On June 18, 2019 ArQule, Inc. (Nasdaq: ARQL) reported that Marc Schegerin, Chief Financial Officer and Head of Strategy, will present at the BMO Prescriptions for Success Healthcare Conference on June 25, 2019 at 8:00 a.m. ET at the The Mandarin Oriental New York, New York (Press release, ArQule, JUN 18, 2019, View Source [SID1234537145]).

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The live webcast of the presentation will be available via the "Investors & Media" section of ArQule’s website, www.arqule.com, under "Events & Presentations." A replay of the webcast will be available shortly after the conclusion of the presentation.

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On June 18, 2019 Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported that it has filed a preliminary prospectus supplement (the "Canadian Supplement") to its Canadian short form base shelf prospectus dated March 6, 2019 (the "Base Prospectus") in connection with an offering of its common shares and pre-funded warrants to purchase its common shares (the "Offering") (Press release, Zymeworks, JUN 18, 2019, View Source [SID1234537146]). The Canadian Supplement was filed with the securities regulatory authorities in each of the provinces and territories of Canada. A preliminary prospectus supplement (the "U.S. Supplement," together with the Canadian Supplement, the "Supplements") was also filed with the U.S. Securities and Exchange Commission (the "SEC") as part of a registration statement on Form S-3, as amended, including a prospectus which became effective January 31, 2019 (the "Registration Statement"), pursuant to which the securities will be offered in the United States.

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The Company also expects to grant to the underwriters a 30-day over-allotment option to purchase up to an additional 15% of the number of common shares offered in the Offering. The Offering is expected to be priced in the context of the market, with the final terms of the Offering to be determined at the time of pricing. There can be no assurance as to whether or when the Offering may be completed, or as to the actual size or terms of the Offering. The closing of the Offering will be subject to customary closing conditions, including the listing of the common shares on the TSX and NYSE and any required approvals of each exchange. The pre-funded warrants will not be listed on the TSX or the NYSE.

The Offering is expected to raise total gross proceeds of approximately US$150.0 million, before deducting underwriting discounts and commissions and estimated offering expenses. The Company intends to use the net proceeds of the Offering (i) to accelerate and expand the global development of ZW25 both as a single agent and in combination with other anti-cancer agents in a variety of HER2-expressing tumors, including gastroesophageal, breast and other underserved cancers; (ii) to accelerate and expand the clinical development of ZW49; (iii) to advance other novel preclinical programs, including those involving non-HER2-expressing tumors; and (iv) for general corporate purposes.

J.P. Morgan Securities, LLC is acting as active book-running manager for the Offering. Wells Fargo Securities, LLC and Stifel, Nicolaus & Company, Incorporated are acting as passive book-running managers, Raymond James Ltd. is acting as co-lead manager and Ladenburg Thalmann & Co. Inc. is acting as co-manager.

The Supplements and the Registration Statement contain important detailed information about the Offering. A copy of the Canadian Supplement can be found on SEDAR at www.sedar.com and www.sec.gov, and a copy of the U.S. Supplement and the related Registration Statement can be found on EDGAR at www.sec.gov. Copies of the Supplements may also be obtained from J.P. Morgan Securities, LLC, Attention; Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204; Wells Fargo Securities, LLC, Attention; Equity Syndicate Department, 375 Park Avenue, New York, NY 10152, by telephone at (800) 326-5897, or by email at [email protected]; or Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at (415) 364-2720, or by email at [email protected]. Prospective investors should read the Supplements and the Registration Statement before making an investment decision.

This news release shall 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 province, state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such province, state or jurisdiction.

On June 18, 2019 Alligator Bioscience (Nasdaq Stockholm: ATORX), a biotechnology company developing antibody-based pharmaceuticals for tumor-directed immunotherapy, reported that the company has submitted clinical trial authorization (CTA) application to initiate a Phase I study of its fully owned 4-1BB antibody ATOR-1017 for the treatment of metastasizing cancer (Press release, Alligator Bioscience, JUN 18, 2019, View Source [SID1234538663]).

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ATOR-1017 is an immunostimulatory IgG4 antibody that activates tumor-specific T cells and NK cells through the costimulatory receptor 4-1BB. T cells and NK cells have the capacity to detect and kill tumor cells, making 4-1BB a particularly attractive target for cancer immunotherapy.

ATOR-1017 has a unique profile related to the fact that its immunostimulatory function is stronger in areas where immune cells are abundant, notably in tumors. This creates an opportunity for a strong immune activation, while minimizing side effects for the patient.

The upcoming Phase I study will be a first-in-human, dose escalation study in patients with advanced cancer. It will be conducted at 3 sites in Sweden and will enroll up to 50 patients. The primary objective of the study is to assess the safety and tolerability of ATOR-1017 and to determine the recommended dose for the subsequent Phase II studies.

"We look forward to begin patient recruitment following approval of the ATOR-1017 application by regulators. Our data support its potential to generate a potent and long-lasting immune response or even to induce immunity to cancer, while minimizing side effects through tumor-directed immune activation. This will be the third of our drug candidates to enter the clinic, as we continue to make great progress developing the next generation of cancer immunotherapies", said Per Norlén, CEO of Alligator Bioscience.

