Atyr Pharma Inc., of San Diego, said it initiated two new discovery programs from its tRNA synthetase platform to investigate functionality of selected fragments of alanyl-tRNA synthetase and aspartyl-tRNA synthetase in immunology, fibrosis and cancer. Initial research will focus on further clarifying effects of the fragments on NK cell biology in cancer. The discovery programs will identify target receptors for tRNA synthetase fragments to characterize the mechanism of action of the proteins. Atyr also is developing ATYR-1923, a clinical-stage product candidate that binds to the neuropilin-2 receptor and is designed to down-regulate immune engagement in inflammatory lung diseases.
Celltrion Group, of Incheon, Korea, said that CT-P59, its anti-COVID-19 monoclonal antibody treatment candidate, confirmed neutralizing potency against emerging virus mutations and that the company has begun developing a neutralizing antibody cocktail treatment with CT-P59. The Korea Disease Control and Prevention Agency assessed and independently confirmed CT-P59 successfully neutralizes the SARS-CoV-2 variants first identified in the U.K. (B.1.1.7), the company said, in addition to the previously identified six variant genome mutations of SARS-CoV-2 (variants S·L·V·G·GH·GR). The agency also said the cocktail therapy of CT-P59 with another monoclonal antibody candidate demonstrated neutralizing capability against the U.K. (B.1.1.7) and South African (B1.351) variants.
China SXT Pharmaceuticals Inc., of Taizhou, China, said it inked a nonbinding letter of intent to acquire 70% of the equity of Jiangsu Renji Pharmaceutical Chain Co. Ltd. in exchange for an undisclosed amount of cash and common shares. The companies said final terms will be negotiated following an audit of Renji. The transaction’s close also is subject to approval by China SXT’s board and Renji’s shareholders.
Dnatrix Inc., of Houston, said data demonstrate the oncolytic immunotherapy DNX-2401 (tasadenoturev; Delta-24-RGD) induces a potent antitumor immune response, hinders development of disseminated disease and leads to longer survival. Administering DNX-2401 resulted in extended overall survival in early and advanced PNET and AT/RT mouse models, including models of disseminated disease, the company said. Dnatrix is prepping DNX-2401 for a global pivotal phase III trial for patients with recurrent glioblastoma.
Dyno Therapeutics Inc., of Cambridge, Mass., said its new research demonstrates that using artificial intelligence generates a diversity of adeno-associated virus (AAV) capsids toward identifying functional variants capable of evading the immune system. The research, published in Nature Biotechnology, focuses on rapid production of a large library of distinct AAV capsid variants designed by machine learning models. Nearly 60% of the variants produced were determined to be viable, a significant increase over the typical yield of <1% using random mutagenesis, a standard method of generating diversity, according to Dyno.
Exscientia Ltd., of Oxford, U.K., and the Alzheimer’s Research U.K. University of Oxford Drug Discovery Institute said they will collaborate to develop therapies targeting neuroinflammation for treating Alzheimer’s disease (AD). The collaboration will focus on a specific neuroinflammatory pathway implicated in AD development. Activation of the NLRP3 inflammasome has been shown to have an important role in AD pathogenesis, the company said. While there have been other efforts to develop anti-inflammatory drugs for AD, targeting NLRP3 inflammasome inhibition in the brain is an innovative therapeutic approach, according to Exscientia, which specializes in artificial intelligence.
New preclinical data from Gain Therapeutics Inc., of Bethesda, Md., focusing on identifying and optimizing allosteric binding sites, were presented at the 17th annual Worldsymposium. Gain said its structurally targeted allosteric regulators (STAR) candidates for treating Gaucher disease enhanced Gcase activity in a neuronal cell model and reduced toxic accumulation of Gcase substrate. It also said STAR candidates for treating GM1 gangliosidosis and Morquio B increase beta-gal maturation and delivery to the lysosome and enhance beta-gal activity in a panel of fibroblast cell lines. Gain is developing treatments for difficult-to-treat disorders characterized by protein misfolding.
Fresh preclinical data from M6P Therapeutics, of St. Louis, showed that phosphorylated acid beta-glucosidase (M-011, GcaseM6P) enzyme replacement therapy leads to better tissue distribution, cellular uptake and efficacy in the Gaucher D409A mouse model compared to conventional alpha-mannosyl terminated beta-glucosidase. Gaucher disease is a rare, inherited metabolic disorder in which deficiency of the enzyme beta-glucosidase results in harmful accumulation of glycolipids, specifically glucocerebroside, within the bone marrow, spleen and liver. In multiple in vivo experiments in a Gaucher mouse model, the company said M-011 was more efficacious than imiglucerase in several key parameters, including broader tissue and cell distribution, reduction of macrophage infiltration into liver and lung tissue, and reduction in the number and size of Gaucher storage cells.
Macrogenics Inc., of Rockville, Md., said a $10 million milestone has been achieved related to development of retifanlimab outside the U.S., under its exclusive global collaboration and license agreement with Wilmington, Del.-based Incyte Inc. Retifanlimab is an investigational anti-PD-1 monoclonal antibody designed by Macrogenics and licensed to Incyte. The FDA has accepted for priority review Incyte’s BLA for retifanlimab as a potential treatment for adult patients with locally advanced or metastatic squamous carcinoma of the anal canal who have progressed on, or who are intolerant of, platinum-based chemotherapy.
Mind Medicine Inc. (Mindmed), of New York, said it formed a partnership with startup Mindshift Compounds AG, of Zug, Switzerland, to develop and patent compounds with psychedelic or empathogenic properties. Initial compounds have been synthesized by Mindshift, with related patent applications filed by Mindmed, which plans to begin phase I trials as early as the first quarter of 2022 through its clinical trial platform for psychedelic and empathogenic compounds in Switzerland. Related synthesis intellectual property (IP) and pharmaceutical technology will be owned outright by Mindmed. In addition, Mindshift will provide IP related to new psychedelic compounds exclusively to Mindmed.
