On May 2, 2017 Altor BioScience Corporation (Altor), a leading developer of novel cytokine-based immunotherapeutics for cancer and infectious diseases, reported that it has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for its investigational interleukin-15 (IL-15) agonist complex, ALT-803, in combination with bacillus Calmette-Guérin (BCG), for the treatment of patients with non-muscle invasive bladder cancer (NMIBC) (Press release, Altor BioScience, MAY 2, 2017, View Source [SID1234518799]). The FDA’s Fast Track program is designed to expedite the development and review of drugs to treat serious conditions and fill unmet medical needs.

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ALT-803 is currently being evaluated in a Phase Ib/II clinical trial to investigate the safety and efficacy of intravesical ALT-803 in combination with BCG in adult patients with BCG-naïve NMIBC as well as a separate Phase II clinical trial to investigate the safety and efficacy of intravesical ALT-803 in combination with BCG in adult patients with BCG-unresponsive NMIBC. Results from the recently completed Phase Ib NMIBC study will be presented at the American Urological Association Annual Meeting in Boston on May 12, 2017. The FDA Fast Track designation will apply to clinical development of ALT-803 in combination with BCG for the treatment and prophylaxis of carcinoma in situ (CIS) of the urinary bladder, as well as for the prophylaxis of primary or recurrent stage Ta and/or T1 papillary tumors following transurethral resection (TUR) in patients with NMIBC.

Hing C. Wong, Ph.D., Chief Executive Officer of Altor BioScience, said: "We are thrilled that the FDA has granted Fast Track designation for ALT-803 in NMIBC. This is a key milestone for advancing our NMIBC program. Patients with NMIBC have few treatment options and there is a significant unmet medical need for novel therapies in NMIBC, particularly in patients who are unresponsive to BCG. We are looking forward to working closely with FDA to facilitate our clinical program in this important indication."

About ALT-803

ALT-803 is a proprietary, novel IL-15 superagonist complex, which demonstrates improved pharmacokinetic properties and enhanced anti-tumor activity compared to IL-15 in preclinical studies. These studies also demonstrated that ALT-803 simultaneously mobilizes both the innate and adaptive arms of the immune system to elicit rapid, robust, and long-lasting responses against cancer and virally-infected cells. ALT-803 also potently activates NK cells and enhances antibody-dependent cell-mediated cytotoxicity (ADCC) of antibodies in various experimental models. Combination studies of ALT-803 with antibodies, targeted agents, and vaccines are underway and will further explore the role of ALT-803 in immunotherapy combinations for various disease indications. ALT-803 is currently being evaluated in multiple clinical trials for patients with solid or hematological tumors and in HIV infected individuals.

On May 2, 2017 GlycoMimetics, Inc. (NASDAQ: GLYC) reported the publication of results from a preclinical study that showed its drug candidate GMI-1271, an E-selectin antagonist, was able to restore sensitivity to bortezomib (the frontline standard of care for patients with multiple myeloma) in animal models of disease (Press release, GlycoMimetics, MAY 2, 2017, View Source [SID1234518798]). The study, entitled "E-selectin Ligands Recognised by HECA452 Induce Drug Resistance in Myeloma, which is Overcome by the E-selectin Antagonist, GMI-1271," was published in an online preview of the journal Leukemia on April 25, 2017.

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E-selectin ligands are recognized by an antibody known as HECA452. In this manuscript, researchers described that E-selectin ligands expressed on myeloma cell surfaces and recognized by HECA452 induced a more aggressive form of multiple myeloma, which is insensitive to bortezomib. Through use of GMI-1271, sensitivity to the proteasome inhibitor therapy, bortezomib, was able to be restored in this highly resistant myeloma model.

"The results in this preclinical study demonstrate that targeting E-selectin may provide a novel approach to treatment of patients with multiple myeloma and could potentially restore sensitivity to chemotherapy and, in particular, proteasome inhibitor therapy," said John L. Magnani, Ph.D., Vice President and Chief Scientific Officer of GlycoMimetics.

GlycoMimetics is currently sponsoring a Phase 1/2 clinical trial in Europe in which patients whose multiple myeloma disease is resistant to bortezomib or carfilizomib can have GMI-1271 added to their treatment regimen to test whether sensitivity to the proteasome inhibitor can be restored. GMI-1271 is also currently being tested in a Phase 1/2 trial in acute myeloid leukemia (AML). GMI recently announced that updated data from this AML trial will be presented at the 2017 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. As part of this AML trial, researchers are testing patient samples to determine whether levels of E-selectin ligand as measured by HECA452 correlate with response to treatment with GMI-1271.

