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Xynomic Completes Pre-IND Meeting with US FDA for XP-102, a Novel Pan-RAF Inhibitor against Colorectal Cancer and Lung Cancer

On June 12, 2019 Xynomic Pharmaceuticals Holdings, Inc. ("Xynomic", Nasdaq: XYN), a clinical stage US-China oncology drug development company, reported that it recently held a pre-IND meeting with the U.S. Food and Drug Administration (FDA) for its pan-PAF inhibitor XP-102 (BI 882370) for the treatment of cancers (Press release, Xynomic Pharmaceuticals, JUN 12, 2019, http://xynomicpharma.com/en/xynomic-completes-pre-ind-meeting-with-us-fda-for-xp-102-a-novel-pan-raf-inhibitor-against-colorectal-cancer-and-lung-cancer/ [SID1234537089]). The FDA addressed Xynomic’ questions related to CMC, nonclinical and clinical protocol, and provided valuable advice on overall clinical development plan to advance this drug candidate. Xynomic is on track to file this Investigational New Drug ("IND") application in the second half of 2019.

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XP-102 is a second generation potent and selective pan-RAF inhibitor uniquely binding to the DFG-out conformation, whereas marketed BRAF inhibitors occupy the DFG-in conformation. In the colorectal cancer (CRC) animal models, XP-102 showed superior anti-tumor activity to vemurafenib, a marketed BRAF inhibitor in both the Colo-205V600V/Emodel and HT-29V600V/E model. XP-102 in combination with cetuximab induced tumor regressions in the less sensitive HT-29 model.

"Our meeting with the FDA was a major step forward and the feedbacks provided by the agency was valuable in our development of clinical and regulatory strategies that will support our goal of advancing XP-102 through clinical development," said Y. Mark Xu, Xynomic’ Chairman and CEO. "We believe that XP-102 holds potential as an innovative therapy against B-RAF V600 mutated solid tumors including CRC and non-small cell lung cancer and hairy cell leukemia."

MediciNova to Present at the JMP Securities Life Sciences Conference

On June 12, 2019 MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), reported that Geoffrey O’Brien, JD/MBA, Vice President and Executive Officer, will present a corporate overview at the JMP Securities Life Sciences Conference on Wednesday, June 19, 2019 at 11:30 am at the St. Regis New York Hotel in New York City (Press release, MediciNova, JUN 12, 2019, View Source [SID1234537066]). MediciNova will be available for one-on-one meetings at this conference and investors may request a one-on-one meeting through JMP Securities.

NuCana Receives Orphan Drug Designation from the U.S. Food and Drug Administration for Acelarin® for the Treatment of Biliary Tract Cancer

On June 12, 2019 NuCana plc (NASDAQ: NCNA) reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for the Company’s investigational drug, Acelarin (NUC-1031), for the treatment of biliary tract cancer (Press release, Nucana BioPharmaceuticals, JUN 12, 2019, View Source [SID1234537054]). Acelarin is a new chemical entity and is NuCana’s ProTide transformation of gemcitabine.

"We are pleased to have received orphan drug designation from the FDA for Acelarin in biliary tract cancer," said Hugh Griffith, NuCana’s Founder and Chief Executive Officer. "There is a high unmet need for patients suffering from this cancer type. Our Phase Ib study of Acelarin combined with cisplatin showed an approximate doubling of the response rate expected with the standard of care, gemcitabine plus cisplatin, with several patients achieving significant reductions in their tumor volume as well as further tumor shrinkage over time. We believe Acelarin represents a potential significant advance in biliary tract cancer and we remain on track to open our global Phase III study in combination with cisplatin as a front-line treatment for patients with advanced biliary tract cancer in 2019."

Orphan drug designation is granted by the FDA to drugs that are defined as those intended for the treatment, prevention or diagnosis of rare diseases or conditions that affect fewer than 200,000 people in the United States. Orphan drug designation provides certain benefits and incentives that may include tax credits towards the cost of clinical trials and prescription drug user fee waivers.

