On May 3, 2018 Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company focused on discovering and developing highly targeted cancer immunotherapies, reported that Dr. Adi Hoess, CEO, will present at Deutsche Bank’s 43rd Annual Health Care Conference on Tuesday, May 8, 2018 at 10:40 am ET (Press release, Affimed, MAY 3, 2018, View Source [SID1234526099]).

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A live webcast of the conference presentation can be accessed through the "Events" section on the "Investors & Media" page of the Affimed website at www.affimed.com/events.php. A replay of the presentation will be available from Affimed’s website for 30 days following the conference.

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 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 Valeant Pharmaceuticals International, Inc. (NYSE/TSX: VRX) ("Valeant") reported that Paul S. Herendeen, executive vice president, Finance, and chief financial officer, is scheduled to participate at the Goldman Sachs Third Annual Leveraged Finance Conference in Rancho Palos Verdes, Calif. on Thursday, May 10, 2018 at 2:10 p.m. PDT (5:10 p.m. EDT) (Press release, Valeant, MAY 3, 2018, http://ir.valeant.com/news-releases/2018/05-03-2018-130141166 [SID1234526026]).

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A live webcast and audio archive of the event will be available on the Investor Relations page of the Valeant web site at: http://ir.valeant.com/events-and-presentations/2018.

On May 3, 2018 Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS), a clinical-stage biopharmaceutical company focused on the development and commercialization of precisely targeted oncology therapies, reported financial results for the first quarter ended March 31, 2018, and provided a business update (Press release, Corvus Pharmaceuticals, MAY 3, 2018, View Source;p=RssLanding&cat=news&id=2346944 [SID1234526064]).

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"We made important progress in advancing our clinical programs and building our pipeline, with several notable developments in the first quarter that reinforce our continued leadership in the development of therapies targeting the adenosine pathway," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "We are now enrolling patients in our Phase 1/1b trial evaluating CPI-006 as a monotherapy, in combination with CPI-444 and in combination with Keytruda (pembrolizumab). We believe this is the first human clinical trial in oncology to evaluate the effect of dual-blockade of the adenosine pathway by inhibiting both CD73 and the A2A receptor. With the initiation of this new trial and our ongoing Phase 1/1b clinical trial with our A2A receptor antagonist CPI-444, we continue to have one of the most advanced programs addressing the adenosine pathway. Our clinical trials with CPI-444 are expanding in both renal cell and lung cancer and are designed to evaluate its use in earlier lines of therapy."

RECENT ACHIEVEMENTS
CPI-444: A2A Receptor Antagonist of Adenosine

Amended the clinical trial protocol for the ongoing Phase 1/1b clinical trial evaluating CPI-444, the Company’s lead product candidate, administered alone and in combination with Genentech’s Tecentriq (atezolizumab), an anti-PD-L1 antibody, in up to 50 patients with renal cell cancer (RCC) who have failed no more than two prior treatment regimens, which must have included an anti-PD-(L)1 and a tyrosine kinase inhibitor. Prior to this amendment, RCC patients were eligible and enrolled with up to five (median three) prior treatments regimens.
Continued enrolling patients in the Phase 1b/2 trial, being conducted by Genentech as part of their MORPHEUS platform, which is evaluating CPI-444 and Tecentriq in up to 60 patients with non-small cell lung cancer (NSCLC) who have failed no more than two prior regimens.
CPI-006: Anti-CD73 Antibody

As recently announced, initiated the Phase 1/1b clinical trial evaluating CPI-006, the Company’s anti-CD73 antibody, as a single agent and in combination with CPI-444, and in combination with pembrolizumab. The trial is anticipated to enroll up to 350 patients and is designed to select the dose and evaluate the safety, pharmacokinetics, immune biomarkers and efficacy in patients with NSCLC, RCC, and other cancers who have failed standard therapies.
Preclinical

Advanced Investigational New Drug (IND) enabling studies and additional preclinical trials in spontaneous canine T-cell lymphoma for the Company’s interleukin-2–inducible kinase (ITK) inhibitor and progressed scale-up manufacturing activities in preparation for an anticipated IND filing in late 2018.
Corporate

Raised $64.9 million in net proceeds in March 2018 through an underwritten public offering, broadening our investor base.
FINANCIAL RESULTS
At March 31, 2018, Corvus had cash, cash equivalents and marketable securities totaling $143.9 million. This compared to cash, cash equivalents and marketable securities of $90.1 million at December 31, 2017.

Research and development expenses for the three months ended March 31, 2018 totaled $12.1 million compared to $13.5 million for the same period in 2017. The decrease of $1.4 million was primarily due to the payment of a $3.0 million milestone related to CPI-444 in the first quarter of 2017, partially offset by an increase of $0.5 million in drug manufacturing costs for CPI-006 and an increase of $0.7 million in personnel costs.

General and administrative expenses for the three months ended March 31, 2018 totaled $2.5 million compared to $2.7 million for the same period in 2017. The decrease of $0.2 million was primarily due to a decrease of $0.4 million in patent and public company expenses, offset by an increase of $0.2 million in personnel costs.

The net loss for the three months ended March 31, 2018 was $14.3 million compared to $16.0 million for the same period in 2017. Total stock compensation expense for the three months ended March 31, 2018 was $1.8 million compared to $1.5 million for the same period in 2017.