Archerdx Inc., of Boulder, Colo., said it entered a collaboration with Bristol Myers Squibb Co., of New York, to use Personalized Cancer Monitoring assays to understand potential benefits of minimal residual disease (MRD) detection in cancer patients treated with immunotherapy. Archerdx and BMS will evaluate the clinical samples from cancer patient cohorts with the goal of advancing the use of MRD detection or circulating tumor DNA clearance to potentially inform future therapy selection and/or optimization.
Atyr Pharma Inc., of San Diego, said external research published in The New England Journal of Medicine demonstrated the involvement of neuropilin biology in SARS-CoV-2 infection. The research reported that lung tissue analyzed from patients who died from COVID-19-related respiratory failure shows an increase in the expression of neuropilin-1 (NRP1) and NRP2, suggesting those genes are up-regulated in response to SARS-CoV-2 infection in active sites of inflammation. The company is currently investigating NRP2 receptor biology as a target for a variety of diseases, including cancer and inflammatory disorders, and lead candidate ATYR-1923 is in clinical development for inflammatory lung diseases, including a phase II study in patients with COVID-19-related severe respiratory complications.
Avacta Group plc, of Cambridge, U.K., said its collaborative work with the University of Glasgow has shown that Affimer reagents that bind to the SARS-CoV-2 virus spike protein prevent infection of human cells by a SARS-CoV-2 model virus and therefore provide a potential therapy for COVID-19 infection. Work is continuing to further study the way in which the Affimer reagents prevent infection, and Avacta said it plans to use those data to secure a large pharmaceutical partner to develop the potential therapeutic candidates rapidly.
Bridgebio Pharma Inc., of Palo Alto, Calif., said it entered collaboration agreements with Johns Hopkins University and the University of Florida to support the translation of academic innovations in genetically driven diseases with a goal of clinical development and potential commercialization to reach patients in need. The company is focused on building relationships with academic partners to smooth and speed up the transition from the lab to the patient and will provide sponsorship to select research programs around diseases with a genetic basis, including gene therapies and large and small molecules. In addition, it may conduct proof-of-concept studies for lead therapeutic compounds in relevant mammalian models.
Calypso Biotech BV, of Amsterdam, said AGC Biologics has produced a GMP-grade clinical batch of anti-interleukin-15 antibody CALY-002 to support its clinical trials in several autoimmune indications.
Codagenix Inc., of Farmingdale, N.Y., which is developing prophylactic vaccines and oncolytic virus therapies, said it synthesized a readily scalable live-attenuated vaccine candidate, CDX-005, against COVID-19. The vaccine is currently undergoing safety and efficacy studies in animals and appears markedly attenuated compared to wild-type SARS-CoV-2, with preclinical data expected by early July. The company is collaborating with the Serum Institute of India to develop CDX-005. Following the successful completion of preclinical animal studies, CDX-005 will be manufactured by the Serum Institute and tested in a phase I trial slated to begin in the fall. The institute will simultaneously scale manufacturing for large-scale safety and efficacy studies, in addition to preparations necessary to meet global vaccine supply requirements.
Emergent Biosolutions Inc., of Gaithersburg, Md., said it will strengthen its contract development and manufacturing (CDMO) capabilities by expanding into viral vector and gene therapy. This will involve an investment of $75 million in its Canton, Mass., facility, which is focused on the development and manufacturing of drug substance for live viral vaccines, including the company’s smallpox vaccine.
Gelesis Inc., of Boston, which is developing a hydrogel platform technology to treat overweight, obesity and other chronic metabolic diseases, said it has partnered with China Medical System Holdings Ltd. for the commercialization of Plenity, an orally administered, nonsystemic and non-stimulant aid for weight management, in China. Gelesis will receive $35 million up front in a combination of licensing fees and equity investment with the potential for an additional $388 million in future milestone payments as well as royalties.
GNS Healthcare Inc., of Cambridge, Mass., and the Multiple Myeloma Research Foundation (MMRF) said they entered a five-year partnership to leverage the longitudinal multimodal patient registry data from the MMRF CoMMpass study, the largest genomics dataset of any cancer, with GNS' causal artificial intelligence (AI) and simulation platform to create the next generation of individual patient-level computer models of disease progression and drug response. The collaboration is set up to address key questions for multiple myeloma patients, including identifying subtypes of aggressive disease progression and drivers of patient response to an increasing array of therapeutics, including emerging immunotherapies such as CAR T-cell therapy.
