On September 9, 2015 OncoSec Medical Incorporated ("OncoSec") (NASDAQ: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, reported recent advancements in the field of electroporation (EP) and the future of catheter-based devices to perform minimally invasive intratumoral immunotherapy treatment at the First World Congress on Electroporation and Pulsed Electric Fields in Biology, Medicine and Food & Environmental Technologies in Portoroz, Slovenia (Press release, OncoSec Medical, SEP 9, 2015, View Source [SID:1234507432]).

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In a keynote presentation entitled: "Advances in Clinical Electroporation: Tissue Sensing, Feedback Control, and Catheter Technology," Robert H. Pierce, MD, Chief Scientific Officer, discussed OncoSec’s advances in intratumoral gene electro-transfer, using ‘smart’ tissue-sensing technology and the development of catheter-based electrodes, enabling treatment of deep and visceral tumors.

"We are excited to be presenting our engineering advances at the First World Congress," said Dr. Pierce. "The development of minimally-invasive electroporation devices capable of high-efficiency delivery of immunotherapeutic genes into tumors located anywhere in the body is critical to establishing intratumoral EP-mediated gene therapy as a standard therapeutic modality in immuno-oncology."

OncoSec’s New Catheter Electrode Technology

OncoSec’s new catheter-based electrodes are designed to be compatible with standard medical instrumentation, allowing access to deep and visceral tumors, where they are capable of anchoring to and treating the tumor using OncoSec’s proprietary technology. These all-in-one devices have the ability to inject a DNA-based agent, while deploying electrodes to perform electroporation in a single procedure. Moreover, these devices have an adjustable needle and electrode penetration depth allowing clinicians to treat tumors of varying dimensions to perform minimally invasive intratumoral immunotherapy.

Development of Tissue Sensing and Feedback Control

OncoSec is developing ‘smart’ electroporation technology capable of tissue sensing and real-time feedback control of electroporation pulse trains in order to attain optimal gene transfer and minimal electroporation-mediated tissue damage. Dr. Pierce added: "Taken together, these engineering advances can enable access and high-efficiency gene delivery to tumors throughout the body. This is key as we move forward in developing OncoSec’s pipeline of novel intratumoral therapies."

"Our partnership with Rev.1 Engineering and internal bioengineering expertise have allowed OncoSec to enhance our ImmunoPulse platform and position the Company as a leader in gene electro-transfer technologies in cancer immunotherapy," said Punit Dhillon, President and CEO of OncoSec. "We are also strengthening our intellectual property portfolio in the area of gene and drug delivery via electroporation to reach visceral tumors and enhance the uptake of therapeutic agents."

Licensing of University of South Florida Catheter Electrode Patent

OncoSec secured an exclusive license for a specific patented technology from the University of South Florida Research Foundation (USFRF). The patent provides a device and related methods to deliver molecules to cells that comprise any tissue. The patent includes a catheter-based electrode and methods to deliver molecules to cardiac tissue, blood vessels, other tissues/organs that can be accessed through a luminal tissue and luminal tissues. The device also functions as a non-catheter based electrode for performing the same functions. Financial terms of this agreement were not disclosed.

For more information about OncoSec and its technologies, please visit: www.oncosec.com.

On September 9, 2015 Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM) (NASDAQ:PPHMP), a biopharmaceutical company focused on developing therapeutics to stimulate the body’s immune system to fight cancer, reported financial results for the first quarter of fiscal year (FY) 2016 ended July 31, 2015, and provided an update on its advancing clinical pipeline and other corporate developments (Press release, Peregrine Pharmaceuticals, SEP 9, 2015, View Source [SID:1234507437]).

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Highlights Since April 30, 2015:
"Over the years, Peregrine’s foundational science and positive clinical results have consistently pointed to bavituximab’s potential as a high-value, next-generation anti-cancer agent," said Steven W. King, president and chief executive officer of Peregrine. "In the last three months, these achievements have compelled others to align with us as we continue to develop bavituximab. In May, Peregrine announced an exciting collaboration with Memorial Sloan Kettering Cancer Center to evaluate combinations of bavituximab with other checkpoint inhibitors and immune stimulatory agents for the purpose of developing new and increasingly effective anti-cancer treatments. Only three months later, we announced a collaboration with AstraZeneca to clinically evaluate bavituximab in combination with AstraZeneca’s investigational anti-PD-L1 immune checkpoint inhibitor, durvalumab (MEDI4736) in multiple solid tumors. These collaborations with world leaders in immuno-oncology speak to the promise of bavituximab and validate our ever-growing enthusiasm for the investigational product. We look forward to advancing both of these programs and completing enrollment of our SUNRISE trial in the next few months."