"We look forward to presenting an update on our AML clinical trial at the ASCO (Free ASCO Whitepaper) Annual Meeting and to sharing what is known so far about E-selectin ligand expression in the context of that trial," said Helen Thackray, M.D., Chief Medical Officer of GlycoMimetics.

About Multiple Myeloma

Multiple myeloma is an incurable form of blood cancer where the plasma cells in the bone marrow grow uncontrollably and may not function well while other blood forming cells (e.g., white/red blood cells and blood platelets) are suppressed. Normal plasma cells are an important part of the body’s immune defense and play a critical role in the production of antibodies. Multiple myeloma can therefore lead to infections, anemia, destruction of bone tissue and kidney problems. While some advances have been made in treatment, there remains a large unmet medical need for patients with multiple myeloma.

About GMI-1271

GMI-1271 is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance within the bone marrow microenvironment. Preclinical research points to the drug’s potential role in blocking E-selectin-mediated chemo-resistance pathways as well as moving cancerous cells out of the protective environment of the bone marrow where they hide and escape the effects of chemotherapy.

On May 2, 2017 Nativis Inc., a clinical stage life science bio-electronics company developing non-invasive, safe and highly effective treatments for cancers and other serious diseases, reported the peer reviewed publication of a research paper in the Journal of Neuro-Oncology (JNO) on a novel technology to treat brain cancer Nativis Inc., a clinical stage life science bio-electronics company developing non-invasive, safe and highly effective treatments for cancers and other serious diseases, reported the peer reviewed publication of a research paper in the Journal of Neuro-Oncology (JNO) on a novel technology to treat brain cancer (Press release, Nativis, MAY 2, 2017, View Source [SID1234518797]).

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Leading the efforts behind the research paper were Charles Cobbs, MD, Chair of the Nativis Medical & Scientific Advisory Board and Director of the Ben & Catherine Ivy Center for Advanced Brain Tumor Treatment at Swedish Neuroscience Institute, and Michael Prados, MD, Director of Translational Research at the Department of Neurological Surgery at the University of California, San Francisco. The article in JNO provided data by the research team identifying the significance of using the Nativis Voyager technology electromagnetic fields (EMF) in the ultra-low radio frequency energy (ulRFE) range to affect brain cancer cells at the molecular level. This technology was used to demonstrate the specificity and cellular effects on human derived glioblastoma (GBM) brain cancer cells. It was shown that this technology can specifically knock down EGFR gene expression, with resulting biological effects, in human primary (GBM) cells by exposing these cells to physical-EGFR siRNA and RFE-siEGFR signal. EGFR is a commercially proven target with multiple bio-pharmaceutical products approved to treat several different types of cancer.
"Brain cancer is known to be one of the most difficult cancers to treat due to the blood-brain barrier that makes delivery of pharmaceutical treatment difficult and ineffective," said Dr. Cobbs. "The Nativis Voyager technology delivers treatment via electronic signal, therefore by-passing the problems of delivering standard chemotherapy, and other drug treatment and the accompanying harsh physical effects that patients suffer."
"We continue to be encouraged about our Voyager technology to treat brain cancer as this research paper demonstrates," said Chris Rivera, Chief Executive Officer of Nativis. "These findings are the first, to our knowledge, that demonstrate specific molecular gene knockdown using ulRFE energy. Our strategy is to replicate the biological effects of commercially approved drugs and other therapeutic agents with our ulRFE technology. We have several research collaborations in the US and globally for work on human health, as well as other markets and sectors, including veterinary and plant science. It appears that our technology may be utilized in many ways and over multiple platforms to treat disease and other maladies. With the successful development of our ulRFE technology for the treatment of glioblastoma multiforme (GBM), a very complex and difficult area to treat, the impact for patients with GBM and other diseases could be monumental."

Further comments were made by Nativis Medical and Scientific Board Member Victor Levin, MD, Founder of the Society of Neuro Oncology (SNO) and Emeritus Professor of Neuro-Oncology at The University of Texas, M.D. Anderson Cancer Center. "This research is very important as it provides additional support for the importance of this technology to patients with CNS cancers and other tumors. The application of this research provides, for the first time, the possibility of treating human diseases with low energy electromagnetic field technology that can reduce the production of signaling proteins within tumor cells. Given that new drug development is almost absent for CNS cancers and those available today are of limited efficacy and produce a wide range of side effects making creating effective drug combinations difficult, the RFE approach is truly a bright light for patients in the future. This is true for brain cancer and likely equally true for other diseases affecting the brain. The implications and possible uses of this novel approach cannot be underestimated," Dr. Levin added.

