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Iovance Biotherapeutics, Inc., Corporate Presentation – July 2019

On July 2, 2019, Iovance Biotherapeutics, Inc. (the "Company") presented its corporate presentation (Presentation, Iovance Biotherapeutics, JUL 2, 2019, View Source [SID1234537373]).

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Immunicom Secures $11 Million in Series B Investment Round

On July 2, 2019 Immunicom, Inc., a biotechnology company awarded FDA Breakthrough Device Designation for its non-pharmaceutical solution for treating late-stage metastatic cancer, reported that raised $11 million in a Series B investment round (Press release, Immunicom, JUL 2, 2019, View Source [SID1234537372]). Several private equity family offices participated in the Series B financing which now increases Immunicom’s overall capital raised to $20 million.

"Proceeds from this financing will help fund the 170-patient, randomized, multi-center, triple-negative breast cancer clinical trial we began May 31, while also fueling continued expansion of Immunicom’s global strategic partnerships," said Amir Jafri, the company’s Founder and CEO. "We are making great strides towards our vision of introducing a cancer immunotherapy that has the potential to be safer than most presently available treatments and very cost-effective. We truly appreciate the ongoing support of our investment partners for enabling us to achieve a rapid growth trajectory."

The revolutionary new immunotherapy treatment Immunicom has developed is called Immunopheresis and offers the potential to revitalize a cancer patient’s immune system to naturally fight tumor cells without introducing any new chemicals, proteins or antibodies into the body. Performed utilizing out-patient procedures analogous to standard dialysis treatments for removing unwanted waste products from a patient’s bloodstream through external filtration, Immunopheresis uses Immunicom’s proprietary blood filtering device technology to extract tumor-produced proteins in the bloodstream that inhibit the body’s natural immune system from attacking and eradicating tumors. This approach provides for a potentially robust immune response against the tumor cells and is intended to function also as an ideal adjunct therapy to existing treatments.

"Immunicom is uniquely positioned to have a fundamental impact on improving the lives of cancer patients worldwide," added David Schlotterbeck, Chairman of Immunicom and the former Co-Chairman of Cardinal Health. "Successfully bringing to market a medical device that not only has strong potential to treat a wide variety of cancer types, but with relatively straightforward design modifications may be reconfigured to treat other major illnesses as well, would be an industry game-changer. And that is precisely the objective our organization strives to achieve."

GNS Healthcare Chosen to Present Discovery of New Clinical Predictors of Overall Survival in Metastatic Colorectal Cancer at ESMO 2019 in Collaboration with the Alliance for Clinical Trials in Oncology

On July 2, 2019 GNS Healthcare (GNS), a leading precision medicine company, together with the Alliance for Clinical Trials in Oncology (Alliance), is reported discoveries of predictive biomarkers for metastatic colorectal cancer (mCRC) patient response to receiving different treatments of cetuximab, bevacizumab, and panitumumab this week at the ESMO (Free ESMO Whitepaper) World Congress on Gastrointestinal Cancer 2019 conference held in Barcelona, Spain (Press release, GNS Healthcare, JUL 2, 2019, View Source [SID1234537371]). Patient subpopulation-specific prognostic factors of overall survival (OS) were also discovered. The in silico patient models identified AST level, primary side of tumor, intra-abdominal metastasis status as ubiquitous predictors of OS. KRAS status and hemoglobin levels were found to be predictors specific to the side of tumor location.

The study titled "Bayesian machine learning on CALGB/SWOG 80405 (Alliance) and PEAK data identifies heterogeneous landscape of clinical predictors of overall survival (OS) in different populations of metastatic colorectal cancer (mCRC)" was selected to be presented in a poster discussion session, Friday July 5 from 10 am–5:15 pm local time.

Identification of prognostic factors of OS for subpopulations of patients with colorectal cancer is the key to better risk stratification at treatment initiation and identifying predictive factors for treatment response is crucial for making personalized treatment decisions.

In this study, one of several conducted by GNS and the Alliance, Bayesian machine learning approach was applied to the CALGB/SWOG 80405 (Alliance) and PEAK clinical trials datasets to discover gender and primary side specific predictors of OS in mCRC and patient subpopulations with better response to a given treatment.

Using clinical data from more than 2,000 patients with mCRC and GNS’ powerful causal AI platform, Reverse Engineering & Forward Simulation (REFS), nine independent predictive model ensembles were built to understand predictive biomarkers for patient response to receiving different treatments (cetuximab, bevacizumab, or panitumumab) and to identify patient subpopulation-specific prognostic factors of OS.

The study also identified gender-specific predictors, specifically creatinine level, intra-abdominal metastasis status, and the interaction of albumin and neutrophil levels. Urine protein levels were shown to be predictive of better efficacy from cetuximab treatment in patients with mCRC and left-sided tumors.

"We have never been in a better position to unravel drivers of disease and patient response to specific drugs. We built an in silico patient model of colorectal cancer and were able to uncover biomarkers that tell us which patients will respond to which treatment, and most importantly, why. This is what will get us to the point of delivering personalized medicine and eradicating disease," said Colin Hill, GNS Chairman, CEO, and Co-Founder.

"There is no such thing as a one-size-fits-all approach," said Alan P. Venook, MD, Study Chair for the CALGB/SWOG 80405 (Alliance) study, Madden Family Distinguished Professor of Medical Oncology and Translational Research at the University of California-San Francisco, and Shorenstein Associate Director for Program Development at the Helen Diller Family Comprehensive Cancer Center. "The better we understand how this disease progresses and which biomarkers predict treatment response, the closer we will get to curing it. We are committed to leveraging the best tools at hand – GNS’ powerful AI, comprehensive data, and the best minds in research – to cure cancer."

