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 2 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 Date01 Aug 2024

Sponsor / Collaborator

The Sidney Kimmel Comprehensive Cancer Center

[+1]

NCT06268015 / Not yet recruitingPhase 2IIT

Botensilimab and Balstilimab Optimization in Colorectal Cancer (BBOpCo)

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 Date01 Jul 2024

Sponsor / Collaborator

Duke University

[+2]

NCT06346197 / Not yet recruitingPhase 3IIT

A Multicenter, Randomised, Comparative, Open-label Phase III Aiming to Compare the Survival of Patients With Locally Advanced or Metastatic MSI/dMMR Esogastric Adenocarcinomas Treated by a Combination of Immune Checkpoint Inhibitors (Botensilimab + Balstilimab) Versus the Standard of Care (FOLFOX/XELOX + Nivolumab)

CIME is a multicenter, randomised, comparative, open-label phase III study aiming to compare the survival of patients suffering from MSI-H/dMMR locally advanced or metastatic oeasogastric adenocarcinoma treated by a bi-immunotherapy (experimental arm) versus standard current treatment (FOLFOX/XELOX + nivolumab : standard arm).

Start Date15 May 2024

Sponsor / Collaborator

Centre Léon Bérard Lyon et Rhône-Alpes

[+1]

100 Clinical Results associated with Botensilimab

100 Translational Medicine associated with Botensilimab

100 Patents (Medical) associated with Botensilimab

476

Literatures (Medical) associated with Botensilimab

05 Jan 2024·Science (New York, N.Y.)Q1 · CROSS-FIELD

Microbiota-dependent activation of CD4 ⁺ T cells induces CTLA-4 blockade–associated colitis via Fcγ receptors

Q1 · CROSS-FIELD

Article

Author: Yu, Jiali ; Shaw, Michael H ; Lei, Yu Leo ; Sato, Yosuke ; Vatan, Linda ; Kryczek, Ilona ; Caruso, Roberta ; Xie, Yuying ; Zou, Weiping ; Matsumoto, Masanori ; Lo, Bernard C ; Núñez, Gabriel ; Inohara, Naohiro

Immune checkpoint inhibitors can stimulate antitumor immunity but can also induce toxicities termed immune-related adverse events (irAEs). Colitis is a common and severe irAE that can lead to treatment discontinuation. Mechanistic understanding of gut irAEs has been hampered because robust colitis is not observed in laboratory mice treated with checkpoint inhibitors. We report here that this limitation can be overcome by using mice harboring the microbiota of wild-caught mice, which develop overt colitis following treatment with anti-CTLA-4 antibodies. Intestinal inflammation is driven by unrestrained activation of IFNγ-producing CD4 + T cells and depletion of peripherally induced regulatory T cells through Fcγ receptor signaling. Accordingly, anti-CTLA-4 nanobodies that lack an Fc domain can promote antitumor responses without triggering colitis. This work suggests a strategy for mitigating gut irAEs while preserving antitumor stimulating effects of CTLA-4 blockade.

01 Jan 2024·Thoracic cancer

IgG4‐related retroperitoneal fibrosis induced by nivolumab and ipilimumab in a patient with non‐small cell lung cancer: A case report

Author: Katsurada, Yuka ; Tanigaki, Tomomi ; Ito, Koki ; Serizawa, Yusuke ; Kato, Yoshiki ; Igarashi, Shunya ; Kawana, Akihiko ; Matsukida, Akira ; Ogawa, Takunori ; Nishimura, Masashi ; Kimizuka, Yoshifumi ; Fujikura, Yuji ; Tsuchiya, Motohiro ; Ogata, Sho

Abstract:

IgG4‐related diseases are adverse events that occur after receiving treatment with immune checkpoint inhibitors (ICI). This study reports the first case of IgG4‐related retroperitoneal fibrosis after the administration of chemotherapy with nivolumab and ipilimumab (NI therapy). An 80‐year‐old man developed lower abdominal pain eight months after NI therapy was initiated. Although the primary lesion maintained its reduced size on computed tomography, there was an increase in the soft tissue shadows intensity around the abdominal aorta, bladder, and seminal vesicles, suggesting retroperitoneal fibrosis. Blood tests showed elevated IgG4 levels. Computed tomography‐guided biopsy of the retroperitoneum showed B cell‐dominant lymphocyte infiltration consistent with IgG4‐related retroperitoneal fibrosis and characteristic CD8‐positive lymphocyte infiltration, suggestive of the involvement of cytotoxic T cells. Based on the clinical, imaging, and pathological findings, the patient was diagnosed with IgG4‐related retroperitoneal fibrosis due to ICI. Immunotherapy discontinuation alone did not result in improvement; therefore, steroid therapy was initiated. In clinical practice, IgG4‐related retroperitoneal fibrosis can occur as an immune‐related adverse event when administering anti‐PD‐1 and anti‐CTLA‐4 antibodies for cancer immunotherapy. Early steroid therapy could be effective in controlling this immune‐related adverse event.