Clinical Development Highlights
Peregrine and AstraZeneca entered into a cancer immunotherapy clinical trial collaboration to evaluate bavituximab in combination with AstraZeneca’s investigational anti-PD-L1 immune checkpoint inhibitor, durvalumab (MEDI4736). The planned Phase I/Ib trial will evaluate the safety and efficacy of bavituximab in combination with durvalumab in multiple solid tumors. Peregrine is working closely with AstraZeneca to finalize the trial design.

Phase III SUNRISE clinical trial in non-small cell lung cancer (NSCLC) continues to enroll patients and remains on track to complete patient enrollment by end of calendar year 2015.

Peregrine announced plans to expand the bavituximab clinical development program to include a Phase II trial to evaluate the combination of bavituximab and Opdivo (nivolumab), an anti-PD-1 antibody, in previously treated, metastatic NSCLC. This trial is expected to be initiated by the end of calendar year 2015.

Peregrine announced plans to expand the bavituximab clinical development program to include a Phase II/III trial to evaluate bavituximab with chemotherapy combinations in HER2-negative metastatic breast cancer. This trial is expected to be initiated by the end of calendar year 2015.

Supportive Research Highlights
Peregrine and Memorial Sloan Kettering Cancer Center entered into a research agreement to explore the potential of Peregrine’s proprietary PS-targeting antibody platform. The goal of the research is to identify effective treatments combining bavituximab with other checkpoint inhibitors or immune stimulating agents.

New data presented at the International Association for the Study of Lung Cancer’s (IASLC’s) World Conference on Lung Cancer (WCLC) from a translational study of bavituximab demonstrated the ability of bavituximab, alone or in combination with docetaxel, to induce signs of immune activation in non-small cell lung cancer (NSCLC) patient-derived tumor samples, particularly when there was negative PD-L1 expression in the tumor sample. These data further support the potential mechanistic synergies for bavituximab with chemotherapy and checkpoint inhibitors targeting the PD-1/PD-L1 pathway.

Summary data presented at the Combination Immunotherapy Strategies session at the 10th Annual Immunotherapy and Vaccine Summit (ImVacS), highlighted key findings from several recent bavituximab-focused studies including: the potential of bavituximab to shift the tumor microenvironment from immuno-suppressive in which tumors evade immune detection to a state of immune activation in which the immune system recognizes and fights the tumor; bavituximab’s potential to increase the number of activated CD8+ cells in the tumor, which stimulates PD-1 expression, potentially increasing the number of patients able to respond to PD-1 and PD-L1 targeting immunotherapies; and, results from several clinical and preclinical studies in a range of tumor types showing that bavituximab and bavituximab-like antibodies, in combination with conventional therapy, have consistently demonstrated estimated survival curves that plateau.

Data from preclinical studies presented at the 2015 ASCO (Free ASCO Whitepaper) annual meeting demonstrated the ability of the company’s PS-targeting antibodies to significantly increase the prevalence of tumor infiltrating CD8+ T-cells and immune-activating cytokines, while decreasing tumor-promoting macrophages and myeloid cells. These findings highlight the ability of the antibodies to enhance the anti-tumor effects of both chemotherapy and immune checkpoint inhibitors.

Avid Bioservices Highlights
Avid’s new manufacturing suite is fully constructed and the first internal pilot run is currently underway to verify all systems and equipment are properly functioning. Company plans to announce the launch of the new facility in the near term, allowing us to meet our internal manufacturing timelines as well as those of our third-party clients.

Contract manufacturing committed backlog reached $42 million from existing customers covering services to be completed in FY 2016 and into FY 2017.

Corporate Highlights
The European Patent Office (EPO) granted Patent Number 2,269,656, licensed to Peregrine titled "Selected Antibodies Binding to Aminophospholipids and their Use in Treatment, Such as Cancer." The patent covers bavituximab as a composition of matter and for use in therapy, such as for treating cancer including in combination with radiotherapy or chemotherapy, e.g., with docetaxel. This important patent expands upon the company’s intellectual property portfolio, which now numbers more than 140 worldwide issued patents and pending applications for the bavituximab oncology program.

Financial Results
Total revenues for the first quarter of FY 2016 were $9,671,000, compared to $5,496,000 for the same quarter of the prior fiscal year. The increase was primarily attributed to an increase in contract manufacturing revenue generated from Avid Bioservices.
Contract manufacturing revenue from Avid’s clinical and commercial biomanufacturing services provided to its third-party clients for the first quarter FY 2016 were $9,379,000, compared to $5,496,000 for the same quarter of the prior fiscal year. Peregrine expects third-party contract manufacturing revenue for FY 2016 to be between $30 and $35 million. In addition to providing biomanufacturing services to its third-party clients, Avid will continue to support the clinical and potential commercialization of bavituximab.

