This is a single-arm, interventional, pilot clinical trial. Fifteen evaluable patients will have tumor-informed ctDNA testing at baseline and start botensilimab and balstilimab treatment. They will receive botensilimab and balstilimab in 6-week cycles until progression, after which mFOLFOX6 and bevacizumab or panitumumab will be added to the regimen. Subjects will have safety testing at baseline and every two weeks while on study drug. Study treatment with botensilimab and balstilimab, mFOLFOX6, and bevacizumab or panitumumab will be continued until radiographic or clinical progression, toxicity, or patient withdrawal. Subjects will have one safety follow up visit 30 days after the last treatment and will be followed for survival every 12 weeks for up to 2 years.

Start Date18 Nov 2024

Sponsor / Collaborator

Duke University

[+2]

NCT06411691 / RecruitingPhase 1IIT

Pooled Mutant KRAS-Targeted Long Peptide Vaccine Combined With Balstilimab and Botensilimab for Patients With Stage IV MMR-p Colorectal Cancer and Pancreatic Ductal Adenocarcinoma

Phase 1b study evaluating the efficacy and immune response to a synthetic long peptide mutant KRAS vaccine (SPL mKRASvax) combined with Balstilimab and Botensilimab for unresectable or metastatic mismatch repair-proficient (MMR-p) colorectal cancer (mCRC) or unresectable or metastatic MMR-p pancreatic ductal adenocarcinoma (PDAC) patients with measurable disease following first-line FOLFIRINOX/FOLFOXIRI (FFX).

Start Date04 Nov 2024

Sponsor / Collaborator

The Sidney Kimmel Comprehensive Cancer Center

[+2]

NCT06575725 / WithdrawnPhase 2IIT

A Phase 2 Study of Botensilimab, Balstilimab and Regorafenib in Patients With Microsatellite Stable Colorectal Cancer

This phase II trial studies how well the combination of botensilimab, balstilimab and regorafenib works compared to botensilimab and balstilimab in treating patients with microsatellite stable colorectal cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as botensilimab and balstilimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Regorafenib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals tumor cells to multiply. This helps to slow or stop the spread of tumor cells. The combination of botensilimab, balstilimab and regorafenib or botensilimab and balstilimab may be a safe and effective treatment for advanced or metastatic microsatellite stable colorectal cancer.

Start Date01 Nov 2024

Sponsor / Collaborator

City of Hope National Medical Center

[+1]

100 Clinical Results associated with Balstilimab

100 Translational Medicine associated with Balstilimab

100 Patents (Medical) associated with Balstilimab

Literatures (Medical) associated with Balstilimab

01 Sep 2024·NATURE MEDICINE

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

Article

Author: Curiel, Tyler J ; O'Day, Steven J ; Fakih, Marwan G ; Lenz, Heinz-Josef ; Sanborn, Rachel E ; Schwartz, Gary K ; Abou-Alfa, Ghassan K ; Grossman, Joseph E ; Delepine, Chloe ; Mednick, Gabriel ; El-Khoueiry, Anthony B ; Balmanoukian, Ani S ; Patel, Jaymin M ; Wilky, Breelyn A ; Stebbing, Justin ; Mahadevan, Daruka ; Tsimberidou, Apostolia M ; Wu, Wei ; Gordon, Michael S ; Sharma, Sunil ; Rosenthal, Katherine ; Chand, Dhan ; Segal, Neil H ; Pimentel, Agustin ; Moser, Justin C ; Bullock, Andrea J ; Schlechter, Benjamin L ; Bockorny, Bruno

Abstract:

