Agenus Stock Price, News & Analysis

Agenus (NASDAQ: AGEN) has voluntarily withdrawn its Biologics License Application (BLA) for balstilimab, following the FDA's recommendation after the early approval of pembrolizumab. The BLA for balstilimab had received Fast Track and Priority Review status and was scheduled for action on Dec. 16, 2021. Balstilimab demonstrated a 20% response rate in PD-L1 positive patients during trials, outperforming pembrolizumab's 14%. Agenus plans to launch expanded access programs for balstilimab and will discontinue its BRAVA trial, potentially saving over $100M in R&D expenses.

Agenus (NASDAQ: AGEN) has announced the triggering of a $20 million milestone payment from Bristol Myers Squibb following the first patient dosing in the Phase 1 study of AGEN1777, a bispecific anti-TIGIT antibody. This agreement includes a total of $200 million upfront and up to $1.36 billion in additional milestones. AGEN1777 aims to enhance immune response against cancers, particularly targeting difficult tumors like non-small cell lung cancer. The trial's focus on safety and tolerability will help set the recommended Phase 2 dose.

Agenus Inc (NASDAQ: AGEN) announced the acceptance of an abstract detailing updated Phase 1 clinical trial results for AGEN1181, an Fc-enhanced anti-CTLA-4, alone and in combination with balstilimab (anti-PD-1). This will be presented at the Society for Immunotherapy of Cancer's 36th Annual Meeting, scheduled for November 10-14, 2021. The presentation aims to enhance understanding of AGEN1181's efficacy in treating advanced solid tumors. The full abstract will be accessible on November 9, 2021, in the investor section of their website.

Agenus (NASDAQ: AGEN) presented final results from a Phase 2 study on the Bal/Zal combination therapy for recurrent/metastatic cervical cancer at the ESMO Virtual Conference. With a median follow-up of 19.4 months, the objective response rate was 26%, including 9% complete responses. The combination exhibited improved responses across histology subgroups, including those previously unresponsive to therapies. No unexpected toxicities were observed, and further data on AGEN1181 is anticipated later this year.

Agenus has launched SaponiQx, a subsidiary focused on novel adjuvant discovery and vaccine design. This initiative partners with Ginkgo Bioworks to enhance vaccine efficacy and sustainability through innovative adjuvant technologies. SaponiQx aims to deliver a secure supply of known adjuvants and develop new vaccines. The company's lead product, QS21 Stimulon™, already demonstrates long-term efficacy in vaccines. The collaboration is designed to address the global challenge of vaccine access during pandemics and enhance the efficiency of vaccine manufacturing processes.

Agenus (NASDAQ: AGEN), a clinical-stage immuno-oncology company, recently announced participation in two upcoming conferences. Jennifer Buell, PhD, President and COO, will present at the H.C. Wainwright 23rd Annual Global Investment Conference on-demand starting September 13, 2021. Additionally, she will speak at the Baird 2021 Global Healthcare Conference on September 15, 2021, from 4:20 p.m. to 4:50 p.m. ET. A webcast replay for the Baird conference will be available on the company's website. Agenus focuses on therapies that utilize the body’s immune system to combat cancer.

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.