PROVECTUS BIOPHARMACEUTICALS ANNOUNCES POSTER PRESENTATION ON
PV-10 AT SOCIETY FOR IMMUNOTHERAPY OF CANCER 2016 ANNUAL MEETING

On November 14, 2016 Provectus Biopharmaceuticals, Inc. (OTCQB: PVCT, www.provectusbio.com), a clinical-stage oncology and dermatology biopharmaceutical company ("Provectus" or the "Company"), reported the presentation of data on PV-10 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2016 Annual Meeting (Press release, Provectus Pharmaceuticals, NOV 14, 2016, View Source [SID1234516603]).

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The abstract for the presented data, titled "Intralesional Injection with Rose Bengal and Systemic Chemotherapy Induces Anti-Tumor Immunity in a Murine Model of Pancreatic Cancer," poster 264, is available at
View Source
Dr. Shari Pilon-Thomas, Associate Member, Department of Immunology, Moffitt Cancer Center, presented the poster on Saturday, November 12, 2016. The published abstract concludes that, in the murine model studied, "Regression of untreated pancreatic tumors by IL injection of PV-10 in concomitant tumor supports the induction of a systemic anti-tumor response. Addition of [Gemcitabine] chemotherapy enhances the effects of IL PV-10 therapy." The presented poster concludes that, "These results may warrant a clinical trial to evaluate the combination of IL PV-10 with gemcitabine in metastatic pancreatic cancer patients."
Eric Wachter, Ph.D., Chief Technology Officer of Provectus, noted, "According to statistics from the American Cancer Society, pancreatic cancer has grown from 33,730 new cases in the U.S. in 2006 to 53,070 new cases expected in 2016. Over the same period, deaths increased from 32,300 to 41,780, and this is now the 4th most common cause of cancer death in men and women alike. The 5-year overall survival rate is 8%. Thus, this is an area in oncology with a large and growing unmet need."

Wachter continued, "The work reported by Pilon-Thomas and colleagues shows that PV-10 has therapeutic activity in murine models of pancreatic cancer, and that this is augmented when intralesional PV-10 is combined with systemic gemcitabine (GEM), a standard chemotherapeutic agent used to treat this disease. Supporting this observation, their poster showed that PV-10 elicited interferon-gamma production, a hallmark of the induction of an anti-tumor immune response, along with regression of uninjected bystander tumors. They also showed that myeloid derived suppressor cells (MDSC) decreased when GEM was used alone or in combination with PV-10. Since MDSC have an inhibitory effect on a number of immune effector cells, including CD8+ T cells, dendritic cells and NK T cells, the apparent combination effect could result from reduced immune suppression by GEM coupled with immunologic stimulation by PV-10. PV-10 has previously been shown to produce tumor-specific anti-tumor immune responses in melanoma and colorectal carcinoma that includes activation of CD8+ T cells."

Wachter concluded, "We agree with the conclusions of the poster, that these results warrant clinical testing. Since pancreatic cancer frequently metastasizes to the liver, this could be a logical extension of our current investigations of PV-10 administered percutaneously to hepatic tumors."

The SITC (Free SITC Whitepaper) 2016 Annual Meeting was held at the Gaylord National Hotel & Convention Center in National Harbor, Maryland, November 9-13, 2016.

Eleven Biotherapeutics Reports Third Quarter 2016 Financial Results

On November 14, 2016 Eleven Biotherapeutics, Inc. (NASDAQ:EBIO), a late-stage clinical oncology company advancing a broad pipeline of novel product candidates based on its Targeting Protein Therapeutics (TPTs) platform, reported financial results for the third quarter ended September 30, 2016, and recent business highlights (Press release, Eleven Biotherapeutics, NOV 14, 2016, View Source [SID1234516598]).

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"This is an exciting period for Eleven. We completed the Roche licensing deal, including $30 million in upfront and milestone payments received to date. We also completed the acquisition of Viventia Bio Inc. which allowed us to become a late-stage oncology company. Perhaps most excitingly, we are making significant progress in moving forward what we believe could be therapeutics that materially improve patients’ lives. We anticipate complete enrollment in the first half of next year for our Phase 3 clinical trial of Vicinium as a potential treatment for high-grade non-muscle invasive bladder cancer, and expect topline data in the first half of 2018," said Stephen Hurly, President and Chief Executive Officer of Eleven Biotherapeutics. "We also plan to initiate our Phase 2 trial in late-stage squamous cell carcinoma of the head and neck with Proxinium in combination with a checkpoint inhibitor in the first half of 2017. Also in 2017, we plan on submitting an IND with the FDA for our lead product in our systemic pipeline based on our proprietary payload deBouganin. With the combined expertise of Eleven and the Viventia team, I am very excited about the opportunities we have ahead."

