On June 18, 2019 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported the closing of an underwritten public offering of 8,000,000 shares of its common stock, at a price to the public of $0.75 per share (Press release, Navidea Biopharmaceuticals, JUN 18, 2019, View Source [SID1234537134]). Of the total shares sold in the offering, 4,000,000 shares were placed with John Kim Scott, Jr., a principal stockholder in the Company, who agreed to purchase such shares at a purchase price of $0.75 per share. The aggregate gross proceeds from the offering, before deducting the underwriting discounts, commissions, and offering expenses, were approximately $6.0 million.

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H.C. Wainwright & Co. acted as sole book-running manager for the offering.

Navidea intends to use the net proceeds from the offering to fund its research and development programs, including continuing to advance its Phase 2b and Phase 3 clinical trials of Tc99m tilmanocept in patients with rheumatoid arthritis, and for general working capital purposes and other operating expenses.

A registration statement on Form S-3 was filed by Navidea with the U.S. Securities and Exchange Commission ("SEC") and was declared effective by the SEC on December 27, 2017. A prospectus supplement and an accompanying prospectus relating to and describing the terms of the offering and the shares of common stock being offered was filed with the SEC on June 17, 2019, and is available on the SEC’s website at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained from H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, or by calling (646) 975-6996 or by emailing [email protected], or at the SEC’s website at View Source

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities of the Company, nor shall there be any sale of Navidea’s common stock in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On June 18, 2019 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company focused on the development of precision medicines for oncology, reported that it has commenced an underwritten public offering, subject to market and other conditions, to issue and sell shares of its common stock (Press release, Kura Oncology, JUN 18, 2019, View Source [SID1234537133]). In connection with the offering, Kura expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of its common stock offered in the public offering. 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.

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SVB Leerink and Cowen are acting as joint book-running managers in the offering.

The securities described above are being offered by Kura pursuant to a shelf registration statement on Form S-3, including a base prospectus, that was previously filed by Kura with the Securities and Exchange Commission (the "SEC") and that was declared effective on November 21, 2018. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available for free on the SEC’s website located at View Source Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering, when available, may be obtained from 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 Cowen and Company, LLC c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, or by telephone at (631) 592-5973, or by email at [email protected].

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

About Kura Oncology

On June 18, 2019 Triumvira Immunologics, Inc. (Triumvira), a private, clinical-stage biopharmaceutical company developing a novel platform for engineering T cells to attack cancers, reported that both the U.S. Food & Drug Administration (FDA) and Health Canada have cleared Triumvira’s Investigational New Drug (IND) and Clinical Trial Applications (CTA) for its novel T cell therapy product TAC01-CD19 in patients with CD19-postive B-cell malignancies (Press release, Triumvira Immunologics, JUN 18, 2019, View Source [SID1234537132]). The Phase 1/2 study (TACTIC-19) is expected to be initiated in the third quarter of 2019.

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Paul Lammers, MD, MSc., President and CEO of Triumvira commented, "Obtaining FDA and Health Canada clearance of our first IND for this novel approach fulfills our goal to be a clinical stage biotechnology company and demonstrates our commitment to bringing this innovative treatment to patients. TAC01-CD19 will be tested at five leading lymphoma clinical study centers in the U.S. and Canada. Based on its preclinical profile, TAC01-CD19 has the potential to represent a significant advancement in T cell therapy."

About TAC01-CD19
Despite transformational efficacy with existing approved Chimeric Antigen Receptor T Cells (CAR-T), a significant unmet need remains due to substantial CAR-T toxicities and limited tumor types where CAR-T is effective. Triumvira is developing a proprietary T Cell Antigen Coupler (TAC) technology platform which is biologically distinct from CAR-T. The first of our pipeline product candidates, TAC01-CD19 is a novel T cell therapy product targeting CD19 for use in B-cell malignancies. The product comprises patient-derived T cells that have been genetically engineered to express the CD19 T cell Antigen Coupler (TAC). Preclinical data suggest that TAC01-CD19 has the potential for being highly efficacious with minimal side effects in hematological malignancies.

About CD19 and Diffuse Large B Cell Lymphoma (DLBCL)
CD19 is a B cell marker and is expressed on the surface of B cell malignancies such as Diffuse Large B Cell Lymphoma. DLBCL is a subtype of Non-Hodgkin Lymphomas (NHLs)and is expected to impact approximately 26,000 patients annually in the U.S. Even though significant improvements in therapies have occurred in the past years, about 45% of patients with DLBCL die of either their disease or of non-cancerous causes.

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.

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