Ano Pharmaceuticals AN0025 and Mercadon KEYTRUDA ® phase 1b clinical drug was completed in the United States as the first patient administration.

The study (AN0025S0103) is an open, multi-center clinical phase 1b trial conducted in the United States and Europe, including dose-limiting toxicity (DLT) observation and expansion phase 2 phases, designed to assess the safety and initial efficacy of AN0025 in combination with KEYTRUDA® the treatment of multiple locally advanced/metastasis solid tumors.
During the dose-limiting toxicity observation period, the trial will include patients with urethral cortical cell carcinoma or squamous/non-squamous non-small cell lung cancer (NSCLC) to verify the safety and tolerance of AN0025 and KEYTRUDA® and decide whether to advance to the extended period;
. In the United States, the first patients in the group have been given drugs at the University of Utah's Huntsman Cancer Institute, and patient recruitment is underway at the University of Texas MD Anderson Cancer Center and the University of Virginia Cancer Center.
All patients in the group will receive a combined treatment of AN0025 and KEYTRUDA® until the patient's course of treatment progresses, either with dose-limiting toxicity, or out of clinical practice for up to 35 cycles (approximately 2 years).
in each study queue, keyTRUDA® will be given at a fixed dose of 200 mg/kg once every 3 weeks for different doses of AN0025.
"In preclinical studies, AN0025 combined radiotherapy, chemotherapy, and immuno-checkpoint inhibitors showed anti-tumor activity in different malignancies, and we believe that the combination of AN0025 and KEYTRUDA® will hopefully lead to new treatment options for many cancer patients, including those who develop their condition after first- or second-line treatment and those who are unresponsive or resistant to PD-1 immunotherapy.
" Dr. Lars Birgerson, Chief Development Officer, Ano Pharmaceuticals, said, "We hope to provide innovative oncology treatments that address some of the clinically unsealed needs and enable patients to live longer while having a better quality of life."
" AN0025S0103 study AN0025S0103 is an open, multi-center clinical phase 1b trial conducted in the United States and Europe, including two phases of dose-limiting toxicity (DLT) observation and expansion phases, designed to assess the safety and initial efficacy of AN0025 in combination with KEYTRUDA® for the treatment of a variety of locally advanced/metastasis solid tumors.
All patients in the group will receive a combined treatment of AN0025 and KEYTRUDA® until the patient's course of treatment progresses, either produces intosatable toxicity, or withdraws from the clinic for up to 35 cycles (approximately 2 years).
in each study queue, keyTRUDA® will be given at a fixed dose of 200 mg/kg once every 3 weeks for different doses of AN0025.
an antagonist on AN0025 (EP4 antagonist) AN0025 is a leading global research advance in highly active and highly selective oral E-type prostate litag 4 antagonists that promote the body's immune role by acting on EP4 subjects to alter tumor microenvironments.
AN0025 has been shown to have strong anti-cancer activity and immune benefits in clinical pre vitro and in vivo trials, and combination (e.g. radiotherapy, immunosuppressant inhibitors) can significantly inhibit the growth of multiple tumors.
announced its Phase 1b clinical trial data for the treatment of local late-stage rectal cancer as a new complementary therapy at ESMO in 2019, with nearly 40% of patients requiring no surgical treatment or postoperative specimens achieving complete pathological remission, encouraging results, and the combination of AN0025 and standard preoperative treatment deserves further clinical research.
About Ano Pharmaceuticals Ano Pharmaceuticals is a clinically-stage global biopharmaceutical company focused on the global development of the first innovative drug, with a focus on being a pioneer in "global new" oncology drugs.
Currently, three products are in the mid-to-late stages of clinical life, including the FDA fast-track qualified AN2025 (buparlisib) project, which is in the process of global multi-center clinical phase 3; The Global Multi-Center Clinical Phase 3, the Global Potential FIC Oncology Immune AN0025 (EP4 Antagonist) project, has completed the European and American Phase 1b clinical trials for the treatment of local late-stage rectal cancer as a new complementary therapy, and the European and American Clinical Phase IB trials for the treatment of multiple solid tumors in combination with KEYTRUDA® are under way.
keyTRUDA ® a registered trademark owned by Merck Sharp and Dohme Corp, a subsidiary of Mercer East in Kenneworth, New Jersey, USA.
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