Zymeworks Initiates Phase 1 Trial of ZW171 in Mesothelin-Expressing Advanced Cancers
Zymeworks Inc. (Nasdaq: ZYME), a biotechnology firm in the clinical phase, is advancing a varied portfolio of innovative, multifunctional biotherapeutics aimed at enhancing treatment standards for hard-to-manage diseases. The company has announced that the initial participant has been administered the investigational therapy ZW171 as part of the first-in-human Phase 1 trial (NCT06523803), which is focused on assessing the safety and tolerability of this treatment for patients with advanced or metastatic ovarian cancer, non-small cell lung cancer (NSCLC), and other malignancies expressing MSLN.
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MSLN exhibits significant expression across various tumor types, notably in ovarian cancer and moderately in NSCLC. This expression profile makes it a promising candidate for therapeutic intervention using our proprietary T cell engager technology. Preclinical investigations have shown that ZW171 effectively induces strong in vivo selective destruction of target cells overexpressing MSLN and enhances MSLN-related T cell activation. This minimizes the likelihood of on-target-off-tumor adverse effects, as well as reduces the risk of peripheral T cell activation and cytokine release syndrome.
Data shared at the 2023 American Association for Cancer Research Annual Meeting indicate that ZW171 displays superior anti-tumor effectiveness relative to benchmarks in MSLN-positive tumor models and is well tolerated in cynomolgus monkeys at doses up to 30 mg/kg2.
“We are excited to have commenced the clinical assessment of ZW171 for patients with ovarian cancer and NSCLC, as it shows the potential to be a highly effective treatment with a favorable safety profile based on our preclinical findings,” stated Jeff Smith, M.D., FRCP, Executive Vice President and Chief Medical Officer at Zymeworks. “Starting this trial represents a noteworthy advancement in our goal to introduce a new therapeutic option for patients with challenging cancers and underscores our ambition to move forward with two therapeutic candidates, ZW171 and ZW191, into clinical trials in 2024.”
The Phase 1 trial consists of two segments, is open-label, and is multi-center, projected to enroll around 160 adult patients suffering from advanced MSLN-overexpressing cancers. The first part of the trial will assess the safety and tolerability of ZW171, including dose escalation among participants with advanced ovarian cancer and NSCLC; secondary outcomes will gauge pharmacokinetics and confirmed objective response rates. The second segment will expand doses into three groups (ovarian cancer, NSCLC, and a mixed cohort for any MSLN-positive individuals) and will investigate the anti-tumor efficacy of ZW171, with primary focus on safety and tolerability and secondary endpoints evaluating progression-free survival, duration of response, and overall survival. The Company plans to execute the Phase 1 study at research sites across the United States, Europe, and the Asia-Pacific region.
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According to the data provided by the Synapse Database, As of October 21, 2024, there are 12 investigational drug for the CD3 x MSLN target, including 9 indications, 13 R&D institutions involved, with related clinical trials reaching 2, and as many as 7177 patents.
The drug ZW-171 is a Bispecific T-cell Engager (BiTE) that targets CD3 x MSLN. It falls under the therapeutic areas of neoplasms, endocrinology and metabolic disease, respiratory diseases, urogenital diseases, and digestive system disorders. The active indications for ZW-171 include mesothelin positive neoplasms, non-small cell lung cancer, ovarian cancer, and pancreatic cancer.