The abstract of this paper can be seen at View Source." target="_blank" title="View Source." rel="nofollow">View Source

Leading the efforts behind the research paper were Charles Cobbs, MD, Chair of the Nativis Medical & Scientific Advisory Board and Director of the Ben & Catherine Ivy Center for Advanced Brain Tumor Treatment at Swedish Neuroscience Institute, and Michael Prados, MD, Director of Translational Research at the Department of Neurological Surgery at the University of California, San Francisco. The article in JNO provided data by the research team identifying the significance of using the Nativis Voyager technology electromagnetic fields (EMF) in the ultra-low radio frequency energy (ulRFE) range to affect brain cancer cells at the molecular level. This technology was used to demonstrate the specificity and cellular effects on human derived glioblastoma (GBM) brain cancer cells. It was shown that this technology can specifically knock down EGFR gene expression, with resulting biological effects, in human primary (GBM) cells by exposing these cells to physical-EGFR siRNA and RFE-siEGFR signal. EGFR is a commercially proven target with multiple bio-pharmaceutical products approved to treat several different types of cancer.

"Brain cancer is known to be one of the most difficult cancers to treat due to the blood-brain barrier that makes delivery of pharmaceutical treatment difficult and ineffective," said Dr. Cobbs. "The Nativis Voyager technology delivers treatment via electronic signal, therefore by-passing the problems of delivering standard chemotherapy, and other drug treatment and the accompanying harsh physical effects that patients suffer."

"We continue to be encouraged about our Voyager technology to treat brain cancer as this research paper demonstrates," said Chris Rivera, Chief Executive Officer of Nativis. "These findings are the first, to our knowledge, that demonstrate specific molecular gene knockdown using ulRFE energy. Our strategy is to replicate the biological effects of commercially approved drugs and other therapeutic agents with our ulRFE technology. We have several research collaborations in the US and globally for work on human health, as well as other markets and sectors, including veterinary and plant science. It appears that our technology may be utilized in many ways and over multiple platforms to treat disease and other maladies. With the successful development of our ulRFE technology for the treatment of glioblastoma multiforme (GBM), a very complex and difficult area to treat, the impact for patients with GBM and other diseases could be monumental."

Further comments were made by Nativis Medical and Scientific Board Member Victor Levin, MD, Founder of the Society of Neuro Oncology (SNO) and Emeritus Professor of Neuro-Oncology at The University of Texas, M.D. Anderson Cancer Center. "This research is very important as it provides additional support for the importance of this technology to patients with CNS cancers and other tumors. The application of this research provides, for the first time, the possibility of treating human diseases with low energy electromagnetic field technology that can reduce the production of signaling proteins within tumor cells. Given that new drug development is almost absent for CNS cancers and those available today are of limited efficacy and produce a wide range of side effects making creating effective drug combinations difficult, the RFE approach is truly a bright light for patients in the future. This is true for brain cancer and likely equally true for other diseases affecting the brain. The implications and possible uses of this novel approach cannot be underestimated," Dr. Levin added.

The abstract of this paper can be seen at View Source

On May 2, 2017 Gilead Sciences, Inc. (Nasdaq: GILD) reported its results of operations for the first quarter ended March 31, 2017 (Press release, Gilead Sciences, MAY 2, 2017, View Source [SID1234518816]).

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The financial results that follow represent a year-over-year comparison of the first quarter 2017 to the first quarter 2016. Total revenues were $6.5 billion in 2017 compared to $7.8 billion in 2016. Net income was $2.7 billion or $2.05 per diluted share in 2017 compared to $3.6 billion or $2.53 per diluted share in 2016. Non-GAAP net income, which excludes amounts related to acquisition-related, up-front collaboration, stock-based compensation and other expenses, was $2.9 billion or $2.23 per diluted share in 2017 compared to $4.3 billion or $3.03 per diluted share in 2016.

Three Months Ended
March 31,
(In millions, except per share amounts) 2017 2016
Product sales $ 6,377 $ 7,681
Royalty, contract and other revenues 128 113
Total revenues
$ 6,505 $ 7,794

Net income attributable to Gilead $ 2,702 $ 3,566
Non-GAAP net income* $ 2,949 $ 4,274

Diluted earnings per share $ 2.05 $ 2.53
Non-GAAP diluted earnings per share*
$ 2.23 $ 3.03

* Non-GAAP net income and non-GAAP diluted earnings per share exclude acquisition-related, up-front collaboration, stock-based compensation and other expenses. A reconciliation between GAAP and non-GAAP financial information is provided in the tables on pages 7 and 8.