Third Quarter and Recent Business Highlights:

Completed acquisition of Viventia Bio Inc., creating a company focused on the development of novel therapies based upon antibody fragments genetically fused to cytotoxic proteins, or TPTs, as new treatments in areas of oncology. Eleven’s pipeline now includes Viventia’s lead product candidates Vicinium and Proxinium. Both product candidates are anti-EpCAM (epithelial cell adhesion molecule) fusion proteins that have been optimized for local tumor administration.
Vicinium is in a Phase 3 clinical trial for high grade non-muscle invasive bladder cancer (NMIBC) with topline data expected in the first half of 2018. In a Phase 2 clinical trial, Vicinium demonstrated a complete response rate of 40% at three months with no patients discontinuing treatment due to treatment related serious adverse events. To date, Vicinium has been evaluated in more than 100 patients in previously completed clinical trials.
Proxinium is expected to enter a Phase 2 clinical trial in combination with a checkpoint inhibitor in the first half of 2017 for the treatment of late-stage squamous cell carcinoma of the head and neck. In previous clinical trials, Proxinium was generally well-tolerated and showed signs of anti-tumor activity. Proxinium has received orphan drug designation from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), and Fast Track designation from the FDA.
Completed exclusive License Agreement with Roche for IL-6 antagonist antibody technology, including EBI-031. Eleven granted Roche an exclusive, worldwide license to develop and commercialize EBI-031 and all other IL-6 antagonist antibody technology owned by Eleven. Eleven has received $30 million in payments from Roche, including a $7.5 million upfront payment in connection with the effectiveness of the License agreement, and a $22.5 million milestone payment based on the IND application for EBI-031 becoming effective. Under the terms of the License Agreement, Eleven could receive up to an additional $240 million upon the achievement of certain future regulatory, development and commercialization milestones. In addition, Eleven is entitled to receive royalties based on net sales of potential future products containing EBI-031 or any other potential future products containing other Eleven IL-6 compounds.
Third Quarter 2016 Financial Results:

Revenue: Revenue was $28.7 million for the three months ended September 30, 2016, compared to $0.1 million for the same period in 2015. The increase was due to the revenue recognized from the License Agreement with Roche.
R&D Expenses: Research and development expenses were $2.8 million for the three months ended September 30, 2016, compared to $6.7 million for the same period in 2015. The decrease was primarily due to a decrease of isunakinra-related development expenses, for which development activities are no longer ongoing, as well as decreases in EBI-031 related development expenses due to the License Agreement with Roche.
G&A Expenses: General and administrative expenses were $6.4 million for the three months ended September 30, 2016, compared to $2.7 million for the same period in 2015. The increase was primarily due to increased severance, retention and stock-based compensation expenses and professional fees related to our review of strategic alternatives and the acquisition of Viventia.
Net Income (Loss): Net income was $19.5 million, or $0.95 per basic share and $0.91 per diluted share, for the three months ended September 30, 2016, compared to a net loss of $9.7 million, or $0.50 per basic and diluted share, for the same period in 2015. The change was primarily the result of the revenue recognized from the License Agreement with Roche.
Cash and Cash Equivalents: Cash and cash equivalents were $30.7 million as of September 30, 2016. We believe that our cash and cash equivalents as of September 30, 2016 will enable us to fund our operating expenses into 2018.
Events and Presentations:

Protein & Antibody Engineering Summit (PEGS) Europe, October 31-November 4, 2016 in Lisbon, Portugal.
European Antibody Congress, November 14-16, 2016 in Basel, Switzerland.

New Study Demonstrates Anti-Tumor Advantages for Combination Treatment Featuring Peregrine Pharmaceuticals’ PS-Targeting Antibodies in a Preclinical Melanoma Model

On November 14, 2016 Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM) (NASDAQ:PPHMP), a biopharmaceutical company committed to improving patient lives by manufacturing high quality products for biotechnology and pharmaceutical companies and advancing its proprietary R&D pipeline, reported the presentation of positive data from multiple new preclinical studies of the company’s phosphatidylserine (PS)-targeting antibodies (Press release, Peregrine Pharmaceuticals, NOV 14, 2016, View Source [SID1234516592]). Study results highlight that PS-targeting antibodies similar to bavituximab synergize with checkpoint inhibitors and radiation to improve anti-tumor activity in various animal tumor models. Importantly, the improved anti-tumor activity seen in these studies was even greater when PS-targeting therapy was a part of triple combination treatment including anti-PD-1 and another therapy. Data were presented by Peregrine scientists, as well as researchers from Memorial Sloan Kettering Cancer Center (MSK), at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2016 Annual Meeting, which was held November 9-13, 2016 in National Harbor, MD.

