On May 9, 2023 Agenus Inc. (Nasdaq: AGEN), an immuno-oncology company with an extensive pipeline of clinical and preclinical-stage cancer treatments, reported a corporate update and provided financial results for the first quarter 2023 (Press release, Agenus, MAY 9, 2023, View Source [SID1234631224]).
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"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," said Dr. Garo Armen, Chief Executive Officer of Agenus. "Agenus is committed to advancing our development programs to make botensilimab available to patients ASAP."
Botensilimab Combination
Unprecedented activity in 70 patients with non-MSI-H colorectal cancer and 24 patients with recurrent platinum resistant/refractory ovarian cancer:
Agenus presented botensilimab/balstilimab combination data at a late-breaking oral session at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) – Gastrointestinal Cancers Symposium (ASCO-GI) in January 2023 and at the Society of Gynecologic Oncology (SGO) 2023 Annual Meeting on Women’s Cancer in March 2023
The combination showed unprecedented responses and survival benefit in 70 patients with non-microsatellite instability-high (non-MSI-H) colorectal cancer, including:
12-month overall survival of 63% (compared to 25% reported for standard of care) 1,2
Overall response rate of 23% (compared to 1-2%1,2 reported for standard of care and 1-5%3,4 reported for other PD-(L)1 + CTLA-4 combinations)
In 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
Agenus 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
In 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 and 3-10% for other PD-(L)1 + CTLA-4 combinations6,7)
Agenus 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
Upcoming Presentations
Updated 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 (Free ESMO Whitepaper) World Congress on Gastrointestinal Cancer (ESMO-GI), to be held June 18 – July 1, 2023 in Barcelona, Spain
Data from a single-arm, open-label Phase 2 study of balstilimab and zalifrelimab (1st generation CTLA-4) plus doxorubicin in patients with advanced sarcomas selected for oral presentation at the ASCO (Free ASCO Whitepaper) 2023 Annual Meeting, to be held June 2-6 in Chicago, IL
Complete 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 (Free ASCO Whitepaper)
Clinical Pipeline and Corporate Partnerships
Additional presentation at ASCO (Free ASCO Whitepaper) involving Agenus’s clinical pipeline involving collaborations include:
Abstract #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)
Abstract # TPS6104: Phase 2 Trial of Retifanlimab (anti–PD-1) in Combination With INCAGN02385 (anti–LAG-3) and INCAGN02390 (anti–TIM-3) as First-Line Treatment in Patients With PD-L1–Positive Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck
Abstract #2599: A Phase 1/2 Study of retifanlimab (INCMGA00012, Anti–PD-1), INCAGN02385 (Anti–LAG-3), and INCAGN02390 (Anti–TIM-3) Combination Therapy in Patients (Pts) With Advanced Solid Tumors
Abstract #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
Agenus shareholders received dividend of shares in MiNK Therapeutics (NASDAQ: INKT)
On May 1st, 2023, Agenus distributed a dividend of approximately 5,000,000 shares it owned of its subsidiary MiNK Therapeutics’ 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, an allo-INKT cell therapy, showing clinical and biomarker responses in solid tumor cancers at AACR (Free AACR Whitepaper) 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.
First Quarter 2023 Financial Results:
We 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.
For 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.
Financial Highlights
(in thousands, except per share data)
(unaudited)
March 31,
December 31,
2023
2022
Cash, cash equivalents and short-term investments
$
189,233
$
193,358
Three months ended March 31,
2023
2022
Revenues, research and development
$
2,612
$
6,740
Revenues, non-cash royalty
19,106
17,634
Revenues, other
1,184
1,567
Total Revenue
22,902
25,941
Research and development expenses
57,118
42,442
General and administrative expenses
18,237
18,953
Cost of service revenue
2,294
543
Other (income) loss
(721
)
191
Non-cash interest expense
17,273
14,952
Non-cash contingent consideration fair value adjustment
(406
)
(536
)
Net loss
$
(70,893
)
$
(50,604
)
Net loss per share attributable to Agenus Inc. common stockholders
$
(0.22
)
$
(0.19
)
Cash used in operations
$
58,526
$
52,391
Non-cash operating expenses
$
24,935
$
21,069
Conference Call
Date: May 9, 2023, 8:30am ET
Dial-in numbers: 646-307-1963 (US-NY) & 800-715-9871 (Ex-US)
Event ID: 9144113
Webcast
A webcast and replay of the conference call will be accessible from the Events & Presentations page of the Company’s website at View Source and via View Source
References
1 Mayer et al. NEJM 2015
2 Grothey et al. Lancet 2013
3 Chen et al. JAMA Oncol. 2020
4 Overman et al. ASCO (Free ASCO Whitepaper) 2016
5 Mutch DG, et al. J Clin Oncol. 2007;25(19): 2811-2818
6 View Source
7 Hinchcliff et al. Gynecologic Oncology 2021
About Botensilimab
Botensilimab is a novel, multifunctional CTLA-4 investigational antibody that has been designed to extend clinical benefits to "cold" tumors that have not historically responded to standard of care or investigational therapies, as well as to expand clinical benefit in "hot" tumors, where immunotherapies are approved but benefit only a minority of patients. In addition to binding to the CTLA-4 receptor, its Fc-enhanced structure induces a memory immune response, downregulates regulatory T cells, activates existing T cells, as well as primes and expands new T cells, thereby promoting a more effective and durable immune response to cancer.
In a Phase 1 clinical study of more than 350 patients, botensilimab has demonstrated clinical responses in nine different cold and treatment-refractory solid tumor cancers, either alone or in combination with Agenus’ PD-1 antibody, balstilimab (data presented at ASCO (Free ASCO Whitepaper) GI 2023, SGO 2023, SITC (Free SITC Whitepaper) 2022, and CTOS 2022). Agenus is conducting global, randomized Phase 2 trials in non-MSI-H colorectal cancer, melanoma, and pancreatic cancer as part of its ACTIVATE trial programs. Additional information about these botensilimab trials can be found at www.clinicaltrials.gov under the identifiers NCT05608044, NCT05630183, and NCT05529316, respectively. A global Phase 3 trial in non-MSI-H colorectal cancer is expected to launch in 2023.
About AGEN2373
AGEN2373 is a novel anti-CD137 agonist that has been designed to activate T and NK cells while mitigating liver toxicities common to the CD137 target class. CD137 (4-1BB) is an activating receptor expressed on T and NK cells. Upon binging to CD137, AGEN2373 is designed to stimulate the growth and activation of cytotoxic T and NK cells, triggering a lasting memory response to cancer. AGEN2373 binds to a unique epitope designed to achieve this response specifically within the tumor microenvironment. This selective binding is designed to avoid serious side effects associated with CD137 activation in the liver that have been reported by competitor molecules. AGEN2373 has demonstrated preliminary clinical activity and has been well tolerated by patients without signs of liver toxicity (Tolcher et al. ASCO (Free ASCO Whitepaper) 2021).