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ArQule to Present Clinical Data for its Reversible BTK Inhibitor, ARQ 531, at the American Society of Hematology 2019 Annual Meeting

On November 25, 2019 ArQule, Inc. (Nasdaq: ARQL) reported that final clinical data from the company-sponsored phase 1 study of ARQ 531 will be presented on December 9, 2019 at the 61stAmerican Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition in Orlando, Florida (Press release, Arqule, NOV 25, 2019, View Source [SID1234551637]). The poster presentation will highlight the final data set with respect to ARQ 531’s safety profile, clinical activity and durability across multiple refractory B-cell malignancies, including C481-mutant chronic lymphocytic leukemia (CLL).

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Presentation Details
Title: Final Results of Phase 1, Dose Escalation Study Evaluating ARQ 531 in Patients with Relapsed or Refractory B-cell Lymphoid Malignancies
Abstract #: 4298
Session Name: CLL: Therapy, excluding Transplantation: Poster III
Date: Monday, December 9, 2019
Presentation Time: 6:00- 8:00 p.m. EST
Location: Orange County Convention Center, Hall B

ArQule will host a conference call and webcast for investors on Monday, December 9, 2019 at 8:15 a.m. EST to discuss the ARQ 531 clinical data. The live webcast can be accessed in the "Investors and Media" section of our website, www.arqule.com, under "Events & Presentations" or by visiting link here. You may also listen to the call by dialing (877) 868-1831 within the U.S. or (914) 495-8595 outside the U.S. and providing conference ID 4573858. A replay will be available two hours after the completion of the call and can be accessed in the "Investors & Media" section of our website, www.arqule.com, under "Events and Presentations."

ArQule management will also be hosting an Investor Event to answer questions and discuss these data in Orlando on Monday, December 9, 2019 from 8:00–10:00 p.m. EST. Investors, sell side analysts, and industry representatives are welcome to attend. For event details and to RSVP, please email [email protected].

About BTK and ARQ 531

Bruton’s tyrosine kinase, BTK, is a therapeutic target that has been clinically proven to inhibit B-cell receptor signaling in blood cancers. ARQ 531 is an orally bioavailable, potent and reversible dual inhibitor of both wild type and C481S-mutant BTK. The C481S-mutation is a known resistance mechanism for first generation irreversible BTK inhibitors. ARQ 531 has demonstrated a manageable safety profile, predictable PK, profound pharmacodynamic effects and signs of clinical activity.

WuXi Vaccines is investing $ 240 million in production facility in Ireland

On November 25, 2019 WuXi Biologics ("WuXi Bio") (2269.HK), a world-leading open access technology platform for biologics that provides complete solutions for the discovery, development and manufacture of biological compounds , has reported that its subsidiary WuXi Vaccines, a human factor vaccine development and production company (CDMO), is investing $ 240 million in a new vaccines manufacturing facility in Ireland, following a LOI of 20 years, WuXi Vaccines Signed at the beginning of the year (Press release, WuXi Biologics, NOV 25, 2019, View Source [SID1234551635]).

WuXi Vaccines to Build a $ 240 Million Manufacturing Facility in Ireland

WuXi Vaccines to Build a $ 240 Million Manufacturing Facility in IrelandLatest Image of WuXi Biologics Factory of the Future in Ireland
The Memorandum of Understanding covers a new, dedicated manufacturing facility, including production of active pharmaceutical ingredients (MFG15), manufacturing of pharmaceutical products (DP5) and quality control (QC) laboratories. A vaccine product is being produced there for a large international pharmaceutical company that is to be marketed worldwide. The new vaccine production site, which is scheduled to be approved, will be built within the WuXi Biologics campus, adjacent to the "Factory of the Future." The biologic drug manufacturing facility is scheduled to begin commercial production in 2021.

Heather Humphreys TD , Irish Minister for the Economy, Enterprise and Innovation said: "I am delighted that WuXi Vaccines is creating 200 highly skilled jobs. These are added to the 400 jobs that WuXi Biologics announced last year for Dundalk. Today’s news is further proof that the border region is an attractive investment location. "

Eileen Sharpe , Head of Growth, Europe and New Business Units at the Irish Industrial Development Authority (IDA) commented, "A second major investment by WuXi Biologics at its Dundalk site is great news. As the first contract manufacturing operation in Ireland, this second planned project will significantly strengthen our life science ecosystem and provide important impetus for Ireland as a production location. "

