This phase II trial tests how well fluorouracil, oxaliplatin and leucovorin calcium (folinic acid) (FOLFOX) with botensilimab and balstilimab given before surgery (neoadjuvant) works in treating patients with rectal adenocarcinoma that has not spread to other parts of the body (localized). Currently, neoadjuvant therapy for rectal cancer includes chemotherapy and chemoradiation. Despite these aggressive treatments, only about half of patients achieve a complete clinical response. In fact, over half of rectal cancer patients go on to have surgery and often suffer post-surgery complications involving urine and bowel problems. Thus, there has been an increased focus on non-surgical treatments. Chemotherapy drugs, such as fluorouracil, oxaliplatin and leucovorin calcium, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as botensilimab and balstilimab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving neoadjuvant FOLFOX with botensilimab and balstilimab may improve the rate of complete response and decrease the need for surgery and radiation therapy in patients with localized rectal adenocarcinoma.

Start Date30 Jun 2025

Sponsor / Collaborator

City of Hope National Medical Center

[+1]

NCT06843551

/ Not yet recruitingPhase 2IIT

A Phase 2 Single Arm Trial of Stereotactic Body Radiation Therapy Followed by Dual Immune Checkpoint Inhibition for Patients With Metastatic Pancreatic Ductal Adenocarcinoma - The Miami "EMPIRE" Trial - Eradication of Metastatic Pancreatic Cancer With Immuno-Radiation

The purpose of this study is to assess if radiation therapy (which uses high-energy radiation to damage or destroy cancer cells) combined with immune checkpoint inhibitors (medications that helps the body recognize and attack cancer cells) will be beneficial for patients with metastatic pancreatic ductal adenocarcinoma.

Start Date01 Jun 2025

Sponsor / Collaborator

University of Miami

[+1]

NCT06843434

/ RecruitingPhase 2IIT

A Phase II Study of Neoadjuvant Botensilimab and Balstilimab Immunotherapy for Mismatch Repair Proficient Rectal Adenocarcinoma

The purpose of this study is to find out whether the combination of botensilimab and balstilimab (BOT/BAL) is a safe and effective treatment that causes few or mild side effects for people with mismatch repair proficient (MMRp)/microsatellite stable (MSS) locally advanced rectal adenocarcinoma. The investigators will also find out whether BOT/BAL is an effective treatment when given in combination with standard chemotherapy.

Start Date20 Feb 2025

Sponsor / Collaborator

Memorial Sloan Kettering Cancer Center

[+1]

100 Clinical Results associated with Botensilimab

100 Translational Medicine associated with Botensilimab

100 Patents (Medical) associated with Botensilimab

411

Literatures (Medical) associated with Botensilimab

01 Apr 2025·Esophagus

Exploring novel immunotherapy in advanced esophageal squamous cell carcinoma: Is targeting TIGIT an answer?

Review

Author: Guo, Jhe-Cyuan ; Chuang, Chien-Huai ; Hsu, Chih-Hung ; Kato, Ken

Abstract:

Esophageal squamous cell carcinoma (ESCC) is a prevalent and highly lethal malignancy in Asia. Recent advancements in immune checkpoint inhibitors (ICIs) have markedly transformed the systemic therapy landscape for ESCC. Anti-PD-1-based combination with chemotherapy or with ipilimumab, an anti-CTLA-4 antibody, have been established as the new standard first-line treatments for patients with advanced ESCC. Moreover, anti-PD-1 monotherapy has demonstrated improved efficacy and survival compared with second-line chemotherapy in previously treated patients with ESCC. Novel ICIs targeting other immune checkpoints also show potential for enhancing anticancer therapy in advanced ESCC.The TIGIT/PVR pathway represents a new immune checkpoint. Preclinical studies have indicated that the dual blockade of TIGIT and PD-1 can enhance antitumor immune responses. Clinical trials have reported that combining anti-TIGIT with anti-PD-1/PD-L1 antibodies elicited clinical responses in patients with advanced ESCC. In the first-line systemic therapy setting, combinations of dual ICIs targeting TIGIT and PD-1/PD-L1 plus platinum-based chemotherapy have demonstrated acceptable toxicity profiles and promising antitumor activity in several phase II trials and one phase III study. However, the role of adding an anti-TIGIT antibody to the current standard of anti-PD-1/PD-L1 plus platinum-based chemotherapy in first-line therapy for advanced ESCC remains to be fully determined, necessitating further clinical trials. Ongoing studies are also investigating the role of anti-TIGIT, with or without anti-PD-1/PD-L1, in locoregional ESCC. Additional research is essential to optimize the potential of anti-TIGIT therapy in ESCC and other malignancies by identifying predictive biomarkers, determining optimal antibody types, and gaining key mechanistic insights.

