XP-105 / Xynomic, Boehringer Ingelheim, Evotec - LARVOL DELTA

A dose escalation pharmacokinetic (PK) and pharmacodynamic (PD) study of mTORC1/2 inhibitor XP-105 (BI 860585) as monotherapy and in combination with exemestane or paclitaxel in patients (pts) with advanced solid tumors. (ASCO 2019) - P1; "The MTD for XP-105 monotherapy and in combination with exemestane or paclitaxel was defined as 220 mg and 160mg once daily, respectively. Combination regimens showed higher activity as compared to monotherapy with durable OR in about 20% of pts. The observed safety profile of XP-105 compared favorably to those reported from other mTOR inhibitors."

Clinical • Combination therapy • Monotherapy • PK/PD data • Oncology

A Phase 1 Study of mTORC1/2 Inhibitor BI 860585 as a Single Agent or with Exemestane or Paclitaxel in Patients with Advanced Solid Tumors. (PubMed, Cancers (Basel)) - P1 | "The MTD was determined in all arms. Antitumor activity was observed with BI 860585 monotherapy and in combination with exemestane or paclitaxel."

Clinical • Journal • P1 data • Dental Disorders • Fatigue • Immunology • Oncology • Solid Tumor • Stomatitis

Xynomic Pharma Receives Fast-Track Designation from the US FDA for Abexinostat as 4L Therapy Treating Follicular Lymphoma (GlobeNewswire, Xynomic Pharmaceuticals Holdings, Inc.) - "SHANGHAI, Sept 23, 2019 (GLOBE NEWSWIRE) -- Xynomic Pharmaceuticals Holdings, Inc (“Xynomic”, stock ticker: XYNO), a clinical stage US-China oncology drug development company, today announced that the U.S. Food and Drug Administration (“FDA”) has granted Fast-Track designation to Xynomic’s lead drug candidate abexinostat, for use as a single agent, as a fourth-line treatment of relapsed or refractory follicular lymphoma (“FL”). Xynomic is conducting a potentially pivotal Phase 2 trial of abexinostat, for use as a single agent, as a fourth-line treatment of relapsed or refractory FL in the U.S. and Europe. FDA has already granted Fast-Track designation to abexinostat, in combination with pazopanib, as a first- or second-line treatment of renal cell carcinoma. Its lead drug candidate, abexinostat, is in global potentially pivotal clinical trials for the treatment of renal cell carcinoma (in combination with pazopanib) and non-Hodgkin’s lymphoma (as a single agent)...."

Regulatory

Xynomic Pharmaceuticals, Inc. will present at ASCO 2019 Annual Meeting, will sponsor an EU investigator meeting for potentially pivotal kidney cancer trial, and appoints Interim Chief Accounting Officer (PRNewswire) - P1, N=90; NCT01938846; Sponsor: Boehringer Ingelheim; "Xynomic Pharmaceuticals...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, 2019 - June 4, 2019. The presentation will show Phase 1 data of XP-105 (also known as BI 860585), Xynomic's Phase 2 ready, ATP-competitive, third generation mTORC1/2 Inhibitor, 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."

P1 data