IO Biotech Reports its Off-the-Shelf Therapeutic Cancer Vaccine, IO102-IO103, in Combination with KEYTRUDA® Demonstrates Promising Activity and Durability in First-line Treatment of Patients with Metastatic Lung Cancer in Phase 2 IOB-022 Study

— Metastatic non-small cell lung cancer (NSCLC) patients treated in the first line setting with IO102-IO103 in combination with Keytruda^® demonstrated promising activity with an overall response rate of 55% unconfirmed/48% confirmed, disease control rate of 81%, and approximately 50% of patients without disease progression at 12 months; median duration of response not reached —

— Safety profile consistent with prior studies with the combination, showing no unexpected toxicities compared to anti-PD1 monotherapy, and low-grade transient injection site reactions as the most common treatment related adverse event —

— The data from this NSCLC cohort combined with the recent positive squamous cell carcinoma of the head and neck (SCCHN) cohort data presented at ESMO 2024 and previously reported positive Phase 1/2 study in melanoma demonstrate the potential of IO102-I0103 to be effective in broad patient populations —

— Pre-clinical data for IO Biotech’s second T-win vaccine candidate, IO112 targeting arginase 1, demonstrates anti-tumor activity with dynamic changes in the tumor microenvironment (TME) driven by the vaccine-targeted modulation of immunosuppressive tumor-associated macrophages (TAMs) —

— Data presented at the Society for Immunotherapy of Cancer’s Annual Meeting —

NEW YORK, Nov. 07, 2024 (GLOBE NEWSWIRE) — IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, off-the-shelf, immune modulating therapeutic cancer vaccines, announced data from the NSCLC cohort in the company’s Phase 2 basket trial of IO102-IO103, the company’s lead investigational candidate, given in combination with Merck’s (known as MSD outside of the United States and Canada) anti-PD-1 therapy KEYTRUDA^® (pembrolizumab) (IOB-022/KN-D38). These data, as well as new pre-clinical data from IO Biotech’s second vaccine candidate, IO112, will be presented at the Society for Immunotherapy of Cancer’s 39th Annual Meeting (SITC 2024) in Houston on November 8-10, 2024.

“These data build on the growing clinical evidence for IO102-IO103 in hard-to-treat cancers. These Phase 2 NSCLC data evaluating IO102-IO103 in combination with pembrolizumab demonstrated a positive trend in ORR compared to benchmark data in the evaluable patient population with no unexpected toxicity,” stated Jonathan Riess, MD, principal investigator of the trial and Director, Thoracic Oncology at the UC Davis Comprehensive Cancer Center. “We need new treatments that can extend the durability of response for lung cancer patients. No progression in nearly half of the patients in this study at 12 months is a positive signal.”

The presentation contains clinical and biomarker data from the fully enrolled cohort of patients (n=37) with previously untreated metastatic stage NSCLC with PD-L1 high TPS ≥ 50. The data from 31 efficacy evaluable patients demonstrated:

• A 55% unconfirmed (16 partial responses, 1 complete response), 48% confirmed overall response rate (ORR) in a PD-L1 high population of patients with NSCLC
• An 81% disease control rate (DCR)
• No disease progression at 12 months in approximately 50% of patients
• An encouraging 8.1-month median progression-free survival (PFS)
• Median duration of response (DOR) not yet reached
• A safety profile consistent with previously reported data when combining IO102-IO103 with anti-PD-1 monotherapy
• Vaccine-specific T cell responses to both IO102 (IDO1) and IO103 (PD-L1) were detected in patients on treatment

“The results of the combination of IO102-IO103 with the anti-PD-1 therapy pembrolizumab in the NSCLC cohort, combined with the promising data presented at ESMO for the SCCHN cohort and the previous Phase 1/2 data in melanoma, add to the body of evidence that our dual-approach of targeting tumor cells and immune suppressive cells in the tumor microenvironment may drive a meaningful clinical benefit across a range of hard-to-treat cancers,” said Qasim Ahmad, MD, Chief Medical Officer of IO Biotech. “Importantly, we are observing promising activity with no unexpected toxicity and safety concerns, which addresses a high unmet medical need and an important gap in current treatment options for patients.”

To date, the safety profile observed in this study (IOB-022/KN-D38) is consistent with prior studies of IO102-IO103 in combination with checkpoint inhibitors, with no unexpected systemic toxicity compared to anti-PD-1 monotherapy and low-grade transient injection site reactions reported as the most common treatment related adverse events​. Data from the squamous cell carcinoma of the head and neck (SCCHN) cohort of this study were presented at the 2024 European Society for Medical Oncology congress in September that demonstrated the cohort met its primary endpoint of ORR with encouraging PFS data.

