- Forlong Biotechnology has completed manufacturing and analytical method transfer for its FL115 program with JOINN Biologics.
- The company plans to initiate GMP batch production to support a pivotal clinical trial in non-muscle invasive bladder cancer.
Forlong Biotechnology has announced the completion of the technical transfer of its manufacturing process and analytical methods for the FL115 program, in collaboration with JOINN Biologics. The milestone enables the company to proceed with GMP batch production in preparation for a pivotal clinical trial in non-muscle invasive bladder cancer (NMIBC).
FL115 is an engineered IL-15/IL15Rα-Fbody fusion protein designed to optimise half-life and biodistribution. The company stated that the drug substance and drug product have demonstrated stability and solubility at 20 mg/ml, alongside a GMP manufacturing process designed for scalability and cost efficiency.
The program is currently being evaluated in an ongoing clinical study in Bacillus Calmette-Guérin (BCG) unresponsive NMIBC. According to the company, 10 patients have received FL115 as a monotherapy and 42 patients have been treated with FL115 in combination with BCG via intravesical delivery.
The completion of the manufacturing transfer is intended to support upcoming clinical development milestones, including preparation for pivotal studies and regulatory discussions. The company expects to generate a clinical dataset to support engagement with regulatory authorities on trial design and registration plans by the end of 2026.
“CMC readiness is an important pillar of the FL115 program and we greatly appreciate the expertise and effort of JOINN Biologics as our manufacturing partner. Together we will advance FL115 into the pivotal clinical stage for NMIBC in 2027.”
Dong Wei, Chief Executive Officer of Forlong Biotechnology
