On August 8, 2023 Agenus Inc. ("Agenus") (Nasdaq: AGEN), a leader in developing novel immunological agents to treat various cancers, reported results for the second quarter 2023 (Press release, Agenus, AUG 8, 2023, View Source [SID1234633950]).
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Key accomplishments and highlights include:
Botensilimab Update: Botensilimab/balstilimab combination data presented at ESMO (Free ESMO Whitepaper)-GI demonstrated median overall survival (mOS) of 20.9 months and a 23% overall response rate (ORR), both surpassing data reported for standard of care in 3L+ Non-MSI-H colorectal cancer (CRC) in patients without active liver metastases.
Regulatory: The U.S. FDA granted Fast Track designation for the botensilimab/balstilimab combination in 3L+ Non-MSI-H CRC in patients without active liver metastases. Agenus is exploring global accelerated approval strategies for CRC.
Clinical Trial Progress: Ongoing Phase 2 ACTIVATE trials in CRC and melanoma expected to fully enroll by end of year.
AGEN2373 Update: AGEN2373 Phase 1 dose escalation data presented at ASCO (Free ASCO Whitepaper) demonstrated promising monotherapy clinical responses in patients with advanced solid tumors.
"Botensilimab, alone or in combination with balstilimab, continues to display remarkable clinical activity in over 600 patients treated across nine late-stage, treatment resistant solid tumor cancers, demonstrating great potential to revolutionize the role of immunotherapy in cancer treatment," said Chief Executive Officer, Garo Armen, Ph.D. "Agenus is committed to advancing our diverse clinical pipeline with a focus on expediting our first regulatory submission for the botensilimab/balstilimab combination in colorectal cancer. Our data has demonstrated an unprecedented survival benefit over what has been reported for standard of care, underscoring this combination as an important potential treatment option for patients with non-MSI-high colorectal cancer, which represents 85% of the population of patients with colorectal cancer1."
Botensilimab/Balstilimab ("Bot/Bal") Combination in 3L+ Non-MSI-H Metastatic CRC Data Presented at the ESMO (Free ESMO Whitepaper)-GI World Congress on Gastrointestinal Cancer in June 2023:
In 69 evaluable patients with non-MSI-High CRC without active liver metastases, results demonstrated a meaningful improvement over standard of care in both overall response rate (ORR%) and median overall survival (mOS):
mOS of 20.9 months as compared to the recently reported 12.9-month benchmark with standard care.2
ORR of 23% as compared to the recently reported 2.8%1 benchmark with standard care.
In April 2023, the U.S. FDA granted Fast Track designation to the bot/bal combination for patients with non-MSI-H/dMMR metastatic CRC without active liver metastases.
The ACTIVATE Phase 2 trial in this patient population is on target to conclude enrollment by year-end. Planning is underway for a Phase 3 CRC study; with Fast Track designation from the FDA, study design and timing will be determined as we discuss our filing approach with the agency.
A Biologics License Application to the FDA is planned in 2024.
Botensilimab in Other Advanced Solid Tumor Cancers:
Lung: Enrollment continues for a Phase 1b trial targeting PD-(L)1 +/- chemotherapy relapsed/refractory non-small-cell lung cancer (NSCLC); data update planned by year-end.
Melanoma: Ongoing global enrollment in Phase 2 ACTIVATE trial with data update planned in 2024.
Ovarian: Phase 1b trial in patients with platinum-resistant ovarian cancer (PROC) demonstrated a 33% ORR and 67% disease control rate among primarily high-grade, heavily pretreated patients (presented at SGO in March 2023).
Sarcomas: Updated data for a Phase 1b cohort with advanced sarcomas to be presented at ESMO (Free ESMO Whitepaper) on October 21st 2023.
AGEN2373 Data Presented at the ASCO (Free ASCO Whitepaper) 2023 Annual Meeting:
Complete results from the first-in-human monotherapy dose escalation study of AGEN2373, a CD137 agonist, in patients with advanced solid tumors:
Reported responses in metastatic prostate cancer, ampullary carcinoma, and vulvar squamous cell carcinoma highlight the potential impact of AGEN2373.
AGEN2373 is the first CD137 agonist antibody to report single-agent responses with no major toxicities.
Clinical data are consistent with mechanistic design intent of AGEN2373 to avoid hepatic toxicity, a typical constraint of CD137-targeted agonists.
Leadership Appointments:
In alignment with Agenus’ next phase of growth and anticipated commercialization of the bot/bal combination, the company announced the following key executive appointments:
Robin Taylor, Ph.D., Chief Commercial Officer.
Homa Yeganegi, Chief Product Strategy and Global Medical Affairs Officer.
Stephanie Fagan, Chief Communications Officer.
Second Quarter 2023 Financial Results:
We ended our second quarter 2023 with a cash, cash equivalent and short-term investment balance of $157.6 million, compared to $193.4 million at December 31, 2022. In addition, we have raised $20.3 million through sales of our common stock under our at market issuance sales agreement since the end of Q2 2023.