ISA101b Archives - ISA Therapeutics BV

ISA to Present Results of Randomized Phase II Study of ISA101b in Head and Neck Cancer at the ASCO Annual Meeting 2024

28 May 2024

Dr. Caroline Even (Institut Gustave Roussy, Paris), Principal Investigator, will present results from OpcemISA, a randomized, placebo controlled clinical trial in advanced head-and-neck cancer

Data from a state of the art double blind placebo controlled phase 2 trial in 199 patients with advanced HPV16 induced head and neck cancer give direction as to which patients are true candidates for ISA101b, to be confirmed in phase 3

Oegstgeest, 28 May 2024 – ISA today announces that Dr Caroline Even, oncologist at Institut Gustave Roussy, will present the results of the double blind OpcemISA clinical trial with 199 patients at the ASCO annual conference.

ISA Pharmaceuticals to present at the ASCO Annual Meeting 2024

16 Apr 2024

An abstract detailing results from a randomized, placebo-controlled trial in advanced head and neck cancer, was accepted for oral presentation

Results provide key insights for the clinical application of cancer vaccines

Oegstgeest, 16 April 2024 – ISA today announced acceptance of its ISA101b study abstract as an oral presentation at the upcoming 2024 American Society of Clinical Oncology (ASCO) Annual meeting. This abstract describes results of a randomized trial in advanced head and neck cancer with its lead therapeutic vaccine ISA101b. These results provide key insights in the clinical application of cancer vaccines.

ISA101b is a cancer vaccine that targets human papillomavirus type

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

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 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 Completes Enrolment in Randomized Double Blind Phase 2 Clinical Trial of ISA101b in HPV16 induced Oropharyngeal Cancer

30 Nov 2022

Study designed to investigate the efficacy and safety of ISA101b added to checkpoint inhibitor therapy in Human Papilloma Virus type 16 (HPV16) induced oropharyngeal cancer (OPC).Trial is part of an extensive clinical development program for ISA101b in a collaboration with Regeneron.Top line interim results anticipated in third quarter of 2023.

Oegstgeest, 30 November 2022 – ISA Pharmaceuticals B.V., a clinical stage biotech company developing immunotherapies to treat cancers and infectious diseases, is delighted to announce that it has completed enrolment in its Phase 2 clinical trial named OpcemISA.

The OpcemISA trial has enrolled 194 patients and is a large randomized, double blind,

Professor Melief to receive 2022 SITC Pedro J. Romero Award

08 Sep 2022

The Pedro J. Romero Award recognizes individuals who have made outstanding contributions to the cancer immunotherapy fieldSecond SITC award this year to Professor Melief who will be honoured at the 37th SITC Annual Meeting

Oegstgeest, 8 September 2022 – ISA is delighted to announce that our CSO Professor Dr. Cornelis “Kees” Melief has been awarded the 2022 Pedro J. Romero Service to JITC Award by the Society for Immunotherapy of Cancer (SITC). This Award recognizes individuals who made immeasurable contributions to the Journal for Immunotherapy of Cancer (JITC) – the official journal of the SITC. The award will be presented at the SITC’s 37th

ISA to present key learnings for cancer vaccine development at the ESMO Immuno-Oncology Congress

07 Dec 2021

Oegstgeest, December 7, 2021 – ISA’s very own Chief Scientific Officer, Cornelis “Kees” Melief, M.D., Ph.D., will be presenting key learnings in cancer vaccine development in an educational session at the ESMO Immune-Oncology Congress 2021, taking place on 8th – 11th December 2021 in Geneva, Switzerland and online.

Key learnings include:

Direct correlation between strength of cancer vaccine-induced immune response and clinical responseCombination therapy of cancer vaccine with standard of care and/or checkpoint blockers necessary for improved outcomes in treatment of late stage cancers

Session: New indications in head and neck (H&N) cancer (incl anaplastic thyroid) (ID 8)Presentation title: HPV vaccination for H&N

ISA Pharmaceuticals Receives Fast Track Designation for Lead Product ISA101b

14 Sep 2021

Fast Track designation for the treatment of recurrent and metastatic HPV16-positive oropharyngeal cancer to improve survival and delay progression

Oegstgeest, September 14th, 2021 – ISA announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its lead product ISA101b, for the treatment of recurrent and metastatic oropharyngeal cancer (OPC) that is positive for Human Papilloma Virus type 16 (HPV16).

The Fast Track process is designed to facilitate the development of investigational treatments that demonstrate the potential to address unmet medical needs in serious or life-threatening conditions. Programs with Fast Track designation can benefit from early and frequent

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