On May 3, 2018 RhoVac AB ("RhoVac") reported that the company has been awarded the European Commission grant under the EU’s research and innovation programme Horizon 2020, with significant appraisal score of "Very good to Excellent" (Press release, RhoVac, MAY 3, 2018, View Source [SID1234555935]).

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Horizon 2020 EU funding supports Small and Medium-sized Enterprises (SME) with breakthrough innovation projects and a market-creating potential. The highly competitive fund is only offered to SMEs which fall under European Innovation Council’s (EIC) SME definition. The fund is part of the Horizon 2020 work programme 2018-2020, funding high-potential innovations in the EU. The fund offers Europe’s brightest and boldest innovators the funding for breakthrough ideas with the potential to create entirely new markets or revolutionise existing ones. The round of applications in February 2018, has been highly competitive with success rate of 12.6% among 2009 submitted proposals.

RhoVac is pleased to announce that company’s RV001 cancer vaccine project, currently in clinical phase I/II focusing on patients with diagnosed prostate cancer, has been awarded the phase I grant. RhoVac has received a significant total score of 13.80 out of 15, which indicates "Very good to Excellent" in the appraisal scale. Company’s application has received excellent scores for major sub-criterions, such as (but not limited to):

Impact: substantial patient’s need for the innovation, realistic analysis of market, scalability and large market size, potential to create new markets generated by the new innovation, knowledge protection, overall strategy and business model.
Excellence: game-changing and breakthrough innovation and clear development outline
Quality and efficiency of implementation: team commitment with deep technical/management experience and realistic timeframe
The SME instrument will boost fast company growth and market-creating innovation thanks to staged funding and ramped up business acceleration services. Following completion of this phase I, RhoVac is preparing to apply for phase II of the Horizon 2020 grant to be submitted in Q4 2018.

Comments from RhoVac´s CEO, Anders Ljungqvist
-We are delighted to receive this €50,000 grant from the European Commission, but what is most important and rewarding is to see the rating that we are acknowledged for: our innovative approach, our understanding of patient’s need and the high quality in RhoVac’s project management. This rating is highly motivating for us in our continuing effort to further develop the RV001 project. This grant will be funded to prepare a feasibility report, as a requirement by European Commission, which will then be the basis for the upcoming phase II application within the program framework.

On May 3, 2018 Ferring Pharmaceuticals reported the signing of an agreement giving the company the option to secure global commercialisation rights to nadofaragene firadenovec/Syn3 (rAd-IFN/Syn3), a novel gene therapy being developed by FKD Therapies Oy (FKD) as a treatment for patients with high-grade non-muscle invasive bladder cancer (NMIBC), who are unresponsive to Bacillus Calmette-Guérin (BCG) therapy (Press release, Ferring Pharmaceuticals, MAY 3, 2018, View Source [SID1234551851]). This option is exercisable on marketing approval from the US FDA. Ferring will create a new US oncology division with the specialist knowledge and presence to introduce novel advanced therapies to the market.

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rAd-IFN/Syn3 is currently undergoing Phase 3 development in the US under the sponsorship of Finnish gene therapy specialists FKD. The results of the earlier Phase 2 trial, published in the Journal of Clinical Oncology, reported 35% of BCG unresponsive NMIBC bladder cancer patients given one dose of rAd-IFN/Syn3 every three months, were free of high-grade disease at one year1. The ongoing Phase 3 study is designed to establish the efficacy and safety of the product. rAd-IFN/Syn3 has been awarded Fast Track and Breakthrough Therapy designations by the FDA.

"We are excited about the potential to commercialise rAd-IFN/Syn3, a novel gene therapy for bladder cancer patients," said Michel Pettigrew, President of the Executive Board and Chief Operating Officer, Ferring Pharmaceuticals. "The gene therapy sector is growing rapidly and building a presence in this specialised area is a very positive opportunity for Ferring."

Bladder cancer is one of the most frequently occurring cancers with an estimated 430,000 new cases being reported worldwide each year2. It is the fourth most common cancer in men in the US3 and is the most expensive cancer to treat on a life-time basis, with a high burden on patients, their relatives and healthcare systems4. In high-grade NMIBC patients, BCG is the gold standard treatment and although effective, over 60% of cases eventually re-occur5, 6. The outcome for such patients is poor, with total cystectomy (complete removal of the bladder) to prevent the cancer spreading to other organs generally being the next treatment option. As such, the BCG unresponsive population is one of high unmet clinical need.