Total costs and expenses in the first quarter of FY 2016 were $23,425,000, compared to $18,667,000 in the first quarter of FY 2015. This increase was primarily attributable to current quarter increases in research and development expenses associated with the SUNRISE Phase III trial and increases in the cost of contract manufacturing associated with higher reported revenue. For the first quarter of FY 2016, research and development expenses were $13,918,000, compared to $10,201,000 for the first quarter of FY 2015. For the first quarter of FY 2016, cost of contract manufacturing was $4,608,000, compared to $3,583,000 for the first quarter of FY 2015.

Peregrine’s consolidated net loss attributable to common stockholders was $15,101,000, or $0.08 per share, for the first quarter of FY 2016, compared to a net loss attributable to common stockholders of $14,157,000, or $0.08 per share, for the same prior year quarter.

Peregrine reported $59,016,000 in cash and cash equivalents as of July 31, 2015 compared to $68,001,000 at fiscal year ended April 30, 2015.

More detailed financial information and analysis may be found in Peregrine’s Quarterly Report on Form 10-Q, which will be filed with the Securities and Exchange Commission today.

(Filing, 10-Q, Peregrine Pharmaceuticals, SEP 9, 2015, View Source [SID:1234507438])

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On September 9, 2015 Mirati Therapeutics, Inc. ("Mirati") (NASDAQ: MRTX), an oncology company focusing on genetic and epigenetic drivers of cancer, reported it will present data at the International Association of Lung Cancer (IASLC) 16th World Conference on Lung Cancer on the first non-small cell lung cancer (NSCLC) patient with AXL gene amplification enrolled in the MGCD265 Phase 1b expansion cohort (Filing, 8-K, Mirati, SEP 9, 2015, View Source [SID:1234507446]). Data will be presented showing the patient had a confirmed Partial Response (PR) based on RECIST criteria. Additionally, the Company announced a confirmed PR in a NSCLC patient with MET gene amplification who was enrolled in the MGCD265 expansion cohort.

"Out of four non-small cell lung cancer patients whom have had at least one scan in the ongoing MGCD265 expansion cohort, two patients have RECIST-confirmed PRs. Those PRs, together with tumor regressions seen in all four of these patients, demonstrate the potentially significant clinical benefit of MGCD265 in patients with lung cancer," said Charles M. Baum, M.D., Ph.D., President and CEO, Mirati. "The study is progressing well due to the enthusiasm of the clinical investigators, and this has resulted in increased screening and enrollment at the clinical trial sites. Currently, nine patients with MET or AXL genetic alterations have been enrolled in the study. In light of the dramatic response being presented in the patient with AXL gene amplification at today’s World Conference on Lung Cancer, we felt it was appropriate to provide an interim update on the program. As previously indicated, we will provide a more in-depth update when we have additional data."

NSCLC Patient with Axl Gene Amplification

The male patient was diagnosed with metastatic adenocarcinoma of the lung, with multiple tumors in both lungs which had spread to the lung cavity and lymph nodes. Prior to treatment with MGCD265, he had received multiple chemotherapies, as well as an experimental agent combined with chemotherapy, with the best response being disease progression. After 2 cycles of treatment with MGCD265, tumor imaging showed a PR with a tumor reduction of 42.3% compared to baseline. After 4 cycles of treatment, the PR was confirmed with a tumor reduction of 48.8% based on RECIST criteria. The patient, who remains on study in Cycle 7, also showed improvement in clinical symptoms. Prior to starting treatment with MGCD265, the patient was oxygen dependent. Shortly after treatment with MGCD265, he was off oxygen and able to ride his bike up to seven miles per day.

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"To our knowledge, this is the first reported case of an objective response in a patient with a tumor harboring AXL gene amplification," said Geoffrey Shapiro, Principal Investigator and Director of the Early Drug Development Center, Department of Medical Oncology, Dana-Farber Cancer Institute. "This response, coupled with the patient’s significant symptomatic improvement, provides clinical validation that AXL genomic alterations can result in oncogene addiction in patients with non-small cell lung cancer. We will continue to explore MGCD265, a potent kinase inhibitor, in patients with MET or AXL genomic alterations, in an effort to improve cancer treatment by targeting genetic drivers of cancer."

