2023 Archives - ISA Therapeutics BV

ISA reports highlights of randomized Phase 2 cancer vaccine trial in head & neck cancer

12 Dec 2023

Study indicates clear route to market despite not meeting the primary endpoint of 6 months’ overall response rate (ORR) in the entire population

In a predefined subgroup of patients there was a doubling of ORR (51.9% vs 26.7% for placebo) and improved overall survival which sets the stage for a confirmatory Phase 3 trial

Oegstgeest, 12 December 2023 — ISA today announced positive anti-tumor response data with ISA101b, an HPV16 directed therapeutic cancer vaccine given in combination with Libtayo®, an anti-PD1 checkpoint inhibitor (CPI). The data were generated in the OpcemISA trial, a large scale randomized double blind study that is ongoing

ISA to Present at the 4th Annual Virtual H.C. Wainwright HBV Conference on October 25th

24 Oct 2023

Oegstgeest, The Netherlands, 24 October 2023 – ISA is pleased to announce that it will be presenting during the 4th Annual H.C. Wainwright Virtual HBV Conference – October 25th. The presentation by Gerben Moolhuizen, CEO of ISA Pharmaceuticals, will highlight key characteristics and progress in the development of ISA104, a therapeutic vaccine aimed to aid in achieving functional cure of patients suffering from chronic hepatitis B infection.

Presentation details:

4th Annual Virtual H.C. Wainwright HBV Conference

Date: 25 October 2023

Presentation title: Targeted Immune System Activation using SLPs in chronic HBV

Time: 5:00 – 5:30pm CET

ISA104 immunotherapy has been designed to create a strong and

First Patient with Chronic Hepatitis B Dosed with ISA104 in First-in-Human Phase 1 Study

31 Aug 2023

Study by Erasmus MC marks first clinical development milestone for ISA104 immunotherapeutic treatment of chronic hepatitis B infection

Oegstgeest, The Netherlands, 31 August 2023 – ISA is pleased to announce that the first patient has been dosed in the HEB-PEP study. This first-in-human (FIH) phase 1 study investigates the use of ISA104, a novel treatment aimed to establish functional cure in Chronic Hepatitis B patients. Dosing took place at the Liver Unit of the Erasmus Medical Center in Rotterdam, the sponsor of this dose escalation study.

The HEB-PEP study will investigate the safety, tolerability and efficacy of different doses of ISA104 in

The combination of ISA101b and Libtayo® shows promising results in patients whose head and neck cancer progressed on anti-PD1 therapy

06 Jun 2023

Early data presented at ASCO annual meeting 2023 shows encouraging responses to treatment in a very difficult to treat patient population

Dr. Anthony Kong (Guy’s and St Thomas’ Hospitals, London), Principal Investigator, presented data from ProcemISA, an ongoing clinical trial in anti-PD1 resistant advanced HPV16+ head and neck cancer

Oegstgeest, The Netherlands, 6 June 2023 – ISA presented the first clinical data of the combination of ISA101b (peltopepimut-S) and Regeneron’s anti-PD-1 Libtayo® (cemiplimab) at the ASCO annual meeting in Chicago.

Dr. Kong presented data regarding 26 patients with recurrent and/or metastatic Human Papilloma Virus type 16 (HPV16) positive oropharyngeal cancer (OPC, a form

ISA to Present First Clinical Trial Data from the Phase II Study of ISA101b and Libtayo® (cemiplimab) Combination in Head and Neck Cancer at the ASCO Annual Meeting 2023

25 May 2023

Oegstgeest, The Netherlands, 25 May 2023 – ISA today announces that it will present the first clinical data of the combination of ISA101b and Regeneron’s PD-1 inhibitor Libtayo® (cemiplimab) in patients with recurrent metastatic Human Papilloma Virus type 16 (HPV16) induced head and neck cancers who progressed on pembrolizumab or nivolumab.

Patients with recurrent and/or metastatic HPV16 positive OPC who experienced disease progression during or within 6 months after prior anti-PD1 therapy were to be treated until disease progression or withdrawal. Patients that never responded to prior treatment were also included. Further information can be found on clinicaltrials.gov (NCT04398524). Recruitment in

ISA to Present Pre-clinical Data on its Protective SLP Therapy Against SARS-CoV-2 at the CIMT Annual Meeting

27 Apr 2023

Oegstgeest, The Netherlands, 27 April 2023 – ISA is pleased to announce that it will be presenting data evaluating the response to its T cell inducing SLP therapy against SARS-CoV-2 in collaboration with the Leiden University Medical Center (LUMC) and Centre for Human Drug Research (CHDR) at the 20th Annual Meeting of the Association for Cancer Immunotherapy (CIMT), being held in Mainz, Germany on 3-5 May, 2023.

Details of the presentation are as follows:

Presentation title: T cell inducing SLP vaccine against SARS-CoV-2 for protection of patients with spontaneous or therapy-induced B cell deficiencies

Session: Therapeutic Vaccination, New Targets New Leads, Tumor Biology

ISA Pharmaceuticals to Attend and Present at Upcoming Scientific and Business Conferences

20 Apr 2023

Oegstgeest, The Netherlands, 20 April 2023 – ISA is pleased to announce that it will be participating and presenting in person, at the following scientific and business conferences in May and June of 2023.

ISA’s versatile synthetic long peptide (SLP®) immunotherapy platform is yielding multiple, highly promising clinical stage immunotherapeutics for the treatment of different cancer types and infectious diseases. It has demonstrated to be best-in-class technology to strongly and specifically activate the human immune system. SLP immunotherapeutics have been tested in multiple human clinical proof-of-concept and phase 2 trials, both as monotherapies and in combination with checkpoint inhibitors or standard-of-care

ISA Pharmaceuticals and Cancer Focus Fund Announce $5 Million Investment to Support First-in-Human Trial of ISA’s Novel Immunotherapy ISA103 in Uveal Melanoma

04 Jan 2023

─Clinical Trial of PRAME-Targeting Immunotherapy ISA103 in rare ocular cancer to be conducted at MD Anderson Cancer Center─

Oegstgeest, Netherlands and Houston, Texas, January 4, 2023 – ISA Pharmaceuticals B.V., a clinical stage biotech company developing immunotherapies to treat cancers and infectious diseases, and Cancer Focus Fund, LP, a unique investment fund established in collaboration with The University of Texas MD Anderson Cancer Center to provide funding and clinical expertise to advance promising cancer therapies, today announced that Cancer Focus Fund is investing $5 million in funding to support ISA103, ISA’s PRAME-targeting immunotherapy,