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]

NCT06782932

/ Not yet recruitingPhase 1/2IIT

A Pilot Study Comparing Neoadjuvant and Adjuvant GVAX vs a Mutated KRAS Peptide Vaccine Given With Anti-PD-1 and Anti-CD137 for the Treatment of Surgically Resectable Pancreatic Adenocarcinoma

The purpose of this study is to determine the optimal dose of AGEN2373 that is safe when given in combination with balstilimab and Pancreatic GVAX Whole Cell Vaccine and evaluate the safety and clinical activity of balstilimab and AGEN2373 in combination with GVAX (Arm 1) or mKRASvax (Arm 2) in surgically resectable pancreatic adenocarcinoma.

Start Date01 Apr 2025

Sponsor / Collaborator

The Sidney Kimmel Comprehensive Cancer Center

[+3]

100 Clinical Results associated with Balstilimab

100 Translational Medicine associated with Balstilimab

100 Patents (Medical) associated with Balstilimab

Literatures (Medical) associated with Balstilimab

17 Feb 2025·CLINICAL CANCER RESEARCH

The Prostaglandin EP4 Antagonist Vorbipiprant Combined with PD-1 Blockade for Refractory Microsatellite-Stable Metastatic Colorectal Cancer: A Phase Ib/IIa Trial

Article

Author: Cristarella, Eleonora ; Niger, Monica ; Vitalini, Cristina ; Rovati, Lucio C. ; Chiodoni, Claudia ; Morano, Federica ; Zaffaroni, Nadia ; Brambilla, Nadia ; Girolami, Federica ; Doldi, Valentina ; Ghelardi, Filippo ; Giacovelli, Giampaolo ; Benincasa, Elena ; Pietrantonio, Filippo ; Palazzo, Michele ; Nichetti, Federico ; Sabella, Giovanna ; Manca, Paolo

Abstract:

Purpose::

Novel combinations are required to overcome resistance to immune checkpoint inhibitors in proficient mismatch repair (pMMR) or microsatellite-stable (MSS) metastatic colorectal cancer (mCRC). We aimed to determine whether vorbipiprant, a prostaglandin E2 receptor EP4 subtype antagonist, can convert immune-resistant mCRC into a tumor responsive to anti–PD-1 inhibition.

Patients and Methods::

This phase Ib/IIa prospective, open-label, single-arm trial followed a 3 + 3 dose-escalation and dose-optimization design. A total of 28 patients with chemorefractory pMMR/MSS mCRC were given dose-escalated oral vorbipiprant (30, 90, or 180 mg twice daily), along with biweekly intravenous balstilimab (3 mg/kg), an anti–PD-1 antibody. The primary endpoints included safety and the disease control rate (DCR). Secondary endpoints were the overall response rate, duration of response, progression-free survival, and overall survival.

Results::

No dose-limiting toxicities were observed. Of the 28 patients, seven (25%) experienced serious adverse events, but only one was attributed to vorbipiprant and one to balstilimab. The trial achieved a DCR of 50% observed across the entire cohort. In the subgroup of patients with liver metastases (n = 12), the DCR was 25%. The overall response rate was 11%, with three patients showing a partial response (median duration of response, 7.4 months). The median progression-free survival was 2.6 months, and the median overall survival was 14.2 months. Translational exploratory analyses suggested that vorbipiprant may boost response to anti–PD-1 in patients with immunogenic tumors.

Conclusions::

The combination of vorbipiprant and a PD-1 inhibitor (balstilimab) yielded sufficient activity in refractory pMMR/MSS mCRC, which is worthy of confirmation in future clinical trials in biomarker-enriched populations.