Data from the study will be presented on September 9, 2015 in an oral presentation titled, "Evaluation of the MET/Axl Receptor Tyrosine Kinase (RTK) Inhibitor MGCD265 in a Patient with Metastatic Non-Small Cell Lung Cancer (NSCLC) Harboring AXL Amplification" by Lynette Sholl, M.D, Assistant Professor, Translational Research Group, Brigham and Women’s Hospital. The presentation is part of the New Kinase Targets session, Treatment of Advance Diseases – NSCLC track (abstract # 3611) from 6:30 – 8:00 PM MT/5:30 – 7:00 PM PT in Colorado Convention Center, Four Seasons Ballroom F3+F4.

Interim Update on the Ongoing MGCD265 Phase 1b Expansion Cohort

MGCD265 is an inhibitor of the MET and Axl receptor tyrosine kinases which, when mutated or amplified, can be drivers of tumor growth. Preclinical data have shown that MGCD265 can potently inhibit tumor cell growth in vitro, and demonstrate marked tumor regression in tumor xenograft models exhibiting MET gene amplification and MET exon 14 deletions.

This multi-national, multi-site, open label, single agent study is designed to evaluate the safety, pharmacokinetics/pharmacodynamics and clinical activity of twice-daily MGCD265 in patients who have failed at least one prior therapy. The study continues to enroll patients with MET or AXL gene alterations. MGCD265 has been well tolerated at the recommended Phase 2 dose, which has demonstrated full inhibition of both MET and Axl tyrosine kinases, and is the only kinase inhibitor that we know of in clinical development that has demonstrated potent and selective inhibition of both MET and Axl.

As of September 1, 2015, 9 patients with genetic alterations in MET or AXL have been enrolled in the expansion cohort, including 7 with NSCLC and 2 with other solid tumors. The Company disclosed that 2 of the 4 NSCLC patients, who are currently evaluable (having had at least 1 on-treatment scan), have confirmed PRs based upon RECIST criteria, including the patient with AXL amplification highlighted above and a patient with MET gene amplification. Both patients remain on study. All 4 of the evaluable NSCLC patients showed clinically significant tumor regressions. Of the 9 patients enrolled, 7 remain on study for up to 8+ months.

About MET and Axl in NSCLC

MET is highly expressed in NSCLC tumors. Extensive preclinical and emerging clinical data indicate that MET is a driver of tumor growth when it is genetically altered by point mutations, exon 14 deletion mutations, and/or gene amplification in a significant fraction (6-7%) of NSCLC patients. MET gene amplification and MET mutations, including exon 14 deletion mutations, each exhibit the key characteristics of driver oncogenes in NSCLC.

Axl is over-expressed in patients with advanced NSCLC and has been associated with poor prognosis. Amplification and rearrangements of the AXL tyrosine kinase gene also appear to be a driver of tumor growth and occur in up to 2% of patients with NSCLC. Preclinical data has shown that dysregulation of Axl is implicated in tumor progression and resistance to standard and targeted cancer therapies. Extensive preclinical and clinical data also indicate that both MET and Axl are important factors in resistance to EGFR inhibitors, as well as the third-generation EGFR inhibitors.

About MGCD265

MGCD265 is a tyrosine kinase inhibitor that potently and selectively targets tumors in patients with driver alterations in MET (gene amplification and mutations) and AXL (gene amplification and rearrangements) that occur in approximately 8% of patients with non-small cell lung cancer (NSCLC). MGCD265 is in the expansion phase of a Phase 1/1b dose escalation study for NSCLC patients with MET or AXL genetic alterations. Genetic alterations in these targets have been implicated as drivers of tumor growth and disease progression in NSCLC, gastroesophageal cancer and other solid tumors. Mirati retains worldwide rights to MGCD265.

On September 8, 2015 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) and granted Priority Review for alectinib (known as Alecensa in Japan and the U.S.), an oral investigational anaplastic lymphoma kinase (ALK) inhibitor, for the treatment of people with ALK-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib (Press release, Hoffmann-La Roche , SEP 8, 2015, View Source [SID:1234507421]). Alectinib was granted Breakthrough Therapy Designation by the FDA in June 2013 for people with ALK-positive NSCLC whose disease progressed on crizotinib.

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"Alectinib was granted Priority Review by the FDA based on results from two studies showing the medicine shrank tumours in people with ALK-positive NSCLC that progressed on crizotinib," said Sandra Horning, M.D., Roche’s Chief Medical Officer and Head of Global Product Development. "There is a need for new treatment options in this patient population, especially because the disease often spreads to the brain at progression."

