Hinova Pharmaceuticals’ HP518 gets FDA fast track designation in triple-negative breast cancer

Hinova Pharmaceuticals Inc. (688302.SH), a trailblazer in the biopharmaceutical industry, has achieved a significant milestone with the U.S. Food and Drug Administration (FDA) granting Fast Track designation to its investigational drug, HP518. This drug is being developed specifically for the treatment of Androgen-receptor positive (AR+) triple-negative breast cancer (TNBC), a notably aggressive subtype of breast cancer that currently lacks targeted treatment options.

HP518 is at the forefront of cancer research as a potent PROTAC (Proteolysis Targeting Chimera) AR degrader, which has shown promising results in preclinical studies. These studies revealed its effectiveness in reducing tumor size significantly in AR+ TNBC animal models, alongside a favorable safety profile. This promising outcome is particularly impactful considering that TNBC, which makes up about 15-20% of all breast cancer cases, desperately needs new therapeutic options due to its aggressive nature and lack of hormonal receptors that are present in other breast cancer types.

Noteworthy is the potential of HP518 in targeting the androgen receptor, a protein expressed in up to 50% of TNBC cases. The drug degrades both the wild-type AR and clinically relevant AR ligand-binding domain (LBD) mutants, including L702H, demonstrating a novel mechanism of action that could lead to effective new treatments.

The FDA’s Fast Track designation is designed to speed up the development and review processes for drugs that address severe conditions and fill an unmet medical need. This status not only facilitates more frequent communication with the FDA but also ensures eligibility for Accelerated Approval and Priority Review, should the drug meet relevant criteria during its development stages.

Dr. Yuanwei Chen, Chief Executive Officer of Hinova, expressed his enthusiasm about this development, stating, “We are thrilled to receive Fast Track designation from the FDA for HP518. This designation underscores the significant need for new treatment options for patients with TNBC and highlights the potential of our investigational therapy to make a meaningful impact on this devastating disease.”

As part of the next steps in its strategic development plan, Hinova intends to update its existing IND (Investigational New Drug application) for TNBC to accelerate the advancement of HP518. The company remains committed to navigating the clinical development process swiftly and effectively, with the hope of bringing this promising new therapy to patients in need soon.