FL115 / Forlong Biotech - LARVOL DELTA

A Study of Subcutaneous FL115 Monotherapy in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=29 | Not yet recruiting | Sponsor: Suzhou Forlong Biotechnology Co., Ltd

Monotherapy • New P1 trial • Oncology • Solid Tumor

Forlong Biotechnology…announced approval to initiate a Phase I study of FL115 subcutaneous injection (administered once every three weeks) in patients with advanced solid tumors in Australia (Businesswire) - "The study has been approved under Australia’s Therapeutic Goods Administration (TGA) Clinical Trial Notification (CTN) scheme, following review by the Human Research Ethics Committee (HREC)."

New P1 trial • Solid Tumor

Forlong Biotechnology Announces Successful Completion of GMP Pivotal Batch Production for FL115 (IL-15 Superagonist), Ready to Support Upcoming Phase III Clinical Trial in Non-Muscle Invasive Bladder Cancer (NMIBC) (Businesswire)

Commercial • Bladder Cancer

Safety, pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activities of FL115, a novel IL-15 superagonist, from the first-in-human study in patients with locally advanced/metastatic solid tumors. (ASCO 2026) - P1, P1/2 | "FL115 is the first IL-15 superagonist as monotherapy has shown a favorable safety profile and promising signs of durable antitumor activities in heavily pretreated patients, along with significant and sustained expansion of NK and T cell population and unique robust transient induction of interferon-γ. A Phase II study of FL115 with Bacillus Calmette-Guérin in patients with nonmuscle invasive bladder cancer (NCT07122414) and a Phase Ib study of FL115 (IV) in combination with an anti-PD-1 antibody in solid tumor patients (NCT07131202) are ongoing, and a Phase I study of FL115 subcutaneous injection will be initiated soon (IND submitted)."

Clinical • First-in-human • Metastases • P1 data • PK/PD data • Bladder Cancer • Cervical Cancer • Genito-urinary Cancer • Neutropenia • Oncology • Solid Tumor • CD8 • IFNG • IL6

FL115, a novel IL-15 superagonist rationally designed to minimize safety risks for cancer immunotherapy (AACR 2026) - "Our study revealed the mechanism underlying the superior safety of FL115 over ALT803 while exhibiting comparable anti-tumor activities. These findings highlight the rational design strategy of FL115 as next-generation IL-15-based superagonist, supporting its favorable safety and preliminary clinical responses observed in multiple Phase 1 clinical studies."

Clinical • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • IL15 • IL6

Development of FL115, a novel IL-15 superagonist, as subcutaneous injection for cancer immunotherapy (AACR 2026) - "Compared to IV injection, subcutaneous FL115 in rats and monkeys showed a significant delay (up to 4-6 hours) and drastic lowering of Cmax (up to 26.7×) with bioavailability at ~60% as well as good linearity in PK file. FL115 at approximately 9 mg per injection site in rabbits showed no significant gross skin irritation. These results support continuing development of FL115 as subcutaneous injection for cancer immunotherapy."

Oncology • Solid Tumor • CD8 • IFNG • IL15 • IL6

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) (Businesswire) - "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 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....Together we will advance FL115 into the pivotal clinical stage for NMIBC in 2027'."

Commercial • New trial • P1/2 data • Bladder Cancer

Forlong Biotechology to Present Preclinical Data from FL115, a novel interleukin-15 (IL-15) superagonist…at the 2026 AACR Annual Meeting (Businesswire) - "Poster 7932 further elucidated mechanism of action underlying FL115 BIC profile, with Cryo-EM analysis of FL115/FcRn/β2M complex. In vivo, RNA-Seq and single-cell transcriptomics revealed FL115 reshaped the tumor microenvironment by enhancing NK and T cells infiltration without not triggering activation of neutrophils and macrophage. Poster 6459 showed significant potential of FL115 subcutaneous formulation. Compared to IV injection, subcutaneous injection of FL115 resulted in drastic lowering of Cmax (up to 26.7×) with bioavailability at ~60% as well as good linearity in PK file."

Preclinical • Oncology

A Study of FL115 in Combination With a PD-1 Antibody in Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=130 | Recruiting | Sponsor: Suzhou Forlong Biotechnology Co., Ltd | Not yet recruiting ➔ Recruiting | Initiation date: Sep 2025 ➔ Jan 2026

Enrollment open • Trial initiation date • Solid Tumor

A Study of FL115 Monotherapy in Unresectable or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=30 | Active, not recruiting | Sponsor: Suzhou Forlong Biotechnology Co., Ltd | Recruiting ➔ Active, not recruiting | Trial primary completion date: Aug 2025 ➔ Jun 2026

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

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

First-in-human • Monotherapy • Trial completion • Trial completion date • Trial primary completion date • Oncology • Solid Tumor • PD-L1

Forlong Biotechology Announced Activation of Phase Ib/II Study of FL115 (IL-15 Superagonist) in combination with anti-PD-1 Antibody for Patients with Advanced Solid Tumor and Acceptance of IND for FL115 Subcutaneous Injection by NMPA (Businesswire) - "The Phase Ib/II study (NCT07131202) is an open-label, multicenter study to evaluate the safety, tolerability, preliminary efficacy, pharmacokinetics, and pharmacodynamics of FL115 in combination with an anti-PD-1 monoclonal antibody through IV infusion in patients with advanced solid tumors. The first clinical study site, Sun Yat-sen University Cancer Center, is now open and actively screening eligible participants....FL115 subcutaneous formulation expects to significantly enhance NK and T cell stimulation and clinical efficacy while improving safety profile by lowering release of certain cytokines. An abstract...has been accepted for presentation at the upcoming AACR Annual Meeting 2026."

New trial • Preclinical • Trial status • Solid Tumor

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