A Priority Review designation is granted to medicines that the FDA has determined to have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease. Breakthrough Therapy Designation is designed to expedite the development and review of medicines intended to treat serious or life-threatening diseases and to help ensure people have access to them through FDA approval as soon as possible. The NDA for alectinib includes data from two Phase II studies (NP28761 and NP28673), and the FDA will make a decision on approval by 4 March 2016.

ALEX, an ongoing, global randomised Phase III study is comparing alectinib to crizotinib as an initial (first-line) treatment for people with advanced NSCLC whose tumours were characterised as ALK-positive by a companion immunohistochemistry (IHC) test developed by Roche Diagnostics.

About the NP28761 and NP28673 Studies
Results from the Phase II NP28761 and NP28673 studies were recently presented at the 2015 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper).

NP28761 is a North American, single-arm, open-label, multicentre trial evaluating the safety and efficacy of alectinib in 87 people with ALK-positive NSCLC whose disease progressed on crizotinib.

– Response assessment by an independent review committee (IRC) showed that alectinib shrank tumours (objective response rate, ORR) in 47.8% (95% confidence interval [CI] 35.6%-60.2%) of people treated with alectinib, as measured by Response Evaluation Criteria in Solid Tumours (RECIST v1.1).
– Investigator assessment showed that alectinib shrank tumours in this group of people with a similar response rate (ORR of 46.0%, [95% CI 35.2%-57.0%]).

– Activity was also observed in the central nervous system (CNS), as shown by a CNS ORR by IRC of 68.8% (95% CI 41.3%-89.0%) in people whose disease had already spread to the brain or other parts of the CNS at study entry.

– People whose tumours shrank in response to alectinib continued to respond for a median of 7.5 months (duration of response [DOR], immature data).

– The immature median progression-free survival (PFS) was 6.3 months (95% CI 5.5 months–not estimable) based on 40% of events.

In study NP28761, alectinib demonstrated a safety profile consistent with that observed in previous studies.
– The most common Grade 3 or higher adverse events were increased muscle enzymes (increased blood levels of creatine phosphokinase; 8%), increased liver enzymes (alanine aminotransferase; 6%, and aspartate aminotransferase; 5%) and shortness of breath (dyspnea; 3%).

NP28673 is a global, single-arm, open-label, multicentre trial evaluating the safety and efficacy of alectinib in 138 people with ALK-positive NSCLC whose disease progressed on crizotinib.

– An IRC analysis showed that alectinib shrank tumours (ORR of 50.0%, [95% CI 40.8%-59.1%]) in this group of people, as measured by RECIST.

– Assessment by investigator was consistent with the IRC and also showed that alectinib shrank tumours in this group of people (ORR of 47.8%, [95% CI 39.3%-56.5%]).

– Activity was also observed in the CNS, as shown by a CNS ORR by IRC of 57.1% (95% CI 39.4%-73.7%) in people whose disease had already spread to the brain or other parts of the CNS at study entry.

– People who achieved a response continued to respond for a median of 11.2 months (DOR, immature data based on 33% of events, [95% CI 9.6 months-not estimable]).

– The median PFS for people who received alectinib was 8.9 months (95% CI 5.6 months-11.3 months) based on 58% of events.
Alectinib demonstrated a safety profile in study NP28673 consistent with that observed in previous studies.
– The most common Grade 3 or higher adverse event was shortness of breath (dyspnea; 4%).

About alectinib
Alectinib (RG7853/AF-802/RO5424802/CH5424802) is an oral medicine created at Chugai Kamakura Research Laboratories for certain people with NSCLC whose tumours are identified as ALK-positive. ALK-positive NSCLC is often found in younger people who have a light or non-smoking history. The people whose NSCLC is ALK-positive almost always have adenocarcinoma.
Early studies with alectinib have shown activity on brain metastases, indicating that the drug may be taken up in the brain. The brain is protected by the Blood-Brain Barrier, a network of tightly joined cells that line the inside of the blood vessels in the brain and spinal cord. One of the ways the Blood-Brain Barrier prevents molecules from affecting the brain is to actively eject them from the barrier through a process known as ‘active efflux’. The active efflux system does not recognise alectinib, which means that it may travel into and throughout brain tissue.

The Global Phase III studies of alectinib include a companion test developed by Roche Diagnostics. Alectinib is marketed in Japan by Chugai Pharmaceutical, a member of the Roche Group.

About Roche in lung cancer
Lung cancer is a major area of focus and investment for Roche, and we are committed to developing new approaches, medicines and tests that can help people with this deadly disease. Our goal is to provide an effective treatment option for every person diagnosed with lung cancer. We currently have two approved medicines to treat certain kinds of lung cancer and more than 10 medicines being developed to target the most common genetic drivers of lung cancer or to boost the immune system to combat the disease.