On October 2, 2020 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that Dr. Roger M. Perlmutter will be retiring as Executive Vice President and President, Merck Research Laboratories (MRL). Dr. Perlmutter will be succeeded by Dr. Dean Y. Li, effective Jan. 1, 2021 (Press release, Merck & Co, OCT 2, 2020, View Source [SID1234567969]). Dr. Perlmutter will remain as a non-executive director, MRL through June 30, 2021 to facilitate a seamless transition.

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"Since rejoining the company seven years ago, Dr. Roger Perlmutter has had a profound impact on Merck and the patients we exist to serve. During his tenure as its President, Merck Research Laboratories have made historic breakthroughs in immuno-oncology and other fields of medicine that have both transformed clinical practice and vastly improved patient outcomes. Roger’s legacy will include a rejuvenated research and development organization, staffed by world class scientists, clinicians and professionals and led by Dr. Dean Li. As a result of Roger’s hands-on and inspirational leadership, MRL is well positioned to bring forward lifesaving medicines and vaccines for many years to come," said Kenneth C. Frazier, chairman and chief executive officer, Merck. "I am enormously grateful for Roger’s decision to return to Merck and for his many meaningful contributions to science, medicine and the health and wellbeing of people around the world."

Since Roger Perlmutter’s appointment as President, Merck Research Laboratories in April 2013, the company has received more than 100 regulatory approvals for its medicines and vaccines globally. This includes more than 15 novel vaccines and therapeutics, including those for multiple cancers, diabetes, and infections caused by Ebola virus, human immunodeficiency virus, hepatitis C virus and cytomegalovirus. Most notably, under Roger’s leadership, Merck has established KEYTRUDA as a foundational immunotherapy for cancer, which continues to transform cancer care throughout the world. Since its first approval, in the U.S., KEYTRUDA has received approval for over 25 indications across 16 tumor types as well as indications for microsatellite instability-high/mismatch repair deficient and tumor mutational burden-high cancers.

"It has been an honor to lead the talented people of Merck Research Laboratories during the last seven years," said Dr. Perlmutter. "I look forward to continuing to work with Dean over the next few months to advance our scientific strategy and continue the strong momentum in our pipeline."

Dean Li is currently Senior Vice President of Discovery Sciences and Translational Medicine, MRL. He joined Merck in 2017 as Vice President and head of Translational Medicine. Prior to joining Merck, Dr. Li held positions of increasing responsibility in translational medical research at the University of Utah. Most recently he served as the H.A. & Edna Benning Professor of Medicine and Cardiology, Chief Scientific Officer, Associate Vice President and Vice Dean at the University of Utah Health System. During his tenure at the University of Utah, he co-founded multiple biotech companies based upon research conducted in his laboratory, including Recursion Pharmaceuticals, Hydra Biosciences and Navigen Pharmaceuticals. Dean received a bachelor’s degree from the University of Chicago and his medical degree, doctorate degree, and training in clinical medicine and cardiology at Washington University School of Medicine in St. Louis. He is a member of the American Society for Clinical Investigation and the Association of American Physicians.

"Since joining us in 2017, Dean has demonstrated strong leadership in building our discovery and translational medicine capabilities, advanced our pipeline and paved the way for Merck Research Laboratories to build on its singular legacy," said Mr. Frazier. "Dean’s strong clinical background and deep scientific and technological expertise make him the right leader to ensure sustained execution of our broad portfolio during this important time."

"Powerful new technologies continue to fuel important progress in enabling the discovery and development of new and better medicines and vaccines," said Dr. Li. "I am very grateful to Roger for his mentorship and the guidance of his leadership team over the past three years and am excited by the opportunity to build upon MRL’s legacy of scientific excellence and innovation."

On October 2, 2020 Axcelead Drug Discovery Partners Inc.（Axcelead, President: Yoshinori Ikeura）and Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE:4151, President and CEO: Masashi Miyamoto) reported that the companies have started collaboration on the development of innovative small-molecule drugs based on a novel drug discovery technology platform (Press release, Kyowa Hakko Kirin, OCT 2, 2020, View Source [SID1234567957]).

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By integrating Axcelead ‘s broad range of small-molecule drug discovery technologies and experience with Kyowa Kirin’s innovative drug discovery technologies, the companies will be able to build a novel small-molecule drug discovery technology platform. Utilizing this technology platform the companies aim to expand R&D pipeline of Kyowa Kirin through the discovery of multiple innovative drug candidates for diverse targets that were inaccessible so far.

