On March 23, 2017 Medigene AG (FSE: MDG1, Prime Standard, TecDAX), reported details on the Company’s first clinical trial with T-cell receptor-modified T cells, planned to start in late 2017 (Press release, MediGene, MAR 23, 2017, View Source [SID1234518258]). Medigene will use an HLA-A2:01-restricted T-cell receptor (TCR) that targets PRAME, a well characterized tumor antigen. Medigene identified a TCR candidate for this target that demonstrates favorable safety and efficacy in extensive preclinical studies. Data on Medigene’s selected TCR candidate will be presented at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting taking place from April 1-5, in Washington, D.C., USA.

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Subject to regulatory approval, Medigene intends to start a combined Phase I/II safety and feasibility trial of its TCR targeting PRAME, named MDG1011, in patients with advanced hematological diseases, namely acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) and multiple myeloma (MM). The Phase I part of this First-in-Man trial is designed as a dose escalation, testing up to 4 dose cohorts in a 3+3 design. The chosen dose will then be further tested in the Phase II part which will include a prospective control group and might potentially be extended into further malignancies. Final details, including trial size, study sites and timelines will become available after clinical trial approval by the competent authority.

Prof. Dolores Schendel, CEO and CSO of Medigene, commented: "Based on extensive preclinical assessment, we are convinced that our TCR specific for the PRAME antigen with high avidity, potent antitumor efficacy and a favorable safety profile will enable us to execute a unique clinical program. This particular trial design examining various indications in parallel allows for faster decisions about future clinical development options based on multiple clinical data sets."

The antigen PRAME (Preferentially Expressed Antigen in Melanoma) was first discovered in melanoma and is overexpressed in a variety of solid cancer indications and several hematological malignancies, while its expression pattern in normal tissue is mainly limited to testis, making it an attractive target for adoptive T cell therapy. As this antigen is expressed intracellularly, it is an ideal candidate for a TCR approach, which otherwise could not be targeted with chimeric antigen receptor (CAR) T cells. Medigene already uses PRAME as a target in its ongoing DC-vaccine trial in AML, where the favorable safety profile of this vaccine allowed the trial to advance into Phase II in April 2016 (Phase I/II final data expected for late 2019).

To view the abstract of the upcoming AACR (Free AACR Whitepaper) presentation please visit: bit.ly/2nnExnY

About Medigene’s TCR technology: The TCR technology aims at arming the patient’s own T cells with tumor-specific T-cell receptors. The receptor-modified T cells are then able to detect and efficiently kill tumor cells. This immunotherapy approach attempts to overcome the patient’s tolerance towards cancer cells and tumor-induced immunosuppression by activating and modifying the patient’s T cells outside the body (ex vivo).

TCR therapy is developed to utilize a higher number of potential tumor antigens than other T cell-based immunotherapies, such as chimeric antigen receptor T cell (CAR T) therapy. Medigene is preparing the clinical development of its first TCR candidates and is establishing a pipeline of recombinant T-cell receptors, and has established Good Manufacturing Practice (GMP)-compliant processes for their combination with patient-derived T cells.

Medigene’s TCR technology for adoptive T-cell therapy is one of the company’s three highly innovative and complementary immunotherapy platforms in immuno-oncology.

On March 23, 2017 GlobeImmune, Inc. reported it has entered into a definitive purchase agreement for the sale of 12,835,490 shares of its common stock to NantCell, Inc., a member of the NantWorks ecosystem of companies (Press release, GlobeImmune, MAR 23, 2017, View Source [SID1234528328]). In connection with the sale of its common stock, NantCell has agreed to pay GlobeImmune $100,000 in cash and issue to GlobeImmune 200,000 shares, an estimated $2.0 million in value, of NantCell’s common stock.

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"We are pleased to enter into this strategic agreement with NantCell," said Timothy C. Rodell, M.D., Chairman of GlobeImmune. "We believe that, with NantCell’s resources, this combination could leverage GlobeImmune’s Tarmogen technology platform to accelerate development of our programs in oncology and infectious disease," continued Dr. Rodell.

"GlobeImmune has continued to impact the oncology industry by putting innovative drug candidates forward to treat cancer and infectious diseases," said Dr. Patrick Soon-Shiong, founder of NantCell. "In our mission to win the war against cancer, our team welcomes opportunities to engage with companies who are revolutionizing cancer care and treatments. We are looking forward to leveraging the expertise of GlobeImmune."

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]).

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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.

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.

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"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."

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.

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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.