Forlong Biotechnology Announced CMC Readiness to Initiate GMP Batch Production to Support Upcoming Pivotal Clinical Trial for FL115 (IL-15 Superagonist) in Nonmuscle Invasive Bladder Cancer (NMIBC)

SHANGHAI & SUZHOU, China--(BUSINESS WIRE)--Forlong Biotechnology, a clinical-stage biotech company focusing on developing transformative cytokine therapies for patients with severe unmet needs, today announced 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).

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 1^st 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.

About Forlong Biotechnology

Forlong Biotechnology is a clinical-stage biotech company focusing on developing transformative cytokine therapies for cancer patients with severe unmet needs. It has established four proprietary synthetic immunology platforms: Fbody ® Long-acting Technology Platform, Fc engineering platform, Syntokine® Synthetic Cytokine Platform and AI-driven Intelligent Biomolecular Discovery Platform. The leading candidate FL115 is interleukin-15 (IL-15) superagonist with best-in-class potential, currently being advanced to combo therapy with PD-(L)1 antibodies in Phase I for patients with solid tumors and combo therapy with BCG in Phase II for patients with NMIBC. Its second candidate FL116 is a PD-1 antibody fused with interleukin-18 (IL-18) mutein which is engineered to bind IL-18 receptor and not IL-18BP (a decoy), and has demonstrated potent tumor-killing efficacy in multiple in vivo tumor models resistant to immune checkpoint inhibitors.

About JOINN Biologics

JOINN Biologics is a premier global CDMO committed to delivering end-to-end biopharmaceutical services. Our capabilities span early developability assessment, preclinical and clinical development, through to commercial manufacturing, with dedication on integrity, quality, and operational efficiency. We operate three state-of-the-art facilities strategically located in California (USA), Beijing, and Guangzhou (China). Our extensive experience includes the development and regulatory filing of antibodies, antibody-drug conjugates, fusion proteins, recombinant proteins and vaccines for markets in China, the United States, Europe, and other global regions. A key milestone in our growth was the acquisition of Lonza's large molecule facility in early 2025. This site maintains the infrastructure, equipment, and quality systems aligned with Lonza global standards, and we have retained over 80% of Lonza's technical staff, ensuring continuity of expertise and operational excellence.

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