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ISA101b (cemiplimab) is a PD-1 inhibitor vaccine drug candidate, which is currently being evaluated for the treatment of patients with advanced HPV16-positive oropharyngeal cancer.
Lead Product(s): Human Papillomavirus Vaccine,Cemiplimab
Therapeutic Area: Oncology Product Name: ISA101b
Highest Development Status: Phase II Product Type: Vaccine
Partner/Sponsor/Collaborator: Regeneron Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 12, 2023
Details:
ISA101b immunotherapy targets human papillomavirus type 16 (HPV16) positive cancers. It induces strong and specific immune responses to the HPV16 virus, and (re-)establishes a powerful and targeted T-cell immune response against infected and/or cancerous cells and tissues.
Lead Product(s): Human Papillomavirus Vaccine,Cemiplimab
Therapeutic Area: Oncology Product Name: ISA101b
Highest Development Status: Phase II Product Type: Vaccine
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 30, 2022
Details:
ISA101b, consists of 12 synthetic long peptide derived from oncogenic protein of HPV 16 virus in combination with nivolumab in cancer demonstrated deep and durable responses have a positive effect on patient prognosis with patients disease-free for more than 44 months.
Lead Product(s): Human Papillomavirus Vaccine,Nivolumab
Therapeutic Area: Oncology Product Name: ISA101b
Highest Development Status: Phase II Product Type: Vaccine
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 01, 2022
Details:
In a new phase 2 study, ISA101b induces strong and specific immune responses to HPV16 virus proteins, and (re-)establishes a powerful T-cell immune response against virus infected and/or cancerous cells and tissues.
Lead Product(s): Human Papillomavirus Vaccine,Cemiplimab
Therapeutic Area: Oncology Product Name: ISA101b
Highest Development Status: Phase II Product Type: Vaccine
Partner/Sponsor/Collaborator: Regeneron Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 14, 2021
Details:
Libtayo is an anti-PD-1 antibody that is being jointly developed by Regeneron and Sanofi. The phase 2 study enrols patients with advanced HPV16 positive oropharyngeal head and neck cancer that failed previous anti-PD1 treatment.
Lead Product(s): Human Papillomavirus Vaccine,Cemiplimab
Therapeutic Area: Oncology Product Name: ISA101b
Highest Development Status: Phase II Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 08, 2021
Details:
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.
Lead Product(s): Human Papillomavirus Vaccine,Pembrolizumab
Therapeutic Area: Oncology Product Name: ISA101b
Highest Development Status: Phase II Product Type: Vaccine
Partner/Sponsor/Collaborator: UPMC Hillman Cancer Center
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 26, 2021
Details:
ISA101b is a clinical-stage immunotherapy targeting HPV16-induced diseases such as cervical and oropharyngeal cancer. It induces specific immune responses to the oncogenic E6 and E7 proteins of HPV16 and is based on ISA's proprietary Synthetic Long Peptide (SLP®) technology.
Lead Product(s): Human Papillomavirus Vaccine,Cemiplimab
Therapeutic Area: Oncology Product Name: ISA101b
Highest Development Status: Phase II Product Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 01, 2020
Details:
The new oropharyngeal cancer trial is the 3rd trial planned under the clinical collaboration between ISA Pharmaceuticals and Regeneron. ISA101b is currently in a Phase 2 trial for first- and second-line HPV16+ head-and-neck cancer in combination with Libtayo.
Lead Product(s): Human Papillomavirus Vaccine,Cemiplimab
Therapeutic Area: Oncology Product Name: ISA101b
Highest Development Status: Phase II Product Type: Large molecule
Partner/Sponsor/Collaborator: ISA Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration June 17, 2020
Details:
A strong correlation was seen between strength of the HPV-specific immune response and overall survival (OS).
Lead Product(s): Human Papillomavirus Vaccine
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase II Product Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 19, 2020