ISA Pharmaceuticals Commences Patient Treatment in Third Phase 2 Clinical Trial with the Combination of ISA101b and Libtayo® (cemiplimab)

08 Sep 2021

• The phase 2 study enrols patients with advanced HPV16 positive oropharyngeal head and neck cancer that failed previous anti-PD1 treatment• The trial is part of a clinical development plan that is aimed at a Biological License Application (BLA) for this combination immunotherapy

Oegstgeest, The Netherlands, September 8, 2021 – ISA announces the start of patient dosing in a pivotal clinical trial investigating the combination of ISA101b and Libtayo® (cemiplimab) in advanced HPV16 positive oropharyngeal cancer. This new study is the third with active recruitment under ISA Pharmaceuticals’ strategic immuno-oncology collaboration with Regeneron.

The oropharyngeal cancer phase 2 study (NCT04398524) will include

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

26 Jan 2021

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

Leiden, The Netherlands, January 26, 2020 – ISA Pharmaceuticals B.V. 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

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ISA Pharmaceuticals Strengthens Strategic Immuno-Oncology Collaboration with Regeneron

17 Jun 2020

Leiden, The Netherlands, June 17, 2020, — ISA Pharmaceuticals B.V., a private clinical-stage immunotherapy company, today announced plans to initiate a potentially pivotal clinical trial for the combination of ISA101b and Libtayo® (cemiplimab) in oropharyngeal cancer, a type of head-and-neck cancer, under its strategic immuno-oncology collaboration with Regeneron. In addition, Regeneron will increase its equity stake in ISA Pharmaceuticals.

The new oropharyngeal cancer trial is
the third trial planned under the clinical collaboration between ISA Pharmaceuticals
and Regeneron. ISA101b, an immunotherapy targeting human papillomavirus type 16
(HPV16), is currently in a Phase 2 clinical trial for first- and second-line
HPV16-positive head-and-neck cancer in combination with

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ISA Pharmaceuticals announces CervISA publication

19 Mar 2020

Synergy between Synthetic Long Peptides (SLP®) immunotherapeutics and standard chemotherapy in late stage cancer including meaningful survival improvements in SLP immune responders

Leiden, The Netherlands, 19 March 2020 — ISA Pharmaceuticals B.V., a clinical-stage immunotherapy company, announces publication of its phase 2, CervISA study in the peer-reviewed journal “Science Translational Medicine”. The paper titled ‘Strong vaccine responses during chemotherapy are associated with prolonged survival’ can be found here.

The CervISA study was an open label, phase 2 study in patients with late stage HPV16 positive cervical cancer. Seventy-seven patients were treated with ISA Pharma’s lead product, ISA101b, an HPV16-specific immunotherapeutic

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