Advaxis Inc., of Princeton, N.J., said it will fund a phase I study of ADXS-504, a Listeria monocytogenes-based immunotherapy, with Columbia University Irving Medical Center. The open-label study will evaluate the safety and tolerability of ADXS-504 monotherapy, administered via infusion, in as many as 18 patients with elevated prostate-specific antigen in the blood after radical prostatectomy or radical radiotherapy and who are not currently receiving androgen ablation therapy. The study will also evaluate preliminary clinical and immune responses following treatment with ADXS-504 monotherapy. Advaxis said ADXS-504 is expected to induce an innate immune response followed by the adaptive response and modification of the immunosuppressive tumor microenvironment by reducing regulatory T cells and myeloid-derived suppressor cell frequencies.
Amneal Pharmaceuticals Inc., of Bridgewater, N.J., said it completed its acquisition of 98% interest in Kashiv Biosciences LLC, of Piscataway, N.J. 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.
Anixa Biosciences Inc., of San Jose, Calif., said proof-of-concept animal study results are prompting the next development stage of its antiviral COVID-19 therapy. Anixa and Ontochem GmbH, of Halle, Germany, are developing the oral, room-temperature stable, antiviral therapy. Data showed that administration to infected hamsters did not cause any noticeable adverse effects, and monitoring of weight and general animal behavior demonstrated comparable efficacy of both Anixa compounds as well as remdesivir (Gilead Sciences Inc.), according to Anixa.
Can-Fite Biopharma Ltd., of Petach Tikva, Israel, said it completed preclinical studies demonstrating that a cannabidiol-rich T3/C15 cannabis fraction inhibited the growth of liver HEP-3b hepatocellular carcinoma cells via the A3AR by inhibiting Wnt- and NF-kappa B-related regulatory pathways. The Wnt signaling pathway is known to be highly active in controlling the growth of liver cancer cells, according to Can-Fite. An A3AR antagonist, MRS-1523, reversed the effect demonstrating that the inhibitory effect is mediated via Can-Fite’s target, A3AR.rich. T3/C15 cannabis fraction induces inhibition of liver cancer cell growth, the company added.
Chinook Therapeutics Inc., of Vancouver, British Columbia, disclosed a transaction with Van Herk Investments, a European life science investor, to create and fund a new company called Sairopa with a pipeline focused on research and development of non-renal monoclonal antibodies generated through Berkeley, Calif.-based Aduro Biotech Inc.’s B-Select platform. Chinook, which merged with Aduro, will own about 40% of Sairopa after the first tranche of financing from Van Herk and have one seat on Sairopa’s board.
Emergent Biosolutions Inc., of Gaithersburg, Md., said it remains on track with its manufacturing agreements related to COVID-19 vaccines and confirmed that there are no changes to its financial guidance for 2021. In addition, the company received a contract modification to increase the original task order by $23 million from the U.S. Biomedical Advanced Research and Development Authority. The money will be used for the purchase of biologics manufacturing equipment specific to New Brunswick, N.J.-based Johnson & Johnson’s COVID-19 vaccine for the potential expansion of manufacturing of that bulk drug substance into a third suite of Emergent’s Baltimore Bayview facility.
Panacea Biotec Ltd., of New Delhi, India, will produce 100 million doses of Russia's Sputnik V COVID-19 vaccine per year, the Russian Direct Investment Fund said, though no timelines were provided.
Sorrento Therapeutics Inc., of San Diego, signed an agreement to acquire Acea Therapeutics Inc., also of San Diego. Included is abivertinib, a small-molecule tyrosine kinase inhibitor that selectively targets both a mutant form of the EGFR and Bruton’s tyrosine kinase, which was originally identified from Acea’s compound library. At the closing of the merger, Acea’s equity holders will receive up to an aggregate of $38 million in shares of Sorrento common stock, subject to certain adjustments, based on a price per share calculated in accordance with the merger agreement. Subject to the achievement of certain clinical and sales milestones, Sorrento will also provide Acea equity holders with up to $450 million in additional payments.
Teneobio Inc., of Newark, Calif., said it will receive a milestone payment from collaborator New Brunswick, N.J.-based Johnson & Johnson related to the start of a phase I study with bispecific JNJ-75348780 in B-cell lymphoid malignancies, including non-Hodgkin lymphoma and chronic lymphocytic leukemia.
Vir Biotechnology Inc., of San Francisco, said preclinical data showed the ability of VIR-7831, its SARS-CoV-2 monoclonal antibody (MAb), to maintain neutralizing activity against a mutation in the receptor binding domain (RBD) of SARS-CoV-2 called L452R, found in the California variant (B.1.427/B.1.429). Study results also showed that the L452R mutation reduced both the neutralization potency of plasma from 43 vaccinated and nine convalescent donors and the neutralization activity of 14 RBD-specific and 10 N-terminal domain-specific MAbs, including three at the clinical stage. The data were published on bioRxiv and submitted to a peer-reviewed journal.
Virpax Pharmaceuticals Inc., of Berwyn, Pa., reported results of a preclinical sciatic nerve study in rabbits designed to evaluate nerve damage from locally injected Probudur, a liposomal prolonged bupivacaine release candidate. Rabbit limbs injected with free bupivacaine showed signs of neurotoxicity with mild motor myelin damage, while rabbit limbs dosed with Probudur, at 10 times more than free bupivacaine, showed no signs of nerve damage. Further, nerves injected with Probudur showed mild signs of inflammation and small residues of the hydrogel in granulomas, indicating a long residence time of the hydrogel at the injection site without histopathological signs of nerve damage.