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Initial results from Peregrine’s ongoing collaboration with MSK researchers were featured in a poster presented by Sadna Budhu, Ph.D., at SITC (Free SITC Whitepaper) 2016. A team of MSK researchers led by cancer immunotherapy thought-leaders, Taha Merghoub, Ph.D. and Jedd D. Wolchok, M.D., Ph.D., evaluated the effects of combining PS-targeting, anti-PD-1 and radiation therapies in the mouse B16 melanoma model. Study data showed that PS-targeting antibodies synergize with both anti-PD-1 and radiation therapy to improve anti-cancer activity. PS-targeting treatment in combination with radiation, as well as triple combination of PS-targeting treatment, anti-PD-1 and radiation, led to a reduction in tumor burden. Median survival for the triple combination treatment still had not been reached at the end of the 80-day observation period with other arms in the study showing median survival that ranged from 24-70 days.

Researchers also evaluated the impact of the PS-targeting and radiation combination treatment on the level and type of immune activity. These results demonstrated that the combination led to a change in the tumor microenvironment, shifting it from immunosuppressive in which tumors are protected to immune active in which tumors are more susceptible to treatment. Analysis of local immune responses in the tumors of the treated animals showed that the combination treatment increased the number of tumor associated macrophages and shifted the macrophage polarization from the immunosuppressive M2 type to the immune active M1 type. When systemic immune responses were analyzed following triple combination of PS-targeting treatment, anti-PD-1 and radiation, researchers also saw evidence of increased immune activity. This was illustrated by key indicators of immune activity, including increases in CD8+ T-cell activation, effector cytokine production and differentiation into effector memory cells.
"Based on these study results, we believe that the targeting of PS is having meaningful activity within the tumor microenvironment in the B16 melanoma model," stated Dr. Wolchok. "It appears that this activity creates a more immune active environment in which other treatments, including radiation, are able to have a greater anti-tumor impact."

"We have noted that the combination of PS-targeting treatment and radiation, as well as triple combination of PS-targeting treatment, radiation and anti-PD-1, resulted in clear advantages in anti-tumor activity in the mouse B16 melanoma model," said Taha Merghoub, Ph.D., co-director of the Ludwig Collaborative Laboratory at MSK. "We believe that these findings suggest the potential benefit of combining these agents to improve the outcomes of patients with cancer. With this in mind, we think this research may play an important role in designing future clinical trials of PS-targeting agents in melanoma and other cancers."
A second study, conducted by Peregrine, evaluated the effects of combining PS-targeting, anti-PD-1 and anti-LAG3 therapies in the E0771 triple negative breast cancer (TNBC) model. Initial findings from this study were previously reported and demonstrated that eight of the ten (80%) animals receiving the PS-targeting, anti-PD-1 and anti-LAG3 treatment combination experienced complete tumor regressions, whereas there were no animals (0/10) in the anti-PD-1 and anti-LAG3 combination treatment arm that had a complete regression. New data presented for the first time at SITC (Free SITC Whitepaper) demonstrated that the triple combination established a specific and prolonged anti-tumor immune response which protected those eight animals that achieved a complete tumor regression against a re-challenge with the same E0771 TNBC model tumor cells. This sustained anti-tumor response demonstrates the ability of the triple combination treatment to trigger immune system memory and support adaptive immune responses against reemerging disease in the E0771 TNBC model.

Further highlighting the immune impact of the PS-targeting/anti-PD-1/anti-LAG3 treatment combination were initial results of a new analysis from this study using the nCounter PanCancer Immune Profiling Panel from NanoString Technologies. Data from the analysis demonstrated that the triple combination induced a greater shift in the tumor microenvironment from immunosuppressive to immune active as compared to all other treatment groups. This was evidenced by greater increases in the activity of several critical immune activating pathways, including presentation and processing of antigens and signaling and activation of T-cells, for the triple combination as compared to all other treatments.

