On January 8, 2021 Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in genetic testing and precision medicine, reported that it received its first reimbursement decision for the Myriad myChoice Diagnostic System, which helps determine if women with ovarian cancer will benefit from the PARP inhibitor, Zejula (niraparib) (Press release, Myriad Genetics, JAN 8, 2021, View Source [SID1234573707]). myChoice was approved by Japan’s Ministry of Health, Labour and Welfare in September 2020 as a companion diagnostic for this indication and the reimbursement decision is now in effect.

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"Myriad’s myChoice test is the only one of its kind to be approved for reimbursement in Japan," said Nicole Lambert, president of Myriad Genetic Laboratories. "This decision further advances precision medicine and helps ensure that more Japanese women have access to the most advanced therapies in their fight against ovarian cancer."

Myriad has been collaborating with Takeda Pharmaceutical Company in Japan since 2017 on the development of companion diagnostics to extend the benefit of the newest and most innovative treatments to more patients. Takeda is the largest pharmaceutical company in Asia and one of the top 10 largest pharmaceutical companies in the world by revenue.

"This most recent approval enables physicians to have the best options available to effectively treat women with ovarian cancer," said Professor Daisuke Aoki, M.D., Ph.D., Department of Obstetrics and Gynecology, Keio University School of Medicine, Tokyo, Japan. "Physicians can immediately use Myriad myChoice to identify patients that could potentially benefit from treatment with Zejula."

In August 2020, myChoice was exclusively cited and the only named commercial companion diagnostic by the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in new recommendations on the use of PARP inhibitors for the treatment and management of certain patients with advanced ovarian cancer. The new recommendations, based on clinical trial results, were published in the Journal of Clinical Oncology.

Myriad has partnered with SRL Inc., a subsidiary of the H.U. Group Holdings, Inc., to commercialize the myChoice Diagnostic System in Japan.

About SRL
Since the establishment in 1970, SRL, Inc., a member of the H.U. Group Holdings, Inc., Japan-based leading healthcare group, has been providing comprehensive testing services as the largest commercial clinical laboratory in Japan. SRL carries out nearly 400,000,000 tests per year, covering a wide range of testing services including general/emergency testing, esoteric/research testing, companion diagnostics tests, genomic analysis, and etc. For more information, please visit View Source

About the myChoice Diagnostic System
Myriad myChoice is the most comprehensive homologous recombination deficiency (HRD) test, enabling physicians to identify patients with tumors that have lost the ability to repair double-stranded DNA breaks, resulting in increased susceptibility to DNA-damaging drugs such as platinum drugs or PARP inhibitors. The myChoice test comprises tumor sequencing of the BRCA1 and BRCA2 genes and a composite of three proprietary technologies (loss of heterozygosity, telomeric allelic imbalance and large-scale state transitions). For more information, visit: View Source

Zejula (niraparib) is a licensed product from GSK (formerly TESARO. Inc).

On January 8, 2021 TG Therapeutics, Inc. (NASDAQ: TGTX) reported that Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, will present at the 39th Annual J.P. Morgan Healthcare Conference, being held virtually (Press release, TG Therapeutics, JAN 8, 2021, View Source [SID1234573706]). The presentation is scheduled to take place on Tuesday, January 12, 2021 at 2:00 PM ET.

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A live webcast of this presentation will be available on the Events page, located within the Investors & Media section, of the Company’s website at View Source A replay of the webcast will be available on TG’s website following the event.

On January 8, 2021 ATP, a leading life sciences venture capital firm, and Biolojic Design, a biotechnology company that computationally designs functional antibodies, reported that unveiled Aulos Bioscience, a new company that is developing highly differentiated interleukin-2 (IL-2)-binding monoclonal antibodies as therapeutics against solid tumors (Press release, ATP, JAN 8, 2021, View Source [SID1234573705]). ATP has committed $40 million in Series A funding to advance Aulos’ lead molecule from preclinical stage through clinical proof of concept, with human trials expected to start later this year.

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"ATP created Aulos with Biolojic to develop antibodies with unique properties that we believe hold best-in-class promise among IL-2 targeted therapies," said Michael Ehlers, M.D., Ph.D., Chief Scientific Officer of and venture partner at ATP. "Biolojic has designed elegant and impressively simple molecules that redirect IL-2 to low-affinity effector T-cells away from high-affinity regulatory T-cells by binding to the body’s own IL-2, steering it away from immune suppression and towards immune activation. Other drug candidates that redirect IL-2 fail to target naturally occurring IL-2 and introduce complex, modified, exogenous versions of IL-2 that are often difficult to manufacture and can have unfavorable pharmacokinetic properties. We think that the advantages of the Aulos approach could enable us to deliver a new mainstay in fighting multiple cancers."

