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 is an immunotherapy company developing treatments for various cancers and infectious diseases. ISA Pharmaceuticals has best-in-class technology to stimulate and activate the human immune system, specifically T cells, to fight diseased or infected cells. ISA Pharmaceuticals has a collaboration with Regeneron for its lead asset, ISA101b, an immunotherapy targeting human papillomavirus type 16 (HPV16)-induced cancer. ISA101b is currently in a Phase 2 clinical trial for first- and second-line HPV16-induced head-and-neck cancer, in combination with Libtayo, a PD-1 antibody.
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
This article by Anna Scherer, posted on the Accelerating Cancer Immunotherapy Research (ACIR) website, very elegantly explains ISA’s CervISA study, which was published recently in Science Translational Medicine. Click here to access the ACIR article.
Blog by Arthur N. Brodsky, PhD, published on Cancerresearch.org on 27 March 2020. Click here to access the original article.
Just weeks after International Human Papilloma Virus (HPV) Awareness
Day, new results
from two long-time Cancer Research Institute (CRI) scientists highlighted the
promise of immunotherapy against HPV-associated cervical cancer.
In a phase 1/2 study, women with advanced, recurrent, or
metastatic cervical cancer were treated with the combination of an
HPV-targeting vaccine and standard-of-care chemotherapy. Of 72 evaluable
patients, 43 percent had their tumors shrink.
Led by Cornelis J.
M. Melief, M.D, Ph.D., and Sjoerd H. van der Burg, Ph.D.,
this clinical breakthrough was the latest fruit borne by the duo, both of
whom have been supported
The platform for the medical research community MedNous wrote an article about our CervISA study:
Synthetic long peptides deliver response
A therapeutic cancer vaccine consisting of synthetic long peptides has delivered a meaningful survival benefit for cervical cancer patients when administered in combination with standard-of-care chemotherapy.
Sunday 22 March 2020A therapeutic cancer vaccine consisting of synthetic long peptides has delivered a meaningful survival benefit for cervical cancer patients when administered in combination with standard-of-care chemotherapy. The Phase 2 trial showed that the vaccine and carboplatin/paclitaxel chemotherapy were associated with prolonged survival.
The study was led by Cornelis Melief, chief scientific officer of ISA Pharmaceuticals
Synergy between Synthetic Long Peptides (SLP®) immunotherapeutics and standard chemotherapy in late stage cancer including meaningful survival improvements in SLP immune responders
Leiden, The Netherlands, 19 March 2020 — ISA Pharmaceuticals B.V., a clinical-stage immunotherapy company, announces publication of its phase 2, CervISA study in the peer-reviewed journal “Science Translational Medicine”. The paper titled ‘Strong vaccine responses during chemotherapy are associated with prolonged survival’ can be found here.
The CervISA study was an open label, phase 2 study in patients with late stage HPV16 positive cervical cancer. Seventy-seven patients were treated with ISA Pharma’s lead product, ISA101b, an HPV16-specific immunotherapeutic