RALEIGH, N.C. and SHANGHAI—Xynomic Pharmaceuticals, Inc., a clinical stage U.S.-China oncology drug development company, has announced that Xynomic and its collaborators will present at the American Society of Clinical Oncology (ASCO) 2019 Annual Meeting to be held in Chicago from May 31, - June 4.
An oral presentation entitled “A Dose Escalation Pharmacokinetic and Pharmacodynamic Study of mTORC1/2 Inhibitor XP-105 (BI 860585) as Monotherapy and in Combination with Exemestane or Paclitaxel in Patients with Advanced Solid Tumors” will be presented by Dr. Filippo G. De Braud, a lead investigator at Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy. The presentation will show Phase 1 data of XP-105 (BI 860585), Xynomic’s Phase 2 ready, ATP-competitive, third generation mTORC1/2 Inhibitor, which was used alone or in combination with exemestane or paclitaxel in patients with advanced solid tumors. XP-105 is a potent dual inhibitor designed to overcome mTORC1 inhibition resistance.
This Phase 1 trial enrolled a total of 90 patients. 41 patients were in Arm A, where XP-105 was used as a monotherapy; 25 patients were in Arm B, where XP-105 was used in combination with exemestane; and 24 patients were in Arm C, where XP-105 was used in combination with paclitaxel. Combination regimens showed higher activity as compared to monotherapy.
In the monotherapy arm, stable disease (SD) was reported in 8 patients (20%), with a median duration of 11 months. In the exemestane combination arm, 4 (16%) partial responses (PR) were reported. In the paclitaxel combination arm, 1 complete response (CR) and 4 PRs were reported (OR rate 21%). Disease control rate (CR/PR/SD) was 20%, 28%, and 58% in the monotherapy, XP-105/exemestane and XP-105/paclitaxel arms, respectively. In the XP-105/paclitaxel combination the most frequent drug-related adverse events (AEs) were diarrhea and fatigue (58.3% each), hyperglycemia (54.2%) and anemia (50%). Grade ≥3 AEs were hyperglycemia, fatigue, diarrhea, anemia and leukopenia.
In addition, Xynomic is sponsoring an investigator meeting on Friday, March 22 in Athens, Greece. The investigator meeting will bring together European Union physicians, care providers and clinical research coordinators. The participants are from current and prospective clinical trial sites in the potentially pivotal Phase 3 clinical trial of testing Xynomic’s abexinostat, in combination with pazopanib, against renal cell carcinoma. The participants will be presented with trial design, protocol and study management as a part of the preparation of the trial start and patient recruitment.
Xynomic’s board of directors also recently appointed Ms. Jinwei Coco Kou as the interim chief accounting officer. Kou will be responsible for overseeing all accounting functions such as ledger accounts, financial statements and cost control systems. Before joining Xynomic, Kou was the chief financial officer at Salion Food Condiment Company Limited, and a managing director at Marcum Bernstein & Pinchuk LLP; she has also worked for Deloitte Touche Tohmatsu.
Kou is a CPA in both the U.S. and China, and holds a Bachelors degree in Economics majoring in Finance, and a Master’s degree in Economics majoring in Risk Management and Insurance, both from Peking University. She also holds an Executive MBA degree jointly granted by Columbia Business School, London Business School and Hong Kong University Business School.