On May 12, 2016 Varian Medical Systems (NYSE: VAR), leader in radiotherapy systems and software for the treatment of cancer, reporte that they have been selected by The Christie NHS Foundation Trust to provide Eclipse treatment planning software for the proton center currently under construction at the Manchester hospital (Press release, Varian Medical Systems, MAY 12, 2016, View Source [SID:1234512336]). Varian is already supplying treatment equipment for the two UK national proton centers being constructed at The Christie and at University College Hospital in London.

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"We selected Varian as the proton treatment planning software provider because of the technical excellence and strong connectivity of its systems, together with the fact that Varian is a well-established and reliable supplier of cancer treatment equipment and software," said Matthew Clarke, The Christie’s lead physicist for proton treatment planning. "The ability of the Eclipse system to enable robust optimization of treatment plans as well as truly adaptive planning based on images taken during the treatment were instrumental in our decision."

"The unrivalled connectivity of Varian’s software means everything is stored in one location and can be accessed across the site – there’s no need to keep importing and exporting information," added Matthew Clarke. "It means we can have a truly paperless department with overall workflow that is much more efficient than would be the case with independent systems. We are working closely with Varian to build a system that entirely meets our needs."

Steve Laws, Varian’s VP of software sales in EMEIA, said, "Varian is proud to have been selected to provide advanced treatment planning software for this major new facility. This decision recognizes our long-term commitment to the proton therapy market and our ability to offer a level of compatibility and technical excellence that no other oncology software provider can match."

The Christie NHS Foundation Trust has ordered 12 proton treatment planning licenses as well as three licenses for conventional radiotherapy planning. It is also expanding its current ARIA oncology information management network and adding Varian’s Velocity system, which offers large-scale archival image storage and management and serves as a centralized repository for all diagnostic, planning and delivery information. The site will also be the first UK adoption of Varian’s new FullScale virtualized platform which aids efficiency for a center’s IT, administrative and clinical staff.

Although patient treatments are not due to commence at The Christie Proton Center until the summer of 2018, the Eclipse system will be delivered considerably earlier as proton physicists intend to use the system to do parallel plans for patients who are currently sent to the U.S. for proton treatments. "These parallel plans will greatly increase our experience in proton planning using Eclipse," added Matthew Clarke.

On May 12, 2016 Sanofi reported that it has filed for premerger notification under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR) with the U.S. Department of Justice Antitrust Division and the Federal Trade Commission regarding its intention to acquire Medivation, Inc (Press release, Sanofi, MAY 12, 2016, View Source [SID:1234512334]). (NASDAQ: MDVN). As announced on April 28, 2016, Sanofi proposed to acquire Medivation for $52.50 per share, representing an all-cash transaction valued at approximately $9.3 billion.

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On May 12, 2016 OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) reported ts first quarter 2016 financial results and provided a summary of anticipated milestones (Press release, OncoGenex Pharmaceuticals, MAY 12, 2016, View Source [SID:1234512331]).

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Financial Results and Anticipated Near-term Milestones

As of March 31, 2016, the company’s cash, cash equivalents, and short-term investments were $46.1 million compared with $55.2 million as of December 31, 2015.

Based on current expectations, OncoGenex believes that its cash, cash equivalents, and short-term investments will be sufficient to fund its currently planned operations into the third quarter of 2017. Depending on timing of enrollment or event-driven final analyses, the expected key milestones and activities are as follows:

