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."

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.

1stOncology’s ‘Commercial Interests at EHA (Free EHA Whitepaper) 2018‘ report highlights the landscape of commercial oncology drug development presenting abstracts at the 2018 European Hematology Association meeting. Below is some interesting headline points our analyst team picked from EHA (Free EHA Whitepaper) 2018, but if you would like to get the full picture, we invite you to 48 hours of free access to our European Hematology Association (EHA) (Free EHA Whitepaper) 2018 whitepaper report. Sign up here for your free access.

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On June 18, 2018 NeuroVive Pharmaceutical AB and BridgeBio Pharma reported that BridgeBio has entered into an exclusive licensing agreement for a subset of succinate prodrug chemistry under NeuroVive’s NVP015 program (Press release, BridgeBio, JUN 18, 2018, View Source [SID1234576278]). BridgeBio also announced that it has launched a subsidiary company Fortify Therapeutics to further develop this chemistry for local treatment of Leber’s Hereditary Optic Neuropathy (LHON), with an initial financial commitment of $20 million USD. NeuroVive’s NVP015 program for other mitochondrial disorders will continue without any changes in focus or timelines.

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LHON is caused by mitochondrial DNA mutations in subunits of NADH dehydrogenase (complex I), leading to reduced oxidative phosphorylation and energy production in retinal cells. The disease predominantly affects young adults, and results in sudden onset of progressive and severe vision loss. The licensed succinate prodrugs have the potential to overcome the disease by bypassing the dysfunctional metabolic pathway, providing an alternate source of energy to the retinal cells.

"As a targeted treatment for a genetic disease, the LHON program is a clear fit with the BridgeBio model," said Neil Kumar, Ph.D., CEO of BridgeBio. "We have been impressed with the ability of these compounds to rescue specific genetic mitochondrial deficiencies, and we have assembled a team of international experts to further develop a subset of the NVP015 chemistry to address this devastating disease."

Fortify Therapeutics will develop selected lead compounds derived from NeuroVive’s novel NVP015 succinate prodrug program into drug candidates for the localized treatment of LHON. These compounds have been selected because they have properties that make them suitable for delivery to the eye.

The licensing agreement for this particular subset of the NVP015 program has a total deal value of approximately $60 million USD, which includes limited initial funding for research, and later milestone payments and a single digit royalty stream, that are dependent on successful development and market approval.

"The agreement with BridgeBio is important to both NeuroVive and our innovative NVP015 program, as it validates the quality of the program, our business development model and potential in a variety of mitochondrial disorders," commented NeuroVive CEO Erik Kinnman, M.D., Ph.D. "We will work closely with BridgeBio to further develop this chemistry subset and make the LHON program successful. It is important to note that our intentions for the NVP015 program are unchanged, and we are progressing towards experimental proof-of-principle during 2018."

This information is information that NeuroVive Pharmaceutical AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out below, at 08:30 a.m. CET on 18 June 2018.

About LHON
Leber’s Hereditary Optic Neuropathy (LHON) is a disease caused by mitochondrial DNA mutations in subunits of NADH dehydrogenase (complex I), a component of the electron transport chain. This results in dysfunctional oxidative phosphorylation and ATP production, leading to degeneration of the retinal ganglion cells and loss of central vision. LHON most commonly affects males in their second or third decade of life. The prevalence of LHON in Europe is between 1:30,000-1:50,000.

About NVP015
One of the most common causes of mitochondrial diseases relates to Complex I dysfunction, i.e. when energy conversion in the first of the five protein complexes in the mitochondrion that are essential for effective energy conversion does not function normally. This is apparent in disorders including Leigh’s Syndrome and MELAS, both of which are very serious diseases with symptoms such as muscle weakness, epileptic fits and other severe neurological manifestations. The NVP015 project is based on a NeuroVive innovation in which the body’s own energy substrate, succinate, is made available in the cell via a prodrug technology. A prodrug is an inactive drug that is activated first when it enters the body by the transformation of its chemical structure. Results from the NVP015 project were published in the prestigious Nature Communications journal in August 2016.