First Patient Treated in Phase II Combination Trial of ISA Pharmaceuticals’ Lead Immunotherapy ISA101b with Keytruda®

First Patient Treated in Phase II Combination Trial of ISA Pharmaceuticals’ Lead Immunotherapy ISA101b with Keytruda^®

Combination aimed at priming and driving durable patient immune responses to cancer

Leiden, The Netherlands, January 26, 2020 – ISA Pharmaceuticals B.V., a clinical-stage company dedicated to developing rationally designed immunotherapeutics for oncology and infectious disease, today announced that the first patient has been dosed with its lead product ISA101b in a Phase II trial conducted and sponsored by UPMC Hillman Cancer Center, the University of Pittsburgh, PA, and supported by Merck Sharp & Dohme Corp and ISA Pharmaceuticals B.V.

The study in previously untreated patients with intermediate-risk head and neck cancer associated with human papilloma virus subtype 16 (HPV-16) will evaluate the efficacy of ISA101b and pembrolizumab (Keytruda^®) in combination with cisplatin and radiotherapy. The principal investigator is Robert L. Ferris MD, PhD, Director of UPMC Hillman Cancer Center in Pittsburgh and Associate Vice Chancellor for Cancer Research at the University of Pittsburgh School of Medicine. Dr. Ferris is a paid member of the US Scientific Advisory Board for the Merck Sharp & Dohme Corp. This study was supported in part by a research grant from the Investigator-Initiated Studies Program of Merck Sharp & Dohme Corp.

The investigator-initiated, single-arm, open-label ‘Phase II Study Evaluating HPV-16 vaccination (ISA101b) and Pembrolizumab plus Cisplatin Chemoradiotherapy for Intermediate Risk HPV-16 associated Head and Neck Squamous Cell Carcinoma’ aims to enroll 50 patients with end of enrollment expected in late 2022.

The primary endpoint of the trial is 2-year progression-free survival (PFS) in patients with newly diagnosed, local-regionally advanced, intermediate risk HPV-associated head and neck cancer.

“For head and neck cancer patients at risk for tumor recurrence, chemo- and radiation therapy are being combined with PD-1 immune checkpoint inhibitors,” said Dr. Ferris. “We seek to leverage the effect of immunotherapy to enhance T cell specific immune responses against HPV, to provide for a more profound and durable anti-tumor effect. To explore this, we have chosen the synthetic long peptide (SLP) therapeutic HPV immunotherapy ISA101b. ISA Pharmaceuticals has demonstrated that HPV, as the predominant cause of this type of cancer, harbours powerful antigens against which virus-specific T cells will mount an attack on the cancer, and we will attempt to enhance this benefit using anti-PD1 pembrolizimab.”

“Currently immunotherapies combined with additional treatments are emerging as the most promising approach in oncology,” said Prof. Cornelis Melief, Chief Scientific Officer of ISA Pharmaceuticals. “Consistent with this, we have demonstrated in multiple trials that ISA101b is highly synergistic with various complementary cancer treatments. Our product has shown very promising results in Phase II combination trials with standard chemotherapy¹ and the checkpoint inhibitor nivolumab². This new trial will provide valuable insights into the effect of immunomodulation in the early stage adjuvant setting, in addition to our ongoing randomized Phase II ISA101b trial with cemiplimab in late stage oropharyngeal cancer. We very much look forward to the results.”

For further details of this study, please refer to https://clinicaltrials.gov/ and Identifier: NCT04369937.