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Agenus (AGEN) Tanks on Colorectal Cancer Study Interim Data
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Shares of Agenus Inc. (AGEN - Free Report) plunged 58.8% on Jul 18 after the company announced the outcome of its end-of-phase II (EOP2) meeting with the FDA regarding the accelerated development of its immunotherapy combination botensilimab (BOT) and balstilimab (BAL).
The BOT/BAL combination is being studied for the treatment of adult patients with relapsed/refractory microsatellite stable colorectal cancer (r/r MSS CRC) with no active liver metastases.
The FDA discouraged the accelerated approval pathway for the BOT/BAL combination in r/r MSS CRC. As per the regulatory body, the objective response rate (ORR) observed in the phase II study might not convert to survival benefit.
AGEN announced top-line interim data from a phase II study that evaluated the BOT/BAL combination in r/r MSS CRC. The interim data demonstrated the best activity at 75 mg BOT/240mg BAL combination, which led to an ORR of 19.4%. Also, at the same dose, 90% of the patients were alive.
Shares of Agenus have plunged 55.9% so far this year compared with the industry’s decline of 1.4%.
Image Source: Zacks Investment Research
Per the press release, the company has reached an agreement with the FDA on the proposed dose of the BOT/BAL combination for a phase III study. The agreed dosing of the BOT/BAL combination regimen is BOT (75mg) once every six weeks for up to four doses in combination with BAL (240mg) once every two weeks for up to two years.
The FDA has also proposed to include a BOT monotherapy arm in the phase III study. AGEN is currently looking for a partner in the United States to conduct the phase III study.
Botensilimab is AGEN’s proprietary, novel and multifunctional CTLA-4 investigational antibody to treat cold tumors that have not historically responded to standard-of-care or investigational therapies.
Apart from CRC, the BOT/BAL combination has also demonstrated clinical activity in other cancer indications, such as lung cancer, melanoma and pancreatic cancers.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have improved from $4.41 to $4.44. Earnings per share estimates for 2025 have improved from $4.85 to $5.42. Year to date, shares of ANIP have jumped 11.3%.
ANIP’s earnings beat estimates in each of the trailing four quarters, the average surprise being 53.90%.
In the past 60 days, estimates for Adaptive Biotechnologies’ 2024 loss per share have narrowed from $1.30 to $1.29, while loss per share estimates for 2025 have narrowed from $1.08 to $1.02. Year to date, shares of ADPT have lost 13.6%.
ADPT’s earnings beat estimates in two of the trailing four quarters, meeting the same once and missing on the remaining occasion, the average surprise being 0.65%.
In the past 60 days, estimates for RAPT Therapeutics’ 2024 loss per share have narrowed from $2.94 to $2.93. Loss per share estimates for 2025 have narrowed from $2.06 to $2.05. Year to date, shares of RAPT have plunged 86.2%.
RAPT’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 3.19%.
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Agenus (AGEN) Tanks on Colorectal Cancer Study Interim Data
Shares of Agenus Inc. (AGEN - Free Report) plunged 58.8% on Jul 18 after the company announced the outcome of its end-of-phase II (EOP2) meeting with the FDA regarding the accelerated development of its immunotherapy combination botensilimab (BOT) and balstilimab (BAL).
The BOT/BAL combination is being studied for the treatment of adult patients with relapsed/refractory microsatellite stable colorectal cancer (r/r MSS CRC) with no active liver metastases.
The FDA discouraged the accelerated approval pathway for the BOT/BAL combination in r/r MSS CRC. As per the regulatory body, the objective response rate (ORR) observed in the phase II study might not convert to survival benefit.
AGEN announced top-line interim data from a phase II study that evaluated the BOT/BAL combination in r/r MSS CRC. The interim data demonstrated the best activity at 75 mg BOT/240mg BAL combination, which led to an ORR of 19.4%. Also, at the same dose, 90% of the patients were alive.
Shares of Agenus have plunged 55.9% so far this year compared with the industry’s decline of 1.4%.
Image Source: Zacks Investment Research
Per the press release, the company has reached an agreement with the FDA on the proposed dose of the BOT/BAL combination for a phase III study. The agreed dosing of the BOT/BAL combination regimen is BOT (75mg) once every six weeks for up to four doses in combination with BAL (240mg) once every two weeks for up to two years.
The FDA has also proposed to include a BOT monotherapy arm in the phase III study. AGEN is currently looking for a partner in the United States to conduct the phase III study.
Botensilimab is AGEN’s proprietary, novel and multifunctional CTLA-4 investigational antibody to treat cold tumors that have not historically responded to standard-of-care or investigational therapies.
Apart from CRC, the BOT/BAL combination has also demonstrated clinical activity in other cancer indications, such as lung cancer, melanoma and pancreatic cancers.
Zacks Rank & Stocks to Consider
Agenus currently carries a Zacks Rank #3 (Hold).
Some top-ranked stocks in the biotech sector are ANI Pharmaceuticals, Inc. (ANIP - Free Report) , Adaptive Biotechnologies Corporation (ADPT - Free Report) and RAPT Therapeutics, Inc. (RAPT - Free Report) , each 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 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have improved from $4.41 to $4.44. Earnings per share estimates for 2025 have improved from $4.85 to $5.42. Year to date, shares of ANIP have jumped 11.3%.
ANIP’s earnings beat estimates in each of the trailing four quarters, the average surprise being 53.90%.
In the past 60 days, estimates for Adaptive Biotechnologies’ 2024 loss per share have narrowed from $1.30 to $1.29, while loss per share estimates for 2025 have narrowed from $1.08 to $1.02. Year to date, shares of ADPT have lost 13.6%.
ADPT’s earnings beat estimates in two of the trailing four quarters, meeting the same once and missing on the remaining occasion, the average surprise being 0.65%.
In the past 60 days, estimates for RAPT Therapeutics’ 2024 loss per share have narrowed from $2.94 to $2.93. Loss per share estimates for 2025 have narrowed from $2.06 to $2.05. Year to date, shares of RAPT have plunged 86.2%.
RAPT’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 3.19%.