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Oncodesign announces the launch of its first clinical study on a
radiotracer in patients with non-small cell lung cancer

On July 12, 2016 ONCODESIGN (ALONC – FR0011766229), a biotechnology company serving the pharmaceutical industry in the discovery of new therapeutic molecules to fight cancer and other serious illnesses with no known effective treatment, reported the official launch of a clinical study focusing on the evaluation of its first radiotracer in humans, as part of the IMAkinib project conducted jointly with Cyclopharma and the study sponsor, the Cancer Centre Georges-François Leclerc (CGFL) in Dijon (Press release, Oncodesign, JUL 12, 2016, View Source [SID:1234513845]).

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The objective of this radiotracer (ODS2004436) is to measure increased EGFR1 kinase activity during the development of a tumour, to select the treatment best suited to individual patients and to detect the emergence of any resistance early on. The radiotracer will be visualised by PET (Positron Emission Tomography), a standard nuclear imaging technique used for clinical diagnosis.

Mutations activating EGFR kinase are responsible for non-small cell lung adenocarcinoma, which accounts for 10 to 15% of lung cancers and affects 6,000 patients each year in France alone.

The clinical study, authorised by the French National Agency for Medicines and Health Products ANSM, is now ready to begin at the CGFL Cancer Centre, which has been granted the CLIP designation2 to conduct early-stage clinical trials. The first patient with lung cancer will be recruited within the next few weeks in the medical oncology department of the CGFL Cancer Centre in Dijon (Dr. Isambert, Head of the early-stage unit).

The objective of this phase 0/1 is to demonstrate the sensitivity and specificity of the radiotracer in human lung tumours. The clinical study will include 3 successive stages, designed to verify the specific labelling of tumours expressing the mutated EGFR receptor, verify the absence of significant marking on non-mutated tumours, and finally confirm the findings in a larger number of patients.

"With the advent of targeted therapies and precision medicine, the development of new molecular imaging biomarkers has become essential to provide the best treatment for patients," comments Prof. Fumoleau, Director of the CGFL Centre. "As a founding member of the Pharmimage platform with Oncodesign, it was only natural that we should conduct this phase 0/1 clinical study on the first radiotracer generated by the IMAkinib programme."

"This radiotracer was generated using our Nanocyclix technology, a chemical platform of next generation kinase inhibitors. The specificity of our molecules is a key advantage for the development of therapeutic molecules as well as for associated biomarkers, in a context of precision medicine and personalised treatments," adds Jan Hoflack, PhD, CSO of Oncodesign. "Our approach, which combines research on new therapies and identification of high-precision imaging tracers as of the first stage of our discovery programmes, is unique."

"Reaching the clinical stage in the development of an internal program for the first time is crucial for Oncodesign and its teams. It marks the culmination of 20 years of work and commitment to Oncodesign’s mission, i.e. provide patients with new cancer treatments," concludes Philippe Genne, PhD, founder and CEO of Oncodesign. "The IMAkinib project launched in 2009 includes several radiotracer programmes, the most advanced being the development of the radiotracer targeting the activated EGFR receptor. Our role in this programme is that of a pioneer in pharmaco-imaging focusing on new molecular markers. As this approach may lead to more effective treatments of tumours expressing EGFR-activating mutations using specific kinase inhibitors, it is important to identify such mutations."

About IMAkinib

IMAkinib is an Oncodesign research programme, conducted jointly with Cyclopharma and Ariana Pharmaceuticals. This programme received a grant from Bpifrance of €10.3m as part of the Industrial Strategic Innovation Programme, with an overall funding of €25m. The objective of IMAkinib is to develop biomarkers used in nuclear medicine to provide diagnostic solutions in oncology and help select the treatment best suited to individual patients, then monitor its efficacy and any potential resistance. The radiotracers developed are small molecules generated by Oncodesign’s Nanocyclix technology, labelled with radioactive 18F-fluorine [18F]. The IMAkinib programme includes several independent projects, the most advanced entering its phase 0/1 clinical study in lung cancer. Oncodesign has also worked jointly with Guerbet, and the teams of Prof. Denis Guilloteau of University François Rabelais in Tours and Dr Louisa Barré of CEA-Cycéron in Caen, on the development of radiochemical synthesis and on the preclinical studies on the radiotracer targeting the EGFR receptor.

