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Novartis focuses Pharmaceuticals Division by creating two business units, Novartis Pharmaceuticals and Novartis Oncology; appoints leaders to the Executive Committee of Novartis

On May 17, 2016 Novartis reported changes to focus its Pharmaceuticals Division by creating two business units reporting to the CEO: Novartis Pharmaceuticals and Novartis Oncology (Press release, Novartis, MAY 17, 2016, View Source [SID:1234512486]).

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These business units will form the Innovative Medicines Division at Novartis. The leader of each business will join the Executive Committee of Novartis (ECN) effective July 1, 2016. Paul Hudson will be appointed CEO, Novartis Pharmaceuticals and Bruno Strigini will become CEO, Novartis Oncology. Both will report directly to Joseph Jimenez, CEO of Novartis. With these changes, David Epstein, currently Division Head and CEO, Novartis Pharmaceuticals, has decided to leave Novartis.

The new structure reflects the importance of oncology to Novartis following the successful integration of the oncology assets acquired from GSK. Novartis expects this change to help drive our growth and innovation strategy, with an increased focus and improved execution for both the Novartis Oncology and Novartis Pharmaceuticals business units.

Paul Hudson, currently Executive Vice President, North America and member of the Executive Committee, AstraZeneca, will join Novartis and lead Novartis Pharmaceuticals. Prior to his role in North America, Paul Hudson served as the leader of AstraZeneca’s Japanese business. Novartis Pharmaceuticals will include the franchises Neuroscience, Ophthalmology, Immunology and Dermatology, Respiratory, Cardio-Metabolic and Established Medicines. Mr. Hudson has broad pharmaceutical industry experience and in particular in cardiovascular and immunology, which complement Novartis’ major product launches. He will be based at the global headquarters of the Innovative Medicines Division and the Novartis Pharmaceuticals business unit, which will be in Basel, Switzerland.

Bruno Strigini, currently Head of Novartis Oncology, will lead the Novartis Oncology business unit, comprised of the franchises Oncology and Cell and Gene Therapies. Mr. Strigini joined Novartis in 2014 from Merck & Co. to lead the oncology business and was instrumental in the successful integration of the oncology assets acquired from GSK. He will be based at the global headquarters of the Innovative Medicines Division and the Novartis Oncology business unit which will be in Basel, Switzerland.

David Epstein, currently Division Head and CEO of Novartis Pharmaceuticals, has decided to leave Novartis and explore new challenges from the US. "We would like to thank David for his substantial contribution to the development and growth of Novartis and its people over many years. He built our leading Oncology business and over the last six years has steered our Pharmaceuticals Division through a period of excellence in innovation, execution and improved financial results. Over the course of his career he and his teams have been responsible for leading the development and commercialization of an industry leading number of new medicines including groundbreaking therapies such as Glivec, Gilenya, Cosentyx and Entresto(TM). I want to express my personal appreciation for all David has done for Novartis and patients and wish him continued success," said Joe Jimenez, CEO of Novartis.

From July 1, 2016 Novartis will continue to have three focused, customer-facing divisions: Innovative Medicines (formerly the Novartis Pharmaceuticals division), which will include the Novartis Pharmaceuticals and Novartis Oncology business units; Sandoz, the generics and biosimilar division, which includes the Retail Generics, Anti-Infectives and Biopharmaceuticals franchises; and Alcon, the eye care devices division, which includes the Surgical and Vision Care franchises. The divisions will be supported by Novartis Institutes for BioMedical Research, Global Drug Development and Novartis Operations, which includes Technical Operations and Novartis Business Services.

NantKwest Provides Update on Clinical Programs at Bank of America Healthcare Conference Multiple Immunotherapy Combinations Announced as Part of Cancer Moonshot 2020 Initiative

On May 17, 2016 NantKwest Inc. (Nasdaq:NK), a pioneering, next generation, clinical-stage immunotherapy company focused on harnessing the unique power of our immune system using natural killer (NK) cells to treat cancer, infectious diseases and inflammatory diseases, reported an update today on the company’s aNK, haNK and taNK clinical programs in a presentation at the Bank of America Merrill Lynch 2016 Health Care Conference in Las Vegas, Nevada (Press release, NantKwest, MAY 17, 2016, http://ir.nantkwest.com/phoenix.zhtml?c=254059&p=RssLanding&cat=news&id=2168882 [SID:1234512456]).

