On November 11, 2016 Atreca, Inc., a biotechnology company focused on developing novel therapeutics based on a deep understanding of the human immune response, reported positive preclinical findings generated using the Company’s Immune Repertoire Capture (IRC) technology, presented at the SITC (Free SITC Whitepaper) 2016 Annual Meeting, which is taking place in National Harbor, Maryland, November 9-13, 2016 (Press release, Atreca, NOV 11, 2016, View Source [SID1234522962]). In a poster titled, "Immune Profiling of an Elite Responder Following Checkpoint Inhibitor Therapy Reveals Functional Anti Tumor Antibodies Within Expanded IgG Lineages," a research team including scientists at Atreca and collaborators at a leading institution reported key research findings, including:

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Atreca’s IRC technology generated diverse antibodies from the active immune response of an individual with Stage 4 melanoma who had experienced long-term non-progression of disease following cancer regimens including anti-CTLA4 immunotherapy. These antibodies were sequenced from the patient’s blood plasmablasts, activated B cells that play a critical role in immune responses.
In in vitro assays, antibodies were shown to selectively bind tumor tissue but not normal tissue and to bind tumor types beyond the cancer type of the original patient.
Select antibodies demonstrated in vitro tumor killing through antibody-dependent cellular cytotoxicity (ADCC).
"Atreca is pioneering next-generation approaches to cancer immunotherapy based on our ability to elucidate the repertoire of cancer patient antibodies and T cell receptors (TCRs) contributing to positive outcomes," stated Daniel Emerling, Ph.D., Atreca’s Senior Vice President, Research. "In our presentation at SITC (Free SITC Whitepaper), we reported sequencing of over 2500 plasmablasts and identification of clonal antibody families from one exceptional cancer responder. By generating natively paired antibody heavy and light chain sequences, we were able to confirm the ability of a patient’s antibodies to target tumor cells and destroy them, including tumor types unrelated to that of the patient."

"Atreca is advancing a pipeline of therapeutic candidates that can drive and focus the activity of immune responses in cancer immunotherapy, particularly those unleashed by checkpoint inhibitors and immune activators," said Tito A. Serafini, Ph.D., Atreca’s President, Chief Executive Officer, and Co-Founder. "We are thrilled to present data highlighting the power and productivity of our platform at one of the leading cancer immunotherapy conferences. Our lead program is rapidly advancing in preclinical in vivo studies, and we look forward to further progress of our additional programs across multiple indications."

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On November 11, 2016 OncoSec Medical Incorporated ("OncoSec") (NASDAQ: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, reported new clinical data from a Phase II Investigator Sponsored Trial led by the University of California, San Francisco (UCSF) (Press release, OncoSec Medical, NOV 11, 2016, View Source [SID1234516530]). The data was presented today at an oral poster presentation (#466) by Dr. Alain Algazi at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) ("SITC") Annual Meeting in National Harbor, MD.

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This single-arm, open-label trial assessed the combination of OncoSec’s investigational intratumoral therapy, ImmunoPulse IL-12, and Merck’s KEYTRUDA (pembrolizumab) in patients with unresectable metastatic melanoma. A predictive biomarker was used to enroll patients that have a low likelihood of response to an anti-PD1 agent alone, and the purpose of the trial is to assess whether the addition of ImmunoPulse IL-12 can increase response rates in these patients.

The full-text abstract is available and can be viewed on SITC (Free SITC Whitepaper)’s website at www.sitcancer.org. The poster presentation and handout showing the data of the 40% overall response rate (ORR) in patients predicted not to respond to pembrolizumab are available in the Publications section of OncoSec’s website.

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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.

On November 10, 2016 Celsion Corporation (NASDAQ:CLSN), an oncology drug development company, reported financial results for the quarter and nine month period ended September 30, 2016 and provided an update on its development programs for ThermoDox, the Company’s proprietary heat-activated liposomal encapsulation of doxorubicin and GEN-1, an IL-12 DNA-based immunotherapy (Press release, Celsion, NOV 10, 2016, View Source [SID1234516538]).

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"Over the last nine months, we have realized meaningful progress with respect to our two lead programs, ThermoDox and GEN-1. Importantly, we are well positioned to sustain this momentum through the balance of 2016 and beyond," said Michael H. Tardugno, Celsion’s chairman, president and CEO. "The initial data from our GEN-1 program provides highly valuable insights into its favorable clinical and safety profile indicating a great deal of potential in both first and second-line ovarian cancer, and we look forward to reporting additional data from our ongoing OVATION study before year-end."