Previous results from these collaborations were presented in June 2018 at the ASCO (Free ASCO Whitepaper) Annual Meeting in Chicago, Illinois and at ESMO (Free ESMO Whitepaper) 2018 in Munich, Germany.

As one of the most common cancers in the U.S., there are an estimated 140,000 new cases of colorectal cancer diagnosed each year. There is still much to learn about the factors that drive progression and for patients with mCRC, the optimal treatment is still unknown.

About the Alliance for Clinical Trials in Oncology
The Alliance for Clinical Trials in Oncology develops and conducts clinical trials with promising new cancer therapies, and utilizes the best science to develop optimal treatment and prevention strategies for cancer, as well as research methods to alleviate side effects of cancer and cancer treatments. The Alliance is part of the National Clinical Trials Network (NCTN) sponsored by the National Cancer Institute (NCI) and serves as a research base for the NCI Community Research Oncology Program (NCORP).
To learn more about the Alliance, visit www.AllianceforClinicalTrialsinOncology.org.

Apexian Pharmaceuticals’ Clinical Candidate, APX3330, to Be Studied in Diabetic Models of Preleukemic Cells With Specific Mutations to Leukemia

On July 2, 2019 Apexan Pharmaceuticals, Inc. is reported that The National Heart, Lung and Blood Institute (NHLBI) of the National Institutes of Health has awarded a $2.3 million grant to Dr. Reuben Kapur and Dr. Mark R. Kelley, investigators in the Wells Center for Pediatric Research at the IU School of Medicine, to conduct studies that focus on preleukemic stem cells bearing specific mutations and their progression to full-blown cancer in the context of diabetes (Press release, Apexian Pharmaceuticals, JUL 2, 2019, View Source [SID1234537370]). The funds will also be used to examine and assess cancer progression in animal models under conditions of hyperglycemia, or high blood sugar, over the next four years. In these studies, they will build on their recently published work in Cell Stem Cell, demonstrating that APX3330 blocks this progression under conditions of inflammation.

APX3330 is a lead compound of Apexian Pharmaceuticals, Inc., a clinical stage drug development company focused on advancing APX3330 for the treatment of diseases mediated by the APE1/Ref-1 protein. Dr. Kelley is the Chief Scientific Officer of Apexian.

Results of Apexian’s recently completed Phase I clinical trial of APX3330 in patients with advanced, end-stage solid tumors were presented at the annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper). The study confirmed the safety profile of APX3330 when given chronically as an orally-administered pill and identified a recommended phase II dose for further clinical development of APX3330 in a variety of possible indications.

Tumor biopsy data from the study confirmed the mechanism of action of APX3330 interacting with its molecular target, the APE1/Ref-1 protein, a gatekeeper for transcription factor activity. According to Dr. Kelley, "Given the importance of the APE1/Ref-1 protein in a variety of disease processes, including cancer, diabetic macular edema (DME) and inflammatory bowel disease (ulcerative colitis) and others, the phase I results confirm APX3330’s ability to control the drug target in humans. The NHLBI grant will be used to increase our understanding of the links between diabetes and cancer, allowing us to explore the potential of APX3330 in these areas of high unmet medical need."

A2A Pharmaceuticals Appoints Dr. Sotirios Stergiopoulos Chief Executive Officer

On July 2, 2019 A2A Pharmaceuticals Inc. (A2A), a biotechnology company committed to the advancement of innovative scientific research and new therapeutic agents, reported the appointment of Dr. Sotirios G. Stergiopoulos as President and Chief Executive Officer (Press release, A2A Pharmaceuticals, JUL 2, 2019, View Source [SID1234537369]). He has held the position as Founder and Chairman of the Board since 2016. Sotirios will maintain a seat on the Board of Directors.

Dr. Stergiopoulos joins A2A from Ipsen where he served as the Chief Medical Officer, SVP and Head of Global Medical Affairs since January 2017. In this role, he was responsible for the overall medical and clinical governance of the company, as well as the creation of a global medical affairs organization. Dr. Stergiopoulos played a key role in Ipsen’s oncology TA strategy. Sotirios held numerous leadership positions in the pharmaceutical industry with companies including Novartis, Bayer, and Celgene.

Dr. Stergiopoulos is a physician executive with a B.S. from Stony Brook University, an M.D. from Poznan University of Medical Sciences, and an M.B.E.E. from the Johns Hopkins University. He has trained at the National Institutes of Health, the Albert Einstein College of Medicine, and Harvard University.

Edward Painter, who has served as CEO of A2A since 2016, will take the role of Chief Investment Officer and Chairman of the Board. Edward will work with Sotirios to optimize the allocation of capital across A2A’s programs and build the management team.

Mr. Painter remarked, "I am delighted to have succeeded in recruiting Sotirios to the CEO role at A2A. His leadership in the pharmaceutical industry, as well as experience in clinical medicine and Oncology drug development, will be critical to A2A’s advancement of therapeutics for Oncology and other life-threatening diseases into the clinic for the patients that need them."

Dr. Stergiopoulos explained, "A2A’s novel approach to drug development has the potential to bring true best in class therapies to patients suffering with cancer and other difficult to treat diseases. I am encouraged by the platform utilized by A2A to pursue difficult targets and look forward to working alongside Edward and the team at A2A to translate the technology into therapies for patients."