About Biliary Tract Cancer

Biliary tract cancer is a form of cancer that develops in the bile duct system, which connects the liver, gallbladder, and small intestine, moving bile – a fluid that helps digest fats – to the small intestine. Approximately 178,000 new cases of biliary tract cancer are diagnosed each year worldwide, with more than 12,000 of those diagnoses in the United States.

Tolero Pharmaceuticals Announces First Patient Dosed with Investigational Agent TP-0903 in Phase 1/2 Study in Patients with Previously Treated Chronic Lymphocytic Leukemia andSmall Lymphocytic Lymphoma

On June 12, 2019 Tolero Pharmaceuticals, Inc., a clinical-stage company focused on developing novel therapeutics for hematological and oncological diseases, reported that the first patient has been dosed in a Phase 1/2 study evaluating the investigational agent TP-0903, an AXL receptor tyrosine kinase (RTK) inhibitor, in patients with previously treated chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) (Press release, Tolero Pharmaceuticals, JUN 12, 2019, View Source [SID1234537051]). The open-label, dose-escalation, safety, pharmacokinetics, and pharmacodynamic study will evaluate the dose-limiting toxicities and clinical activity of oral TP-0903 administered in patients with previously treated CLL/SLL, as monotherapy or in combination with ibrutinib.

"Although there have been significant advances in the treatment of CLL and SLL in recent years, there remains an area of clinical unmet need for patients who have had disease progression or relapse with available therapies." said David J. Bearss, Ph.D., Chief Executive Officer of Tolero Pharmaceuticals. "The initiation of this study will allow us to learn more about the clinical profile of TP-0903 and the role of AXL receptor tyrosine kinase (RTK) inhibition in patients with previously treated CLL and SLL."

The primary outcome measures of the Phase 1 study are to determine dose-limiting toxicities and the incidence of treatment-emergent adverse events of oral TP-0903 administered once daily for 28 days in patients with previously treated CLL/SLL. Secondary outcome measures of the Phase 1 study include pharmacokinetics. The recommended Phase 2 dose (RP2D) will be determined in Phase 1 of the study. Phase 2 of the study will begin after the completion of Phase 1. The primary outcome measure of Phase 2 will be to determine the objective response rate according to guidelines set forth by the 2018 International Workshop on CLL. Secondary outcome measures of the Phase 2 study include assessment of duration of response and rate of overall survival.

In Phases 1 and 2 of the study, patients will be assigned to one of two defined patient groups. Patients in Group 1, which includes those who are intolerant to or have progressed on B-cell receptor antagonists and/or BCL-2 antagonists, will receive TP-0903 monotherapy. Patients in Group 2, which includes those who have progression of disease on ibrutinib and the treating provider considers continuation of ibrutinib therapy to be in the best interest of the patient, will receive combination therapy of TP-0903 and ibrutinib. Additional information on this trial, including comprehensive inclusion and exclusion criteria, can be accessed at www.ClinicalTrials.gov (NCT03572634).

About TP-0903
TP-0903 is an investigational oral AXL receptor tyrosine kinase (RTK) inhibitor under evaluation in a Phase 1/2 study in patients with CLL/SLL (NCT03572634) and a Phase 1b study in patients with advanced solid tumors (NCT02729298). Tolero is exploring parallel clinical development paths for TP-0903 in both solid and hematologic malignancies.

About AXL Kinase
AXL belongs to the TAM (Tyro3, AXL and Mer) family of receptor tyrosine kinases and is overexpressed in many human cancers.1 It plays a key role in tumor cell proliferation, survival, metastasis, cellular adhesion and avoidance of the immune response. The overexpression of AXL is associated with a poor patient prognosis and drug resistance.2

Zymeworks to Present at Raymond James Life Sciences and MedTech Conference

On June 12, 2019 Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported that management will present at the upcoming Raymond James Life Sciences and MedTech Conference taking place June 18-19, 2019 in New York, NY (Press release, Zymeworks, JUN 12, 2019, View Source [SID1234537050]).

The Company’s presentation will be on Wednesday, June 19, 2019 at 11:30 a.m. ET.