As part of that presentation, additional details were shared on the following highlighted clinical studies all expected to be initiated in the second half of 2016:

The aNK Phase II clinical study in Merkel cell carcinoma is advancing as planned with an interim data analysis planned for the second half of 2016.
A HER2.taNK Phase I/II clinical study in glioblastoma and breast cancer
A haNK Phase I/II clinical study in breast cancer in combination with trastuzumab (Herceptin)
A haNK Phase I/II clinical study in breast cancer combination with trastuzumab and an adenovirus-based HER2 vaccine
A haNK Phase I/II clinical study in gastric cancer in combination trastuzumab and AMG337, an oral, small molecule MET inhibitor
A haNK Phase I/II clinical study in Ewing’s sarcoma in combination with ganitumab, a human monoclonal antibody against type 1 insulin-like growth factor receptor (IGF1R)
A haNK Phase I/II clinical study in rhabdomyosarcoma in combination with ganitumab and dasatinib
A haNK Phase I/II clinical study in bladder cancer in combination with ALT-803, a novel IL-15 based immune system stimulating agent
Commenting on NantKwest’s clinical progress, Patrick Soon-Shiong, MD, Chairman and CEO remarked, "The complex biology of cancer requires a similarly complex war against cancer that will require combination immunotherapy. We believe NantKwest’s novel, off-the-shelf natural killer cell therapy represents a critical backbone that enables the up regulation of both the innate immune system and the adaptive immune system to begin to successfully fight the war against cancer."

Dr. Soon-Shiong continued, "I am also pleased to announce that with the proceeds from our IPO, the company has rapidly expanded its manufacturing capabilities and with the infrastructure now in place, we are now ready to translate these programs into human clinical studies over the next 6-12 months and look forward to sharing more details on these individual clinical trials over the next few months."

To listen to the presentation in its entirety, the link to the presentation can be found on the NantKwest website at:

https://www.veracast.com/webcasts/baml/healthcare2016/id95107262726.cfm

in the investor relations section of the NantKwest website.

10-Q – Quarterly report [Sections 13 or 15(d)]

Oncbiomune has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, OncBioMune Pharmaceuticals, 2017, MAY 16, 2016, View Source [SID1234522122]).

8-K – Current report

On May 16, 2016 Diffusion Pharmaceuticals Inc. (OTCQX: DFFN), a clinical stage biotechnology company focused on the development of novel small molecule therapeutics for cancer, reported financial results for the first quarter ended March 31, 2016 and provided an overview of recent corporate highlights (Filing, Q1, RestorGenex, 2016, MAY 16, 2016, View Source [SID:1234512489]). The quarterly results will be filed shortly on Form 10-Q with the SEC.

David Kalergis, Chairman and Chief Executive Officer of Diffusion, said, "We are pleased with the direction that we are heading following the merger with RestorGenex Corporation. We are continuing to expand our team and welcomed Tom Byrne as General Counsel. We also continue to advance our plan to expand the clinical development pipeline for TSC from GBM to first line pancreatic cancer."

Corporate Highlights

In January 2016, Diffusion Pharmaceuticals LLC completed a reverse merger with RestorGenex Corporation in an all-stock transaction. Following the close of the reverse merger, RestorGenex was renamed Diffusion Pharmaceuticals Inc. and its ticker symbol was changed to "DFFN".

In April 2016, Thomas Byrne joined Diffusion as General Counsel and transitioned from his prior positon on the Board of Directors. Mr. Byrne is continuing to oversee Diffusion’s intellectual property strategy, which he has directed since Diffusion was founded in 2001.

First Quarter 2016 Results

Research and development expenses were $2.4 million for the quarter ended March 31, 2016, compared to $732,000 for the quarter ended March 31, 2015. This increase was primarily a result of an increase in drug manufacturing costs and initiating the TSC pancreatic cancer program.

General and administrative expenses were $3.9 million for the quarter ended March 31, 2016, compared to $459,000 for the quarter ended March 31, 2015. The increase was attributed to costs associated with the merger and operating as a public company, including corporate insurance, professional fees and financial reporting fees.

Net loss was $6.2 million for the quarter ended March 31, 2016, compared to a net loss of $1.2 million for the quarter ended March 31, 2015. The increase in the net loss was due primarily to higher expenses associated with the increased research and development expenses, and general and administrative expenses summarized above.

Cash and cash equivalents were $5.9 million for the quarter ended March 31, 2016, compared to $2.0 million for quarter ended March 31, 2015.

8-K – Current report

On May 16, 2016 Sophiris Bio Inc. (NASDAQ: SPHS) (the "Company" or "Sophiris"), a biopharmaceutical company developing topsalysin (PRX302) for the treatment of urological diseases, reported financial results for the three months ended March 31, 2016 (Filing, Q1, Sophiris Bio, 2016, MAY 16, 2016, View Source [SID:1234512460]).