25 Feb 2025·PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA

pH-dependent dissociation from CTLA-4 in early endosomes improves both safety and antitumor activity of anti-CTLA-4 antibodies

Article

Author: Liu, Yang ; Zheng, Pan ; Zhou, Haoyue ; Liu, Mingyue ; Fields, James K. ; Du, Xuexiang ; Lenardo, Michael J. ; Zhang, Peng ; Li, Dongyang ; Li, Jinmei ; Yan, Kepeng ; Zhang, Yan ; Wang, Benyu ; Ye, Lei ; Mei, Song ; Zhang, Meiyu

Anti-CTLA-4 Abs (ACAs) are a breakthrough for cancer therapy, but their potential is limited by immunotherapy-related adverse events (irAE). We previously reported that ACAs with acidic pH-sensitive binding to CTLA-4 exhibit higher antitumor activity with fewer irAE. We now test a panel of variants of Ipilimumab (Ipi), the first ACA cancer therapeutic, for tumoricidal efficacy and irAE. Surprisingly, not all pH-sensitive Ipi variants exhibited an enhanced therapeutic index. Ipi13, which retained binding to CTLA-4 at pH 6.0 but dissociated at lower pH, showed no enhancement. By contrast, Ipi25, which dissociates from CTLA-4 at pH 6.0, the pH of the early endosome (EE), showed greater tumor regression and less severe irAE. Confocal microscopy showed that Ipi13 maintained colocalization with CTLA-4 at the late endosomes (LE) and lysosomes resulting in lysosomal degradation of CTLA-4. Conversely, Ipi25 did not colocalize with CTLA-4 in LE or lysosomes after endocytosis but allowed both proteins to transfer to recycling endosomes. EE dissociation was also characteristic of variants of Tremelimumab (Treme), another clinical ACA, that showed better efficacy and fewer side effects. Thus, our data reveal the significance of early intracellular dissociation from CTLA-4 to improve ACAs for safer and more effective cancer immunotherapy.

01 Feb 2025·IMMUNOLOGY AND CELL BIOLOGY

Exploring the dynamics of T‐cell responses: a combined approach using EdU incorporation and proliferation dye dilution assay

Article

Author: Freen‐van Heeren, Julian J ; Raaphorst, Hilde ; Turksma, Annelies W ; Saou, Latifa ; ten Brinke, Anja ; Lougheed, Sinéad ; Rensink, Irma ; van Kleef, Nadine D

Abstract:

Understanding antigen‐specific T‐cell responses is crucial for advancing immunotherapies and vaccine development. This study proposes a novel approach combining two complementary assays: the 5‐ethynyl‐2′‐deoxyuridine (EdU) incorporation assay (tracking proliferation over 0–48 h) and the VPD450 dye dilution assay (tracking proliferation over 4–6 days). Integrating these techniques provides additional insights into T‐cell proliferation kinetics. Both assays were independently optimized using anti‐CD3 and anti‐CD28 polyclonal T cell stimulation. 1 μM VPD450 is suitable for assessing T‐cell proliferation. The EdU concentration should match the stimulation strength, requiring higher concentrations to efficiently track DNA replication detection during increased cellular division. Day 5 was the optimal read‐out day for the EdU incorporation assay. We then combined the VPD450 dye dilution and EdU incorporation assays. As a proof of principle, we stimulated PBMCs from healthy donors with tetanus toxoid to assess antigen‐specific T‐cell responses. Additionally, we demonstrated the assay's application in drug research by evaluating proliferation in a mixed lymphocyte reaction with abatacept, an agonistic anti‐CTLA‐4 antibody. This combined approach offers qualitative insights into T‐cell proliferation kinetics, beneficial for assessing novel vaccine efficiency or for designing new treatments targeting T cell proliferation, such as in autoimmune settings.

