Agenus Q2 2024 Operational and Financial Results

Agenus Inc. (Nasdaq: AGEN), a prominent company in the field of immuno-oncology, recently shared a corporate update and financial results for the second quarter of 2024. The company, headquartered in Lexington, Massachusetts, has made significant strides in developing innovative cancer therapies, particularly through its BOT/BAL program.

Key Developments and Clinical Achievements:

Agenus has released promising interim data from a Phase 2 trial of BOT/BAL for relapsed/refractory MSS colorectal cancer. The results are consistent with previous studies, showing robust tumor reductions and, in some cases, complete responses in patients who had no other treatment options. Dr. Garo Armen, Chairman and CEO of Agenus, emphasized the potential of BOT/BAL to address difficult cancer cases and highlighted the ongoing collaboration with global health authorities to expedite access to these treatments.

The BOT/BAL clinical program, involving approximately 1,100 patients, has demonstrated significant activity across 10 different cancers, including both early and late-stage diseases. The data reveal durable tumor reductions and complete responses in patients who had not responded to approved therapies. These findings have been presented at various conferences and published in leading scientific journals.

Topline interim data from the Phase 2 trial in relapsed/refractory MSS colorectal cancer showed a RECIST confirmed overall response rate (ORR) of 19.4% and a 6-month overall survival (OS) rate of 90% in the selected BOT 75mg/BAL combination cohort. The safety profile of BOT/BAL remains manageable with no new safety signals observed.

Recent publications in Nature Medicine and Cancer Discovery have highlighted the promising results of the BOT/BAL combination in metastatic MSS colorectal cancer, which affects 95% of metastatic colorectal cancer patients.

Updated results from the NEST study in neoadjuvant colorectal cancer presented at ESMO GI demonstrated unprecedented activity of BOT/BAL in MSS colorectal cancer. In the NEST-2 cohort, 78% of patients achieved at least a 50% tumor reduction, and 56% achieved complete pathologic responses. The toxicities were well managed, and no surgeries were delayed due to adverse events.

At the American Society of Clinical Oncology (ASCO) Annual Meeting, new analyses showcased BOT/BAL activity in metastatic colorectal cancer across challenging sites, including peritoneal metastases, soft tissue, bone, and brain. The ORR ranged from 18-33%, and disease control rates ranged from 67-82%. Median overall survival remained consistent, ranging from 20.7 months to not reached.

Regulatory and Collaborative Efforts:

Agenus has initiated engagement with the European Medicines Authority (EMA) and plans additional meetings to explore registration paths for BOT/BAL in other regions, including the UK, Canada, Australia, Israel, and Brazil. The company also anticipates releasing further data later this year across the BOT/BAL program beyond MSS colorectal cancer, showcasing the therapy's uniquely differentiated clinical activity.

Agenus has aligned with the FDA on the design and dosing regimen for an upcoming Phase 3 study in relapsed/refractory MSS colorectal cancer. Despite the FDA's suggestion against submitting interim results for Accelerated Approval, Agenus plans to present more mature data to support its strategy.

Partnerships and Financial Update:

Agenus recently closed the first tranche of a $75 million royalty financing led by Ligand Pharmaceuticals and is actively pursuing potential out-licensing transactions for several pipeline assets. These include AGEN1777, previously licensed to Bristol Myers Squibb, and AGEN2373, for which Gilead's option period has expired.

To support its efforts, Agenus is launching a Named Patient Program for BOT/BAL, enabling early access to the investigational combination for eligible patients before commercial availability. This program aims to provide hope to patients with critical needs, particularly those with colorectal cancer and other solid tumors that have not responded to standard treatments.

Financially, Agenus ended the second quarter of 2024 with a consolidated cash balance of $93.7 million, up from $76.1 million at the end of 2023. The company reported revenues of $23.5 million for the second quarter and $51.5 million for the first half of 2024. The net loss for the same periods was $54.8 million and $118.3 million, respectively.

Agenus continues to advance its mission of delivering innovative cancer therapies through robust clinical development and strategic partnerships, aiming to transform cancer treatment and improve patient outcomes.

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