04 Nov 2024·NEURO-ONCOLOGY

Fc-enhanced anti-CTLA-4, anti-PD-1, doxorubicin, and ultrasound-mediated blood–brain barrier opening: A novel combinatorial immunotherapy regimen for gliomas

Article

Author: Kim, Kwang-Soo ; Najem, Hinda ; Horbinski, Craig ; Chand, Dhan ; Habashy, Karl ; Billingham, Leah ; Zhao, Junfei ; Lee-Chang, Catalina ; Huber, Olivia ; Butowski, Nicholas ; Muzzio, Miguel ; Saganty, Ruth ; Padney, Surya ; Miska, Jason ; Zhang, Bin ; Chen, Li ; Levey, Daniel ; Morin, Benjamin M ; Savitsky, David A ; Arrieta, Víctor A ; Dmello, Crismita ; Zhang, Daniel Y ; Heimberger, Amy B ; Hu, Jian ; Rabadan, Raul ; Castro, Brandyn ; Zhang, Peng ; Canney, Michael ; Phillips, Joanna J ; Gould, Andrew ; Stupp, Roger ; Amidei, Christina ; Marques, Marilyn ; Sonabend, Adam M

Abstract:

Background:

Glioblastoma is a highly aggressive brain cancer that is resistant to conventional immunotherapy strategies. Botensilimab, an Fc-enhanced anti-CTLA-4 antibody (FcE-aCTLA-4), has shown durable activity in “cold” and immunotherapy-refractory cancers.

Methods:

We evaluated the efficacy and immune microenvironment phenotype of a mouse analogue of FcE-aCTLA-4 in treatment-refractory preclinical models of glioblastoma, both as a monotherapy and in combination with doxorubicin delivered via low-intensity pulsed ultrasound and microbubbles (LIPU/MB). Additionally, we studied 4 glioblastoma patients treated with doxorubicin, anti-PD-1 with concomitant LIPU/MB to investigate the novel effect of doxorubicin modulating FcγR expressions in tumor-associated macrophages/microglia (TAMs).

Results:

FcE-aCTLA-4 demonstrated high-affinity binding to FcγRIV, the mouse ortholog of human FcγRIIIA, which was highly expressed in TAMs in human glioblastoma, most robustly at diagnosis. Notably, FcE-aCTLA-4-mediated selective depletion of intratumoral regulatory T cells (Tregs) via TAM-mediated phagocytosis, while sparing peripheral Tregs. Doxorubicin, a chemotherapeutic drug with immunomodulatory functions, was found to upregulate FcγRIIIA on TAMs in glioblastoma patients who received doxorubicin and anti-PD-1 with concomitant LIPU/MB. In murine models of immunotherapy-resistant gliomas, a combinatorial regimen of FcE-aCTLA-4, anti-PD-1, and doxorubicin with LIPU/MB, achieved a 90% cure rate, that was associated robust infiltration of activated CD8+ T cells and establishment of immunological memory as evidenced by rejection upon tumor rechallenge.

Conclusions:

Our findings demonstrate that FcE-aCTLA-4 promotes robust immunomodulatory and anti-tumor effects in murine gliomas and is significantly enhanced when combined with anti-PD-1, doxorubicin, and LIPU/MB. We are currently investigating this combinatory strategy in a clinical trial (clinicaltrials.gov NCT05864534).

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.

125

News (Medical) associated with Balstilimab

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

06 Mar 2025

·www.prnewswire.com

ImmunoGenesis Doses First Patient in Phase 1/2 Clinical Trial of IMGS-101 in Combination With Balstilimab (anti-PD-1) and Zalifrelimab (anti-CTLA-4) in Relapsed or Refractory Advanced Prostate, Pancreatic, and HPV(-) Head & Neck Tumors

