FL115 / Forlong Biotech - LARVOL DELTA

Preliminary Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of FL115, a Novel IL-15 Superagonist, From a Phase 1 Study in Patients With Advanced Solid Tumors (SITC 2025) - P1 | "One patient at 30 ug/kg experienced a Grade 3 drug-related cytokine release syndrome at Day 1 and recovered at Day 2 with routine supportive care alone, without the need for vasopressor treatment or low-flow nasal cannula or tocilizumab. All participants provided written informed consent before enrollment.Consent Written informed consent was obtained from the patient for publication of this abstract and any accompanying images. A copy of the written consent is available for review by the Editor of this journal."

Clinical • Late-breaking abstract • Metastases • P1 data • PK/PD data • Oncology • Solid Tumor • CD8

Forlong Dosed First Patient in Phase 2 Clinical Trial of FL115, a novel interleukin-15 (IL-15) superagonist, for nonmuscle invasive bladder cancer (NMIBC) (Businesswire) - "The study will assess the anti-tumor effect of the combination therapy, including Complete Response Rate and Duration for carcinoma in situ (CIS) NMIBC patients, and Disease Free Survival and Relapse Free Survival for papillary (Ta/T1) NMIBC patients....The start of the Phase 2 clinical trial builds on positive data from the Phase 1 trial where FL115 demonstrated favorable safety and efficacy in the same patient population. As a monotherapy at the recommended dose for expansion, 4/6 patients achieved responses longer than 3 months, of which 2 patients achieving responses longer than 9 months."

P1 data • Trial status • Bladder Cancer

A Study of FL115 Monotherapy in Unresectable or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Suzhou Forlong Biotechnology Co.,Ltd,

Monotherapy • New P1 trial • Oncology • Solid Tumor

A Study of Intravesical FL115 Alone or in Combination With BCG in Non-Muscle Invasive Bladder Cancer (clinicaltrials.gov) - P1/2 | N=80 | Recruiting | Sponsor: Suzhou Forlong Biotechnology Co.,Ltd,

New P1/2 trial • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

A Study of FL115 Injection in Combination With a PD-1 Antibody in Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=130 | Not yet recruiting | Sponsor: Suzhou Forlong Biotechnology Co.,Ltd,

New P1/2 trial • Solid Tumor

First-in-Human, Phase I, Open-label, Multicenter, Dose Escalation Clinical Study (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Suzhou Forlong Biotechnology Co.,Ltd, | Trial completion date: Sep 2025 ➔ Sep 2026 | Trial primary completion date: May 2025 ➔ May 2026

Monotherapy • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

First-in-Human, Phase I, Open-label, Multicenter, Dose Escalation Clinical Study (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Suzhou Forlong Biotechnology Co.,Ltd, | Active, not recruiting ➔ Recruiting

Enrollment open • Metastases • Monotherapy • Oncology • Solid Tumor