Amgen To Discuss Data Supporting Biologics License Application For ABP 501, A Biosimilar Candidate To Adalimumab

On July 12, 2016 Amgen (NASDAQ:AMGN) reported that the Company will discuss data supporting the ABP 501 Biologics License Application (BLA) with the U.S. Food and Drug Administration’s (FDA) Arthritis Advisory Committee (Press release, Amgen, JUL 12, 2016, View Source;p=RssLanding&cat=news&id=2184704 [SID:1234513830]). ABP 501 is a biosimilar candidate to Humira (adalimumab), an anti-tumor necrosis factor-alpha (TNF-α) monoclonal antibody, which is approved in many regions for the treatment of several inflammatory diseases.

During the meeting, Amgen will present a comprehensive data package which supports biosimilarity of ABP 501 to adalimumab based on analytical, nonclinical, clinical and pharmacokinetic data, including results from two Phase 3 studies conducted in moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis. The Phase 3 studies met their primary endpoints showing clinical comparability to adalimumab. Safety and immunogenicity of ABP 501 were also comparable to adalimumab.

"As a developer of innovative medicines and biosimilars, Amgen has worked diligently to apply our more than 35 years of experience in biotechnology to the development of biosimilars," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Today, we’re looking forward to discussing the efficacy, safety and immunogenicity profile of ABP 501, Amgen’s first prospective biosimilar, with the FDA advisory committee. If approved, ABP 501 has the potential to provide an additional treatment option for patients with chronic inflammatory diseases, as well as play a key role in long-term disease management."

The FDA has set a Biosimilar User Fee Act (BsUFA) target action date of Sept. 25, 2016 for ABP 501.

About ABP 501

ABP 501 is a biosimilar candidate to adalimumab, an anti-TNF-α monoclonal antibody, which is approved in many regions for the treatment of several inflammatory diseases. The active ingredient of ABP 501 is an anti-TNF-α monoclonal antibody that has the same amino acid sequence as adalimumab. ABP 501 has the same pharmaceutical dosage form and strength as adalimumab (U.S.) and adalimumab (EU).

Provectus Biopharmaceuticals Announces Acceptance of Abstract for Poster Presentation at European Society for Medical Oncology 2016 Congress

On July 12, 2016 Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT, www.provectusbio.com), a clinical-stage oncology and dermatology biopharmaceutical company ("Provectus" or "The Company"), reported that the European Society for Medical Oncology’s Scientific Committee has accepted an abstract for a poster presentation detailing the use of PV-10 as a treatment for stage III and IV melanoma as part of ESMO (Free ESMO Whitepaper)’s 2016 Congress (Press release, Provectus Pharmaceuticals, JUL 12, 2016, View Source [SID:1234513829]).

The exact date and time of the presentation, titled "Intralesional Rose Bengal for Stage III and IV Melanoma," has yet to be decided. When the schedule is set, the details for this abstract, #3438, will be available at View Source

In addition, the abstract will also be published in the ESMO (Free ESMO Whitepaper) 2016 Congress Abstract Book, a supplement to the official ESMO (Free ESMO Whitepaper) journal, Annals of Oncology. ESMO (Free ESMO Whitepaper) has not yet announced the final publication number. The ESMO (Free ESMO Whitepaper) 2016 Congress will be held in Copenhagen, Denmark, from October 7-11, 2016.

PRIMA BIOMED COLLABORATES IN INVESTIGATOR SPONSORED NEW CLINICAL TRIAL FOR IMP321 IN SOLID TUMORS

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".

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

EVELO AND EPIVA MERGE TO CREATE THE LEADING IMMUNO-MICROBIOME PLATFORM COMPANY

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.

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.