Nuvation Bio Inc., of New York, said that it completed its business combination with Panacea Acquisition Corp., a special purpose acquisition company sponsored by Ecor1 Capital, following approval by Panacea's shareholders. The move was previously approved by Nuvation shareholders. Nuvation’s management team is set to lead the combined company, expected to have a cash position of approximately $830 million after transaction costs, including approximately $646 million held in Panacea's trust account and received in concurrent private financings led by Ecor1 with participation from 683 Capital, Ally Bridge Group, Avidity Partners, Deerfield Management Co., Irving Investors, Monashee Investment Management LLC, Orbimed, Wellington Management and other existing Nuvation shareholders, including Baupost Group, Boxer Capital of the Tavistock Group, Fidelity Management & Research Co. LLC, Omega Funds, Perceptive Advisors, Redmile Group and Surveyor Capital (a Citadel Company). On Feb. 11, the combined company began trading as Nuvation Bio Inc. on the New York Stock Exchange under the ticker NUVB, closing the day at $9.84 for a loss of 58 cents. Jefferies was lead financial advisor to Nuvation Bio, with Cowen and Co. as financial advisor to Panacea and private placement agent.
Olix Pharmaceuticals Inc., of Suwon, South Korea, said OLX-104C, a self-delivering RNAi agent in development to treat androgenic alopecia, or hair loss, showed signs of efficacy in a preclinical model. OLX-104C was administered topically to a mouse model with suppressed hair growth (dihydrotestosterone administered mouse). The study evaluated the percentage of hair regrowth and duration of knockdown of the target protein, AR, following a single injection. Mice that received OLX-104C showed substantial hair regrowth vs. controls, and results suggested that a single dose could inhibit expression of the target gene for more than three weeks. The findings were presented at SMI Group’s 12th annual RNA Therapeutics Conference.
Portage Biotech Inc., of Toronto, said in a corporate update that it received approval from Nasdaq to list its common shares on the exchange, where they are expected to begin trading on Feb. 25 as PRTG. Portage shares, which currently trade on the OTC Pink as PTGEF, closed on Feb. 11 at $24 for a gain of $5.45.
Protalix Biotherapeutics Inc., of Carmiel, Israel, said it formed an exclusive worldwide license with Sarcomed USA Inc., of Houston, covering the use of alidornase alfa, or PRX-110, to treat human respiratory diseases via inhaled delivery. Protalix is developing alidornase alfa, a chemically modified plant cell-expressed recombinant form of human deoxyribonuclease 1 (DNase 1), administered through inhalation, to treat cystic fibrosis and other respiratory diseases. Sarcomed is investigating whether a DNase 1 compound may influence the chronic pulmonary inflammation seen in pulmonary sarcoidosis. The agreement calls for Sarcomed to identify and select pharmaceutical candidates under the license and to oversee their R&D. Protalix is entitled to an initial cash payment of $3.5 million and to regulatory and commercial milestone payments and tiered sales royalties. The companies also plan to negotiate clinical and commercial supply agreements for alidornase alfa, with Sarcomed retaining the right to terminate the license if this step is not completed.
Repertoire Immune Medicines Inc., of Cambridge, Mass., said it formed a research collaboration with Dana-Farber Cancer Institute to advance discovery of tumor antigen targets and development of relevant therapeutic candidates in human papillomavirus-positive (HPV+) head and neck cancers. Dana-Farber agreed to provide blood and tissue samples from people with newly diagnosed or with late-stage, recurrent HPV+ oropharyngeal cancer. Repertoire will use its Decode discovery platform to identify antigens, evaluate tumor antigen expression and profile the tumor microenvironment. The collaboration is expected to inform Repertoire’s selection of tumor antigens for T-cell therapy investigation with the potential to enter clinical trials. Financial terms were not disclosed.
Sandoz International GmbH, a division of Novartis AG, of Basel, Switzerland, said it agreed to acquire the cephalosporin antibiotics business from Glaxosmithkline plc (GSK), of London. The agreement includes rights to the branded drugs Zinnat (cefuroxime), Zinacef (cefuroxime) and Fortum (ceftazidime) in more than 100 markets, excluding the U.S., Australia and Germany, where GSK previously divested certain rights, and India, Pakistan, Egypt, Japan and China, where GSK retained rights. Sandoz agreed to pay $350 million at closing and to make milestone payments of up to $150 million. The transaction is expected to close in the second half of 2021. Sandoz plans eventually to manufacture Zinnat at sites in its network. In the meantime, GSK agreed to supply Zinnat to Sandoz under a manufacturing and supply agreement while supporting a transfer of manufacturing operations over a period of approximately four years.
The U.K.’s Cell and Gene Therapy (CGT) Catapult and contract development and manufacturing organization Rentschler Biopharma SE, of Laupheim, Germany, said Rentschler will establish its manufacturing capability in advanced therapy medicinal products, including adeno-associated virus vectors, through an investment over five years at the CGT Catapult site in Stevenage, U.K.
Vyne Therapeutics Inc., of Bridgewater, N.J., said its board approved a 1-for-4 reverse split of its common stock (NASDAQ:VYNE), which will begin trading on a split-adjusted basis when the market opens on Feb. 16. The reverse split will reduce the number of common shares issued and outstanding from approximately 205 million to approximately 51 million. On Feb. 11, VYNE closed at $2.66 for a loss of 28 cents.