Affinity Biosciences Pty. Ltd., of Melbourne, Australia, disclosed the discovery of potent antibodies with therapeutic potential against COVID-19. In March, Affinity commenced screening its library of a hundred billion human antibodies to discover those that might neutralize SARS-CoV-2. After discovering a number of candidate antibodies that block the virus spike protein from binding to its human receptor, Affinity engaged The Peter Doherty Institute for Infection and Immunity in April to conduct testing using the virus in the laboratory. The Doherty Institute has confirmed that Affinity's antibodies can completely neutralize the infectivity of SARS-CoV-2 at a single digit mcg/ml concentration in a five-day virus neutralization assay. The antibodies have high affinity for the SARS-CoV-2 spike protein at around 20 picomolar, driven by an exceptionally slow off-rate, a measure of how long the antibody remains bound to its target, the company said.
Affyimmune Therapeutics Inc., of Natick, Mass., disclosed advancements in its affinity-tuned CAR T-cell programs and technology in three presentations at the recent annual meeting of the American Association for Cancer Research. One presentation reported on a new CAR T design for localized and inducible cytokine release. The other two described their affinity-tuned CAR T-cell design approach that maintains robust tumor cell killing while reducing toxicity. The company has an open IND for the treatment of relapsed or refractory thyroid cancer using an affinity-tuned CAR T cell targeting the ICAM-1 protein, which is overexpressed in advanced thyroid cancer.
Alexion Pharmaceuticals Inc., of Boston, completed the acquisition of Portola Pharmaceuticals Inc., of South San Francisco. The acquisition adds Andexxa (coagulation factor Xa [recombinant], inactivated-zhzo), marketed as Ondexxya in Europe, to Alexion’s commercial portfolio. Andexxa is the first and only approved such agent.
Anivive Lifesciences Inc., of Long Beach, Calif., started two preclinical studies to further evaluate the in vivo efficacy and safety of GC-376 as a treatment for COVID-19. The firm filed a pre-IND request earlier this year. The company licensed the exclusive worldwide rights to GC-376 from Kansas State University for use as a treatment in humans and animals. The drug is described as a potentially first-in-class, small-molecule protease inhibitor.
Fibrogenesis Inc., of Houston, disclosed the identification of molecular mechanisms associated with the potent reduction of lung inflammation previously reported by the company in an animal model of COVID-19 lung failure. The company made public data demonstrating that administration of Pneumoblast resulted in dramatic alterations of cytokines. Specifically, it reduced concentrations of the inflammatory cytokines interleukin-1 (IL-1) beta, IL-6, IL-8, IL-17, IL-18 and tumor necrosis factor-alpha.
Immatics NV, of Tuebingen, Germany, disclosed the completion of its business combination with Arya Sciences Acquisition Corp., of Houston, a special purpose acquisition company sponsored by Perceptive Advisors. Immatics commenced trading on Nasdaq. Shares (NASDAQ:IMTX) closed July 2 at $15.05.
Ipsen SA, of Paris, said it will join the collaboration with Exelixis Inc., of Alameda, Calif., and Roche Holding AG, of Basel, Switzerland, and participate in the funding of the recently initiated Contact-01 and Contact-02 global phase III pivotal trials. Contact-01 is evaluating the safety and efficacy of Cabometyx (cabozantinib, Exelixis Inc.) in combination with Tecentriq (atezolizumab, Roche Holding AG) in patients with metastatic non-small-cell lung cancer who have been previously treated with an immune checkpoint inhibitor and platinum-containing chemotherapy. Contact-02 is evaluating the safety and efficacy of Cabometyx given in combination with Tecentriq vs. a second novel hormonal therapy in men with metastatic castration-resistant prostate cancer who have previously been treated with one hormonal therapy.
Inimmune Corp., of Missoula, Mont., was awarded a $2 million Small Business Innovation Research grant for its phase II program to advance a novel adjuvant and delivery system for vaccines. Inimmune will further develop a synthetic vaccine adjuvant through formulation and delivery technologies. The team will advance a stable and safe adjuvant delivery platform designed to elicit strong immune responses against a variety of infectious diseases, including COVID-19, the company said.
