On September 23, 2019 Flagship Pioneering, a unique life science innovation enterprise, reported that it unveiled Omega Therapeutics – a genomics medicine company focused on selectively directing the human genome to treat and cure disease by precisely controlling genomic expression without changing nucleic acid sequences (Press release, Omega Therapeutics, SEP 23, 2019, View Source [SID1234561269]). Mahesh Karande has been appointed as the company’s President, CEO and member of the Board of Directors. Mr. Karande was the former President and CEO of Macrolide Pharmaceuticals and a long-time Novartis AG executive where he held positions of increasing responsibility running large businesses in the U.S. and internationally. Flagship Pioneering developed and launched Omega Therapeutics through its innovation foundry, Flagship Labs.

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Since its founding in 2017, under the leadership of David Berry, M.D., Ph.D., General Partner of Flagship Pioneering, Omega Therapeutics has created a proprietary platform that precisely tunes Insulated Genomic Domains (IGDs), the fundamental regulator, or GenomStats, of the human genome, which are 3D closed-loop structures of DNA that control genomic activity, to unlock the native power of the genome to cure diseases. This enables the unique, rapid development of specific therapeutics that treat disease and help patients, without altering nucleic acid sequences, with implications across a variety of indications. Engineered genomic modulators, called Omega Controllers, precisely tune genomic activity to desired therapeutic levels to address the biological root of disease. Our therapeutics are designed to be more specific and durable and, as such, potentially more effective therapeutic options for patients.

"By mapping the topology of the human genome and using computational biology, we have been able to identify the correct genomic target for a therapeutic influence. Omega’s proprietary platform technology allows us to develop therapeutics for disease control, and potentially impact the way we treat and manage a broad range of illnesses," said Dr. Berry. "In addition to our own capabilities for therapeutic development, our technology also presents the opportunity to partner and optimize other targeted in vivo and ex vivo therapeutics to enhance their ability to treat disease and further help a wide range of patient populations with significant unmet needs."

Many health conditions, particularly complex diseases, are the result of malfunctions in the regulation of gene expression. Omega leverages the founding Flagship team’s pioneering innovations that extended the breakthrough work on epigenetics by Richard Young, Ph.D., Professor of Biology, Massachusetts Institute of Technology, and Member of the Whitehead Institute, and Rudolf Jaenisch, M.D., Professor of Biology, Massachusetts Institute of Technology and Founding Member of the Whitehead Institute, who first described how genomic activity is controlled by 3D closed-loop structures of DNA, now called Insulated Genomic Domains (IGDs), that contain one or more genes and their regulatory elements.

These insulated, or closed-loop, structures ensure that interaction between the regulatory elements and gene(s) leading to gene expression is contained within the IGD. Diseases often manifest due to alterations in gene expression or changes in IGD structure. As such, the IGD is the fundamental regulator, or GenomStat, of the human genome. Omega is pioneering the discovery and development of precision Omega Controllers to control the GenomStat. By precisely tuning the GenomStat, Omega Controllers regulate single- or multi-gene expressions to desired levels to treat or cure disease. Scientific strategy and research and development will be led by Chief Science Officer, Thomas McCauley, Ph.D., former Shire executive and more recently CSO of Macrolide Pharmaceuticals and CSO of Translate Bio (formerly RaNA Therapeutics).

"Flagship is focused on discovering value and innovating well beyond the boundaries of current research in order to build first-of-their-kind companies. Omega’s proprietary product-platform is taking an entirely new approach to tackling important, unsolved diseases," said Noubar Afeyan, Ph.D., Chief Executive Officer of Flagship Pioneering and Chair of Omega’s Board of Directors. "The executive team, board of directors and scientific advisors have created an unparalleled company that fits the extraordinary scope of the therapeutic potential of Omega Controllers, a new class of medicines."

"The depth and breadth of our platform gives us the ability to create transformative genomic medicines that deliver specificity of targeting, tunability, and durability of single and multi-gene expression, all without altering nucleic acid sequences. Our platform enables us to develop proprietary Omega Controllers, a new class of therapeutics targeting the control of a wide range of diseases in unprecedented ways," said Mr. Karande. "With a team of world-class scientists, founders and advisors, we are already executing several ambitious early-stage discovery programs in the near-term, as we strengthen our platform to address the vast opportunity of treating diseases resulting from genomic malfunction or dysregulation."

