On September 20, 2016 Varian Medical Systems (NYSE: VAR) reported it will be exhibiting and demonstrating its latest radiotherapy and radiosurgery treatment, care coordination and analytics technologies and software September 25-27 in Boston, MA at the 2016 American Society for Radiation Oncology (ASTRO) Annual Meeting, booth 5063 (Press release, Varian Medical Systems, SEP 20, 2016, View Source [SID:SID1234515257]). The company also will be hosting its users meeting on Saturday, September 24 prior to the ASTRO meeting.

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Some of the Varian solutions highlighted in booth demonstrations will include:

InSightive 1.2 analytics solution which now supports both radiation and medical oncology data analytics for more informed decision making in the clinic
A new cloud-based software platform to make multi-disciplinary oncology care coordination simpler and smarter
High definition radiosurgery technology designed to improve dose conformality with the tumor and simplify dose delivery
ProBeam proton therapy system, the first fully-integrated image-guided IMPT (intensity-modulated proton therapy) solution for adaptive therapy
The Varian users meeting will provide attendees with new insights on the latest Varian technology. User meeting topics include:

Non-coplanar SRS treatment planning
The value of knowledge-based planning
InSightive analytics for streamlining clinical workflow
Velocity software and multi-modality imaging and therapy for enhanced decision-making
Proton therapy
Combination therapy: Radiotherapy and Immunotherapy
Evidenced-based oncology care
A complete user meeting agenda can be viewed at View Source

The Varian exhibit in Booth #5063 at the Boston Convention and Exhibition Center will be open during show hours from 10:00am to 5:00pm Sunday through Tuesday.

On September 20, 2016 Oncology Venture Sweden AB (OV:ST) and Cadila Pharmaceuticals Ltd., Ahmedabad, State of Gujarat, India reported the entering of a co-development agreement to develop the anticancer product LiPlaCis in combination with its Drug Response Predictor – DRP (Press release, Oncology Venture, SEP 20, 2016, View Source;and-its-drug-respo,c2082912 [SID1234561591]). The aim is to evaluate the LiPlaCis efficacy in several different indications and perform a randomized phase 3 trial as corner stone and part of the data package study for marketing approval by the FDA, EMA, CDSCO (Central Drugs Standard Control Organization of India). The mutual goal is to sell or out license the product in combination with its Companion Diagnostic (DRP) when the clinical benefit has been documented. Cadila will perform four (4) phase 2 and one pivotal, randomized phase 3 trial over a period of three years. Initiation of individual studies will be announced separately. Cadila will invest in kind in research and drug development activities in 310 cancer patients and DRP screening of more than 1400 patients. In the consortium of owners now including Cadila Pharmaceuticals, LiPlasome, MPI and Oncology Venture – Oncology Venture owns 29% of the total value of the LiPlaCis project after Phase 3. Cadila has commercialization rights in India, Russia, Africa and South East Asia (ASEAN countries only). Oncology Venture has the commercialization rights in America, Europe and China and RoW. Oncology Venture is responsible for the manufacturing and will provide the product. Estimated costs for product in 2017-2018 is 0,6 MUSD. Cadila will in collaboration with an expert team in Oncology Venture set up a laboratory for the tissue handling in India. The DRP analysis will be paid by Cadila and Oncology Venture will provide the DRP evaluations. When developed, the parties may choose to market themselves in their own territories or out-license or sell to a third party. The potential of LiPlaCis sales in the two major indications alone in breast cancer in USA and EU is in excess of 700 MUSD annually and if successful LiPlaCis would compete in a market which currently has a value in excess of 5 billion USD in lung cancer in Europe and USA.

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Around 310 cancer patients will according to the deal partake in clinical trials at a FDA and EMA quality level.
The agreement is entered between Cadila Pharmaceuticals Ltd. and Oncology Venture ApS which is 100% owned by Oncology Venture Sweden AB. Cadila Pharmaceuticals Ltd. is one of the largest privately held pharmaceutical companies in India.

