On May13, 2016 Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT, www.pvct.com), a clinical-stage oncology and dermatology biopharmaceutical company ("Provectus" or "the Company"), reported that an article has been published detailing the immuno-ablative mechanism of action of PV-10, the Company’s novel investigational drug for cancer (Press release, Provectus Pharmaceuticals, MAY 13, 2016, https://www.pvct.com/pressrelease.html?article=20160513.1 [SID:1234512371]).

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The article, titled, "Intralesional Rose Bengal in Melanoma Elicits Tumor Immunity Via Activation of Dendritic Cells by the Release of High Mobility Group Box 1," appears as an advance publication in Oncotarget, an Open-Access journal, and can be accessed by visiting:

View Source

The article documents results of a multi-year, multidisciplinary translational medicine program led jointly by Shari Pilon-Thomas and Amod A. Sarnaik of Moffitt Cancer Center in Tampa, Florida. The authors report detailed data on the mode in which intralesional injection of PV-10 (rose bengal) selectively kills tumor cells and the immunologic signaling that results from tumor ablation, starting with release of High Mobility Group Box 1 (HMGB1, a Damage-Associated Molecular Pattern molecule released by dying cancer cells that can serve as an immunological adjuvant to promote phagocytosis, antigen-presentation, and dendritic cell activation). The authors then follow this signaling through antigen uptake and dendritic cell activation, T cell priming and activation in peripheral blood, and culminating in a tumor-specific immune response marked by T cell infiltration and regression of uninjected tumors.

Eric Wachter, CTO of Provectus, observed, "The Moffitt researchers have systematically documented each of the key steps in the immuno-oncology cycle described by Chen and Mellman in their landmark review article (Oncology Meets Immunology: the Cancer-Immunity Cycle. Immunity 2013; 39: 1-10). In an exemplary demonstration of translational medicine, this team identified important immunologic markers in model systems and verified key facets of these in clinical trial participants, and similarly identified other markers in clinical trial participants and substantiated these in mouse models. While a number of their main observations were previously reported at scientific meetings, these are presented here in detailed, integrated fashion for the first time."

Shari Pilon-Thomas of Moffitt, stated, "Concordance of tumor-specific T cells in peripheral blood of clinical trial participants and mice led us to look for triggers of T cell activation. Working back from these observations, we found that HMGB1 release was common in mouse and man after tumor ablation with PV-10. These results support PV-10 ablation and the resulting tumor necrosis as the upstream trigger for systemic anti-tumor response."

Wachter noted, "This paper is a watershed event in the development of PV-10, walking the reader through all the steps of immune activation after PV-10 injection, from immunogenic cell death and signaling via release of HMGB1, dendritic cell recruitment and infiltration into draining lymph nodes, activation of tumor-specific T cells, and killing of uninjected tumors upon infiltration by these T cells."

Wachter added, "This mechanism of action informed the design of the two active PV-10 clinical trials: NCT02288897 in patients with locally advanced cutaneous melanoma (melanoma limited to the skin) to test the hypothesis that PV-10 alone can produce a systemic immune response that translates to longer progression free survival (PFS); and NCT02557321 in patients with later stage melanoma to test whether combination of PV-10 with the recently approved systemic immunotherapy, pembrolizumab, can ‘induce and boost’ an immune response against melanoma."

On May 13, 2016 SciBase reported the first quarter in figures (Press release, SciBase, MAY 13, 2016, View Source [SID:1234512370]).

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Total net sales amounted to TSEK 1,066 (1,057).
The loss after tax amounted to TSEK 11,600 (9,179).
The loss per share amounted to SEK 1.40 (1.84).
The cash flow from current operations was negative in the amount of TSEK 11,247 (9,197).
Significant margin improvement with gross margin increasing to 26.3% in Q1 (2.6% Q1 15).
Important events during the quarter

SciBase’s PMA application was accepted on January 14th as complete starting the formal evaluation process by the FDA. There has been a high level of interaction between SciBase and the FDA during and continuing after the first quarter.
Continued good growth in key market Germany with total sales up 20% and electrode sales volume up 49%.
SciBase has signed a distribution agreement for Switzerland with CDP SWISS AG. The sales and marketing effort of SciBase’s melanoma detection product Nevisense will initially focus on the nearly 400 dermatologists that work in private clinics in Switzerland.
A change in the Company’s board of directors was communicated as Viktor Dvrota, as a result of his appointment as Head of Investment at Karolinska Development, has resigned from SciBase’s Board of Directors. Alternate director Andreas Pennervall will take his place.
Important events after the end of the period

On April 25th, the Annual Report for 2015 was published.
Apr 1 2015 –
Jan 1 – Mar 31 Mar 31 2016 Jan 1 – Dec 31
THE GROUP 2016 2015 Rolling-12 2015
Net sales, SEK ths 1 066 1 057 4 160 4 151
Gross margin, % 26,3% 2,6% 8,5% 2,5%
Equity/Asset ratio, % 94,4% 73,0% 94,4% 95,1%
Net indebtness, multiple 0,06 0,37 0,06 0,05
Cash equivalents, SEK ths 122 241 17 313 122 241 133 736
Cashflow from operating activities, SEK ths -11 247 -9 197 -48 638 -46 588
Earnings per share (before and after dilution), SEK* -1,40 -1,84 -5,68 -6,01
Shareholder’s equity per share, SEK* 16,19 4,71 17,34 21,09
Average number of shares, 000’* 8 285 4 985 7 735 6 910
Number of shares at closing of period, 000’* 8 285 4 985 8 285 8 285
Share price at end of period, SEK 23,50 - 23,50 31,00
Average number of employees 18 14 15 14
*Adjusted for in May 2015 performed reversed split, 40:1

On May 13, 2016 Novocure (NASDAQ: NVCR) reported that it will present new data at the American Association of Immunologists’ Annual Meeting on May 13-17, 2016, in Seattle showing that Tumor Treating Fields (TTFields) in combination with PD-1 inhibitors led to additive efficacy in the treatment of non-small cell lung cancer (NSCLC) in vivo (Press release, NovoCure Ltd, MAY 13, 2016, View Source [SID:1234512369]). The results presented demonstrate that:
TTFields exhibit treatment duration-dependent intrinsic cytotoxic effects on cancer cells. Longer periods of exposure to TTFields result in significant decreases in cancer cell counts and increases apoptotic events.