144

News (Medical) associated with Botensilimab

18 Mar 2025

·www.globenewswire.com

MiNK Therapeutics Reports Fourth Quarter & Full Year 2024 Results and Highlights Business Progress

NEW YORK, March 18, 2025 (GLOBE NEWSWIRE) -- MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company pioneering the development of allogeneic, off-the-shelf invariant natural killer T (iNKT) cell therapies, today announced its financial results for the fourth quarter and full year 2024, highlighting significant business progress and clinical advancements. The company will host a conference call and webcast at 8:30 a.m. ET. “Throughout 2024, MiNK advanced its mission to bring off-the-shelf iNKT cell therapies to patients fighting hard-to-treat cancers and severe immune-related disorders,” said Dr. Jennifer Buell, President and Chief Executive Officer of MiNK Therapeutics. “We made significant clinical strides, strengthened our manufacturing foundation, and forged strategic alliances. Through disciplined capital management, we are positioned to scale efficiently and seize new collaboration opportunities for value creation. With our rapid AI-driven drug discovery platform generating a world-class library of phosphorylated neoantigens and proprietary TCRs, MiNK is uniquely poised to progress a new standard in oncology and beyond.” Operational Highlights Clinical Advancements Expanding Benefit in Cancer Where Standards Fail: Presentations at leading oncology conferences—including AACR IO, ASCO GI, and SITC—demonstrated that AgenT-797 enhanced immune activation, improved checkpoint inhibitor efficacy, and augmented bispecific engagers in heavily pretreated patients and preclinical models. A Phase 2 Investigator-Sponsored Trial (Memorial Sloan Kettering Cancer Center) in second-line advanced gastric cancer (NCT06251973) is actively enrolling. Early data suggest promising activity when combining AgenT-797 with botensilimab/balstilimab (BOT/BAL) and chemotherapy.Immunologic Activity in Inflammatory Lung Conditions (ARDS): Published results in Nature Communications and presented at the American Thoracic Society (ATS) showed AgenT-797’s potential in acute respiratory distress, with an approximately 80% survival rate among VV ECMO patients versus 10% in hospital controls. Late-stage trials are designed and planned for upcoming discussion with the regulatory agencies. Next-Generation iNKT Programs PRAME-TCR iNKTs: Demonstrated high specificity and potent tumor-killing against intracellular cancer targets resistant to conventional therapies. MiNK’s expertise in accessing a proprietary library of phosphorylated peptides and personalized neoantigens supports the generation of high-quality TCRs.MiNK-215 (IL-15 Armored CAR-iNKT): Robust anti-tumor activity in models of metastatic colorectal cancer, reshaping the immunosuppressive tumor microenvironment. These data, including exciting findings from AACR IO on the importance of neoantigen targeting, underscore MiNK’s commitment to evolving next-generation iNKT treatments that could potentially tackle the most challenging cancer types. Strategic Growth and Manufacturing Optimization MiNK’s state-of-the-art manufacturing process enables the production of billions of donor-derived iNKT cells per run, scalable to support rapid global distribution, aimed at reducing logistical hurdles, cost, and enhancing patient access.In October 2024, MiNK entered into a research