Dr. Chris Chen, CEO of WuXi Biologics and Chairman of WuXi Vaccines, commented, "We look forward to our first production facility in Ireland, where a vaccine for a major international pharmaceutical company is being manufactured. Complex processes, extensive analytical testing and strict regulatory requirements make vaccine production difficult. Process and quality control are extremely important for product quality. This new project covers the exclusive production of a vaccine for a major international pharmaceutical company to be marketed worldwide. It is one of the first of its kind in the industry and further demonstrates the technical expertise, world-class quality and commercial manufacturing expertise that WuXi Biologics will bring to Dundalk. WuXi Biologics and WuXi Vaccines are eager to

DNAtrix Presents Positive Results from the Phase 2 CAPTIVE/KEYNOTE-192 Study of DNX-2401 in Combination with Pembrolizumab for Glioblastoma at the 2019 SNO Annual Meeting

On November 24, 2019 DNAtrix, a leader in the development of oncolytic viruses for cancer therapy, reported that updated safety and efficacy data from the fully-enrolled Phase 2 CAPTIVE / KEYNOTE-192 study of DNX-2401 (tasadenoturev), DNAtrix’s oncolytic adenovirus, followed by pembrolizumab for patients with recurrent glioblastoma (Press release, DNAtrix, NOV 24, 2019, View Source [SID1234551636]). The data demonstrate that the therapy elicits durable clinical activity and has a favorable safety profile. These results are being presented at the Society for Neuro-Oncology (SNO) Annual Meeting held from November 22-24, 2019 in Phoenix, Arizona.

A total of 48 patients with recurrent glioblastoma were treated at 15 participating clinical sites with the regimen of DNX-2401, followed by pembrolizumab. The majority of patients experienced clinical benefit following treatment, including durable complete and partial responses. Interim median overall survival for patients is currently 12.3 months. In addition, the interim safety analysis demonstrates that the therapy has a positive benefit-risk profile, there were no unanticipated adverse events and patients remained on pembrolizumab for a median of 5.5 months with a maximum of 34 cycles.

"The data hold great promise for patients afflicted with glioblastoma, the most common form of adult brain cancer. Glioblastoma is a disease associated with near uniform fatality. The results are striking in this context," said Clark Chen, MD, PhD, Professor, Lyle French Chair in Neurosurgery and Department Head at the University of Minnesota, presenting author for the CAPTIVE / KEYNOTE-192 study. "The results suggest that the combination of DNX-2401 and pembrolizumab has the potential to revolutionize the care of glioblastoma patients. I look forward to the rigorous studies aimed to validate the efficacy of DNX-2401."

"These interim data from our CAPTIVE trial are a significant milestone for us in the development of DNX-2401 as an innovative treatment for glioblastoma," said Frank Tufaro, PhD, CEO of DNAtrix. "Importantly, these data suggest that DNX-2401 has a superior clinical benefit and safety profile compared to currently approved chemotherapy for recurrent glioblastoma, and we are particularly pleased that, together with pembrolizumab, DNX-2401 elicited a number of robust and durable antitumor responses."

About CAPTIVE / KEYNOTE-192
CAPTIVE / KEYNOTE-192 is a Phase 2 multicenter study evaluating a single intratumoral injection of DNX-2401 (tasadenoturev) followed by standard dosing with pembrolizumab every three weeks to determine the safety and efficacy in patients with recurrent glioblastoma.

About DNX-2401 (Tasadenoturev)
DNX-2401 is an oncolytic adenovirus engineered specifically to infect, replicate in, and kill cancer cells to elicit an immune response. Prior clinical studies have demonstrated that DNX-2401 was well tolerated and extended survival for patients with recurrent glioblastoma. DNX-2401 is currently being evaluated in several clinical trials, including a multicenter Phase 2 study evaluating DNX-2401 with pembrolizumab for adult patients with recurrent glioblastoma. DNX-2401 has been granted PRIME and Orphan designation by the EMA, and Fast Track and Orphan designation by the FDA.

Chi-Med Highlights Oral Presentations at 2019 ESMO Asia Annual Meeting

On November 23, 2019 Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) reported that analyses from two clinical studies of savolitinib and fruquintinib at the fifth European Society for Medical Oncology Asia Congress ("ESMO Asia") on November 22 to 24, 2019 in Singapore (Press release, Hutchison China MediTech, NOV 23, 2019, https://www.chi-med.com/oral-presentations-at-2019-esmo-asia-annual-meeting/ [SID1234552849]).

Savolitinib: the TATTON study was selected as a late-breaking presentation in the Presidential Session at ESMO (Free ESMO Whitepaper) Asia.

