AgenT-797

LEXINGTON, Mass.--( BUSINESS WIRE )--Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology, today announced 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 Gastrointestinal Cancers (ASCO GI) Symposium. The conference will take place on January 23-25, 2025, in San Francisco, California. 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 21 st , 2025. Data presented at the conference will be available to view in the publications section of the Agenus website ( https://agenusbio.com/publications ) following the ASCO GI Meeting. *Agenus Sponsored Study 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. For more information, visit www.agenusbio.com or @agenus_bio. Information that may be important to investors will be routinely posted on our website and social media channels. About Botensilimab (BOT) Botensilimab (BOT) is a human Fc enhanced CTLA-4 blocking antibody designed to boost both innate and adaptive anti-tumor immune responses. Its novel design leverages mechanisms of action to extend immunotherapy benefits to “cold” tumors which generally respond poorly to standard of care or are refractory to conventional PD-1/CTLA-4 therapies and investigational therapies. Botensilimab augments immune responses across a wide range of tumor types by priming and activating T cells, downregulating intratumoral regulatory T cells, activating myeloid cells and inducing long-term memory responses. Approximately 1,100 patients have been treated with botensilimab and/or balstilimab in phase 1 and phase 2 clinical trials. Botensilimab alone, or in combination with Agenus’ investigational PD-1 antibody, balstilimab, has shown clinical responses across nine metastatic, late-line cancers. For more information about botensilimab trials, visit www.clinicaltrials.gov with the identifiers NCT03860272, NCT05608044, NCT05630183, and NCT05529316. Forward-Looking Statements This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding its botensilimab and balstilimab programs, expected regulatory timelines and filings, and any other statements containing the words "may," "believes," "expects," "anticipates," "hopes," "intends," "plans," "forecasts," "estimates," "will," “establish,” “potential,” “superiority,” “best in class,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under the Risk Factors section of our most recent Annual Report on Form 10-K for 2023, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and Agenus undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.

NEW YORK, Nov. 14, 2024 (GLOBE NEWSWIRE) -- MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company pioneering the discovery, development, and commercialization of allogeneic, off-the-shelf, invariant natural killer T (iNKT) cell therapies to treat cancer and other immune-mediated diseases, today announced results for the third quarter 2024. MiNK will host a conference call and webcast at 8:30 a.m. ET. “Our progress this quarter reflects MiNK’s commitment to advancing effective and scalable therapies in cancer and immune-mediated diseases,” said Jennifer Buell, PhD, Chief Executive Officer of MiNK Therapeutics. “We have continued to expand our iNKT cell therapy platform and partnerships to address high-need areas, recently showcasing the versatility of iNKT cells in two presentations at SITC. Our clinical programs are advancing with the ongoing Phase 2 study in second-line and later-stage gastric cancer, with initial data anticipated early next year. These developments underscore our momentum in delivering impactful treatments for patients.” Recent Business Updates: Board Appointment: Dr. Robert Kadlec, a recognized authority in biodefense, pandemic preparedness, and public health strategy, has joined MiNK’s Board of Directors. Dr. Kadlec’s expertise in public health and biodefense will support MiNK’s iNKT cell platform in addressing critical infectious diseases.Research Collaboration: MiNK and Autonomous Therapeutics, a pioneer in disease-activated RNA medicines, entered into a research collaboration to target and treat metastatic tumors. The collaboration combines Autonomous’ encrypted RNA™ (encRNA) technology with MiNK’s iNKT cell therapies, MiNK-215 and agenT-797, with the goal of developing therapies to effectively target metastatic cancer cells.SITC 2024 Presentations: Two poster presentations at the Society for Cancer Immunotherapy (SITC) 2024 Annual Meeting highlighted the potential of