collaboration with Autonomous Therapeutics to develop precision RNA-iNKT therapies for metastatic tumors. This collaboration is actively underway.In 2024, MiNK raised $5.8M in private financing and is prioritizing externally funded clinical trials to effectively sustain and advance its iNKT cell programs. “We believe MiNK Therapeutics is on solid footing to pioneer the next generation of cell therapies,” added Dr. Buell. “We will continue to pair scientific discipline with operational rigor, a strategy designed to enable value-inflection in 2025 and beyond.” Financial Highlights We ended the year with a cash balance of $4.6 million. Cash used in operations for the three and twelve months ended December 31, 2024, was $1.7 million, and $9.6 million, respectively, compared to $3.0 million and $15.8 million for the same periods in 2023. Net loss for the year ended December 31, 2024 was $10.8 million, or $2.86 per share, compared to net loss for the same period in 2023 of $22.5 million or $6.54 per share. Summary Consolidated Financial Information Condensed Consolidated Balance Sheet Data(in thousands)(unaudited) December 31, 2024 2023 Cash and cash equivalents$4,577 $3,367 Total assets 5,721 4,552 Other Financial Information(in thousands)(unaudited) Three months ended December 31, Year ended December 31, 2024 2023 2024 2023 Cash used in operations$1,728 $3,036 $9,555 $15,763 Non-cash expenses 757 1,155 770 3,798 Condensed Consolidated Statements of Operations Data(in thousands, except per share data)(unaudited) Three months ended December 31, Year ended December 31, 2024 2023 2024 2023 Operating expenses: Research and development$1,406 $3,311 $6,336 $15,490 General and administrative 809 2,189 4,314 7,431 Change in fair value of related party note 288 - 638 - Operating loss 2,503 5,500 11,288 22,921 Other income, net (39) (41) (503) (463) Net loss$2,464 $5,459 $10,785 $22,458 Per common share data, basic and diluted: Net loss$0.62 $1.58 $2.86 $6.54 Weighted average number of common shares outstanding, basic and diluted 3,957 3,456 3,773 3,436 Conference Call Dial-in numbers: 646-307-1963 (New York), 800-715-9871 (USA & Canada) Conference ID: 8023784 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/s9hd6k7m/. 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. About AgenT-797 AgenT-797 is an allogeneic invariant natural killer T (iNKT) cell therapy that harnesses the dual power of innate and adaptive immunity. iNKTs function as “master regulators,” combining the cytotoxic capabilities of NK cells with T-cell–like antigen recognition and memory. This unique biology enables a robust, pathogen-agnostic immune response that can be directed against hard-to-treat tumors. Manufactured by MiNK Therapeutics in Lexington, MA, agenT-797 is a scalable, off-the-shelf product designed to provide accessible, transformative treatment options. In clinical trials, agenT-797 can bolster peripheral memory T-cell activation, enhance tumor infiltration, and potentially improve outcomes for patients with solid cancers (Cytryn et al. AACR IO 2024, Oncogene. 2024) and to combat inflammation in critically ill patients with severe respiratory pathology (Nature Communications. 2024). 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, as well as the collaboration between MiNK and Agenus. 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 Agenus with 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

