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On December 12, 2018 Avacta Group plc (AIM: AVCT), the developer of Affimer biotherapeutics and reagents, is reported that Dr Jose Saro has been appointed as Chief Medical Officer to lead the Group’s therapeutic development strategy and drive the in-house programmes into the clinic (Press release, Avacta, DEC 12, 2018, View Source [SID1234532032]).

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Dr Saro brings over 20 years’ experience in the pre-clinical, translational and early clinical development of oncology assets, spanning small molecules, biologics and drug conjugates. Dr Saro joins Avacta from Roche where he held the role of Senior Translational Medicine Leader at the Roche Innovation Center Zurich in which he focused on immuno-oncology and the development of combination products.

Prior to his position at Roche, Dr Saro was Executive Director Oncology Global Development and Medical Affairs at Bristol Myers Squibb, based in Paris, where he led and contributed to many oncology clinical development programmes, including Sprycel, Ipilimumab (Yervoy anti-CTLA4), Nivolumab (anti-PD1), anti-PDL1, anti KIR, anti LAG3, Brivanib, MEK inhibitor and Elotuzumab.

Previously, Dr Saro was Executive Director of Translational Medicine and Early Clinical Development (Oncology) at Novartis. Prior to that, he held senior positions at Eisai, and Wyeth.

Dr Saro has also experience of the small biotech environment, having spent several years as Vice President Oncology Clinical Development at PharmaMar, an oncology focused biotech. There, he was Head of Clinical Research & Development teams, comprising approximately 45 people, located in both Madrid and Boston, MA.

Alastair Smith, Chief Executive of Avacta Group commented: "I am delighted that Dr Jose Saro is joining Avacta to lead the therapeutic development strategy and to drive the in-house Affimer programmes into the clinic. His extensive experience in developing pre-clinical assets and translating those into clinical development will be an invaluable asset to Avacta.

Jose joins Avacta at a hugely exciting time as we progress towards the first Affimer clinical studies, which is a significant value inflection point for both the technology and Group. We very much look forward to working with Jose on our established programmes and on leveraging his knowledge to expand the pipeline of innovative and valuable immuno-oncology assets for the future."

Dr Jose Saro commented: "Due to their simple structure, Affimer proteins can be formatted to deliver the right characteristics required for the next generation of immuno-oncology therapeutics.

There are many opportunities for such a platform technology, and the recent collaboration with Tufts University Medical School is one example of a potentially game changing approach that is possible with Affimers.

I am very excited to be part of Avacta as it continues to develop such transformative approaches using the Affimer platform, that I believe will be a huge benefit to many oncology patients who currently have limited therapeutic options."

On December 12, 2018 AVEO Oncology (NASDAQ: AVEO) reported that it has entered into a clinical collaboration with AstraZeneca to evaluate the safety and efficacy of AstraZeneca’s IMFINZI (durvalumab), a human monoclonal antibody directed against programmed death-ligand 1 (PD-L1), in combination with FOTIVDA (tivozanib), AVEO’s oral, once-daily, potent and highly-selective vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR-TKI) in first-line hepatocellular carcinoma (HCC), or liver cancer, in a Phase 1/2 study (Press release, AVEO, DEC 12, 2018, View Source [SID1234532033]).

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AVEO will serve as the study sponsor, with study costs shared equally by both parties and clinical drug supplied by each respective company. The Phase 1 portion of the study is expected to commence in 2019.

"We are thrilled to collaborate with AstraZeneca to explore another tivozanib-immunotherapy combination and look forward to understanding the potential of combining tivozanib with durvalumab in liver cancer," said Michael Bailey, president and chief executive officer of AVEO. "TKI-immunotherapy combinations have demonstrated important clinical potential across multiple tumor types, though toxicities associated with these combinations have limited their potential use. Our goal is to establish tivozanib as the TKI of choice for use with immunotherapies by demonstrating efficacy with reduced toxicity."