IMGS-101 is the only known reducer of solid tumor hypoxia, offering the potential to enhance the efficacy of immunotherapy HOUSTON, March 6, 2025 /PRNewswire/ -- ImmunoGenesis, a clinical-stage biotech company developing innovative, science-driven immunotherapies, today announced the first patient has been dosed in the company's Phase 1/2 clinical trial of its hypoxia reversal agent IMGS-101 (evofosfamide) in combination with Balstilimab (anti-PD-1) and Zalifrelimab (anti-CTLA-4) at The University of Texas MD Anderson Cancer Center in Houston, Texas. Tumor hypoxia (low oxygen levels) is an immunosuppressive factor in solid tumors. By reversing hypoxia, IMGS-101 may improve the efficacy of immunotherapies in cancer types that are otherwise resistant to immune-based treatments. Continue Reading ImmunoGenesis The Phase 1/2, open-label, multicenter study (NCT06782555) consists of a dose escalation and expansion portion to evaluate the safety, pharmacokinetics, and anti-tumor activity of IMGS-101 in combination with Balstilimab and Zalifrelimab in adult patients with locally advanced or metastatic castration-resistant prostate cancer (CRPC), pancreatic cancer, and human papillomavirus-(HPV) negative squamous cell carcinoma of the head and neck (SCCHN). The study is being conducted in collaboration with Agenus, a clinical-stage immuno-oncology company developing the checkpoint inhibitors Balstilimab and Zalifrelimab. "Launching this trial represents a significant milestone in our mission to target key mechanisms of immune resistance," said ImmunoGenesis President and CEO James Barlow. "By targeting and reversing hypoxia, we aim to unlock the immune system's full potential and redefine the therapeutic landscape for these cancers with high unmet medical needs." "This trial marks an exciting step forward in addressing one of the key challenges in cancer immunotherapy," said Dr. Charles Schweizer, Senior Vice President of Clinical Development at ImmunoGenesis. "Hypoxia limits T-cell infiltration and suppresses immune responses, especially in prostate, pancreatic, and head and neck cancers. By reversing hypoxia, IMGS-101 may restore T-cell access to tumors, enhancing the effectiveness of checkpoint inhibitors and potentially transforming outcomes in these hard-to-treat cancers." About ImmunoGenesis ImmunoGenesis is a clinical-stage biotech company dedicated to transforming immuno-oncology by targeting key mechanisms of immune resistance. The company's lead product, IMGS-001, is a cytotoxic, dual-specific PD-L1/PD-L2 antibody currently in a phase 1a/b clinical trial for the treatment of immune-excluded ("cold") tumors, which account for more than half of all cancers. In addition to its lead program, the company is developing a number of novel approaches to overcome immune resistance in cold tumors. ImmunoGenesis designs therapies to address the pathology of these tumors, overcoming immune exclusion to elicit a robust immune response. For more information, visit . About IMGS-101 IMGS-101, also known as Evofosfamide, is a 2-nitroimidazole prodrug of the cytotoxin bromo-isophosphoramide mustard (Br-IPM) originally developed as a hypoxia-activated prodrug. ImmunoGenesis' Founder, Dr. Michael A. Curran from MD Anderson, demonstrated in his lab that IMGS-101 has the unique ability to address one of the most significant immunosuppressive barriers by reversing hypoxia. In pre-clinical models and a Phase 1 clinical study, IMGS-101 restored T-cell function and showed early signs of synergizing with checkpoint inhibitors. ImmunoGenesis is developing IMGS-101 as a hypoxia-reversal agent that can condition tumors to respond to checkpoint inhibition. About Balstilimab 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. It has been evaluated in >900 patients to date and has demonstrated clinical activity and a favorable tolerability profile in several tumor types. Balstilimab is being developed by Agenus, Inc. About Zalifrelimab Zalifrelimab is a novel, fully human monoclonal immunoglobulin G1 (IgG1) designed to block CTLA-4 (cytotoxic T-lymphocyte associated antigen 4) from interacting with its ligands CD80 and CD86. CTLA-4 is a negative regulator of immune activation that is considered a foundational target within the immuno-oncology market. Zalifrelimab is being developed by Agenus, Inc. Disclosure Dr. Curran's financial relationship with ImmunoGenesis is managed and monitored by the MD Anderson Conflict of Interest Committee. Contact ImmunoGenesis Investors: James Barlow President and CEO [email protected] SOURCE Immunogenesis Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ImmunotherapyPhase 1Clinical Result

100 Deals associated with Balstilimab

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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	United States	Recepta Biopharma SA	30 Jan 2022
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
Advanced cancer	Phase 3	United States	Agenus, Inc.	02 Aug 2021
Advanced cancer	Phase 3	Armenia	Agenus, Inc.	02 Aug 2021
Metastatic Cervical Carcinoma	Phase 3	United States	Agenus, Inc.	02 Aug 2021
Metastatic Cervical Carcinoma	Phase 3	Armenia	Agenus, Inc.	02 Aug 2021
Recurrent Cervical Cancer	Phase 3	United States	Agenus, Inc.	02 Aug 2021
Recurrent Cervical Cancer	Phase 3	Armenia	Agenus, Inc.	02 Aug 2021

