A shortage of efficacy compared to placebo in a phase II study of treating cognitive impairment has put Aptinyx Inc. on the defensive. The company’s oral, small-molecule NMDA receptor modulator, NYX-458, was being studied in 99 patients with mild cognitive impairment or mild dementia associated with Parkinson’s disease or Lewy body dementia. Based on the results, Aptinyx has decided to stop the therapy’s development and to close its phase IIb study of another oral, small molecule, NYX-783, for treating post-traumatic stress disorder. The company said it will take cost-cutting measures to preserve capital and to support exploring strategic alternatives. Shares of Aptinyx (NASDAQ:APTX) dropped 65% at midday to about 20 cents each.

TC Biopharm hacks through gamma delta ‘jungle’ in AML

T-cell specialist TC Biopharm plc is pioneering gamma delta (γδ) work with Omnimmune, an allogeneic unmodified cell therapy, at the phase II stage in acute myeloid leukemia (AML). CEO Bryan Kobel told BioWorld that his firm is “the leader in the γδ jungle.” Co-founded by Michael Leek and Angela Scott, who serve as chairperson and chief operating officer, respectively, TC gained its technology from Tokyo-based Medinet, and broadened the methodology “exponentially,” he said.

Newco news: New era in genetic medicines beckons as Aera arrives on scene

Armed with $193 million in combined series A and B rounds, Aera Therapeutics aims to address current challenges with delivering gene-based therapies via a self-assembling human-derived protein platform it has in-licensed from a well-known Harvard scientist’s lab. The company’s protein nanoparticle genetic medicine delivery technology is designed to leverage the discovery of endogenous proteins derived from ‘retroelements’ that can form capsid-like structures, which can package and transfer nucleic acid cargo. “Genetic medicines – comprising both a payload and a delivery system – are powerful modalities with wide-ranging therapeutic applications for the treatment of human disease,” said Akin Akinc, CEO of the Boston-headquartered company.

Health Canada lays out the rules for psychedelics in treatment

In light of the growing interest in the use of psilocybin, MDMA and other psychedelics in psychotherapy, Health Canada issued a notice yesterday spelling out how licensed providers can obtain the drugs through the agency’s special access program (SAP) on a case-by-case basis. If a SAP request is authorized, the sale of the drug is exempt from Canada’s Food and Drug Regulations. However, authorization “is not a broad statement or opinion that the drug is safe, efficacious or of high quality, rather, that the sale is justifiable in the context of a medical emergency,” Health Canada said.

Eluminex raises $40M series B for biosynthetic cornea, ophthalmology pipeline

Ophthalmic startup Eluminex Biosciences Ltd. closed a $40 million series B round to progress its pipeline of ophthalmic assets and recombinant human collagen technology. Eluminex’s pipeline includes multi-targeted antibody molecules for vision-threatening retinal diseases and an oral small molecule for rare inherited pediatric retinal dystrophies, but its lead asset, EB-301, is a biosynthetic cornea derived from recombinant human type III collagen. It is in late-stage development for visual acuity deficits associated with corneal blindness due to stable, non-infectious stromal lesions amenable to anterior lamellar keratoplasty.

Biocytogen out-licenses bispecific antibody to Chipscreen in ¥596M deal

Biocytogen Pharmaceuticals Co. Ltd.’s wholly owned subsidiary, Eucure (Beijing) Biopharma Co. Ltd., licensed exclusive greater China rights to YH-008 to Shenzhen Chipscreen Biosciences Co. Ltd. in a ¥596 million (US$86 million) deal. Chipscreen subsidiary, Chipscreen Newway Biosciences Co. Ltd., will develop and commercialize the bispecific antibody in mainland China, Hong Kong, Macau and Taiwan. Chipscreen Biosciences will pay ¥40 million up front to Biocytogen, which will also be eligible to receive up to ¥360 million in potential development milestone payments, and up to ¥196 million in sales milestone payments, as well as tiered royalties based on net sales.

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