The CNIPA grant expands intellectual property protection for the anti-MYCN drug candidate and strengthens the program’s international development pathway.
Biogenera announces that the China National Intellectual Property Administration (CNIPA) has granted a patent related to BGA002, the Company’s most advanced program. Based on Biogenera’s proprietary peptide nucleic acid (PNA) technology, this drug candidate is being developed to treat tumors characterized by alterations in the MYCN gene, with high-risk neuroblastoma as its initial indication.
Extending patent protection to China is an important step in safeguarding the program in a key pharmaceutical market. It also strengthens the prospects for the international development of BGA002, including through Biogenera’s B2B out-licensing model, which involves licensing agreements with partners for the development and commercialization of therapeutic programs.
BGA002 and the MYCN target
MYCN is an oncogene implicated in several aggressive cancers. It has long been considered difficult to target using conventional pharmacological approaches. Biogenera’s PNA technology is designed to target the expression of the gene.
MYCN alterations have been reported in several pediatric cancers, including alveolar rhabdomyosarcoma, medulloblastoma, ependymoma, retinoblastoma and Wilms tumor. In adults, they have also been identified in certain forms of neuroendocrine prostate cancer and small-cell lung cancer.
BGA002’s clinical development program is expected to begin with high-risk neuroblastoma. Other cancers characterized by MYCN alterations may represent potential future development pathways, subject to further studies.
From patent protection to clinical development
BGA002 has received orphan drug designation from both the FDA and the EMA and has completed production of its clinical batch in accordance with GMP standards. The Phase I clinical trial is expected to begin in the first quarter of 2027 at the University of Padua, under the direction of Professor Alessandra Biffi.
The patent grant in China therefore strengthens intellectual property protection as the program moves toward the clinical stage. The patent protects the innovation; it does not constitute marketing authorization for BGA002.
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