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
• 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
Grant accelerates clinical development of immunotherapy to treat chronic hepatitis B virus infection
Oegstgeest, 20 July 2021 – ISA Pharmaceuticals B.V. is pleased to announce that a consortium between the Erasmus MC and ISA has been awarded a Private-Public Partnerships (PPP) Allowance made available by Health~Holland, Top Sector Life Sciences & Health, to conduct a first-in-human, phase 1 study of ISA104 to treat hepatitis B in chronically infected patients.
The clinical study, to be conducted in close collaboration with the Gastroenterology & Hepatology department of the Erasmus MC, is entitled the ‘HEB-PEP study’. The project starts in August 2021 and the clinical
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
Oegstgeest, The Netherlands, May 04, 2021 – ISA announces publication in Nature Reviews Cancer of a review of therapeutic cancer vaccines. The paper is co-authored by ISA’s Chief Scientific Officer, Prof. Cornelis “Kees” Melief in collaboration with key opinion leaders at international institutions including the Icahn School of Medicine at Mount Sinai, New York, the Parker Institute of Cancer Immunotherapy, San Francisco, and the Leiden University Medical Center in The Netherlands. This is the link to the online article.
The Nature Reviews Cancer paper summarizes key insights gleaned from previous successful and non-successful therapeutic vaccine trials. It provides an overview
Oegstgeest, May 3rd, 2021 – ISA is happy to announce it has moved into its new location in the Biopartner 5 building, situated in the western part of the Leiden/Oegstgeest BioScience park.
Our new address is:De Limes 72342 DH OegstgeestThe Netherlands
The novel ISA facilities constitute a doubling in size of office and lab space, compared to its former location, with possibilities to further expand. Over the past period ISA has grown substanially and will continue to do so in the coming period. This new location is perfectly suited to accommodate this growth.
The Biopartner 5 building is designed with emphasis on sustainability:
ISA106’s promising results in preclinical tests warrant fast entry into human studies to address the need for effective COVID-19 therapy
March 3rd, 2021 – ISA announces that it has completed pre-clinical work for ISA106, a novel COVID-19 immunotherapy and is planning clinical trials. A phase 1 dose finding study in healthy volunteers will start in the next few months.
ISA106 is an immunotherapy agent that is intended to treat patients with SARS-CoV2 infections, and prevent progressive pneumonia and further complications – thereby avoiding admission to hospital and ICU. It is designed to elicit a robust T cell immune response specifically against SARS-CoV2,
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
Interview with ISA Pharmaceuticals’ CSO, Professor Kees Melief on the need for a therapeutic that specifically drives the T cell immune response against SARS-CoV2.
Winter can be the worst time for respiratory diseases. As the nights draw in and we huddle together against the cold and dark, sneezing and wheezing, we spread our coughs, colds, and worse. Many people can find breathing a struggle in a normal winter, and this year there is the COVID-19 virus stalking the land, seeking lungs to infiltrate, causing the terrible pandemic that we are all caught up in. Whilst the news is, finally, full