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Good day, everybody. Damian right here with the newest biotech startup to downsize, a novel thought in most cancers therapy, and some main catalysts on the calendar.
The necessity-to-know this morning
- Kyverna Therapeutics, a biotech creating CAR-T remedies for autoimmune ailments, filed for an initial public offering. Its lead product, known as KYV-101, is a patient-specific, CD19-targeted cell remedy for lupus nephritis, at present in a mid-stage scientific trial.
A buzzy biotech cuts workers, acknowledges setbacks
Dewpoint Therapeutics, a biotech startup that has raised almost $300 million, has laid off 15% of its workers and acknowledged a pair of high-profile partnerships fell aside.
In 2018, as STAT’s Jason Mast studies, Dewpoint launched an rising discipline of science known as biomolecular condensates, microscopic droplets that shuttle molecules round a cell. Issues haven’t gone completely to plan. Each Pfizer and Merck dropped out of partnerships that might use Dewpoint’s know-how to develop an HIV remedy, in Merck’s case, and, for Pfizer, to deal with a type of muscular dystrophy.
Within the midst of a tumultuous fundraising local weather in biotech — “for a preclinical firm, it’s not even value having that dialogue,” CEO Ameet Nathwani mentioned — Dewpoint determined to downsize and give attention to getting its first two medicines into scientific trials subsequent yr.
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A second nod for the primary CRISPR drugs
The FDA expanded its approval of Casgevy, a genome-editing drugs from Vertex Prescription drugs and CRISPR Therapeutics, to incorporate sufferers with beta thalassemia, an inherited blood dysfunction.
As STAT’s Adam Feuerstein studies, the FDA’s choice comes a month after the company authorized Casgevy as a one-time therapy for sickle cell illness, making it the primary CRISPR-based drugs obtainable within the U.S.
Casgevy makes use of the gene-editing know-how CRISPR to genetically modify a affected person’s personal blood stem cells to provide excessive ranges of fetal hemoglobin — the wholesome, oxygen-carrying type of hemoglobin that’s produced throughout fetal growth however usually shuts down quickly after beginning.
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Chemo causes hair loss. A startup needs to alter that
Among the many most dreaded negative effects of chemotherapy is the close to assure that sufferers will lose their hair. “It’s greater than vainness,” mentioned Sarah Schellhorn, a medical oncologist at Yale Most cancers Middle. “It’s about wanting sick. It’s about how they’re perceived by others.”
Perseus Therapeutics, a biotech firm based final yr, has an thought to alter that. As STAT’s Angus Chen studies, Perseus is within the early phases of creating an antibody therapy that might defend hair follicle cells from the consequences of chemo.
All of it stems from the work of a Duke College grad pupil, who was finding out whether or not boosting a protein known as TSLP would speed up wound therapeutic in mice. It didn’t, however the handled rodents grew markedly hairier than their counterparts, setting in movement experiments that led to Perseus’ lead program.
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Biotech’s massive any-day-now information
Whereas the J.P. Morgan Healthcare Convention introduced a good bit of reports, a couple of of biotech’s most hotly anticipated happenings went with out a point out, that means they’ve turn into any-day-now disclosures which can be positive to maneuver markets.
Vertex Prescription drugs will quickly have information from three Part 3 research testing whether or not its novel, non-addictive ache therapy can enhance the lives of sufferers who’ve just lately undergone surgical procedure. The corporate mentioned it expects leads to “early 2024,” at any time when that is perhaps, and the multibillion-dollar way forward for its ache analysis depends on success.
Eli Lilly is awaiting FDA approval for donanemab, its therapy for Alzheimer’s illness. The corporate hasn’t disclosed an anticipated choice date, however Wall Avenue figures it’ll be this quarter. The thriller right here isn’t whether or not donanemab shall be authorized — the supporting proof seems to fulfill the FDA’s established requirements — however how Lilly will worth, place, and launch its product.
Extra reads
- Extra sufferers are getting their meds on-line. Huge Pharma needs in on the motion, STAT
- Allakos to drop pores and skin illness drug after mid-stage research failure, shares slide, Reuters
- Survey: Confusion over key necessities means scientific trials aren’t registered and outcomes aren’t reported, STAT
