Astellas Announces Acceptance of XOSPATA® (gilteritinib) for Regulatory Review in China by the National Medical Products Administration

On April 9, 2020 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") reported a new drug application (NDA) for the oral once-daily therapy XOSPATA (gilteritinib), for the treatment of adult patients who have relapsed (disease that has returned) or refractory (resistant to treatment) acute myeloid leukemia (AML) with a FLT3 mutation (FLT3mut+), has been accepted by the National Medical Products Administration (NMPA) for regulatory review in China (Press release, Astellas, APR 9, 2020, View Source [SID1234556230]).

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AML is a cancer that impacts the blood and bone marrow,1 and its incidence increases with age.2 It is estimated that every year, around 80,000 people in China are diagnosed with leukemia.3 AML is one of the most common types of leukemia in adults.4

AML patients with a FLT3 mutation have a particularly poor prognosis, with a median survival of less than six months following treatment with salvage chemotherapy.5 The status of FLT3 mutation can change over the course of AML treatment, even after relapse. As such, a patient’s mutation status should be determined to help inform the best treatment approach.6

About Gilteritinib
Gilteritinib was discovered through a research collaboration with Kotobuki Pharmaceutical Co., Ltd., and Astellas has exclusive global rights to develop, manufacture and commercialize gilteritinib. Gilteritinib was approved in the U.S. and Japan in 2018, Europe and Canada in 2019, and Korea, Brazil and Australia thus far in 2020 for the treatment of adult patients who have relapsed or refractory FLT3mut+ AML.7,8,9,10,11,12,13 As of April 2020, gilteritinib is available in the U.S., Japan and selected countries in Europe.

Gilteritinib is a FMS-like tyrosine kinase 3 (FLT3) and has demonstrated inhibitory activity against FLT3-ITD, a type of FLT3mut+ that is seen in approximately one-third of patients with AML, as well as FLT3-TKD mutation. FLT3-ITD is a common driver mutation that presents with a high burden and poor prognosis.14

Entry into a Material Definitive Agreement.

On April 9, 2020, SCYNEXIS, Inc. ("SCYNEXIS") reported that it has entered into a Senior Convertible Note Purchase Agreement (the "Note Purchase Agreement") with Puissance Life Science Opportunities Fund VI (the "Investor") (Filing, 8-K, Scynexis, APR 9, 2020, View Source [SID1234556229]). Pursuant to the Note Purchase Agreement, on April 9, 2020, SCYNEXIS issued and sold to the Investor $10.0 million aggregate principal amount of its 6.0% Senior Convertible Notes due 2026 (the "Notes"). The Notes were issued and sold for cash at a purchase price equal to 100% of their principal amount, in reliance on the exemption from registration provided by Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), due to the notes being issued to one financially sophisticated investor.

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The Notes will bear interest at a rate of 6.0% per annum, payable semiannually in arrears on April 15 and October 15 of each year, beginning October 15, 2020. The Notes will mature on April 15, 2026, unless earlier converted, redeemed or repurchased. The Notes constitute general, senior unsecured obligations of SCYNEXIS.

The holders of the Notes may convert their Notes at their option at any time prior to the close of business on the business day immediately preceding April 15, 2026 into shares of SCYNEXIS’s common stock. The initial conversion rate is 1,111.1111 shares of common stock per $1,000 principal amount of Notes, which is equivalent to an initial conversion price of approximately $0.90 per share, and is subject to adjustment in certain events described in the Note Purchase Agreement. Holders who convert may also be entitled to receive, under certain circumstances, an "interest make-whole payment" (as defined in the Note Purchase Agreement) payable in shares of common stock. In addition, following certain corporate events that occur prior to the maturity date, SCYNEXIS will, in certain circumstances, increase the conversion rate for a holder who elects to convert its Notes in connection with such a corporate event. Unless SCYNEXIS seeks and receives stockholder approval, the number of shares that SCYNEXIS may deliver in connection with a conversion of the Notes, including those delivered in connection with an "interest make-whole payment" or a "make-whole fundamental change" (each as defined in the Note Purchase Agreement), will not exceed a cap of 19,386,000 shares of common stock, which is approximately 19.99% of the shares of common stock of SCYNEXIS outstanding on March 1, 2020.

