted into a CAR T-cell therapy candidate targeting renal cell carcinoma. The NIH will lead and oversee the candidate’s manufacturing and development.
Adaptive Biotechnologies Corp., of Seattle, said it formed a translational collaboration with Astrazeneca plc, of Cambridge, U.K., to assess the use of ImmunoSEQ T-map, a product that combines the sequencing and mapping capabilities of Adaptive’s immune medicine platform to map T-cell receptors (TCRs) to antigens, across Astrazeneca’s oncology portfolio. Astrazeneca agreed to provide biological samples from people with cancer, which Adaptive will sequence and deliver TCR-antigen mapping data that may inform signatures of immune response or resistance to cancer therapies. Adaptive is set to receive quarterly payments from Astrazeneca plus sequencing and data mapping fees. The pharma retained an option to form a separate agreement with Adaptive to develop and commercialize a companion diagnostic or therapeutic application based on T-map data. In addition, the nonexclusive, pan-portfolio oncology collaboration may be expanded to cover additional therapeutic areas, including autoimmunity and infectious diseases.
Allyx Therapeutics Inc., of New Haven, Conn., said it completed a license agreement with Bristol Myers Squibb Co., of New York, to develop Allyx’s therapy, ALX-001, a small-molecule modulator of metabotropic glutamate receptor 5 for treating Alzheimer’s disease. Allyx said it plans to advance ALX-001 into clinical trials in 2021. The agreement includes a sublicense of certain rights from Yale University.
Amneal Pharmaceuticals Inc., of Bridgewater, N.J., and Kashiv Biosciences LLC, of Piscataway, N.J., said they have agreed that Amneal will acquire a 98% interest in Kashiv Specialty Pharmaceuticals LLC. Amneal will pay $70 million in cash at closing and $30 million more in cash one year later. Kashiv could also receive up to an additional $8 million in contingent payments by hitting certain regulatory milestones. Kashiv Specialty Pharmaceuticals is developing complex generics and novel 505(b)(2) drugs.
Atai Life Sciences AG, of Berlin, said it acquired a majority stake in Recognify Life Sciences, which is developing a treatment for cognitive impairment associated with schizophrenia. Research shows that the treatment modulates the effect of the cholinergic, NMDA and GABA type B receptor systems central to learning and memory, Atai said. Formed in 2018, Atai said it is developing treatments for mental health patients that include psychedelic compounds and digital therapeutics.
Avantgen Inc., of San Diego, said it licensed a panel of its anti-SARS-CoV-2 antibody clones to IGM Biosciences Inc., of Mountain View, Calif., for COVID-19 therapy development. Avantgen said it identified a panel of high-affinity human monoclonal antibody clones that bind to two distinct epitopes on the receptor binding domain of the SARS-CoV-2 spike protein. Avantgen said it granted IGM the rights to convert the antibody clones into IgA or IgM formats. Avantgen received an undisclosed up-front payment from IGM and is eligible to receive milestone and royalty payments.
Beactica Therapeutics AB, of Stockholm, and Scotland’s University of Dundee will collaborate in a project to inhibit Werner syndrome helicase, which the company said is an enzyme required for DNA replication and repair as well as a target for tumors with microsatellite instability. Beactica specializes in identifying and optimizing allosteric binders and evaluates ternary degradation complexes formed by PROTACS based on those binders.
Berkeley Lights Inc., of Emeryville, Calif., said it launched Opto Plasma B Discovery 4.0, an antibody discovery workflow, by advancing from B cells to lead molecules in one week. The workflow, the company said, allows for sampling four times more relevant biodiversity, screening of up to 100,000 cells and functional testing with highly sensitive cell-based assays. Berkeley Lights said its platform captures deep phenotypic, functional and genotypic information for thousands of single cells in parallel and can also deliver live biology in the form of the best cells.
Capricor Therapeutics Inc., of Los Angeles, and Lonza Ltd. will collaborate to develop CAP-1002, an allogeneic cell therapy, to treat Duchenne muscular dystrophy and COVID-19 complications. The agreement is designed to expand Capricor’s manufacturing capacity for late-stage clinical trials and commercialization. Operations will begin with a tech-transfer to Lonza in Houston to perform process development activities for late-clinical and commercial-scale GMP manufacturing of CAP-1002.
Cybin Inc., of Toronto, said that its wholly controlled subsidiary, Adelia Therapeutics Inc., achieved earn-out milestones for the period commencing Nov. 15, 2020, including the successful synthesis of multiple tryptamine derivatives in sufficient quantities to initiate in vitro proof of principle. Class B common shares in the capital of the Acquiror will be issued to Adelia shareholders totaling CA$1 million (US$803,419). Cybin is developing low-dose psychedelic therapeutics for psychiatric and neurological conditions.
