On October 28, 2015 CytRx Corporation (Nasdaq: CYTR), a biopharmaceutical research and development company specializing in oncology, reported that a poster titled "A Phase 1b/2 Study of Aldoxorubicin plus Ifosfamide/Mesna in Untreated Sarcoma Patients" will be presented at the 20th Annual Connective Tissue Oncology Society (CTOS) Annual Meeting in Salt Lake City, Utah, November 4 – 7, 2015 (Press release, CytRx, OCT 28, 2015, View Source;p=RssLanding&cat=news&id=2103413 [SID:1234507814]). The poster will discuss the trial design and current results of CytRx’s on-going clinical trial in patients with metastatic soft and non-soft tissue sarcomas. In this study, 7 subjects received 170 mg/m2 aldoxorubicin, and 3 subjects received 250 mg/m2 aldoxorubicin (125 or 185 mg/m2 doxorubicin equivalents), administered intravenously every 4 weeks. All patients also received 1 gram/m2/day ifosfamide/mesna administered as a continuous 24 hour infusion for up to 14 days, every 4 weeks. As of September 30, 2015, 8 subjects demonstrated tumor shrinkage, with 3 subjects having documented partial responses. Six subjects are still receiving treatment. Grade 3 or 4 adverse events included neutropenia (90%), anemia (70%), nausea or vomiting (10%) and febrile neutropenia (10%). No subject exhibited cardiotoxicity by echocardiogram.

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Dr. Sant Chawla M.D., F.R.A.C.P., Director of the Sarcoma Oncology Center and principal investigator for this trial stated, "The use of doxorubicin with ifosfamide and mesna remains a treatment option for many sarcoma patients. Replacing doxorubicin with aldoxorubicin may lead to improved clinical outcomes for these first-line sarcoma patients, since we already know that aldoxorubicin demonstrated superiority to doxorubicin in the previously completed Phase 2b trial in first-line tissue sarcomas."

"The presentation of the Phase 1b/2 clinical trial data at CTOS demonstrates to the sarcoma community the potential use of aldoxorubicin as part of a multi-drug regimen to treat sarcomas," said Steven A. Kriegsman, CytRx’s Chairman and Chief Executive Officer. "The on-going trial will generate important dosing, safety and efficacy data in treatment-naive patients. We remain excited about the prospects of aldoxorubicin in our pivotal global Phase 3 trial in sarcoma patients that have previously received chemotherapy, with top-line data expected in the second half of 2016."

Phase 1b/2 Trial Design

Aldoxorubicin is administered at escalating doses by intravenous infusion (IVI) on Day 1 every 28 days, and 1 gm/m2/day of ifosfamide and an equivalent dose of mesna is administered via continuous infusion with a portable at-home pump for up to 14 days every 28 days starting on Day 1 of each cycle, until disease progression, unacceptable toxicity or the patient withdraws consent. The primary objective of the trial is to determine the preliminary safety of administration of aldoxorubicin in combination with ifosfamide in patients with metastatic, locally advanced, or unresectable STS as measured by the frequency and severity of adverse events (AEs), abnormal findings on physical examination, laboratory tests, vital signs, echocardiograms (ECHO) or multiple-gated acquisition (MUGA) scans, electrocardiogram (ECG) results, and weight. The secondary objective of the trial is to evaluate the activity of aldoxorubicin in combination with ifosfamide/mesna in this population, assessed by overall response rate (ORR), progression-free survival (PFS) and PFS at 4 and 6 months. This Phase 1b/2 trial is being conducted at the Sarcoma Oncology Center in Santa Monica, California.

About Soft Tissue Sarcoma

Soft tissue sarcoma is a cancer occurring in muscle, fat, blood vessels, tendons, fibrous tissues and connective tissue, and can arise anywhere in the body at any age. According to the American Cancer Society, there are approximately 50 types of soft tissue sarcomas. In 2015 more than 11,900 new cases were diagnosed in the U.S. and approximately 4,900 Americans died from this disease. In addition, approximately 40,000 new cases and 13,000 deaths in the U.S. and Europe are part of a growing underserved market.

