AnHeart Therapeutics Receives FDA Clearance of IND Application to Initiate Global Phase 2 Study of Safusidenib in Glioma

AnHeart Therapeutics Receives FDA Clearance of IND Application to Initiate Global Phase 2 Study of Safusidenib in Glioma




AnHeart Therapeutics Receives FDA Clearance of IND Application to Initiate Global Phase 2 Study of Safusidenib in Glioma

– Safusidenib is a novel, selective and potent mutant isocitrate dehydrogenases 1 (mIDH1) inhibitor that has shown high blood-brain barrier permeability

– Phase 1 clinical data indicates safusidenib can be a potential best-in-class therapy for IDH1 mutant lower grade glioma

– Phase 2 clinical trial will further evaluate the safety and efficacy of safusidenib in IDH1 mutant lower grade glioma patients

NEW YORK–(BUSINESS WIRE)–#FDAAnHeart Therapeutics, a clinical-stage global biopharmaceutical company committed to developing novel precision oncology therapeutics, announced today that the U.S. Food & Drug Administration (FDA) has accepted its Investigational New Drug (IND) application to proceed with a global Phase 2 study of safusidenib for the treatment of patients with IDH1 mutant glioma. Glioma is a type of cancer that develops in the glial cells of the brain.

“Receiving IND clearance from US FDA to advance safusidenib into a global Phase 2 trial in glioma represents an important milestone, as we continue to advance our clinical pipeline of precision oncology therapeutics,” said Bing Yan, M.D., Co-Founder and Global Chief Medical Officer, AnHeart Therapeutics. “We are excited about the prospects of our mIDH1 inhibitor and how it can address the unmet medical need for patients with glioma, one of the most common type of primary brain tumors.”

“Current standard of care treatment for IDH mutant glioma is far from satisfying, and no targeted therapy or immuno-therapy has been approved to treat lower grade glioma patients with IDH1 mutations. We look forward to working with AnHeart Therapeutics to further develop safusidenib in the clinical setting for IDH1 mutant glioma patients who desperately need therapies with a better efficacy and safety profile,” said David A. Reardon, M.D., Dana-Farber Cancer Institute and Harvard Medical School.

Safusidenib is a potent, small molecule mIDH1 inhibitor. Mutations in IDH1 are frequently found in various tumor types such as glioma, cholangiocarcinoma, and chondrosarcoma. Safusidenib has also shown high blood brain barrier penetration from prior studies.

A Phase 1 clinical trial of safusidenib in glioma patients demonstrated a promising efficacy and safety profile in 12 non-enhancing and 35 enhancing glioma patients. The objective response rate (ORR) was 33% and 17% in non-enhancing and enhancing patients, respectively.

The Phase 2, multicenter, open label, clinical study will evaluate the efficacy and safety of safusidenib in patients with WHO Grade II or Grade III glioma.

About Glioma

Glioma is a type of cancer that develops in the glial cells of the brain. Gliomas are classified into Grades I, II, III or IV. Mutations in IDH1 are present in the majority of adult Grade II and Grade III gliomas (together categorized as lower grade glioma). IDH1 mutations are observed in about 75% of lower-grade gliomas, where no approved targeted therapy is available. Approximately 30,000 patients are newly diagnosed with mIDH1+ lower-grade glioma in the US, Europe and China annually.

About AnHeart Therapeutics

AnHeart Therapeutics (“AnHeart”) is a clinical-stage global biopharmaceutical company developing a broad pipeline of novel or next-generation precision oncology therapeutics with high unmet medical needs. Its lead asset, taletrectinib, is a potential best-in-class next-generation ROS1 inhibitor currently in Phase 2 registrational trials for the first-line TKI-naïve and second-line TKI-pre-treated patients with ROS1 fusion-positive non-small cell lung cancer (NSCLC). The Company’s pipeline also includes safusidenib, a mIDH1 inhibitor in Phase 2 trials with good brain penetration for multiple solid tumors with mIDH1 mutations and AB-329, an AXL inhibitor in Phase 1 studies to be used in combination with checkpoint inhibitor or chemotherapies in NSCLC or other solid tumors. The Company operates from offices in the US and China. For more information, visit www.anhearttherapeutics.com.

Contacts

Investors:

Weiqing Wang, PhD

ir@anhearttherapeutics.com
212-466-6378

Media:

Kimberly Ha

KKH Advisors

917-291-5744

kimberly.ha@kkhadvisors.com