Pre-clinical data from IO112, IO Biotech’s second therapeutic cancer vaccine candidate derived from the company’s T-win^® platform, also presented at SITC 2024
Arginase 1 (Arg1) plays a central role in immune suppression, and its overexpression has been reported in several cancers including renal cell carcinoma, pancreatic cancer, and head and neck cancer. Importantly, all immune suppressive myeloid cells in the TME express Arg1, and their key roles in cancer immune resistance mechanisms have been well described. The data presented in the poster showcase that IO112 vaccination leads to robust expansion of Arg1-specific T cells, which in turn directly target and reprogram immune suppressive TAMs, leading to tumor growth inhibition.

“Our present data confirm the hypothesis that the primary and direct target of IO112 treatment are TAMs – and, what is striking, is how dynamically the vaccine-induced T cells are impacting TAMs,” said Ayako Wakatsuki Pedersen, PhD, Senior Vice President of Translational Research at IO Biotech. “Treatment with IO112 results in TAMs changing their phenotype completely, from immune suppressive to highly pro-inflammatory, driving the modulation of the TME, and facilitating the immune attack on tumor cells. These data give us further confidence in our T-win^® platform, a unique approach to induce a proinflammatory and anti-tumorigenic TME via T cells that attack the primary drivers of immune suppression. This strong data adds to the rationale for IO112 clinical development, and we look forward to submitting an IND for IO112 in 2025.”

The posters can be found on the “Posters & Publications” page of the IO Biotech website. Details for the presentations are below:

Title: A phase 2 trial of the IO102-IO103 cancer vaccine plus pembrolizumab: results from the first-line (1L) cohort of PD-L1 high metastatic non-small cell lung cancer (NSCLC)
Presenter: Jonathan W. Riess, MD, MS, UC Davis Comprehensive Cancer Center
Abstract/Poster number: 756
Date: Saturday, November 9, 2024
Location: Exhibit Halls AB – George R. Brown Convention Center
Times: Poster hall: 9:00 a.m. – 8:30 p.m. CDT; Poster session 12:15 – 1:45 p.m.; Poster reception 7:00-8:30 p.m.

Title: Immune modulating vaccine against arginase 1 controls tumor growth via modulation of tumor-associated macrophages
Presenters: Evelina Martinenaite, PhD, Senior Scientist, Translational Research, and Inés Lecoq, PhD, Scientist, Translational Research, IO Biotech
Abstract/Poster number: 1038
Date: Saturday, November 9, 2024
Location: Exhibit Halls AB – George R. Brown Convention Center
Times: Poster hall: 9:00 a.m. – 8:30 p.m. CDT; Poster session 12:15 – 1:45 p.m.; Poster reception 7:00-8:30 p.m.

About IO102-IO103

IO102-IO103 is an investigational off-the-shelf therapeutic cancer vaccine designed to kill both tumor cells and immune-suppressive cells in the tumor microenvironment (TME) by stimulating activation and expansion of T cells against indoleamine 2,3-dioxygenase (IDO) positive and programmed death-ligand 1 (PD-L1) positive cells. The company is currently conducting a pivotal Phase 3 trial (IOB-013/KN-D18; NCT05155254) investigating IO102-IO103 in combination with pembrolizumab versus pembrolizumab alone in patients with advanced melanoma, a Phase 2 basket trial (IOB-022/KN-D38; NCT05077709) investigating IO102-IO103 in combination with pembrolizumab as first line treatment in patients with solid tumors, and a Phase 2 basket trial (IOB-032/PN-E40; NCT05280314) investigating IO102-IO103 in combination with pembrolizumab as neo-adjuvant/adjuvant treatment of patients with solid tumors.

The clinical trials are sponsored by IO Biotech and conducted in collaboration with Merck, which is supplying pembrolizumab. IO Biotech maintains global commercial rights to IO102-IO103.

KEYTRUDA^® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About IO Biotech

IO Biotech is a clinical-stage biopharmaceutical company developing novel, immune-modulating therapeutic cancer vaccines based on its T-win^® platform. The T-win platform is based on a novel approach to cancer vaccines designed to activate T cells to target the immunosuppressive cells in the tumor microenvironment. IO Biotech is advancing its lead cancer vaccine candidate, IO102-IO103, in clinical trials, and additional pipeline candidates through preclinical development. Based on positive Phase 1/2 first line metastatic melanoma data, IO102-IO103, in combination with pembrolizumab, has been granted a breakthrough therapy designation for the treatment of advanced melanoma by the US Food and Drug Administration. IO Biotech is headquartered in Copenhagen, Denmark and has US headquarters in New York, New York.

For further information, please visit www.iobiotech.com. Follow us on our social media channels on LinkedIn and X (@IOBiotech).

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 the timing or outcome of primary analysis of the company’s Phase 3 trial, other 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, IO Biotech undertakes no obligation to update these statements, whether as a result of any new information, future developments or otherwise.

Contact:

Investors
Maryann Cimino, Director of Investor Relations
IO Biotech, Inc.
617-710-7305
mci@iobiotech.com

Media
Julie Funesti
Salutem
917-498-1967
julie.funesti@salutemcomms.com