Microsatellite stable metastatic colorectal cancer (MSS mCRC; mismatch repair proficient) has previously responded poorly to immune checkpoint blockade. Botensilimab (BOT) is an Fc-enhanced multifunctional anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody designed to expand therapy to cold/poorly immunogenic solid tumors, such as MSS mCRC. BOT with or without balstilimab (BAL; anti-PD-1 antibody) is being evaluated in an ongoing expanded phase 1 study. The primary endpoint is safety and tolerability, which was evaluated separately in the dose-escalation portion of the study and in patients with MSS mCRC (using combined dose-escalation/dose-expansion data). Secondary endpoints include investigator-assessed RECIST version 1.1–confirmed objective response rate (ORR), disease control rate (DCR), duration of response (DOR) and progression-free survival (PFS). Here we present outcomes in 148 heavily pre-treated patients with MSS mCRC (six from the dose-escalation cohort; 142 from the dose-expansion cohort) treated with BOT and BAL, 101 of whom were considered response evaluable with at least 6 months of follow-up. Treatment-related adverse events (TRAEs) occurred in 89% of patients with MSS mCRC (131/148), most commonly fatigue (35%, 52/148), diarrhea (32%, 47/148) and pyrexia (24%, 36/148), with no grade 5 TRAEs reported and a 12% discontinuation rate due to a TRAE (18/148; data fully mature). In the response-evaluable population (n = 101), ORR was 17% (17/101; 95% confidence interval (CI), 10–26%), and DCR was 61% (62/101; 95% CI, 51–71%). Median DOR was not reached (NR; 95% CI, 5.7 months–NR), and median PFS was 3.5 months (95% CI, 2.7–4.1 months), at a median follow-up of 10.3 months (range, 0.5–42.6 months; data continuing to mature). The combination of BOT plus BAL demonstrated a manageable safety profile with no new immune-mediated safety signals and encouraging clinical activity with durable responses. ClinicalTrials.gov identifier: NCT03860272.

01 Oct 2023·Oncogene

Neoadjuvant botensilimab plus balstilimab response pattern in locally advanced mismatch repair proficient colorectal cancer.

Article

Author: Siolas, Despina ; Khan, Sahrish ; Nguyen, Alana T H ; Hunt, Daniel H ; Khan, Uqba ; Jafari, Mehraneh D ; Hidalgo, Manuel ; Garrett, Kelly A ; Hissong, Erika ; Lowenfeld, Lea ; Swed, Brandon ; Wood, Madeleine ; Ocean, Allyson J ; Samstein, Benjamin ; Uppal, Nikhil P ; Hyun, Jini ; Popa, Elizabeta C ; Rocca, Juan P ; Yeo, Heather ; Zhou, Xi Kathy ; Kasi, Pashtoon Murtaza ; Shah, Manish A ; Pigazzi, Alessio

In patients with locally advanced cancer without distant metastases, the neoadjuvant setting presents a platform to evaluate new drugs. For mismatch repair proficient/microsatellite stable (pMMR/MSS) colon and rectal cancer, immunotherapy has shown limited efficacy. Herein, we report exceptional responses observed with neoadjuvant botensilimab (BOT), an Fc-enhanced next-generation anti-CTLA-4 antibody, alongside balstilimab (BAL; an anti-PD-1 antibody) in two patients with pMMR/MSS colon and rectal cancer. The histological pattern of rapid immune response observed ("inside-out" (serosa-to-mucosa) tumor regression) has not been described previously in this setting. Spatial biology analyses (RareCyte Inc.) reveal mechanisms of actions of BOT, a novel innate-adaptive immune activator. These observations have downstream implications for clinical trial designs using neoadjuvant immunotherapy and potentially sparing patients chemotherapy.

01 Jul 2022·Journal of clinical oncology : official journal of the American Society of Clinical Oncology

Abscobal Effect of Balstilimab and Zalifrelimab Combination as Second-Line Treatment for Advanced Cervical Cancer

Letter

Author: Özdemir, Nuriye ; Aslan, Volkan ; Sütcüoğlu, Osman ; Özet, Ahmet ; Yazıcı, Ozan

107

News (Medical) associated with Balstilimab

12 Nov 2024

·www.businesswire.com

Agenus Reports Third Quarter 2024 Financial Results and Strategic Advancements in BOT/BAL Development

