Long-Term Study Confirms Efficacy of ISA Pharmaceuticals T-Cell Activating Immunotherapy in Combination with Checkpoint Inhibitor


– Data published in the Journal of ImmunoTherapy of Cancer confirms the efficacy of the combined treatment (anti-PD1 + ISA101b)

– Deep and durable responses have a profound positive effect on patient prognosis with patients disease-free for over 44 months

– Enhancement of tumor infiltration by immune cells predicted treatment response

OEGSTGEEST, Netherlands, March 1, 2022 /PRNewswire/ — ISA Pharmaceuticals BV, a clinical-stage biotechnology company developing immunotherapies to treat cancers and infectious diseases, today announces the publication of extension data from a pivotal study using lead product ISA101b in the Journal of ImmunoTherapy of Cancer, ISA101 and nivolumab for Cancer HPV-16+: updated clinical efficacy and immune correlates of response, Guimaraes Sousa, Michael Curran, Bonnie Glisson et al. in collaboration with the MD Anderson Cancer Center in Houston, TX.

The initial study of Massarelli et al. was published in 2018*. He studied ISA101b in combination with nivolumab (OPDIVO®), an anti-PD1 checkpoint inhibitor, in head and neck cancer. In this open-label study, 22 patients with recurrent/metastatic human papillomavirus type 16 (HPV16+) oropharyngeal cancer (OPC) were treated. The objective response rate (ORR) in this hard-to-treat patient population was 36%, with a median overall survival (mOS) of 17.5 months.

Two patients in the first study showed a complete response to treatment. This follow-up study shows that they survived disease-free for more than 44 months.

Teacher. dr. Cornelis Meliefscientific director of ISA Pharmaceuticals, noted: “We are delighted to see the results of this pivotal study published as we continue to develop an exciting pipeline of cancer vaccines. Our work shows that a combination of ISA101b and anti-PD-1 remains a promising treatment considerably improving the prognosis of patients and in the long term. long term answers.

ISA’s product portfolio consists of several synthetic long peptide (SLP) therapies for cancer and infectious diseases. The SLP approach is designed to elicit a long-lasting and broad T-cell immune response to specific diseases. It allows the patient’s own immune system to attack and destroy tumor cells or viruses for significant clinical benefit. 101b is based on this technology and is currently being studied in HPV16+ cancers in combination with Libtayo® (cemiplimab) in three phase 2 clinical trials as part of a strategic collaboration with Regeneron. Libtayo is an anti-PD-1 antibody jointly developed by Regeneron and Sanofi.

*Massarelli et al, JAMA Oncology 2018

About ISA101b

ISA101b immunotherapy targets human papillomavirus type 16 (HPV16) positive cancers. It induces strong and specific immune responses against the HPV16 virus, and (re-)establishes a potent and targeted T cell immune response against infected and/or cancerous cells and tissues. ISA101b utilizes ISA’s patented Synthetic Long Peptide (SLP®) technology. ISA101b is in late-stage clinical trials for HPV16-induced cancer in a collaboration with US pharmaceutical company Regeneron.

About ISA Pharmaceuticals

ISA Pharmaceuticals is an immunotherapy company developing treatments for various cancers and infectious diseases. ISA Pharma has best-in-class technology to stimulate and activate the human immune system, especially T cells, to fight diseased or infected cells. Its lead asset ISA101b is a clinical-stage asset for cancer induced by human papillomavirus type 16 (HPV16). Other assets are in preclinical development and include immunotherapies to treat patients with chronic hepatitis B infections, cancers that overexpress PRAME, cancers caused by other types of HPV than HPV16 or SARS-CoV2 infections. For more information, please visit www.isa-pharma.com.


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SOURCEISA Pharmaceuticals


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