For further information, please contact:
Cecilia Hofvander, Director Investor Relations & Communications
Phone +46 46 540 82 06
E-mail: [email protected]

The information was submitted for publication, through the agency of the contact person set out above, at 4:15 p.m. CEST on June 18, 2019.

On June 18, 2019 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) reported that the Ministry of Health, Labor and Welfare (MHLW) of Japan has approved VANFLYTA (quizartinib), an oral FLT3 inhibitor, for the treatment of adult patients with relapsed/refractory FLT3-ITD acute myeloid leukemia (AML), as detected by an MHLW-approved test (Press release, Daiichi Sankyo, JUN 18, 2019, View Source [SID1234537131]).

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Approval of VANFLYTA in Japan is based on the results from the global pivotal phase 3 QuANTUM-R study and a phase 2 study of VANFLYTA in Japan in patients with relapsed/refractory FLT3-ITD AML. Results from QuANTUM-R, which was the first randomized phase 3 study to show that a FLT3 inhibitor prolonged overall survival as an oral, single agent compared to chemotherapy in patients with relapsed/ refractory FLT3-ITD AML, were recently published in The Lancet Oncology.[1]

"With the approval of VANFLYTA, patients with relapsed/refractory FLT3-ITD AML in Japan will now have access to this important new treatment option that specifically targets the underlying driver of disease, and has a proven survival benefit compared to chemotherapy," said Wataru Takasaki, PhD, Corporate Officer, Head of Oncology Function and Head of R&D Division in Japan, Daiichi Sankyo. "We are proud that VANFLYTA is the first of seven new molecular entities we are committed to delivering by 2025 with the goal of transforming science into innovative treatments for patients with cancer."

Results of the global, phase 3 QuANTUM-R study demonstrated a statistically significant improvement in overall survival when comparing VANFLYTA to salvage chemotherapy. The hazard ratio for VANFLYTA was 0.76 [95% CI: 0.58, 0.98], and the median overall survival was 6.2 months [95% CI: 5.3, 7.2] in patients receiving VANFLYTA compared to 4.7 months [4.0, 5.5] salvage chemotherapy. The most common treatment-related adverse drug reactions in those receiving VANFLYTA were nausea (33.2%, 80/241 patients), electrocardiogram QT prolonged (24.9%, 60/241 patients), anemia (24.9%, 60/241 patients), and thrombocytopenia (21.2%, 51/241 patients) in the Japanese labeling. The open-label, single-arm phase 2 study evaluating VANFLYTA in Japanese patients with relapsed/ refractory FLT3-ITD AML met its primary endpoint of achieving a pre-determined composite complete remission rate at interim analysis, triggering an early stop of the study due to efficacy. The efficacy and safety profile of VANFLYTA observed in the phase 2 study in Japan appears consistent with that of QuANTUM-R.

About FLT3-ITD AML

AML is an aggressive blood and bone marrow cancer that causes uncontrolled growth and accumulation of malignant white blood cells that fail to function normally and interfere with the production of normal blood cells.[2] AML is the most common adult leukemia in Japan,[3] with approximately 5,500 new cases diagnosed each year. The five-year survival rate of AML reported from 2005 to 2011 was approximately 26 percent, which was the lowest of all leukemias.2

FLT3 gene mutations are one of the most common genetic abnormalities in AML.[4] FLT3-ITD is the most common FLT3 mutation, affecting approximately one in four patients with AML.[5] FLT3-ITD is a driver mutation that presents with high leukemic burden and has poor prognosis and a significant impact on disease management for patients with AML.[6]

Patients with FLT3-ITD AML have a worse overall prognosis, including an increased incidence of relapse, an increased risk of death following relapse, and a higher likelihood of relapse following hematopoietic stem cell transplantation, as compared to those without this mutation.[7], [8]

About VANFLYTA

VANFLTYA, an oral FLT3 inhibitor, is the lead product in the AML Franchise of Daiichi Sankyo. It has been granted Breakthrough Therapy designation for the treatment of adult patients with relapsed/ refractory FLT3-ITD AML by the FDA; Fast Track designation for the treatment of relapsed/refractory AML by the FDA; and, also has been granted Orphan Drug designation by both the FDA and the European Commission (EC) for the treatment of AML and by the Japan MHLW for the treatment of FLT3-mutated AML.

A broad and comprehensive development program is underway including phase 3 development in combination with standard chemotherapy in newly diagnosed FLT3-ITD AML (QuANTUM-First) in the U.S., EU and Japan; phase 1/2 development for pediatric and young adult relapsed/refractory FLT3-ITD AML in North America and the EU; and phase 1 development in combination with an investigational MDM2 inhibitor, milademetan, for relapsed/refractory FLT3-ITD AML and newly-diagnosed FLT3-ITD AML unfit for intensive chemotherapy in the U.S.

Milademetan is an investigational agent that has not been approved for any indication in any country. Safety and efficacy have not been established. VANFLYTA currently is only approved for use in Japan.