Presentation Title: TATTON Expansion Cohorts: A Phase Ib Study of Osimertinib Plus Savolitinib in Patients (pts) with EGFR-Mutant, MET-Positive NSCLC Following Disease Progression on a Prior EGFR-TKI
Presenting Author: Ji-Youn Han, Center for Lung Cancer, National Cancer Center, Korea
Other Authors: Lecia V. Sequist, Myung-Ju Ahn, Byoung Chul Cho, Helena Yu, Sang-We Kim, James C-H Yang, Jong Seok Lee, Wu-Chou Su, Dariusz Kowalski, Sergey Orlov, Mireille Cantarini, Remy B. Verheijen, Anders Mellemgaard, Paul Frewer, Xiaoling Ou, Geoffrey Oxnard
Abstract #: LBA2
Session: Presidential Session
Date & Time: Saturday, November 23, 2019, 11:40 AM
Location: Suntec Singapore Convention & Exhibition Centre, Hall 406
Earlier results of this study (cut-off date of August 31, 2017) were first presented on October 17, 2017 at the World Conference on Lung Cancer (WCLC).[i] Interim results from this study (cut-off date of February 28, 2018) were presented on March 31, 2019 at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting[ii] (clinicaltrials.gov identifier: NCT02143466).

The TATTON trial supports SAVANNAH, an ongoing Phase II clinical trial exploring the combination of savolitinib and Tagrisso to overcome mesenchymal epithelial transition receptor ("MET")-driven endothelial growth factor receptor ("EGFR")-tyrosine kinase inhibitors ("TKI") resistance following treatment with Tagrisso (clinicaltrials.gov identifier: NCT03778229).

Savolitinib is a potent and selective inhibitor of MET, an enzyme which has been shown to function abnormally in many types of solid tumors. In clinical studies to date in over 1,000 patients globally, savolitinib has shown promising signs of clinical efficacy in patients with MET gene alterations in lung cancer, kidney cancer, and gastric cancer with an acceptable safety profile. Chi-Med is currently testing savolitinib in global partnership with AstraZeneca, both as a monotherapy and in combinations.

Fruquintinib (Elunate): Final results from the Phase II study of fruquintinib in combination with Iressa in China in the first-line setting for patients with advanced or metastatic non-small cell lung cancer ("NSCLC") with EGFR activating mutations will be presented. The primary objective of this exploratory study is to determine the safety and tolerability and median progression-free survival (PFS) of the fruquintinib and Iressa combination.

Presentation Title: Phase II Study of Fruquintinib Plus Gefitinib in Stage IIIb/IV NSCLC Patients Harboring EGFR Activating Mutations
Presenting Author: Shun Lu, Shanghai Chest Hospital, Shanghai Jiao Tong University
Other Authors: Jianying Zhou, Xiaomin Niu, Yiping Chen, Weiguo Su
Abstract #: 478O
Session: Mini Oral session – Thoracic cancers
Date & Time: Saturday, November 23, 2019, 5:00 PM
Location: Suntec Singapore Convention & Exhibition Centre, Hall 407
Earlier results of this study (cut-off date of October 10, 2017) were first presented on October 15, 2017 at the World Conference on Lung Cancer (WCLC)[iii] (clinicaltrials.gov identifier: NCT02976116).

Fruquintinib is a highly selective and potent oral inhibitor of vascular endothelial growth factor receptor ("VEGFR") 1/2/3. VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. Fruquintinib was designed to improve kinase selectivity to minimize off-target toxicities, improve tolerability and provide more consistent target coverage. Chi-Med retains all rights to fruquintinib outside of China and is partnered with Eli Lilly and Company in China.

Entry into a Material Definitive Agreement

On November 23, 2019, Adaptimmune Therapeutics plc (the "Company") reported that it has entered into Amendment No. 1 effective as of November 18, 2019 (the "Amendment") to the License Agreement and Sublicense Agreement effective as of December 19, 2012 (the "License Agreements") and the Commercial Development and Supply Agreement effective as of June 1, 2016 (the "Supply Agreement"), which the Company entered into with Life Technologies Corporation, an affiliate of Thermo Fisher Scientific Inc (Filing, 8-K, Adaptimmune, NOV 23, 2019, View Source [SID1234551693]). The Amendment changed the License Agreements from exclusive licensing agreements to a non-exclusive agreement. The Amendment also contained adjustments to the Company’s minimum purchase obligations under the Supply Agreement. The foregoing description of the Amendment is only a summary of the material terms thereof, and does not purport to be complete. The description is qualified in its entirety by reference to the Amendment, which will be filed as an exhibit to the Company’s Annual Report on Form 10-K for the year ended December 31, 2019.