01 Jan 2024·Journal of molecular medicine (Berlin, Germany)

Identifying survival of pan-cancer patients under immunotherapy using genomic mutation signature with large sample cohorts

Article

Author: He, Jia ; Li, Kang ; Li, Shuang ; Cao, Lei ; Wang, Yuanyuan ; Wang, Meng ; Zhang, Liuchao ; Wang, Liuying ; Ji, Jianxin

Although immune checkpoint inhibitors have led to durable clinical response in multiple cancers, only a small proportion of patients respond to this treatment. Therefore, we aim to develop a predictive model that utilizes gene mutation profiles to accurately identify the survival of pan-cancer patients with immunotherapy. Here, we develop and evaluate three different nomograms using two cohorts containing 1,594 cancer patients whose mutation profiles are obtained by MSK-IMPACT sequencing and 230 cancer patients receiving whole-exome sequencing, respectively. Using eighteen genes (SETD2, BRAF, NCOA3, LATS1, IL7R, CREBBP, TET1, EPHA7, KDM5C, MET, KMT2D, RET, PAK7, CSF1R, JAK2, FAT1, ASXL1 and SPEN), the first nomogram stratifies patients from both cohorts into High-Risk and Low-Risk groups. Pan-cancer patients in the High-Risk group exhibit significantly shorter overall survival and progression-free survival than patients in the Low-Risk group in both cohorts. Meanwhile, the first nomogram also accurately identifies the survival of patients with melanoma or lung cancer undergoing immunotherapy, or pan-cancer patients treated with anti-PD-1/PD-L1 inhibitor or anti-CTLA-4 inhibitor. The model proposed is not a prognostic model for the survival of pan-cancer patients without immunotherapy, but a simple, effective and robust predictive model for pan-cancer patients' survival under immunotherapy, and could provide valuable assistance for clinical practice.

287

News (Medical) associated with Botensilimab

28 Jun 2024

·www.biospace.com

Significant Tumor Reductions in Neoadjuvant MSS Colon Cancer Patients Treated with Botensilimab/Balstilimab Presented at ESMO GI Conference