"Our mission is to contribute to the discovery of innovative drugs as the best partner for people engaged in drug discovery, based on the technology and know-how we have accumulated through our research in the pharmaceutical industry and the vast amount of drug discovery data we have collected," said Yoshinori Ikeura, President of Axcelead. "We are delighted to be able to develop fundamental technologies that will open up a new era of small-molecule drugs and contribute to the discovery of drugs for a variety of previously inaccessible drug targets."

"We are actively engaged in small-molecule drug discovery by rational drug design including our proprietary structural analysis technology of disease-associated biomolecules", said Yoshifumi Torii, Ph.D., Executive Officer, Vice President, Head of R&D Division of Kyowa Kirin. "I am delighted to collaborate with Axcelead through integration of both companies’ technologies to overcome the difficulties of small-molecule drug discovery and create innovative drugs."

With the advances of biotechnology in the field of drug discovery research, many companies are now focusing their efforts on the research for new drugs with various modalities, such as biologics and nucleic acid drugs that act on drug targets that have been difficult to approach with small-molecule drugs. On the other hand, small-molecule drugs have a lower burden on patients in terms of administration than biologics. They also have the potential to lower drug prices by reducing manufacturing costs, which can be expected to be advantageous in terms of healthcare financing. For this reason, the social need for small-molecular drugs will continue to be high, and further technological innovation is desired In this regard, the development of innovative fundamental technologies that can expand the range of drug targets in small-molecule drugs will promote a paradigm shift in small-molecule drug discovery research and open up a new era of small-molecule drugs.

Axcelead is the first integrated drug discovery solutions provider in the pharmaceutical industry in Japan, having succeeded the drug discovery research capabilities of Takeda Pharmaceutical Company Limited. The company provides integrated services, from discovery of drug targets to optimization of small-and medium-molecule drug candidates, in which the company has particular expertise, and to the process of bridging the gap to clinical development.

Kyowa Kirin commits to innovative drug discovery driven by state-of-the-art technologies. The company focuses on creating new values in the four therapeutic areas: nephrology, oncology, immunology/allergy and neurology. Under the Kyowa Kirin brand, the employees from 40 group companies across North America, EMEA and Asia/Oceania unite to champion the interests of patients and their caregivers in discovering solutions wherever there are unmet medical needs.

On October 2, 2020 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it filed an application with the Ministry of Health, Labour and Welfare (MHLW) for the expanded use of FoundationOne CDx Cancer Genomic Profile as a companion diagnostic (CDx) for the fibroblast growth factor receptor (FGFR) inhibitor pemigatinib for patients with FGFR2 fusion positive locally advanced or metastatic cholangiocarcinoma on September 30,2020 (Press release, Chugai, OCT 2, 2020, View Source [SID1234567900]).

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"Cholangiocarcinoma is a disease with high unmet medical needs that has limited treatment options. Currently, FGFR2 is identified as a driver gene for cholangiocarcinoma and molecular-targeted therapies are being evaluated to treat the disease," said Dr. Osamu Okuda, Chugai’s President and COO. "We are committed to obtaining approval of FoundationOne CDx Cancer Genomic Profile as a CDx of pemigatinib as early as possible in order to contribute to treatment approaches for patients with the disease."

The filing aims to expand the use as a companion diagnostic to identify patients who could benefit from pemigatinib for the treatment of FGFR2 fusion positive locally advanced or metastatic cholangiocarcinoma by detecting FGFR2 fusion genes. Incyte Biosciences Japan submitted an application for pemigatinib for the treatment of FGFR2 fusion positive locally advanced or metastatic cholangiocarcinoma to the MHLW on September 14, 2020. The MHLW designated pemigatinib as an orphan drug for the indication.

As a leading company in the field of oncology, Chugai is committed to realizing advanced personalized oncology care and contributing to patients and healthcare professionals through improving access to comprehensive genomic profiling.

About FoundationOne CDx Cancer Genomic Profile
Developed by Foundation Medicine Inc., FoundationOne CDx Cancer Genomic Profile is a next-generation sequencing based in vitro diagnostic device for the detection of substitutions, insertion and deletion alterations, and copy number alterations in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. The program is available as a companion diagnostic for multiple molecular-targeted drugs approved in Japan.

