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NeoImmuneTech Announces Clinical Collaboration with Bristol Myers Squibb to Evaluate NT-I7 (Hyleukin-7™) in Combination with Nivolumab

On April 9, 2020 NeoImmuneTech, Inc., a clinical-stage T cell-focused biopharmaceutical company, reported it has entered into a clinical collaboration agreement with Bristol Myers Squibb (NYSE: BMY) to evaluate the combination of NeoImmuneTech’s NT-I7 (also known as Hyleukin-7), a long-acting IL-7, and Bristol Myers Squibb’s Opdivo (nivolumab), a PD-1 blocking antibody (Press release, NeoImmuneTech, APR 9, 2020, View Source [SID1234556235]).

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The goal of the Phase 2 study is to establish safety and tolerability, and to evaluate preliminary anti-tumor activity of the combination in subjects with advanced or metastatic gastric, gastro-esophageal junction (GEJ), or esophageal adenocarcinoma (EAC). The results of this study will be used to further clinical development of this combination in these tumor types.

"According to the American Cancer Society1, approximately 46,000 Americans will be diagnosed with gastric and/or esophageal cancers in 2020, and 27,200 will die from these devastating diseases," said NgocDiep Le, M.D., Ph.D., Executive VP and Chief Medical Officer of NeoImmuneTech (NIT). "This Phase 2 trial is based on the scientific rationale and results of preclinical studies demonstrating that NT-I7, our unique T-cell amplifier, worked synergistically with checkpoint inhibitors such as Opdivo to broaden and deepen the anti-tumor response."

Se Hwan Yang, Ph.D., President and Chief Executive Officer of NIT, added: "The clinical collaboration between NeoImmuneTech and Bristol Myers Squibb is based on our shared commitment to developing new therapeutic options that could improve outcomes for patients living with serious diseases such as gastric, GEJ or esophageal cancers. Further, it strengthens NIT’s position as pioneers of T cell-centered immuno-oncology therapeutics by focusing on enhanced clinical outcomes through a novel mechanism of action."

Under the terms of the agreement, NeoImmuneTech will be the sponsor of the trial and Bristol Myers Squibb will supply nivolumab for use in the study. While the first study will focus on gastric/GEJ/EAC cancers, under the terms of this Master Clinical Trial Collaboration Agreement, the two companies may conduct additional combination trials in the future.

Opdivo is a registered trademark of Bristol Myers Squibb.

About NT-I7

NT-I7 (also known as Hyleukin-7) is the only clinical-stage long-acting human IL-7 and is uniquely positioned to address unmet medical needs in immuno-oncology. IL-7 is a fundamental cytokine for naïve and memory T-cell development and for sustaining immune response to chronic antigens (as in cancer). NT-I7’s exhibits a favorable PK/PD and safety profiles, making it an ideal combination partner for immunotherapy standard of care (SOC) such as Checkpoint Inhibitor and CAR-T therapies. NT-I7 is being studied in multiple clinical trials in solid tumors, and being planned for testing in hematologic malignancies, additional solid tumors and other immunology-focused indications.

BioSpecifics Appoints Joseph Truitt as Interim Chief Executive Officer

On April 9, 2020 BioSpecifics Technologies Corp. (NASDAQ: BSTC), a biopharmaceutical company that originated and continues to develop collagenase-based therapies with a first-in-class collagenase-based product marketed as XIAFLEX in North America, reported that the Board of Directors has appointed Joseph Truitt as interim Chief Executive Officer (Press release, BioSpecifics Technologies, APR 9, 2020, View Source [SID1234556234]). He will also serve on the Company’s Board of Directors. Mr. Truitt succeeds J. Kevin Buchi, who served as CEO since October 2019, and has departed the company.

"We are delighted to have Joe on board and believe he will play a major role in helping to shape the future of BioSpecifics. Joe is a highly experienced biopharma executive with a strong track record of clinical, commercial, and operational leadership. The Board of Directors remains strongly focused on its corporate strategy of fully maximizing near- and long-term sustainable value creation, including full exploration of opportunities within the CCH portfolio of commercial and pipeline assets, as well as identifying external strategic opportunities. We believe BioSpecifics is poised for a new leg of growth bolstered by strong fundamentals," said Jennifer Chao, Chairman of the Board of Directors. "As we continue on this path, we would like to thank Kevin for what he accomplished during his tenure with the company and wish him well in his future endeavors."

Prior to joining BioSpecifics, Mr. Truitt was most recently Chief Executive Officer of Achillion Pharmaceuticals, Inc. since May 2018. He joined the company in 2009 and had previous roles of Chief Operations Officer and Chief Commercial Officer. Under his leadership, the company was acquired by Alexion Pharmaceuticals, Inc. for $1.2 billion. Mr. Truitt joined Achillion from Viropharma, Inc. following its acquisition of Lev Pharmaceuticals. At Lev, Mr. Truitt was most recently Vice President of Business Development and Product Strategy and led the build out of the commercial team and infrastructure in preparation for product launch. Mr. Truitt joined Lev from Johnson & Johnson, where he was Vice President of Sales and Operations and directed commercial operations and had P&L responsibility for sales, operations and national accounts at the company’s OraPharma subsidiary. Mr. Truitt holds a BS degree in Marketing from LaSalle University, Philadelphia, and an MBA degree from St. Joseph’s University, Philadelphia.

"I am excited to take on the role of interim CEO of BioSpecifics. There are very significant value creation opportunities and I look forward to working closely with the Board of Directors and team to fully execute on the Company’s clearly defined corporate objectives," said Joseph Truitt, interim Chief Executive Officer.

West to Host First-Quarter 2020 Conference Call

On April 9, 2020 West Pharmaceutical Services, Inc. (NYSE: WST), a global leader in innovative solutions for injectable drug administration, reported that it will release first-quarter 2020 financial results before the market opens on Thursday, April 23, 2020, and will follow with a conference call to discuss the results and business expectations at 9:00 a.m. Eastern Time (Press release, West Pharmaceutical Services, APR 9, 2020, View Source [SID1234556233]). To participate on the call, please dial 877-930-8295 (U.S.) or 253-336-8738 (International). The conference ID is 1865786.

A live broadcast of the conference call will be available at the Company’s website, www.westpharma.com, in the "Investors" section. Management will refer to a slide presentation during the call, which will be made available on the day of the call. To view the presentation, select "Presentations" in the "Investors" section of the Company’s website.

An online archive of the broadcast will be available at the site three hours after the live call and will be available through Thursday, April 30, 2020, by dialing 855-859-2056 (U.S.) or 404-537-3406 (International). The conference ID is 1865786.

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]).

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.

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.