Abbvie Inc., of North Chicago, Evolus Inc., of Newport Beach, Calif., and Medytox Inc., of Seoul, South Korea, settled their litigation over the right to sell Jeuveau (botulinum toxin type A). Abbvie and Medytox will grant Evolus a license covering their intellectual property in exchange for undisclosed milestone and royalty payments.
Algernon Pharmaceuticals Inc., of Vancouver, British Columbia, said it awarded the contract to manufacture the active pharmaceutical ingredient and finished product for its formulation of AP-188 (N,N-dimethyltryptamine, or DMT) to Canadian-based Dalton Pharma Services. Algernon plans to file an IND meeting request with the FDA shortly and has started planning its phase I and phase II studies. DMT is a hallucinogenic tryptamine drug producing effects similar to those of other psychedelics like LSD. Algernon has said preclinical data indicate DMT may help patients who have suffered strokes.
AMR Action Fund, of Boston, closed its fund of more than $140 million with funding from the Boehringer Ingelheim Foundation, the European Investment Bank and the Wellcome Trust. AMR plans to invest in clinical research of new antibiotics for resistant bacteria with a goal of bringing two to four new antibiotics to patients by 2030.
China SXT Pharmaceuticals Inc., of Taizhou, China, said its 1-for-4 reverse split of ordinary shares was approved by the company’s board Jan. 23, and was expected to become effective Feb. 19, trading on a split-adjusted basis when the market opens on Feb. 22.
Cleveland Biolabs Inc., of Buffalo, N.Y., filed a Form S-4 with the U.S. SEC in conjunction with its previously announced merger agreement with Fort Collins, Colo.-based Cytocom Inc. The merger will potentially close during the second quarter of 2021. The combined company is expected to trade on Nasdaq under the symbol CYTO.
Fordoz Pharma Inc., of East Windsor, N.J., said it entered an agreement with Lipomedix Ltd., of Jerusalem, for manufacturing its lead compound, pegylated liposomal Promitil (PL-MLP), for a phase II study. Terms were not disclosed.
Jaguar Health Inc., of San Francisco, signed a memorandum of understanding with the lead sponsor of the planned Dragon special purpose acquisition company (SPAC) for Jaguar's EU subsidiary, Napo EU, to be the target of Dragon SPAC, which is planning on listing on AIM Italia. In conjunction with the proposed spin-off, Jaguar's U.S. subsidiary, Napo Pharmaceuticals Inc., plans to grant Napo EU a license to sell Mytesi (crofelemer) in Europe, excluding Russia.
Life Biosciences Inc., of Boston, said two studies published in Nature showed that therapies targeting the biology of aging have the potential to not only slow the progression but also to reverse aging-related disease. In one study, conducted in cell lines and in animal models, researchers rejuvenated damaged or aged cells in the eye with a gene therapy that induced expression of three of the Yamanaka factor proteins. This gene therapy allowed nerves in the eye to regrow after injury and safely restored vision, both in old mice and in a mouse model of glaucoma. A second study reported that the diminished ability of old mouse and human hematopoietic stem cells (HSCs) to produce new blood cells is correlated with a decline in chaperone-mediated autophagy, which breaks down unwanted proteins in cells and recycles them into nutrients. When CMA was activated in the hematopoietic stem cells of geriatric mice, either genetically or by treatment with a small molecule, the old stem cells regained the capacity of young stem cells to generate new blood cells.
Metabolon Inc., of Morrisville, N.C., will provide its Precision Metabolomics services to Cleveland Clinic through the analysis of large-scale population health initiatives, which Cleveland Clinic plans to use to further its research and drug development initiatives.
Novavax Inc., of Gaithersburg, Md., said it signed a memorandum of understanding with Gavi, the vaccine alliance, to provide 1.1 billion cumulative doses of NVX-CoV2373, Novavax’ recombinant protein-based COVID-19 vaccine candidate, for the COVAX facility. The vaccine doses will be manufactured and distributed globally by Novavax and Serum Institute of India (SII), the latter under an existing agreement between Gavi and SII. NVX-CoV2373 is being studied in two ongoing pivotal phase III trials in the U.S., Mexico and the U.K.
Precision Biosciences Inc., of Durham, N.C., said data published in Molecular Therapy describes three-year follow-up results showing long-term stable reduction of low-density lipoprotein (LDL) cholesterol levels in nonhuman primates (NHPs) following in vivo gene editing of the PCSK9 gene with its ARCUS genome editing platform. Researchers at the University of Pennsylvania delivered a gene encoding an ARCUS nuclease by adeno-associated virus to inactivate the PCSK9 gene and inhibit protein expression, which would normally prevent receptors from removing excess LDL in the liver. NHPs have been monitored for more than three years and have continued to show a sustained reduction in LDL cholesterol levels while maintaining stable gene editing without any obvious adverse effects. After the one-time vector administration more than three years ago, NHPs treated with ARCUS have experienced stable reductions of up to 85% in PCSK9 protein levels and a 56% reduction of LDL cholesterol levels.
Sensorion SAS, of Montpellier, France, presented preclinical data at the 2021 Association for Research in Otolaryngology Virtual Midwinter Meeting, showing that SENS-401 yielded significant treatment benefits in rats with severe hearing loss when initiated with a delay up to seven days after the initial acoustic trauma. SENS-401 is Sensorion’s lead small molecule, in phase II trial for sudden sensorineural hearing loss, with a second clinical trial to launch in the second half of 2021 for the treatment of cisplatin-induced ototoxicity.
TFF Pharmaceuticals Inc., of Austin, Texas, said, in collaboration with the U.S. Army Medical Research Institute of Infectious Diseases, it obtained positive preclinical in vitro data from TFF-formulated biodefense countermeasures. The first two countermeasures under the collaboration, a monoclonal antibody against Ebolavirus Zaire and a recombinant vesicular stomatitis virus vaccine candidate against Venezuelan equine encephalitis virus, were TFFD-formulated and tested for efficacy in a well-established in vitro neutralization assay. Data showed that the activity of both vaccines were preserved after TFFD. Formulation optimization and long-term stability testing are ongoing. Next steps will be in vivo testing in appropriate animal models.