ZW-171

Scrapping ZW171 means that, for now, Zymeworks is back to having just one asset in the clinic.\n Zymeworks is abandoning a T-cell engager after assessing the cancer drug’s benefit-risk profile in a phase 1 study.The biopharma has been evaluating the candidate, dubbed ZW171, in patients with ovarian or non-small cell lung cancers. The company had used the trial to establish a maximum dose of the therapy before deciding that “further dose evaluation in the current trial would be unlikely to support a benefit-risk profile consistent with the desired monotherapy target product profile.”Cytokine release syndrome—a potentially serious side effect of cancer immunotherapies that redirect T cells—was well managed in the phase 1 study, according to Zymeworks’ Sept. 2 release.Still, these toxicities limited the upper dose of ZW171 that could be considered for treatment, while being “consistent with mesothelin-related on-target off-tumor toxicity,” the company added.“While this is a disappointing outcome given the promising preclinical activity observed with ZW171, we are deeply grateful to the patients, providers and caregivers for their support and participation in the ZW171 phase 1 study,” Zymeworks CEO Kenneth Galbraith said in the release.“As part of Zymeworks’ disciplined approach to the management of our broad product portfolio, we are committed to careful and consistent evaluation of clinical progress for each product candidate to ensure our resources are directed towards those product candidates with the greatest potential impact for patients,” Galbraith added. Scrapping ZW171 means that, for now, Zymeworks is back to having just one asset in the clinic in the form of the phase 1-stage antibody-drug conjugate ZW191 for advanced FR⍺-expressing solid tumors.However, the company is gearing up to launch a clinical study of its GPC3-targeting ADC ZW251 later this year, while seeking the FDA nod next year to take its DLL3-directed trispecific T-cell engager ZW209 into the clinic.Zymeworks has already scaled back its clinical strategy once this year when the company shifted resources away from a planned phase 1 study of a NaPi2b-targeting ADC called ZW220 in March.The biopharma has one drug on the market in the form of the HER2 bispecific antibody Ziihera, which brought its partner Jazz Pharmaceuticals $5.5 million in sales in the second quarter.

Plus, news about Zenas BioPharma, OMass Therapeutics, Merck, Bayer, Convalife Pharmaceuticals, Mabwell Bioscience, CapVest, Stada and vTv Therapeutics: 💰 Servier licenses Ideaya Biosciences’ cancer drug: The French pharma is getting the ex-US rights to Ideaya’s experimental uveal melanoma drug for $200 million upfront. Servier could fork over another $320 million in biobucks for the Phase 2/3 candidate, which is named darovasertib. — Kyle LaHucik 🧪 Zymeworks discontinues work on T cell engager: The biotech determined that its additional dose evaluation in a Phase 1 trial of ZW171 wouldn’t yield the benefit-risk profile it wanted. Zymeworks had planned to test the TCE in cancers with high levels of mesothelin. — Jaimy Lee 🧾 Zenas BioPharma makes a royalty deal: Royalty Pharma is paying $75 million upfront and up to $300 million total in exchange for the royalties on sales of obexelimab, Zenas’ experimental bifunctional monoclonal antibody that’s being tested in several autoimmune diseases. An increasing number of biotechs are inking royalty deals to bolster their balance sheets. — Jaimy Lee 🇨🇭 OMass Therapeutics, Roche ink deal: The Swiss drugmaker is paying $20 million upfront for the rights to develop and commercialize OMass’ preclinical oral inflammatory bowel disease program. There are also more than $400 million in milestones and tiered royalties on the table. — Jaimy Lee 🫀 Merck and Bayer’s Verquvo fails a Phase 3 study in heart failure: The companies have been testing the drug in adults with stable chronic heart failure and reduced ejection fraction. Verquvo is already approved to treat a different subset of patients with heart failure. — Jaimy Lee 🇨🇳 Two Chinese biotechs file for IPOs in Hong Kong: This includes Convalife Pharmaceuticals , a decade-old cancer drug developer with one approved medicine and 16 others in development, and Mabwell Bioscience , a cancer and age-related diseases biotech founded eight years ago. Mabwell is already listed on the Shanghai Stock Exchange STAR Market. It tried for an HKEX listing in January but let its filing lapse. The companies are the latest to file to go public in the still active IPO market in Hong Kong. — Kyle LaHucik 🇩🇪 CapVest Partners takes a majority stake in Stada: Sources told The Financial Times that Stada has a valuation of roughly €10 billion, including debt. Bain Capital and Cinven acquired Stada in 2017 and then took the German pharma company private. Stada was known as a generics maker but has since broadened its business into consumer healthcare and specialty drugs. The deal is expected to close in the first half of next year — Jaimy Lee 💊 vTv Therapeutics’ $80M private placement: The company plans to use the funding to advance cadisegliatin, its Phase 3 adjunctive therapy to insulin for patients with type 1 diabetes. The PIPE’s investors include several institutional investors and the T1D Fund. — Jaimy Lee