Omega Therapeutics is targeting the biological root of disease and designing novel therapeutics and optimizing current therapies to potentially address a wide range of disease categories, including rare genetic diseases, immunology, inflammation, metabolic diseases and oncology.

The Omega Therapeutics Board of Directors:

– David Berry, M.D., Ph.D., General Partner, Flagship Pioneering, Co-founder, Omega Therapeutics

– Richard Young, Ph.D., Professor of Biology, Massachusetts Institute of Technology, Member, Whitehead Institute

– Paul-Peter Tak, M.D., Ph.D., Chief Executive Officer, Kintai Therapeutics, Venture Partner, Flagship Pioneering, former Senior Vice President and Global Head of R&D for Immuno-inflammation, Oncology and Infectious Disease, as well as Chief Immunology Officer, GlaxoSmithKline (GSK)

– Mary Szela, Chief Executive Officer, TriSalus Life Sciences, former Chief Executive Officer, Novelion Therapeutics, and Chief Executive Officer, Melinta Therapeutics

– Mahesh Karande, President and Chief Executive Officer, Omega Therapeutics

– Noubar Afeyan Ph.D., Co-founder and Chairman of the Board, Omega Therapeutics, CEO Flagship Pioneering

ABOUT MAHESH KARANDE, PRESIDENT AND CHIEF EXECUTIVE OFFICER

Mahesh Karande is deeply experienced in running biopharma businesses across discovery, preclinical development, clinical development, commercialization and product life-cycle management stages. He has strong leadership and operational experience combined with a global work history spanning the United States, Europe, Asia and Africa. Most recently, Mr. Karande, as President and CEO, took Macrolide Pharmaceuticals, from discovery into early development. Earlier, Mr. Karande spent several years at Novartis, leading various U.S. and international business units. Mr. Karande left Novartis to join Intarcia Therapeutics as VP and General Manager to lead the launch of their first product; a role he left to take the helm at Macrolide.

On September 23, 2019 Innate Pharma SA (the "Company" – Euronext Paris: FR0010331421 – IPH) reported that it will provide an update on its clinical trial pipeline at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2019 Congress in Barcelona, Spain, September 27-October 1, 2019 (Press release, Innate Pharma, SEP 23, 2019, View Source [SID1234539684]). Highlights will include preliminary results of STELLAR-001, a Phase I dose escalation study of the anti-C5aR antibody, IPH5401, in combination with durvalumab in advanced solid tumors. In addition, updated data from ongoing clinical trials evaluating lead asset, monalizumab, partnered with AstraZeneca, will be presented.

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"We are very pleased to present new data on two of our clinical assets at ESMO (Free ESMO Whitepaper) Congress 2019. Our poster on IPH5401 will be the first clinical data presentation for this agent in combination with an anti-PD-L1 antibody in oncology," commented Pierre Dodion, Chief Medical Officer of Innate Pharma. "We will also present late follow-up clinical data on the combination of monalizumab and cetuximab in head and neck cancer. We look forward to sharing this new, promising clinical data to the medical community."

Poster presentations September 30, 2019, 12:00-13:00 – Poster Area Hall 4

Preliminary results of STELLAR-001, a dose escalation phase I study of the anti-C5aR, IPH5401, in combination with durvalumab in advanced solid tumors. (ID 1285)
Poster #1203P | Presenter: Christophe Massard (Villejuif, France)
Monalizumab in combination with cetuximab in patients (pts) with recurrent or metastatic (R/M) head and neck cancer (SCCHN) previously treated or not with PD-(L)1 inhibitors (IO): 1-year survival data. (ID 1242)
Poster #1134P | Presenter: Roger B. Cohen (Philadelphia, PA, USA)
Durvalumab + monalizumab, mFOLFOX6, and bevacizumab in patients (pts) with metastatic microsatellite-stable colorectal cancer (MSS-CRC) (ID 3681)
Poster #1201P | Presenter: May Cho (Sacramento, CA, USA)

On September 23, 2019 Immune Therapeutics, Inc. (OTC: IMUN) (IMUN) ("Immune" "IMUN" or the "Company"), a clinical late-stage T-Cell Activation biopharmaceutical company focused on the development immunotherapies for the treatment of autoimmune and inflammatory conditions, cancer, HIV/AIDS and animal diseases on a global basis is reported the appointment of Michael K. Handley as the new Chief Executive Officer of Immune Therapeutics’ and Member of the Board of Directors (Press release, Immune Therapeutics, SEP 23, 2019, View Source [SID1234539700]). IMUN also announces the resignation of its former CEO, and Director, Noreen Griffin.

