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Ribociclib (LEE011) Receives Regulatory Approval in U.S. as a First-Line Treatment for HR+/HER2- Advanced Breast Cancer with an aromatase inhibitor

On March 23, 2017 Otsuka Pharmaceutical Co., Ltd ("Otsuka") is pleased to reported that the U.S. FDA has granted regulatory approval to Novartis for ribociclib (compound number: LEE011), on which Otsuka’s Cambridge-U.K. based subsidiary Astex and Novartis Institutes for BioMedical Research (NIBR) scientists jointly developed and optimised the chemical structure of ribociclib, which was then progressed through clinical trials by Novartis (Press release, Otsuka, MAR 23, 2017, View Source [SID1234518241]). Manufacturing and marketing approval was granted to Novartis for use of the drug as a first-line treatment in combination with an aromatase inhibitor for patients with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced breast cancer.

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Novartis, which developed ribociclib, will market it in the U.S. as Kisqali.

(Novartis announced the contents of this news release on March 13, 2017.)

Astex will receive from Novartis a regulatory approval milestone payment and future royalty payments based on product sales in accordance with their agreement made in 2005.

Ribociclib is a cyclin-dependent kinase inhibitor developed by Novartis Institutes for Biomedical Research in a research collaboration with Astex. This drug helps slow tumor proliferation by inhibiting two proteins (CDK4 & CDK6) which, when over-activated, can enable cancer cells to grow and divide quickly. Novartis received the regulatory approval under the US FDA Breakthrough Therapy designation and Priority Review programs.

In a clinical trial, a group treated with letrozole alone, a standard therapeutic treatment, was compared to a group treated with a combination of ribociclib and letrozole. The primary endpoint of progression-free survival (the period during which cancer does not progress and is in a stable state) was extended significantly in the group treated with the combination of ribociclib and letrozole.

ABG Sundal Collier AB (”ABGSC”) has notified Oncopeptides AB (publ) that stabilisation measures regarding the Company’s shares have been effected.

On March 22, 2017 ABGSC reported that it is acting as stabilisation manager in connection with the offer to acquire shares in the Company and the listing on Nasdaq Stockholm (the "Offering"), and ABGSC may, acting as a stabilisation manager, effect transactions aimed at supporting the market price of the shares at levels above those which might otherwise prevail in the open market (Press release, Oncopeptides, MAR 22, 2017, View Source [SID1234574078]).

Such stabilisation transactions may be effected on Nasdaq Stockholm, the OTC market, or otherwise, at any time during the period starting on the date of commencement of trading in the shares on Nasdaq Stockholm and ending no later than 30 calendar days thereafter. ABGSC is, however, not required to undertake any stabilisation, and there is no assurance that stabilisation will be undertaken. Stabilisation, if undertaken, may furthermore be discontinued at any time without prior notice. In no event will transactions be effected to support the market price of the shares at levels above the price in the Offering.

In order to cover potential over-allotment in relation to the Offering, the Company has, at the request of the Joint Global Coordinators (ABGSC and Carnegie Investment Bank AB) committed to issue up to 2,119,565 additional new shares, corresponding to a maximum of 15 percent of the number of shares in the Offering at a price corresponding to the price in the Offering.

Calithera Biosciences, Inc. Prices Public Offering of 6,830,000 shares of Common Stock

On March 22, 2017 Calithera Biosciences, Inc. (NASDAQ:CALA), a clinical-stage pharmaceutical company focused on discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer, reported the pricing of its previously announced underwritten public offering of 6,830,000 shares of its common stock at a price to the public of $10.25 per share (Press release, Calithera Biosciences, MAR 22, 2017, View Source [SID1234535252]). Gross proceeds to Calithera from the offering are expected to be approximately $70.0 million, before deducting underwriting discounts and commissions and estimated offering expenses. All of the shares of common stock are being offered by Calithera. In addition, Calithera has granted the underwriters a 30-day option to purchase up to 1,024,500 of additional shares of common stock at the public offering price. The offering is expected to close on March 27, 2017, subject to customary closing conditions.

Leerink Partners is acting as sole book-running manager for the offering. Wells Fargo Securities is acting as a lead manager and JMP Securities is acting as a co-manager for the offering.

A shelf registration statement relating to the offered shares of common stock was filed with the Securities and Exchange Commission (SEC), and was declared effective on November 24, 2015. A preliminary prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and are available on the SEC’s website, located at www.sec.gov. Copies of the final prospectus supplement and accompanying prospectus related to the offering may be obtained, when available, from Leerink Partners LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA, 02110, by email at [email protected], or by telephone at (800) 808-7525, ext. 6132.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities 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.

FACIT Announces Investment in Propellon Therapeutics

On March 22, 2017 FACIT reported a seed stage investment in Propellon Therapeutics (the "Company" or "Propellon"), a start-up created by FACIT focused on developing a portfolio of WDR5-targeted anti-cancer therapeutics (Press release, FACIT, MAR 22, 2017, View Source [SID1234532028]). FACIT’s investment, combined with non-dilutive capital, achieves a targeted $3.0M financing for the lead program. The seed funding enables Propellon to accelerate the nomination of a candidate drug and position the Company for financing and/or entering a strategic partnership for clinical trials in patients with haematological cancers.

"Since forming the Company, significant progress has been made towards identification of a clinical candidate," said Jeff Courtney, President of FACIT. "Our investment will further accelerate the advancement of this exciting first-in-class therapeutic and is a critical step in FACIT’s strategy to support early-stage oncology innovations in the Province."

"Our partnership with the Drug Discovery team at the Ontario Institute for Cancer Research has yielded substantial progress toward a breakthrough epigenetic therapy for haematological malignancies. FACIT’s resources and funding ensures the Company moves to the next stage of development and growth in Ontario," said Dr. David O’Neill, President of Propellon. "Propellon has entered strategic discussions to further advance our promising lead program and the Company through a Series A financing round. This timely seed investment allows the Company to maintain development momentum and select the best partners for bringing this important therapy to patients in need."

Aprea Therapeutics Announces Research Collaboration with Memorial Sloan Kettering Cancer Center

On March 22, 2017 Aprea Therapeutics, a privately held, clinical stage biopharmaceutical company developing novel anticancer therapies targeting the tumor suppressor protein p53, reported a collaboration with Memorial Sloan Kettering Cancer Center to study the effects of reactivation of tumor suppressor protein p53 by APR-246 (Press release, Aprea, MAR 22, 2017, View Source [SID1234518261]).

The goal of the collaboration is to evaluate and characterize preclinical efficacy of APR-246 in combination with multiple other anti-cancer agents and across multiple tumor types. The Principal Investigator of the study is Taha Merghoub, Ph.D., and he will be conducting the research in collaboration with the laboratory of Jedd D. Wolchok, M.D., Ph.D., Chief of Melanoma and Immunotherapeutics Service, Department of Medicine.

"We are excited to initiate this new collaboration with Memorial Sloan Kettering," said Christian S. Schade, President and Chief Executive Officer of Aprea Therapeutics AB. "These studies will not only provide important insight into the effects of APR-246-induced p53 reactivation but also inform the rationale for novel combination therapies to be tested in future clinical trials."