— Study Meets Encouraging Overall Response Rate Secondary Endpoint Progression-Free Survival Data in Squamous Cell Carcinoma of the Head and Neck Cohort —
— No New Security Alerts or Additional Systemic Security Concerns Observed —
— The data were presented at the Congress of the European Society of Medical Oncology (ESMO) —
NEW YORK, Sept. 14, 2024 (GLOBE NEWSWIRE) — IO Biotech (Nasdaq: IOBT ), a clinical-stage biopharmaceutical company developing novel, off-the-shelf, immunomodulatory therapeutic cancer vaccines, announced encouraging data on Phase. A basket 2 trial of IO102-IO103, the company’s lead investigational therapeutic cancer vaccine candidate, in combination with Merck’s (known as MSD outside the United States and Canada) anti-PD-1 therapy KEYTRUDA ® (pembrolizumab) (IOB-022/KN) -D38) At the 2024 ESMO Congress in Barcelona, ​​September 13-17.
The presentation includes 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. study supporting the potential clinical benefit of this combination regimen for these patients. Data from 18 patients evaluated for efficacy demonstrated:
- The achievement of the primary endpoint confirmed an overall response rate (ORR) of 44.4% in the PD-L1 high population of patients with SCCHN regardless of HPV status.
- An encouraging median progression-free survival (PFS) of 6.6 months.
- 66.7% disease control rate (DCR).
- 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 a first-line treatment for patients with recurrent or metastatic SCCHN, including HPV-positive and -negative patients, said Jonathan Riess, MD, study principal investigator and Director, UC Davis Thoracic Oncology at the 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 compound should be conducted to build on the results of this Phase 2 trial.
Based on our data from studies in head and neck cancer and melanoma, there is accumulating evidence that the combination of IO102-IO103 with anti-PD-1 therapy and pembrolizumab may be a safe and effective first-line treatment for patients with this disease. a number of cancers, including metastatic and difficult-to-treat diseases, said Qasim Ahmed, MD, chief medical officer at IO Biotech. Importantly, more than half of the patients in this trial had a progression-free survival of more than 180 days, with an mPFS of 6.6 months. These data support 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 first-line treatment in up to 60 patients. Patients with metastatic non-small cell lung cancer (NSCLC) with recurrent or metastatic SCCHN with PD-L1 TPS ‰¥ 50% and PD-L1 CPS ‰¥ 20. The primary endpoint of the study is the overall response rate. Based on the data cutoff of August 2, 2024, patients with at least 2 baseline tumor assessments or who discontinued treatment after 2 cycles of the study were considered efficacy evaluable and included in the ESMO poster presentation.
To date, the safety profile observed in this study (OB-022/KN-D38) is consistent with previous studies of IO102-IO103 in combination with checkpoint inhibitors, with no additional significant systemic toxicity compared to anti-PD1 monotherapy and low-grade treatment. The most commonly reported treatment-related adverse events were transient injection site reactions‹. 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 and Publications page of the IO Biotech website. Details for the presentation are below:
Poster Phase 2 trial of vaccine IO102-IO103 and pembrolizumab: completed cohort for first-line (1L) treatment of 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
About IO102-IO103
IO102-IO103 is an off-the-shelf therapeutic cancer vaccine designed to kill tumor cells and immunosuppressive cells in the tumor microenvironment (â„¢E) by stimulating T cell activation and expansion 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 alone in patients with advanced melanoma. D38; NCT05077709) a Phase 2 basket trial (IOB-032/PN-E40; NCT05280314) investigating IO102-IO103 in combination with pembrolizumab in combination with pembrolizumab in patients with solid tumors (IOB-032/PN-E40; NCT05280314) adjuvant/adjuvant treatment of patients with solid tumors.
The clinical trials are funded by IO Biotech and conducted in collaboration with Merck, which supplies pembrolizumab. IO Biotech holds global commercial rights to IO102-IO103.
KEYTRUDA ® is a registered trademark of Merck Sharp (OTC 🙂 & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
About IOB-022/KN-D38 Phase 2 Solid Tumor Basket Trial
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 non-small cell lung cancer (NSCLC). and squamous cell carcinoma of the head and neck (SCCHN). IO Biotech is sponsoring the Phase 2 trials and Merck is providing pembrolizumab. IO Biotech holds global commercial rights to IO102-IO103.
About IO Biotech
IO Biotech is a clinical-stage biopharmaceutical company developing novel immunomodulating therapeutic cancer vaccines based on the T-win ® platform. The T-win platform is based on a novel approach to cancer vaccines designed to activate T cells to target 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, was granted breakthrough therapy designation by the US Food and Drug Administration for the treatment of advanced melanoma. IO Biotech is headquartered in Copenhagen, Denmark and has US headquarters in New York, New York.
For more information, visit www.iobiotech.com. Follow us on LinkedIn and our social media channels 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. Forward-looking statements regarding the timing or outcome of the Company’s Phase 3 trial preliminary analysis, other current or future clinical trials, their progress, enrollment or results, or the Company’s financial condition or cash flow runway are not IO Biotech’s current information. based on assumptions and expectations regarding future events and trends that affect or may affect its business, strategy, operations or financial performance, actual results and other events may differ materially from those expressed or implied in such statements due to numerous risks and uncertainties can Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or measured. 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 relied upon unduly. Except to the extent required by law, IO Biotech undertakes no obligation to update these statements 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
Health
917-498-1967
Julie.Funesti@salutecomms.com
Source: IO Biotech