On or after April 15, 2023, SCYNEXIS has the right, at its election, to redeem all or any portion of the Notes not previously converted if the last reported sale price per share of common stock exceeds 130% of the conversion price on each of at least 20 trading days (whether or not consecutive) during the 30 consecutive trading days ending on, and including, the trading day immediately before the date SCYNEXIS sends the related redemption notice. The redemption price will be 100% of the principal amount of the Notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date.

If a "fundamental change" (as defined in the Note Purchase Agreement) occurs, then, subject to certain exceptions, SCYNEXIS must offer to repurchase the Notes for cash at a repurchase price of 100% of the principal amount of the Notes to be repurchased, plus accrued and unpaid interest to, but excluding, the repurchase date. A "fundamental change" includes the failure of SCYNEXIS’s VANISH-306 clinical study of oral ibrexafungerp in vulvovaginal candidiasis to achieve its pre-specified primary endpoint with statistical significance (p ≤ 0.05) superiority over placebo.

If certain bankruptcy and insolvency-related events of default with respect to SCYNEXIS occur, the principal of, and accrued and unpaid interest on, all of the then outstanding Notes shall automatically become due and payable. If any other event of default occurs and is continuing, the holders of at least 25% in principal amount of the outstanding Notes, by notice to SCYNEXIS, may declare the principal of, and accrued and unpaid interest on, all of the then outstanding Notes to be due and payable. Notwithstanding the foregoing, the Note Purchase Agreement provides that, to the extent SCYNEXIS elects, the sole remedy for an event of default relating to certain failures by SCYNEXIS to comply with certain reporting covenants in the Note Purchase Agreement will, for the first 180 days after such event of default, consist exclusively of the right to receive additional interest on the Notes.

Heron Therapeutics to Present at the 19th Annual Needham Virtual Healthcare Conference

On April 9, 2020 Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, reported that Barry Quart, Pharm.D., President and Chief Executive Officer of Heron Therapeutics, will present at the 19th Annual Needham Virtual Healthcare Conference on Tuesday, April 14th, 2020 at 2:50 p.m. ET (Press release, Heron Therapeutics, APR 9, 2020, View Source [SID1234556228]). The conference is being held in a virtual format.

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A live webcast of the presentation will be available on the Company’s website at www.herontx.com in the Investor Resources section. A replay of the presentation will be archived on the site for 60 days.

Bolt Biotherapeutics Appoints Edith Perez, M.D., as Chief Medical Officer

On April 9, 2020 Bolt Biotherapeutics, Inc., a private clinical-stage biotechnology company developing its Immune-Stimulating Antibody Conjugate (ISAC) platform technology to harness the power of the immune system to treat cancer, reported the appointment of Edith Perez, M.D., as chief medical officer (Press release, Bolt Biotherapeutics, APR 9, 2020, View Source [SID1234556227]).

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An internationally recognized translational researcher and cancer specialist, Dr. Perez has extensive experience in medical leadership with oncology drug development, translational clinical trials, biomarkers and precision medicine. Throughout her career, Dr. Perez has developed a wide range of clinical trials exploring the use of new therapeutic agents for the treatment and prevention of breast cancer. She has authored more than 400 peer-reviewed articles and is invited frequently to lecture at national and international meetings. In addition to her work in industry, Dr. Perez has held positions within AACR (Free AACR Whitepaper), ASCO (Free ASCO Whitepaper) and the NCI.

"With our first Boltbody therapeutic program in clinical development, Edith’s contributions as a member of our senior leadership team will have an immediate impact," said Randall Schatzman, Ph.D., chief executive officer of Bolt. "This is one of the most important additions to our company at a time that we are ramping up all of our drug development activities. Bolt is one of the most advanced companies that is focused on the emerging area of ISACs. Edith brings to us the relevant experience and insights to enable us to maintain our leadership position while driving forward clinical development of myeloid-based cancer therapeutics."

Dr. Perez commented, "Bolt’s technology platform has broad promise for the future of cancer therapies and could help a wide range of patients who have limited treatment options with current immunooncology therapeutics. I look forward to leading Bolt’s team in clinical development and strategy. Leveraging Bolt’s unique platform, we will address the unmet need to expand and improve targeted therapies, starting with BDC-1001 in solid tumors that express HER2 and are refractory to or ineligible for current HER2-targeting treatments. Our expanded strategy includes the development of Boltbody ISACs for other oncolytic targets, as well as in additional therapeutic indications."