About Aldoxorubicin

The widely used chemotherapeutic agent doxorubicin is delivered systemically and is highly toxic, which limits its dose to a level below its maximum therapeutic benefit. Doxorubicin also is associated with many side effects, especially the potential for damage to heart muscle at cumulative doses greater than 450 mg/m2. Aldoxorubicin combines doxorubicin with a novel single-molecule linker that binds directly and specifically to circulating albumin, the most plentiful protein in the bloodstream. Protein-hungry tumors concentrate albumin, thus increasing the delivery of the linker molecule with the attached doxorubicin to tumor sites. In the acidic environment of the tumor, but not the neutral environment of healthy tissues, doxorubicin is released. This allows for greater doses (3 ½ to 4 times) of doxorubicin to be administered while reducing its toxic side effects. In studies thus far there has been no evidence of clinically significant effects of aldoxorubicin on heart muscle, even at cumulative doses of drug well in excess of 2,000 mg/m2.

On October 28, 2015 Merck (NYSE:MRK), known as MSD outside the United States and Canada, reported that KEYTRUDA (pembrolizumab), the company’s anti-PD-1 therapy for the treatment of advanced melanoma and metastatic non-small cell lung cancer in patients whose disease has progressed after other therapies, received the Prix Galien USA 2015 Award for Best Biotechnology Product (Press release, Merck & Co, OCT 28, 2015, View Source [SID:1234507818]).

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"As a company built on a foundation of scientific excellence, Merck is honored to again have been chosen as a recipient of this prestigious award," said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. "This achievement is a testament to the remarkable contributions of everyone at Merck, as well as the many physicians and patients who participated in our clinical trials, in helping to bring KEYTRUDA to patients."

The Prix Galien Award recognizes the pharmaceutical industry’s outstanding achievement in the development of new medicines. An internationally recognized award, the Prix Galien was founded in France in 1969 by French pharmacist Roland Mehl and is considered the highest accolade for pharmaceutical research and development.

This latest award for KEYTRUDA is Merck’s seventh Prix Galien USA award in nine years. The company was previously recognized for ZOSTAVAX (2013), VICTRELIS (2012), ROTATEQ (2010), ISENTRESS (2008) and JANUVIA and GARDASIL (2007). In total, around the world, Merck has won the Prix Galien 40 times, making Merck the most-awarded company of all time.

On October 28, 2015 – Igenica Biotherapeutics, Inc., a company focused on the discovery and development of innovative antibody-based therapies for the treatment of cancer, reported that it has entered into an oncology research agreement with MedImmune, the global biologics research and development arm of AstraZeneca (NYSE: AZN) (Press release, Igenica, OCT 28, 2015, View Source [SID1234519302]). Igenica and MedImmune will evaluate the potential of antibody-drug conjugates (ADCs) targeting Surface Antigen in Leukemia (SAIL), a novel cell surface protein with high prevalence of expression in a variety of hematologic malignancies and several solid tumors. Preclinical data have supported the selective targeting of tumors expressing SAIL with ADCs.

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Under the agreement, Igenica will contribute its proprietary anti-SAIL antibodies, including IGN786, and its proprietary SNAP ADC drug linker, and MedImmune will provide its proprietary anti-tumor payload. Igenica and MedImmune will then jointly investigate the resulting novel ADC in preclinical studies.

MedImmune will receive an option to an exclusive worldwide license to anti-SAIL antibodies and antibody-drug conjugates resulting from the collaboration. Igenica will receive an exclusive option fee and, if MedImmune exercises its option, is also eligible to receive an upfront license fee, clinical, regulatory and commercialization milestones, and royalties on net sales. MedImmune will fund all development and commercialization costs under a license agreement.

"We are pleased to collaborate with MedImmune, a leading biotechnology company, to build on our pioneering research," commented John Celebi, Chief Business Officer, Igenica. "This agreement provides a strong opportunity to realize the potential value of IGN786 and complements our strategy focused on targeting drugs to block the immunosuppressive activities of immune cells in the tumor microenvironment to reinvigorate or activate de novo anti-tumor responses."

"We look forward to working with Igenica Biotherapeutics on developing a novel antibody-drug conjugate in hematology," said Ronald Herbst, Vice President, Oncology Research & Development, MedImmune. "Developing next generation antibody-drug conjugates is a key strategic area for us, and we are committed to advancing our pipeline in this area both externally and internally."

About IGN786 and SAIL
IGN786 is a humanized monoclonal antibody that binds to SAIL, a cell surface protein with high prevalence of expression in a variety of hematologic malignancies and several solid tumors. Igenica was the first to describe the biological properties of human SAIL and elucidate its potential as an antibody-drug conjugate approach (Blood Cancer Journal (2015) 5, e316). Preclinical data with IGN786 have supported the selective targeting of tumors expressing SAIL with antibody-drug conjugates.

