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 Agendia, Inc., a world leader in precision oncology for breast cancer, reported the presentation of four studies at the 12th European Breast Cancer Conference (EBCC-12) (Press release, Agendia, OCT 2, 2020, View Source [SID1234567987]). The data include a poster on further stratification of subtyping with BluePrint in breast cancer, as well as oral presentations that focus on the MINDACT trial, with a general trial update and in-depth analyses on screen- versus interval-detected breast cancers and the use of MammaPrint to evaluate lobular cancers.

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Following are the four data sets accepted to the EBCC-12, which can be found at www.conferences.eortc.org/ebcc12:

Screen-detected breast cancers have different tumor biology and better prognosis compared to interval breast cancers (Presentation #ORAL-011, 12:50-1:00PM CEST, 3 October)
Clinical Utility of MammaPrint testing in Invasive Lobular Carcinoma: Results from the MINDACT phase III trial (Presentation #ORAL-007, 1:50-2:00PM CEST, 2 October)
Updated results of the MINDACT trial: 70-gene signature to guide de-escalation of chemotherapy in early breast cancer (Presentation #ORAL-021, 1:00-1:10PM CEST, 3 October)
BluePrint Molecular Subtyping Recognizes Single and Dual Subtype Tumors with Implications for Therapeutic Guidance (Abstract #518, Poster Session B, 2 October)
Oral presentations for MammaPrint focused on sub-studies within the 9-year follow-up data for the ground-breaking MINDACT study. These data included:

An evaluation of the association between tumor biology and survival by mode of detection, which found that while both screen-detected and interval breast cancers showed very good 8-year DMFI rates, in patients with MammaPrint High Risk tumors, there was a significant difference in DMFI between screen- and interval-detected cancers. The results suggest that combining MammaPrint and the cancer detection method may improve risk stratification of patients with early stage breast cancer.
An analysis that showed that MammaPrint is a clinically useful test for patients diagnosed with invasive lobular carcinoma, the second most common histological subtype of breast cancer. In this evaluation, MammaPrint classified 16% of lobular tumors as genomically High Risk, for which more aggressive treatment would be recommended. In contrast, the assay classified 38% of this type of cancer as genomically Low Risk, for which the standard should be omission of chemotherapy even if the patient is clinically high risk. These data reinforce MammaPrint’s ability to help facilitate treatment decisions based on the biology of a tumor.
In addition, new data in a general MINDACT follow up was presented by Emiel Rutgers, M.D., Ph.D., FRCS, Chair and Professor in Surgical Oncology at the Netherlands Cancer Institute. The analysis confirmed the clinical utility of MammaPrint, with the data shown at EBCC-12 confirming that a MammaPrint Low Risk score can guide de-escalation of adjuvant chemotherapy in patients with clinically high risk breast cancer.

Finally, an Agendia-led study found that a small proportion of tissue samples (about 2%), when evaluated by the molecular subtyping test BluePrint, will display a dual genomic subtype instead of the typical single subtype. This secondary or even tertiary subtype, in some cases, has specific genomic characteristics that may help physicians understand the deeper biology of these tumors and the possible implications for treatment.

"These data are evidence of Agendia’s continuing commitment to support research to further our knowledge of breast cancer, for optimal patient care," said William Audeh, M.D., M.S., Chief Medical Officer at Agendia. "We are proud to share these multi-faceted data with the researchers, physicians, and advocates who will attend EBCC-12 and apply this information to improve treatment outcomes for their patients."

The variety of data accepted for inclusion at EBCC-12 underscore Agendia’s commitment to the pursuit of research that will allow for breast cancer patients and their care teams to confidently make the most personalized treatment decisions.

About MINDACT

MammaPrint, the 70-gene risk of recurrence assay for patients with early-stage breast cancer, is supported by level 1A clinical evidence from MINDACT, a landmark trial sponsored by the EORTC (EORTC-10041/BIG3-04). The study found that clinically high-risk patients with a MammaPrint Low Risk result could safely de-escalate treatment and forgo chemotherapy. Long-term follow-up data from MINDACT, presented at the 2020 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), confirmed and built upon the findings published in the New England Journal of Medicine in 2016.

The MINDACT trial enrolled 6,693 breast cancer patients. At the five-year follow-up mark, the trial showed that tumor analysis and reclassification by the MammaPrint 70-gene expression signature enabled a 46 percent reduction in the use of chemotherapy for clinically high-risk patients that were reclassified by the genetic assay to be genomically Low Risk. Nine-year follow-up data will be published in depth later this year, and further validate MINDACT as a positive de-escalation study for chemotherapy and continues to demonstrate MammaPrint’s clinical utility when determining a breast cancer patient’s need for chemotherapy.

On October 2, 2020 Select Medical Holdings Corporation ("Select Medical") (NYSE: SEM), reported that it will release the financial results for its third quarter ended September 30, 2020 on Thursday, October 29, 2020 after the market closes (Press release, Select Medical, OCT 2, 2020, View Source [SID1234567988]).

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Select Medical will host a conference call regarding its third quarter results, as well as the impact of the COVID-19 pandemic on each of its reporting segments, on Friday, October 30, 2020, at 9:00am ET. The domestic dial in number for the call is 1-866-440-2669. The international dial in number is 1-409-220-9844. The conference ID for the call is 6297066. The conference call will be webcast simultaneously and can be accessed at Select Medical Holdings Corporation’s website www.selectmedicalholdings.com.

For those unable to participate in the conference call, a replay will be available until 11:00am ET, November 6, 2020. The replay number is 1-855-859-2056 (domestic) or 1-404-537-3406 (international). The conference ID for the replay will be 6297066. The replay can also be accessed at Select Medical Holdings Corporation’s website, www.selectmedicalholdings.com.

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 Unum Group (NYSE: UNM) reported that it will release its third quarter 2020 results October 27, at approximately 4:15 p.m. Eastern time (Press release, Unum Therapeutics, OCT 2, 2020, https://www.prnewswire.com/news-releases/unum-group-to-release-third-quarter-2020-results-and-host-conference-call-301145053.html [SID1234567989]). The earnings release and financial supplement will be available in the Investors section of the company’s website, which can be directly accessed at www.investors.unum.com.

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Members of Unum Group senior management will host a conference call Wednesday, October 28, at 8 a.m. Eastern time to discuss the results of operations for the third quarter. Topics may include forward-looking information, such as guidance on future results or trends in operations, as well as other material information. Interested parties are invited to listen and participate in the question-and-answer segment by dialing the appropriate number.

A live webcast of the call will be accessible from the Investors section of the company’s website in a listen-only mode. It is recommended that interested parties access the webcast approximately 5-10 minutes prior to the start of the call. The company will maintain a replay of the call on its website through Wednesday, November 4. Interested parties may access the replay by dialing the appropriate number.