In order to submit an IND for ZW251 by mid-2025, Zymeworks needs to “reprioritize resources,” with ZW220 taking the hit.\n Zymeworks has pumped the brakes on plans to take one of its antibody-drug conjugates into the clinic so it can prioritize another candidate.The company entered 2025 with a goal of getting two ADCs, dubbed ZW220 and ZW251, into phase 1 trials for solid tumors this year. ZW220 targets human NaPi2b, while ZW251 targets Glypican-3.In its fourth-quarter earnings results, Zymeworks said it is stepping up its plans for ZW251 “based on our encouraging preclinical results and the unique potential opportunity to help hepatocellular carcinoma patients.” The goal is now to submit an IND for the therapy in the coming months. “ZW251 provides a new therapeutic modality option targeting GPC3 for hepatocellular carcinoma and represents an emerging opportunity in oncology that has yet to be fully realized,” Zymeworks Chief Scientific Officer Paul Moore, Ph.D., said in the March 5 release. “With a potential best-in-class design and differentiated mechanism, we believe our pipeline presents meaningful opportunities for both strategic partnerships and value creation, and we look forward to initiating a phase 1 trial for ZW251 this year.”In order to hit this deadline, Zymeworks needs to “reprioritize resources,” with ZW220 taking the hit.“As a result, we have paused preparations for the commencement of phase 1 studies of ZW220 at this time,” the biopharma said. However, Zymeworks still believes ZW220 “remains a highly differentiated, IND-ready ADC with encouraging preclinical data and strong commercial rationale with partnership potential.” “We look forward to providing future updates on the development for ZW220,” Zymeworks added.In November, the company launched another ADC, dubbed ZW191, into a phase 1 trial to assess its potential as a treatment for advanced FR⍺-expressing solid tumors. The same month, Zymeworks’ Jazz Pharmaceuticals-partnered prospect Ziihera secured FDA approval for unresectable or metastatic HER2+ (IHC 3+) biliary tract cancer.

ADCPhase 1Drug Approval

06 Mar 2025

·endpts.com

Corrected: Merck KGaA’s mixed Phase 2 lupus results; Zymeworks pauses work on ADC

Plus, news about Tris Pharma and ARS Pharmaceuticals: Merck KGaA’s lupus drug yields mixed data in mid-stage trial: The drugmaker’s TLR7/8 inhibitor, called enpatoran, missed one of two Phase 2 primary endpoints in a cohort of patients with systemic lupus erythematosus, according to chief financial officer Helene von Roeder on the company’s earnings call on Thursday. The drug previously showed promise patients with cutaneous lupus in the same trial, and Merck said the overall data support further development. — Ayisha Sharma Zymeworks deprioritizes ADC: The company is pausing Phase 1 development of ZW220, which is designed to target sodium-dependent phosphate transporter 2b. It had been considering testing the ADC in ovarian and non-small cell lung cancer. Zymeworks noted that the program still has “strong commercial rationale with partnership potential.” — Max Gelman Tris Pharma reports another Phase 3 success for pain drug: The treatment, called cebranopadol, succeeded in a trial measuring its pain reduction abilities after surgical bunion removal. The win comes less than two months after a Phase 3 study in patients who had undergone tummy tucks also met its primary endpoint. The drug is designed to target the pathway used by painkillers like Vicodin and morphine to create their sedative and analgesic effects as well as another receptor that has a “modulatory role” on that pathway (though it still belongs to the broader family of opioid receptors). — Max Gelman ARS Pharmaceuticals’ neffy gets another approval: The company said Wednesday that the FDA approved neffy 1 mg to treat Type I allergic reactions in children who are at least 4 years old and hit a weight requirement. The nasal spray was first approved in the US last summer. — Jaimy Lee Editor’s note: This article and its headline were corrected to note that Merck KGaA’s lupus trial had mixed data and to correct a quote attribution. A previous version of the article incorrectly stated that the trial had failed.

Phase 3Phase 2Drug ApprovalPhase 1ADC

06 Mar 2025

·firstwordpharma.com

Zymeworks walks back plans to advance ADC pair, picks one to focus on instead

Less than two months after Zymeworks detailed its goal of submitting paperwork to start clinical trials for two antibody-drug conjugate (ADC) candidates in 2025, the biotech has adjusted its expectations.During the company's 2024 earnings report on Wednesday, Zymeworks said it's pausing work on an application for ZW220, an NaPi2b-targeted ADC, to instead focus on ZW251, with a submission targeted for mid-2025. The prioritised ADC is directed against glypican-3 (GPC3), a protein expressed on hepatocellular carcinoma (HCC) cells. According to Zymeworks, the decision to concentrate on ZW251 was based on "encouraging preclinical results," as well as the "unique potential opportunity" to help patients with HCC."ZW251 provides a new therapeutic modality option… and represents an emerging opportunity in oncology that has yet to be fully realised," Chief Scientific Officer Paul Moore said in a company release, adding that the programme has "a potential best-in-class design and differentiated mechanism."The company emphasised that ZW220 hasn't been discontinued, though it hinted it may be on the hunt for a collaborator to take the ADC into the clinic. Zymworks said the candidate has "encouraging preclinical data and strong commercial rationale with partnership potential."The reshuffled timeline might also affect Zymeworks' overarching goal of completing five investigational new drug (IND) applications by the first half of 2026. The company has already brought two assets into the clinic — bispecific antibody ZW171 and ZW191, an ADC — and ZW251 will mark the third. In addition to ZW220, Zymworks is also developing ZW209, a trispecific T cell engager targeting DLL3-expressing tumor cells. Zymeworks' stock slipped about 7% on Thursday.

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Indication	Highest Phase	Country/Location	Organization	Date
Non-Small Cell Lung Cancer	Preclinical	-	Zymeworks BC, Inc.	-
Ovarian Cancer	Preclinical	-	Zymeworks BC, Inc.	-

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