Product Sales

Total product sales for the first quarter of 2017 were $6.4 billion compared to $7.7 billion for the same period in 2016. Product sales for the first quarter of 2017 were $4.5 billion in the United States, $1.3 billion in Europe and $661 million in other locations. Product sales for the first quarter of 2016 were $4.4 billion in the United States, $1.6 billion in Europe and $1.7 billion in other locations.

Antiviral Product Sales

Antiviral product sales, which include sales of our HIV, chronic hepatitis B (HBV) and chronic hepatitis C (HCV) products, were $5.8 billion for the first quarter of 2017 compared to $7.2 billion for the same period in 2016.

HIV and HBV product sales were $3.3 billion compared to $2.9 billion for the same period in 2016. The increase was primarily due to the continued uptake of our tenofovir alafenamide (TAF) based products, Genvoya (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg), Descovy (emtricitabine 200 mg/tenofovir alafenamide 25 mg) and Odefsey (emtricitabine 200 mg/rilpivirine 25 mg/tenofovir alafenamide 25 mg).
HCV product sales, which consist of Harvoni (ledipasvir 90 mg/sofosbuvir 400 mg), Sovaldi (sofosbuvir 400 mg) and Epclusa (sofosbuvir 400 mg/velpatasvir 100 mg), were $2.6 billion compared to $4.3 billion for the same period in 2016. The decline was due to lower sales of Harvoni and Sovaldi across all major markets, partially offset by sales of Epclusa, which was launched in the United States and Europe in June and July 2016, respectively.
Other Product Sales

Other product sales, which include Letairis (ambrisentan), Ranexa (ranolazine) and AmBisome (amphotericin B liposome for injection), were $536 million for the first quarter of 2017 compared to $498 million for the same period in 2016.

Operating Expenses

Three Months Ended
March 31,
(In millions) 2017 2016
Research and development expenses (R&D) $ 931 $ 1,265
Non-GAAP R&D expenses* $ 889 $ 769

Selling, general and administrative expenses (SG&A) $ 850 $ 685
Non-GAAP SG&A expenses* $ 807 $ 638

* Non-GAAP R&D and SG&A expenses exclude acquisition-related, up-front collaboration, stock-based compensation and other expenses. A reconciliation between GAAP and non-GAAP financial information is provided in the tables on pages 7 and 8.

During the first quarter of 2017, compared to the same period in 2016:

R&D expenses decreased primarily due to the 2016 impact of up-front collaboration expenses related to Gilead’s license and collaboration agreement with Galapagos NV and impairment charges related to in-process R&D. These decreases were partially offset by expenses associated with Gilead’s purchase of a U.S. Food and Drug Administration (FDA) priority review voucher.
Non-GAAP R&D expenses* increased primarily due to expenses associated with Gilead’s purchase of an FDA priority review voucher.
SG&A expenses and non-GAAP SG&A expenses* increased primarily due to higher branded prescription drug fee expense.
Cash, Cash Equivalents and Marketable Securities

As of March 31, 2017, Gilead had $34.0 billion of cash, cash equivalents and marketable securities compared to $32.4 billion as of December 31, 2016. Cash flow from operating activities was $2.9 billion for the quarter. During the first quarter of 2017, Gilead utilized $565 million on stock repurchases and paid cash dividends of $687 million.

Full Year 2017 Guidance Reiterated

Gilead reiterates its full year 2017 guidance, initially provided on February 7, 2017:

(In millions, except percentages and per share amounts) Initially Provided
February 7, 2017
Net Product Sales $22,500 – $24,500
Non-HCV Product Sales $15,000 – $15,500
HCV Product Sales $7,500 – $9,000
Non-GAAP*
Product Gross Margin 86% – 88%
R&D Expenses $3,100 – $3,400
SG&A Expenses $3,100 – $3,400
Effective Tax Rate 25.0% – 28.0%
Diluted EPS Impact of Acquisition-related, Up-front Collaboration, Stock-based Compensation and Other Expenses $0.84 – $0.91

* Non-GAAP Product Gross Margin, R&D and SG&A expenses and effective tax rate exclude acquisition-related, up-front collaboration, stock-based compensation and other expenses. A reconciliation between GAAP and non-GAAP full year 2017 guidance is provided in the tables on page 9.

