Agenus has Announced Five Presentations at 2025 ASCO GI Highlighting BOT/BAL Activity Across Colorectal and Gastric Cancers

Presentations will showcase new data reinforcing BOT/BAL’s potential across different lines of treatment in colorectal cancer, including the neoadjuvant setting

Agenus, a leading company in immuno-oncology, has announced five presentations highlighting the potential of botensilimab (BOT), an Fc-enhanced anti-CTLA-4 antibody, in combination with balstilimab (BAL), an anti-PD-1 antibody, at the upcoming ASCO Gastrointestinal Cancers Symposium. The event is scheduled for January 23-25, 2025, in San Francisco, California.

The presentations will focus on BOT/BAL’s efficacy across three key colorectal cancer treatment settings: late-line metastatic, first-line, and neoadjuvant.

The studies emphasize the combination’s consistent activity in microsatellite stable (MSS) colorectal cancer—representing over 80% of CRC cases with limited treatment options—as well as its effectiveness in microsatellite instability-high (MSI-H) CRC.

Additionally, one presentation will explore the use of BOT/BAL with invariant natural killer T cells (iNKTs) in treating 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. We aim to transform outcomes at every stage of disease and deliver renewed hope for patients worldwide,” – said Dr. Garo Armen, Chairman and CEO of Agenus.

 

Presentation Details

Abstract Title: Botensilimab plus balstilimab in relapsed/refractory microsatellite stable metastatic colorectal cancer: a phase 1 trial

Authors: Marwan Fakih, Neil Segal, Benjamin Schlechter, Thierry Andre, Filippo Pietrantonio, Benny Johnson, Alexander Vasilyev, Smitha Krishnamurthi, Salvatore Siena, Wells Messersmith, Virgilio Souza E Silva, Andrew Paulson, Elena Elez, Cathy Eng, Sabine Tejpar, Michel Ducreux, Wei Wu, Joseph Grossman, Eric Van Cutsem, Manuel Hidalgo

Abstract Number: 23
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
Presenting Author: Dr. Marwan Fakih

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

Authors: Filippo Ghelardi, Margherita Ambrosini, Alessandra Raimondi, Giovanna Sabella, Riccardo Cerantola, Federica Palermo, Samantha Di Donato, Daniele Spada, Stefano Tamberi, Eleonora Perissinotto, Francesca Bergamo, Alessandro Passardi, Emiliano Tamburini, Riccardo Rosati, Andrea Sartore-Bianchi, Marcello Guaglio, Chiara Cremolini, Isacco Montroni, Sara Lonardi, Filippo Pietrantonio

Abstract Number: 158
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
Presenting Author: Dr. Filippo Ghelardi

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

Authors: Samuel Cytryn, Steven Maron, Yelena Janjigian

Abstract Number: TPS515
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
Presenting Author: Dr. Samuel Cytryn

Abstract Title: Neoadjuvant botensilimab (BOT) plus balstilimab (BAL) in resectable mismatch repair proficient (pMMR) and deficient (dMMR) colorectal cancer (CRC): NEST clinical trial update

Authors: Erika Hissong, Mehraneh Jafari, Sahrish Khan, Pashtoon Kasi, Preethi Guniganti, Allyson Ocean, Despina Siolas, Heather Yeo, Uqba Khan, Alessio Pigazzi, Areeb Lutfi, Zhengming Chen, Manish Shah, Manuel Hidalgo

Abstract Number: 207
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
Presenting Author: Dr. Erika Hissong

Abstract Title: A phase 1 trial of folinic acid, fluorouracil, oxaliplatin, bevacizumab, botensilimab, balstilimab (FOLFOX-3B) in microsatellite stable metastatic colorectal cancer.

Authors: Marwan Fakih, Xiaochen Li, Jian Ye, Nikeeta Prajapati, Chongkai Wang

Abstract Number: 180
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
Presenting Author: Dr. Marwan Fakih

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 following the ASCO GI Meeting.

About Agenus

Agenus is a leading immuno-oncology company targeting cancer with a comprehensive pipeline of immunological agents. The company was founded in 1994 with a mission to expand patient populations benefiting from cancer immunotherapy through combination approaches, using a broad repertoire of antibody therapeutics, adoptive cell therapies (through MiNK Therapeutics) and adjuvants (through SaponiQx).

Agenus has robust end-to-end development capabilities, across commercial and clinical cGMP manufacturing facilities, research and discovery, and a global clinical operations footprint. Agenus is headquartered in Lexington, MA.

About Botensilimab (BOT)

Botensilimab (BOT) is a human Fc-enhanced CTLA-4 blocking antibody designed to stimulate both innate and adaptive anti-tumor immune responses. Its innovative design enables it to deliver immunotherapy benefits to “cold” tumors—those that typically respond poorly to standard treatments or are resistant to conventional PD-1/CTLA-4 therapies and experimental treatments. Botensilimab enhances immune activity across various tumor types by priming and activating T cells, reducing intratumoral regulatory T cells, activating myeloid cells, and inducing durable memory responses.

To date, approximately 1,100 patients have received botensilimab and/or balstilimab in phase 1 and phase 2 clinical studies. Administered alone or in combination with Agenus’ investigational PD-1 antibody balstilimab, botensilimab has demonstrated clinical activity in nine metastatic, late-stage cancers.

Further Reading:

Three decades of pioneering in Immune Oncology – Agenus

Botensilimab: A Revolutionary Fc-Enhanced CTLA-4 Inhibitor Transforming Cancer Immunotherapy

Botensilimab’s mechanism of action and potential in addressing treatment-resistant cancers

New Paper Alert! Promising Results for MSS Colorectal Cancer Treated with Balstilimab and Botensilimab

Agenus and Tanner Pharma Partner to Expand Global Access to BOT/BAL