iTeos Therapeutics (NASDAQ:ITOS) has been making significant strides in the field of immunotherapy, focusing on a molecule targeting TIGIT, a checkpoint with a complex history in cancer clinical research. The company’s approach has been garnering growing optimism, especially in the realm of lung cancer treatment. With the anticipation of data readouts at this year’s ESMO meeting, the recent findings have shed light on the potential of iTeos’ innovative approach to enhancing immunotherapy for challenging malignancies.
Pipeline Updates
The primary product candidate in iTeos’ pipeline is belrestotug, an anti-TIGIT antibody designed to boost antitumor immunity, particularly in combination with an anti-PD-1 antibody like dostarlimab, known as Jemperli by GSK. A significant development for ITOS this year was the initiation of a randomized, phase 3 trial named GALAXIES-Lung-301. This trial compares belrestotug versus placebo in conjunction with pembrolizumab (Keytruda) in patients with advanced, PD-L1-high non-small cell lung cancer (NSCLC).
At ESMO 2024, iTeos presented findings from the GALAXIES Lung-02 study, which enrolled patients with PD-L1-high, advanced NSCLC to receive pembrolizumab alone, dostarlimab alone, or various dosing regimens of dostarlimab plus belrestotug. The study’s main objective was to assess response rates of the different treatment approaches. Results from substudy 1 revealed that dostarlimab alone led to a clinical response in 37.5% of patients, while the arms combining dostarlimab and belrestotug showed response rates ranging from 63.3% to 76.7%. These findings suggest promising clinical activity of the combination therapy in lung cancer.
Financial Overview
As of the most recent quarterly filing, iTeos held $251.1 million in cash and equivalents, with an additional $320.2 million in short-term investments. The company recognized $35 million in collaboration revenue related to a milestone payment for initiating the phase 3 trial for belrestotug. Operating expenses reached $49.2 million, resulting in a net loss of $7.1 million for the quarter. With a cash runway of over three years, iTeos is well-positioned to reach critical milestones and pursue approval for its innovative therapies.
Strengths and Risks
One of iTeos’ strengths lies in its sufficient cash reserves to support its research and development efforts. With a cash runway extending over three years, the company has the financial stability to progress through key milestones. Additionally, the promising clinical activity demonstrated by the combination therapy in lung cancer indicates a potential breakthrough in immunotherapy.
However, there are risks associated with the data presented at ESMO 2024. While the response rates appear encouraging, there is a need for caution in interpreting the results, as response rate alone may not be indicative of long-term success. Safety concerns, particularly the increase in high-grade toxicities, pose a significant risk to the potential approval of the therapy. Furthermore, the limited patient population targeted in the trial highlights the need for further research and validation in broader patient cohorts.
Bottom-Line Summary
iTeos has presented compelling data at ESMO 2024, indicating promising clinical activity of its anti-TIGIT therapy in combination with pembrolizumab for NSCLC. While there are risks and uncertainties associated with the findings, the company’s innovative approach to enhancing immunotherapy warrants further exploration. With a market cap of approximately $600 million, iTeos holds significant upside potential if it can establish a strong foothold in the field of cancer immunotherapy. As the company continues to advance its pipeline and pursue critical milestones, it remains a compelling candidate for investment consideration.
In conclusion, iTeos’ recent data presentation at ESMO 2024 has shed light on the potential of its anti-TIGIT therapy in improving immunotherapy outcomes for patients with NSCLC. With a strong financial foundation and promising clinical activity, iTeos is poised to make significant advancements in the field of cancer treatment. While challenges and risks persist, the company’s innovative approach holds promise for revolutionizing cancer care and improving patient outcomes.