On October 28, 2015 Varian Medical Systems (NYSE:VAR) reported non-GAAP net earnings of $1.04 per diluted share and GAAP earnings of $0.99 per diluted share for the fourth quarter of fiscal year 2015 (Press release, Varian Medical Systems, OCT 28, 2015, View Source [SID:1234507824]). For the full fiscal year 2015, non-GAAP earnings were $4.29 per diluted share, and GAAP earnings were $4.09 per diluted share. Varian’s revenues totaled $818 million for the fourth quarter of fiscal year 2015, up 1 percent from the year-ago quarter and up 6 percent in constant currency. Varian’s revenues for the full fiscal year were $3.1 billion, up 2 percent versus fiscal year 2014 and up 6 percent in constant currency. The company ended the fourth quarter with a $3.5 billion backlog, up 10 percent from the end of fiscal year 2014.

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"During the quarter, our Oncology Systems business generated healthy constant currency order growth, the Particle Therapy business gathered momentum, and the Imaging Components business continued to experience declines in orders, revenues and margins," said Dow R. Wilson, CEO of Varian Medical Systems. "As we previously reported, we experienced a shortfall of high-margin revenues in our Oncology business when several TrueBeam systems and related software slipped out of the quarter."

The company finished the fiscal year with $845 million in cash and cash equivalents and $496 million of debt. Cash flow from operations was $153 million for the fourth quarter and $470 million for the fiscal year. During the quarter, the company spent $128 million to repurchase about 1.5 million shares of common stock.

Oncology Systems

Oncology Systems’ fourth quarter revenues totaled $633 million, up 2 percent from the same quarter of fiscal year 2014 and up 9 percent in constant currency. Annual revenues were $2.3 billion, even with the prior fiscal year, and up 6 percent in constant currency.

Fourth-quarter gross orders were $919 million, equal to the year-ago quarter and up 5 percent in constant currency. In the Americas, fourth quarter Oncology gross orders declined by 5 percent in dollars and constant currency. In EMEA, gross orders were up 13 percent in dollars and up 25 percent in constant currency. In APAC, gross orders declined by 3 percent in dollars but rose 6 percent in constant currency. Annual Oncology gross orders were $2.7 billion, even with fiscal year 2014 and up 6 percent in constant currency. In the Americas, annual gross orders were up 1 percent in dollars and constant currency. In EMEA gross orders were flat in dollars but up 12 percent in constant currency. In APAC, order growth was also flat in dollars but up 9 percent in constant currency.

"Oncology gross orders were strong in EMEA during the quarter when we booked orders for over 100 systems," said Wilson. "North American orders grew by 4 percent in the quarter driven by customers continuing to upgrade to newer technologies, replacements of competitors’ products, and increased software sales. We believe we gained share in constant currency in all regions."

Imaging Components

Imaging Components revenues were $155 million for the fourth quarter, down 8 percent from the year-ago period, and $611 million for the fiscal year, down 7 percent from fiscal year 2014. Gross orders were $165 million for the fourth quarter, down 30 percent from the year-ago period, and totaled $605 million for the fiscal year, down 16 percent from fiscal year 2014.

"Price erosion in response to aggressive euro- and yen-based competitors was the principal cause of the decline in orders and revenues for panels and tubes in our Imaging Components business," said Wilson. "Gross orders for security products were down $63 million or 57 percent for the fiscal year, and annual revenues fell by $34 million or 37 percent, due largely to instability in key international markets. The company has initiated a restructuring program to right-size the Imaging Components business and to get it back on a growth track."

During the fourth quarter of fiscal year 2015, the company paid approximately €52 million in cash to acquire Claymount Investments B.V., a privately-held, Netherlands-based supplier of components and subsystems for X-ray imaging equipment manufacturers.

Other

The company’s Other category, including the Varian Particle Therapy business and the Ginzton Technology Center, recorded revenues of $30 million for the fourth quarter and $144 million for fiscal year 2015. It generated gross orders of $141 million in the quarter and $317 million for the fiscal year. During the quarter, the Particle Therapy business booked orders for three proton therapy centers, comprising two in the UK and one in New York. "It is gratifying to see growing global market demand for Varian’s proton therapy systems," said Wilson. "We are gaining momentum in this important clinical space."

