On November 10, 2016 Argos Therapeutics Inc. (Nasdaq:ARGS) ("Argos"), an immuno-oncology company focused on the development and commercialization of individualized immunotherapies based on the Arcelis technology platform, reported that the company will be presenting at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 31st Annual Meeting to be held November 11-13 at the Gaylord National Hotel and Convention Center in National Harbor, Maryland.

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Mark DeBenedette, Ph.D., director of immunology for Argos, will present two posters on Friday, November 11th from 12:15-1:30pm ET in Prince George’s Exhibition Hall AB:

"Immunological impact of check point blockade on dendritic cell driven T cell responses; A cautionary tale" (205)
"Multi-Kinase Inhibitors for the Treatment of mRCC: Implications for Combined Therapy with AGS-003; an Autologous Dendritic Cell Immunotherapy" (259)
The SITC (Free SITC Whitepaper) 31st Annual Meeting provides a multidisciplinary educational and interactive environment focused on improving outcomes for current and future patients with cancer by incorporating strategies based on basic and applied cancer immunotherapy. For more information visit View Source

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

On November 10, 2016 Provectus Biopharmaceuticals, Inc. (OTCQB:PVCT, www.provectusbio.com), a clinical-stage oncology and dermatology biopharmaceutical company ("Provectus" or the "Company"), reported its financial results for the quarter ended September 30, 2016 (Press release, Provectus Pharmaceuticals, NOV 10, 2016, https://www.pvct.com/pressrelease.html?article=20161110.1 [SID1234516712]).

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Third Quarter Results and Balance Sheet Highlights

Our cash and cash equivalents were $5,178,076 at September 30, 2016, compared with $4,891,313 at June 30, 2016. As of December 31, 2015, cash and equivalents were $14,178,902.

Shareholders’ equity at September 30, 2016 was $5,309,712. This compares to shareholders’ equity of $9,140,166 at June 30, 2016, and $16,316,941 as of December 31, 2015.

For additional information regarding Provectus’ results of operations and financial condition for the third quarter ended September 30, 2016, please see Provectus’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 9, 2016.

Management will host its 2016 third quarter business update conference call on Monday, November 14, 2016 at 4 pm Eastern Standard Time. Management will provide a business update on PV-10 and PH-10 to the investment community and answer questions from investors.

Those who wish to participate in the conference call may telephone 877-407-4019 from the U.S. International callers may telephone 201-689-8337 approximately fifteen minutes before the call. A webcast will also be available at www.provectusbio.com.

A digital replay will be available by telephone approximately two hours after the completion of the call until March 4, 2017 and may be accessed by dialing 877-660-6853 from the U.S. or 201-612-7415 for international callers, and using the Conference ID # 13648197.

On November 10, 2016 Celsion Corporation (NASDAQ:CLSN) reported data from the third cohort of patients in its Phase Ib dose escalating clinical trial (the OVATION Study) combining GEN-1, the Company’s DNA-based immunotherapy, with the standard of care for the treatment of newly-diagnosed patients with advanced ovarian cancer who will undergo neoadjuvant chemotherapy followed by interval debulking surgery (Press release, Celsion, NOV 10, 2016, View Source [SID1234516462]). In the first nine patients dosed, GEN-1 plus standard chemotherapy produced impressive results, with no dose limiting toxicities and highly promising efficacy signals in this difficult to treat cancer.

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"While the patient number in this trial may be small, the consistency and robust nature of the data across all three cohorts and the encouraging clinical responses underscore the potential of GEN-1 to serve as an effective, safe IL-12 immunotherapy in ovarian cancer," said Nicholas Borys, M.D., Celsion’s chief medical officer. "I am particularly impressed with the pathological response data, which is known to be associated with prolonged survival in this patient population. The data generated support continued evaluation of GEN-1 in ovarian cancer, and we look forward to seeing how GEN-1 performs in the fourth and final study cohort."
The OVATION Study is designed to enroll three to six patients per dose cohort with the goal of identifying a safe, tolerable and therapeutically active dose of GEN-1 by recruiting and maximizing an immune response. The first three cohorts each enrolled three patients. Enrollment in the fourth cohort is ongoing, and Celsion expects to complete the OVATION Study this year and report data in early 2017. Future studies of GEN-1 will include a Phase I/II study combining GEN-1 with Avastin and Doxil.

OVATION Study – Totality of Results in the First Three Cohorts
Of the first nine patients dosed, one patient demonstrated a complete response (CR), five patients demonstrated partial response (PR) and three patients demonstrated stable disease (SD), as measured by RECIST criteria. This translates to a 100% disease control rate (DCR), and 66% objective response rate (ORR).

Eight patients had successful resections of their tumors, with four patients having an R0 resection, which indicates a microscopically margin-negative resection in which no gross or microscopic tumor remains in the tumor bed, and three patients with a R1 resection, indicating microscopic residual tumor. One patient had an R2, indicating macroscopic residual tumor. One patient in the second cohort was ineligible for debulking surgery due to a medical complication unrelated to the study or the study drug.

