Adicet Bio Inc., of Menlo Park, Calif., said it received a $10 million milestone payment from Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., for meeting key preclinical development goals with ADI-002, an allogeneic off-the-shelf gamma delta T-cell product candidate that targets solid tumors. ADI-002 is being developed and engineered to express a GPC3-targeting chimeric antigen receptor and IL-15. Adicet and Regeneron, whose collaboration and licensing agreement began in 2016, plan to identify and validate targets and then develop a pipeline of engineered immune-cell therapeutics for the targets. Regeneron has the option to obtain development and commercial rights for a certain number of the candidates and Adicet has an option to participate in the development and commercialization on the products or is entitled to royalty payments by Regeneron. Immune-cell therapy product candidates developed and commercialized by Adicet under the agreement will be subject to payment of royalties to Regeneron.
Aerpio Pharmaceuticals Inc., of Cincinnati, and the U.S. government’s Medical Technology Enterprise Consortium will evaluate razuprotafib in a randomized trial to prevent and treat acute respiratory distress syndrome in adults with moderate to severe COVID-19. The consortium will provide up to $5.1 million toward the clinical trial, and Aerpio will kick in $2.8 million. The consortium was established as an enterprise partnership including industry and academia to facilitate research and development activities. The partnership will provide resources to support a second COVID-19 phase II trial with razuprotafib, which is being investigated for its potential to prevent and treat the severe respiratory distress in COVID-19 patients.
Celularity Inc., of Florham Park, N.J., said it was awarded a $750,000 COVID-19 Project grant by the California Institute for Regenerative Medicine. The grant supports California institutions participating in the phase I/II trial of human placental hematopoietic stem cell-derived natural killer cells for treating adults with COVID-19. The University of California, Irvine is the first California site to open for patient enrollment. Celularity said it will evaluate the antiviral activities of its cryopreserved investigational product, CYNK-001, in underserved and disproportionately affected populations with COVID-19.
Cohbar Inc., of Menlo Park, Calif., reported in vivo data demonstrating antifibrotic effects of multiple peptide analogues in preclinical models of idiopathic pulmonary fibrosis (IPF). In co-cultures of human lung cells, Cohbar’s candidate, CB-5138-1, decreased expression of key fibrosis biomarkers, including alpha smooth muscle actin (αSMA), and collagen types I and III. CB-5138-1 also decreased the transformation of healthy lung cells into fibrotic cells after induction by TGF-beta1, resulting in reduced production of the fibrotic components αSMA and pro-collagen I alpha 1. In vivo, CB-5138-1 decreased lung fibrosis and inflammation in the prophylactic mouse model of IPF, initiating treatment with the peptide immediately after fibrosis induction by bleomycin, and in the therapeutic mouse model of IPF, starting peptide treatment one week after induction.
Evotec SE, of Hamburg, Germany, and Secarna Pharmaceuticals GmbH & Co. KG, of Marburg, Germany, said they formed a strategic partnership providing for a long-term platform collaboration on antisense oligonucleotide (ASO)-based therapeutics across multiple targets and indications. The companies identified an initial program, which was not disclosed, and are moving to establish a pipeline of co-owned ASO therapies. The partners expect to seek transactions for the co-owned assets with biotech and pharmaceutical companies through a variety of deal structures. Financial terms of the arrangement were not disclosed.
Genecentric Therapeutics Inc., of Durham, N.C., and Erasmus University Medical Center in Rotterdam, the Netherlands, said they entered a research collaboration to identify RNA-based drug response markers and novel, targeted therapies in the setting of non-muscle invasive bladder cancer (NMIBC). The research will characterize the tumor and immune biology, as well as the tumor microenvironment related to NMIBC, and will apply Genecentric’s Bladder Cancer Subtype Profiler, among other novel assays, to predict disease progression and drug response in those patients.
Genfit SA, of Lille, France, said pivotal data describing the derivation and validation of its non-invasive blood-based diagnostic, NIS4, were accepted for publication by The Lancet Gastroenterology & Hepatology. NIS4 is in development to identify individuals with nonalcoholic steatohepatitis (NASH) and at-risk NASH. The technology is an algorithm that incorporates four independent NASH-associated biomarkers – miR-34a-5p, A2M, YKL-40 and HbA1c – to produce a score used to identify those with or without at-risk NASH. The study detailed NIS4 algorithm development and clinical validation against the liver biopsy reference standard in two independent populations comprising data from more than 700 patients. In addition to high overall diagnostic performance, NIS4 provided consistent results in subpopulations compared to other noninvasive tests evaluated in the same individuals.
IMV Inc., of Dartmouth, Nova Scotia, said Canadian government agencies agreed to contribute up to CA$4.75 million (US$3.58 million) to advance phase I development of its vaccine candidate, DPX-COVID-19, to prevent COVID-19 infection. The company is set to receive CA$4.15 million in advisory services and funding from the National Research Council of Canada industrial research assistance program (NRC IRAP), Atlantic Canada Opportunities Agency and Next Generation Manufacturing Canada to support rapid scale-up of the DPX-COVID-19 manufacturing process and its evaluation in a phase I trial. IMV also received CA$600,000 from the NRC IRAP innovation assistance program. The phase I trial in Canada is expected to begin in the third quarter, with a phase II trial expected to start in the U.S. and Canada by year-end 2020. DPX-COVID-19 is a peptide-based vaccine formulated with IMV’s DPX liposome delivery technology.