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The cellular response to TTFields is characterized by exposure of calreticulin on the cell surface, release of high-mobility group box-1 (HMGB1), and secretion of adenosine triphosphate – all of which are hallmark features of immunogenic cell death that can potentially generate a systemic anticancer immune response.

The combined treatment of TTFields and anti-PD-1 (αPD-1) in an NSCLC in vivo model led to a significant decrease in tumor volume compared to sham controls and to anti-PD-1 alone.

PD-L1, the ligand which binds PD-1 on immune cells, was maximized on the immune cells themselves in the combination treatment.
"Our research indicates that TTFields in combination with PD-1 immunotherapies may be another possible treatment paradigm for solid tumors that should be investigated clinically, particularly for those solid tumors whose standard of care currently includes – or is evolving to include – PD-1 immunotherapies," said Dr. Eilon Kirson, Chief Science Officer and Head of Research and Development at Novocure. "We are excited to learn more about the potential benefits of combining TTFields with PD-1 immunotherapies in a variety of solid tumors."

On May 13, 2016 Trillium Therapeutics Inc. (NASDAQ:TRIL; TSX: TR) a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported a corporate update and reported financial results for the three months ended March 31, 2016 (Press release, Trillium Therapeutics, MAY 13, 2016, View Source [SID:1234512367]).

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"We made significant progress during the first quarter of 2016, positioning our oncology pipeline for long-term growth. Firstly, we advanced our lead CD47 clinical program on schedule, and secondly, we acquired Fluorinov, a preclinical company with a proprietary fluorine-based chemistry platform," said Dr. Niclas Stiernholm, president and chief executive officer of Trillium. "We are intensifying our internal research efforts on the biology of the CD47 pathway in order to understand how to best combine CD47 blockade with other therapies, and to elucidate the potential advantages of using a SIRPaFc fusion protein compared to a CD47-specific antibody. Additionally, key development activities related to the Fluorinov acquisition, involving several of its preclinical programs, are now underway."

Corporate Update

The Phase I dose escalation clinical trial treating patients with advanced hematologic malignancies with TTI-621, an IgG1 SIRPaFc fusion protein targeting CD47, is progressing according to established timelines and an update on the trial is planned for the end of the year.
At the AACR (Free AACR Whitepaper) 2016 Annual Meeting in April, Trillium presented data showing that TTI-621 promotes phagocytosis of lymphoma cells by diverse types of macrophages, including M2 macrophages, which are often implicated in tumor progression.
Following the acquisition of Fluorinov Pharma in January 2016, the company has quickly integrated its staff and operations. Preclinical development plans are currently being finalized.
Trillium has completed its relocation to a larger research and development facility and continues to grow key staff, with specific emphasis on the clinical and regulatory areas. The company has also added external resources in the form of additional legal and intellectual property support, as well as assistance with investor relations and corporate communications.
First Quarter 2016 Financial Results

(Amounts in Canadian dollars)

As of March 31, 2016, Trillium had cash of $65.8 million. During the first quarter, the company used $9.5 million of cash for the acquisition of Fluorinov; $6.0 million for operations; recorded a net foreign exchange loss on cash of $3.6 million; and used $1.8 million for capital purchases related to its new office and laboratory facility.

Net loss for the three months ended March 31, 2016 of $7.2 million compared to a loss of $4.7 million for the three months ended March 31, 2015. The net loss was higher due mainly to a net foreign currency loss of $3.6 million from holding US denominated cash with a weakening US dollar, amortization of $0.7 million on Fluorinov intangible assets and higher research and development spending. This was partially offset by the recognition of a deferred tax recovery in relation to the acquisition of Fluorinov of $3.7 million.

On May 13, 2016 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company dedicated to innovative therapeutics addressing cancer and other unmet medical needs, reported financial results for the three months ended March 31, 2016 (Press release, CASI Pharmaceuticals, MAY 13, 2016, View Source [SID:1234512363]).

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The Company reported a net loss for the first quarter of 2016 of ($1.8 million), or ($0.04) per share, compared with a net loss of ($1.8 million), or ($0.06) per share, for the same period last year. As of March 31, 2016, CASI had cash and cash equivalents of $13.9 million.

Sara B. Capitelli, Vice President, Finance and Principal Accounting Officer, commented, "Our research and development expenses for the first quarter increased over the prior year due to start-up costs and patient enrollment costs associated with our FLC trial in the U.S. Our general and administrative expenses for the first quarter decreased over the prior year due to cost savings associated with business development and investor relations activities. As we continue to execute our clinical development plans in the U.S., Canada and China, we expect operating expenses to increase in 2016."

Dr. Ken Ren, Chief Executive Officer, commented, "We are pleased with our first quarter financial results, which are indicative of the operational efficiencies we have achieved. Our fundamentals remain strong and we believe the outlook for CASI is excellent. In 2016, we look forward to further advancement of ENMD-2076 and our other internal programs, and further progress in our in-licensed programs from Spectrum Pharmaceuticals. With the recent expansion of our business development team, we expect to accelerate our licensing activities and secure further partnerships to expand our pipeline as we move forward to becoming a fully-integrated world-class pharmaceutical company."