ORIC Pharmaceuticals Announces Regulatory Clearance of Clinical Trial Application for ORIC-114 in Advanced Solid Tumors with EGFR or HER2 Exon 20 Alterations or HER2 Amplifications
Excerpt from the Press Release:
SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, Jan. 25, 2022 (GLOBE NEWSWIRE) — ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, today announced clearance of its Clinical Trial Application (CTA) by the regulatory authorities of the Republic of Korea for ORIC-114, a brain penetrant, orally bioavailable, irreversible inhibitor designed to selectively target EGFR and HER2 with high potency against exon 20 insertion mutations.
“This marks our third IND/CTA regulatory clearance in the last eight months and further demonstrates the productivity and commitment of our team as we expand our clinical portfolio to advance our mission on behalf of patients,” said Jacob M. Chacko, M.D., president and chief executive officer. “We are encouraged by the brain penetrant properties and selectivity that ORIC-114 has demonstrated in preclinical studies, and we look forward to advancing the program into a Phase 1 study in the coming months. As we enter 2022, we are well positioned with five expected clinical updates across four clinical programs through the first half of 2023, and with cash and investments to fund our operating plan into the first half of 2024.”
About ORIC-114
ORIC-114 is a brain penetrant, orally bioavailable, irreversible inhibitor designed to selectively target EGFR and HER2 with high potency against exon 20 insertion mutations. ORIC-114 has demonstrated systemic tumor regressions and strong intracranial antitumor activity in various EGFR exon 20 insertion NSCLC and HER2-positive breast cancer models. ORIC-114 also compares favorably in head to head in vivo studies versus multiple approved and clinical stage EGFR exon 20 and HER2 inhibitors. The company plans to initiate a Phase 1b single agent study in patients with advanced solid tumors with EGFR or HER2 exon 20 alterations or HER2 amplification and will allow patients with CNS metastases that are either treated or untreated but asymptomatic. The company expects to report initial data from this trial in the first half of 2023.
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