On July 12, 2016 Prima BioMed Ltd (ASX: PRR; NASDAQ: PBMD) reported a new collaborative study investigating the intra-tumoural injection of IMP321 (Filing, 6-K, Prima Biomed, JUL 12, 2016, View Source [SID:1234513866]). The investigator sponsored study will be conducted by the Institute of Clinical Cancer Research, Krankenhaus Nordwest GmbH in Frankfurt Germany ("IKF"; Institute for clinical oncology research at the Northwest University Hospital in Frankfurt). The new study will explore the potential for IMP321 as an activator of dendritic cells found within solid cancer tumours.
The new clinical trial is called "INSIGHT: An explorative, single centre, open-label, phase I study to evaluate the feasibility and safety of intra-tumoural, intra-peritoneal, and subcutaneous injections with IMP321 (LAG-3Ig fusion protein) for advanced stage solid tumour entities".

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The Lead Investigator of this up to 40 patients trial is Professor Doctor Salah-Eddin Al-Batran, the Medical Director of the IKF. The study will commence subject to receiving the necessary approvals from the competent regulatory authority and ethics committee.
Dr Al-Batran commented: "The promising results from previous studies and favourable safety profile of IMP321 have led us to conduct a phase I trial investigating a potential enhancement of the immune-activating effects of IMP321 by new routes of administration. Furthermore, we will explore the possibility to extend the positive results obtained by subcutaneous injections of IMP321 in metastatic renal cell and breast carcinomas to further solid tumour entities."

Marc Voigt, Chief Executive of Prima, said: "This is potentially an exciting new therapeutic application for IMP321 and is the result of the extensive research carried out by Dr Frédéric Triebel and the Prima team in our Paris laboratory. It is the first ever investigation into whether direct injection of IMP321 into a solid tumour can activate the antigen presenting cells located inside the tumour to boost the body’s immune response. As this trial is investigator initiated, it will also not require any significant near-term resource commitment from Prima."

Clinical Trial Synopsis

Title of Study INSIGHT: An explorative, single centre, open-label, phase I study to evaluate the feasibility and safety of intra-tumoural, intra-peritoneal, and subcutaneous injections with IMP321 (LAG-3Ig fusion protein) for advanced stage solid tumour entities
Objectives
Feasibility, safety and toxicity
Immune response in whole blood and tumour tissue
Identification of biomarkers that correlate with clinical response / clinical outcome
Study design Monocentre, open-label, phase I study
Planned Sample size up to 40 patients
Clinical trial identifier: To be determined

On July 12, 2016 Flagship Ventures reported the merger of its portfolio companies Evelo Biosciences and Epiva Biosciences to create the leading immuno-microbiome company, developing therapeutics for cancer, autoimmune and inflammatory diseases (Press release, Evelo Biosciences, JUL 12, 2016, View Source [SID:1234513849]). The new entity will keep the name Evelo Biosciences and operate under the leadership of CEO and President, Simba Gill, Ph.D. Noubar Afeyan, Ph.D., CEO of Flagship Ventures, was named chairman of the combined company.

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Evelo and Epiva were both founded by Flagship’s VentureLabs innovation foundry in 2014 and followed the lineage of prior VentureLabs-founded microbiome companies Seres Therapeutics (launched in 2012) and Indigo Agriculture (launched in 2013). The Evelo-Epiva merger results in a 42-person company and combines each team’s pioneering research findings, product candidates and intellectual property protected by over 50 patents and applications. Flagship has financed the company with about $40 million to date and plans to make additional investments to support its rapid growth.

The combined entity establishes the definitive immuno-microbiome therapeutics platform, building upon both organizations’ recognition that the microbiome and immune system interact to form a largely unrecognized and uncharacterized metasystem, the immuno-microbiome. Evelo is at the forefront of deciphering the interactions between the immune system and the microbiome to discover novel therapeutics.