"Today, bladder cancer patients have very limited medical options and new treatments that delay or prevent total removal of the bladder and improve clinical outcomes are urgently needed for patients," said Professor Klaus Dugi, Chief Medical Officer, Ferring Pharmaceuticals. "Phase 2 clinical results for rAd-IFN/Syn3 were very encouraging and we look forward to the Phase 3 data."

Gene therapy is one of a new class of therapeutic treatments known as advanced therapy medicinal products. rAd-IFN/Syn3 is built on adenoviral vector technology, a non-integrating vector, and results in enhanced expression of the therapeutic protein interferon alfa 2b. To date, it has completed three clinical trials in the US.

About rAd-IFN/Syn3

rAd-IFN/Syn3 (nadofaragene firadenovec/Syn3) is an investigational gene therapy consisting of an adenovirus containing the gene interferon alfa-2b. It is administered by catheter into the bladder, where the virus enters the cells of the bladder wall. Inside the cells, the virus breaks down leaving the active gene to do its work. The internal gene/DNA machinery of the cells picks up the gene and translates its DNA sequence, resulting in the cells secreting high quantities of interferon alfa-2b protein, a naturally occurring protein the body uses to fight cancer. This novel gene therapy approach turns the patient’s own bladder wall cells into multiple interferon microfactories, enhancing the body’s natural defences against the cancer. The Phase 3 trial for rAd-IFN/Syn3 opened in 2016 with up to 150 patients to be enrolled across 35 centers in the US.

On May 3, 2018 Athenex, Inc. (Nasdaq:ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported that it will release first quarter 2018 earnings results on May 14, 2018 (Press release, Athenex, MAY 3, 2018, View Source;p=RssLanding&cat=news&id=2346736 [SID1234526019]). The Company will host a conference call and audio webcast on Monday, May 14, 2018 at 9:00 a.m. Eastern Time.

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To participate in the call, dial (855) 227-0567 (domestic) or (612) 979-9912 (international) fifteen minutes before the conference call begins and reference the conference passcode 9093904. A replay will be available approximately one hour after the recording through Monday, May 21, 2018 and can be accessed by dialing (855) 859-2056. The live conference call and replay can also be accessed via audio webcast at the Investor Relations section of the Company’s website, located at www.athenex.com. An archive will be available at this website until June 14, 2018.

On May 3, 2018 Asterias Biotherapeutics, Inc. (NYSE American:AST), a biotechnology company dedicated to developing cell-based therapeutics to treat neurological conditions associated with demyelination and cellular immunotherapies to treat cancer, reported that it will release first quarter 2018 financial and operating results on Wednesday, May 9, 2018 after the close of the U.S. financial markets (Press release, Asterias Biotherapeutics, MAY 3, 2018, View Source;p=RssLanding&cat=news&id=2346893 [SID1234526047]). The Company will host a conference call and webcast on May 9, 2018 at 5:00 p.m. ET / 2:00 p.m. PT to discuss the results and corporate developments.

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For both "listen-only" participants and those participants who wish to take part in the question-and-answer portion of the call, the dial-in number in the U.S./Canada is 877-591-4959. For international participants outside the U.S./Canada, the dial-in number is 719-325-2329. For all callers, refer to Conference ID 8804469. To access the live webcast, go to View Source

A replay of the conference call will be available for one month beginning about two hours after the conclusion of the live call, by calling toll-free (from U.S./Canada) 888-203-1112 ; international callers dial 719-457-0820. Use the Conference ID 8804469. Additionally, the archived webcast will be available at View Source

On May 3, 2018 Intrexon Corporation (NYSE: XON), a leader in the engineering and industrialization of biology to improve the quality of life and health of the planet, reported it will release first quarter 2018 financial results after the market closes on Thursday, May 10th, 2018 (Press release, Intrexon, MAY 3, 2018, View Source [SID1234526074]). The Company will host a conference call that day at 5:30 PM ET to discuss the results and provide a general business update.

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Intrexon Corporation logo. (PRNewsFoto/Intrexon Corporation)

The conference call may be accessed by dialing 1-888-317-6003 (Domestic US), 1-866-284-3684 (Canada), and 1-412-317-6061 (International) and providing the number 3130312 to join the Intrexon Corporation Call. Participants may also access the live webcast through Intrexon’s website in the Investors section at View Source