Agenus Inc. AGEN 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.
Agenus Inc. Price and Consensus
Agenus Inc. price-consensus-chart | Agenus Inc. Quote
Zacks Rank and Stocks to Consider
Agenus currently has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the same industry are Aptinyx APTX, Acadia Pharmaceuticals ACAD and ADMA Biologics ADMA, all carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 90 days, the Zacks Consensus Estimate for Aptinyx’s 2023 loss per share has narrowed from 77 cents to 47 cents. In the past year, shares of Aptinyx have fallen by 87.2%.
APTX beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 6.56%.
In the past 90 days, the Zacks Consensus Estimate for Acadia Pharmaceuticals’ 2023 loss per share has narrowed from 87 cents to 57 cents. In the past year, shares of Acadia Pharmaceuticals have fallen by 10.8%.
ACAD beat estimates in two of the trailing four quarters, missing the mark on the other two occasions, delivering an average negative earnings surprise of 6.33%.
In the past 90 days, the consensus estimate for ADMA Biologics’ 2023 loss per share has narrowed from 19 cents to 14 cents. In the past year, shares of ADMA Biologics have increased by 63%.
ADMA beat estimates in three out of the trailing four quarters, delivering an average earnings surprise of 2.88%.
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