Dr. Perez will maintain a clinical affiliation as Professor of Medicine at the Mayo Clinic and director of the Mayo Clinic Breast Cancer Translational Genomics Program, where she has practiced for two decades. Prior to joining Bolt, Dr. Perez was the vice president and head of the BioOncology-U.S. medical affairs unit at Genentech for three years. She earned her medical degree from the University of Puerto Rico School of Medicine in San Juan and completed her residency in internal medicine at the Loma Linda University Medical Center in California. In addition, she completed her fellowship training at the University of California, Davis. Dr. Perez is board certified in internal medicine, medical oncology and hematology.

TANGO THERAPEUTICS RAISES $60 MILLION SERIES B FINANCING AND STRENGTHENS EXECUTIVE TEAM

On April 9, 2020 Tango Therapeutics, a biotechnology company focused on discovering and delivering the next generation of targeted cancer therapies, reported the closing of an oversubscribed Series B financing of $60 million led by Boxer Capital of the Tavistock Group (Press release, Tango Therapeutics, APR 9, 2020, View Source [SID1234556226]). Cormorant Asset Management and Casdin Capital are additional new investors in the round.

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"We are very fortunate to have the support of this strong syndicate of cross-over investors as we bring our first targeted therapies based on the genetic concept of synthetic lethality to well-defined patient populations," said Barbara Weber, MD, President and Chief Executive Officer of Tango. "This financing will support our lead program into IND-enabling studies early next year as well multiple other ongoing target and drug discovery efforts."

Additionally, Tango announced leadership appointments of Daniella Beckman, Chief Financial Officer, John C. Ross, Vice President of Human Resources and Samy Tadros, Vice President of Business Development.

Daniella Beckman, CPA, brings more than 20 years of strategic, financial and operational experience to her role at Tango overseeing finance, investor relations and business development. She served as interim Chief Financial Officer for Tango since its inception, and prior to that, for other early-stage biotechnology companies, including Neon Therapeutics. Previously, Ms. Beckman was the Chief Financial Officer of Idenix Pharmaceuticals, where she oversaw finance, investor relations and IT until it was acquired by Merck in 2014. Prior to serving as CFO, Ms. Beckman served as corporate controller for Idenix. She previously held finance positions at Coley Pharmaceuticals, Biogen Idec and PricewaterhouseCoopers. Ms. Beckman serves on the board of directors of Translate Bio. Ms. Beckman has a BA in business administration/accounting from Boston University and is a certified public accountant in Massachusetts.

John C. Ross, MS, MHRIR, joins Tango after serving as senior director of human resources for the surgical medical device business at Alcon, formerly a division of Novartis. Mr. Ross helped to facilitate the company’s spinoff from Novartis in 2019. Prior to Alcon, he served in multiple human resources leadership roles in Novartis Oncology and Novartis General Medicines in the U.S. and Europe. Mr. Ross also has held HR leadership roles at Google and Honeywell. Mr. Ross earned a BS in communications from the University of Texas at Austin and an MS in human resources and industrial relations from the University of Illinois.

Samy Tadros, MS, MBA, joins Tango from Celgene, recently acquired by Bristol Myers Squibb, where he served as Executive Director, Business Development and Global Alliances. Mr. Tadros spent more than ten years at Celgene, leading multiple cross-functional teams and closing many important transactions for Celgene. Mr. Tadros’ transactions spanned the spectrum from early research agreements to late stage development and commercialization deals. Before joining Celgene, Mr. Tadros worked at Charles River Labs and Schering-Plough. Mr. Tadros has a BS in biochemistry from Concordia University, an MS from the Temple University School of Pharmacy and an MBA from Fairleigh Dickinson University.

"We’re thrilled Daniella has agreed to join our team as CFO and to welcome John and Samy into these key leadership roles," added Dr. Weber. "Insights from all three industry leaders will be invaluable as we advance our pipeline of next-generation targeted cancer therapies and bring novel therapies to patients."