On April 15, 2026 Forlong Biotechnology, a clinical-stage biotech company focusing on developing transformative cytokine therapies for patients with severe unmet needs, reported that its FL115 Program has successfully completed technical transfer of manufacturing process and analytical methods by its manufacturing partner JOINN Biologics INC, and will soon initiate production of GMP batches to support upcoming pivotal clinical trial in nonmuscle invasive bladder cancer (NMIBC).
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FL115 is an engineered IL-15/IL15Rα-Fbody fusion protein, of which Fbody is a single-chain Fc engineered to maintain FcRn affinity while eliminating binding of FcγRs and complement systems, aiming to optimize protein half-life and biodistribution. FL115 drug substance and drug products have demonstrated superb stability and solubility at 20 mg/ml, as well as robust GMP manufacturing process with low cost.
A clinical study of FL115 (NCT07122414) in Bacillus Calmette-Guérin (BCG) unresponsive NMIBC has been ongoing. After 1st patient dosing in August 2024, 10 patients have been dosed with FL115 alone and 42 patients have been dosed with FL115 in combination with BCG so far, all through intravesical delivery.
"We are excited about the potential best-in-class profile of FL115 in BCG unresponsive NMIBC, supported by preliminary safety and efficacy data across multiple dose-levels," said Dong Wei, Ph.D., Chief Executive Officer of Forlong Biotechnology, "we are on track to have a robust clinical data set to discuss with regulatory authorities on our pivotal clinical trial design and registration plan by 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."
About FL115
FL115 is an engineered IL-15/IL15Rα-Fbody fusion protein, aiming to enhance anti-tumor immunity via IL-15-mediated signaling on NK and CD8+ T cells while minimizing complexity from Fc. FL115 has demonstrated significant anti-tumor activities as a monotherapy or as part of combination therapy in vivo, and can be manufactured by a robust and efficient process with excellent product stability. Clinically, FL115 has demonstrated favorable safety profile and preliminary clinical responses as a monotherapy, and has the best-in-class potential to synergize with current and emerging T cell-targeting immunotherapies through combination therapy to significantly improve the treatment outcome for patients. It is currently being investigated in combination with Bacillus Calmette-Guérin (BCG) in a Phase 2 clinical trial to evaluate safety and preliminary efficacy in patients with nonmuscle invasive bladder cancer (NMIBC) and in combination with an anti-PD1 monoclonal antibody in a Phase 1b/2 clinical trial to evaluate safety and preliminary efficacy in patients with advanced solid tumors.
(Press release, Forlong Biotechnology, APR 15, 2026, View Source [SID1234664422])