Of the eight surgically treated and evaluable patients, one patient demonstrated a complete pathological response (cPR), three patients demonstrated a micro pathological response (microPR), and four patients demonstrated a macroPR. These data compare favorably to historical data, which indicate that cPRs are typically seen in less than 7% of patients receiving neoadjuvant chemotherapy followed by surgical resection. cPRs have been associated with a median overall survival of 72 months, which is more than three years longer than those who do not experience a cPR. In addition, microPRs are seen in approximately 30% of patients, and are associated with a median overall survival of 38 months¹.

Seven patients who completed treatment follow-up experienced a dramatic (greater than 90%) drop in their CA-125 protein levels as of their most recent study visit. CA-125 is used to monitor certain cancers during and after treatment. CA-125 is present in greater concentrations in ovarian cancer cells than in other cells. A 50% reduction in CA-125 levels is considered meaningful. Six patients maintained CA-125 levels below the standard cutoff level of 35 U/mL.

OVATION Study – Top Line Translational Data from First Two Cohorts
Celsion also reported initial translational data from the first two cohorts of the OVATION study. Tumor and blood samples collected before the start of the neoadjuvant chemotherapy (NACT) and after the completion of GEN-1 treatment at debulking surgery are being analyzed for immune cell populations. Top line data demonstrates intriguing immunological changes in the tumor that are consistent with the activation of the immune system. Specifically,
In tumor tissue, there was an increase in cytotoxic CD8+ T-cell density in three out of four evaluable patients at debulking surgery. There was a decrease in immunosuppressive FoxP3+ T-cells in two out of those 4 patients. The ratio of CD8+/FoxP3+ cells was increased in all four evaluable patients. High tumor infiltrating CD8+ T-cell density, low FoxP3+ T-cell density or high CD8+/FoxP3+ ratio demonstrate a potential shift in tumor environment to favoring immune stimulation following NACT + GEN-1 therapy. For the remaining two patients the post-treatment tumor tissue was not available. In one of those two patients there was complete pathological response hence no tumor tissue was present to provide a post-treatment comparison. In the other patient the debulking surgery was not performed due to disease related complications.

In plasma samples, there appeared to be no significant change in T-cell density following the treatment. The density of myeloid derived suppressor cells that are associated with immunosuppression in ovarian cancer were either decreased or did not increase in post-treatment samples.

Additional immune analysis of biological tissue including cytokine ELISA from the first two patient cohorts and a complete analysis of the two higher dose cohorts is in progress.

"The clinical and translational data generated to date are meaningful and reinforce our confidence in the potential of GEN-1 to address advanced Stage III and IV ovarian cancer, a population clearly in need of effective therapies," said Dr. Khursheed Anwer, Ph.D., MBA, Celsion’s chief scientific officer. "We anticipate completion of enrollment in the fourth patient cohort in the coming weeks, and will continue to assess a potential accelerated clinical development path for GEN-1. In parallel, we are currently evaluating translational data from the study, which we expect to report before the end of the fourth quarter."

On November 10, 2016 Bio-Path Holdings, Inc. (NASDAQ: BPTH), a biotechnology company leveraging its proprietary DNAbilize liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, reported its financial results for the third quarter ended September 30, 2016 and also provided an update on recent corporate developments (Filing, Q3, Bio-Path Holdings, 2016, NOV 10, 2016, View Source [SID1234516508]).

"Throughout the third quarter and in recent weeks, we have made meaningful progress across our clinical and corporate development programs. Earlier this month, we were pleased to announce the enrollment and dosing of the first patient in the efficacy portion of our Phase 2 clinical study of BP1001 for the treatment of acute myeloid leukemia," said Peter Nielsen, President and CEO of Bio-Path Holdings. "Recently, the European Medicines Agency granted orphan drug designation to BP1001 for the treatment of AML, which recognizes the potential of our DNAbilize technology, underscores the significant unmet medical need in this debilitating disease, and provides regulatory provisions that can accelerate the review process and expand our market exclusivity."

Recent Corporate Highlights

· Announced First Patient Dosed in Phase 2 Trial Evaluating BP1001 in Acute Myeloid Leukemia. In November, the Company announced the enrollment and dosing of the first patient in the efficacy portion of its Phase 2 clinical study of BP1001, a liposomal Grb2 antisense for the treatment of acute myeloid leukemia (AML). The primary endpoint of the study is the number of patients who achieve Complete Remission (CR), including CR with incomplete hematologic recovery (CRi) and CR with incomplete platelet recovery (CRip). Secondary endpoints assessing the safety and efficacy of BP1001 include overall survival, time to response, duration of response, and adverse events as evaluated by physical examination findings, vital signs and clinical laboratory tests.

