Agenus Inc. ( AGEN Quick Quote AGEN - Free Report) announced that the FDA has granted Fast Track Designation to the experimental combination of botensilimab (AGEN1181) and balstilimab (AGEN2034). The designation is for patients with non-microsatellite instability-high (MSI-H)/deficient mismatch repair metastatic colorectal cancer with no active liver involvement. The stock of the company jumped 15.9% on Monday following the news.
In the past year, shares of Agenus have lost 27% compared with the industry’s 11.9% decline.
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Botensilimab is Agenus’ proprietary, novel and multifunctional CTLA-4 investigational antibody to treat “cold” tumors that have not historically responded to standard-of-care or investigational therapies. Botensilimab is being studied either alone or in combination with Agenus’ PD-1 antibody, balstilimab, in a phase Ib study of more than 350 patients. It displayed clinical responses in nine, previously intestinal obstruction unresponsive, solid tumor cancers.
Per the press release, the patient group targeted with this designation includes those who are heavily pretreated, resistant or intolerant to fluoropyrimidine, oxaliplatin and irinotecan, and those who have also received a VEGF inhibitor, an EGFR inhibitor and/or a BRAF inhibitor, if indicated. This represents a huge unmet medical need. Agenus is conducting a global phase II study of botensilimab in combination with balstilimab compared with the standard of care in non-MSI-H colorectal cancer patients.
The designation, granted by the FDA, was based on positive and statistically significant results from Agenus’ ongoing studies of the botensilimab/balstilimab combination in patients with non-MSI-H colorectal cancer. Results from the combination therapy showed an overall response rate of 23% and a 12-month survival rate of 63% compared with a 1-2% overall response rate and a 25% 12-month survival rate reported for the standard of care.
Agenus is also currently conducting phase II studies in pancreatic cancer and melanoma, besides non-MSI-H colorectal cancer as part of its ACTIVATE trial programs.
Management is keen on utilizing the important benefits that the Fast Track designation offers, along with the potential eligibility for a Priority Review.
Agenus expects to launch a global phase III study of the botensilimab/balstilimab combination in non-MSI-H colorectal cancer in 2023.
Zacks Rank and Stocks to Consider
Agenus currently has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the same industry are
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