On December 18, 2024 Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology, reported five presentations featuring botensilimab (BOT, an Fc-enhanced anti-CTLA-4 antibody) plus balstilimab (BAL, an anti-PD-1 antibody) at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers (ASCO GI) Symposium (Press release, Agenus, DEC 18, 2024, View Source [SID1234649207]). The conference will take place on January 23-25, 2025, in San Francisco, California.

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The presentations will showcase BOT/BAL’s activity across three distinct colorectal cancer settings—late-line metastatic, first-line, and neoadjuvant treatment. The studies demonstrate BOT/BAL’s consistent activity in microsatellite stable (MSS) colorectal cancer (CRC), which accounts for over 80% of CRC cases and has limited treatment options, as well as its efficacy in microsatellite instability-high (MSI-H) CRC. Additionally, one presentation will feature BOT/BAL and invariant natural killer T cells (iNKTs) in patients with refractory gastric cancer.

"These presentations will highlight BOT/BAL’s potential to benefit patients across colorectal cancer treatment settings, including the neoadjuvant, late-line, and first-line settings," said Dr. Garo Armen, Chairman and CEO of Agenus. "We aim to transform outcomes at every stage of disease and deliver renewed hope for patients worldwide."

Presentation Details

Abstract Title: Preliminary results from a randomized, open-label, phase 2 study of botensilimab (BOT) with or without balstilimab (BAL) in refractory microsatellite stable metastatic colorectal cancer with no liver metastases (MSS mCRC NLM)*
Abstract Number: 23
Presenting Author: Dr. Marwan Fakih
Session: Rapid Oral Abstract Session C: Cancers of the Colon, Rectum, and Anus
Session Date and Time: 1/25/2025, 9:15 AM-10:00 AM PST

Abstract Title: Preoperative botensilimab (BOT) with or without balstilimab (BAL) for patients with resectable locally advanced pMMR or dMMR colon cancer: Results from the UNICORN trial by GONO
Abstract Number: 158
Presenting Author: Dr. Filippo Ghelardi
Session: Poster Session C: Cancers of the Colon, Rectum, and Anus
Session Date and Time: 1/25/2025, 7:00 AM-7:55 AM PST

Abstract Title: A phase II study of agenT-797 (invariant natural killer T-cells), botensilimab (Fc-enhanced CTLA-4 inhibitor) and balstilimab (anti-PD-1) in patients with advanced, refractory gastroesophageal adenocarcinoma
Abstract Number: TPS515
Presenting Author: Dr. Samuel Cytryn
Session: Trials in Progress Poster Session A: Cancers of the Esophagus and Stomach and Other Gastrointestinal Cancers
Session Date and Time: 1/23/2025, 11:30 AM-1:00 PM PST

Abstract Title: Neoadjuvant botensilimab (BOT) plus balstilimab (BAL) in resectable mismatch repair proficient (pMMR) and deficient (dMMR) colorectal cancer (CRC): NEST clinical trial update
Abstract Number: 207
Presenting Author: Dr. Erika Hissong
Session: Poster Session C: Cancers of the Colon, Rectum, and Anus
Session Date and Time: 1/25/2025, 7:00 AM-7:55 AM PST

Abstract Title: A phase 1 trial of folinic acid, fluorouracil, oxaliplatin, bevacizumab, botensilimab, balstilimab (FOLFOX-3B) in microsatellite stable metastatic colorectal cancer.
Abstract Number: 180
Presenting Author: Dr. Marwan Fakih
Session: Poster Session C: Cancers of the Colon, Rectum, and Anus
Session Date and Time: 1/25/2025, 7:00 AM-7:55 AM PST

Complete abstracts will be released at 5:00 PM ET on January 21st, 2025. Data presented at the conference will be available to view in the publications section of the Agenus website (View Source) following the ASCO (Free ASCO Whitepaper) GI Meeting.