Lyell Immunopharma Inc., of South San Francisco, and Pact Pharma Inc., also based in South San Francisco, said they established a strategic partnership to jointly develop and test a next generation personalized cancer T-cell therapy against solid tumors. The companies bring to the table technologies to develop a personalized T-cell therapy using patients' own T cells through nonviral precision genome engineering for tumor neoantigen specificity while overcoming potential tumor resistance and T-cell exhaustion in treating patients with solid cancers. Pact will receive up-front and milestone payments.
Mind Medicine Inc., of Toronto, said it will pursue N,N-dimethyltryptamine (DMT), the principally active ingredient in ayahuasca, as part of its R&D collaboration with the University Hospital Basel's Liechti Lab. Mindmed is providing startup funding for a phase I trial testing various intravenous dosing regimens of DMT that is expected to begin in the fourth quarter of 2020. DMT is a naturally occurring psychedelic substance designed to cause a rapid onset and offset of action compared to psychedelic substances such as psilocybin or LSD.
Ocuphire Pharma Inc., of Farmington Hills, Mich., will merge with Rexahn Pharmaceuticals Inc., of Rockville, Md. The combined company will be called Ocuphire with the Nasdaq ticker OCUP. Institutional health care and other accredited investors, including certain Ocuphire directors and executives, will invest $21.15 million in a private placement to close before the merger’s close. Investors in the pre-merger financing will receive Ocuphire common stock prior to closing, which converts into Rexahn common stock when the merger closes. Shares of Rexahn (NASDAQ:REXN) gained 66 cents, or 23%, to close June 18 at $3.50.
Sarepta Therapeutics Inc., of Cambridge, Mass., and Selecta Biosciences Inc., of Watertown, Mass., entered a research license and option agreement granting Sarepta an option to license the rights to develop and commercialize Selecta’s immune tolerance platform, ImmTOR, for use in Duchenne muscular dystrophy (DMD) and certain limb-girdle muscular dystrophies (LGMDs). Before exercising its option, Sarepta will conduct research and evaluate ImmTOR’s ability to minimize or prevent the formation of neutralizing antibodies to adeno-associated virus in connection with the administration of Sarepta’s DMD and LGMD gene therapy candidates. Sarepta will make an initial payment to Selecta, which is eligible to receive certain preclinical milestone fees. If Sarepta exercises its options to enter any commercial license agreements, Selecta will be eligible for additional development, regulatory and commercial milestone payments as well as tiered royalties on net product sales. Additional financial details were not disclosed.
Synairgen plc, of Southampton, U.K., said it expanded the placebo-controlled, home-based COVID-19 trial of SNG-001, an inhaled formulation of interferon-beta1a, to include patients who have tested positive for coronavirus across the U.K. Visits to the trial website showed the majority of eligible patients who have completed the online assessment lived too far from Synairgen’s virus testing laboratory in Southampton for entry into the trial.
Tonix Pharmaceuticals Holding Corp., of New York, said it expanded its collaboration with Southern Research to include a study of T-cell immune responses to SARS-CoV-2 in volunteers who have recovered or remain asymptomatic after exposure to COVID-19. The research is part of an ongoing collaboration between Tonix and Southern Research to develop and conduct animal testing of Tonix’s TNX-1800, a live replicating virus vaccine designed to protect against COVID-19. The data will support interpretation of animal trial results with TNX-1800, which are expected in the fourth quarter of 2020.
Urovant Sciences Inc., of Irvine, Calif., and Basel, Switzerland, entered an exclusive three-year distribution agreement with Sunovion Pharmaceuticals Inc., of Marlborough, Mass., for services to support the commercialization of vibegron, an oral, once-daily small-molecule beta-3 agonist for treating overactive bladder. The agreement covers account management, contract operations, third-party logistics and trade and retail distribution. Both companies are subsidiaries of Sumitomo Dainippon Pharma Co. Ltd.
Valneva SE, of Saint-Herblain, France, and Bavarian Nordic A/S, of Copenhagen, said they signed a binding term sheet to establish a partnership for the marketing and distribution of their commercial products. Under the terms, Valneva will commercialize Bavarian Nordic’s marketed vaccines, leveraging its commercial infrastructure in Canada, the U.K., France and Austria, and will also take responsibility for Belgium and the Netherlands, where it will set up new commercial operations. Bavarian Nordic will commercialize Valneva’s marketed products in Germany and Switzerland. The partnership includes vaccines that protect against rabies, Japanese encephalitis, tick-borne encephalitis and cholera. Financial terms were not disclosed.