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-- Study Meets Overall Response Rate Primary Endpoint, Encouraging Secondary Endpoint Progression-Free Survival Data in Squamous Cell Carcinoma of the Head and Neck Cohort -- -- No New Safety Signals or Added Systemic Safety Concerns Observed -- -- Data Presented at the European Society for Medical Oncology (ESMO) Congress -- Sept. 14, 2024 -- IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, off-the-shelf, immune-modulating therapeutic cancer vaccines, announced promising data from the Phase 2 basket trial of IO102-IO103, the company’s lead investigational therapeutic cancer vaccine candidate, 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) at the 2024 ESMO Congress in Barcelona from September 13-17. The presentation contained clinical and biomarker data from a cohort of patients with recurrent or metastatic (advanced) squamous cell carcinoma of the head and neck (SCCHN) with PD-L1 CPS ≥ 20 (PD-L1 high), contributing to the growing body of research supporting the potential clinical benefit of this combination regimen for these patients. The data from 18 efficacy evaluable patients demonstrated: Achievement of the primary endpoint – confirmed 44.4% overall response rate (ORR) in a PD-L1 high population of patients with SCCHN irrespective of HPV status. An encouraging 6.6-month median progression-free survival (PFS). A 66.7% disease control rate (DCR). A safety profile consistent with previously reported data when combined with anti-PD-1 monotherapy. T-cell responses to both IO102 (targeting IDO) and IO103 (targeting PD-L1) were detected after treatment. “These encouraging data further support the potential of IO102-IO103 in combination with pembrolizumab as first-line treatment for patients with recurrent or metastatic SCCHN including HPV-positive and -negative patients,” stated Jonathan Riess, MD, principal investigator of the trial and Director, Thoracic Oncology at the UC Davis Comprehensive Cancer Center. “Given the need for new treatment options that are effective, safe and accessible for head and neck cancer patients, further investigation of this combination should be conducted to build on the findings of this Phase 2 trial.” “With the data we’ve presented from studies in head and neck cancer and in melanoma, evidence is accumulating that the combination of IO102-IO103 with the anti-PD-1 therapy pembrolizumab could be a safe and efficacious first-line treatment for patients with a range of cancers, including those with metastatic and difficult-to-treat disease,” said Qasim Ahmad, MD, Chief Medical Officer of IO Biotech. “Importantly, with mPFS of 6.6 months, more than half of the patients in this trial had over 180 days of progression-free survival. These data are supportive of further investigation of this combination regimen as part of our commitment to transform the lives of cancer patients through our novel therapeutic vaccine.” The Phase 2 basket study (IOB-022/KN-D38; NCT05077709) is a non-comparative, open-label trial to investigate the safety and efficacy of IO102-IO103 in combination with pembrolizumab as a first-line treatment in up to 60 patients with metastatic non-small cell lung cancer (NSCLC) with PD-L1 TPS ≥ 50% and recurrent or metastatic SCCHN with PD-L1 CPS ≥ 20. The primary endpoint of the study is overall response rate. Patients enrolled in the study who had at least 2 post-baseline tumor assessments or who discontinued after 2 cycles of study treatment as of the data cut off of August 2, 2024 were considered efficacy evaluable and were included in the ESMO poster presentation. To date, the safety profile observed in this study (OB-022/KN-D38) is consistent with prior studies of IO102-IO103 in combination with checkpoint inhibitors, with no added significant systemic toxicity compared to anti-PD1 monotherapy and low-grade transient injection site reactions reported as the most common treatment related adverse events​. The trial has completed enrollment of patients in all cohorts. Data from the non-small cell lung cancer (NSCLC) cohort of this study will also be presented at another medical meeting in the fall. The poster can be found on the “Posters & Publications” page of the IO Biotech website. Details for the presentation are below: Poster Title: A phase 2 trial of the IO102-IO103 vaccine plus pembrolizumab: completed cohort for first line (1L) treatment of advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN) Presentation number: 1022P Presenter: Jonathan W. Riess, MD, MS (UC Davis Comprehensive Cancer Center) Date: Saturday, September 14, 2024 Time: 12:00 PM – 1:00 PM CEST 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. IOB-022/KN-D38 (NCT05077709) is a non-comparative, open-label trial to investigate the safety and efficacy of IO102-IO103 in combination with pembrolizumab in first-line advanced cancers in non-small cell lung cancer (NSCLC) and squamous cell carcinoma of the head and neck (SCCHN). IO Biotech is sponsoring the Phase 2 trial and Merck is supplying pembrolizumab. IO Biotech maintains global commercial rights to IO102-IO103. 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. The content above comes from the network. if any infringement, please contact us to modify.