Extended BOT/BAL Therapy Yields Pronounced Improvements in Tumor Reductions LEXINGTON, Mass.--(BUSINESS WIRE)-- Agenus Inc. (“Agenus”) (Nasdaq: AGEN), a leader in developing novel immunological agents to treat various cancers, today announced results from an investigator-sponsored trial (IST) of botensilimab and balstilimab (BOT/BAL) in the neoadjuvant setting for colon cancer. Data were presented at the 2024 European Society for Medical Oncology (ESMO) Gastrointestinal Cancers Congress in Munich, Germany. Dr. Pashtoon Kasi, the originator of this groundbreaking study, stated, “The rapid and complete resolution of aggressive MSS colorectal cancer tumors observed in this study is unprecedented in the field. The exceptional activity of the BOT/BAL combination therapy in the neoadjuvant setting offers new hope for patients facing this challenging cancer subtype. Furthermore, the pattern of response and the lack of clinical recurrence speaks to the curative potential of one’s own body to fight cancer.” Study Highlights: Enrollment: 20 patients were evaluable at the data cutoff with available pathology results, 17 microsatellite stable (MSS) and 3 high microsatellite instability (MSI-H). Treatment Regimens: Both cohorts received one dose of botensilimab with balstilimab. The NEST-1 cohort received one additional dose of balstilimab two weeks later, whereas the NEST-2 cohort received up to 3 additional doses of balstilimab. Clinical Findings: Pathologic Response: In the NEST-2 cohort, 78% (7/9) of MSS patients achieved pathologic responses of at least 50% tumor regression, with 56% (5/9) reaching complete pathologic responses. Surgical Outcomes and Safety: No surgeries were delayed due to adverse events, and no patients had unresolved immune related adverse events. Side effects were manageable, and no new safety concerns emerged. Pathologic Response (>50% Regression) Complete Pathologic Response (100% Regression) NEST-1 (N=10) MSS (N=8) 5 (63%) 1 (13%) MSI-H (N=2) 2 (100%) 1 (50%) NEST-2 (N=10) MSS (N=9) 7 (78%) 5 (56%) MSI-H (N=1) 1 (100%) 1 (100%) Overall MSS (N=17) 12 (71 %) 6 (35%) MSI-H (N=3) 3 (100%) 2 (67%) “The significant tumor reductions observed with the early use of BOT/BAL therapy before surgery underscore its paradigm-changing potential in neoadjuvant colon cancer, potentially minimizing the rate of disease recurrence and the need for invasive procedures and chemotherapy in the future,” said Dr. Steven O’Day Chief Medical Officer at Agenus. “The responses in MSS patients were particularly profound, and extending the treatment duration in the NEST-2 cohort further amplified these effects. We are focused on expanding BOT/BAL’s application in the neoadjuvant setting to improve treatment for individuals living with cancer.” The presentation is available on the Agenus website at . 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 900 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 with the identifiers NCT03860272, NCT05608044, NCT05630183, and NCT05529316. About Colorectal Cancer Colorectal cancer (CRC) is the second leading cause of cancer death in the United States, comprising an estimated 8.3% of cancer-related deaths annually. Although overall mortality from CRC has declined, survival remains poor for advanced disease, and the burden is shifting to a younger population. Alarmingly, from 1995 to 2019, the number of patients under the age of 55 who were diagnosed with CRC in the United States nearly doubled. About Agenus Agenus is a leading immuno-oncology company targeting cancer and infectious diseases with a comprehensive pipeline of immunological agents. The company’s mission is 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 is headquartered in Lexington, MA. For more information, visit 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 a 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.

ImmunotherapyClinical ResultPhase 2

27 Jun 2024

·www.globenewswire.com

BioAtla to Host Virtual R&D Day on Clinical Program and Pipeline Updates on July 25, 2024

SAN DIEGO, June 27, 2024 (GLOBE NEWSWIRE) -- BioAtla, Inc. (Nasdaq: BCAB), a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics for the treatment of solid tumors, today announced it will host a virtual R&D Day around the Company’s clinical programs and pipeline updates on Thursday, July 25, 2024 at 10:00 AM ET. To register, click here. A live question and answer session will follow the presentation. About BioAtla®, Inc.BioAtla is a global clinical-stage biotechnology company with operations in San Diego, California, and in Beijing, China through our contractual relationship with BioDuro-Sundia, a provider of preclinical development services. Utilizing its proprietary Conditionally Active Biologics (CAB) technology, BioAtla develops novel, reversibly active monoclonal and bispecific antibodies and other protein therapeutic product candidates. CAB product candidates are designed to have more selective targeting, greater efficacy with lower toxicity, and more cost-efficient and predictable manufacturing than traditional antibodies. BioAtla has extensive and worldwide patent coverage for its CAB technology and products with greater than 765 active patent matters, more than 485 of which are issued patents. Broad patent coverage in all major markets include methods of making, screening and manufacturing CAB product candidates in a wide range of formats and composition of matter coverage for specific products. BioAtla has two first-in-class CAB programs currently in Phase 2 clinical testing, mecbotamab vedotin, a novel conditionally active AXL-targeted antibody-drug conjugate (CAB-AXL-ADC), and ozuriftamab vedotin, a novel conditionally active ROR2-targeted antibody-drug conjugate (CAB-ROR2-ADC). The Phase 2 stage CAB-CTLA-4 antibody, evalstotug, is a novel CTLA-4 inhibitor designed to reduce systemic toxicity and potentially enable safer combination therapies with checkpoint inhibitors such as anti-PD-1 antibody. The company’s first dual CAB bispecific T-cell engager antibody, BA3182, is currently in Phase 1 development. BA3182 targets EpCAM, which is highly and frequently expressed on many adenocarcinomas while engaging human CD3 expressing T cells. To learn more about BioAtla, Inc. visit www.bioatla.com. Forward-looking statements Statements in this press release contain "forward-looking statements" that are subject to substantial risks and uncertainties. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "expect," "believe," "will," "may," "should," "estimate," "project," "outlook," "forecast" or other similar words. Examples of forward-looking statements include, among others, statements we make regarding our business plans and prospects and whether our clinical trials will support registration; plans to form collaborations and other strategic partnerships for selected assets; achievement of milestones; results, conduct, progress and timing of our research and development programs and clinical trials; expectations with respect to enrollment and dosing in our clinical trials, plans and expectations regarding future data updates, clinical trials, regulatory meetings and regulatory submissions; the potential regulatory approval path for our product candidates; expectations about the sufficiency of our cash and cash equivalents to fund operations; and expectations regarding R&D expenses and cash burn. Forward-looking statements are based on BioAtla's current expectations and are subject to inherent uncertainties, risks and assumptions, many of which are beyond our control, difficult to predict and could cause actual results to differ materially from what we expect. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, among others: potential delays in clinical and pre-clinical trials; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, or regulatory approval dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; whether regulatory authorities will be satisfied with the design of and results from the clinical studies or take favorable regulatory actions based on results from the clinical studies; our dependence on the success of our CAB technology platform; our ability to enroll patients in our ongoing and future clinical trials; the successful selection and prioritization of assets to focus development on selected product candidates and indications; our ability to form collaborations and partnerships with third parties and the success of such collaborations and partnerships; our reliance on third parties for the manufacture and supply of our product candidates for clinical trials; our reliance on third parties to conduct our clinical trials and some aspects of our research and preclinical testing; potential adverse impacts due to any resurgence of COVID-19 and its variants; and those other risks and uncertainties described in the section titled "Risk Factors" in our Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 26, 2024 and our other reports as filed with the SEC. Forward-looking statements contained in this press release are made as of this date, and BioAtla undertakes no duty to update such information except as required under applicable law. Internal Contact:Richard WaldronChief Financial OfficerBioAtla, Inc.rwaldron@bioatla.com858.356.8945 External Contact:Bruce MackleLifeSci Advisors, LLCbmackle@lifesciadvisors.com