Custirsen
Announcing results from the AFFINITY trial, the phase 3 trial evaluating a survival benefit for custirsen in combination with cabazitaxel as second-line chemotherapy in approximately 630 patients with castrate-resistant prostate cancer. The final analysis for the intent-to-treat population is expected in the third quarter of 2016.
Announcing results from the ENSPIRIT trial, the phase 3 trial evaluating a survival benefit for custirsen in combination with docetaxel as second-line chemotherapy in approximately 700 patients with non-small cell lung cancer. The final survival analysis is expected in the first half of 2017.
Apatorsen
Announcing results from the Borealis-2 trial, an investigator-sponsored, randomized phase 2 trial evaluating apatorsen in combination with docetaxel treatment compared to docetaxel treatment alone in patients with advanced or metastatic bladder cancer. Final results are expected in the second half of 2016.
Announcing survival results from the Spruce trial, the investigator-sponsored, randomized, placebo-controlled phase 2 trial evaluating apatorsen treatment with carboplatin and pemetrexed chemotherapy in patients with previously untreated advanced non-squamous NSCLC. Overall survival results, including evaluation of patients with high baseline serum Hsp27 levels, are expected in the second half of 2016.
Completing a submission-ready investigational new drug application regarding apatorsen via intravesical administration in combination with Bacillus Calmette-Guerin (BCG) treatment in patients with non-muscle invasive bladder cancer.
Revenue for the three months ended March 31, 2016 and 2015 was $2.9 million and $1.4 million, respectively. The increased revenue in 2016 as compared to 2015 was due to higher collaboration revenue recognized on the deferred revenue as a result of higher ENSPIRIT costs. This was partially offset by a decrease in collaboration revenue recognized for the AFFINITY trial as a result of a decrease in associated clinical activities.

Total operating expenses for the three months ended March 31, 2016 and 2015 were $7.4 million and $6.4 million, respectively. Net loss for the three months ended March 31, 2016 and 2015 was $3.7 million and $4.5 million, respectively.

As of May 12, 2016 OncoGenex had 29,914,226 shares outstanding.

On May 12, 2016 ImmunoCellular Therapeutics, Ltd. ("ImmunoCellular") (NYSE MKT: IMUC) reported financial results for the first quarter of 2016 (Press release, ImmunoCellular Therapeutics, MAY 12, 2016, View Source [SID:1234512328]).

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Andrew Gengos, ImmunoCellular Chief Executive Officer, commented: "We continue to make progress in all aspects of implementing our ICT-107 registration trial in patients with newly diagnosed glioblastoma. Over half of the targeted clinical sites in the US have been activated and are screening patients. We anticipate that all sites in the US can be activated by the middle of 2016. In Europe, the process of gaining regulatory approval for the trial and bringing clinical trial sites online is going very well. Clinical trial applications have been approved by the regulatory authorities in the Netherlands and the UK, and we are involved in interactions with the six other country authorities where the trial will be conducted. We also have received regulatory approval to start the trial in Canada. We expect to manufacture clinical supplies for the first qualifying patients in Canada and Europe in the third quarter. As the competitive landscape in newly diagnosed glioblastoma evolves, we continue to think that our phase 3 registration program, with the strong foundational support of placebo-controlled phase 2 data, is the best designed program underway in this indication. We are pleased with the progress we made in the first quarter, and believe that 2016 will be a year of accomplishment and value creation for our company."

For the quarter ended March 31, 2016, ImmunoCellular incurred a net loss of $5.6 million, or $0.06 per basic and diluted share, compared to a net loss of $1.4 million, or $0.02 per basic and diluted share, for the quarter ended March 31, 2015.

During the first quarter 2016, the Company incurred $4.7 million of research and development expenses compared to $2.1 million in the prior year quarter while general and administrative expenses remained relatively constant between periods. The $2.6 million increase in research and development expenses primarily reflects the additional expenses associated with the phase 3 trial of ICT-107. During the first quarter of 2016, the Company recorded a credit to other income of $500,000 related to reflect a write-down of the Company’s warrant liability, compared to a credit to other income of $1.8 million during the same period in 2015.

The Company also reported that cash used in operations in the first quarter of 2016 was $5.4 million compared to $3.0 million in the prior year quarter. The increase primarily reflects that additional research and development expenditures in the current year. As of March 31, 2016, the Company had $17.5 million in cash.

On May 12, 2016 Argos Therapeutics, Inc. (Nasdaq:ARGS), an immuno-oncology company focused on the development and commercialization of individualized immunotherapies for the treatment of cancer based on the Arcelis technology platform, reported financial results for the first quarter ended March 31, 2016 and provided an update on the Company’s clinical programs (Press release, Argos Therapeutics, MAY 12, 2016, View Source [SID:1234512326]).