Patients who received IO Biotech's vaccine with Keytruda experienced median progression-free survival of 6.6 months and a disease control rate of 66.7%. Immune checkpoint inhibitors are the superheroes of cancer therapy. Drugs like Bristol Myers Squibb’s Opdivo and Merck’s Keytruda are among the most profitable in the world—Keytruda pulled in $25 billion last year, making it the bestselling drug of 2023. But every good superhero needs a sidekick.During the 2024 European Society for Medical Oncology congress, Copenhagen-based IO Biotech presented data showing that its IO102-IO103 cancer vaccine, in combination with Keytruda (pembrolizumab), delivered an objective response rate of 44.4%, hitting the primary endpoint of a phase 2 trial in patients with advanced squamous cell carcinoma of the head and neck (SCCHN).“With the data we’ve presented from studies in head and neck cancer and in melanoma, evidence is accumulating that the combination of IO102-IO103 with the anti-PD-1 therapy pembrolizumab could be a safe and efficacious first-line treatment for patients with a range of cancers, including those with metastatic and difficult-to-treat disease,” IO Biotech's chief medical officer, Qasim Ahmad, M.D., said in a Sept. 14 release. IO Biotech’s IO102-IO103 vaccine is actually a combination of two vaccines that each prime patients’ T cells to target tumors. IO102 induces the immune cells to go after indoleamine-2,3-dioxygenase (IDO), an enzyme found inside of cells, while IO103 directs them toward programmed death-ligand 1 (PD-L1), a protein embedded in the cell membrane. Both IDO and PD-L1 are used by cancer cells to avoid being targeted and destroyed by the body’s immune system.By activating T cells against IDO and PD-L1, the theory is that the body’s immune system will join the fight against cancerous cells.The IOB-022/KN-D38 phase 2 trial had a total of 63 patients enrolled across cancer types as of Aug. 2, with 21 SCCHN patients enrolled. SCCHN patients who received the vaccine with Keytruda experienced median progression-free survival of 6.6 months and a disease control rate of 66.7%.Adverse events were common, with 20 of 21 patients experiencing side effects. Most were of low severity, like rash, fatigue and a reaction at the injection site. One patient suffered a severe treatment-related adverse event, immune thrombocytopenia, which was managed with corticosteroid treatment. Two patients discontinued treatment due to side effects of conjunctivitis and colitis, while another died of an unrelated illness during the trial. That left 18 patients for the data analysis.Data from the cohort of patients with non-small cell lung cancer will be presented at another meeting this fall, IO Biotech said in the release.Merck is collaborating on the IO102-IO103 trials, but IO Biotech maintains global commercial rights to the vaccines, according to the release. IO’s assets aren’t the only cancer vaccines Merck is auditioning for a supporting role alongside Keytruda. At the American Society of Clinical Oncology meeting in June, the Big Pharma shared data from a phase 2 trial of an mRNA vaccine being developed with Moderna. At a typical follow-up of 34.9 months, the vaccine and Keytruda combo reduced the risk of recurrence or death by 49% compared to Keytruda alone in patients with resected melanoma.IO Biotech raised a $155 million series B in 2021 to advance its cancer vaccines. The Danish company is also testing IO102-IO103 in combination with Opdivo (nivolumab) and BMS' relatlimab in a phase 2 trial in untreated, unresectable melanoma. The vaccine-Opdivo combo received a breakthrough-therapy designation from the FDA in 2020.Earlier this year at the World Vaccine Congress, Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, expressed the agency’s willingness to review new cancer vaccines.