Corporate Highlights

Announced that Alessandro Riva, MD, joined the company as Senior Vice President and therapeutic area head for hematology and oncology.
Announced the recipients of Gilead’s HIV cure grants program, a fund totaling more than $22 million, which will support 12 new HIV cure research projects. These projects will be conducted by leading academic institutions, non-profit organizations and community groups from around the world, focusing on three key areas: translational research, efficacy studies in animal models and community perspectives of HIV cure.
Product and Pipeline Updates announced by Gilead during the First Quarter of 2017 include:

Antiviral and Liver Diseases Programs

Presented data at the 2017 Conference on Retroviruses and Opportunistic Infections which included the announcement of:
Positive results from a Phase 2 study evaluating the efficacy, safety and tolerability of a combination of bictegravir (75 mg) (BIC) and emtricitabine/tenofovir alafenamide (200/25 mg) (FTC/TAF) versus dolutegravir (50 mg) (DTG) and FTC/TAF in treatment-naïve, HIV-1 infected adults. Results found that the BIC+FTC/TAF and DTG+FTC/TAF regimens both demonstrated high virologic response rates at week 24 and week 48.
Positive findings from a preclinical study evaluating HIV capsid inhibitors (CAIs) for potential use as a long-acting antiretroviral (ARV) treatment. The study identified novel HIV-1 CAIs with highly potent antiviral activity and a favorable resistance profile to existing ARVs in vitro.
Positive 144-week data from two Phase 3 studies (Studies 104 and 111) evaluating the safety and efficacy of Genvoya for the treatment of HIV-1 infection in treatment-naïve adults. Through week 144, Genvoya demonstrated significantly higher rates of virologic suppression compared to Stribild (elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg), based on the percentage of patients with HIV-1 RNA levels less than 50 copies/mL. Patients receiving Genvoya also demonstrated favorable renal and bone laboratory parameters compared to those treated with Stribild.
Announced that the marketing authorization application for the investigational, once-daily, single-tablet regimen of sofosbuvir 400 mg, velpatasvir 100 mg and voxilaprevir 100 mg (SOF/VEL/VOX) for the treatment of HCV-infected patients has been fully validated and is under assessment by the European Medicines Agency. Gilead also previously submitted a new drug application to FDA for SOF/VEL/VOX. Under the Prescription Drug User Fee Act, FDA has set a target action date of August 8, 2017.
Announced that the European Commission granted marketing authorization for Vemlidy (tenofovir alafenamide 25mg), a once-daily tablet for the treatment of chronic hepatitis B virus infection in adults and adolescents (aged 12 years and older with body weight at least 35 kg).
Non-GAAP Financial Information

The information presented in this document has been prepared by Gilead in accordance with U.S. generally accepted accounting principles (GAAP), unless otherwise noted as non-GAAP. Management believes non-GAAP information is useful for investors, when considered in conjunction with Gilead’s GAAP financial information, because management uses such information internally for its operating, budgeting and financial planning purposes. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of Gilead’s operating results as reported under GAAP. Non-GAAP measures may be defined and calculated differently by other companies in the same industry. A reconciliation between GAAP and non-GAAP financial information is provided in the tables on pages 7, 8 and 9.

On May 2,2017 Celyad (Euronext Brussels and Paris, and NASDAQ:CYAD), a leader in the discovery and development of cell therapies, reported a non-exclusive license agreement with Novartis for Celyad’s US patents for the production of allogeneic CAR-T cells (Press release, Celyad, MAY 2, 2017, View Source [SID1234518791]). This license agreement is related to two targets currently under development by Novartis.

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The agreement includes Celyad’s intellectual property rights under United States Patent No. 9,181,527 related to allogeneic human primary T-Cells that are engineered to be T-Cell Receptor (TCR) deficient and express a Chimeric Antigen Receptor (CAR). The granted claims are not limited to specific CARs or specific methods of generating allogeneic CAR T-cells, such as genome editing or genetic engineering.

Under the terms of the agreement Celyad receives an upfront payment and is eligible to receive success based clinical, regulatory and commercial milestone payments. If all success based milestones are achieved, Celyad is eligible to receive payments, including the upfront payment, totalling $96 million. In addition, Celyad will receive single digit royalties based on net sales of the licensed target associated products. Novartis has the option to extend the agreement to additional targets and/or to convert its license into an exclusive license. Celyad retains all rights to grant further licenses to third parties for the use of allogeneic CAR-T cells.

Celyad will not be involved in the development of Novartis’ CAR-T cells. Celyad will continue to focus on the development of its CAR-T pipeline, including its allogeneic NKR-2 T-cell immunotherapy in the EU and US territories and in collaboration with Ono Pharmaceuticals, its partner in Japan, Taiwan and Korea.

Dr. Christian Homsy, CEO of Celyad, said: "This non-exclusive agreement with Novartis recognizes the importance of our IP for companies developing allogeneic CAR-T therapies".