LEXINGTON, Mass.--( BUSINESS WIRE )--Agenus Inc. (“Agenus” or the “Company”) (Nasdaq: AGEN), an immuno-oncology company focused on innovation, today provided a corporate update and reported financial results for the third quarter of 2024. “BOT/BAL represents one of the most significant advancements in cancer immunotherapy, showing remarkable results in MSS colorectal cancer where previous treatments have fallen short,” said Garo Armen, Ph.D., Chairman and CEO of Agenus. “Its potential extends beyond this challenging cancer type, with promising efficacy seen in the neoadjuvant setting and other hard-to-treat cancers. While we are excited by these achievements, we remain mindful of the financial challenges that come with advancing such breakthrough therapies. We are focused on strategic initiatives, including asset monetization and operational efficiencies, to strengthen our financial position and continue driving forward. We are confident in our path and unwavering in our commitment to deliver innovative treatments that redefine patient care and create long-term value for our patients and shareholders.” Key Highlights from Q3 2024 Breakthrough Clinical Progress - Botensilimab (BOT) and balstilimab (BAL) continues to deliver unprecedented outcomes across multiple cancer settings. Neoadjuvant MSS Colorectal Cancer (CRC) : BOT/BAL is advancing in 3 ISTs with consistent clinical activity in MSS CRC, a tumor historically resistant to immunotherapy. Initial results from Cornell study ( ESMO GI 2024 ) show groundbreaking potential; results from additional trials in Italy and the Netherlands expected to be presented at prestigious oncology conferences in early 2025. Broad and Durable Responses in Sarcoma and other cancers : Presentations at ESMO 2024 highlighted BOT/BAL’s clinical activity advanced sarcomas and other difficult-to-treat cancers, reinforcing its potential to redefine cancer treatment. Additional data updates are expected to be shared at key oncology conferences in the coming months. Expanding Patient Access Globally - Agenus is committed to expanding patient access to BOT/BAL through Compassionate Use and Named Patient Programs, providing innovative treatment options for patients with limited alternatives. These programs empower physicians to deliver advanced care as regulatory frameworks evolve to support broader patient access. Strategic Financial Initiatives - Agenus is actively pursuing a disciplined approach to strengthen its financial foundation: Operational Efficiencies : Cash outflows have been significantly reduced through focused measures. Asset Monetization : Discussions to monetize real estate assets are progressing, reflecting increased interest and opportunities following the recent U.S. elections, which have positively impacted financial markets. These monetization efforts are expected to provide near-term cash infusions to support operations. Near-Term Transaction : Agenus is also advancing discussions on a strategic transaction designed to deliver substantial resources. The company views its current financial initiatives as a bridge to this transformative step, which is expected to position Agenus for long-term growth while maximizing value for shareholders. Regulatory Alignment - Ongoing discussions with the European Medicines Agency (EMA) have progressed to agreement on dose selection and trial design for the pivotal Phase 3 study in MSS CRC, marking significant progress in BOT/BAL’s development. These achievements reflect a collaborative effort to enable access to this transformative combination to patients worldwide. Q3 2024 Financial Summary Agenus ended the third quarter 2024 with a consolidated cash balance of $44.8 million compared to $76.1 million on December 31, 2023. In addition, the Company has raised $7.1 million through sales of common stock under its market issuance sales agreement since the end of the third quarter 2024. Cash used in operations for the nine months ended September 2024 was $129.7 million, reduced from $183.8 million for the nine months ended September 2023. For the three and nine months ended September 30, 2024, Agenus recognized revenue, which includes non-cash revenue, of $25.1 million and $76.6 million, respectively. This compares to $24.3 million and $72.5 million for the same periods in 2023. Net loss for the three and nine months ended September 30, 2024, is $67.2 million and $185.5 million, respectively, and includes non-cash operating expenses of $40.5 million and $112.3 million, respectively. This compares to a net loss for three and nine months ended September 30, 2023, of $64.5 million and $208.9 million, respectively. Financial Highlights (in thousands, except per share data) (unaudited) September 30, 2024 December 31, 2023 Cash, cash equivalents and short-term investments $ 44,784 $ 76,110 Cash raised since quarter end $ 7,087 Three months ended September 30, Nine months ended September 30, 2024 2023 2024 2023 Revenue, including non-cash royalties 25,112 24,314 76,626 72,513 Research and development expenses 41,058 51,443 121,753 167,846 General and administrative expenses 17,275 18,909 50,947 57,562 Cost of service revenue 146 303 368 2,851 Other income (486 ) (866 ) (6,603 ) (2,470 ) Non-cash interest expense 36,196 19,057 97,489 55,977 Non-cash fair value adjustment (1,863 ) - (1,863 ) (398 ) Net loss $ (67,214 ) $ (64,532 ) $ (185,465 ) $ (208,855 ) Net loss per share attributable to Agenus Inc. common stockholders $ (3.08 ) $ (3.29 ) $ (8.65 ) $ (11.43 ) Cash used in operations $ 53,292 $ 65,231 $ 129,663 $ 183,800 Non-cash operating expenses $ 40,529 $ 28,122 $ 112,304 $ 82,004 Conference Call Date: Tuesday, November 12 th , at 8:30 a.m. ET To access dial-in numbers, please register here . Conference ID: 73242 Webcast A live webcast and replay of the conference call will be accessible on the company’s website at https://investor.agenusbio.com/events-and-presentations . About Botensilimab Botensilimab 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 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. 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. 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.

