Boston, MA., October 2, 2023. – Oncoheroes Biosciences, Inc. (“Oncoheroes”) announced today that the U.S. Food and Drug Administration (FDA) has allowed the Boston-based biotech to proceed with the investigation of two potential drugs for pediatric oncology.
In August, Oncoheroes submitted two Investigational New Drug (IND) applications to the FDA, seeking permission to initiate clinical trials for two compounds in their portfolio: volasertib and dovitinib. After FDA’s thorough review and evaluation, Oncoheroes reported that both INDs have received the green light from the FDA to move forward, opening the door to innovative treatment options for pediatric cancer patients.
"Receiving these announcements in the final days of Childhood Cancer Awareness Month has been an extraordinary gift," remarked Ricardo Garcia, Co-founder and CEO of Oncoheroes. "Our ongoing mission is to reshape the landscape of pediatric oncology, and these milestones accomplished stand as a testament to the dedication and determination of the entire Oncoheroes team."
This achievement is not just a cause for celebration within the company but also a beacon of hope for the countless children and their families whose lives may be positively impacted by these potential drugs.
Oncoheroes extended their gratitude to everyone who has contributed to this journey— team, consultants, collaborators, investors, supporters, and the patients and families who inspire them every day.
About volasertib:
Volasertib is an inhibitor of Polo-like-kinase 1 (PLK1), an enzyme known to be involved in disease progression in a number of cancers. Oncoheroes licensed the compound from Boehringer Ingelheim, which was developing it for the treatment of Acute Myeloid Leukemia until the company decided to discontinue the compound for strategic reasons. Preclinical data support further development of volasertib for rhabdomyosarcoma and other pediatric cancer indications.
About dovitinib:
Dovitinib is a pan-tyrosine kinase inhibitor targeting fibroblast growth factor receptor (FGFR), vascular endothelial growth factor receptor (VEGFR), and other receptor tyrosine kinases (RTKs). Oncoheroes acquired a pediatric exclusive license of dovitinib from Allarity Therapeutics in 2022. This drug class is considered interesting for the treatment of pediatric bone sarcomas and the clinical development of dovitinib is supported by an exploratory biomarker that would allow the identification of potential responders to the drug.
About Oncoheroes:
Oncoheroes is a Boston-based biotech company exclusively focused on the discovery and development of better drugs for children and adolescents with cancer. Our vision is to deliver benefits to young cancer patients and create value in the process. Oncoheroes is actively looking for in-licensing opportunities in the pediatric oncology space while working to generate new proprietary assets for a number of pediatric cancer indications with high unmet medical needs.