"It is very encouraging to see the consistent increase in anti-tumor activity triggered by triple combination treatments that combine PS-targeting agents and anti-PD-1 with other cancer treatments. By demonstrating this activity across multiple studies in multiple tumor models, we are continuing to build scientific support for the therapeutic potential of adding PS-targeting therapies in combination with other cancer treatments, including checkpoint inhibitors such as anti-PD-1," said Jeff T. Hutchins, Ph.D., Peregrine’s vice president, preclinical research. "As cancer research continues to explore the potential of combination treatments that marry complementary mechanisms, we are pleased to see that our efforts continue to generate data supporting the role that PS-targeting agents such as bavituximab may play in this area."

Bavituximab is an investigational monoclonal antibody that targets PS. Signals from PS inhibit the ability of immune cells to recognize and fight tumors. Bavituximab is believed to override PS mediated immunosuppressive signaling by blocking the engagement of PS with its receptors as well as by sending an alternate immune activating signal. Previous studies demonstrated PS-targeting antibodies shift the functions of immune cells in tumors, resulting in multiple signs of immune activation and anti-tumor responses. Peregrine continues to support and guide clinical development through the evaluation of the preclinical equivalent of bavituximab, ch1N11, in animal model studies.

Peregrine’s clinical development strategy for bavituximab currently focuses on small, early-stage, proof-of-concept trials evaluating the drug in combination with other cancer treatments. This approach includes the recently announced grants awarded by the National Comprehensive Cancer Network (NCCN) to support three different clinical trials of bavituximab treatment combinations. These trials will evaluate novel bavituximab combinations in glioblastoma, head and neck cancer, and hepatocellular carcinoma including an immunotherapy combination. Additionally, Peregrine continues to advance its pre-clinical collaboration with Memorial Sloan Kettering Cancer Center with the goal of evaluating combinations of bavituximab with other checkpoint inhibitors and immune stimulatory agents. The intent behind this strategy is to focus our research and development spending to further validate bavituximab’s combination potential as we seek to advance the program though a pharmaceutical or biotechnology partner.

Mateon Provides Corporate Update and Reports Third Quarter 2016 Financial Results

On November 14, 2016 Mateon Therapeutics, Inc. (Nasdaq:MATN), a biopharmaceutical company developing vascular disrupting agents (VDAs) for the treatment of orphan oncology indications, reported a corporate update and reported financial results for the third quarter of 2016 (Press release, Mateon Therapeutics, NOV 14, 2016, View Source [SID1234516590]).

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Recent Corporate Highlights

Entered into a collaboration with U.S. Oncology Research for their participation in Mateon’s Phase 2/3 FOCUS Study evaluating CA4P in combination with bevacizumab (Avastin) and chemotherapy for the treatment of patients with platinum-resistant ovarian cancer.
Continued to expand the number of U.S. investigator sites participating in the FOCUS Study.
Expanded the FOCUS Study into Europe, with sites in Belgium now actively recruiting patients.
Completed enrollment in the second cohort and initiated the third cohort of OX1222, an open-label dose-ranging study of OXi4503 in combination with cytarabine, in patients with relapsed/refractory acute myeloid leukemia (AML).
Received an issued patent for pre-clinical cathepsin-inhibiting compounds from the U.S. Patent and Trademark Office.
Expanded Board of Directors with appointment of two experienced biopharmaceutical executives.
"I am pleased that our most advanced clinical trial, the FOCUS Study, remains on track and now has 20 investigator sites qualified to enroll patients," stated William D. Schwieterman, M.D., Mateon’s President and Chief Executive Officer. "Importantly, we are seeking to demonstrate improvement over the current standard of care in platinum-resistant ovarian cancer, and positive results from this trial could ultimately change the treatment paradigm in ovarian cancer, as well as the much broader field of vascular-targeted therapy in a variety of other solid tumor cancers. Therefore, the results of this clinical trial are critical to our goal of creating long-term shareholder value."

Financial Results for the Third Quarter of 2016

For the third quarter of 2016, Mateon reported a net loss of $3.2 million compared to a net loss of $3.6 million for the third quarter of 2015. R&D expenses decreased to $2.1 million in the third quarter of 2016, compared to $2.5 million in the third quarter of 2015, while general and administrative expenses increased to $1.2 million for the third quarter of 2016 compared to $1.1 million for the third quarter of 2015.

At September 30, 2016, Mateon had cash, cash equivalents and short-term investments of $16.3 million, which the Company currently believes is sufficient to fund operations through the availability of key clinical data from the FOCUS Study, which is expected in the second half of 2017.