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Mr. Handley maintains an extensive background in the life science sector, dating back over two decades with cross-functional experience in product commercialization, regulatory and clinical affairs, operations, mergers and acquisitions, financing, market development and partnering/licensing. He has founded multiple health industry enterprises and held executive, management and advisory positions in a substantial number of leading public and private pharmaceutical and biotechnology companies. Mr. Handley retains an expansive history in drug development with multiple patents and peer-reviewed publications in the areas of oncology, anti-infectives, inflammation and neuroscience. He has assisted or led in the global commercialization of seventeen products that account for over six billion dollars in sales annually and has secured millions of dollars in private equity and venture capital for numerous high growth organizations.

"We are pleased to welcome Michael Handley, a highly regarded professional in our field, and believe he is a good fit with our development strategy and look forward to benefiting from his extensive experience and perspective. Mr. Handley is a distinguished Pharmaceutical Executive who adds a vast degree of knowledge and experience to Immune Therapeutics as we restructure and move forward with the development and commercialization of our pipeline of immunotherapies."" stated Dr. Roscoe Moore, Jr. DVM, MPH, PhD Former Assist US Surgeon Gen (retired)., Chairman of the Board, Immune Therapeutics. Dr. Moore Jr. added, "On behalf of the Immune Therapeutics Board of Directors, I would also like to thank Ms. Griffin for her contributions during the five years that she has led Immune Therapeutics, Inc."

Mr. Handley is currently the Chief Executive Officer and Chairman at Aletheia Therapeutics Corp. a private biopharmaceutical company focused on the development and commercialization of therapies for the treatment of cancer. Additionally, he holds board positions at Medavate Corp. and Symbios Technologies, Inc. He has held leadership positions at Johnson & Johnson and Amgen, as well as Genentech, where he assisted in the launch of Avastin & Tarceva. Mr. Handley retained numerous roles in an Executive capacity that contribute to his seasoned global expertise in the drug development arena including former Chief Executive Officer and Director at Armis Biopharma, Inc., Vice President of Quality, Clinical and Regulatory Affairs at Vessix Vascular, Inc. (acquired by Boston Scientific), Chief Compliance Officer and Vice President of Global Regulatory Affairs at The Spectranetics Corporation (acquired by Phillips) and Executive Affiliate/Senior Principal for the management-consulting firm Pittiglio Rabin Todd & McGrath (acquired by PricewaterhouseCoopers). In addition to a multitude of other healthcare positions, Mr. Handley graduated from Colorado State University with degrees in Biology and Physiology and minors in chemistry and neuroanatomy. He also attended the executive MBA program at the Graziadio School of Business and Management at Pepperdine University.

"Michael Handley has had a distinguished career as a successful drug developer in the biopharmaceutical industry with expertise in leading clinical strategy, design and management of novel oncology and inflammatory programs, experience that aligns perfectly with our goal to bring our T-Cell Activation therapies to patients in need," said Noreen Griffin, former Chief Executive Officer and Director, Immune Therapeutics. "Mike brings to Immune Therapeutics significant business development and strategy experience, perfectly suited to help us maximize the opportunities we see with our platform. On behalf of the entire team, I want to welcome Michael K. Handley and we look forward to his leadership and contributions."

"I am excited to be joining Immune Therapeutics and leading the effort to develop and commercialize the next generation of immunotherapies" said Mr. Handley. "I believe there is an opportunity to fundamentally change the way we treat cancer and other disease states by using new agents that target the activity of the human immune system."

On September 23, 2019 City of Hope reported that it has opened and is treating the first patients in its CAR T cell trial for prostate cancer that has spread to other parts of the body (Press release, City of Hope, SEP 23, 2019, View Source [SID1234539717]). The trial uses a CAR T cell – also developed at City of Hope – that targets the prostate stem cell antigen (PSCA) in prostate cancer.

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The trial, which can enroll up to 33 patients, aims to find the appropriate dose of PSCA CAR T cells that a patient should receive and any side effects that the treatment may cause. Researchers will also study the expansion and persistence of the CAR T cells, survival outcomes and other findings.