iNKT cell therapies in advancing cancer treatment: AgenT-797 demonstrated enhanced activity of checkpoint inhibitors and bispecific engagers in combination.PRAME-targeted TCR iNKT cell therapy showcased the potential to address limitations of traditional T cell therapies in targeting solid tumors such as NSCLC, ovarian cancer, melanoma, and sarcoma. Preclinical studies indicate that PRAME-TCR-iNKTs can specifically target and kill tumor cells. Solid Tumor Clinical Program: AgenT-797 is advancing in an enrolling Phase 2 trial in second-line and later-stage advanced gastroesophageal cancer at Memorial Sloan-Kettering Cancer Center, with results expected at a major conference in early 2025.Graft-versus-Host Disease (GvHD) Program: MiNK is advancing initiation of Phase 1 trial with external financial support to investigate agenT-797 for the treatment of GvHD, in collaboration with leading research institutions in the U.S. and EU for dosing to start in 2025. Financial Results MiNK ended the quarter with a cash balance of $6.3 million reflecting cash used in operations for the three and nine months ended September 2024 of $3 million and $7.8 million, respectively, reduced from $7.8 million and $12.7 million, for the same period in 2023. Net loss for the three and nine months ended September 30, 2024, was $1.8 million, or $0.05 per share, and $8.3 million, or $0.22 per share, respectively. This compares to $5.1 million, or $0.15 per share, and $17 million or $0.50 per share, for the same periods in 2023. Summary Consolidated Financial Information Condensed Consolidated Balance Sheet Data(in thousands)(unaudited) September 30, 2024 December 31, 2023 Cash and cash equivalents$6,328 $3,367 Total assets 7,375 4,552 Other Financial Information(in thousands)(unaudited) Three months ended September 30, Nine months ended September 30, 2024 2023 2024 2023 Cash used in operations$2,995 $4,209 $7,828 $12,727 Condensed Consolidated Statements of Operations Data(in thousands, except per share data)(unaudited) Three months ended September 30, Nine months ended September 30, 2024 2023 2024 2023 Operating expenses: Research and development$541 $3,427 $4,930 $12,179 General and administrative 1,163 1,796 3,505 5,242 Change in fair value of related party note 181 - 350 - Operating loss 1,885 5,223 8,785 17,421 Other income, net (78) (107) (464) (422) Net loss$1,807 $5,116 $8,321 $16,999 Per common share data, basic and diluted: Net loss$(0.05) $(0.15) $(0.22) $(0.50)Weighted average number of common shares outstanding, basic and diluted 39,534 34,498 37,115 34,293 Conference Call Dial-in numbers: 646-307-1963 (New York), 800-715-9871 (USA & Canada) Conference ID: 5606166 Webcast A live webcast and replay of the conference call will be accessible from the Events & Presentations page of the Company’s website at https://investor.minktherapeutics.com/events-and-presentations and via https://edge.media-server.com/mmc/p/ukmiq8bo/. About MiNK Therapeutics MiNK Therapeutics is a clinical-stage biopharmaceutical company pioneering the discovery, development, and commercialization of allogeneic invariant natural killer T (iNKT) cell therapies to treat cancer and other immune-mediated diseases. MiNK is advancing a pipeline of both native and next generation engineered iNKT programs, with a platform designed to facilitate scalable and reproducible manufacturing for off-the-shelf delivery. The company is headquartered in New York, NY. For more information, visit https://minktherapeutics.com/ or @MiNK_iNKT. Information that may be important to investors will be routinely posted on our website and social media channels. Forward Looking Statements This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding the therapeutic potential, anticipated benefit, plans and timelines of iNKT cells and encrypted RNA, as well as the collaboration between MiNK and Autonomous Therapeutics. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These forward-looking statements are subject to risks and uncertainties, including the factors described under the Risk Factors section of the most recent Form 10-K, Form 10-Q and the S-1 Registration Statement filed with the SEC. MiNK cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and MiNK and Autonomous undertake no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. Investor Contact 917-362-1370 investor@minktherapeutics.com Media Contact 781-674-4428 communications@minktherapeutics.com