Delving into the Latest Updates on Balstilimab with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Balstilimab (USAN/INN)

+ [1]

Target

PD-1

Mechanism

PD-1 inhibitors(Programmed cell death protein 1 inhibitors)

Therapeutic Areas

NeoplasmsUrogenital DiseasesImmune System Diseases+ [9]

Active Indication

Uterine Cervical CancerAdvanced cancerstomach adenocarcinoma+ [28]

Inactive Indication

Locally Advanced Malignant Solid Neoplasm

Originator Organization

Agenus, Inc.

Active Organization

Betta Pharmaceuticals Co., Ltd.

Agenus, Inc.

National Cancer Institute

+ [2]

Inactive Organization-

Drug Highest PhaseNDA/BLA

First Approval Date-

RegulationFast Track (US)

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Gene Sequence

Sequence Code 13223719H

Source: *****

Sequence Code 13223716L

Source: *****

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 / Not yet recruitingPhase 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

Hope Medical Center

[+1]

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 Oct 2024

Sponsor / Collaborator

Agenus, Inc.

100 Clinical Results associated with Balstilimab

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100 Translational Medicine associated with Balstilimab

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100 Patents (Medical) associated with Balstilimab

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11

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

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

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

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

Letter

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

104

News (Medical) associated with Balstilimab

08 Oct 2024

·www.prnewswire.com

AGEN Investors Have Opportunity to Lead Agenus Inc. Securities Fraud Lawsuit

NEW YORK, Oct. 8, 2024 /PRNewswire/ -- Rosen Law Firm, a global investor rights law firm, reminds purchasers of securities of Agenus Inc. (NASDAQ: AGEN) between January 23, 2023 and July 17, 2024, both dates inclusive (the "Class Period"), of the important November 5, 2024 lead plaintiff deadline. So what: If you purchased Agenus securities during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement. What to do next: To join the Agenus class action, go to call Phillip Kim, Esq. toll-free at 866-767-3653 or email [email protected] for information on the class action. A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than November 5, 2024. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. Details of the case: According to the lawsuit, throughout the Class Period, defendants made false and/or misleading statements and/or failed to disclose that: (1) the combination therapy of botensilimab, an antigen 4 blocking antibody that is in a Phase 2 clinical trial for the treatment of pancreatic cancer and melanoma, and balstilimab, an anti-PD-1 antagonist that has completed a Phase 2 clinical trial to treat second line cervical cancer, was less effective than defendants had led investors to believe; (2) accordingly, botensilimab and balstilimab's clinical results, as well as their regulatory and commercial prospects, were overstated; and (3) as a result, Agenus' public statements were materially false and misleading at all relevant times. When the true details entered the market, the lawsuit claims that investors suffered damages. To join the Agenus class action, go to or call Phillip Kim, Esq. toll-free at 866-767-3653 or email [email protected] for information on the class action. No Class Has Been Certified. Until a class is certified, you are not represented by counsel unless you retain one. You may select counsel of your choice. You may also remain an absent class member and do nothing at this point. An investor's ability to share in any potential future recovery is not dependent upon serving as lead plaintiff. Follow us for updates on LinkedIn: , on Twitter: or on Facebook: . Attorney Advertising. Prior results do not guarantee a similar outcome. Contact Information: Laurence Rosen, Esq. Phillip Kim, Esq. The Rosen Law Firm, P.A. 275 Madison Avenue, 40th Floor New York, NY 10016 Tel: (212) 686-1060 Toll Free: (866) 767-3653 Fax: (212) 202-3827 [email protected] SOURCE THE ROSEN LAW FIRM, P. A. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Patent InfringementClinical Result

08 Oct 2024

·www.prnewswire.com

Levi & Korsinsky Announces the Filing of a Securities Class Action on Behalf of Agenus Inc.(AGEN) Shareholders

