OncoBay Clinical is a boutique clinical research organization (CRO) that is a subsidiary of the Moffitt Cancer Center and has extensive experience in oncology drug development
Hillstream BioPharma, Inc. (Nasdaq: HILS) ("Hillstream"
or the "Company"), a biotechnology company developing therapeutic
candidates targeting drug resistant and devastating cancers using
ferroptosis, an emerging new anti-cancer mechanism resulting in
iron-mediated cell death, and immuno-oncology targeted novel biologics,
has selected immune-oncology clinical research organization (CRO), OncoBay Clinical, to
provide comprehensive clinical and regulatory support for the clinical
development program for its lead drug candidate HSB-1216.
HSB-1216, Hillstream’s most advanced candidate, utilizes ferroptosis, an emerging new anti-cancer mechanism resulting in iron-mediated cell death (IMCD) of drug-resistant cancers. As part of the agreement, OncoBay Clinical’s engagement will provide comprehensive clinical expertise across data management, statistical programming, scientific writing, regulatory affairs and clinical operations services for clinical, and observational studies. Additionally, OncoBay will leverage the support of a multitude of top scientific advisors and highly experienced teams to support Hillstream.
“OncoBay is a natural partner for us, complementing the oncological expertise of our team,” said Randy Milby, CEO of Hillstream BioPharma. “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 program.”
“We are excited to be partnering with Hillstream BioPharma on the development of HSB-1216,” said Krystyna Kowalczyk, President and CEO of OncoBay Clinical. “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 program and ultimately make an impact on patients.”
About OncoBay Clinical
OncoBay
Clinical is a global boutique contract research organization (CRO)
specializing in immuno- oncology/cell therapy and other complex oncology
programs. OncoBay offers strategic and full- service custom-curated
solutions for global pharmaceutical and biotech companies looking to
advance their product or device. Originated from Moffitt Cancer Center,
OncoBay embeds scientific expertise, operational excellence and
integration of technology including AI analytics to drive quality and
data integrity. Built on years of oncology expertise, an advanced
technology framework, a highly aligned site network, and a skilled team
of experienced professionals, OncoBay is committed to operational
excellence from start to finish. For more information, visit Oncobay.com and follow us on Facebook, Twitter and LinkedIn.
Hillstream BioPharma, Inc. is a biotechnology company developing a focused portfolio of therapeutic candidates targeting drug resistant and devastating cancers. The Company anticipates submitting an investigational new drug application and plans to initiate a clinical study in the second half of 2023 with HSB-1216, which targets ferroptosis, an emerging new anti-cancer mechanism, resulting in iron mediated cell death (IMCD) of drug resistant cancers. The Company’s emerging immuno-oncology pipeline is led by HSB-3215, a novel anti-HER2 monoclonal antibody targeting unique epitopes with a novel mechanism of action. The erbB/HER family of cell surface proteins include well-known and validated drug targets including HER2 and HER3 found in multiple solid tumors, including breast, lung, GYN, endocrinological and CNS.
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