Outlook

"We believe that for fiscal year 2016 total company non-GAAP earnings will be in the range of $4.45 to $4.55 per diluted share and revenues will increase by about 4 to 5 percent on a reported basis," said Wilson. "For the first quarter of fiscal year 2016, we expect revenues to be roughly even with the year-ago quarter in dollars. With ongoing challenges experienced by Imaging Components in the second half of fiscal year 2015 as well as the effect of year-over-year changes in currency exchange rates, we expect non-GAAP earnings for the first quarter of fiscal year 2016 to be in the range of $0.88 to $0.92 per diluted share."

Non-GAAP Items

Beginning this quarter, the company is reporting non-GAAP operating earnings, non-GAAP net earnings and non-GAAP diluted earnings per share to provide comparisons against prior periods excluding certain items that may not be indicative of its core operating results and business outlook, allow better comparability among company peers, and provide additional transparency. Non-GAAP operating earnings and non-GAAP net earnings exclude the following items that are included under GAAP: amortization of intangible assets, acquisition-related expenses and or benefits, restructuring charges, impairment charges, significant litigation charges or benefits and associated legal costs. From time to time, the company may exclude other items if it is consistent with the goal of providing useful information to investors. Tax effects on non-GAAP items are calculated based on the company’s effective tax rate other than when the underlying item has a materially different tax treatment. Additional details and a table reconciling the GAAP to non-GAAP financial measures are included in this release.

On October 28, 2015 Cellectis (Paris:ALCLS) (NASDAQ:CLLS) (Alternext: ALCLS – Nasdaq: CLLS) reported that a series of three production runs of UCART19, its lead TALEN gene edited product candidate, was performed, confirming the implementation of Cellectis’ manufacturing process in GMP conditions (Filing, 6-K, Cellectis, OCT 28, 2015, View Source [SID:1234507825]).

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The manufacturing process for Cellectis’ allogeneic CAR T-cell product line, Universal CARTs or UCARTs, yields frozen, off-the-shelf, allogeneic, engineered CAR T-cells. UCARTs are meant to be readily available CAR T-cells for a large patient population. The TALEN-based gene editing (knock-out of the TCR-alpha and CD52 genes) is designed to suppress T-cell alloreactivity and confer resistance to alemtuzumab to the T-cells. This important milestone shows that UCARTs can be manufactured in GMP conditions. It also demonstrates the industrial production of UCART19, as well as the capacity of Cellectis’ pipeline of UCART product candidates to be manufactured for clinical investigations.

"It is very exciting to lead a novel allogeneic gene therapy platform at the critical time when a R&D concept is translated into a GMP clinical grade industrial product to be investigated in clinical studies," said Arjan Roozen, Vice President, GMP Solutions and Manufacturing.

"Cellectis has reached a critical milestone both for the Company and our industry, creating new opportunities for patients. Historically, cell-based therapies have grown in the world of individual grafts. With TALEN-based gene editing they have now started moving toward that of industrial pharmaceutical products broadly available to patients, and Cellectis, as a leading company in the field of gene editing, is at the forefront of this evolution," added David J.D. Sourdive, Executive Vice President, Corporate Development.

About UCART19

UCART19 is a potential best-in-class allogeneic engineered T-cell product for treatment of CD19 expressing hematologic malignancies, initially developed in Chronic lymphocytic leukemia (CLL) and Acute lymphoblastic leukemia (ALL). Servier has an option under the collaboration agreement to acquire the exclusive rights to further develop and commercialize UCART19. Engineered allogeneic CD19 T-cells currently stand out as a real therapeutic innovation for treating various types of leukemia and lymphoma. Cellectis’ approach with UCART19 is based on the preliminary positive results from clinical trials using products based on the CAR technology and has the potential to overcome the limitation of the autologous current approach by providing an allogeneic frozen, "off-the-shelf" T-cell based medicinal product.

Arjan Roozen, Vice President GMP Solutions and Manufacturing

Arjan Roozen received a BSc degree in molecular microbiology from Larenstein, Velp in The Netherlands. Arjan joined Cellectis in March 2015. In his present position of VP GMP Solutions & Manufacturing, he is responsible for all GMP pharmaceutical manufacturing activities including the biological raw materials.

Before joining Cellectis, Arjan worked for over 20 years at different biotechnology departments at Centocor, Solvay Pharmaceuticals, Biogen Idec, Crucell, Proxy laboratories and Pharmacell and gained significant experience in QC, QA and manufacturing GMP aspects. The last 4 years within Pharmacell, Arjan Roozen was responsible for GMP operations involved in significant number of cell therapy technology transfer projects as well as responsible for cell therapy commercial products. He was also involved in regulatory audit and filings for EMA and FDA.