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
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
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
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
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