Inovio’s Cancer Immunotherapy (INO-3112) Generates T Cell Immune Responses in Tumor Tissue and Peripheral Blood in Patients with HPV-Associated Head and Neck Cancer

On November 14, 2016 Inovio Pharmaceuticals, Inc. (NASDAQ:INO), reported an interim data analysis showing that its INO-3112 cancer immunotherapy product generated antigen-specific CD8+ killer T cell responses measured both in tumor tissue and in peripheral blood from subjects with head and neck cancer associated with human papillomavirus (HPV) (Press release, Inovio, NOV 14, 2016, View Source [SID1234516589]). The immunology results show that INO-3112 treatment generated robust HPV16/18 specific CD8+ T cell responses in peripheral blood in four of five subjects who also showed increased T cell activation in resected tumor tissue samples. These four subjects remained disease free in continuing follow-up that ranged from nine to 24 months at the time of analysis. One subject with only minimal increases in T cell immune responses developed progressive disease at 11 months post start of the study. These results were presented November 12th at the 2016 Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) in National Harbor, Maryland.

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Dr. J. Joseph Kim, Inovio’s President and CEO, said, "In immuno-oncology, it’s all about the T cells. We now have evidence in cancer patients that our immunotherapy product can generate antigen-specific CD8+ killer T cell responses in the tumor, a major step forward towards an effective immunotherapy. This study gives us an important opportunity to evaluate a novel treatment approach using a DNA vaccine platform to increase immune activation by generating a robust in-vivo T cell response, especially in the tumor, and potentially decreasing tumor recurrence in HPV positive head and neck cancer patients."

INO-3112, an active immunotherapy targeting HPV 16/18 combined with a DNA plasmid for IL-12 as an immune activator, is designed to activate patients’ immune responses to specifically target and kill HPV associated tumors. This open label phase I/IIa study has fully enrolled twenty-two subjects with HPV-positive head and neck squamous cell carcinoma and is intended to assess the safety, tolerability, and immunogenicity of INO-3112 in two treatment groups. Additionally, the study is evaluating the anti-tumor response and progression free survival of patients. The first group enrolled six subjects who were treated with INO-3112 before and after resection of their tumor. One subject withdrew consent after surgery, leaving five evaluable subjects in this group. All of these subjects received one dose of INO-3112 (averaging 14 days and ranging 7 to 28 days) prior to definitive surgery plus three additional doses post-surgery. The second group enrolled sixteen subjects who received four doses of INO-3112 after at least two months following completion of definitive chemoradiation or surgery and adjuvant chemoradiation therapy.

This poster presentation provided immune response and disease free survival data from the first treatment group. CD8+ and FoxP3 T cell expression were evaluated in tumor samples obtained before and after surgery. In addition, ELISpot analysis was performed to determine the number of T cells capable of secreting IFN-γ in response to HPV antigen stimulation. Four of five subjects had robust T cell response as measured by blood ELISpot assay and the same four subjects also showed an average increase of 60% of CD8+ to FoxP3 ratio measured by immunohistochemistry post vaccination, demonstrating increased infiltration of CD8+ T cells as well as reduction of regulatory T cells measured by FoxP3 expression in tumor tissue. These four subjects remained disease free with follow-up ranging from nine to 24 months to date. One subject with only a marginal increase in ELISpot response magnitude to HPV and no increase in CD8+/FoxP3 ratio in tumor tissue post INO-3112 developed progressive disease at 11 months post-treatment.

Overall the characteristics of these immune response data mirrored those previously observed in a phase IIb clinical study of VGX-3100 for HPV-associated cervical dysplasia. In that study, strong CD8+ T cell immune responses were positively correlated with achievement of primary and secondary efficacy endpoints. VGX-3100 is the first therapy to demonstrate that activated killer T cells induced in the body have the power to clear neoplastic lesions as well as the virus which caused the disease.

Inovio is continuing subject monitoring and comprehensive immune analyses for both cohorts of this study and expects multiple reports of additional data throughout 2017.

In August 2015, Inovio licensed INO-3112 to MedImmune, the global biologics research and development arm of AstraZeneca, for an upfront payment of $27.5 million, $700 million in potential development and commercial milestone payments, and royalties on INO-3112 product sales.

About HPV-Caused Head & Neck Cancer

Human papillomavirus (HPV) is the most common sexually transmitted disease in the United States, currently infecting about 79 million Americans. HPV is known to play a major role in the development of head and neck cancers, which include cancers of the oral cavity, oropharynx, nose/nasal passages and larynx. In 2016 an estimated 48,330 persons will get oral cavity or oropharyngeal cancer in the U.S. New cases of head and neck cancer occur nearly three times more often in men as in women. Incidence rates of head and neck cancers have been on the rise, especially HPV-associated oropharyngeal cancer in men, and are expected to continue growing.