Yanay Ofran, Ph.D., Chief Executive Officer of Biolojic Design and acting CEO of Aulos Bioscience, said: "We are excited to partner with ATP to bring our unique computationally designed antibodies to patients. Biolojic’s AI-based platform designs mono- and multi-specific human antibodies that target pre-determined epitopes with exquisite precision and execute functions previously not carried out with antibodies. These capabilities are illustrated by the Aulos anti-IL-2 antibody approach, which has the potential to fully unlock the power of the patient’s own IL-2. We see Aulos as an opportunity to dramatically change the cancer treatment landscape. Moreover, we believe this will be the first ever computationally designed antibody to enter human trials."

Aulos Bioscience will be based in Cambridge, MA. The company’s Board of Directors is chaired by Dr. Ehlers and includes as members Dr. Ofran; Yechezkel Barenholz, Ph.D., Professor of Biochemistry at the Hebrew University Hadassah Medical School who is known as an innovator of therapeutic applications of liposomes and nanomedicine, notably as a co-inventor of Doxil (doxorubicin); Joseph A. Yanchik III, a venture partner at ATP and founder of companies including Aileron Therapeutics and Tokai Pharmaceuticals (now Novus Therapeutics); and Raj Chopra, FRCP, FRCPath, FRSB, Ph.D., an ATP venture partner, former director of the Cancer Research UK Cancer Therapeutics Unit at the Institute of Cancer Research in London, and co-founder of Monté Rosa Therapeutics.

Dr. Ehlers and Dr. Ofran will present more information about Aulos Bioscience at the 39th annual J.P. Morgan Healthcare Conference on Thursday, January 14, 2021. The live stream is scheduled to begin at approximately 10:25 am EST. A link to the webcast will be available on the Aulos website at aulosbio.com.

On January 8, 2021 Varian (NYSE: VAR) reported its first quarter fiscal year 2021 earnings release date (Press release, Varian Medical Systems, JAN 8, 2021, View Source [SID1234573703]).

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The Company will report results for the first quarter of fiscal year 2021 after market close on Tuesday, January 26, 2021.

In light of the pending transaction with Siemens Healthineers, Varian will not be hosting a conference call for its first quarter fiscal year 2021 earnings.

For automatic e-mail alerts regarding Varian news and events, investors can subscribe on the company website: View Source

On January 8, 2021 Fate Therapeutics, Inc. (the "Company" or "Fate Therapeutics") (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported the closing of an underwritten public offering of 5,122,807 shares of its common stock, which included 701,754 shares that were issued pursuant to the full exercise of the underwriters’ option to purchase additional shares, at a public offering price of $85.50 per share (Press release, Fate Therapeutics, JAN 8, 2021, View Source [SID1234573702]). In addition, in lieu of common stock to certain investors, the Company announced the closing of an underwritten public offering of pre-funded warrants to purchase 257,310 shares of its common stock at a purchase price of $85.499 per pre-funded warrant, which equals the public offering price per share of the common stock less the $0.001 exercise price per share of each pre-funded warrant. Aggregate net proceeds from this offering are expected to be approximately $432 million after deducting underwriting discounts and commissions and other estimated offering expenses. Fate Therapeutics intends to use the net proceeds from the offering to fund clinical trials and nonclinical studies of its product candidates, the manufacture of its clinical product candidates, the expansion of its cGMP compliant manufacturing operations, including the construction, commissioning and qualification of its new facility, the conduct of preclinical research and development, and for general corporate purposes.

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Jefferies, BofA Securities, SVB Leerink and Barclays acted as joint book-running managers for the offering. Wells Fargo Securities acted as lead manager for the offering, and Cantor Fitzgerald & Co. and Oppenheimer & Co. Inc. acted as co-managers for the offering.

The securities described above were offered by Fate Therapeutics pursuant to an automatic shelf registration statement on Form S-3 (File No. 333-228513) that was previously filed by Fate Therapeutics with the Securities and Exchange Commission (the "SEC") and automatically became effective upon filing on November 21, 2018. A final prospectus supplement related to the offering was filed with the SEC on January 7, 2021 and is available on the SEC’s website at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the securities offered may also be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by e-mail at [email protected] or by telephone at (877) 547-6340; BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attention: Prospectus Department, or by email at [email protected]; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525 ext. 6132 or by email at [email protected]; or Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (888) 603-5847 or by email at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.