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Chugai’s ALK Inhibitor “Alecensa®” Approved for the Treatment of First Line Therapy on ALK-Positive Non-Small Cell Lung Cancer in Taiwan

On May 16, 2018 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that Chugai Pharma Taiwan Ltd., a wholly owned subsidiary of Chugai, obtained approval from the Taiwan Food and Drug Administration (TFDA), for "Alecensa," anaplastic lymphoma kinase (ALK) inhibitor, for the treatment of "patients with ALK-positive, advanced non-small cell lung cancer (NSCLC) (Press release, CHUGAI PHARMACEUTICAL CO, MAY 16, 2018, View Source [SID1234526670])."

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"The results of the J-ALEX study conducted by Chugai and the ALEX study conducted overseas showed that Alecensa will greatly contribute to the treatment of patients who receive at an early stage." said Dr. Yasushi Ito, Chugai’s Senior Vice President, Co-Head of Project & Lifecycle Management Unit. "Following approval for first line treatment in the US and the EU in 2017, it is a great pleasure for Chugai that Alecensa has been approved for primary treatment in Taiwan followed by Japan and South Korea in the Asia region."

This approval is based on results from the phase III ALEX study. The ALEX study evaluates the efficacy and safety of Alecensa compared with crizotinib in people with ALK-positive NSCLC who had not received prior systemic therapy (first-line).

In the study, Alecensa significantly reduced the risk of disease worsening or death by 47% (primary endpoint, HR=0.53, 95%CI: 0.38-0.73, stratified log-rank test, p<0.0001) compared to crizotinib as assessed by independent review committee. Median progression-free survival (PFS) was 25.7 months (95%CI: 19.9-not estimable) for people who received Alecensa compared with 10.4 months (95%CI: 7.7-14.6) for people who received crizotinib.

The safety profile of both drugs was consistent with that observed in previous studies, with no new findings.

In addition, Alecensa significantly reduced the risk of the cancer spreading to or growing in the brain or central nervous system (CNS) compared to crizotinib by 84% (HR=0.16, 95%CI: 0.10-0.28, stratified log-rank test, p<0.0001). This was based on a time to CNS progression analysis in which there was a lower risk of progression in the CNS as the first site of disease progression for people who received Alecensa (12%) compared to people who received crizotinib (45%).

About Alecensa
Alecensa is a highly selective oral ALK inhibitor created by Chugai. Outside of Japan, Alecensa is currently approved in the United States, Europe, Kuwait, Israel, Hong Kong, Canada, South Korea, Switzerland, India, Australia, Singapore, Taiwan, Thailand, Liechtenstein, Argentina, United Arab Emirates, Saudi Arabia and Turkey for the treatment of people with metastatic (advanced) ALK-positive NSCLC whose disease has worsened after, or who could not tolerate treatment with, crizotinib and in the US, EU, Australia, Turkey, Switzerland and South Korea for the treatment of first line therapy on ALK-positive metastatic NSCLC.

In Japan, Alecensa is available to patients with "ALK fusion gene positive unresectable, recurrent/advanced NSCLC" and is marketed by Chugai. The approved dosage and administration in Japan is "300mg alectinib administered orally twice daily for adult patient."

Note: The dosage and administration of the ALEX study is "600mg alectinib administered orally twice daily," which is different from the Japanese dosage and administration.

Trademarks used or mentioned in this release are protected by law.

Nordic Nanovector ASA: Invitation to First Quarter 2018 Results Presentation and Webcast

On May 15, 2018 Nordic Nanovector ASA (OSE: NANO) reported its first quarter 2018 results on Wednesday, 30 May 2018 (Press release, Nordic Nanovector, MAY 15, 2018, View Source [SID1234553504]).

First Quarter 2018 Results Presentation and Webcast

A presentation by Nordic Nanovector’s senior management team will take place at 8:30 am CEST on 30 May at:

Thon Hotel Vika Atrium, Munkedamsveien 45, 0250 Oslo

Meeting Room: NYLAND

The presentation will be recorded as a webcast and will be available at www.nordicnanovector.com in the section: Investors & Media

The results report and the presentation will be available at www.nordicnanovector.com in the section: Investors & Media/Reports and Presentation/Interim Reports/2018 from 7:00 am CEST the same day.

Results presentation in Norwegian

As announced in April, a separate presentation of the results in Norwegian, to be hosted by Nordic Nanovector’s CFO and Interim CEO, and its VP IR & Corporate Communications, will take place on Thursday, 31 May 2018 at 8:30 am CEST at:

Thon Hotel Vika Atrium, Munkedamsveien 45, 0250 Oslo

Meeting Room: VIPPETANGEN

To attend the meeting please email – [email protected]

The presentation will NOT be recorded as a webcast

10-Q – Quarterly report [Sections 13 or 15(d)]

Genprex has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Genprex, 2018, MAY 15, 2018, View Source [SID1234527544]).