Business Highlights:

● On May 12, 2016, the Company announced the engagement Oppenheimer & Co. Inc. as its financial advisor to assist with the evaluation of various strategic alternatives.

● On May 11, 2016, the Company announced the closing of a public offering of common shares and warrants in which the Company raised net proceeds of $4.6 million.

● On May 7, 2016, the Company presented positive data from its Phase 3 clinical trial of topsalysin as a treatment for the symptoms of benign prostatic hyperplasia ("BPH") as a late breaking poster at the 111th American Urological Association Annual Meeting. A copy of the poster is available on the Company’s website at www.sophirisbio.com.

● On January 28, 2016, the Company announced that a review of the 6-month biopsy data from the first seven patients in the localized prostate cancer trial was completed.

"We are encouraged by the interim data from our Phase 2a topsalysin proof of concept trial for the treatment of localized prostate cancer announced earlier this year, and remain on track to complete this clinical trial by the end of this quarter," stated Randall Woods, president and CEO of Sophiris Bio. "We believe that the positive data from our Phase 3 BPH clinical trial and the encouraging initial data from our localized prostate cancer clinical trial further de-risk the development programs."

Mr. Woods added: "The funds raised in the financing strengthen our balance sheet as we review various strategic alternatives to advance the clinical development of topsalysin and create value for shareholders."

Phase 2a Proof of Concept Clinical Trial for Localized Prostate Cancer:

In May 2015 we initiated a single-center, open-label Phase 2a proof of concept clinical trial ("POC trial") of topsalysin for the treatment of localized low to intermediate risk prostate cancer. We believe that the highly targeted mechanism by which topsalysin selectively destroys prostate tissue in BPH makes topsalysin a potential targeted focal treatment for localized prostate cancer. A total of 18 patients with clinically significant, localized low to intermediate risk prostate cancer have been enrolled in this ongoing POC trial.

On January 28, 2016 we announced the biopsy data at six months on the first seven patients to complete the POC trial. A review of the biopsy data from the first seven patients showed that four patients experienced a response to treatment, including: one patient who experienced complete ablation of the tumor where there was no evidence of the treated tumor on a targeted biopsy at six months following treatment; and three patients who experienced either a reduction in the maximum cancer core length or a reduction in the Gleason pattern. Three patients had no response to treatment. No serious adverse events have been observed to date in this clinical trial and no new safety signals have been reported. We expect to have final data on all 18 patients by the end of the second quarter of 2016.

Financial Results:

At March 31, 2016, we had cash, cash equivalents and securities available-for-sale of $5.4 million and net working capital of $3.0 million. Taking into consideration the net proceeds of $4.6 million from our financing completed on May 11, 2016, we now expect that our cash, cash equivalents and securities available-for-sale will be sufficient to fund our operations for at least the next twelve months assuming that we do not initiate any additional clinical development of topsalysin beyond our on-going Phase 2a POC trial. We will need to obtain additional capital to fund a second Phase 3 clinical trial of topsalysin for the treatment of the symptoms of BPH and for any future clinical development of topsalysin for the treatment of localized prostate cancer and to fund our ongoing operations. We are actively evaluating strategic alternatives, including potential partnering arrangements, financings or a strategic transaction. We expect our research and development expense and general and administrative expenses to decrease as a result of the completion of our Phase 2a POC trial at the end of the second quarter of 2016 and as a result of the layoff of five of our ten employees during May 2016, resulting in an annualized reduction in compensation and benefit expenses of $0.9 million, net of severance. As of March 31, 2016, the outstanding principal balance of our term loan was $4.8 million on which we make principal and interest payments monthly.

The Company reported a net loss of $2.2 million ($0.13 per share) for the three months ended March 31, 2016 compared to a net loss of $4.3 million ($0.26 per share) for the three months ended March 31, 2015.

Research and development expenses

Research and development expenses were $0.9 million for the three months ended March 31, 2016 compared to $3.1 million for the three months ended March 31, 2015. The decrease in research and development costs is attributable to decreases in the costs associated with the Company’s completed Phase 3 PLUS-1 clinical trial of topsalysin, costs associated with the manufacturing activities for topsalysin and personnel related costs. These decreases are partially offset by an increase in costs associated with the Phase 2a POC trial for localized low to intermediate risk prostate cancer which enrolled its first patient in the second quarter of 2015.

General and administrative expenses

General and administrative expenses were $1.2 million for the three months ended March 31, 2016 compared to $1.0 million for the three months ended March 31, 2015. The increase is primarily due to increases in legal, accounting and professional services costs.