- Independent data monitoring committee recommends that the company’s Phase 3 trial evaluating IO102-IO103 in combination with pembrolizumab in first-line advanced melanoma patients continue without any modifications; the trial is enrolling patients at more than 80 active sites globally.
- Encouraging initial data reported from 9 evaluable non-small cell lung cancer patients from the company’s ongoing Phase 2 solid tumor basket trial evaluating IO102-IO103 in combination with pembrolizumab; the company anticipates additional data from this study in 2023.
- Agreed to support an investigator-initiated study with Johns Hopkins University evaluating the addition of IO102-IO103 to neoadjuvant pembrolizumab and adjuvant pembrolizumab prior to curative-intent surgical care for squamous cell carcinoma of the head and neck (SCCHN), expected to begin in the first half of 2023.
New York, New York - January 9, 2023: IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulating cancer vaccines based on its T-win® vaccine platform, today provided a business update.
“Throughout 2022, the team at IO Biotech made major progress on multiple fronts - advancing our lead program into a global Phase 3 pivotal trial for patients with advanced melanoma, initiating a Phase 2 solid tumor basket study for IO102-IO103 in combination with pembrolizumab, and continuing research on our pipeline assets,” said Mai-Britt Zocca, Ph.D., President and Chief Executive Officer of IO Biotech. “At year end, we had more than 80 clinical trial sites in the United States, Europe, Australia, Israel and South Africa active in our Phase 3 trial, and we observed strong interest and accelerating enrollment trends in both the Phase 3 melanoma trial and the Phase 2 basket study for multiple solid tumors. Importantly, today we report encouraging initial data from the first 9 efficacy evaluable patients in the lung cancer cohort from our Phase 2 study with four patients achieving a partial response and four patients with stable disease.”
Dr. Zocca continued, “In 2023, we are focusing our full attention on clinical execution and advancing our clinical experience with IO102-IO103, through both our own clinical trials as well as various investigator-initiated studies. We now have four investigator-initiated studies underway in the United States and Europe, with an additional grant being finalized. The level of enthusiasm from leading cancer institutions around the world to work with our novel, investigational immune-modulating vaccine we believe is a testament to the potential broad applicability of an off-the-shelf cancer vaccine with a favorable safety profile.”
- The independent data monitoring committee for the company’s Phase 3 trial (IOB-013/KN-D18) evaluating IO102-IO103 in combination with pembrolizumab in first-line advanced melanoma patients convened its first meeting in December to review initial safety data from the trial and recommended that the trial continue without any modifications; the trial is enrolling patients at more than 80 active sites globally. The trial protocol calls for an interim analysis of overall response rate one year after 75% of the patients have been enrolled, which could allow for submission of a Biologics License Application for an accelerated approval in the US.
- The company recently agreed to support an investigator-initiated study with Johns Hopkins University evaluating the addition of IO102-IO103 to neoadjuvant pembrolizumab and adjuvant pembrolizumab prior to curative-intent surgical care for squamous cell carcinoma of the head and neck (SCCHN). The trial is expected to begin in the first half of 2023. The company is now supporting four investigator-initiated trials evaluating IO102-IO103 in combination regimens across a variety of cancer types.
- Encouraging initial data was reported today for the first time from 10 lung cancer patients in the company’s Phase 2 basket study (IOB-022/KN-D38) evaluating IO102-IO103 in combination with pembrolizumab in patients with non-small cell lung cancer, head and neck cancer, or bladder cancer. Of the 10, 9 were efficacy evaluable per protocol having received at least one full cycle of treatment. Among the 9 evaluable patients, 4 patients had a partial response while 4 had stable disease; one patient had progressive disease. The safety profile observed to date in this study is consistent with prior clinical experience with IO102-IO103. The company anticipates reporting additional data from this study in 2023.
“These initial data suggest that the combination of IO102-IO103 with pembrolizumab is active,” said David Gandara, MD, Co-Director, Center for Experimental Therapeutics in Cancer at UC Davis Comprehensive Cancer Center, the lead center for the study. “If these early data are sustained, I believe they would translate into a successful study and could support further development of this combination for patients with non-small cell lung cancer.”
The company ended 2022 with approximately $142.7 million in cash and cash equivalents (preliminary and unaudited) and anticipates this will be sufficient to fund operations into mid-2024.