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- \nAt a late-breaking presentation at ASCO-GI, botensilimab\/balstilimab combination demonstrated a 63% 12-month overall survival rate in metastatic colorectal cancer patients who have failed a median of four prior treatments, more than double the survival rate reported for available treatments<\/p>\n<\/li>\n
- \nBotensilimab\/balstilimab combination data update selected for late-breaking oral session at the ESMO-GI conference in June 2023<\/p>\n<\/li>\n
- \nFDA granted Fast Track Designation to the botensilimab\/balstilimab combination in colorectal cancer in April 2023<\/p>\n<\/li>\n
- \nAt a plenary session at SGO, botensilimab\/balstilimab combination showed 33% overall response rate in platinum-resistant ovarian cancer patients<\/p>\n<\/li>\n
- \nPhase II ACTIVATE trials expected to fully enroll in second half of 2023<\/p>\n<\/li>\n
- \nAGEN2373 monotherapy data to be presented at ASCO in June 2023<\/p>\n<\/li>\n
- \nBalstilimab\/zalifrelimab data in the treatment of sarcoma to be presented at ASCO oral session in June 2023<\/p>\n<\/li>\n<\/ul>\n
LEXINGTON, Mass.–(BUSINESS WIRE<\/a>)–
\nAgenus Inc. (Nasdaq: AGEN), an immuno-oncology company with an extensive pipeline of clinical and preclinical-stage cancer treatments, today provided a corporate update and reported financial results for the first quarter 2023.<\/p>\n\n“With over 350 patients dosed with botensilimab in our Phase 1 study, we have demonstrated 20-50% response rates in 9 solid tumor cancers. These results suggest that botensilimab could provide significant benefit to patients who have not responded to or failed other available treatments,\u201d said Dr. Garo Armen, Chief Executive Officer of Agenus. \u201cAgenus is committed to advancing our development programs to make botensilimab available to patients ASAP.”<\/p>\n
\nBotensilimab Combination<\/b><\/p>\n
\nUnprecedented activity in 70 patients with non-MSI-H colorectal cancer<\/a> and 24 patients with recurrent platinum resistant\/refractory ovarian cancer<\/a>:<\/p>\n
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- \nAgenus presented botensilimab\/balstilimab combination data at a late-breaking oral session at the American Society of Clinical Oncology \u2013 Gastrointestinal Cancers Symposium (ASCO-GI) in January 2023 and at the Society of Gynecologic Oncology (SGO) 2023 Annual Meeting on Women\u2019s Cancer in March 2023<\/p>\n<\/li>\n
- \nThe combination showed unprecedented responses and survival benefit in 70 patients with non-microsatellite instability-high (non-MSI-H) colorectal cancer, including:<\/p>\n
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- \n12-month overall survival of 63% (compared to 25% reported for standard of care) 1,2<\/sup><\/li>\n
- \nOverall response rate of 23% (compared to 1-2%1,2 <\/sup>reported for standard of care and1-5%3,4 <\/sup>reported for otherPD-(L)1 + CTLA-4 combinations)<\/p>\n<\/li>\n<\/ul>\n<\/li>\n
- \nIn April 2023, the FDA granted Fast Track Designation to the botensilimab\/balstilimab combination for the treatment of non-MSI-H\/deficient mismatch repair (dMMR) metastatic colorectal cancer patients without active liver involvement who are resistant or intolerant to fluoropyrimidine, oxaliplatin, or irinotecan, and have also received a VEGF inhibitor, an EGFR inhibitor, and\/or a BRAF inhibitor<\/p>\n<\/li>\n
- \nAgenus is conducting a global, randomized Phase 2 trial in this patient population under its ACTIVATE trial program, and a global Phase 3 trial is expected to commence in 2023<\/p>\n<\/li>\n
- \nIn 24 ovarian cancer patients who were resistant or refractory to platinum chemotherapy, the botensilimab\/balstilimab combination showed a 33% response rate (compared to ~10% reported for standard of care5<\/sup> and 3-10% for other PD-(L)1 + CTLA-4 combinations6,7<\/sup>)<\/p>\n<\/li>\n
- \nAgenus continues to enroll PD-(L)1 relapsed\/refractory NSCLC patients in its Phase 1b study and plans to launch a randomized phase 3 study if the previously reported ~50% response rates continue<\/p>\n<\/li>\n<\/ul>\n
