On August 24, 2020 Adlai Nortye Ltd. ("Adlai Nortye"), a global clinical-stage biopharmaceutical company reported that the first patient has been dosed in a phase 1b clinical trial (AN0025S0103) to evaluate AN0025, an investigational, potentially first in class oral EP4 antagonist, in combination with Merck’s KEYTRUDA (pembrolizumab) in patients with locally advanced/metastatic solid tumors (Press release, Adlai Nortye Biopharma, AUG 24, 2020, View Source [SID1234563957]).

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AN0025S0103 is an open-label, multicenter, phase 1b study in the U.S. and Europe to evaluate the safety and preliminary efficacy of AN0025 in combination with pembrolizumab in patients with locally advanced/metastatic tumors. It will include a dose-limiting toxicity (DLT) observation phase followed by an expansion phase. In the DLT phase, it will enroll patients with urothelial carcinoma of the bladder, or squamous or non-Squamous NSCLC, to assess safety and tolerability. This will be determined whether or not to move on to the expansion phase, which will enroll patients diagnosed with urothelial carcinoma, NSCLC, TNBC, Cervical cancer, and MSS CRC. The first patient was dosed at Huntsman Cancer Institute (HCI) at the University of Utah. In the U.S., the study is also enrolling patients from The University of Texas MD Anderson Cancer Center and The University of Virginia Cancer Center.

All enrolled patients will be treated with AN0025 and pembrolizumab until the patient experiences disease progression, unacceptable toxicity or withdraws consent, or for a maximum of 35 cycles (approximately 2 years). The dose of Pembrolizumab will remain constant at 200 mg every 3 weeks (Q3W) for each dose level of AN0025 and in each cohort.

"In preclinical studies, AN0025 combined with radiotherapy, chemoradiotherapy and with immune checkpoint inhibitors demonstrated antitumor activity in different malignancies. We are optimistic that the combination of AN0025 (EP4 Antagonist) with KEYTRUDA could have meaningful clinical benefit in patients with locally advanced/metastatic solid tumors," said Dr. Lars Birgerson, CDO and CEO of Adlai Nortye USA. "This new combination may provide a new systemic treatment option for many cancer patients, including PD-1/PD-L1 treatment refractory or relapsed patients. We hope to bring innovative cancer treatments to patients with unmet medical needs, to help patients live longer and better."

About AN0025S0103

AN0025S0103 is an open-label, multicenter, phase 1b study to evaluate the safety and preliminary efficacy of AN0025 in combination with pembrolizumab in patients with locally advanced/metastatic tumors. It will include a dose-limiting toxicity observation phase followed by an expansion phase. All enrolled patients will be treated with AN0025 and Pembrolizumab until the patient experiences disease progression, unacceptable toxicity or withdraws consent, or for a maximum of 35 cycles (approximately 2 years). The dose of pembrolizumab will remain constant at 200 mg every 3 weeks (Q3W) for each dose level of AN0025 and in each cohort.

About AN0025 (EP4 Antagonist)

AN0025 (previously E7046) is an investigational, potentially first in class oral EP4 antagonist that blocks prostaglandin E2 from binding to its subtype 4 receptor (EP4) changing the immunosuppressive character of the tumor microenvironment. Based on preliminary results, it is well tolerated in patients with solid tumors. A Phase 1b study of AN0025 in combination with the standard of care in a neoadjuvant setting for locally advanced rectal cancer showed excellent results, with nearly 40% of patients not requiring surgery or achieving a complete pathological response in the post-surgical specimen in this study.