The American startup Oncoheroes Biosciences, specialized in new childhood cancer therapies, just granted the exclusive worldwide license of volasertib for adult cancer to Notable Labs, a pioneering biopharmaceutical in preventive and precision medicine.
Under the terms of the agreement, the financial details of which have not been made public, Oncoheroes will retain the global license for the development and commercialization of the drug in pediatric oncology and will continue its commitment to childhood cancer.
Volasertib is an inhibitor of PLK-1 kinase, a enzyme involved in a wide range of solid tumors and hematological cancers. The compound was discovered and developed by Boehringer Ingelheim for acute myeloid leukemia, until the company decided to discontinue development for strategic reasons, after a phase III study in adults failed to meet its expectations.
In 2019, Oncoheroes obtained the worldwide and exclusive license of the drug with the aim of continuing clinical development in the younger cancer patients and, in 2020, it achieved its designation as Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) by the Food and Drug Administration (FDA) for the treatment of pediatric rhabdomyosarcoma (RMS) , the most common soft tissue cancer in children and adolescents.
“The granting of RPDD status to volasertib represents an important milestone for Oncoheroes, since it allows the possibility of obtaining a Priority Review Voucher (PRV) at the time of its approval. The companies that own the PRV can use it at any time to reduce the review time by the FDA of one of their candidates to become a new drug, allowing them to go to market earlier ”, explains Ricardo García, co-founder and CEO of Oncoheroes.
“The PRV is only granted to companies that are developing drugs for rare or orphan diseases, such as Oncoheroes with childhood cancer. However, the companies that receive a PRV are not interested in using it, but in selling it, since the FDA allows us to transfer it and large pharmaceutical companies are very interested in getting it and willing to pay for it. The current market value of the PRV is $ 100 million. Most of the new drugs that Oncoheroes are planning to develop are eligible to receive a PRV ”.
Oncoheroes has started the production of volasertib and is working with the European Consortium for Innovative Therapies for Children with Cancer (ITCC) with the aim of starting in 2022 a phase Ib / II clinical trial in pediatric rhabdomyosarcoma, sponsored by the University of Birmingham and the Cancer Research UK.
Committed to childhood cancer
The business model of Oncoheroes is to develop a portfolio of potential new drugs for childhood cancer, through three strategies: own R&D, licensing of drugs in the clinical phase and collaborations with the pharmaceutical industry, academia, hospitals, foundations and patient associations.
“Childhood cancer is not like that of adults and requires a different treatment. So much so that some of the most devastating childhood cancers only occur in children. Unfortunately, in most cases, pediatric oncologists are forced to adjust adult treatments for them. Today, only five drugs developed and approved specifically for childhood cancer are available, despite the fact that it remains the leading cause of death from disease in children. Furthermore, treating children with medications that have not been designed for them implies that a large percentage of survivors will experience lifelong side effects associated with toxicity and that, in some cases, they can be very serious “, explains Cesare Spadoni, co-founder and COO of Oncoheroes.