Upcoming Presentations<\/b><\/p>\n
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- \nUpdated data on the botensilimab\/balstilimab combination in non-MSI-H metastatic colorectal cancer patients selected for a late breaking oral presentation at the upcoming ESMO World Congress on Gastrointestinal Cancer (ESMO-GI), to be held June 18 \u2013 July 1, 2023 in Barcelona, Spain<\/p>\n<\/li>\n
- \nData from a single-arm, open-label Phase 2 study of balstilimab and zalifrelimab (1st<\/sup> generation CTLA-4) plus doxorubicin in patients with advanced sarcomas selected for oral presentation at the ASCO 2023 Annual Meeting, to be held June 2-6 in Chicago, IL<\/p>\n<\/li>\n
- \nComplete results from the monotherapy arm of the first-in-human dose escalation study of AGEN2373 in patients with advanced solid tumors will also be presented in a poster discussion at ASCO<\/p>\n<\/li>\n<\/ul>\n\n
Clinical Pipeline and Corporate Partnerships<\/b><\/p>\n
\nAdditional presentation at ASCO involving Agenus’s clinical pipeline involving collaborations include:<\/p>\n
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- \nAbstract #424868: Targeting minimal residual disease (MRD) in resected RAS mutated pancreatic cancer with vaccine TG01\/QS-21 +\/- PD-1 inhibitor, balstilimab: A randomized phase II study (TESLA)<\/p>\n<\/li>\n
- \nAbstract # TPS6104: Phase 2 Trial of Retifanlimab (anti\u2013PD-1) in Combination With INCAGN02385 (anti\u2013LAG-3) and INCAGN02390 (anti\u2013TIM-3) as First-Line Treatment in Patients With PD-L1\u2013Positive Recurrent\/Metastatic Squamous Cell Carcinoma of the Head and Neck<\/p>\n<\/li>\n
- \nAbstract #2599: A Phase 1\/2 Study of retifanlimab (INCMGA00012, Anti\u2013PD-1), INCAGN02385 (Anti\u2013LAG-3), and INCAGN02390 (Anti\u2013TIM-3) Combination Therapy in Patients (Pts) With Advanced Solid Tumors<\/p>\n<\/li>\n
- \nAbstract #2541: A phase 1\/2 study of the safety, tolerability, and preliminary efficacy of the anti-GITR monoclonal antibody, INCAGN01876, combined with immunotherapies (IO) in patients (Pts) with advanced cancers<\/p>\n<\/li>\n<\/ul>\n
Agenus shareholders received dividend of shares in MiNK Therapeutics (NASDAQ: INKT)<\/b><\/p>\n
\nOn May 1st<\/sup>, 2023, Agenus distributed a dividend of approximately 5,000,000 shares it owned of its subsidiary MiNK Therapeutics\u2019 common stock to shareholders who held Agenus shares as of April 17, 2023, with a ratio of 0.0146 shares of MiNK (NASDAQ: INKT) per share of Agenus. The announced dividend distribution preceded MiNK’s presentation of its lead product, agenT-797<\/a>, an allo-INKT cell therapy, showing clinical and biomarker responses in solid tumor cancers at AACR in April 2023. This distribution allows Agenus shareholders to benefit from future growth of MiNK through direct ownership. The shares that were distributed as part of this dividend were not part of a new stock offering.<\/p>\n
First Quarter 2023 Financial Results:<\/b><\/p>\n
\nWe ended our first quarter 2023 with a cash, cash equivalent and short-term investment balance of $189.2 million, compared to $193.4 million at December 31, 2022. Since quarter end we have raised $13.6 million through sales under our at market issuance sales agreement.<\/p>\n
\nFor the first quarter ended March 31, 2023, we recognized revenue of $22.9 million and incurred a net loss of $70.9 million (including non-cash expenses of $24.9 million) or $0.22 per share.<\/p>\n
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- \nComplete results from the monotherapy arm of the first-in-human dose escalation study of AGEN2373 in patients with advanced solid tumors will also be presented in a poster discussion at ASCO<\/p>\n<\/li>\n<\/ul>\n\n
- \nOverall response rate of 23% (compared to 1-2%1,2 <\/sup>reported for standard of care and1-5%3,4 <\/sup>reported for otherPD-(L)1 + CTLA-4 combinations)<\/p>\n<\/li>\n<\/ul>\n<\/li>\n
- \n12-month overall survival of 63% (compared to 25% reported for standard of care) 1,2<\/sup><\/li>\n
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