Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 242 |
| INN | Balstilimab |
| Status | Clinical |
| Drug code(s) | AGEN2034 |
| Brand name | None |
| mAb sequence source | mAb human |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG4 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | PD-1 |
| Indications of clinical studies | Angiosarcoma, Advanced Solid Tumors, With Expansion to Second-Line Cervical Cancer |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Phase 2 pivotal |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | April 11, 2017 |
| Start of Phase 2 | June 01, 2019 |
| Start of Phase 3 | |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | None |
| Date of first US approval | |
| INN, US product name | None |
| US or EU approved indications | None |
| Company | Agenus Inc. |
| Licensee/Partner | Betta Pharmaceuticals, Recepta biopharma |
| Comments about company or candidate | Nov 2024: Ongoing discussions with the European Medicines Agency have progressed to agreement on dose selection and trial design for the pivotal Phase 3 study in MSS CRC, marking significant progress in BOT/BAL’s development. https://investor.agenusbio.com/news/news-details/2024/Agenus-Reports-Third-Quarter-2024-Financial-Results-and-Strategic-Advancements-in-BOTBAL-Development/default.aspx. Apr 2023: Apr 2023: FDA grants Fast Track Designation for the combination of botensilimab (AGEN1181) and balstilimab (AGEN2034). The designation is for patients with non-microsatellite instability-high (MSI-H)/deficient mismatch repair (dMMR) metastatic colorectal cancer with no active liver involvement. Mar 2023: The company plans to launch a phase 3 study of combo wth botensilimab among MSS-CRC patients by the end of this year. NCT05608044 Phase 2 combo wth botensilimab in colorectal cancer started in Nov 2022. October 22, 2021 I Agenus announced a strategic decision to withdraw its Biologics License Application (BLA) for balstilimab, its PD-1 inhibitor. The decision to withdraw the BLA does not change the development plans for balstilimab combinations. Following the full approval of pembrolizumab, announced four months earlier than the FDA goal date, the U.S. Food and Drug Administration (FDA) no longer considered it appropriate to review the BLA for accelerated approval and recommended Agenus withdraw. Agenus’ priority remains developing balstilimab as a necessary component of highly effective and affordable combination therapies, both with its own portfolio and with partners, including in combination with Agenus’ next-generation CTLA-4, AGEN1181 April 19, 2021 Agenus Inc. announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA). The BLA has been submitted for the accelerated approval of balstilimab, Agenus’ anti-PD-1 antibody, for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy September 18, 2020 I Agenus Inc. announced the initiation of the rolling submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for balstilimab alone for the treatment of recurrent/metastatic cervical cancer. July 2020: Agenus announced the closing of a $20 million equity investment, at $4.03 per share, by Betta Pharmaceuticals bringing the total received to $35M. The equity investment by Betta Pharmaceuticals is part of the broader immuno-oncology (I-O) partnership that Agenus and Betta Pharmaceuticals announced in June 2020. Under the partnership Agenus is also eligible to receive up to $100 million in potential milestones plus royalties on net sales. In exchange Betta received exclusive rights for the development and commercialization of balstilimab and zalifrelimab, as both monotherapies and combination therapies, excluding intravesical delivery, in greater China, including Mainland China, Hong Kong, Macau and Taiwan. Agenus expects to file 2 BLAs this year for accelerated approval of the combination of balstilimab and zalifrelimab and balstilimab monotherapy in metastatic cervical cancer. April 2020: Fast Track designation by FDA for balstilimab as a monotherapy in second line cervical cancer. March 2020: FDA has granted Agenus Fast Track designation for investigation of balstilimab [PD-1] in combination with zalifrelimab [CTLA-4] for the treatment of patients with relapsed or refractory metastatic cervical cancer. NCT04028063 Phase 2 in combo with AGEN1884 in soft tissue sarcoma not yet recruiting as of Aug 9 2019. Enrollment in our two trials which are designed to support a BLA filing has been faster than our earlier projections. Hence clinical data from these trials may come before the end of this year or early next. Which means we may able to file our first BLA earlier than anticipated in 2020. As you know, 2 registration trials underway; either trial or both could potentially support BLA filings. The first of these is our PD-1 monotherapy trial in 2L cervical cancer and the second is a combination trial of PD-1 and CTLA-4, also in 2L CC. April 2019: BLA filing in cervical cancer expected in 2020 with potential approval and commercialization in 2021. NCT03894215 Phase 2 in cervical cancer study started recruiting June 1, 2019. Two Phase 1/2 studies recruiting as of Aug 2018. AGEN2034 was originally developed under a Collaborative Research and Development Agreement between Ludwig Cancer Research, 4-Antibody AG and Recepta Biopharma S.A |
| Full address of company | Lexington, MA 02421-7305 North America United States of America https://agenusbio.com/ |
Immune checkpoint inhibitor. AGEN2034, a novel human IgG4 anti-PD-1 antagonist antibody, potently inhibits PD-1 binding to PD-L1 and PD-L2, resulting in enhanced T cell responsiveness in vitro as well as in a non-human primate model. AGEN2034 combined effectively with AGEN1884, a human IgG1 anti-CTLA-4 antibody, anti-TIGIT or anti-LAG-3 to further enhance T cell responsiveness. (Chand et al 2017 SITC poster). S228P hinge mutation.
| Anticipated events | In discussion with agencies re. regulatory submission; for combo with botensilimab; Phase 3 planned |
| Factor(s) contributing to discontinuation | None |