On May 18, 2022 (GLOBE NEWSWIRE) — Instil Bio, Inc. ("Instil") (Nasdaq: TIL), a clinical-stage biopharmaceutical company focused on developing tumor infiltrating lymphocyte, or TIL, therapies for the treatment of patients with cancer, reported results of genomic and correlative analyses in a cohort of patients with metastatic melanoma treated with TILs manufactured by Instil (ORR of 67% in 14/21 patients) (Press release, Instil Bio, MAY 18, 2022, View Source [SID1234614790]). All TIL products were analyzed using T-cell receptor (TCR) sequencing, RNA and protein expression, and correlated with patient demographic and historical treatment data. Results will be presented at an oral presentation at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 25th Annual Meeting.

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"We believe that TILs represent more than a potential therapy for patients, as they are also a platform to understand fundamental T cell biology," said Bronson Crouch, Chief Executive Officer of Instil Bio. "We are applying the recent advances in analytical technologies to deeply probe the function of TILs, and expect to generate insights that could be foundational for the development of anti-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 points to "master regulator" genes which can be manipulated during TIL manufacturing to enhance TIL activity.

"This correlative analysis is one of the most informative looks to date at T-cell product attributes that impact patient outcomes and underscores the power of single cell analytic approaches to inform our product and process development strategies," said Mark Dudley, Ph.D., Chief Scientific Officer of Instil Bio. "We believe this is one of the first published single-cell analyses of TIL products provided to patients, and the identification of potential manipulations to enhance the efficacy of TILs exemplifies the sort of insights we hope to achieve using our cell therapy data analytics and computational platform."

Details of the oral presentation are as follows:

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

Session Type: Oral Abstract

Session Title: Cell-based Cancer Immunotherapies II

Location: Salon G

Date & Time: Wednesday May 18, 2022, 3:45 – 4:00 pm EDT

Abstract Number: 847

Full abstracts are available on the ASGCT (Free ASGCT Whitepaper) conference website View Source

On May 18, 2022 Accelerating Cancer Immunotherapy Research (ACIR) has featured Immunetune’s presentation during the Cancer Immunotherapy (CIMT) (Free CIMT Whitepaper) Annual Meeting 2022 held May 10-12 in Mainz, Germany (Press release, ImmuneTune, MAY 18, 2022, View Source [SID1234614789]). At CIMT (Free CIMT Whitepaper), our CSO Jeroen van Bergen presented new preclinical results on our neoantigen cancer vaccine in combination with checkpoint inhibitors.

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ACIR’s mission is to accelerate the advancement of cancer immunotherapy by providing, free-of-charge and readily accessible on the internet, a weekly synopsis of the key advances in this fast moving and multifaceted field.

On May 18, 2022 Immatics N.V. (NASDAQ: IMTX, "Immatics"), a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, reported that the first patient has been dosed in the IMA203 and nivolumab combination Phase 1b dose expansion cohort (Press release, Immatics, MAY 18, 2022, View Source [SID1234614788]). This cohort will evaluate Immatics’ TCR-engineered cell therapy (TCR-T) approach ACTengine IMA203 targeting an HLA-A*02-presented peptide derived from PRAME, in combination with Bristol Myers Squibb’s PD-1 checkpoint inhibitor nivolumab, in patients with advanced solid tumors. The objectives of the study will be to evaluate the safety, biological activity, and initial anti-tumor activity of the IMA203 and nivolumab combination.

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"Initiating the second of three dose expansion cohorts is an important milestone in our comprehensive approach to target PRAME. It builds on the successful completion of the dose escalation part of the Phase 1 trial and the early positive clinical data we observed with IMA203," said Cedrik Britten, Chief Medical Officer at Immatics. "We are excited to elucidate how the combination with an immune checkpoint inhibitor could enhance the potency of our engineered IMA203 T cells. We also look forward to initiating the third Phase 1b cohort with IMA203CD8, our next generation approach that additionally harnesses the power of CD4 T cells."

The IMA203 and nivolumab combination Phase 1b dose expansion cohort is expected to enroll up to 18 patients with different types of solid tumors across 10 clinical trial sites in Germany and the U.S. Bristol Myers Squibb will provide Immatics, the study sponsor of the combination trial, with nivolumab as part of a clinical supply agreement. Nivolumab has become the standard of care treatment for many solid cancer indications and we believe it fits well into the IMA203 treatment and observation schedule. According to the clinical trial protocol for ACTengine IMA203, nivolumab will be administered at regular intervals following IMA203 treatment. The primary endpoint of this cohort is to assess the safety of the combination. Anti-tumor activity resulting from the drug combination is a secondary endpoint, which will be assessed through imaging and measured according to the standard Response Evaluation Criteria In Solid Tumors (RECIST).

