Targovax granted EU Patent for mutant-RAS neoantigen platform 2nd generation product TG02

On June 19, 2018 Targovax ASA ("Targovax" or "the Company"; OSE: TRVX), is a clinical stage company focused on developing and commercializing immune activators to target hard to treat solid tumors, reported that the European Patent Office has granted European Patent no 3079715, A Peptide mixture (Press release, Targovax, JUN 19, 2018, View Source [SID1234527398]). The patent protects the composition of Targovax’s mutant-RAS specific neoantigen vaccine TG02, for stimulating the immune system of cancer patients with RAS mutated tumors.

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Targovax’s proprietary mutant-RAS neoantigen vaccine platform is designed to treat patients with tumors harboring RAS mutations. Mutations in the RAS genes are a driving cause of cancer development and progression, and is linked to poor prognosis. By inducing an anti-mutant-RAS specific immune response, the TG products have the potential to delay disease progression and increase survival, with a favorable safety profile compared to chemotherapy and many other treatment options.

TG02 expands the coverage of RAS mutations beyond TG01, and is targeting all relevant RAS exon 2 oncogenic point mutations which are found in the vast majority of all RAS mutated cancers. Currently, TG02 is being tested in an exploratory Phase Ib clinical trial in patients with locally recurrent RAS-mutated colorectal cancer in combination with the checkpoint inhibitor KEYTRUDA (clinical study CT TG02-01). This study will provide important clinical data on the safety, immune activation and mechanism of action of TG02.

Jon Amund Eriksen, inventor of the TG technology and Co-founder of Targovax, said: "We are glad to see the European patent for TG02 being granted, further strengthening Targovax’s intellectual property portfolio covering the very important mutant-RAS trunk neoantigens. RAS is mutated in 20-30% of all cancers, and this 2nd generation product from the TG platform puts Targovax in a position to address an important unmet medical need, which could eventually benefit all RAS mutated cancer patients."

10-Q – Quarterly report [Sections 13 or 15(d)]

Oncbiomune has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Oncbiomune, 2018, JUN 19, 2018, View Source [SID1234527391]).

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eidos therapeutics announces pricing of initial public offering

On June 19, 2018 Eidos Therapeutics, Inc. (Nasdaq: EIDX), a clinical stage biopharmaceutical company focused on addressing the large and growing unmet need in diseases caused by transthyretin (TTR) amyloidosis (ATTR), reported the pricing of its initial public offering of 6,250,000 shares of common stock at a public offering price of $17.00 per share (Press release, Eidos Therapeutics, JUN 19, 2018, View Source [SID1234576277]). All of the shares are being offered by Eidos. The shares are expected to begin trading on the Nasdaq Global Select Market on June 20, 2018 under the ticker symbol "EIDX." The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Eidos, are expected to be approximately $106.3 million. The offering is expected to close on June 22, 2018, subject to the satisfaction of customary closing conditions. In addition, Eidos has granted the underwriters a 30-day option to purchase up to an additional 937,500 shares of common stock at the initial public offering price.

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J.P. Morgan Securities LLC and BofA Merrill Lynch are acting as joint book-running managers for the offering. Barclays Capital Inc. is also participating as a joint book-running manager.

A registration statement relating to these securities was declared effective by the Securities and Exchange Commission on June 19, 2018. The offering will be made only by means of a prospectus, copies of which may be obtained from J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, telephone: (866) 803-9204, or by emailing [email protected]; BofA Merrill Lynch, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, Attention: Prospectus Department, or by emailing [email protected]; or Barclays Capital Inc., c/o Broadridge Financial Solutions, Attn: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, telephone: (888) 603-5847 or by emailing [email protected].

This press 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 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.

Can-Fite Updates on Status of Phase II Advanced Liver Cancer Trial

On June 19, 2018 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, today provided an update on its Phase II clinical trial with drug candidate Namodenoson (CF102) in the treatment of advanced hepatocellular carcinoma (HCC) in patients whose disease has progressed on sorafenib therapy (Press release, Can-Fite BioPharma, JUN 19, 2018, View Source [SID1234527389]). Can-Fite anticipates analyzing the results of this important trial before the end of the current year.

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The global Phase II study is being conducted in the U.S., Europe and Israel. Patients with advanced HCC, Child Pugh B, who failed Nexavar (sorafenib) as a first line treatment are treated twice daily with 25 mg of oral Namodenoson or placebo using a 2:1 randomization. The primary endpoint of the Phase II study is Overall Survival (OS). Secondary endpoints include Progression Free Survival (PFS), safety, and the relationship between outcomes and A3AR expression.

The trial first opened to enrollment in December 2014 and enrollment of 78 patients was completed in August 2017. While the trial continues treating subjects in a blinded fashion (either Namodenoson 25 mg BID or matching placebo), Can-Fite notes that of the 78 subjects originally enrolled, 19 completed at least 12 cycles of treatment (each cycle is 28 days of treatment) of which three completed at least 24 cycles. The longest-treated subject has been receiving study medication for approximately 3 years.

Accumulated safety data to date continues to indicate a favorable safety profile, with no clinically significant novel or emerging events attributed to chronic treatment with Namodenoson.

Michael Silverman, MD, FACP, Can-Fite’s Medical Director says, "While the final analysis of this trial, based on survival, has been delayed past our original projections, we are very happy that the reason for this is the unexpected longevity of patients enrolled into this trial. Historically, HCC patients who have failed treatment with sorafenib and are Child Pugh B, have very limited life expectancy. Although the trial data are still blinded, we are encouraged by the unexpectedly long survival for some patients and hope that this will translate into a survival advantage for the Namodenoson group over the placebo group, and a critical advance for treating patients with HCC."

Can-Fite received Orphan Drug Designation for Namodenoson in Europe and the U.S., as well as Fast Track Status in the U.S. as a second line treatment for HCC.

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is being evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.

VBI Vaccines to Present at 2018 JMP Securities Life Sciences Conference

On June 19, 2018 VBI Vaccines Inc. (Nasdaq: VBIV) ("VBI"), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, reported that Jeff Baxter, President and CEO, will present at the JMP Securities Life Sciences Conference on Thursday, June 21, 2018, at 10:30 a.m. ET at the St. Regis Hotel in New York (Press release, VBI Vaccines, JUN 19, 2018, View Source [SID1234527390]).

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Event: JMP Securities Life Sciences Conference
Date: Thursday, June 21, 2018
Time: 10:30 – 10:55 AM ET
Event Website: View Source