NEW YORK, Oct. 8, 2024 /PRNewswire/ -- Levi & Korsinsky, LLP notifies investors in Agenus Inc. ("Agenus" or the "Company") (NASDAQ: AGEN) of a class action securities lawsuit. CLASS DEFINITION: The lawsuit seeks to recover losses on behalf of Agenus investors who were adversely affected by alleged securities fraud between January 23, 2023 and July 17, 2024. Follow the link below to get more information and be contacted by a member of our team: AGEN investors may also contact Joseph E. Levi, Esq. via email at [email protected] or by telephone at (212) 363-7500. CASE DETAILS: The filed complaint alleges that defendants made false statements and/or concealed that: (i) the combination therapy of their immuno-oncology products, botensilimab and balstilimab was less effective than the defendants had led investors to believe; (ii) accordingly, botensilimab and balstilimab's clinical results, as well as their regulatory and commercial prospects, were overstated; and (iii) as a result, the Company's public statements were materially false and misleading at all relevant times. WHAT'S NEXT? If you suffered a loss in Agenus during the relevant time frame, you have until November 5, 2024 to request that the Court appoint you as lead plaintiff. Your ability to share in any recovery doesn't require that you serve as a lead plaintiff. NO COST TO YOU: If you are a class member, you may be entitled to compensation without payment of any out-of-pocket costs or fees. There is no cost or obligation to participate. WHY LEVI & KORSINSKY: Over the past 20 years, the team at Levi & Korsinsky has secured hundreds of millions of dollars for aggrieved shareholders and built a track record of winning high-stakes cases. Our firm has extensive expertise representing investors in complex securities litigation and a team of over 70 employees to serve our clients. For seven years in a row, Levi & Korsinsky has ranked in ISS Securities Class Action Services' Top 50 Report as one of the top securities litigation firms in the United States. CONTACT: Levi & Korsinsky, LLP Joseph E. Levi, Esq. Ed Korsinsky, Esq. 33 Whitehall Street, 17th Floor New York, NY 10004 [email protected] Tel: (212) 363-7500 Fax: (212) 363-7171 SOURCE Levi & Korsinsky, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Patent Infringement

20 Sep 2024

·www.prnewswire.com

Levi & Korsinsky Reminds Shareholders of a Lead Plaintiff Deadline of November 5, 2024 in Agenus Lawsuit - AGEN

NEW YORK, Sept. 20, 2024 /PRNewswire/ --, September 20, 2024 – Levi & Korsinsky, LLP notifies investors in Agenus Inc. ("Agenus" or the "Company") (NASDAQ: AGEN) of a class action securities lawsuit. CLASS DEFINITION: The lawsuit seeks to recover losses on behalf of Agenus investors who were adversely affected by alleged securities fraud between January 23, 2023 and July 17, 2024. Follow the link below to get more information and be contacted by a member of our team: AGEN investors may also contact Joseph E. Levi, Esq. via email at [email protected] or by telephone at (212) 363-7500. CASE DETAILS: The filed complaint alleges that defendants made false statements and/or concealed that: (i) the combination therapy of their immuno-oncology products, botensilimab and balstilimab was less effective than the defendants had led investors to believe; (ii) accordingly, botensilimab and balstilimab's clinical results, as well as their regulatory and commercial prospects, were overstated; and (iii) as a result, the Company's public statements were materially false and misleading at all relevant times. WHAT'S NEXT? If you suffered a loss in Agenus during the relevant time frame, you have until November 5, 2024 to request that the Court appoint you as lead plaintiff. Your ability to share in any recovery doesn't require that you serve as a lead plaintiff. NO COST TO YOU: If you are a class member, you may be entitled to compensation without payment of any out-of-pocket costs or fees. There is no cost or obligation to participate. WHY LEVI & KORSINSKY: Over the past 20 years, the team at Levi & Korsinsky has secured hundreds of millions of dollars for aggrieved shareholders and built a track record of winning high-stakes cases. Our firm has extensive expertise representing investors in complex securities litigation and a team of over 70 employees to serve our clients. For seven years in a row, Levi & Korsinsky has ranked in ISS Securities Class Action Services' Top 50 Report as one of the top securities litigation firms in the United States. CONTACT: Levi & Korsinsky, LLP Joseph E. Levi, Esq. Ed Korsinsky, Esq. 33 Whitehall Street, 17th Floor New York, NY 10004 [email protected] Tel: (212) 363-7500 Fax: (212) 363-7171 SOURCE Levi & Korsinsky, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Patent Infringement

100 Deals associated with Balstilimab

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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
Locally Advanced Malignant Solid Neoplasm	Preclinical	BR	Agenus, Inc.	11 Apr 2017
Locally Advanced Malignant Solid Neoplasm	Preclinical	EE	Agenus, Inc.	11 Apr 2017
Locally Advanced Malignant Solid Neoplasm	Discovery	PL	Agenus, Inc.	11 Apr 2017
Locally Advanced Malignant Solid Neoplasm	Discovery	BE	Agenus, Inc.	11 Apr 2017
Locally Advanced Malignant Solid Neoplasm	Discovery	FR	Agenus, Inc.	11 Apr 2017
Locally Advanced Malignant Solid Neoplasm	Discovery	ES	Agenus, Inc.	11 Apr 2017
Locally Advanced Malignant Solid Neoplasm	Discovery	CL	Agenus, Inc.	11 Apr 2017