The combination treatment of IMA203 and nivolumab is part of Immatics’ strategy to realize the full clinical potential of IMA203 TCR-T targeting PRAME. Based on this strategy, the company has expanded the IMA203 trial to a total of three Phase 1b dose expansion cohorts – each designed to assess observed objective response rates, demonstrate durability of response, and form the basis for enrollment in pivotal studies. In addition to the IMA203 and nivolumab combination (first patient treated, initial data read-out planned for YE 2022), Immatics will also investigate IMA203 as monotherapy (patient enrollment ongoing, next data read-out planned in 2H 2022) and IMA203CD8, a next-generation cell therapy where IMA203-engineered T cells are co-transduced with a CD8αβ co-receptor (initiation planned for 2Q 2022, initial data read-out planned for YE 2022).

About IMA203 and target PRAME
ACTengine IMA203 T cells are directed against an HLA-A*02-presented peptide derived from preferentially expressed antigen in melanoma (PRAME), a protein frequently expressed in a large variety of solid cancers thereby supporting the programs’ potential to address a broad cancer patient population. Immatics’ PRAME peptide is present at a high copy number per tumor cell and is homogenously and specifically expressed in tumor tissue. The peptide has been identified and characterized by Immatics’ proprietary mass spectrometry-based target discovery platform XPRESIDENT. Through its proprietary TCR discovery and engineering platform XCEPTOR, Immatics has generated a highly specific T cell receptor (TCR) against this target for its TCR-based cell therapy approach, ACTengine IMA203.

About ACTengine
ACTengine is a personalized approach for patients with advanced solid tumors. The patient’s own T cells are genetically engineered to express a novel, proprietary TCR directed against a defined cancer target. The modified T cells are then reinfused into the patient to attack the tumor. The approach is also known as TCR-engineered cell therapy (TCR-T). All Immatics’ ACTengine product candidates can be rapidly manufactured utilizing a proprietary manufacturing process designed to enhance T cell engraftment and persistence in vivo.

The ACTengine T cell products are manufactured at the Evelyn H. Griffin Stem Cell Therapeutics Research Laboratory in collaboration with UTHealth. The ACTengine Programs are co-funded by the Cancer Prevention and Research Institute of Texas (CPRIT).

On May 18, 2022 iBio, Inc. (NYSEA:IBIO) ("iBio" or the "Company"), a developer of next-generation biopharmaceuticals and pioneer of the sustainable, plant-based FastPharming Manufacturing System, reported that it will participate virtually in the H.C. Wainwright Global Investment Conference (Press release, iBioPharma, MAY 18, 2022, View Source [SID1234614787]). The hybrid conference will take place May 23-26, 2022.

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iBio’s pre-recorded presentation will be available on demand during the event for all registered attendees. Beginning on Tuesday, May 24, 2022, the presentation will also be available on the Company’s website at www.ibioinc.com under "News & Events" in the Investors section.

On May 18, 2022 Bicara Therapeutics, a clinical-stage biotechnology company developing dual-action biologics designed to elicit a potent and durable immune response in the tumor microenvironment, reported that it will present updated data from the dose escalation phase of its ongoing Phase 1 trial of BCA101, a bifunctional antibody designed to target the TGF-β trap to EGFR+ tumors, in an oral presentation at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2022 Annual Meeting (Press release, Bicara Therapeutics, MAY 18, 2022, View Source;utm_medium=rss&utm_campaign=bicara-therapeutics-to-present-clinical-data-from-lead-bifunctional-antibody-program-bca101-at-asco-2022-annual-meeting [SID1234614785]). The meeting is being held in Chicago, Illinois and virtually from June 3-7, 2022.

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Details of the presentation are as follows:

Title: A phase 1 trial of the bifunctional EGFR/TGFb fusion protein BCA101 alone and in combination with pembrolizumab in patients with advanced solid tumors

Lead Authors: Philippe L. Bedard, MD, FRCPC & Glenn J. Hanna, MD

Presentation Type: Poster Discussion Session
Session Category: Developmental Therapeutics – Immunotherapy
Date/Time: Sunday, June 5, 2022, 11:30 AM-1:00 PM CDT

Location: Hall D2

About BCA101

BCA101 is a first-in-class EGFR / TGF-β-trap bifunctional antibody designed to enhance both innate and adaptive immune responses directly at the site of the tumor by binding to the well-validated EGFR antigen and disabling TGF-β, a signaling molecule that plays a key role in suppressing the immune response in the tumor microenvironment. Promising preclinical data suggest that BCA101 is superior to the anti-EGFR antibody cetuximab in preventing tumor recurrence, as well as in restoring immune activation. An ongoing Phase 1/1b dose-escalation clinical trial of BCA101 was initiated in July 2020 and has enrolled patients with various advanced solid tumors both as a single agent, as well as in combination with pembrolizumab, a PD-1 inhibitor. A recommended dose for expansion has been declared and the expansion phase of the study is currently enrolling. For more information, please visit study number NCT04429542 at www.clinicaltrials.gov.