Hillstream BioPharma has chosen OncoBay Clinical to provide comprehensive clinical and regulatory support for the development programme of HSB-1216.
The company’s advanced candidate HSB-1216 uses a new anti-cancer mechanism known as ferroptosis.
Under the agreement terms, OncoBay will provide comprehensive clinical expertise across statistical programming, data management and scientific writing.
In addition, OncoBay will offer regulatory affairs and clinical operations services for clinical, and observational trials.
OncoBay will also support Hillstream by providing a multitude of scientific advisors and experienced teams.
OncoBay Clinical president and CEO Krystyna Kowalczyk said: “We are confident that our proven ability to succeed in managing the complexities of oncological research will enable the accelerated development of Hillstream’s HSB-1216 programme and ultimately make an impact on patients.”
Hillstream BioPharma CEO Randy Milby said: “OncoBay is a natural partner for us, complementing the oncological expertise of our team.
“With their experience managing the complexity of oncological research programs and scientific support from the Moffitt Cancer Center, we believe that the team at OncoBay is uniquely positioned to support the advancement of the HSB-1216 development programme.”
Hillstream is also planning to submit an investigational new drug application to initiate a clinical study of HSB-1216 in the next half of this year.
The immuno-oncology pipeline of Hillstream is led by the new anti-HER2 monoclonal antibody targeting unique epitopes, HSB-3215.