"Cadila is one of the largest privately held pharma companies in India. The transformational partnership with Cadila places Oncology Venture in another league. Together with Cadila we aim to take LiPlaCis and its Drug Response Predictor – DRP – through a strong and focused development program with the goal of receiving marketing approval. We will together with Cadila who invests heavily as an ‘in kind’ investment test LiPlaCis in four promising indications: breast, head & neck, skin and esophageal cancer which gives the drug a really good chance to benefit patients who are likely to respond," says Peter Buhl Jensen, M.D., CEO of Oncology Venture. "In this partnership OV has the opportunity to build a much larger value instead of selling it outright. Cisplatin is one of the most used drugs in cancer treatment and the potential sales with the improved LiPlaCis formulation is huge," Buhl Jensen further comments.

On this occasion, Dr. Rajiv Modi, Chairman and Managing Director, Cadila Pharmaceuticals Ltd., said, "Cadila Pharmaceuticals believes in providing world-class healthcare products to improve quality of life of patients. This agreement with Oncology Venture is an affirmation of our commitment to develop novel treatment for those diseases in the realm of unmet medical needs. Cancer affects millions of people around the globe. We look forward to developing the product to benefit millions of patients who are affected by the deadly disease."
 
The Partnership deal
The deal with Cadila Pharmaceuticals will finance and perform studies in a total of 310 cancer patients with highest likelihood of sensitivity to LiPlaCis. The deal covers the following:
1. Screening by the use of the LiPlaCis-DRP of 1 250 metastatic breast cancer patients to identify 250 patients with high likelihood to respond to LiPlaCis treatment and perform a randomized phase 3 trial in these 250 patients comparing standard therapy with LiPlaCis.
2. Through Cadilas strong network and Cadilas CRO run four (4) clinical Phase 2 trials in 20 patients (out of 100 screened) with Head & Neck cancer, 20 prostate cancer patients (out of 100 screened), and 10 skin cancer patients and 10 esophagus cancer patients – the two latter indications are in a high frequency sensitive to cisplatin – of which LiPlaCis is an improved formulation – why the patients will not be screened.

Cadila has commercialization rights in India, Russia, Africa and South East Asia (ASEAN countries only), Oncology Venture has the commercialization rights to America, Europe and China and RoW. Oncology Venture will be responsible for the manufacturing and pay for manufacturing of the product. Estimated costs for product in 2017-2018 is 0,6 MUSD. In the consortium of owners now including Cadila Pharmaceuticals, LiPlasome, MPI and Oncology Venture – Oncology Venture owns 29% of the total value of the LiPlaCis project after Phase 3. When developed parties may choose to market themselves in their own territories or out license or sell to a third party.

About the LiPlaCis license from LiPlasome Pharma and the DRP license from MPI
Oncology Venture has in-licensed LiPlaCis from LiPlasome Pharma and the LiPlaCis DRP from MPI and has now entered a development partnership with Cadila Pharma. The financial impact is as follows: In the consortium of owners now including Cadila Pharmaceuticals, LiPlasome, MPI and Oncology Venture – Oncology Venture owns 29% of the total value of the LiPlaCis project after Phase 3.OV pays for the manufacturing of the product. Oncology Venture did not pay any upfront payment to LiPlasome but pays 2×9 MUSD in sales milestones to LiPlasome once LiPlaCis is commercialized either via a partner or sold on the market. (please see latest company prospectus).Cost of clinical trials in oncology all phases per patient 59.500 USD (PhRMA 2013).
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On September 20, 2016 Palatin Technologies, Inc. (NYSE MKT: PTN), a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical need and commercial potential, reported financial results for its fourth quarter and fiscal year ended June 30, 2016 (Filing, Q4/Annual, Palatin Technologies, 2015, SEP 20, 2016, View Source [SID:SID1234515261]).