Phase 1ADCPhase 2

27 Jun 2024

·www.biospace.com

Cancer Therapy Evaluation Program Announces Availability of Botensilimab for Clinical Studies

LEXINGTON, Mass.--(BUSINESS WIRE)--Agenus Inc. (“Agenus”) (Nasdaq: AGEN), a leader in developing novel immunological agents to treat various cancers, today announced that the Cancer Therapy Evaluation Program (CTEP) is accepting Letters of Intent (LOIs) to conduct clinical studies using botensilimab (BOT), a human Fc enhanced next-generation anti-cytotoxic T-lymphocyte associated protein 4 (CTLA-4) antibody, which is being developed by CTEP as an anticancer agent in collaboration with Agenus Inc. CTEP will also consider requests to supply botensilimab for nonclinical studies. All clinical and nonclinical researchers interested in working with the agent are welcome to apply. All proposals approved by CTEP will be sent to the industry collaborator for a commitment to supply drug for the study. In addition to its commitment to support clinical studies in collaboration with CTEP, Agenus is also committed to supporting nonclinical research by providing investigators with botensilimab and its mouse surrogate. This initiative is designed to facilitate extensive investigations into the drug's potential and identify new potential clinical applications. For additional information on the CTEP program, including a list of therapies approved for use by CTEP, access their website here. 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 900 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 with the identifiers NCT03860272, NCT05608044, NCT05630183, and NCT05529316. About Agenus Agenus is a leading immuno-oncology company targeting cancer and infectious diseases with a comprehensive pipeline of immunological agents. The company’s mission is 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 is headquartered in Lexington, MA. For more information, visit 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 a 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 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
Non-Small Cell Lung Cancer	Phase 2	AM	Agenus, Inc.	01 May 2024
Colorectal Liver Metastases	Phase 2	US	Agenus, Inc.	26 Mar 2024
Liver metastases	Phase 2	US	Agenus, Inc.	26 Mar 2024
Adenocarcinoma of large intestine	Phase 2	US	National Cancer Institute	11 May 2023
Advanced Colorectal Adenocarcinoma	Phase 2	US	National Cancer Institute	11 May 2023
Metastatic Microsatellite Stable Colorectal Carcinoma	Phase 2	US	National Cancer Institute	11 May 2023
Microsatellite Stable Colorectal Carcinoma	Phase 2	US	National Cancer Institute	11 May 2023
Metastatic Pancreatic Ductal Adenocarcinoma	Phase 2	US	Agenus, Inc.	27 Mar 2023
Secondary malignant neoplasm of pancreas	Phase 2	US	Agenus, Inc.	27 Mar 2023
Melanoma	Phase 2	US	Agenus, Inc.	12 Dec 2022