Mr. Tardugno continued, "Our ongoing global, pivotal Phase III OPTIMA Study of ThermoDox in primary liver cancer remains on track with clinical sites currently enrolling patients in 13 countries worldwide. Investigators continue to recognize the value of findings from the HEAT Study and their continued interest reinforces substantial and mounting support for the OPTIMA Study.

The recent independent analysis conducted by the National Institutes of Health provides further confirmatory support indicating that the use of radiofrequency ablation (RFA) for more than 45 minutes in patients treated with ThermoDox can have a correlative impact on reductions in tumor size and overall survival in patients with primary liver cancer."

Recent Developments
Immunotherapy – GEN-1

Announced Positive Data from the First Two Cohorts of the OVATION Study. In July 2016, the Company announced data from the second cohort of patients in its Phase Ib dose escalating clinical trial (the OVATION Study) combining GEN-1 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. In the first six 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. The efficacy data included highly encouraging tumor response rates, successful surgical resections of the eligible patients’ tumors, impressive pathological responses and dramatic, clinically meaningful drops in CA-125 protein levels.

Positive DSMB Review of OVATION Study in Ovarian Cancer. In September 2016, the independent Data Safety Monitoring Board (DSMB) completed its safety review of data from the first three patient cohorts in the ongoing Phase Ib OVATION Study. Based on the DSMB’s recommendation, the study will continue as planned and the Company will proceed with dosing in its fourth and final patient cohort at an escalated dose. Celsion expects the fourth cohort to be fully enrolled this year.

Established a Manufacturing and Commercial Supply Agreement with Hisun for GEN-1. In August 2016, Celsion signed a long term technology transfer, manufacturing and commercial supply agreement with Zhejiang Hisun Pharmaceutical Co. Ltd. The agreement relates to both the clinical and commercial manufacture and supply of GEN-1 for the greater China territory, with the option to expand into other countries in the rest of the world after all necessary regulatory approvals are in effect. With highly cost effective pricing, the agreement will support economically advantaged supply for ongoing and planned clinical studies in the United States and potential future studies of GEN-1 in China as well as Europe.

Chemotherapy – ThermoDox
Announced the Final Overall Survival Data from HEAT Study of ThermoDox in Primary Liver Cancer. In August 2016, the Company announced updated results from its final retrospective analysis of the 701-patient HEAT Study. The overall survival analysis demonstrated that in a large, well bounded, subgroup of 285 patients (41% of the HEAT Study patients), treatment with a combination of ThermoDox and optimized RFA provided an average 54% risk improvement in overall survival compared to optimized RFA alone. The Hazard Ratio (HR) at this analysis is 0.65 (95% CI 0.45 – 0.94) with a p-value of 0.02. Importantly, after 3.5 years of follow up, the median overall survival for the ThermoDox group has yet to be reached and is showing over 80 months survival benefit compared to less than 60 months projection for the optimized RFA only group, which translates into a two year survival benefit.

Announced the Independent NIH Analysis Showing Treatment with ThermoDox Plus RFA may Significantly Improve Overall Survival of Patients with Primary Liver Cancer. In September 2016, the Company announced that the National Institutes of Health (NIH) has conducted an independent retrospective analysis of data from the Company’s HEAT Study. The NIH analysis, which sought to evaluate the correlation between RFA burn time per tumor volume (min/ml) and clinical outcome in patients treated with ThermoDox, concluded that increased RFA burn time per tumor volume substantially improved survival in patients with solitary lesions treated with RFA + ThermoDox compared to patients treated with RFA alone. These findings are consistent with Celsion’s analysis of the HEAT Study data showing that in patients treated with RFA for more than 45 minutes, standardized RFA plus ThermoDox resulted in a statistically significant improvement in overall survival of over two years when compared to standardized RFA alone.

Detailed findings from the NIH study will be presented during oral sessions on Monday, November 28, 2016 at 1:50 pm CT during the 102nd Scientific Assembly and Annual Meeting of the Radiological Society of North America (RSNA) to be held on November 26 – December 2, 2016 in Chicago, IL.

Announced Presentations Highlighting Phase III OPTIMA Study at Two Asia-Pacific Primary Liver Cancer Expert Meetings.
In July 2016, the Company announced that its ongoing Phase III OPTIMA trial evaluating ThermoDox in primary liver cancer was featured during an oral presentation at the 7th Asia-Pacific Primary Liver Cancer Expert (APPLE) Meeting in Hong Kong, China. The presentation highlighted the potential of ThermoDox plus optimized RFA to significantly improve overall survival of newly diagnosed patients.