Phase 2ImmunotherapyFinancial Statement

07 Nov 2024

·www.businesswire.com

Agenus to Present Compelling Data on Botensilimab and AGEN1721 at SITC 2024

LEXINGTON, Mass.--( BUSINESS WIRE )--Agenus Inc. (“Agenus”) (Nasdaq: AGEN), a leader in developing novel immunological agents to treat various cancers, today announced the presentation of new data on two of its promising investigational immunotherapy candidates, botensilimab and AGEN1721, at the Society for Immunotherapy of Cancer (SITC) 2024 Annual Meeting in Houston, Texas. The data, showcasing potential breakthroughs in treating immune-resistant tumors, will be presented by Dhan Chand, Ph.D., Vice President of Research at Agenus. The first two presentations will spotlight botensilimab, an innovative, investigational, Fc-enhanced anti-CTLA-4 antibody that has shown remarkable efficacy in overcoming immune barriers across several treatment-resistant cancers, including glioblastoma, melanoma, colorectal, pancreatic, and breast cancers. Botensilimab’s unique mechanism of action enhances both innate and adaptive immunity to promote optimal T-cell priming, stimulate antigen-presenting cells, and deplete immune suppressing regulatory T cells in the tumor microenvironment, creating a multi-pronged attack on cold and refractory tumors. “These findings represent a significant milestone in understanding how botensilimab can be optimally combined with both established and emerging therapies,” said Dr. Chand. “What’s particularly compelling is the profound efficacy we’re seeing in traditionally ‘cold’ tumors and treatment-resistant cancers—offering potential new options for patients with limited therapeutic choices.” Featured botensilimab presentations: Preclinical dose-pharmacokinetic-efficacy modeling of botensilimab using a mouse surrogate of the Fc-enhanced anti-CTLA-4 antibody 527 Location: Exhibit Halls A B George R. Brown Convention Center Date: Friday, Nov. 8, 2024 - Odd Number Posters Poster Hall Hours: 9 a.m.–7 p.m. Fc-enhanced anti-CTLA-4 antibody, botensilimab, enhances the efficacy of multiple therapeutic modalities in immunotherapy-refractory tumor models 720 Location: Exhibit Halls A B George R. Brown Convention Center Date: Saturday, Nov. 9, 2024 - Even Number Posters Poster Hall Hours: 9 a.m.–8:30 p.m. An additional presentation will cover AGEN1721, a first-in-class, Fc-enhanced bifunctional antibody targeting FAP and TGFβ. AGEN1721 is engineered to remodel the tumor microenvironment by depleting cancer-associated fibroblasts (CAFs) and neutralizing TGFβ’s immunosuppressive effects. By facilitating T-cell infiltration and activation, AGEN1721 effectively transforms cold tumors into "hot," immune-responsive environments. “AGEN1721 represents a breakthrough in addressing the challenges of immune-excluded tumors by targeting key elements that suppress immune activity within the tumor microenvironment,” said Dr. Chand. “The data we’re presenting at SITC 2024 highlight how AGEN1721’s dual-action approach can dismantle barriers to immune infiltration, offering renewed hope for more durable and effective responses against resistant cancers.” Featured AGEN1721 presentation: AGEN1721, a first-in-class Fc-enhanced bifunctional antibody targeting FAP and TGFβ, remodels the tumor microenvironment to overcome cancer-associated fibroblast-mediated immune suppression 1355 Location: Exhibit Halls A B George R. Brown Convention Center Date: Friday, Nov. 8, 2024 - Odd Number Posters Poster Hall Hours: 9 a.m.–7 p.m. About Botensilimab Botensilimab is an investigational 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 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. 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. 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.

ImmunotherapyPhase 2Phase 1AACR

07 Nov 2024

·www.globenewswire.com

MiNK’s iNKT Cell Therapy Shows Potential for Optimal Multi-Combination for Resistant Solid Cancers at SITC 2024

