Agenus Inc. develops immuno-oncology therapies for cancer, with recurring updates centered on botensilimab (BOT) and balstilimab (BAL), its CTLA-4/PD-1 immunotherapy combination. Company news regularly covers clinical data in solid tumors, including metastatic colorectal cancer, melanoma and gastroesophageal cancer, as well as translational biomarker work and combination approaches that use antibody therapeutics, adoptive cell therapy through MiNK Therapeutics and adjuvants.
Agenus updates also address regulatory-authorized access pathways for BOT+BAL, including France's AAC framework and paid named-patient programs where permitted, along with financial results, equity financing activity, commercial readiness, manufacturing collaborations and corporate governance developments.
Agenus Inc. announced promising results from its Phase 2 study of balstilimab for recurrent/metastatic cervical cancer, published in Gynecologic Oncology. The study reported a 20% objective response rate among PD-L1 positive tumors, with a median follow-up of 14.6 months. Notably, responses were also seen in PD-L1 negative patients, highlighting balstilimab's potential efficacy across tumor histologies. The safety profile was manageable, and the company is preparing for further data presentation at the ESMO Congress 2021. Agenus aims to leverage these results as it seeks FDA approval for balstilimab.
Agenus Inc. (NASDAQ: AGEN) announces significant developments in its clinical pipeline, including a $200 million collaboration with Bristol Myers Squibb (BMS) for the anti-TIGIT bispecific antibody, AGEN1777. The FDA has cleared the IND for AGEN1777's clinical enrollment, with Phase 1 dosing starting soon. AGEN1181 is showing promising clinical results and is set for registrational trials by year-end 2021. Furthermore, the FDA accepted the balstilimab BLA for Priority Review, with a PDUFA date of December 16, 2021. The company reported a net loss of $84 million for Q2 2021.
Agenus (NASDAQ: AGEN), an immuno-oncology company, announced that Jennifer Buell, PhD, its President and COO, will participate in a fireside chat at the BTIG Biotechnology Conference 2021 on August 9, 2021, from 3:00 p.m. to 3:25 p.m. ET. The event is exclusively for BTIG clients. Agenus focuses on developing therapies that engage the immune system to combat cancer through a comprehensive pipeline including checkpoint antibodies and vaccines. For more information, visit www.agenusbio.com.
MiNK Therapeutics has submitted a draft registration statement on Form S-1 to the SEC for a proposed initial public offering (IPO) of its common stock. The share count and pricing details will be determined later, with the IPO expected to occur post-SEC review and contingent on market conditions. MiNK operates as a subsidiary of Agenus (NASDAQ: AGEN). This announcement follows compliance with Rule 135 under the Securities Act of 1933, clarifying that it does not represent an offer to sell or buy securities.
Agenus (NASDAQ: AGEN) will announce its Q2 2021 financial results on August 9, 2021, before market open. A conference call is scheduled for the same day at 8:30 a.m. ET to discuss the results and provide a corporate update. The call can be accessed via U.S. and international dial-in numbers, and a live webcast will be available on Agenus' website. Agenus specializes in immuno-oncology, focusing on therapies that engage the immune system to combat cancer.
Agenus (NASDAQ: AGEN) announced that Dr. Steven O'Day, Chief Medical Officer, will participate in a panel at the William Blair Biotech Focus Conference 2021 on July 14, 2021. The panel discussion is titled “Novel Mechanisms and Strategies for Addressing PD-(L)1 Refractory/Resistant Tumors” and will occur from 4:20 p.m. to 5:20 p.m. ET. The event will be webcast live on the Company's website, highlighting Agenus' commitment to advancing immuno-oncology therapies.
Agenus Inc. (NASDAQ: AGEN) announced a global exclusive license with Bristol Myers Squibb for its bispecific antibody program, AGEN1777, and received FDA clearance for an Investigational New Drug application. AGEN1777 targets inhibitory receptors on T and NK cells to enhance anti-tumor activity. The agreement includes a $200 million upfront payment and potential milestones totaling up to $1.36 billion. Phase 1 trials are set to begin in Q3 2021, focusing on safety and preliminary activity in patients with advanced solid tumors.
Agenus, a clinical-stage immuno-oncology company, will have its President and COO, Jennifer Buell, PhD, present at the Raymond James 2021 Human Health Innovation Conference on June 22, 2021, from 8:40 a.m. to 9:10 a.m. ET. The presentation will focus on the company's extensive pipeline, which includes checkpoint antibodies, cell therapies, and vaccines to activate immune responses against cancer and infections. The session will be available via a live webcast on their website.
Agenus Inc. (NASDAQ: AGEN) announced that the FDA accepted its Biologics License Application for balstilimab, an anti-PD-1 antibody aimed at treating recurrent or metastatic cervical cancer post-chemotherapy. The FDA granted Priority Review for this drug, indicating potential for significant treatment improvement. A target action date is set for December 16, 2021. Cervical cancer remains a major health issue, with an estimated 14,000 diagnoses and 4,000 deaths in the U.S. annually. The drug, currently in Phase 2 trials, could provide new options for patients facing limited treatment alternatives.
Agenus (NASDAQ: AGEN) announced its virtual Annual Shareholders Meeting to be held on June 15, 2021, at 5:00 p.m. ET. Registration will start at 4:45 p.m. ET, and shareholders can participate by visiting the provided link and entering their control number. Guests can listen in without a number. A live webcast will be available on the company's website. Agenus focuses on developing immuno-oncology therapies aimed at enhancing the immune response against cancer. For more information, stakeholders can visit the company's website.