News briefing: Assembly Bio scraps microbiome programs; InveniAI, Kyowa Kirin expand partnership to focus on novel targets

More than a year after Gilead’s former R&D chief John McHutchison took the reins at Assembly Biosciences, the San Francisco, California-based company is pulling back from its microbiome program in order to concentrate its resources on advancing a portfolio of therapeutics and core inhibitors related to hepatitis B.

McHuchison said in a statement that the decision to wind down the company’s microbiome program was “difficult.” The company will examine possible alternatives for the program, but if no other options are discovered, its operations will cease by the end of January.

Assembly Biosciences said the decision was “not based on any efficacy, safety, or other data related to Assembly Bio’s microbiome programs.” — Conner Mitchell

InveniAI, Kyowa Kirin expand partnership to focus on novel targets

An expanded collaboration between two companies — one focused on artificial intelligence and one on drug development — will allow a greater foray into novel target development.

InveniAI, a Connecticut-based company that makes artificial intelligence and machine learning tools for drug discovery, and Kyowa Kirin, a Tokyo, Japan-based biopharmaceutical company, announced Wednesday that they are expanding their existing partnership to generate new therapeutic antibodies to address unmet medical needs across multiple diseases.

Under the terms of the agreement, Kyowa Kirin will select multiple programs to advance into clinical development using InveniAI’s AlphaMeld platform. InveniAI will receive an upfront payment, development and commercial milestones, as well as royalties. — Conner Mitchell

Rocket takes off on gene therapy data

Rocket Pharmaceutics is — forgive me — taking off.

The 21-year-old, New York-based biotech announced Phase I data for its gene therapy for the rare cardiovascular disorder Danon disease. Although it’s still early, investors were enthused, sending the stock $RCKT up 79%, from $32.03 to $57.28 and adding well over $1 billion in market value.

The data, one of a handful of early-stage gene therapy announcements Rocket has put out over the past two years, showed that the therapy was safe and succesfully increasing the expression of the target gene, called LAMP2B.

There were also early efficacy data. Danon disease is characterized by weakening of heart muscles. In the trial, though, brain natriuretic peptide, a marker of heart failure, improved by 50% in 2 of 3 patients. Another biomarker, creatine kinase myocardial band, also improved, although Rocket did not disclose by how much. — Jason Mast.

Mycovia heralds a PhIII yeast infection win

Mycovia announced Wednesday that its lead drug, oteseconazole, cleared Phase III trials for chronic yeast infection, also known as recurrent vulvovaginal candidiasis.

The company didn’t break down the full primary endpoint data but said oteseconazole outperformed placebo in the number of patients who had a confirmed infection during the trial, with a p-value < 0.01. The drug was able to prevent a recurrent infection in 96% and 93% of women, they said.

The company expects to apply for approval in the first half of next year. There are currently no approved drugs for the condition. — Jason Mast

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