"The immune system functions in the context of its interactions with the microbiome and vice versa. Deciphering these interactions presents significant opportunities to develop new medicines for patients across multiple disease areas, including next wave cancer immunotherapy and treatment for autoimmune and inflammatory diseases," said Dr. Afeyan, Chairman, Evelo Biosciences and CEO of Flagship Ventures. "As the microbiome field begins to turn its attention to diseases beyond gut infections, we see the combination of these two first-mover companies as an important strategic development aimed at creating sufficient critical mass to lead the field."

"I look forward to accelerating and broadening Evelo’s development through this strategic combination," said Dr. Gill "With our expanded team working together on the immuno-microbiome, we expect to more rapidly advance multiple new product candidates into the clinic, build partnerships and deliver important treatments to patients who need them."

Mark Pruzanski, M.D., co-founder, CEO and President of Intercept Pharmaceuticals, Inc. and David Perry, CEO and President of Indigo Agriculture, join Chairman Noubar Afeyan, Ph.D., CEO Simba Gill, Ph.D., and co-founder David Berry, MD., Ph.D., on Evelo’s Board of Directors. Evelo also has made additions to its executive leadership team: Jackie Papkoff, Ph.D., Senior Vice President, Research; Anil Jina, M.D., Chief Medical Officer; and Derek Adams, Ph.D., Senior Vice President, CMC.

About the New Board Members
Dr. Pruzanski is a co-founder, CEO and President of Intercept Pharmaceuticals, Inc., and has extensive experience in founding and building numerous other life science companies. Before starting Intercept Pharmaceuticals, he was previously a venture partner at Apple Tree Partners, an early-stage life sciences venture capital firm he co-founded in 1999.

Mr. Perry, CEO of Indigo Agriculture, is a serial entrepreneur who has founded and built three innovative companies in the last 18 years, leading the last two through successful IPOs and to multi-billion-dollar market capitalizations. Mr. Perry was most recently CEO and co-founder of Anacor Pharmaceuticals, a biopharmaceutical company, discovering and developing novel small-molecule therapeutics to treat infectious and inflammatory diseases.

Additions to the Executive Leadership Team
Dr. Papkoff joins Evelo as Senior Vice President, Research from the J&J California Innovation Center, where she was one of the founding members and served as Vice President of Immunology. She has held leadership roles in several biotech and pharma companies, including Aventis Pharma, diaDexus Corporation and Megabios Corporation, and was a consulting professor of cancer biology at Stanford University for 10 years.

Dr. Adams is the Senior Vice President, CMC at Evelo Biosciences. During his career, Dr. Adams has focused on the process development and manufacturing of human therapeutics including vaccines, small molecules, and proteins. Prior to Evelo, Dr. Adams was the Vice President of Technical and Strategic Product Development at Alexion Pharmaceuticals, Inc. and lead teams responsible for process technical support of drug substance manufacturing of Varicella and Rotavirus vaccines at Merck & Co. Inc.
Dr. Jina joins Evelo as Chief Medical Officer from Shire where he was Senior Vice President and Head of Global Medical Affairs. Prior to that, Dr. Jina worked at Sanofi as Region Medical Officer, Europe and Country Medical Head, Ireland and at Pfizer as Global Medical Director, Psychiatry and CNS Medical Adviser, UK. He brings extensive global biopharmaceutical industry and clinical experience across multiple therapeutic areas.

On July 12, 2016 Juno Therapeutics, Inc. (Nasdaq: JUNO), a biopharmaceutical company focused on re-engaging the body’s immune system to revolutionize the treatment of cancer, reported that the U.S. Food and Drug Administration has removed the clinical hold on the Phase II clinical trial of JCAR015 (known as the "ROCKET" trial) in adult patients with relapsed or refractory B cell acute lymphoblastic leukemia (r/r ALL) (Press release, Juno, JUL 12, 2016, View Source [SID:1234513848]).

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Under the revised protocol, the ROCKET trial will continue enrollment using JCAR015 with cyclophosphamide pre-conditioning only.