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03860272 (ESMO2024) Manual	Phase 1	Sarcoma	63	Botensilimab+balstilimab (efficacy evaluable)	(lsnqlwjpxt) = 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. bynwvoemwv (okemcjyppt ) View more	Positive	13 Sep 2024
NCT03860272 (NEST-1, Biospace) Manual	Phase 1/2	Colonic Cancer Neoadjuvant \|	20	botensilimab with balstilimab + botensilimabal dosbalstilimablimab (MSS + NEST-1 cohort)	(aegctwwsgk) = cqpccxidqh vjnzcknjuj (uovpvdtfez ) View more	Positive	28 Jul 2024
NCT03860272 (NEST-1, Biospace) Manual	Phase 1/2	Colonic Cancer Neoadjuvant \|	20	botensilimab with balstbalstilimab + botensilimabal dose of balstilimab (MSI-H + NEST-1 cohort)	(aegctwwsgk) = poxgtbvnqt vjnzcknjuj (uovpvdtfez ) View more	Positive	28 Jul 2024
BusinessWire Manual	Phase 2	Metastatic Microsatellite Stable Colorectal Carcinoma	-	Botensilimab 75mg + Balstilimab 240mg	(puazqdtyab) = zupdzklcea lddexqdero (tnthcxhwto, 10.4 - 31.4) View more	Positive	18 Jul 2024
BusinessWire Manual	Phase 2	Metastatic Microsatellite Stable Colorectal Carcinoma	-	Botensilimab 150mg + Balstilimab 240mg	(puazqdtyab) = xqiyksrgjl lddexqdero (tnthcxhwto, 2.7 - 18.1)	Positive	18 Jul 2024
Biospace Manual	Phase 1	Metastatic Microsatellite Stable Colorectal Carcinoma	77	botensilimab + balstilimab	(ulmvmlemuk) = kbmswbuivb vkdgowsyab (tstwvntwba ) View more	Positive	13 Jun 2024
NCT05205330 (ASCO2024) Manual	Phase 1/2	Metastatic Microsatellite Stable Colorectal Carcinoma pMMR/MSS	-	vorbipiprant + balstilimab	(lwquudicob) = csvidseshw nztqirnrzd (gprtuvgtqq ) View more	Positive	24 May 2024
NCT05205330 (ASCO2024) Manual	Phase 1/2		-	vorbipiprant + balstilimab (liver metastases)	(lwquudicob) = ceoqoffhgy nztqirnrzd (gprtuvgtqq ) View more	Positive	24 May 2024
NCT03860272 (ASCO2024) Manual	Phase 1	Microsatellite Stable Colorectal Carcinoma	77	Botensilimab+balstilimab	(zdtgjkenzq) = flyhyvnshb ktphswkcih (utyjdxdgut ) View more	Positive	24 May 2024
NCT04430036 (CTgov)	Phase 2	Muscle Invasive Bladder Carcinoma	4	AGEN2034+gemcitabine+Cisplatin+AGEN1884	prhzvoelmw(dottinvqkw) = zgghipkvux cpzxuniuxk (wgojhhjlka, bdsqohamlx - kwxovdglli) View more	-	04 Apr 2024
NCT05205330 (ESMO2023) Manual	Phase 1/2	Microsatellite instability-high colorectal cancer pMMR \| MSS	28	CR6086+balstilimab	(uufjkppvad) = 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) dlqxatqcqv (afnyabecis )	Positive	22 Oct 2023
NCT05205330 (ESMO2023) Manual	Phase 1/2		28	CR6086+balstilimab (liver metastases)		Positive	22 Oct 2023
NCT03860272 (ESMO2023) Manual	Phase 1	Sarcoma	22	Botensilimab+ balstilimab	(jmvncovhrj) = dbnhogcszy tqtjxdjzso (ktkzkrlowq ) 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	(btejjdsrtj) = xpxxhquzbq koxckztbqr (qcgxkgepmf, 68 - 88) View more	Positive	01 Jul 2023