Cell TherapyPhase 2Financial StatementAACRImmunotherapy

17 Mar 2025

·www.fiercebiotech.com

Agenus CMO touts immunotherapy advances on The Top Line

None\n Agenus Chief Medical Officer Dr. Steven O\'Day joined Fierce\'s Chris Hayden on a recent sponsored episode of The Top Line podcast to discuss the evolving landscape of cancer immunotherapy.O\'Day, a medical oncologist with 30 years of experience, explained the fundamental differences between immunotherapy and traditional cancer treatments like chemotherapy, surgery, and radiation. He emphasized immunotherapy\'s potential for durable responses and even cures by activating the body\'s own T-cells to fight cancer.The conversation addressed the challenges of treating \"cold\" tumors, such as colorectal cancer, which are less visible to the immune system. O\'Day highlighted Agenus\'s pipeline of antibodies, botensilimab (BOT) and balstilimab (BAL), designed to trigger T-cell recognition of these colder cancers.O\'Day expressed his excitement about a potential \"2.0 revolution\" of immuno-oncology, expanding the benefits of immunotherapy to a wider range of cancers. He described BOT and BAL as a \"one-two punch,\" with BOT priming T-cells and BAL preventing their exhaustion.Listen to the full conversation on the latest episode of The Top Line.

Immunotherapy

12 Feb 2025

·www.businesswire.com

Agenus’ BOT/BAL Selected for Two Presentations at Upcoming AACR IO Annual Meeting

LEXINGTON, Mass.--( BUSINESS WIRE )--Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology, today announced that BOT/BAL will be featured in two presentations at the upcoming American Association for Cancer Research (AACR) IO Annual Meeting that will take place on February 23-26 in Los Angeles, California. An oral presentation will highlight interim data from the ongoing Phase 2 study of botensilimab and balstilimab (BOT/BAL) in combination with MiNK Therapeutics’ iNKT cell therapy, AgenT-797, in patients with refractory (2L+) gastric cancer ( NCT06251973 ). A Trial-in-Progress (TiP) poster will feature data from the ongoing Phase 1/2 study of BOT/BAL in first-line MSS colorectal cancer ( NCT05627635 ). Presentation Details: Abstract Title: First-line botensilimab and balstilimab optimization in microsatellite stable colorectal cancer (MSS-CRC) without liver metastasis (BBOpCo) Session : Poster Session A Session Date and Time: Monday, February 24 th , 1:45-4:45 p.m. PST Abstract Title: Biomarker analysis from phase 2 study of AgenT-797 (invariant natural killer T-cells), botensilimab (a Fc-enhanced CTLA-4 Inhibitor) with balstilimab (anti-PD-1) in PD-1 refractory gastroesophageal cancer (GEC) Session : Proffered Papers, Session 2 Session Date and Time: Tuesday, February 25 th , 1:00-1:45 p.m. PST 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. 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. About Balstilimab (BAL) Balstilimab is a novel, fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 (programmed cell death protein 1) from interacting with its ligands PD-L1 and PD-L2. 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. About AgenT-797 AgenT-797 is an allogeneic invariant natural killer T (iNKT) cell therapy, leveraging a unique innate immune cell type that serves as a master regulator of both innate and adaptive immunity. iNKTs combine the cytotoxic capabilities of natural killer (NK) cells with the adaptive memory of T cells, enabling them to elicit a broad range of immune responses in a pathogen-agnostic manner. AgenT-797 is a scalable, “off-the-shelf” cell therapy product, manufactured by MiNK Therapeutics in Lexington, MA, to deliver transformative treatment solutions to patients. 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 2ImmunotherapyAACRCell TherapyPhase 1

