Agenus' botensilimab in combination with balstilimab shows 33% durable responses in ovarian cancer

Agenus’ botensilimab together with balstilimab reveals 33% sturdy responses in ovarian most cancers

Information offered on the plenary session of the Society of Gynecologic Oncology Assembly

  • The handled sufferers suffered from platinum resistant/refractory ovarian most cancers

  • Earlier PD-(L)1/CTLA-4 mixtures reported solely 3-10% responses in comparable affected person populations1.2

  • Outcomes In step with Botensilimab/Balstilimab Advantages in Chilly and Refractory Tumors in 9 Completely different Stable Tumors

LEXINGTON, Mass., March 27, 2023–(BUSINESS WIRE)–Agenus Inc. (Nasdaq: AGEN), an immuno-oncology firm with a pipeline of immunologic brokers concentrating on most cancers and infectious ailments, at this time introduced outcomes from a cohort of 24 evaluable sufferers in a Firm Enlargement Section 1b research of botensilimab (CTLA-4 multifunctional antibody) together with balstilimab (PD-1 antibody) in sufferers with platinum resistant/refractory recurrent ovarian most cancers. These findings, offered in an oral plenary session on the Society of Gynecologic Oncology (SGO) Annual Assembly on Ladies’s Most cancers 2023, confirmed an total response fee (ORR) of 33%.

“These findings add to the rising physique of information exhibiting profound and sturdy efficacy alerts for botensilimab in 9 cold- and treatment-resistant cancers,” mentioned Steven ODay, MD, Chief Medical Officer at Agenus. “Botensilimab is designed with a singular mechanism of motion that stimulates each innate and adaptive immune responses towards most cancers, leading to improved profit over what has been reported for different controller therapies.”

“The mix of botensilimab and balstilimab in platinum-resistant ovarian most cancers reveals promise for substantial enchancment in efficacy over current therapies, which generally produce solely single-digit response charges,” mentioned Bruno Bockorny, MD, Harvard Medical College, Beth Israel Deaconess Medical Middle and principal investigator for the research. “The exceptional efficacy and manageable security profile of this mixture counsel transformative potential for sufferers with ovarian most cancers.”

The ovarian most cancers cohort is an element of a giant research evaluating the security, efficacy, and dose optimization of botensilimab alone and together with balstilimab in a number of stable tumors. Agenus is presently enrolling within the world Section 2 ACTIVATE trial packages in microsatellite steady metastatic colorectal most cancers, melanoma, and pancreatic cancers. Primarily based on the latest constructive outcomes offered on the SITC, Agenus can be increasing the enrollment of its relapsed/refractory anti-PD-(L)1 non-small cell lung most cancers cohort from the Section 1b research and is planning additional research in NSCLC .

Research design and highlights

A complete of 24 evaluable sufferers with recurrent platinum resistant/refractory ovarian most cancers obtained 1 or 2 mg/kg of botensilimab each 6 weeks and three mg/kg of balstilimab each 2 weeks.

Affected person demographics

  • 79% have been excessive grade serous, which has a poor prognosis

  • Sufferers have been closely pretreated, with a median of 4 prior strains of remedy, together with 21% with prior immunotherapy

  • Most sufferers had biomarkers related to a poor response to immunotherapy:

Medical outcomes

  • 33% total response fee (1 full response, 7 partial responses)

  • Illness management fee of 67%.

  • Median length of response not reached

  • Manageable tolerability profile

Presentation particulars

Summary title: Botensilimab, a novel innate/adaptive immune activator, plus balstilimab (Anti-PD-1) in sufferers with platinum-resistant/refractory recurrent ovarian most cancers (NCT03860272)

Presenting creator: Bruno Bockorny, MD, Harvard College, Beth Israel Deaconess Medical Middle

The information offered shall be accessible for viewing within the Publications part of the Agenus web site ( after the SGO convention.


2 Hinchcliff et al. Gynecological Oncology 2021

About Botensilimab

Botensilimab is a brand new investigational multifunctional CTLA-4 antibody designed to increase medical profit to “chilly” tumors which have traditionally failed to reply to customary of care or investigational therapies. Along with binding to the CTLA-4 receptor, its Fc-enhanced construction induces a reminiscence immune response, downregulates regulatory T cells, and gives enhanced T cell priming and activation, thereby amplifying immune responses.

In a Section 1b medical research of over 300 sufferers, botensilimab demonstrated medical responses in 9 stable tumors, alone or together with the Agenus PD-1 antibody, balstilimab. Agenus is conducting world, randomized Section 2 trials in microsatellite-stable colorectal most cancers (MSS CRC), pancreatic most cancers, and melanoma as a part of its ACTIVATE trial program. Further info on these botensilimab research is offered at beneath the identifiers NCT05608044, NCT05630183 and NCT05529316, respectively. A world Section 3 trial of MSS CRC is predicted to launch in 2023.

About Ageno
Agenus is a clinical-stage immuno-oncology firm targeted on discovering and creating therapies that have interaction the physique’s immune system to battle most cancers and an infection. The corporate’s imaginative and prescient is to develop the affected person populations benefiting from most cancers immunotherapy by pursuing mixture approaches that leverage a broad repertoire of antibody therapies, adoptive cell therapies (by means of its subsidiary MiNK Therapeutics), and adjuvants (by means of its subsidiary SoapsQx). The corporate is supplied with a collection of antibody discovery platforms and a state-of-the-art GMP manufacturing facility with the power to assist medical packages. Agenus is headquartered in Lexington, MA. For extra info, go to and our Twitter account @agenus_bio. Info which may be vital to traders shall be posted repeatedly on our web site and on Twitter.

Ahead-Trying Statements

This press launch comprises forward-looking statements made pursuant to the secure harbor provisions of the federal securities legal guidelines, together with statements concerning our applied sciences, therapeutic candidates, and capabilities, resembling statements concerning therapeutic profit and efficacy, mechanism of motion, efficiency, sturdiness and security and tolerability profile of our therapeutic candidates, both alone or together with one another and/or different brokers; statements concerning future plans, together with analysis, medical, regulatory, and commercialization plans; and some other statements containing the phrases “might,” “believes,” “expects,” “anticipates,” “hopes,” “intends,” “plans,” “will,” and related expressions are meant to establish forward-looking statements. These forward-looking statements are topic to dangers and uncertainties that might trigger precise outcomes to vary materially. These dangers and uncertainties embrace, amongst others, the elements described within the Danger Components part of our most up-to-date quarterly report on Kind 10-Q or annual report on Kind 10-Okay filed with the Securities and Change Fee and accessible on our web site : Agenus cautions traders to not place vital reliance on the forward-looking statements contained on this launch. These statements communicate solely as of the date of this press launch, and Agenus undertakes no obligation to replace or revise any statements, besides to the extent required by regulation. All forward-looking statements are expressly certified of their entirety by this cautionary assertion.

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