Forlong Biotechnology, a leading clinical-level biotech company, aims to establish a transitional change in cytokine therapies for extreme unmet needs for a certain patient group proudly declared that the first patient has been dosed in a phase 2 clinical trial investigating FL 115 in merger with Bacillus Calmette-Guerin (BCG). The study will evaluate the anti-tumour impact of the merged therapy involving duration (timeframe) and response rate for carcinoma in situ (CIS) NMIBC patients, and no disease relapse and survival free for patients with papillary (Ta/T1) NMIBC.
The FL115 is a well-designed IL-15/IL-15Rα-Fbody fusion protein focusing on improving the anti-tumour immunity through the IL-15-mediated activation in CD8+ T and NK cells while mitigating the complications from Fc. The start point of the phase 2 clinical trial is empowered by the positive data from the phase 1 trial. The phase 1 trial confirmed that FL115 showed valuable efficacy and safety in the same patient individuals.
Where monotherapy is highlighted as a dose for extension, where 4/6 patients get a response in above 3 months, of which 2 patients get a response above 9 months there this FL115 with BCG will be inspected in the phase 2 trial.
Additionally, the phase 2 clinical trial intends to add three more arms, like BCG unresponsive high-risk papillary NMIBC patients, BCG naïve medium/high-risk NMIBC patients and BCG unresponsive CIS NMIBC patients. The trial for the same will be held at 15 investigator sites in China.
The PhD, Chief Executive Officer of Forlong Biotechnology, Dong Wei, said, “Treating the first patient in our phase 2 trial for FL115 represents a précising moment for Forlong, as we have enhanced our lead candidate further to continue with the examination of the excellence of our synthetic immunology platforms and clinical development. The FL115 stands out uniquely with its preliminary efficacy and safety confirmed in various stages of phase 1 clinical studies in NMIBC and advanced solid tumours.”
Dong added, “With the FL115 interim data for advanced solid tumours will be showcased as late late-breaking abstract at the 40th annual meeting of the Society for Immunotherapy of Cancer (SITC 2025) on 8th November 2025. This trial is a chance and signal for us to announce FL115 as an excellent best in best-in-class IL-15 great agonist and introduce new treatment options for cancer patients seeking urgent treatment.”
Mansi Kadam is a market research writer with over 3 years of experience analyzing trends in the healthcare industry. At Towards Healthcare, she covers innovations in medical sector, sustainability initiatives, and the evolving regulatory landscape.