Significant Highlights
● Bremelanotide – Under development for Hypoactive Sexual Desire Disorder (HSDD):
– Palatin’s two Phase 3 clinical trials for the treatment of HSDD randomized a total of approximately 1,250 women to evaluate efficacy and safety of subcutaneous bremelanotide in premenopausal women with HSDD as an on-demand, as-needed treatment.
– Patient enrollment was completed in the fourth quarter of calendar year 2015.
– Last patient visits for the efficacy portion of the trials were completed in the third quarter of calendar year 2016.
– Topline results are projected to be released early fourth quarter calendar year 2016.
– Issued a key U.S. Patent on May 31, 2016 for methods of treating female sexual dysfunction using the dose and formulation utilized in the Phase 3 trials. The patent expires no earlier than November 2033.
● Financial Transactions:
– August 2016, Palatin closed on an underwritten offering of units with gross proceeds of $9.25 million, with net proceeds, after deducting offering expenses, of approximately $8.5 million. Palatin issued:
■ 11,481,481 shares of common stock and ten-year prefunded Series I warrants to purchase 2,218,045 shares of common stock at an exercise price of $0.01 per share
■ Series H warrants to purchase 10,274,646 shares of common stock at an exercise price of $0.70 per share
– July 2015, Palatin closed on a debt and equity financing with gross proceeds of $30 million, with net proceeds, after deducting offering expenses, of $29.7 million, consisting of:
■ $10 million venture loan, which includes an interest-only payment period for the first eighteen months of a four year secured term loan, and Series G warrants to purchase 549,450 shares of common stock at an exercise price of $0.91 per share
■ $20 million private placement of Series E warrants to purchase 21,917,808 shares of common stock at an exercise price of $0.01 per share and Series F warrants to purchase 2,191,781 shares of common stock at an exercise price of $0.91 per share

● Intellectual Property:
– Issue Notification for U.S. Patent to issue October 4, 2016, with composition of matter claims for a broad group of melanocortin peptides.
– U.S. Patent issued September 20, 2016 with composition of matter claims for a broad family of melanocortin receptor-1 peptides with potential application in inflammatory disease-related and autoimmune indications.

Fourth Quarter and Fiscal Year Ended 2016 Financial Results
Palatin reported a net loss of $(13.4) million, or $(0.09) per basic and diluted share, for the quarter ended June 30, 2016, compared to a net loss of $(12.1) million, or $(0.09) per basic and diluted share, for the same period in 2015. The difference between the three months ended June 30, 2016 and 2015 was primarily attributable to the increase in expenses relating to the Phase 3 clinical trial and development program with bremelanotide for HSDD in the quarter ended June 30, 2016.

For the year ended June 30, 2016, Palatin reported a net loss of $(51.7) million, or $(0.33) per basic and diluted share compared to a net loss of $(17.7) million, or $(0.15) per basic and diluted share for the year ended June 30, 2015. The increase in net loss for the year ended June 30, 2016, compared to the net loss for the year ended June 30, 2015 was primarily attributable to the increase in development costs for the progression of the Phase 3 clinical trials and development of bremelanotide for HSDD and secondarily related to the license and contract revenue recognized in the year ended June 30, 2015.

Revenue
There were no revenues recorded in the quarter or year ended June 30, 2016 or in the quarter ended June 30, 2015. For the year ended June 30, 2015, Palatin recognized $12.9 million of license and contract revenue under the agreement with Gedeon Richter.

Operating Expenses
Operating expenses for the quarter ended June 30, 2016 were $12.7 million, compared to $11.8 million for the comparable quarter of 2015. For the year ended June 30, 2016, Palatin incurred $49.3 million of operating expenses, compared to $30.2 million for the year ended June 30, 2015. The increase in operating expenses for the quarter and the year ended June 30, 2016 was the result of an increase in expenses primarily relating to the Phase 3 clinical trial and development program with bremelanotide for HSDD.