About FGFR
Fibroblast growth factor receptors (FGFRs) play an important role in tumor cell proliferation and survival, migration and angiogenesis (the formation of new blood vessels). Activating mutations, translocations and gene amplifications in FGFRs are closely correlated with the development of various cancers.

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

On October 2, 2020 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it filed an application with the Ministry of Health, Labour and Welfare (MHLW) for the expanded use of FoundationOne CDx Cancer Genomic Profile as a companion diagnostic (CDx) for the tropomyosin receptor kinase (TRK) inhibitor, larotrectinib for the treatment of tropomyosin receptor kinase fusion cancer on July 30, 2020 (Press release, Chugai, OCT 2, 2020, View Source [SID1234567898]).

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"Neurotrophic tyrosine receptor kinase (NTRK) gene fusions are rare and occur across various tumor types regardless of age. Comprehensive genomic profiling is a useful tool for detecting this rare fusion gene," said Dr. Osamu Okuda, Chugai’s President and COO. "We hope FoundationOne CDx Cancer Genomic Profile will become available as a CDx for larotrectinib with this filing and will promote advanced personalized healthcare by providing information that can support informed treatment decisions for more patients."

FoundationOne CDx evaluates substitutions, insertion and deletion alterations (indels), and copy number alteration in 324 genes and select gene rearrangements, inclusive of gene fusions. The filing aims to expand the use of FoundationOne CDx Cancer Genomic Profile as a CDx to identify patients who could benefit from larotrectinib for the treatment of TRK fusion cancer by detecting NTRK gene fusions which produces the TRK fusion protein across solid tumors. The efficacy and safety of larotrectinib was investigated in clinical trials conducted by Bayer; phase I trial of adult patients, the phase II NAVIGATE trial in adult and adolescent patients, and the phase I/II pediatric SCOUT trial. Bayer Yakuhin, Ltd. submitted an application of larotrectinib for the treatment of TRK fusion cancer to the MHLW on May 22, 2020.

As a leading company in the field of oncology, Chugai is committed to advancing personalized oncology care and contribute to patients and healthcare professionals through improving access to comprehensive genomic profiling.

About FoundationOne CDx Cancer Genomic Profile
Developed by Foundation Medicine Inc., FoundationOne CDx Cancer Genomic Profile is a next-generation sequencing based in vitro diagnostic device for the detection of substitutions, insertion and deletion alterations, and copy number alterations in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. The program is available as a companion diagnostic for multiple molecular-targeted drugs approved in Japan.

About larotrectinib
Larotrectinib, a specific oral TRK inhibitor, was exclusively designed to treat tumors that have an NTRK gene fusion. Larotrectinib, was granted Orphan Drug Designation by the Ministry of Health, Labour and Welfare for the expected indication of "Locally advanced or metastatic solid tumor harboring an NTRK gene fusion".

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

On October 2, 2020 Bioscept reported that an agreement has been signed with pre-clinical CAR T development company, Carina Biotech, that will see the advancement of a promising cancer immunotherapy (Press release, Biosceptre, OCT 2, 2020, View Source;utm_medium=rss&utm_campaign=biosceptre-signs-deal-with-carina-biotech [SID1234567897]).

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Biosceptre, a biopharmaceutical company developing targeted therapeutics and immune-oncology products, has acquired the exclusive rights to Carina Biotech’s nfP2X7-targeted CAR-T cells and associated intellectual property, which has shown encouraging cancer-killing capacity against a number of cancers in pre-clinical testing.

Biosceptre and Carina will collaborate to further develop the nfP2X7 CAR-T program with the aim of advancing towards clinical trials in the near future. Under the terms of the deal Carina received an upfront cash payment and equity in Biosceptre.

"With this deal we are building on our commitment to therapies focussed on non-functional P2X7, a cancer target that has been shown to be present on the majority of cancers", said Gavin Currie CEO of Biosceptre. "Our goal is to bring novel therapeutics to patients suffering from a wide range of malignancies and CAR-T therapy is an important part of our immune-oncology approach".

Deborah Rathjen, PhD, CEO of Carina Biotech said

"This agreement with Biosceptre represents a significant milestone for Carina as it is the first commercial agreement involving our proprietary CAR-T technology. We believe that nfP2X7-targeting CAR-T cells hold significant promise as a potential treatment for a range of solid cancers and we are pleased to be working with Biosceptre to further bolster their pipeline of therapies exploiting the novel nfP2X7 target".