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G1 Therapeutics Announces Updated Results from Phase 2 Trial of Trilaciclib in Combination with Chemotherapy Showed Statistically Significant Improvement in Overall Survival in Women with Metastatic Triple-Negative Breast Cancer

On June 18, 2019 G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, reported preliminary overall survival (OS) results from a randomized Phase 2 trial which demonstrated that women with metastatic triple-negative breast cancer (mTNBC) lived significantly longer when receiving trilaciclib and chemotherapy compared with women receiving chemotherapy alone (Press release, G1 Therapeutics, JUN 18, 2019, View Source [SID1234537137]). Detailed data from this trial will be presented at a medical meeting later this year.

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Myelopreservation results, objective response rate (ORR), progression-free survival (PFS) and safety data from this trial were presented at the 2018 San Antonio Breast Cancer Symposium (SABCS). Updated anti-tumor efficacy results demonstrated that women receiving trilaciclib and a chemotherapy regimen of gemcitabine/carboplatin had a statistically significant improvement in OS compared with those receiving gemcitabine/carboplatin alone.

"Triple-negative breast cancer is the most aggressive type of breast cancer, and women diagnosed with metastatic TNBC need new treatment options. We look forward to sharing these data with regulators, as well as presenting findings from this trial at a medical meeting later this year," said Mark Velleca, M.D., Ph.D., Chief Executive Officer. "As a company committed to improving the lives, treatment options and outcomes of those living with cancer, we’re proud to have a pipeline that now includes three investigational therapies with the potential to become new standards of care for those with breast cancer and benefit women at the earliest stages of their disease."

About the Study

This randomized, open-label Phase 2 clinical trial (NCT02978716) enrolled 102 patients with mTNBC who had received 0-2 prior lines of therapy in the recurrent/metastatic setting. In this three-arm trial, all patients received a chemotherapy regimen of gemcitabine/carboplatin (GC). Patients were randomized to receive GC only or GC plus one of two dosing schedules of trilaciclib: trilaciclib administered on the day of chemotherapy or trilaciclib administered the day prior to and the day of chemotherapy. Primary endpoints for the trial included myelopreservation measures; secondary endpoints included additional myelopreservation measures and anti-tumor efficacy measures of ORR, PFS and OS.

Topline OS improvements were statistically significant in both trilaciclib arms compared with the control arm. ORR and PFS data were consistent with results presented at SABCS 2018. The safety and tolerability of trilaciclib were consistent with previously reported data and there have been no serious adverse events attributed to treatment with trilaciclib in this trial.

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About Trilaciclib

Trilaciclib is a first-in-class myelopreservation agent designed to protect the bone marrow from damage by chemotherapy and improve patient outcomes. G1 expects to submit marketing applications in the U.S. and Europe for myelopreservation in small cell lung cancer in 2020. In a randomized trial of women with metastatic triple-negative breast cancer, trilaciclib improved overall survival when administered in combination with chemotherapy compared with chemotherapy alone. The company plans to initiate additional randomized trials to evaluate the myelopreservation and survival benefits of trilaciclib in other tumor types and chemotherapy regimens.

RAPT Therapeutics Completes $37 Million Series C Extension

On June 18, 2019 RAPT Therapeutics, Inc., a clinical-stage immunology-based biopharmaceutical company developing oral small molecules for oncology and inflammatory diseases, reported that it secured an additional $37 million in an extension of its Series C financing (Press release, RAPT Therapeutics, JUN 18, 2019, https://www.rapt.com/rapt-therapeutics-completes-37-million-series-c-extension/ [SID1234537136]). The extension of the financing round included funds and accounts advised by T. Rowe Price Associates, Inc. as well as existing investors The Column Group (through its affiliated Ponoi Capital funds), GV (formerly Google Ventures), Kleiner Perkins, Topspin Partners, and Celgene Corporation.

"We continue to advance our pipeline of oral small molecule therapeutics, with proof-of-concept results expected in the first half of 2020 from our FLX475 program targeting multiple cancers and in mid-2020 from our RPT193 program in atopic dermatitis," said Brian Wong, M.D., Ph.D., president and CEO of RAPT Therapeutics. "We appreciate the belief in our vision to use our immunology-based drug discovery and development engine to bring new therapeutics to patients in need of safe and effective treatment options, both in cancer and in inflammatory disease."

Sesen Bio Announces Proposed Public Offering of Common Stock and Warrants

On June 18, 2019 Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, reported that it intends to offer and sell, subject to market conditions, shares of its common stock and warrants to purchase shares of its common stock in an underwritten public offering (Press release, Eleven Biotherapeutics, JUN 18, 2019, View Source [SID1234537135]). All of the shares of common stock and warrants to purchase shares of common stock to be sold in the offering will be offered by Sesen Bio. The offering is subject to market and other conditions, and 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.

Sesen Bio intends to use the net proceeds from this offering for the clinical development and FDA regulatory submission of Vicinium for the treatment of high-risk non-muscle invasive bladder cancer (NMIBC), the continued development of commercial-scale manufacturing capabilities for Vicinium for the treatment of high-risk NMIBC by our third-party contract manufacturers (including the manufacturing process and technology transfer of Vicinium production to Fujifilm to support such efforts), the development of commercial capabilities for a potential launch of Vicinium, if approved, for the treatment of high-risk NMIBC, including investment to establish and continue to build our commercial infrastructure and supply chain, and general corporate purposes, which may include capital expenditures and other operating expenses.

Canaccord Genuity is acting as the sole book-running manager for the proposed offering.

A shelf registration statement relating to these securities has been filed with the U.S. Securities and Exchange Commission (SEC) and became effective on June 8, 2018. The offering is being made only by means of a written prospectus and a preliminary prospectus supplement and accompanying prospectus relating to the offering that form a part of the registration statement, which will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may be obtained, when available, by contacting Canaccord Genuity LLC, Attention: Syndicate Department, 99 High Street, Suite 1200, Boston, MA 02110, by telephone at (617) 371-3900 or by email at [email protected].

This press release shall not constitute an offer to sell or a 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.

Navidea Biopharmaceuticals Announces Closing of Public Offering of Common Stock

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.

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.

Kura Oncology Announces Commencement of Public Offering of Common Stock

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.

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