· Granted Orphan Drug Designation in the European Union for BP1001 for the Treatment of AML. In November, the Company announced that the European Medicines Agency (EMA) granted orphan drug designation to BP1001 for the treatment of AML. To receive orphan drug designation from the EMA, a therapy must be intended for the treatment of a life-threatening or chronically debilitating rare condition with a prevalence of less than five in 10,000 in the European Union. Orphan drug designation provides incentives designed to facilitate development including fee reductions for protocol assistance, scientific advice and importantly, may provide up to ten years of market exclusivity in the EU following product approval.

Financial Results for the Third Quarter Ended September 30, 2016

The Company reported a net loss of $1.6 million, or $0.02 per share, for the three months ended September 30, 2016, compared to a net loss of $1.5 million, or $0.02 per share, for the same period last year. The increase was primarily due to the release of drug material for our Phase 2 clinical trial for BP1001 in AML and associated clinical trial costs.

Research and development expenses for the three months ended September 30, 2016 increased to $2.3 million, compared to $1.0 million for the same period in 2015. General and administrative expenses for the three months ended September 30, 2016 increased to $0.7 million, compared to $0.5 million for the three months ended September 30, 2015.

As of September 30, 2016, the Company had cash of $11.3 million, compared to $8.9 million at December 31, 2015. Net cash used in operating activities for the nine months ended June 30, 2016 was $6.5 million compared to $4.0 million for the comparable period in 2015.

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On November 10, 2016 Mirna Therapeutics, Inc. (Nasdaq: MIRN), a biopharmaceutical company focused on microRNA-based oncology therapeutics, reported financial results for the third quarter of 2016 and provided an update on recent developments (Press release, Mirna Therapeutics, NOV 10, 2016, View Source [SID1234516571]).

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MRX34 CLINICAL PROGRAM

In September 2016, the Company voluntarily halted the ongoing Phase 1 trial of its first product candidate, MRX34, following multiple immune-related serious adverse events (SAEs) observed in patients dosed with MRX34 over the course of the trial. Three of these immune-related events resulted in the patient’s death. Subsequently, the U.S. Food and Drug Administration (FDA) notified the Company that the Investigational New Drug (IND) Application for MRX34 has been placed on full clinical hold. Among other comments, the FDA requested a final clinical study report be submitted and noted that a risk-benefit summary with sufficient justification for the continued development of MRX34 would be necessary if the Company requested removal of the clinical hold.

"We were disappointed with the outcome of our Phase 1 study, however, our first priority in developing innovative therapeutics is the safety of patients," said President and CEO Paul Lammers, M.D., M.Sc. "Based on our assessment of both potential therapeutic benefit and risk, we have decided to discontinue development of MRX34 and suspend our pipeline R&D programs."

The Company has initiated a plan to reduce personnel and expenses in order to preserve capital and streamline operations, and it plans to focus on meeting regulatory requirements related to closure of the Phase 1 trial as well as other operating activities consistent with the decision to discontinue development of MRX34. The Company also expects to explore and evaluate strategic alternatives with the goal of enhancing stockholder value.

THIRD QUARTER 2016 FINANCIAL RESULTS

• Cash Position and Guidance: Cash, cash equivalents, and marketable securities totaled $66.7 million as of September 30, 2016, compared to $89.7 million as of December 31, 2015. The Company has no debt.

Beginning in the first quarter of 2017, after giving effect to the personnel and expense reductions, the Company expects its quarterly cash burn rate will range from $2.1 million to $2.3 million. This 2017 quarterly guidance includes contractual commitments and obligations, but excludes any one-time charges related to a strategic transaction should one be concluded.

• Research and development expenses: Research and development expenses were $3.4 million and $11.6 million for the three and nine months ended September 30, 2016, respectively, compared to $4.7 million and $12.6 million during the comparable periods in 2015. The decrease for the three and nine months ended September 30, 2016 compared to the same period in 2015 was primarily attributable to higher costs incurred in 2015 associated with our Phase 1 clinical trial for MRX34, specifically adding additional sites and upfront drug manufacturing costs. The decrease in 2016 was partially offset by an increase in employee compensation, benefits and stock compensation.

• General and Administrative Expenses: General and administrative expenses were $2.0 million and $6.1 million for the three and nine months ended September 30, 2016, respectively, compared to $1.6 million and $3.6 million during the comparable periods in 2015. The increase in general and administrative expenses was primarily attributable to increased employee compensation expense due to a higher headcount and higher outside professional and consulting costs, the majority of which were costs to comply with public company operating and reporting requirements.

• Net Loss: Net loss was approximately $5.4 million and $17.6 million for the three and nine months ended September 30, 2016, compared to a net loss of $6.2 million and $16.2 million for the comparable periods in 2015. The results included non-cash, stock-based related compensation charges of $513,000 and $1,202,000 for the three and nine months ended September 30, 2016, respectively, and $210,000 and $561,000 for the comparable periods in 2015.