Dioscure Therapeutics SE, of Bonn, Germany, said new data show its core technology of multivalent single-chain antibodies with a unique molecular mode-of-action can inactivate SARS-CoV-2 virions. The company said its lead candidates, DIOS-202 and DIOS-203, are synergistic combinations of single-domain antibodies derived from camelid heavy chain-only antibodies. Those next-generation immunotherapies against SARS-CoV-2 were designed from detailed structural information of the antibodies’ interaction with its viral target protein and result from functional and evolutionary experiments, the company added. Preclinical studies, Dioscure added, demonstrated DIOS-202 and DIOS-203 selectively target two distinct epitopes of the SARS-CoV-2 spike protein at once, largely preventing the emergence of escape mutants.
Dragonfly Therapeutics Inc., of Waltham, Mass., said Abbvie Inc., of North Chicago, has licensed its first TriNKET drug candidate from Dragonfly, part of a multitarget collaboration begun in November 2019 designed to advance a number of Dragonfly's natural killer cell engager-based immunotherapies for autoimmune and oncology indications. The opt-in grants Abbvie exclusive worldwide intellectual property rights to develop and commercialize products directed to this first specific target. Dragonfly will receive an opt-in payment, as well as potential future development milestone payments and royalties from the sales of any commercialized candidates.
Gilead Sciences Inc., of Foster City, Calif., and Vir Biotechnology Inc., of San Francisco, signed a clinical collaboration to evaluate therapeutic combination strategies aimed at developing a functional cure for chronic hepatitis B virus (HBV). The companies plan to start a phase II trial evaluating combination therapy for both treatment-experienced and treatment-naïve people living with HBV. The multi-arm trial will evaluate different combinations of selgantolimod, Gilead’s investigational TLR8 agonist; VIR-2218, Vir’s investigational small interfering ribonucleic acid; and a commercially sourced, marketed PD-1 antagonist. People in the trial for HBV treatment experience may also receive Gilead’s Vemlidy (tenofovir alafenamide fumarate). The primary outcome of the study will be the proportion of patients achieving a functional cure, defined as an off-therapy loss of hepatitis B surface antigen and HBV DNA from the serum.
Iosbio Ltd., of Burgess Hill, U.K., signed an exclusive worldwide licensing agreement with Immunitybio Inc., of Culver City, Calif., related to Iosbio’s Orapro vaccine platform technology being investigated in trials of Immunitybio’s patented, second-generation human adeno (hAd5) COVID-19 vaccine candidate. Orapro enables oral administration of thermally stable, viral vector vaccines. Those vaccine vectors are engineered to withstand temperatures of up to 50°C, allowing them to pass through the hostile conditions in the stomach without loss of efficacy and providing long-term product stability at ambient temperatures, Iosbio said. Oral administration delivers the vaccine directly to mucosal associated lymphoid tissue, generating mucosal, systemic and T-cell immune responses. Iosbio will be eligible to receive royalties on net worldwide sales of the approved oral vaccine.
La Jolla Pharmaceutical Co., of San Diego, said it and certain of its wholly owned subsidiaries have entered an exclusive licensing agreement with Paion AG, of Aachen, Germany, for Giapreza (angiotensin II) and Xerava (eravacycline) in the European Economic Area, the U.K. and Switzerland. La Jolla will be entitled to receive an up-front cash payment of $22.5 million, potential commercial milestone payments of up to $109.5 million, and double-digit tiered royalty payments based on net sales. La Jolla granted Giapreza is approved by the European Commission as a vasoconstrictor indicated for the treatment of refractory hypotension in adults with septic or other distributive shock who remain hypotensive despite adequate volume restitution and application of catecholamines and other available vasopressor therapies. Xerava is approved by the European Commission for the treatment of complicated intra-abdominal infections in adults.
Medivir AB, of Stockholm, signed an exclusive licensing agreement, through which IGM Biosciences Inc., of Mountain View, Calif., will receive global, exclusive development rights for birinapant, a clinical-stage SMAC mimetic that binds to and degrades inhibitors of apoptosis proteins. The combination of IGM-8444, an IgM antibody targeting death receptor 5 being developed by IGM, and birinapant has been shown to enhance antitumor activity preclinically. Medivir will receive an up-front payment of $1 million upon signing the agreement, followed by an additional $1.5 million when birinapant is included by IGM in phase I studies. The terms of the agreement entitle Medivir, should birinapant be successfully developed and approved, to receive milestone payments up to a total of about $350 million, plus tiered royalties up to midteens on net sales.
