Mixed clinical results led shares of Arvinas Inc. (NASDAQ:ARVN) to trade at $8.34, down $9.21, or 52%, after the company and Pfizer Inc. disclosed results from the phase III Veritac-2 study testing vepdegestrant monotherapy vs. fulvestrant in adults with estrogen receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer. Enrolled were subjects whose disease progressed after treatment with CDK4/6 inhibitors and endocrine therapy. The trial met its primary endpoint in the estrogen receptor 1-mutant (ESR1m) population, turning up a statistically significant and clinically meaningful improvement in progression-free survival compared to fulvestrant. The results exceeded the prespecified target hazard ratio of 0.60 in the ESR1m population, but Arvinas said Veritac-2 fell short of statistical significance with regard to improvement in PFS in the intent-to-treat population.

Cervomed serves up positive extension data in dementia phase IIb study

Positive 16-week extension data from Cervomed Inc.’s phase IIb in dementia with Lewy bodies (DLB) followed a failure from December. New results from the phase IIb Rewind-LB trial testing neflamapimod, a brain-penetrant, orally administered small molecule that inhibits the intracellular enzyme p38MAP kinase alpha, showed that a new batch of neflamapimod capsules led to increased plasma drug concentrations and improvement on the primary outcome measure, change from baseline in Clinical Dementia Rating Sum of Boxes. In December, Cervomed’s small molecule failed the phase IIb Rewind-LB study for early stage DLB by falling short of statistical significance thresholds for the primary and all secondary endpoints.

Kyowa Kirin, Amgen’s rocatinlimab ignites positive response in Rocket study

Analysts were pleasantly surprised by the positive phase III data reported for Kyowa Kirin Co. Ltd./Amgen Inc.’s rocatinlimab, a T-cell rebalancing therapy, in moderate to severe atopic dermatitis (AD). An anti-OX40 fully human monoclonal antibody licensed from Kyowa Kirin in a $1.2 billion deal in 2021, rocatinlimab (also known as KHK-4083 and AMG-451) achieved the co-primary endpoints and all key secondary endpoints in the Rocket Ignite study, which evaluated two doses of rocatinlimab. Amgen is studying the compound in eight phase III Rocket trials.

Leyden Labs raises $70M, acquires Covbio for intranasal flu drugs

Leyden Laboratories BV added a fresh $70 million in financing to advance Panflu, its phase II-ready intranasal pan-influenza prophylactic medicine, while acquiring Cov Biotechnology Pte. Ltd. (Covbio) and its zoonotic virus-targeting portfolio to prepare for the next pandemic. Founded by a quartet of Dutch biotech industry veterans from Janssen Vaccines, Leyden Labs launched in March 2021 with the closing of a €40 million (US$47 million) series A financing round that was led by GV (formerly Google Ventures) and joined by F-Prime Capital, Casdin Capital, LLC and Brook Byers.

At CROI, HIV cure trials raise hopes for broader applicability

On the first full day of the 2025 meeting of the Conference on Retroviruses and Opportunistic Infections, reports from the first HIV cure trial conducted in Africa, the RIO trial and others showed that perhaps, a broadly useful cure is on the horizon. While there are now seven individuals who have been cured of HIV via a bone marrow transplant, and two new cases were presented at the conference, a bone marrow transplant is far too risky for otherwise healthy HIV-infected individuals.

Ending ‘pill penalty’ challenges sacred cow status of IRA

Getting the Ensuring Pathways to Innovative Cures (EPIC) Act through the U.S. Congress to do away with the “pill penalty” in the Medicare drug price negotiations could require an epic effort, given the current politically fueled atmosphere on the Hill. With the Inflation Reduction Act (IRA), which created the negotiations, considered a signature achievement of the Biden administration, the negotiations have become, for many lawmakers, almost a sacred cow that can’t be touched. While the Democrats who passed the IRA without Republican support haven’t been keen to say there’s anything wrong with the legislation, John Stanford, executive director of the Incubate Coalition, told BioWorld he hopes they will realize the need to get on board with what is a “straightforward fix” to put small molecule drugs on the same negotiations clock as biologics.

I&I efforts coming on strong as multiple players advancing on various fronts

Leerink analyst Thomas Smith recently popped the lid off his “five for 2025” in immunological and inflammatory diseases. He finds “potential for disruption” in the year ahead by a number of players, and cited hidradenitis suppurativa, metabolic dysfunction-associated steatohepatitis, myasthenia gravis, atopic dermatitis, and inflammatory bowel disease. He called HS “a serious immuno-dermatology indication that may impact up to 4% of the population, but has been historically underserved, with only one approved biologic treatment.” The second part of BioWorld’s two-part series takes a deeper dive into the space.

Valo raises €19M for immunotherapy work

Finnish cancer immunotherapy specialist Valo Therapeutics Oy has raised €19 million (US$20.7 million) in a round that attracted Italian and Australian investors, and funding the company to the completion of the ongoing phase Ib trial of its lead program in the treatment of solid tumors. The trial of the tumor antigen-coated oncolytic virus, which started in Germany in 2022, will now be extended to sites in Italy and Australia. Valo also will set up a new operating company and research and development center in Naples, Italy, where virus manufacturing will be scaled up.

Clinical trial fraud ends with guilty pleas

In another real-life episode of “sponsor beware,” two owners of a clinical research facility in Florida pleaded guilty yesterday in U.S. district court to fraud charges resulting from their conduct of two clinical trials for potential asthma drugs. Angela Baquero and Ricardo Acuna, owners of A&R Research Group, entered their pleas a week after Matthew Teltser pleaded guilty to making false statements to an FDA investigator regarding his work as a clinical investigator for the trials.

Also in the news

Agomab, Alumis, Alvogen, Arrowhead, Astrazeneca, Beam, Biocon, Bristol Myers Squibb, Celltrion, Design, Eli Lilly, Haya, Incyte, Innocare, Inozyme, Ionis, Johnson & Johnson, Leo Pharma, Madrigal, Matinas, Mineralys, Novo Nordisk, Organon, Psyence, Regeneron, Sanofi, Seaport, SFA, Sunshine, Tenpoint, Trevi, Urogen, Valo, Vertex