100 Deals associated with Botensilimab

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced cancer	Phase 3	France	Agenus, Inc.	15 Oct 2024
stomach adenocarcinoma	Phase 3	France	Agenus, Inc.	15 Oct 2024
Mismatch repair-deficient Solid Tumors	Phase 3	Netherlands	Agenus, Inc.	29 Jan 2024
Solid tumor	Phase 3	Netherlands	Agenus, Inc.	29 Jan 2024
Microsatellite Stable Rectal Carcinoma	Phase 2	United States	Agenus, Inc.	20 Feb 2025
Adenocarcinoma of large intestine	Phase 2	United States	National Cancer Institute	01 Nov 2024
Advanced Colorectal Adenocarcinoma	Phase 2	United States	National Cancer Institute	01 Nov 2024
Locally Advanced Rectal Carcinoma	Phase 2	United States	National Cancer Institute	01 Nov 2024
Metastatic colon cancer	Phase 2	United States	National Cancer Institute	01 Nov 2024
Metastatic Microsatellite Stable Colorectal Carcinoma	Phase 2	United States	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 (Pubmed \| J Clin Oncol) Manual	Phase 1	Sarcoma	64	Botensilimab + Balstilimab	gyxqcyaxal(gokvfkqoxb) = The most common treatment-related adverse event (TRAE) was diarrhea/colitis occurring in 35.9% of patients, with grade 3 in 6.3% of patients. cdrqtjjrgk (bblqlzpmlw )	Positive	27 Jan 2025
				Botensilimab + Balstilimab (angiosarcoma)
NCT05571293 (NEST, ASCO_GI2025)	Phase 2	Microsatellite instability-high colorectal cancer Neoadjuvant pMMR \| dMMR \| MSI-H ... View more	-	Neoadjuvant BOT 75 mg/m2	tmiottiqtv(bwgcgoflua) = grade 2 diarrhea/colitis occurred in 8% qhfybdcfjl (irhzfcwpbb ) View more	Positive	23 Jan 2025
				Neoadjuvant BAL 240 mg/m2
NCT05627635 (ASCO_GI2025)	Phase 1	Microsatellite Stable Colorectal Carcinoma MSS	14	Folinic acid, fluorouracil, oxaliplatin, bevacizumab, botensilimab, balstilimab (FOLFOX-3B)	zqleuohbys(tvreyttrvl) = one pt at DL1 with transient G3 AST/ALT elevation and transient G2 colitis (resolved with steroids and infliximab), one pt at DL1 with G2 hypothyroidism and one patient at DL2 with G2 hyperthyroidism yscriyekei (crxidqpqqx ) View more	Positive	23 Jan 2025
UNICORN (ASCO_GI2025)	Phase 2	Mismatch repair-deficient Colonic Cancer Neoadjuvant pMMR \| dMMR	56	Botensilimab 1 mg/kg	hkmkwktxil(bxdrkepssd) = fkoaabhreq srlgvrpetv (ugibetzdbf ) View more	Positive	23 Jan 2025
				Botensilimab 1 mg/kg + Balstilimab 3 mg/kg	gidzhkyeze(jlyggnaane) = xsoquqebvf hxpopefayn (ewrbltzokg ) View more
NCT05608044 (ASCO_GI2025)	Phase 2	Metastatic Microsatellite Stable Colorectal Carcinoma MSS \| pMMR \| KRAS mutant ... View more	234	Botensilimab 75 mg Q6W	bohgelrtwn(epqvsgsupc) = wgaixbpjwg gpzyvytqsu (eywwbifwzq ) View more	Positive	23 Jan 2025
				Botensilimab 150 mg Q6W	bohgelrtwn(epqvsgsupc) = hatqlsmdjz gpzyvytqsu (eywwbifwzq ) View more
NCT05864534 (Pubmed \| Neuro Oncol)	Phase 2	Glioma	-	FcE-aCTLA-4	ispphlqqrx(cxapbfolcu) = gaumwmuyou nhrsfxzixt (bungdpwjhr )	-	04 Nov 2024
NCT03860272 (ESMO2024) Manual	Phase 1	Sarcoma	63	Botensilimab balstilimab	wqwzcmjeix(mvevmwdvwg) = 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. hyksegwfde (bbdqmrbwco ) 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)	kgtyanecbd(lmnowuaewp) = mphbrchren ydojzmvhvm (jdlabocxhj ) View more	Positive	28 Jul 2024
				botensilimab with balstbalstilimab + botensilimabal dose of balstilimab (MSI-H + NEST-1 cohort)	kgtyanecbd(lmnowuaewp) = qhqvuwxskx ydojzmvhvm (jdlabocxhj ) View more
NCT05608044 (BusinessWire) Manual	Phase 2	Metastatic Microsatellite Stable Colorectal Carcinoma	-	Botensilimab 75mg + Balstilimab 240mg	fvklaomktr(dywjjwjuok) = giwzwaktwu ijbmbehfpy (mtasuvemlq, 10.4 - 31.4) View more	Positive	18 Jul 2024
				Botensilimab 150mg + Balstilimab 240mg	fvklaomktr(dywjjwjuok) = zlutgehbcp ijbmbehfpy (mtasuvemlq, 2.7 - 18.1)
Biospace Manual	Phase 1	Metastatic Microsatellite Stable Colorectal Carcinoma Microsatellite Stable (MSS)	77	botensilimab + balstilimab	aqxmlpavpt(uvkqmoofzl) = edathrlyhd pvbpzszejk (ggpfxxcfyd ) View more	Positive	13 Jun 2024

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