In October 2016, the Company announced the presentation of data from the Company’s HEAT Study, highlighting the curative potential for ThermoDox plus optimized RFA in intermediate primary liver cancer at the 3rd Asian Conference on Tumor Ablation (ACTA) in Seoul, Korea.

Announced Collaboration with the Children’s Research Institute to Evaluate the Use of ThermoDox and High Intensity Focused Ultrasound in the Treatment of Solid Tumors in Children and Young Adults. In October 2016, the Company announced a collaboration with the Children’s Research Institute to conduct a clinical study of ThermoDox in combination with magnetic resonance-guided high intensity focused ultrasound to treat relapsed or refractory solid tumors in children and young adults. This investigator-sponsored Phase I clinical study is being partially funded by the National Institutes of Health and is expected to commence in the fourth quarter of 2016.

Financial Results
For the quarter ended September 30, 2016, Celsion reported a net loss of $6.4 million, or $(0.23) per share, compared to a net loss of $4.3 million, or $(0.19) per share, in the same period of 2015. Operating expenses were $5.7 million in the third quarter of 2016 compared to $4.4 million in the same period of 2015. For the nine month period ended September 30, 2016, the Company reported a net loss of $16.7 million, or $(0.66) per share, compared to $16.9 million, or $(0.79) per share, in the same nine month period of 2015. Operating expenses were $15.9 million in the first nine months of 2016 compared to $16.3 million in the same period of 2015. Net cash used in operations was $13.7 million in the first nine months of 2016 compared to $16.9 million in the same period last year. The Company ended the third quarter of 2016 with $8.7 million of total cash, investments and accrued interest on these investments, which included the proceeds of a $6 million registered direct offering completed during the second quarter.

Research and development costs were $4.2 million in the third quarter of 2016 compared to $2.9 million in the same period last year. Research and development costs were $11.0 million in the first nine months of 2016 and 2015. R&D costs in 2016 reflect lower clinical supply costs for the ThermoDox and GEN-1 clinical studies offset by increased costs associated with the enrollment in the OPTIMA and the OVATION studies when compared to 2015. General and administrative expenses were $1.5 million in the third quarter of 2016 and 2015. General and administrative expenses were $4.9 million in the first nine months of 2016, down 8 percent when compared to the same period of 2015. This decrease was primarily the result of lower personnel related costs and professional fees.

On November 10, 2016 Halozyme Therapeutics, Inc. (NASDAQ: HALO), an oncology biotech developing novel oncology and drug-delivery therapies, and Genentech, a member of the Roche Group, reported an agreement to collaborate on clinical studies evaluating up to eight different tumor types beginning in 2017 (Press release, Halozyme, NOV 10, 2016, View Source [SID1234516465]).

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The first study will be a Phase 1b/2 open-label, multi-arm randomized global study, led by Genentech to evaluate their cancer immunotherapy Tecentriq (atezolizumab), an anti-PD-L1 monoclonal antibody, in combination with Halozyme’s investigational drug, PEGPH20 in six tumor types. Halozyme will supply drug only for the Genentech study. This study will have an initial focus on gastrointestinal malignancies, including pancreatic and gastric cancers.

The second study will be a Phase 1b open-label randomized study led by Halozyme to assess Tecentriq in combination with PEGPH20 and chemotherapy in advanced or metastatic biliary and gallbladder cancers.

"High levels of hyaluronan (HA) have been shown in retrospective clinical reviews to be associated with a poor prognosis when compared to low-HA and in animal models to potentially impede the access of cancer therapy," said Dr. Helen Torley, president and chief executive officer of Halozyme. "We look forward to exploring this combination therapy with our partner in a range of tumors given our shared focus on the tumor microenvironment and longstanding relationship working together on the development of Roche’s Herceptin SC and MabThera SC products for the EU market."

PEGPH20 is an enzyme that temporarily degrades HA, a dense component of the tumor microenvironment that can accumulate in higher concentrations around certain cancer cells, potentially constricting blood vessels and impeding the access of other therapies.

Following the phase 1b portions to assess safety and tolerability of the combinations, the study designs may scale to registration trials. The Halozyme-led study will enroll only patients who are prospectively identified as having tumors with high levels of HA, while initial phases of the Genentech-led study will focus on an all-comer population with a target number of HA-high patients to be enrolled.

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