ORIC Pharmaceuticals Announces Regulatory Clearance of Clinical Trial Application for ORIC-114… | Your money


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 resistance mechanisms therapeutics, today announced that its clinical trial application (CTA) has been approved by regulatory authorities in the Republic of Korea for ORIC-114, an orally bioavailable, irreversible brain-penetrating inhibitor designed to target selectively EGFR and HER2 with high potency against exon 20 insertion mutations.

“This is our third IND/CTA regulatory clearance in the past 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 said Jacob M. Chacko, MD, president. and CEO. “We are encouraged by the brain-penetrating properties and selectivity demonstrated by ORIC-114 in preclinical studies, and we look forward to advancing the program to a Phase 1 study in the coming months. As we enter 2022, we are well positioned with five clinical updates expected across four clinical programs through the first half of 2023, and with cash and investments to fund our operating plan through the first half of 2024. »

About ORIC-114

ORIC-114 is a brain-penetrating, orally bioavailable, irreversible inhibitor designed to selectively target EGFR and HER2 with high potency against exon 20 insertion mutations. ORIC-114 has demonstrated tumor regressions and strong intracranial antitumor activity in various models of EGFR exon 20 NSCLC and HER2-positive breast cancer. ORIC-114 also compares favorably in head-to-head in vivo studies against several approved and clinical-stage EGFR exon 20 and HER2 inhibitors. The company plans to initiate a Phase 1b monotherapy study in patients with advanced solid tumors with EGFR or HER2 exon 20 alterations or HER2 amplification and will enable patients with treated CNS metastases or untreated but asymptomatic. The company expects to report the first data from this trial in the first half of 2023.

About ORIC Pharmaceuticals, Inc.

ORIC Pharmaceuticals is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients by overcoming cancer resistance. ORIC’s lead product candidate, ORIC-101, is a potent and selective small molecule glucocorticoid receptor antagonist that has been associated with resistance to several classes of cancer treatments in various solid tumors. ORIC-101 is currently in two separate Phase 1b trials of ORIC-101 in combination with (1) Xtandi (enzalutamide) in metastatic prostate cancer and (2) Abraxane (nab-paclitaxel) in solid tumors advanced or metastatic. ORIC’s other product candidates include (1) ORIC-533, an orally bioavailable small molecule inhibitor of CD73, a key node in the adenosine pathway thought to play a central role in resistance to chemotherapy-based treatment regimens and immunotherapy, under development for multiple myeloma, (2) ORIC-114, a brain penetration inhibitor designed to selectively target EGFR and HER2 with high potency against exon 20 insertion mutations, developed in several genetically defined cancers, and (3) ORIC-944, an allosteric inhibitor of polycomb repressive complex 2 (PRC2) via the EED subunit, under development for prostate cancer. Beyond these four product candidates, ORIC is also developing several precision drugs targeting other hallmark mechanisms of cancer resistance. ORIC has offices in South San Francisco and San Diego, California. For more information, visit www.oricpharma.comand follow us on Twitter Where LinkedIn.

Caution Regarding Forward-Looking Statements

This press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely statements are forward-looking statements. These forward-looking statements include, among other things, statements regarding development plans and timelines for ORIC-114; the potential benefits of ORIC-114; the plans underlying the clinical trials and development of ORIC; the expected timing of clinical updates for the ORIC-101, ORIC-533, ORIC-114 and ORIC-944 clinical trials; the period over which ORIC estimates that its existing cash and investments will be sufficient to fund its current operating plan; and statements from the president and chief executive officer of the company. Words such as ‘believes’, ‘anticipates’, ‘plans’, ‘expects’, ‘intends’, ‘will’, ‘aims’, ‘potential’ and similar expressions are intended to identify forward-looking statements. The forward-looking statements contained herein are based on ORIC’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those projected in the forward-looking statements due to numerous risks and uncertainties, including, but not limited to: risks associated with the process of discovering, developing and commercializing safe and effective drugs for use for human therapeutic purposes and operating as an early clinical stage company; ORIC’s ability to develop, initiate or complete preclinical studies and clinical trials for, obtain approvals for, and commercialize any of its product candidates; changes in ORIC’s plans to develop and commercialize its product candidates; the possibility that clinical trials of ORIC-101, ORIC-533, ORIC-114, ORIC-944 or any other product candidates will differ from preclinical, initial, interim, preliminary or expected; adverse impacts of the COVID-19 pandemic on ORIC’s operations, including clinical trials; the risk of the occurrence of any event, change or other circumstance that may result in the termination of ORIC’s license agreements; ORIC’s ability to raise any additional financing it needs to pursue its business and product development plans; regulatory developments in the United States and foreign countries; ORIC’s dependence on third parties, including contract manufacturers and contract research organizations; ORIC’s ability to obtain and maintain intellectual property protection for its product candidates; loss of key scientific or management personnel; competition in the industry in which ORIC operates; general economic and market conditions; and other risks. Information regarding the above and additional risks can be found in the section titled “Risk Factors” in ORIC’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the “SEC”) on November 8, 2021. , and future ORIC reports to be filed with the SEC. These forward-looking statements are made as of the date of this press release, and ORIC undertakes no obligation to update any forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law.

Contact: Dominic Piscitelli, CFO [email protected] [email protected]

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