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03860272 (Pubmed \| J Clin Oncol) Manual	Phase 1	Sarcoma	64	Botensilimab + Balstilimab	qkafyihyyj(kaywtdswpy) = 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. hwxwikkcse (ixahgdmepq )	Positive	27 Jan 2025
				Botensilimab + Balstilimab (angiosarcoma)
NCT05627635 (ASCO_GI2025)	Phase 1	Microsatellite Stable Colorectal Carcinoma MSS	14	Folinic acid, fluorouracil, oxaliplatin, bevacizumab, botensilimab, balstilimab (FOLFOX-3B)	fubzmncesd(gjnikczrqu) = 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 jrseidaizh (zmtmkfezvu ) View more	Positive	23 Jan 2025
UNICORN (ASCO_GI2025)	Phase 2	Mismatch repair-deficient Colonic Cancer Neoadjuvant pMMR \| dMMR	56	Botensilimab 1 mg/kg	glubbjwzvf(yqrjehbkmj) = xyhyqlaoqt epdubjxznt (eeazwiihws ) View more	Positive	23 Jan 2025
				Botensilimab 1 mg/kg + Balstilimab 3 mg/kg	hjextigqxp(msehqxpqhu) = xkixwtjryr rcroihnamf (arqubzbgns ) View more
NCT05608044 (ASCO_GI2025)	Phase 2	Metastatic Microsatellite Stable Colorectal Carcinoma MSS \| pMMR \| KRAS mutant ... View more	234	Botensilimab 75 mg Q6W	rrnuqrnnsm(prozfmbpkn) = hhqumnflfi upehliinph (vjhkhtvbhl ) View more	Positive	23 Jan 2025
				Botensilimab 150 mg Q6W	rrnuqrnnsm(prozfmbpkn) = hapndcssyv upehliinph (vjhkhtvbhl ) View more
NCT05864534 (Pubmed \| Neuro Oncol)	Phase 2	Glioma	-	FcE-aCTLA-4	tgsubhqayg(tiqpnlslbj) = gzgvployyh ddgotyggxn (ftazkswdus )	-	04 Nov 2024
NCT03860272 (ESMO2024) Manual	Phase 1	Sarcoma	63	Botensilimab balstilimab	cvxuubrasd(kjpgkcswyy) = 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. dippzzwpal (ctzqonbnbh ) 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)	fjrecabpfz(hihqyltsgj) = tugapxbtjr dhucwaqjkc (qqggaqqqxm ) View more	Positive	28 Jul 2024
				botensilimab with balstbalstilimab + botensilimabal dose of balstilimab (MSI-H + NEST-1 cohort)	fjrecabpfz(hihqyltsgj) = kvqhyvaewk dhucwaqjkc (qqggaqqqxm ) View more
NCT05608044 (BusinessWire) Manual	Phase 2	Metastatic Microsatellite Stable Colorectal Carcinoma	-	Botensilimab 75mg + Balstilimab 240mg	cxrpwmdhqq(tejklkpnno) = psueclsacq keqevmokdg (qukvnyrcme, 10.4 - 31.4) View more	Positive	18 Jul 2024
				Botensilimab 150mg + Balstilimab 240mg	cxrpwmdhqq(tejklkpnno) = olkjrpaeet keqevmokdg (qukvnyrcme, 2.7 - 18.1)
NCT05205330 (ASCO2024) Manual	Phase 1/2	Metastatic Microsatellite Stable Colorectal Carcinoma pMMR/MSS	-	Vorbipiprant 30balstilimab	stlokvrsge(rdllpkemjh) = vqmxcpmeyn bszbfznoxa (ancnlfxvsf ) View more	Positive	24 May 2024
				Vorbipiprant 90balstilimab	stlokvrsge(rdllpkemjh) = xbplcimblf bszbfznoxa (ancnlfxvsf ) View more
NCT04430036 (CTgov)	Phase 2	Muscle Invasive Bladder Carcinoma	4	AGEN2034+gemcitabine+Cisplatin+AGEN1884	cvrkrfjoxt = emxsgxnmnv ervhpuagtm (lgbnozfcyz, zknmzuohvq - fyfiweinuk) View more	-	04 Apr 2024

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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Regulation

Understand key drug designations in just a few clicks with Synapse.

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Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis