New Antibody Drug Conjugate Shows Promising Results in Phase I Study
New Antibody Drug Conjugate Shows Promising Results in Phase I Study
MediLink Therapeutics and BioNTech have reported positive safety and efficacy signals for their new antibody drug conjugate (ADC), YL202/BNT326, in a Phase I study. The ADC targets HER3 and inhibits topoisomerase 1, showing complete and partial responses in patients with pretreated locally advanced and metastatic NSCLC and breast cancer. The drug also demonstrates an acceptable safety profile, with only one dose limiting toxicity event recorded. The primary completion of the study is expected in December 2024, with data set to be shared at ASCO 2024 conference. Merck & Co and Pfizer will also present their ADCs' clinical results at the conference.
Key Takeaways
- YL202/BNT326, an antibody drug conjugate (ADC) developed by MediLink Therapeutics and BioNTech, has shown early safety and efficacy signals in a Phase I study.
- The drug targets HER3 and inhibits topoisomerase 1, delivering a cytotoxic payload to cancer cells.
- The study specifically focuses on patients with EGFR-mutated non-small cell lung cancer (NSCLC) and HR-positive, HER2-negative breast cancer.
- Out of the 46 evaluable patients, there was one complete response, 16 partial responses, and 26 patients with stable disease.
- YL202/BNT326 has demonstrated an acceptable safety and tolerability profile with minimal severe adverse events.
Analysis
The successful Phase I trial of MediLink Therapeutics and BioNTech's HER3 antibody drug conjugate, YL202/BNT326, marks a significant milestone in the development of targeted cancer therapies.
Did You Know?
- Antibody Drug Conjugate (ADC): ADCs combine an antibody with a cytotoxic drug to specifically target cancer cells.
- HER3 (ErbB3): Encodes a protein involved in cell growth, survival, and differentiation and is linked to various cancers.
- Topoisomerase 1: Plays a key role in DNA regulation and is a target for cancer therapy.
- MediLink Therapeutics and BioNTech: Biopharmaceutical companies focused on innovative cancer therapies.