Instil Bio will present a new TIL analysis at American

DALLAS, May 18, 2022 (GLOBE NEWSWIRE) — Instil Bio, Inc. (“Instil”) (Nasdaq: TIL), a clinical-stage biopharmaceutical company focused on developing tumor-infiltrating lymphocyte therapies, or TIL, for the treatment of cancer patients, today announced the results of genomic and correlative analyzes in a cohort of patients with metastatic melanoma treated with TILs manufactured by Instil (ORR of 67% in 14/21 patients). All TIL products have been analyzed using T cell receptor (TCR) sequencing, RNA and protein expression, and correlated with patient demographics and treatment history. The results will be presented in an oral presentation at the American Society of Gene and Cell Therapy (ASGCT) 25and Annual meeting.

“We believe that TILs represent more than a potential therapy for patients, as they also provide a platform for understanding fundamental T cell biology,” said Bronson Crouch, CEO of Instil Bio. “We are applying recent advances in analytical technologies to deeply probe the function of TILs and hope to generate insights that could be fundamental for the development of cancer therapies.”

In the presentation, a correlation between tumor response and clonal expansion of TILs is shown, as well as an inverse correlation between tumor response and specific T cell populations in the product. Expression profiling and transcriptional network analysis point to “master regulator” genes that can be manipulated during TIL manufacture to enhance TIL activity.

“This correlative analysis is one of the most informative looks yet at the attributes of T-cell products that impact patient outcomes and underscores the power of single-cell analytical approaches to inform our product development strategies and process,” said Mark Dudley, Ph.D., Chief Scientific Officer of Instil Bio. “We believe this is one of the first published single-cell analyzes of TIL products delivered to patients, and the identification of potential manipulations to improve the efficacy of TILs illustrates the kind of insights we hope to gain by using our cell therapy data analytics and calculations platform.”

The details of the oral presentation are as follows:

Title: Characterization of Clonal Transcriptomic and T Cell Receptor (TCR) Heterogeneity of Tumor Infiltrating Lymphocyte (TIL) Therapy Infusion Products by Single Cell Sequencing and Correlative Analyzes with Clinical Effectiveness in Patients with Advanced Cutaneous Melanoma

Type of session: Oral summary

Session title: Cellular immunotherapies against cancer II

Location: Lounge G

Date and hour : Wednesday, May 18, 2022, 3:45 p.m. – 4:00 p.m. EDT

Abstract number: 847

Full abstracts are available on the ASGCT conference website https://annualmeeting.asgct.org/

About Instil Bio

Instil Bio, Inc. (Nasdaq: TIL) is a clinical-stage biopharmaceutical company focused on the development of tumor-infiltrating lymphocyte therapies, or (TIL), for the treatment of cancer patients. Instil has assembled an accomplished management team with a successful track record in the development, manufacturing and commercialization of cell therapies. Using Instil’s proprietary, optimized and scalable manufacturing processes at its in-house manufacturing facilities, Instil is advancing its lead TIL product candidate, ITIL-168, for the treatment of advanced melanoma and other solid tumors, as well as ITIL -306, a next-generation, genetically engineered TIL therapy utilizing the CoStAR platform for multiple solid tumors. For more information, visit www.instilbio.com.

Forward-looking statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “anticipates”, “expects”, “future”, “intends”, “targets and “will”, or similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements regarding or involving the therapeutic potential of our product candidates; our research, development and regulatory plans for our product candidates; the timing of our ongoing and potential future clinical trials and studies and the availability of data therefrom, including our expectations regarding the completion of enrollment and the availability of front-line data from our DELTA-1 clinical trial, initiation of our DELTA -2 clinical trial in certain indications, the launch of a phase 1 study of ITIL-306; the ability of us to make submissions regarding, and for our product candidates to receive, regulatory approval from the FDA or equivalent foreign regulatory agencies and whether, if approved, such product candidates will be successfully distributed and commercialized ; the adequacy of our cash resources and our expected cash flow; and other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements, including risks and uncertainties associated with the cost and time involved in the cell therapy product development process and the uncertainty of clinical success, including risks associated with failure or delays in launch, registration, data reporting or completion of clinical studies, as well as the risks that results obtained in preclinical or clinical trials to date may not be indicative of results obtained in ongoing or future trials and that Instil’s product candidates may otherwise not not be effective treatments in their intended indications; the ongoing COVID-19 pandemic, which could materially and adversely affect Instil’s business and operations, including Instil’s ability to timely initiate, enroll and complete its ongoing and future clinical trials; the lengthy and uncertain regulatory approval process; additional regulatory risks associated with developing our product candidates for use in combination with other therapies or third-party product candidates; risks inherent in manufacturing and testing cell therapy products; the sufficiency of Instil’s cash resources, and other risks and uncertainties affecting Instil and its development programs, including those discussed in the section titled “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2021 available on the SEC’s website at www.sec.gov, and in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2022 on file with the SEC. Additional information will be made available in other documents filed from time to time with the SEC. These risks may be amplified by the impacts of the COVID-19 pandemic. Accordingly, these forward-looking statements are not guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. These forward-looking statements speak only as of the date hereof, and we assume no obligation to update these statements except as required by law.

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