The burgeoning psychedelic therapeutics market experienced a boost today 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.

TIL effort center stage after Iovance buys Proleukin from Clinigen

Iovance Biotherapeutics Inc.’s recent acquisition of worldwide rights from Clinigen Ltd. to Proleukin (aldesleukin), an interleukin-2 product used to promote T-cell activity after infusion of tumor-infiltrating lymphocytes (TILs), put the spotlight on Iovance’s TIL phase III program with lifileucel in melanoma. Terms call for Iovance to pay £166.7 million (US$$206.1 million) up front, and a £41.7 million milestone payment upon first approval of lifileucel in advanced melanoma, plus double-digit Proleukin global royalties for Clinigen. The deal is expected to close in the first quarter of this year.

ABVC Biopharma on the path to validating traditional medicine for the modern world

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. “Our clinical trials continue to demonstrate that medicines derived from plants have significant therapeutic benefits with few – if any – side effects in treating serious medical conditions,” he said.

Cadrenal closes on 2023’s first US IPO

Coming off a tough year for raising money, Cadrenal Therapeutics Inc. has completed 2023’s first IPO in the U.S. 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 at midday on Jan. 25, shares were down 8% at $2.94 each. Cadrenal is developing tecarfarin, for treating systemic thromboembolism in patients with end-stage renal disease and atrial fibrillation. The U.S. FDA has granted the cardiorenal therapy fast track designation. Since 2000, BioWorld data show there are at least nine other years ahead of the $4.85 billion raised through IPOs in 2022. The volume also is down significantly, as the 35 IPOs in 2022 are behind 12 other years.

Sysnav Healthcare, Roche to develop digital endpoints for neuromuscular disease

Sysnav Healthcare 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. They now aim to put that experience to work in widening its application to other disorders in which movement is a key parameter.

Also in the news

Allogene, Alvotech, Atomic AI, Awakn, Axcella, Azura, Baudax, Benitec, Bioventure, Carina, Cassava, Catalyst, Cullinan, Decibel, Deciphera, Diamond, Discgenics, Dyadic, Finch, Immpact, Immunis, Innate, Jasper, KSQ, Kura, Mallinckrodt, Memo, Myosana, Oxular, Oxurion, Pfizer, Pliant, Polypid, Precigen, Recce, Rewind, Scisparc, Smart Immune, Tevogen, Verastem, Verrica, Vistagen