AgenT-797 Combination with Checkpoint Inhibitors and Bispecific Engagers Expands Anti-Cancer Benefit PRAME-TCR iNKT Overcomes Challenges from Conventional TCR-T Cells in Solid Cancers NEW YORK, Nov. 07, 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 data from two poster presentations at the Society for Immunotherapy of Cancer’s (SITC) 39th Annual Meeting in Houston, Texas. The presentations showcased new data from MiNK’s iNKT cell therapy programs, agenT-797 and PRAME-TCR. “The data we presented at SITC reflect the potential of iNKT cell therapies to offer meaningful advancements in cancer treatment. AgenT-797 shows important immune modulating effects, enhancing the activity of immune checkpoint inhibitors and bispecific engagers,” said Dr. Marc Van Dijk, CSO at MiNK. “Additionally, our PRAME-TCR iNKT represents a novel and differentiated approach to treat PRAME positive solid tumors. By leveraging iNKT cells’ ability to target the tumor microenvironment without lymphodepletion or HLA-matching, we aim to provide durable, scalable, and accessible solutions for patients with limited treatment options.” AgenT-797 Combination Boosts Activity of Checkpoint Inhibitors and Bispecific Engagers in Challenging Solid Tumors AgenT-797 alone or in combination with anti-PD-1 (nivo or pembro) shows durable disease control in majority of heavily pretreated patients.AgenT-797 combined with bispecific engagers targeting antigens such as MUC16, HER2, Claudin 18.2, and DLL3, promote increased T-cell activation, efficient tumor cell killing, and reduced exhaustion and myeloid cell activity.Ongoing Clinical Studies: AgenT-797 is advancing in an enrolling Phase 2 trial with an innovative five-treatment combination regimen that includes botensilimab, balstilimab, and standard-of-care chemotherapy. This trial targets 2L+ advanced gastroesophageal cancer patients and is being conducted at Memorial Sloan-Kettering Cancer Center, with results expected in 2025. PRAME-TCR iNKT Represents a Promising Targeted Therapy for Refractory Solid Tumors iNKT cells present an ideal platform for tumor-targeting T cell receptor (TCR) expression due to the absence of conventional αβ TCRs and endogenous class I MHC molecules.MiNK’s allogeneic PRAME-targeted TCR addresses the limitations of traditional T cell therapies. As an allogeneic, gene-editing-free solution, it expresses an engineered αβ PRAME-TCR with no risk of heterodimerization, offering a potentially safer and more precise approach.In preclinical studies, PRAME-TCR-iNKTs direct tumor cell killing with high specificity, which highlights the versatility of iNKT cells and their potential of to treat solid tumors such as NSCLC, ovarian, melanoma and sarcoma. Presentation Details Title: AgenT-797 iNKT cell therapy can be combined with next-generation immune checkpoint inhibitors (ICI) and bi-specific engagers to improve the anti-tumor response Abstract Number: 753 Date: Friday, November 8th Title: PRAME-TCR iNKT cell therapy: Opportunity for best-in-class off-the-shelf solid tumor therapy targeting PRAME Abstract Number: 374 Session Date: Saturday, November 9th 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 and curative potential of agenT-797 and iNKT cells the mechanism of action, potency and safety, interim or top-line data, including statements regarding clinical data of agenT-797, the anticipated benefits of agenT-797 and clinical development plans and timelines. 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 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 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. Investor Contact917-362-1370investor@minktherapeutics.com Media Contact781-674-4428communications@minktherapeutics.com

Cell TherapyImmunotherapyPhase 2AACR

100 Deals associated with Balstilimab

External Link

KEGG	Wiki	ATC	Drug Bank
D11820	-	-	DB15676

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Uterine Cervical Cancer	NDA/BLA	US	Recepta Biopharma SA	30 Jan 2022
Advanced cancer	Phase 3	FR	Agenus, Inc.	15 Oct 2024
stomach adenocarcinoma	Phase 3	FR	Agenus, Inc.	15 Oct 2024
Adenocarcinoma of large intestine	Phase 2	US	National Cancer Institute	01 Nov 2024
Advanced Colorectal Adenocarcinoma	Phase 2	US	National Cancer Institute	01 Nov 2024
Locally Advanced Rectal Carcinoma	Phase 2	US	National Cancer Institute	01 Nov 2024
Metastatic colon cancer	Phase 2	US	National Cancer Institute	01 Nov 2024
Metastatic Microsatellite Stable Colorectal Carcinoma	Phase 2	US	National Cancer Institute	01 Nov 2024
Microsatellite Stable Colorectal Carcinoma	Phase 2	US	National Cancer Institute	01 Nov 2024
Rectal Adenocarcinoma	Phase 2	US	National Cancer Institute	01 Nov 2024