Pfizer Inc., of New York, said that, during the second half of 2020, it invested a total of $120 million in four clinical-stage biotech companies as part of the Pfizer Breakthrough Growth Initiative (PBGI). Through PBGI, Pfizer is investing up to $500 million in biotechnology companies, providing funding and access to Pfizer’s scientific expertise to help ensure the continuity of promising clinical development programs of potential future strategic interest to Pfizer. PBGI investments include: $10 million in Vancouver, B.C.-based Essa Pharma Inc.; $25 million in Cambridge, Mass.-based Trillium Therapeutics Inc.; $25 million in Cambridge, Mass.-based Vedanta Biosciences Inc.; and $60 million in Bedford, Mass.-based Homology Medicines Inc.
Pharmadrug Inc., of Toronto, signed a binding letter of intent to acquire Sairiyo Therapeutics Inc. Under the terms of the letter, Pharmadrug proposes to acquire all of the issued and outstanding shares of Sairiyo in consideration for the issuance of an aggregate of 75 million units of Pharmadrug. Each unit will be composed of one common share of Pharmadrug and one common share purchase warrant of Pharmadrug. Each warrant will entitle the holder thereof to acquire one common share in the capital of Pharmadrug at any time on or before the 18-month anniversary of the issuance of the warrants at an exercise price of 10 cents per share. Following completion of the transaction, Sairiyo will be a wholly owned subsidiary of the company.
Point Biopharma Inc., of Toronto, signed a licensing and commercialization agreement with Canprobe for exclusive rights to lutetium–177 octreotate (Lu-Dotatate) for the treatment of neuroendocrine cancer. Canprobe, a joint venture between the University Health Network and the Center for Probe Development and Commercialization, developed Lu-DOTATATE, which is being used in 167 neuroendocrine tumor patients in clinical testing.
Recombinetics Inc., of Eagan, Minn., disclosed a research collaboration with Astrazeneca plc, of Cambridge, U.K., to inform the knowledge base of neurofibromatosis type 1 (NF1), a pediatric disease that affects one in 3,000 births. NF1 patients suffer from a variety of manifestations, including learning disabilities and scoliosis, and are predisposed to tumor development. In April 2020, Koselugo (selumetinib, Astrazeneca plc/Merck & Co. Inc.) became the first FDA-approved therapy for NF1 patients for the treatment of symptomatic, inoperable plexiform neurofibromas. Surrogen, a subsidiary of Recombinetics, has developed several large animal models of neurofibromatoses that exhibit the clinical features seen in patients with those diseases.
Sanofi SA, of Paris, chose Euroapi as the name of its new unit dedicated to the development, production and marketing of active pharmaceutical ingredients (API). Euroapi, which has a portfolio of 200 APIs, is expected to have €1 billion (US$1.22 billion) in sales by 2022. Sanofi is considering an IPO of Euroapi on Euronext Paris in 2022.
Sosei Group Corp., of Tokyo, and Pharmenable Ltd., of Cambridge, U.K., are collaborating to develop drugs targeting an undisclosed challenging G protein-coupled receptor (GPCR) associated with neurological diseases. Sosei will contribute its GPCR-focused structure-based drug design platform, while Pharmenable will add its artificial intelligence-enabled and medicinal chemistry technologies. The companies will share the costs of the discovery and development program and will co-own any resulting products.
Telix Pharmaceuticals Ltd., of Indianapolis, and Artms Inc., of Burnaby, British Columbia, produced multi-Curie quantities of TLX591-CDx, Telix's radiopharmaceutical diagnostic targeting prostate-specific membrane antigen for imaging of prostate cancer using positron emission tomography. The product was stable for six hours.
Turn Biotechnologies Inc., of Mountain View, Calif., licensed epigenetic reprogramming of age (ERA) technology from Stanford University. The ERA technology uses mRNA to deliver transcription factors important to embryonic development to the cells' epigenome.
Valneva SE, of Saint-Herblain, France, is in advanced discussions with the European Commission to supply up to 60 million doses of its inactivated COVID-19 vaccine candidate, VLA-2001. The company expects to report initial safety and immunogenicity data for a phase I/II study in April 2021.
Vedanta Biosciences Inc., of Cambridge, Mass., received a $25 million investment from New York-based Pfizer Inc. Vedanta plans to use the proceeds to fund a phase II study of its live biotherapeutic product VE-202 in patients with inflammatory bowel disease, which is scheduled to begin this year. In exchange for the investment, Pfizer has a right of first negotiation on VE-202.
Verve Therapeutics Inc., of Cambridge Mass., reported preclinical data on base editing of the PCSK9 gene in the liver of nonhuman primates. The treatment produced a 59% reduction in blood low-density lipoprotein cholesterol (LDL-C) at two weeks with an average LDL-C reduction over six months of 61%. The average blood PCSK9 protein level was reduced by 89% over the same time frame. Verve has selected VERVE-101 as its lead adenine base editor product to be developed initially as a treatment of patients with heterozygous familial hypercholesterolemia.