– Results from Phase 2 cervical cancer trial with ISA101 selected for plenary oral presentation

Leiden, The Netherlands, March 28, 2019– ISA Pharmaceuticals B.V., a clinical-stage immuno-oncology company, today announced that its Chief Scientific Officer Prof. Dr. Cornelis Melief will give an oral presentation at the upcoming AACR Annual Meeting 2019 in Atlanta, GA, USA, on March 31, 2019.

The presentation titled “A strong HPV-specific T-cell response after chemo-immunotherapy for advanced cervical cancer is associated with prolonged survival”is scheduled for Sunday, March 31, 2019, as part of the session “Predictive Biomarkers for Immunotherapy” (12:45-2:45pm, Marcus Auditorium- Bldg A-GWCC).

The data will outline the effects of vaccination with ISA Pharmaceuticals´ therapeutic vaccine ISA101 during chemotherapy in 77 patients with advanced, recurrent or metastatic cervical cancer in a dose assessment study.

ISA101 is directed against the HPV16 oncoproteins E6/E7 and is the Company´s clinical-stage lead compound. It is being developed to treat HPV16-induced cancers such as cervical cancer and head-and-neck cancer. Clinical efficacy of ISA101 in combination with Regeneron’s PD-1 inhibitor cemiplimab is currently being tested in a randomized controlled Phase 2 trial in platinum refractory, HPV16-positive oropharyngeal cancer patients (NCT03669718). The results to be presented at AACR form the basis for a planned Phase 3 trial, in which the clinical benefit of the combination of ISA101 plus cemiplimab on top of standard-of-care chemotherapy will be studied in patients with advanced HPV16-positive cervical cancer.

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About ISA Pharmaceuticals

ISA Pharmaceuticals B.V. is an immunotherapy company developing rationally designed, fully synthetic immunotherapeutics against cancer and persistent viral infections. The Company has built a proprietary immunotherapy platform based on the Synthetic Long Peptide (SLP^®) concept and AMPLIVANT^®technology. SLP^®immunotherapies are designed to fully harness and direct the body’s own defenses towards fighting the disease. In December 2017, ISA Pharmaceuticals closed a clinical immuno-oncology collaboration with Regeneron to advance its SLP^®lead compound ISA101, an immunotherapy targeting human papillomavirus type 16 (HPV16)-induced cancer, in combination with cemiplimab (REGN2810, Libtayo^®), a PD-1 (programmed cell death protein 1) antibody in development by Regeneron, which was recently approved by the FDA as monotherapy for patients with advanced cutaneous squamous cell carcinoma. ISA develops a diverse SLP^®immunotherapy portfolio targeting unmet medical needs in cancer and chronic infections, including tailored therapy for rare diseases.

SLP^®and AMPLIVANT^®are registered trademarks in Europe.

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