News | December 27, 2018

Xynomic Pharma Will Present At ASCO-GU Cancers Symposium, Files 3 INDs For Potentially Pivotal Cancer Trials In China, And Expands R&D Operations

Raleigh, N.C and Shanghai /PRNewswire/ - Xynomic Pharma, a clinical stage US-China oncology drug development company, today announced that its Trials-in-Progress poster discussing the ongoing, potentially pivotal, phase 3 trial of abexinostat plus pazopanib as first- or second-line therapy in patients with locally advanced or metastatic renal cell carcinoma (RCC) will be presented by Dr. Rahul Aggarwal of University of California San Francisco, a lead investigator, at the ASCO-Genitourinary Cancers Symposium on February 16, 2019 in San Francisco, California, USA.

Xynomic Pharma has also filed 3 China Investigational New Drug (IND) applications with China National Medical Products Administration (NMPA) to test abexinostat, Xynomic's lead drug candidate and a China Category 1 drug, against RCC and lymphoma. All 3 clinical trials are potentially pivotal and will test (1) abexinostat in combination with pazopanib as a first- or second-line therapy against RCC, (2) abexinostat as a third-line mono therapy against diffuse large B-cell lymphoma, the most common aggressive non-Hodgkin's lymphoma (NHL) subtype according to the Leukemia & Lymphoma Society (LLS), and (3) abexinostat as a third-line mono therapy against follicular lymphoma, the most common indolent NHL subtype according to LLS. The first clinical trial will also be a part of an on-going multinational, multi-center trial. Furthermore, Xynomic Pharma has filed an IND with the NMPA for a fourth trial, not intended for registration purpose in China, to test abexinostat as a fourth-line mono therapy against follicular lymphoma. This fourth trial will be a part of an on-going multinational, multi-center trial.

In addition, Xynomic Pharma has officially commissioned its dedicated R&D Innovation Center in Shanghai, China with a ribbon cutting ceremony. This center is staffed with a team of multinational scientists from China and India and focuses on leveraging kinase inhibition, immuno-oncology and epigenetic modification to discover and develop innovative small molecule oncology drugs. The center is designed to have research capabilities from lead identification to pre-clinical drug candidate selection and development capabilities in early phase clinical trials.

About Xynomic Pharmaceuticals, Inc.
Xynomic Pharmaceuticals, Inc. is a clinical stage oncology-focused biopharmaceutical company. Its current pipeline mainly consists of 3 drug candidates; Xynomic owns global exclusive development, manufacturing and commercialization rights to each of these. Its lead drug candidate abexinostat is in global pivotal clinical trials against renal cell carcinoma (in combination with pazopanib) and non-Hodgkin's lymphoma (as a single agent). Xynomic Pharma's other clinical stage drug candidate XP-105 (BI 860585) is a phase 2 ready, ATP-competitive mTORC1/2 inhibitor against solid tumors. Xynomic's pre-clinical drug candidate XP-102 (BI 882370) is a pan-RAF inhibitor against colorectal cancer and melanoma.

Source: Xynomic Pharmaceuticals, Inc.

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