HPV16 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 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

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 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 announces successful closing of EUR 26 million funding round

13 Jul 2021

Oegstgeest, 13 July 2021, ISA announces the closing of a EUR 26 million funding round with participation from new investors including Invest-NL and existing investors including Regeneron. The proceeds of this round will be used to advance the lead product ISA101b towards first marketing authorization as well as to broaden the clinical pipeline of immunotherapies based on the Synthetic Long Peptide (SLP®) platform technology.

Gerben Moolhuizen, CEO of ISA Pharmaceuticals, said, “We are very happy with the continued support of our existing partners and shareholders. Invest-NL’s support underlines the innovation at ISA Pharma and potential impact of our SLP® immunotherapies for

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

ISA Pharmaceuticals to present at the 33rd International Papillomavirus Conference & Basic Science

20 Jul 2020

ISA Pharmaceuticals receives US Orphan-Drug Designation for ISA101b in HPV16-positive Cervical Cancer

01 Jul 2020

Leiden, The Netherlands, 01 July 2020 — ISA Pharmaceuticals B.V., today announced that it received Orphan Drug Designation from the Food and Drug Administration (FDA) in the USA for its lead product ISA101b for treatment of Human Papilloma Virus type 16 (HPV16)-positive cervical cancer.

According to the latest statistics of the Centers for Disease Control and Prevention, HPV causes more than 34,000 cases of cancer in the United States each year. Cervical cancer is the most common HPV-associated cancer in women, with HPV16 being responsible for approximately 50% of cases. HPV16-positive cervical cancer is the number 2 cause of cancer for women in

ISA Pharmaceuticals to present at the Virtual European Biotech Investor Day 2020

23 Jun 2020

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