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03860272 (ESMO2024) Manual	Phase 1	Sarcoma	63	Botensilimab+balstilimab (efficacy evaluable)	tcxdmxredj(vkapiqjxmo) = Any grade immune-mediated adverse events (AEs) occurred in 52% of pts, most commonly, diarrhea/colitis (38%; 11% Gr3). No Gr4 or 5 treatment-related AEs occurred. dcabxbsmrv (mphcotzhbo ) View more	Positive	13 Sep 2024
NCT03860272 (NEST-1, Biospace) Manual	Phase 1/2	Colonic Cancer Neoadjuvant Microsatellite Stable (MSS) \| MSI-High	20	botensilimab with balstilimab + botensilimabal dosbalstilimablimab (MSS + NEST-1 cohort)	vzanllethu(gihunmnqhm) = blqzxgaiog ctdiendmcw (bwxctyzqnf ) View more	Positive	28 Jul 2024
				botensilimab with balstbalstilimab + botensilimabal dose of balstilimab (MSI-H + NEST-1 cohort)	vzanllethu(gihunmnqhm) = kawggnyvky ctdiendmcw (bwxctyzqnf ) View more
BusinessWire Manual	Phase 2	Metastatic Microsatellite Stable Colorectal Carcinoma	-	Botensilimab 75mg + Balstilimab 240mg	buylyaqelt(ebafqdojmp) = hlarnyoqvz eqkumwsiyw (uygigutcfq, 10.4 - 31.4) View more	Positive	18 Jul 2024
				Botensilimab 150mg + Balstilimab 240mg	buylyaqelt(ebafqdojmp) = cymtmfahyf eqkumwsiyw (uygigutcfq, 2.7 - 18.1)
NCT05205330 (ASCO2024) Manual	Phase 1/2	Metastatic Microsatellite Stable Colorectal Carcinoma pMMR/MSS	-	vorbipiprant + balstilimab	abskdrezmd(jsnbiwgmlr) = eruapshvxm znynrmjkzw (uyiqaszoyk ) View more	Positive	24 May 2024
				vorbipiprant + balstilimab (liver metastases)	abskdrezmd(jsnbiwgmlr) = uwbjfqxjxb znynrmjkzw (uyiqaszoyk ) View more
NCT04430036 (CTgov)	Phase 2	Muscle Invasive Bladder Carcinoma	4	AGEN2034+gemcitabine+Cisplatin+AGEN1884	wuxbbkjmyx(dsldtgyqwa) = nswxnaoqjv allepnuezo (noncketdys, jtolyumuzc - fxentfqjjz) View more	-	04 Apr 2024
NCT05205330 (ESMO2023) Manual	Phase 1/2	Microsatellite instability-high colorectal cancer pMMR \| MSS	28	CR6086+balstilimab	ydmsnqqbse(qkbcwfkiwj) = CR6086-related AEs were grade 1 (G1), except for a serious G4 duodenal ulcer which led to consideration of proton pump inhibitors prophylaxis in all pts.Balstilimab-related AEs were ≤G2 and one was serious (pneumonitis) tvoqlwixeu (qxuicjglkl )	Positive	22 Oct 2023
				CR6086+balstilimab (liver metastases)
NCT03860272 (ESMO2023) Manual	Phase 1	Sarcoma	22	Botensilimab+ balstilimab	unaqoragko(uycbbttwsw) = zvtncucsla daatepwtga (ephelfhnwf ) View more	Positive	21 Oct 2023
NCT04028063 (ASCO2023) Manual	Phase 2	Metastatic Soft Tissue Sarcoma	31	doxorubicin+Zalifrelimab+Balstilimab	zrlkjnotha(cjrkbycvtz) = jxxrofjbbi duabrdoebk (hdzyievfwo, 31 - 72) View more	Positive	26 May 2023
NCT03860272 (ASCO_GI2023) Manual	Phase 1	Metastatic Microsatellite Stable Colorectal Carcinoma	59	Botensilimab 1 mg/kg / 2 mg/kg+Balstilimab 3 mg/kg	kowajrfypm(qhrlaboask) = bjxxwwnkmc goldhyapkr (kxkhvfcumb ) View more	Positive	24 Jan 2023
				Botensilimab 1 mg/kg / 2 mg/kg+Balstilimab 3 mg/kg (1 mg/kg pts)	ruioctdikp(wvtjuqfwgs) = lygcqmdrcx jyfkfejgja (bluiafbsmn, 63 - 100) View more
NCT03860272 (C-800-01, Biospace) Manual	Phase 1	Advanced Sarcoma	13	Balstilimab+Botensilimab	bjjjpoasdy(ydggfkneoc) = ftubcalfmp guzvimktok (logqulghub ) View more	Positive	17 Nov 2022

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