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"We have gotten off to a strong start in 2016. In the first quarter, we were able to accomplish a number of critical activities," said Jeff Abbey, president and chief executive officer. "The most significant of these was securing a financing agreement for up to $60 million. This financing, if fully funded, would provide us with funding for our operations into the second quarter of 2017, which is when we anticipate having a sufficient number of events to permit the primary analysis and assessment of overall survival to occur from the Phase 3 ADAPT trial of our lead product, AGS-003, in metastatic renal cell carcinoma. We look forward to the upcoming review of ADAPT trial data at the meeting of the Independent Data Monitoring Committee (IDMC) in June."

"Also, during the quarter, Dr. Lee Allen joined Argos as our chief medical officer. His experience and guidance have already made an impact on the development of AGS-003, including, in particular, with our preparation for the submission of our Biologics License Application (BLA) that would follow completion of the ADAPT trial, in addition to helping facilitate investigator-initiated trials of AGS-003," Mr. Abbey continued. "Lastly, and to that end, we announced that an investigator-initiated trial of AGS-003 in non-small cell lung cancer opened for enrollment during the quarter. We are excited for this first trial of AGS-003 outside of kidney cancer as we explore the potential activity of this novel immunotherapy in other solid tumors. These developments are all meaningful stepping stones as we continue on the pathway to achieving our goal of becoming a fully-integrated commercial biotechnology company."

First Quarter 2016 Operational Highlights:

In January 2016, Dr. Lee F. Allen joined the Company as chief medical officer
In March 2016, the Company entered into an equity financing agreement for up to $60 million
Will take place in up to three tranches: approximately $20 million in March 2016, approximately $30 million subject to and following the June 2016 IDMC meeting and a company controlled option for up to an additional $10 million subject to and following the late 2016 IDMC meeting
In March 2016, investigator-initiated Phase 2 study of AGS-003 in non-small cell lung cancer opened for enrollment at the Cancer Research Network of Nebraska (CRNN)
Selected First Quarter 2016 Financial Results

Net loss for the three months ended March 31, 2016 was $12.8 million, or $0.57 per share, compared to a net loss of $17.5 million, or $0.89 per share, for the same period in 2015.

Revenue for the three months ended March 31, 2016 totaled $0.1 million compared to $0.2 million for the same period in 2015.

Research and development expenses for the three months ended March 31, 2016 totaled $9.5 million compared to $14.8 million for the same period in 2015. General and administrative expenses for the three months ended March 31, 2016 totaled $3.0 million compared to $2.4 million for the same period in 2015.

As of March 31, 2016, Argos’ cash, cash equivalents and short-term investments totaled $13.8 million compared to $7.2 million as of December 31, 2015.

Conference Call and Webcast Details

Argos executive management will host a conference call beginning at 4:30 p.m. Eastern Time today to discuss these results and to answer questions.

To participate by telephone, please dial (855) 433-0930 (Domestic) or (484) 756-4271 (International). The conference ID number is 7392695. A live and archived audio webcast can be accessed through the Investors section of the Company’s website at www.argostherapeutics.com. The archived webcast will remain available on the Company’s website for twelve (12) months following the call.

About the Arcelis Technology Platform
Arcelis is a precision immunotherapy technology that captures mutated and variant antigens that are specific to each patient’s disease. It is designed to overcome immunosuppression by producing a durable memory T-cell response without adjuvants that may be associated with toxicity. The technology is potentially applicable to a wide range of different cancers, and is designed to overcome many of the manufacturing and commercialization challenges that have impeded other personalized cancer immunotherapies. The Arcelis process uses only a small tumor or blood sample and the patient’s own dendritic cells, which are optimized from cells collected by a single leukapheresis procedure. The proprietary process uses RNA isolated from the patient’s disease sample to program dendritic cells to target disease specific antigens. The activated, antigen-loaded dendritic cells are then formulated with the patient’s plasma and administered via intradermal injection.