Eos Biosciences will attend the 2018 Biotechnology Innovation Organization (BIO) International Convention in Boston, June 2-5, 2018

On May 15, 2018 Eos Biosciences reported it will attend the 2018 Biotechnology Innovation Organization (BIO) International Convention being held June 2-5, 2018, in Boston (Press release, Eos Biosciences, MAY 15, 2018, View Source [SID1234526906]). Eos Biosciences’ Chief Executive Officer, Omar Haffar, Ph.D. and Chief Financial Officer, Thomas Plotts will attend the BIO International Convention.

Celsius Therapeutics Launches with $65 Million in Series A Financing to Develop Precision Therapeutics For People with Autoimmune Diseases and Cancer

On May 15, 2018 Celsius Therapeutics, a company translating single-cell genomic insights into precision therapeutics for autoimmune diseases and cancer, reported with a $65 million Series A financing led by Third Rock Ventures with participation from GV (formerly Google Ventures), Heritage Provider Network, Casdin Capital, Alexandria Venture Investments and other key investors (Press release, Celsius Therapeutics, MAY 15, 2018, View Source [SID1234526810]). Celsius is charting a new course of target and drug discovery by understanding the specific cells, among many others, that are key players in disease and by identifying the genes that are triggering their malfunction.

Celsius’ fundamentally new approach aims to combine the power of single-cell genomic sequencing with computational algorithms to discover first-in-class precision therapies that have a transformative impact on the lives of patients with autoimmune diseases and cancer. To do this, the company applies a systematic approach, starting with single-cell sequencing on defined patient samples to identify and understand the individual cells and their interactions that cause dis-ease.

By analyzing single cells, Celsius’ approach has the potential to understand the causes of disease at an entirely new level of resolution that overcomes limitations of traditional genomic sequencing approaches. Celsius believes this approach could be the key to bring precision medicines to autoimmune diseases for the first time. These cellular insights could also allow Celsius to identify the right combination of treatments for the right patients and build on the promising results seen in the field of immunooncology.

Celsius was co-founded by Aviv Regev, Ph.D., core institute member, chair of the faculty and director of the Klarman Cell Observatory at the Broad Institute of MIT and Harvard, Professor of Biology at MIT and an investigator at the Howard Hughes Medical Institute. Her research revealed that many diseases are driven by the combined dysfunction of several specific cell types, and the interactions between them. Traditional genomic sequencing cannot identify these individual contributions, as only the average can be seen and key critical causes can be missed. For the first time, with the approaches discovered by Aviv and Celsius’ other founders, the company will combine massive datasets of unprecedented size and complexity with sophisticated machine learning algorithms. Celsius will be able to distinguish the specific cells, among many others, that play a key role in disease and identify the genes that are triggering their malfunction. This approach will allow the company to more efficiently identify specific targets for treating diseases in specific patients and ultimately develop medicines for those targets.

"When first meeting with Aviv and her colleagues and learning about the significance of this new technology, we knew this had to become a company. We formed Celsius with the goal of bringing a novel precision medicine approach to underserved patients with autoimmune diseases and certain cancers," said Christoph Lengauer, Ph.D., co-founder and president of Celsius and venture partner at Third Rock Ventures. "With the new level of clarity provided by single-cell sequencing, our team will be able to address many of the challenges of the current treatments and introduce a new class of medicines that will lead to better outcomes and potential cures."

Expert Team of Scientists and Clinicians

Celsius’ founders are established leaders with experience across the company’s entire product engine, from single-cell RNA sequencing to computational biology, disease biology and drug discovery.

• Jeffrey Bluestone, Ph.D., president and chief executive officer, Parker Institute for Cancer Immunotherapy, University of California, San Francisco; A.W. and Mary Margaret Clausen Distinguished Professor

• Vijay Kuchroo, D.V.M., Ph.D., Samuel L. Wasserstrom professor of neurology, Harvard Medical School; senior scientist, neurology, Brigham and Women’s Hospital; associate member, Broad Institute; director, Evergrande Center for Immunologic Diseases, Harvard Medical School and Brigham and Women’s Hospital

• Christoph Lengauer, Ph.D., venture partner, Third Rock Ventures; president, Celsius Therapeutics; adjunct associate professor, Sidney Kimmel Comprehensive Cancer Center at the Johns Hopkins University School of Medicine

• Aviv Regev, Ph.D., Chair of the Faculty and core institute member, and director, Klarman Cell Observatory, Broad Institute; professor, Department of Biology, MIT; Investigator, Howard Hughes Medical Institute

• Ramnik Xavier, M.D., chief of gastroenterology, Massachusetts General Hospital; institute member, Broad Institute; Kurt Isselbacher professor of medicine, Harvard Medical School

Celsius has licensed key technologies from the Broad Institute based on the work of Drs Regev and Kuchroo, including non-exclusive licenses to single-cell technologies and an exclusive license to early stage therapeutic programs.

"Each of us is made up of tens of trillions of cells. At the core of founding Celsius was the new ability to see something we could not see before. We can now see the dysfunction of key cells and their interactions within their neighborhood. Diseases that we have struggled to understand now can become crystal clear. With that clarity, we hope to create novel precision medicines," said Alexis Borisy, partner at Third Rock Ventures and chairman of Celsius Therapeutics. "We believe this approach and the incredible group that has been assembled by the founders have the unique potential to deliver a powerful new class of medicines and make a meaningful difference for patients."