Merck & Co. Inc., of Kenilworth, N.J., and Ridgeback Biotherapeutics LP, of Miami, will develop EIDD-2801, an orally bioavailable form of a ribonucleoside analogue that inhibits replication of multiple RNA viruses, including SARS-CoV-2 for treating COVID-19 patients. Ridgeback will fund, sponsor and conduct clinical trials and fund manufacturing campaigns for clinical supply. Merck and Ridgeback also plan to explore EIDD-2801’s potential in other severe acute viral diseases, such as Ebola.
Minerva Neurosciences Inc., of Waltham, Mass., said it exercised the right to opt out of its agreement with Janssen Pharmaceutica NV, a unit of New Brunswick, N.J.-based Johnson & Johnson, for developing MIN-202 (seltorexant) as an adjunctive treatment of major depressive disorder in patients with insomnia symptoms. Minerva will collect a royalty on seltorexant’s worldwide sales in all indications in the mid-single digits, with no financial obligations to Janssen.
Nugenerex Immuno-Oncology, of Miramar, Fla., said it is launching a vaccine development effort to address a newly identified swine influenza virus. The company has completed a phase I trial with an Ii-Key peptide vaccine designed to elicit an immune response against the H1 hemagglutinin protein of the 2009 H1 swine influenza strain. Nugenerex is developing immunotherapeutic peptide vaccines based on its CD4 T-cell activation platform.
Neuraegis Inc., of Southborough, Mass., reported positive preclinical animal data supporting calpain-2 inhibitors as a therapeutic target in repeated concussion-induced neuropathy and behavioral impairment. A mouse model of repeated concussions demonstrated that calpain-2 genetic deletion or blockade with Neuraegis' calpain-2 inhibitor eliminated pathological consequences of repeated concussions and protected the brain against neuroinflammation, neurodegeneration and cognitive impairment in control mice. Study funding comes from a $3.8 million grant awarded by the U.S. Department of Defense.
Novartis AG, of Basel, Switzerland, agreed to pay $678 million and agreed to new corporate integrity obligations with the U.S. Department of Health and Human Services to change how it delivers peer-to-peer speaker programs in the U.S. In 2011, a whistleblower alleged Novartis used the programs to pay physician speakers unlawful compensation, a violation of the False Claims Act and the Anti-Kickback Statute. The complaint alleged Novartis provided bogus honoraria or speaking fees to physicians for participation in numerous speaker programs connected with certain prescription drugs. Novartis said it will change its sponsored peer-to-peer medical education program to a predominantly digital/virtual format and limit instances in which it pays external health care professionals to deliver education.
Renovacare Inc., of Roseland, N.J., launched the Renovacare R&D Innovation Center in Berlin. The center, which was established through a collaboration with Stemcell Systems GmbH, of Berlin, will provide preclinical support for Renovacare's regulatory submissions for its Skingun, which delivers a spray of a patient’s own skin cells to burns and wounds.
Sorrento Therapeutics Inc., of San Diego, published a pre-print of preclinical data for its COVID-19 vaccine T-VIVA-19, a recombinant fusion protein combining the spike protein S1-domain of SARS-CoV-2 with the Fc portion of the human IgG1 antibody. All mice given T-VIVA-19 developed antibodies against the protein within the first week after treatment. A booster shot three weeks after the initial treatment increased the antibody level. Approximately 80% of mice had neutralizing antibodies.
Strategic Vaccines LLC, a joint venture between Flow Pharma Inc., of Pleasant Hill, Calif., and M7 Tecroup Ltd. Co., of San Francisco, has signed a memorandum of understanding with the Texas A&M Center for Innovation in Advanced Development and Manufacturing to establish a manufacturing center at Texas A&M's College Station using Flow Pharma's Flowvax peptide vaccine platform. The public-private partnership will initially work on the development of a vaccine to prevent COVID-19.