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03860272 (ASCO2024) Manual	Phase 1	Microsatellite Stable Colorectal Carcinoma Microsatellite Stable (MSS)	77	Botensilimab+balstilimab	ingbeibrct(eoiogwuvqv) = ntlhmeeger nvkczurjty (uljgtqtqyl ) View more	Positive	24 May 2024
NCT05571293 (NEST-1, ASCO_GI2024) Manual	Phase 2	Colorectal Cancer Neoadjuvant Proficient DNA Mismatch Repair (pMMR) \| Deficient DNA Mismatch Repair (dMMR) \| MSI-High \| ... View more	12	Botensilimab+balstilimab	zdrchzspoq(iazoxhvxhi) = zompraubxi krfjktjfhw (yfqbiaqxyl ) Met View more	Positive	18 Jan 2024
NCT03860272 (ESMO2023) Manual	Phase 1	Sarcoma	22	Botensilimab+ balstilimab	ujteeewidv(uijhgyzyiq) = pyxgsbsrnx ttpwouzrnf (kngjlqdmgp ) View more	Positive	21 Oct 2023
NCT03860272 (ESMO_GI2023)	Phase 1	Metastatic Microsatellite Stable Colorectal Carcinoma RAS mutations \| BRAF mutations \| tumor mutational burden (TMB)	101	Botensilimab + Balstilimab	tzeqssfjzn(xlcvyxalny) = sercqlfvtt zaslezdbwc (odkbdwleam, 68 - 88) View more	Positive	01 Jul 2023
NCT03860272 (ASCO_GI2023) Manual	Phase 1	Metastatic Microsatellite Stable Colorectal Carcinoma	59	Botensilimab 1 mg/kg / 2 mg/kg+Balstilimab 3 mg/kg	teawbwsiba(ilguawocpq) = hqmdursczj eqgnpavvbb (tncjdiaoio ) View more	Positive	24 Jan 2023
NCT03860272 (ASCO_GI2023) Manual	Phase 1	Metastatic Microsatellite Stable Colorectal Carcinoma	59	Botensilimab 1 mg/kg / 2 mg/kg+Balstilimab 3 mg/kg (1 mg/kg pts)	rjwcibemqj(htdnsfeunp) = ettrnlwjha fecmrpasjm (oyyggyymdp, 63 - 100) View more	Positive	24 Jan 2023
NCT03860272 (C-800-01, Biospace) Manual	Phase 1	Advanced Sarcoma	13	Balstilimab+Botensilimab	bersuabisj(zdhbsmgojl) = lvrljmynsz eehqrxlhbl (oaisnsogpn ) View more	Positive	17 Nov 2022
NCT03860272 (ESMO_GI2022)	Phase 1	Metastatic Microsatellite Stable Colorectal Carcinoma	41	Botensilimab + Balstilimab	bxgsxhkjfr(swqillyuno) = rldnkrocbt duuttoatxd (hasaijsvpy ) View more	-	02 Jul 2022
SWOG S1609 (AACR2020)	Phase 2	Neoplasms \| Small intestine carcinoma	-	Ipilimumab plus nivolumabIpilimumab plus nivolumab	zapgsqvfre(bigjjdwndq) = tdkjkxbsjf qncktiqkiz (xpvqborrjz ) View more	Negative	15 Aug 2020
ACR2019	Not Applicable	Arthritis IL-6 \| IL-17A	-	PD-1 inhibitor monotherapy	kkcrhwwjcf(ajoogudder) = Four patients developed arthritis after PD-1 inhibitor monotherapy and three after combination therapy with CTLA-4 and PD-1 inhibitors. Two patients in the combination therapy group required interleukin (IL)-6 receptor inhibitor therapy in addition to steroids, compared with one patient in the monotherapy group (sulfasalazine). msodcxfxks (xoojfmkhab )	Positive	12 Nov 2019
ACR2019	Not Applicable	Arthritis IL-6 \| IL-17A	-	Combination therapy with CTLA-4 and PD-1 inhibitors		Positive	12 Nov 2019
ASCO2017	Not Applicable	Metastatic melanoma	64	aPD1 + aCTLA4	lckogbpwij(bcerpnglxf) = One death from irAEs occurred related to Toxic Epidermal Necrolysis (TEN) cawvfbuuvi (gmhqnfqqkf ) View more	Positive	30 May 2017

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