FDA Allows Resumption Of BioNTech/MediLink Therapeutics Partnered Phase 1 Study For Cancer Drug With Lower Dose
The FDA has lifted the partial clinical hold on MediLink Therapeutics’ Phase 1 trial for BNT326/YL202, a HER3-targeting antibody-drug conjugate (ADC).
This decision, announced on August 15, follows the submission of a complete response that includes data analysis, updated documentation, and additional risk mitigation measures, the company reported in an SEC filing.
The MediLink-sponsored trial evaluates the early-stage antibody-drug conjugate product candidate BNT326/YL202 as a later-line treatment in heavily pre-treated patients with advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer or HR+/HER2-negative breast cancer.
The FDA has shared with MediLink concerns that BNT326/YL202 may, at higher doses, expose human subjects to an unreasonable and significant risk of illness or injuries.
Also Read: Pfizer, BioNTech’s COVID-19/Flu Combo Vaccine Fails To Meet Key Goal In Late-Stage Study.
Initially paused in June 2024, the clinical trial will resume recruitment, focusing on dose levels not exceeding 3 mg/kg, where the treatment has shown a manageable safety profile and encouraging clinical activity.
The hold stemmed from concerns over dose-dependent treatment-related adverse events (TRAEs), notably a decrease in neutrophil count (neutropenia) and a rise in mucositis cases.
Both conditions are known risks associated with established chemotherapies and can lead to severe infections.
Neutropenia is typically managed through dose adjustments, treatment interruptions, or prophylactic measures like recombinant granulocyte colony-stimulating factors (G-CSFs), depending on the patient’s individualized risk.
In response to these safety concerns, MediLink and BioNTech SE (NASDAQ:BNTX) took proactive measures.
These included halting patient enrollment in dose cohorts above 3 mg/kg and reducing doses for enrolled participants at higher levels.
With the FDA’s approval, MediLink and BioNTech are set to resume clinical development under the revised guidelines, ensuring patient safety while exploring the potential of BNT326/YL202.
Price Action: BNTX stock is up 1.10% to $86.13 at the last check on Monday.
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