Other Income/Expense
Total other income (expense), net, was $(0.6) million for the quarter ended June 30, 2016, compared to $(0.3) million for the quarter ended June 30, 2015. For the year ended June 30, 2016, total other income (expense), net, was $(2.5) million, compared to $(0.9) million for the year ended June 30, 2015. Total other income (expense) for both fiscal years ended June 30, 2016 and June 30, 2015 primarily consists of interest expense related to the venture debt. The increase in total other income (expense), net, for the year ended June 30, 2016 is due to the additional July 2015 venture debt.

Cash Position
Palatin’s cash, cash equivalents and investments were $9.4 million as of June 30, 2016, compared to cash and cash equivalents of $27.3 million at June 30, 2015. Current liabilities were $14.0 million as of June 30, 2016, compared to $7.4 million as of June 30, 2015.

Palatin believes that existing capital resources, together with approximately $8.5 million received from the August 2016 financing, will be adequate to fund our planned operations through the quarter ending December 31, 2016. Assuming the double blind efficacy portion of the Phase 3 clinical trial of bremelanotide for HSDD is successful, as to which there can be no assurance, we will need additional funding to complete required ancillary studies and clinical trials, prepare and submit regulatory filings for product approval, and establish commercial scale manufacturing capability.

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On September 19, 2016 Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel immuno-oncology therapies, reported that it will present preclinical data, and preliminary biomarker data from its ongoing Phase 1/1b study of CPI-444 as a single agent, and in combination with Genentech’s TECENTRIQ (atezolizumab)‎, in both oral and poster presentations at the Second CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper): Translating Science into Survival, which is taking place from September 25-28 in New York (Press release, Corvus Pharmaceuticals, SEP 19, 2016, View Source;p=RssLanding&cat=news&id=2204373 [SID:SID1234515202]).

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Following are details of the oral and poster presentations.

ABSTRACT TITLE: CPI-444: A potent and selective inhibitor of A2AR induces antitumor responses alone and in combination with anti-PD-L1 in preclinical and clinical studies
PRESENTER: Stephen Willingham, Ph.D., senior scientist, Corvus
ORAL SESSION: Plenary Session 2: New Checkpoints
ORAL SESSION DATE, TIME AND LOCATION: Sunday, September 25, 1:30-4:40 p.m. ET, Sheraton Metropolitan Ballroom, Sheraton New York Times Square Hotel
POSTER SESSION: Poster Session A: New Checkpoints
POSTER NUMBER: A048
POSTER PRESENTATION DATE, TIME AND LOCATION: Sunday, September 25, 5:00-7:30 p.m. ET, Americas Hall I, New York Hilton Midtown

On September 19, 2016 Delcath Systems, Inc. (NASDAQ: DCTH), an interventional oncology company focused on treatments for primary and metastatic liver cancers, reported that the company provided a grant to the Ocular Melanoma Foundation (OMF) in support of the organization’s 6th Annual Eye Am Not Alone (EANA) patient education retreat, held in Miami, Florida at the Bascom Palmer Eye Institute on September 9-11, 2016 (Press release, Delcath Systems, SEP 19, 2016, View Source;p=RssLanding&cat=news&id=2204432 [SID:SID1234515223]). Delcath supported a lecture by Jonathan Zager, M.D., FACS, Professor of Surgery in the Cutaneous Oncology and Sarcoma Departments and a Senior Member at Moffitt Cancer Center, and principal investigator for the Company’s FOCUS Phase 3 Clinical Trial for Patients with Hepatic Dominant Ocular Melanoma (the FOCUS Trial).

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The EANA is an annual conference and patient education seminar organized by the OMF and hosted by some of the leading research institutions working on treatments for ocular melanoma. The EANA retreat offers patients and caregivers opportunities to learn about treatment options, clinical trials and other resources available to them as they contend with this difficult to treat cancer.

"Patient advocacy organizations like the OMF are vital sources of support for patients facing an ocular melanoma diagnosis," said Jennifer K. Simpson, Ph.D., MSN, CRNP, President and Chief Executive Officer of Delcath. "We were pleased to sponsor this important conference, and look forward to supporting the mission of the OMF and other patient advocacy organizations working on ocular melanoma in the future."