On June 20, 2018 TG Therapeutics, Inc. (NASDAQ:TGTX) and Novimmune SA, reported that the companies have entered into an exclusive global agreement to collaborate on the development and commercialization of Novimmune’s novel first-in-class anti-CD47/anti-CD19 bispecific antibody known as TG-1801 (previously NI-1701) (Press release, TG Therapeutics, JUN 20, 2018, View Source [SID1234527404]). The companies will jointly develop the product on a worldwide basis, focusing on indications in the area of hematologic B-cell malignancies.

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TG Therapeutics will make up-front and milestones payments based on early clinical development, and will be responsible for the costs of clinical development of the products through the end of Phase II, after which TG Therapeutics and Novimmune will be jointly responsible for all development and commercialization costs of the product. TG Therapeutics and Novimmune will each maintain an exclusive option, exercisable at specific times during development, for TG Therapeutics to license the rights to TG-1801, in which case Novimmune will be eligible to receive additional payments contingent on certain clinical, regulatory and commercial milestones, totaling approximately $185MM as well as tiered royalties on net sales.

TG-1801, a fully-human IgG1, designed to target and deplete B-cells via multiple mechanisms, is based on Novimmune’s kappa-lambda -body format which allows preservation of all favorable properties of a conventional monoclonal antibody while adding bispecific functionalities. One mechanism unique to this bispecific antibody involves blocking of CD47 referred to as the "do not eat me" signal for the body’s phagocytic cells specifically directed to CD19 positive cells. The net effect is highly targeted, potent anti-B-cell tumor phagocytic activity, while avoiding the general toxicity concerns associated with earlier agents targeting the CD47 pathway. Moreover, the co-targeting of CD19 is not only expected to enhance safety but by retaining its IgG1 Fc functionality, this agent is designed to provide a secondary mechanism of anti-tumor activity through the induction of antibody dependent cellular cytotoxicity (ADCC).

TG-1801 is expected to be the first anti-CD47 bispecific antibody worldwide that will go into clinical trials, which are expected to commence later this year or early in 2019.

"We are delighted to see our first bispecific antibody move forward into the clinic with an experienced partner in the field of hematological malignancies, and to provide proof of principle for our completely novel approach," said Chairman and Chief Executive Eduard Holdener. "We are excited about the potential benefit that this new approach could bring to B-cell lymphoma patients."

"We are excited to enter into this collaboration with Novimmune, a leader in antibody engineering, and whose innovations in the field of CD47 bispecific antibodies have generated a potentially more effective and safer approach for targeting of CD47, which was recently validated in the clinical studies as a very promising pathway for tumor targeting, especially in combination with anti-CD20 monoclonal antibodies," stated Michael S. Weiss, Executive Chairman and CEO of TG Therapeutics. Mr. Weiss continued, "TG Therapeutics is focused on building the most comprehensive and effective portfolio for the treatment of hematologic malignancies and autoimmune diseases. TG-1801 has demonstrated encouraging pre-clinical anti-tumor activity both as a single agent and in combination with anti-CD20 monoclonal antibodies. With the addition of TG-1801 to our pipeline, we now have three targeted immunotherapies in-house that can potentially be used together to create a novel non-chemo treatment option that uses the body’s immune system to fight B-cell cancers, including NHL and CLL."

On June 19, 2018, RhoVac AB ("RhoVac") reported that the company has received response from the European Medicines Agency (EMA) on the Scientific Advice Procedure (Press release, RhoVac, JUN 19, 2018, View Source [SID1234555934]). EMA has stated that there are no further preclinical studies needed to be conducted to support the development of the proposed Phase IIb trial and that there is a clear window for early prostate cancer treatment with RhoVac’s drug candidate RV001.

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In alignment with company’s original schedule, RhoVac initiated a Scientific Advice Procedure with EMA in March 2018, to discuss progression of company’s RV001 project into a clinical phase IIb development, and to ensure that RhoVac’s approach was in line with EMA’s guidelines and expectations. Following this, in May, RhoVac was invited to participate at the EMA’s Scientific Advice Working Party’s (SAWP) meeting in London to further discuss the project. Now RhoVac has received the response which was adopted by The Committee for Medicinal Products for Human Use (CHMP) at their meeting 28 – 31 May 2018. The response given by SAWP is based on the questions and supporting documentation RhoVac submitted at the initiation of the procedure.

In summary, EMA has agreed that no further pre-clinical studies are needed to support the proposed phase IIb clinical trial development. EMA has also agreed that the company’s approach in development of a quality specification for RV001 drug candidate was in compliance with relevant regulatory guidelines.

In the response relating to the proposed clinical trial, which targets the early stage of prostate cancer, immediately after radical prostatectomy, EMA agreed that there is a clear window to treat in this stage of the disease using RhoVac’s RV001 drug candidate. Finally, EMA provided valuable advice to further definition of the patient population and on inclusion criteria for the patients to be enrolled in the proposed clinical study.

Comments from RhoVac´s CEO, Anders Ljungqvist

-The Scientific Advice Procedure including the face to face meetings with relevant experts at EMA have been extremely valuable for RhoVac assuring us that we are now in a position to refine and progress our plans for our clinical phase IIb development. To our knowledge, there are no other drugs in development targeting this very early stage of disease progression in prostate cancer while relevant regulatory guidelines for adjuvant treatment in this stage are scarce. The comments and advice from EMA are therefore crucial for the further development of our drug candidate RV001.

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.

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.

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