On December 18, 2024 Iambic Therapeutics, a clinical-stage biotechnology company developing novel therapeutics using its unique AI-driven discovery platform, reported that Tom Miller, Ph.D., Iambic’s Chief Executive Officer and Co-Founder, will present at the 43rd Annual JP Morgan Healthcare Conference (Press release, Iambic Therapeutics, DEC 18, 2024, View Source [SID1234649206]). The presentation will take place on Tuesday, January 14th, at 5 p.m. PT at the Westin St. Francis Hotel in San Francisco.

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Dr. Miller will detail progress and anticipated milestones for Iambic’s emerging pipeline of development candidates, as well as advances to its AI drug discovery platform. The Company’s pipeline currently includes IAM1363, a highly selective, brain penetrant small molecule inhibitor of both wild-type and oncogenic HER2 mutants currently in a Phase 1/1b study, as well as a potential first-in-class selective dual CDK2/4 inhibitor for multiple cancer indications, an allosteric inhibitor for KIF18A, and additional new programs.

On December 18, 2024 Xcovery Holdings, Inc., an oncology focused pharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) has approved ensartinib (Ensacove, Xcovery Holdings, Inc.) for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) (Press release, Xcovery, DEC 18, 2024, View Source [SID1234649205]). This approval marks an important advancement in providing a new first line option for patients with ALK-positive NSCLC.

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Ensartinib is an ALK tyrosine kinase inhibitor (TKI) designed to improve outcomes for patients with ALK-positive NSCLC. The FDA approval is based on data from the pivotal global Phase III eXalt3 clinical trial, in which ensartinib demonstrated statistically significant improvements in progression-free survival (PFS) over crizotinib.

"The approval of Ensartinib by FDA brings another new medicine to patients battling ALK-positive NSCLC, expanding the options to optimize treatment in the first-line setting. This result could not have been achieved without the dedication of our team members and the support of patients, physicians, and all stakeholders involved in the clinical development of Ensartinib," said Giovanni Selvaggi, Chief Medical Officer of Xcovery.

"FDA approval of Ensartinib represents a significant milestone in Xcovery’s mission to advance precision medicine for patients with cancer," said Kevin Sang, CEO of Xcovery. "In addition to Ensartinib, we are continuing our efforts in developing more pipeline targeted drugs for patients worldwide."

About Ensartinib

Ensartinib is a next generation ALK inhibitor jointly developed by Xcovery and Betta Pharmaceuticals. It is indicated for the treatment of adult patients with ALK-positive locally advanced or metastatic NSCLC.

On December 18, 2024 Inceptor Bio, a leading innovator in cell therapy, and GRIT Bio, a clinical-stage immunotherapy developer, reported a strategic partnership to advance IB-T101, a potentially best-in-class CAR-T therapy targeting solid tumors (Press release, Inceptor Bio, DEC 18, 2024, View Source [SID1234649204]).

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IB-T101, Inceptor Bio’s autologous CD70 CAR-T program, utilizes the proprietary OUTLAST platform to reprogram T cells for superior stemness, durability, and effector function in the hostile tumor microenvironment. The program targets clear cell Renal Cell Carcinoma (ccRCC), a cancer with significant unmet medical need and over 300,000 new cases annually worldwide.

"We are excited to partner with GRIT Bio to bring IB-T101 into the clinic and address the urgent need for effective solid tumor therapies," said Dr. Matthias Schroff, CEO of Inceptor Bio. "This collaboration highlights the potential of our proprietary OUTLAST platform, and the data generated will play a critical role in advancing the program as we strive to deliver best-in-class therapies for patients."

Dr. Mengyang Chong, Chief Business Officer of GRIT Bio, shared, "Partnering with Inceptor Bio allows us to bring a highly differentiated CAR-T program to patients. IB-T101 has the potential to transform the treatment landscape for solid tumors, and we are eager to contribute our expertise in clinical development and manufacturing to accelerate its progress."

