The burgeoning psychedelic therapeutics market experienced a boost Jan. 25 as Small Pharma Inc. announced its synthetic, intravenous formulation of N,N-dimethyltryptamine (DMT), SPL-026, led to a statistically significantly, rapid reduction in depression symptoms in patients with major depressive disorder in a phase IIa trial, thus meeting its primary endpoint. DMT is a powerful hallucinogenic tryptamine substance which works as a 5-HT receptor agonist. It is found naturally in various plants, and is a schedule I controlled substance in the U.S. Although lesser known than other psychedelics such as magic mushrooms and LSD, it produces short-lived but intense auditory and visual hallucinogenic effects. Read More
Iovance Biotherapeutics Inc.’s faith in tumor-infiltrating lymphocyte (TIL) therapy lifileucel was further proven by the Jan. 23 acquisition of worldwide rights from Clinigen Ltd. to Proleukin (aldesleukin), an IL-2 product used to promote T-cell activity after infusion of TILs. Terms call for San Carlos, Calif.-based Iovance to pay Clinigen, of Burton Upon Kent, U.K., £166.7 million (US$$206.1 million) right away and a £41.7 million milestone payment upon first approval of lifileucel in advanced melanoma, plus double-digit global royalties for Clinigen. Read More
ABVC Biopharma Inc is headquartered in San Francisco but it has its roots in Taiwan where it is digging into traditional medicine and validating it for the modern world. “There are a number of drugs that can’t be synthesized in the lab,” ABVC CEO Howard Doong told BioWorld, so he is going back to the original source of traditional Chinese medicines to validate them using traditional drug development models. Read More
Coming off a tough year for raising money, Cadrenal Therapeutics Inc. is leading the charge into a new year by completing 2023’s first U.S. IPO. The company closed its IPO of 1.4 million shares at $5 each for $7 million. The stock (NASDAQ:CVKD) began trading Jan. 20 and closed 9.37% downward on Jan. 25 at $2.90 per share. Read More
Sysnav Healthcare SA and Roche Holding AG entered a new collaboration to develop digital endpoints for use in clinical trials of therapies for a range of neuromuscular disorders. The alliance combines Sysnav’s expertise in wearable technologies and movement evaluation with Roche’s clinical experience. It builds on an existing collaboration that led to the qualification of the world’s first digital endpoint, for evaluating therapies in development for Duchenne muscular dystrophy (DMD). They now aim to put that experience to work in widening its application to other disorders in which movement is a key parameter. Read More
Biopharmas raising money in public or private financings, including: Atomic, Deciphera, Jasper, Myosana, Oxurion, Precigen, Pliant, Rewind, Verastem. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Allogene, Awakn, Azura, Baudaxbio, Benitec, Cassava, Discgenics, Dyadic, Finch, Immunis, Memo, Smart Immune, Tevogen, Vistagen. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Catalyst, Eisai, Innate, KSQ, Ono, Recce, Sanofi, Scisparc. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alvotech, Axcella, Biontech, Carina, Cullinan, Decibel, Diamond, Immpact, Kura, Oxular, Pfizer, Polypid, Verrica. Read More