Digital biology firm Recursion Pharmaceuticals Inc., of Salt Lake City, released a preprint on applying deep-learning-driven analysis of cellular morphology to develop a scalable phenomics platform. In proof-of-concept studies, Recursion applied elements of its deep-learning enabled phenomics platform to functionally map a network of cellular immunity, employing a panel of immune stimuli across key cellular contexts. The high dimensional representations of complex immune behavior enabled Recursion to conduct high-throughput screens of nearly 100,000 potential drug starting points and to predict the target of key candidates, enabling rapid prioritization or deprioritization. The paper shares preliminary results from approximately 220,000 unique combinations of compounds, cells and disease perturbations. Recursion is posting images and findings from the preprint at RxRx.ai.
Specifica Inc., of Santa Fe, N.M., said it designed and created an exclusive antibody display library based on its Generation 3 library platform in collaboration with Scholar Rock Holding Corp., of Cambridge, Mass., which will use the collaborative library design to improve the ease and efficiency of discovering antibodies suitable for therapeutic development.
SRI International, of Menlo Park, Calif., said it was awarded a contract of up to $100 million from the National Institute of Allergy and Infectious Diseases (NIAID) of the U.S. NIH to support the R&D of radiation/nuclear medical countermeasures (MCMs). Under the seven-year contract, SRI Biosciences, a unit of SRI International, will provide facilities, expertise and capabilities to advance the MCM development toward FDA approval to mitigate or treat acute radiation syndromes and to treat delayed effects from acute radiation exposure and internal radionuclide contamination. SRI researchers also will support NIAID's ongoing biodosimetry efforts.
Teva Pharmaceutical Industries Ltd., of Tel Aviv, Israel, and Alvotech hf, of Reykjavik, Iceland, said they formed an exclusive partnership to commercialize five biosimilar candidates in the U.S. Alvotech assumed responsibility for the development, registration and supply of the biosimilars, while Teva will market the assets. The originator products of the initial pipeline, which contains biosimilar candidates addressing multiple therapeutic areas, currently generate around $35 billion in U.S. sales. The agreement included an up-front payment and milestone payments over several years, plus profit-sharing from product sales. Other financial terms and product details were not disclosed.
Therapeutics Solutions International Inc., of Oceanside, Calif., said preclinical data suggested memory-protective effects related to Quadramune were seen in an animal model of inflammation-associated memory loss. Animals were treated with Quadramune for three days and exposed to lipopolysaccharide as an inflammatory stimulus before the animals were assessed for their ability to remember a submerged platform. Lipopolysaccharide administration resulted in approximately 57% reduction in memory, but animals that received Quadramune had restoration of memory activity. The study also showed that Quadramune reduced the presence of cytokine-related inflammation in the brain. Quadramune is a dietary supplement comprising green tea extract, pterostilbene, nigella sativa and sulforaphane that the company is assessing preclinically in combination with metformin to treat COVID-19-associated lung damage.
Variation Biotechnologies Inc., an Ottawa-based, wholly owned subsidiary of VBI Vaccines Inc., of Cambridge, Mass., said it was awarded up to CA$56 million (US$42.2 million) from the Canadian government’s strategic innovation fund to support development of its coronavirus program, VBI-2900, through phase II studies. Based on the results of ongoing preclinical mouse studies in collaboration with the National Research Council of Canada, VBI expects to select optimal vaccine candidates in the third quarter of 2020 and begin clinical studies by year-end 2020. VBI plans to use a portion of the funding to finalize manufacturing process development and to expand the work force at its R&D facility in Ottawa.
Verrica Pharmaceuticals Inc., of West Chester, Pa., said it signed an option agreement with Torii Pharmaceutical Co. Ltd., of Tokyo, covering an exclusive license to develop and commercialize in Japan Verrica’s candidates, including VP-102 (cantharidin), to treat molluscum contagiosum and common warts. Torii agreed to pay $500,000 to secure the exclusive option, which it may exercise until the latter of six months following the effective date of the agreement or 10 business days after Verrica provides notification of FDA acceptance of its resubmission of the NDA for VP-102, a protein phosphatase 2A inhibitor. The license agreement, if exercised, calls for Torii to make an up-front payment of $11.5 million, up to $58 million in additional development, regulatory and sales milestone payments and tiered transfer price payments for product supply ranging from mid-30 to mid-40 percentage points of net sales. Torii assumed responsibility for development and regulatory activities in Japan. In July 2020, the FDA issued a complete response letter for VP-102, citing additional information regarding the chemistry, manufacturing and controls process for the drug/device combination product and human factors validation information.
Viacyte Inc., of San Diego, and materials science company W. L. Gore & Associates Inc., of Newark, Del., said they inked an agreement covering the clinical phase of their ongoing collaboration to develop Viacyte’s Encaptra cell delivery system, which is enabled by Gore technologies. Encaptra is a component of Viacyte’s PEC-Encap (VC-01) pluripotent stem cell-derived beta cell progenitor candidate to treat type 1 diabetes. Gore agreed to manufacture and supply a membrane and the device component for use with PEC-Encap and to continue working with Viacyte to optimize device design and implant techniques to support human trials. Gore also agreed to manufacture the Encaptra system for late-stage development and commercial use.
Vyripharm International Inc., a subsidiary of Vyripharm Enterprises LLC, of Houston, said it executed a memorandum of understanding with National Yang-Ming University, of Taipei, Taiwan, to assess the biodistribution and targeting profile of its cannabinoid CB1 receptor antagonist, VYR-206, for the diagnosis and treatment monitoring of neurological disorders. Details of the agreement and financial terms were not disclosed.