Key Takeaways
- Forlong Biotechnology’s JOINN Biologics has produced the pivotal FL115 batch for Phase III trials targeting BCG-unresponsive bladder cancer.
- FL115, an engineered IL-15 fusion protein, has shown strong stability and solubility, supporting ongoing clinical studies.
- The Phase III trial is planned to begin in 2027, building on promising safety and efficacy results from earlier patient dosing.
Manufacturing Milestone Achieved
Forlong Biotechnology, a clinical-stage biotech company dedicated to advancing cytokine therapies, has reached a significant milestone in the development of its investigative drug FL115. The company announced that JOINN Biologics has successfully completed manufacturing the pivotal batch of FL115, which prepares Forlong for its Phase III clinical trial aimed at treating non-muscle invasive bladder cancer (NMIBC) in patients unresponsive to Bacillus Calmette-Guérin (BCG) therapy.
FL115 is a novel engineered IL-15/IL-15Rα-Fbody® fusion protein designed to enhance therapeutic efficacy. The Fbody® technology allows for improved protein stability and biodistribution, crucial for optimizing treatment outcomes. The drug product has maintained excellent solubility and stability at concentrations up to 20 mg/mL, supported by a cost-effective Good Manufacturing Practice (GMP) process.
An ongoing clinical study, registered as NCT07122414, has begun to uncover the potential of FL115. Initial dosing started in August 2024, where 10 patients received FL115 as a solo treatment. Additionally, 52 patients have received FL115 in combination with BCG, administered intravesically at varying dose levels. These initial results have shown impressive safety and efficacy, positioning FL115 as a contender for best-in-class treatment for patients facing BCG-unresponsive NMIBC.
Dr. Dong Wei, CEO of Forlong Biotechnology, expressed optimism about the developments. “FL115 in combination with BCG has demonstrated significant safety and efficacy data. The successful manufacture and release of the pivotal batch is crucial, and we appreciate JOINN Biologics for their expertise in this endeavor,” he stated. Looking ahead, Forlong plans to advance FL115 into pivotal Phase III clinical trials scheduled for 2027, marking a hopeful progression for patients in need of novel cancer therapies.
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