- 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.
“Throughout 2022, the team at
Recent Highlights
- 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
The company ended 2022 with approximately
About the IOB-013/KN-D18 Phase 3 Clinical Trial
IOB-013/KN-D18 (Clinical Trials.gov: NCT05155254) is an open label, randomized Phase 3 clinical trial being conducted in collaboration with Merck of IO102-IO103 in combination with pembrolizumab versus pembrolizumab alone in patients with previously untreated, unresectable or metastatic (advanced) melanoma. Target enrollment is 300 patients from centers spread across
About IOB-022/KN-D38 Phase 2 Solid Tumor Basket Study
IOB-022/KN-D38 is a non-comparative, open label trial to investigate the safety and efficacy of IO102-IO103 in combination with pembrolizumab in each of the following first-line indications: NSCLC, SCCHN, and UBC. The clinical trial is sponsored by
About IO102-IO103
IO102-IO103 is an investigational cancer immunotherapy designed to target the immunosuppressive mechanisms mediated by the key immunosuppressive proteins indoleamine 2,3-dioxygenase (IDO) and PD-L1.
About
For further information, please visit www.iobiotech.com
Forward-looking Statement
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements, including regarding current or future clinical trials, their progress, enrollment or results, or the company’s financial position or cash runway, are based on IO Biotech’s current assumptions and expectations of future events and trends, which affect or may affect its business, strategy, operations or financial performance, and actual results and other events may differ materially from those expressed or implied in such statements due to numerous risks and uncertainties. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements speak only as of the date hereof and should not be unduly relied upon. Except to the extent required by law,
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