The first patient dosed with IOV-4001 has completed the safety observation period.
Iovance Biotherapeutics has dosed the first patient and completed the safety observation period in its phase 1/2 IOV-GM1-201 trial (NCT05361174) of IOV-4001, the company’s tumor infiltrating lymphocyte (TIL) therapy for the intended treatment of previously treated metastatic non-small cell lung cancer (NSCLC) or advanced melanoma.1
“Dosing the first patient with IOV-4001 is an important first step in providing proof-of-concept for delivering genetically modified TIL therapy to solid tumor patients with significant unmet needs and few treatment options. We look forward to dosing the next patient. This trial may also support our broader platform of genetically modified Iovance TIL therapies to potentially address difficult-to-treat solid tumor cancers,” Friedrich Graf Finckenstein, MD, chief medical officer, Iovance, said in a statement.1
IOV-4001 is a genetically modified, TIL therapy that uses Cellectis’ licensed gene-editing technology TALEN to inactivate the gene coding for the PD-1. This modification is intended to enhance the antitumor activity of the TIL mechanism.
The IOV-GM1-201 trial's phase 1 portion’s primary outcome is safety, as measured by adverse events (AEs) and dose-limiting toxicities. The phase 2 portion’s primary outcome measure will be objective response rate. Secondary outcome measures include complete response rate, duration of response, disease control rate, progression-free survival, overall survival, safety and tolerability, and feasibility of manufacturing.
“I am excited about the potential for gene-editing to open new doors for TIL therapy in patients with solid tumor cancers that do not respond well to current treatment options. As the first multicenter clinical trial to investigate a genetically modified TIL therapy, the IOV-GM1-201 trial may pave the way for a promising new treatment approach to cancer,” principal investigator Jason Chesney, MD, PhD, director and endowed professor, UofL Health – Brown Cancer Center, University of Louisville, added.1
Iovance recently announced a rolling biologics license application (BLA) submission for its lead candidate, lifileucel, also a TIL therapy. The submission is for Iovance Biotherapeutics has initiated a rolling biologics license application (BLA) submission for unresectable or metastatic melanoma that progressed on or after prior anti-PD-1/L1 therapy, and if BRAF mutation positive, also prior BRAF or BRAF/MEK inhibitor therapy. The company expects the BLA to be completed in the fourth quarter of 2022.
Lifileucel is being evaluated in the phase 2 C-144-01 clinical study (NCT02360579), which has enrolled 178 participants. The study’ primary endpoint is overall response rate (ORR), and secondary endpoints include other safety and efficacy measures including duration of response, disease control rate, progression-free survival, overall survival, and adverse events (AEs).
“Initiating our rolling BLA submission for lifileucel is a significant step towards our goal to deliver the first individualized, one-time cell therapy for melanoma patients with significant unmet need. In parallel, we are executing our on-boarding and personnel training at authorized treatment centers, education and awareness initiatives, internal capacity planning, and launch readiness activities to prepare for commercialization. The FDA is supportive of our regulatory approach, and we look forward to continuing this collaboration throughout the submission and review process,” Frederick Vogt, PhD, JD, interim president and chief executive officer, Iovance, said in a previous statement.2