Under the terms of the agreement, Inceptor Bio will grant GRIT Bio an exclusive license for IB-T101 in China. GRIT Bio will oversee development, manufacturing, and commercialization. Inceptor Bio is eligible to receive milestone payments and royalties upon IB-T101 achieving certain response criteria and plans to leverage clinical data from this collaboration to support regulatory submissions and development in other regions.

This partnership represents a critical step in Inceptor Bio’s mission to validate the OUTLAST platform as a best-in-class approach for engineered T cell therapies and bring transformative treatments to patients worldwide.

On December 18, 2024 TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the RNA oncology company committed to more effectively treating cancer using RNA therapeutics, reported that the Safety Review Committee (SRC) monitoring its Phase 1 clinical trial has unanimously approved opening of the third cohort of patients based on its favorable review of Cohort 2 safety data (Press release, TransCode Therapeutics, DEC 18, 2024, https://www.prnewswire.com/news-releases/transcode-therapeutics-announces-safety-review-committee-approval-of-opening-third-cohort-and-preliminary-results-from-first-cohort-in-phase-1-ttx-mc138-clinical-trial-302334447.html [SID1234649203]). The therapeutic candidate being evaluated, TTX-MC138, is TransCode’s lead candidate designed to inhibit microRNA-10b, or miR-10b, a microRNA critical to the emergence and progression of many metastatic cancers. The dose administered to the third cohort will be approximately double the dose administered to the second cohort.

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Several patients in the first and second cohort remain on study for continued treatment. No significant safety or dose limiting toxicities have been reported. Analysis of Cohort 1 data for pharmacokinetic (PK) and pharmacodynamic (PD) activity is ongoing and to date suggests that TTX-MC138 demonstrates a PK/PD profile consistent with preclinical results and results from the previous Phase 0 clinical trial. Specifically, results from Cohort 1 confirmed the Phase 0 observation that TTX-MC138 shows evidence of pharmacodynamic activity in the presence of high baseline expression of miR-10b, reaching a 66% inhibition at 24 hours after infusion. Additionally, the concentration of TTX-MC138 in blood plasma as a function of dose in humans was found to be higher than achieved in nonclinical studies, suggesting a favorable pharmacokinetic profile.

"An SRC is a group of clinicians and experts that oversee patient safety during the conduct of a clinical trial. The SRC determines whether and how a study should proceed, including dose escalation and de-escalation decisions in accordance with the study design. The recommendations of the SRC are used to decide whether a clinical trial should be continued as designed, changed, or terminated," commented Sue Duggan, TransCode’s Senior Vice President of Operations. Duggan added, "Enrollment into the study continues based on the cumulative safety data review. Eligible patients may now be screened and scheduled in Cohort 3 for treatment with the next dose level of TTX-MC138 while preliminary data analysis continues."

About TTX-MC138

TTX-MC138 is a first-in-class therapeutic candidate that targets microRNA-10b, a microRNA widely believed to be a driver of metastatic disease. TransCode’s 2023 Phase 0 clinical trial produced evidence of delivery of a radiolabeled version of TTX-MC138 to metastatic lesions and pharmacodynamic activity, even at a microdose of the drug candidate, suggesting a broad therapeutic window for TTX-MC138.

About the Trial

TransCode’s Phase 1 clinical trial is a multicenter, open-label, dose-escalation and dose-expansion study designed to generate critical data to support evaluation of the safety and tolerability of TTX-MC138 in patients with a variety of metastatic solid cancers. While not an endpoint, the trial may provide early evidence of clinical activity of TTX-MC138. The trial comprises an initial dose-escalation phase followed by a dose-expansion phase. The primary objective of the dose-escalation phase is to evaluate the safety and tolerability of escalating dose levels of TTX-MC138. In the dose-expansion phase, the safety, tolerability and anti-tumor activity of TTX-MC138 will be further evaluated in certain tumor types selected based on preliminary results from the dose-escalation phase.

Further information is available at www.clinicaltrials.gov NCT Identifier: (NCT06260774).