Modifi Biosciences Inc. has come a long way very quickly. Spun out of Yale University in 2021, it published data on DNA in Science in July 2022, and is now being acquired by Merck & Co. Inc. for $30 million up front. Ultimately, Modifi shareholders could receive milestones of up to $1.3 billion. The buyout is among the top five of pending biopharma M&As announced in recent months, according to BioWorld data. Merck will get Modifi’s small molecules that go after cancer cells that do not have expression of the DNA repair protein O6-methylguanine methyl transferase. The therapies are being developed to be used in treating glioblastoma and other tumors. The company has preclinical data in several tumor models.

Alto’s ALTO-100 misses endpoints in phase IIb depression study

Shares of Alto Neuroscience Inc. (NASDAQ:ANRO) plunged more than 60% in midday trading on news that the phase IIb study of BDNF-targeting ALTO-100 in major depressive disorder (MDD) missed its primary endpoint, despite the company’s biomarker-based approach. Analysts are awaiting detailed data to determine whether those findings read through to Alto’s other pipeline programs, with data for ALTO-203 and ALTO-300 in MDD expected in the first half of 2025. In the meantime, Alto, which went public in February 2024, said its current cash position should fund operations into 2027.

UK nod for Alzheimer’s drug Kisunla, but NICE says no coverage

The U.K. Medicines and Healthcare products Agency has become the third to approve Eli Lilly and Co. Inc.’s Kisunla (donanemab), but the drug’s spending watchdog has simultaneously ruled the Alzheimer’s disease treatment is not cost effective. The costs of providing Kisunla, including regular infusions and intensive monitoring for serious side effects, balanced against the “relatively small benefit it provides to patients,” means it is not a “good value for the taxpayer,” and should not be reimbursed by the National Health Service, NICE (the National Institute for Health and care Excellence) said.

DBV to pursue accelerated pathway with peanut-allergy patch

Shares of DBV Technologies SA (NASDAQ:DBVT) were trading at 95 cents, up 25 cents, or 35%, on favorable regulatory updates regarding the Viaskin Peanut allergy patch in the U.S. and Europe. DBV has agreed to guidance provided by the U.S. FDA on a pathway under the accelerated approval program for the patch in toddlers ages 1 to 3 years and has received scientific advice from the EMA on an indication in patients 1 to 7 years old. The Montrouge, France-based firm will ask for further talks with the FDA to nail down details.

Cellbion the latest radiopharma contender with upsized IPO

Cellbion Co. Ltd. debuted on the tech-heavy Kosdaq board of the Korea Exchange Oct. 16, with share prices closing upward at ₩20,650 (US$14.94) – outdoing its initial price of ₩15,000 per share for 1.9 million shares. The Korean radiopharmaceutical company raised about ₩28.65 billion (US$20.73 million) from the IPO to advance its lead candidate, Lu-177-DGUL, in a domestic phase II study for prostate cancer. In intraday trading Oct. 16, Cellbion shares (KOSDAQ:208430) rose to a high of ₩25,400 before closing at ₩20,650, recording a 37.6% gain. The funds raised from the IPO will provide a cash runway into 2027 to support R&D and clinical trials.

UK’s MHRA eyes new regs for point-of-care drug manufacturing

The U.K.'s Medicines and Health Care Products Regulatory Agency (MHRA) has posted a series of draft new regulations that will increase the requirements for device makers doing business in the U.K. However, the agency has also floated a regulation for the production of pharmaceuticals at the point of care, a proposal MHRA said is the first of its kind. MHRA said Parliament had provided a statutory instrument that creates an opening for this regulation, which will allow the manufacture of drugs in "small, portable units" that can be sited near patients in need. This is part of the agency's "hospital at home" initiative that includes the concept of a virtual hospital ward.

The BioWorld Insider podcast: A quantum leap into the future of drug development

In the newest BioWorld Insider podcast, Victoria Lipinska, the America's lead for Quantum Innovation Centers at IBM Quantum, talks about the future of drug development using quantum computing. “The new technology is a completely different branch of computing as opposed to what we know right now, and it's meant to complement what we know, not to really replace it,” she said. Quantum computing could lead to more efficient drug discovery by identifying promising compounds faster, understanding their effects at the molecular level, and then reducing the need for costly or time-consuming lab experiments. Lipinska is one of the more than 100 experts who will evaluate the future of health care at the upcoming 2024 Biofuture conference. Each year, a group of trailblazers, disruptors and forward-thinking executives converge to evaluate and forecast the future of health care. This year, BioWorld is a sponsor of the Oct. 28-30 event in New York. If you attend, you'll have the chance to hear panels and join workshops and fireside chats with key opinion leaders like Lipinska.

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