Patients with PSCA-positive castration-resistant prostate cancer that has metastasized to other areas in the body, and who meet other requirements, are eligible for the trial, which includes the National Cancer Institute as a collaborator.

According to the American Cancer Society (ACS), other than skin cancer, prostate cancer is the most common cancer in American men. The ACS estimates that about 174,650 men will be diagnosed with new cases of prostate cancer and about 31,620 deaths will occur due to prostate cancer.

"Patients with advanced prostate cancer are in urgent need of a therapy that could provide a more durable remission," said Tanya Dorff, M.D., City of Hope associate clinical professor in the Department of Medical Oncology & Therapeutics Research, head of the Genitourinary Cancers Program and the trial’s principal investigator. "CAR T cell therapy has cured some cancers that are difficult to treat, and we want to know if we can do that for prostate cancer. Our hope is that this CAR T cell therapy can be a game changer for these patients."

CAR T cell therapy involves taking a patient’s immune cells, known as T cells, from the bloodstream. They are then reprogrammed in a laboratory to recognize and attack a specific cancer-causing protein, such as PSCA, and reintroduced into the patient’s bloodstream, where they get to work destroying targeted tumor cells.

City of Hope will manufacture the CAR T cells using in its own facility, the Cellular Therapy Production Center. This process includes a critical step: The patient’s T cells are reprogrammed with viruses engineered in another of City of Hope’s GMP facilities, the Center for Biomedicine & Genetics. These two facilities, coupled with its Chemical GMP Synthesis Facility, make City of Hope one of the few cancer centers in the world with the ability to produce GMP cellular, genetic and drug-based therapies for its patients.

City of Hope developed the CAR design in its own laboratory with a goal of finding the most effective and long-lasting CAR T cell to target PSCA.

"Developing a CAR T cell therapy for solid tumors is particularly challenging because they need to first reach the solid tumor and then survive in a harsh microenvironment that is filled with cancer cells and other cells that make up the tumor mass," said Saul Priceman, Ph.D., assistant professor in City of Hope’s Department of Hematology & Hematopoietic Cell Transplantation. "This CAR design has allowed for optimal cytokine production, which are chemical messengers that help enhance the anti-tumor activity of a CAR T cell, and destruction of prostate stem cell antigen (PSCA)-positive prostate cancers by the CAR T cells."

The trial is one of the first CAR T trials for prostate cancer in the nation. Since the late 1990s, City of Hope has been a leader in advancing CAR T cell therapies across a range of blood cancers and, in recent years, it has also opened trials for solid tumors, including brain cancer (glioblastoma) for adults and children, HER2-positive breast cancer that has metastasized to the brain and this prostate cancer trial.

City of Hope patents covering the PSCA CAR have been licensed to Mustang Bio.

City of Hope received a Challenge Award in 2013 from the Prostate Cancer Foundation (PCF) to support the CAR T cell therapy’s preclinical development, and in 2016 from PCF, which was matched by City of Hope, to fund the clinical trial. Research is also supported by a generous gift from Barbara and Zach Horowitz and Gary Marsh and Jody Horowitz Marsh.

The trial is part of City of Hope’s T Cell Therapeutics Research Laboratory, which currently has 20 open CAR T and T cell clinical trials.

On September 23, 2019 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on harnessing the body’s immune system to fight cancer, reported that Mohummad Siddiqui, MD, Associate Professor of Surgery at the University of Maryland School of Medicine (UMSOM) has joined its ongoing prostate cancer Cchek Study (Press release, Anixa Biosciences, SEP 23, 2019, View Source [SID1234539685]).

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UMSOM is one of several sites across the United States participating in this study. Study enrollment will be led by Dr. Mohummad Siddiqui, who is also the Director of Urologic Oncology and Robotic Surgery and Chief of Urology at the Baltimore VA Medical Center.

"We are pleased to be working with Dr. Siddiqui and the University of Maryland School of Medicine to further develop our artificial intelligence based prostate cancer diagnostic test," stated Dr. Amit Kumar, President and CEO of Anixa Biosciences. "Significant progress has been made in our efforts to advance the Cchek Prostate Cancer Confirmation test toward commercial launch later this year. We believe the Cchek early cancer detection platform will make a great impact on patient care, and we are pleased by the continued additions to our team of collaboration partners."