Agenus Inc (Nasdaq: AGEN), an immuno-oncology company targeting cancer and infectious diseases with a comprehensive pipeline of immunological agents, on Tuesday reported its Q2 2023 results, showcasing significant progress in its efforts to develop innovative immunological agents for various cancers.

Key highlights include an update on Botensilimab/Balstilimab Combination. Agenus presented combination data for Botensilimab and Balstilimab at ESMO-GI, demonstrating a median overall survival (mOS) of 20.9 months and a 23% overall response rate (ORR). These outcomes surpass the standard of care for 3L+ Non-MSI-H colorectal cancer (CRC) patients without active liver metastases.

The US FDA granted Fast Track designation for the Botensilimab/Balstilimab combination in 3L+ Non-MSI-H CRC patients without active liver metastases. Agenus is exploring accelerated approval strategies for global usage in CRC treatment.

Clinical trials are progressing, with ongoing Phase 2 ACTIVATE trials in CRC and melanoma expected to be fully enrolled by the end of the year.

Phase 1 dose escalation data for AGEN2373 presented at ASCO showed promising monotherapy clinical responses in patients with advanced solid tumors.

The highlight of the ESMO-GI presentation was data from the Botensilimab/Balstilimab combination study. In patients with non-MSI-High CRC without active liver metastases, the combination demonstrated a significant improvement in both ORR and mOS compared to the standard care. The mOS of 20.9 months and an ORR of 23% outperformed the benchmarks set by standard care.

The ACTIVATE Phase 2 trial in this patient population is on track to conclude enrollment by year-end, with plans for a Phase 3 CRC study under discussion with the FDA. A Biologics License Application to the FDA is also planned for 2024.

In addition to the CRC study, Agenus is continuing its clinical trials in various other cancer indications, including lung, melanoma, ovarian and sarcomas, showcasing its commitment to advancing cancer immunotherapy.

Financially, Agenus ended Q2 2023 with a cash balance of USD157.6m, compared to USD193.4m at the end of 2022. The company recognized revenues of USD25.3m and USD48.2m for the three and six months ended 30 June 2023, respectively, with a net loss of USD73.4m and USD144.3m for the same periods.

Agenus' strides in immunotherapy, particularly the positive outcomes seen with Botensilimab and AGEN2373, signal its dedication to advancing treatment options for patients with advanced solid tumours. The company's focus on combining innovative agents and its ongoing clinical trials reflect its commitment to improving cancer care.