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Instil Bio Receives FDA Approval to Initiate Expanded Phase 2 Advanced Melanoma Study

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Shares of Instil Bio Inc. traded 16% higher after the company reported it received IND clearance from the U.S. FDA to initiate a Phase 2 clinical trial in advanced melanoma patients.

Clinical-stage biopharmaceutical company Instil Bio Inc. (TIL:NASDAQ), which concentrates its efforts on developing tumor infiltrating lymphocyte (TIL) therapies for treating cancer, recently announced "clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to initiate DELTA-1, a global Phase 2 clinical trial of ITIL-168 in patients with advanced melanoma whose disease has relapsed after a PD-1 inhibitor and, if positive for a BRAF-activating mutation, a BRAF inhibitor."

The firm explained the Phase 2 DELTA-1 trial had been expanded in consultation with FDA during the time the NDA submission was undergoing full review. The expansion allowed for adding additional patients to the study who have previously been diagnosed with advanced melanoma. Two new patient groups will be added to the study. Cohort 2 will be comprised of individuals who discontinued PD-1 inhibitor therapy due to intolerable toxicity and Cohort 3 will include those patients who had an unsatisfactory response to prior PD-1 inhibitor but have not yet experienced disease progression.

The company indicated that it expects to receive topline efficacy and safety data from the study in 2023 and that if positive results are achieved the trial that would serve in supporting a biologics license application (BLA) submission to the FDA during 2023 as well as a Marketing Authorization Application (MAA) in 2024 to the European Medicines Agency.

Instil Bio's CEO Bronson Crouch commented, "The IND clearance for the DELTA-1 Phase 2 clinical trial is a testament to the talent, experience and devotion of the Instil Bio team…Motivated by patients in need, our organization will develop ITIL-168 commercially as we expand our clinical programs with current and next-generation therapies."

The company's Chief Technical Officer Vijay Chiruvolu, Ph.D., added, "This achievement reflects the depth of cell therapy experience, scientific talent and focused execution of our organizations in both the U.S. and United Kingdom…The development of the product release plan, encompassing the innovative potency assay as part of QC release as well as the comprehensive characterization strategy, was built on expertise from our broad, cross-functional team including research, process development, analytical sciences and translational medicine."

Instil's Chief Medical Officer Zachary Roberts, M.D. Ph.D., remarked, "We are pleased to begin this clinical trial of ITIL-168 in an area of marked unmet medical need. Furthermore, the inclusion of additional cohorts of patients who have not been systematically studied with TIL therapy provides us with the opportunity to learn about the potential role of ITIL-168 in other populations who lack effective therapies."

ITIL-168 was described in the report as "an investigational, autologous cell therapy made from tumor infiltrating lymphocytes, or TILs." Patients own tumors are immediately processed and then cryopreserved. The ITIL-168 cell therapy is then made from each patient's respective digested and cryopreserved tumor to provide an unrestricted T cell receptor (TCR) repertoire.

The company listed that the Phase 2 DELTA-1 clinical trial is a global, multicenter study of adults afflicted with advanced melanoma. Initially, the single-arm study was designed to evaluate the safety and efficacy of ITIL-168. A total of 80 subjects were enrolled in the first cohort in the study. The medicine was administered subsequent to "a 5-day course of lymphodepleting chemotherapy and followed by up to 8 doses of high-dose interleukin-2 (IL-2), in patients whose cancer has progressed following a PD-1 inhibitor and, if positive for a BRAF-activating mutation, a BRAF inhibitor."

Cohort 2 in now expected to enroll about 25 people to study "the efficacy and safety of the regimen in patients who required discontinuation of PD-1 inhibitor(s) due to unacceptable toxicity, regardless of best overall disease response." Cohort 3 as well plans for another group of 25 individuals whose best ongoing response to PD-1 inhibitor(s) is stable disease.

The primary endpoint in the DELTA-1 study was identified as "objective response rate (ORR) according to RECIST v1.1 as assessed by independent central review." Several other secondary endpoints are being measured as well including overall safety, disease control rate, response duration, and progression-free and overall survival rates.

Instil Bio, is a global, clinical-stage biopharmaceutical company headquartered in Dallas, Tex. with research and cell therapy manufacturing operations in Los Angeles, Calif. and Manchester, U.K. The firm focuses on discovering and developing next generation tumor infiltrating lymphocytes (TIL) therapies for use in treatment of cancer patients. Instil is currently working on advancing its lead product candidate, ITIL-168, for the treatment of advanced melanoma and other solid tumors and ITIL-306, which was described in the report as a "next-generation, genetically engineered TIL therapy for multiple solid tumors."

Instil Bio started the day with a market cap of around $2.1 billion with approximately 128.8 million shares outstanding and a short interest of about 4.3%. TIL shares opened slightly higher today at $16.58 (+$0.08, +0.48%) over yesterday's $16.50 closing price. The stock has traded today between $16.30 to $19.70 per share and is currently trading at $19.18 (+$2.68, +16.24%).


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