About Tivozanib (FOTIVDA)

Tivozanib (FOTIVDA) is an oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) discovered by Kyowa Hakko Kirin and approved for the treatment of adult patients with advanced renal cell carcinoma (RCC) in the European Union plus Norway and Iceland. It is a potent, selective and long half-life inhibitor of all three VEGF receptors and is designed to optimize VEGF blockade while minimizing off-target toxicities, potentially resulting in improved efficacy and minimal dose modifications.1,2 Tivozanib has been shown to significantly reduce regulatory T-cell production in preclinical models3, and has demonstrated synergy in combination with nivolumab (anti PD-1) in a Phase 2 study in RCC. Tivozanib has been investigated in several tumors types, including renal cell, hepatocellular, colorectal and breast cancers.

About Durvalumab (IMFINZI)

Durvalumab (IMFINZI) is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumor’s immune-evading tactics and releasing the inhibition of immune responses. As part of a broad development program, durvalumab is being investigated as monotherapy and in combination with immuno-oncology (IO) agents, small molecules, and chemotherapies across a range of tumors and stages of disease.

On December 1, 2018 BiomX Ltd., a microbiome company developing customized phage therapies, reported that it has appointed Dr. Sailaja Puttagunta, M.D., as its Chief Medical Officer (CMO) (Press release, BiomX, DEC 11, 2018, View Source [SID1234532001]). With her extensive experience in conducting Phase I to IV clinical trials, contributing to NDA submissions in anti-microbial disease areas and product launch preparations, Dr. Puttagunta will oversee BiomX’s clinical development and strategy as the company prepares to enter the clinic with its Acne and Irritable Bowel Disease (IBD) programs. The company’s Acne program is expected to enter the clinic in mid 2019, and the IBD program is expected to commence clinical trials in 2020. Dr. Puttagunta will be based in United States’ East Coast and will work closely with BiomX’s Israeli management.

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"Sailaja’s broad experience and knowledge of the U.S. and global drug development field will accelerate our phage therapeutics advancement toward the clinic," stated Jonathan Solomon, CEO of BiomX. "BiomX is also establishing a presence in the U.S. with Sailaja’s appointment. Her clinical expertise and extensive contacts in the medical community will help build a strong foundation for our global footprint."

"BiomX’s novel approach to targeting harmful bacteria in our microbiome, harnessing bacteria’s natural enemies, bacteriophages, bodes great promise not only due to the phages’ lethality, but also due to their high specificity, which enables not harming the beneficial bacteria," added Dr. Puttagunta. "I am looking forward to bringing this technology to the clinic where it has the potential to help patients with chronic and sometimes life-threatening diseases."

Dr. Sailaja Puttagunta, M.D., was most recently Vice President, Development at Iterum Therapeutics, a clinical-stage pharmaceutical company developing antibiotics against multi-drug resistant pathogens. Prior to Iterum, Dr. Puttagunta served as VP, Medical Affairs for Anti-infectives at Allergan from early 2015 and was the VP of Development and Medical Affairs at Durata Therapeutics, Inc. prior to its acquisition by Actavis plc. From 2006 to 2012, Dr. Puttagunta led teams within clinical development and medical affairs on various antibiotic compounds at Pfizer Inc. Dr. Puttagunta has 20 years of clinical, academic and research experience in medicine and in the sub-specialty of infectious diseases. She graduated from Gandhi Medical College in Hyderabad, India and completed her residency in Internal Medicine and a fellowship in Infectious Diseases at Yale University School of Medicine. She also holds an M.S. in Biochemistry from the New York University School of Medicine.

On December 11, 2018 THERADIAG (ISIN: FR0004197747, Ticker: ALTER), a company specializing in in vitro diagnostics and theranostics, reported the appointment by its Board of Directors of Bertrand de Castelnau as its Chief Executive Officer (Directeur Général) (Press release, Theradiag, DEC 11, 2018, View Source;utm_medium=rss&utm_campaign=appointment-of-bertrand-de-castelnau-as-chief-executive-officer-of-theradiag [SID1234532002]).

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Bertrand de Castelnau will replace Michel Finance, whose term expires on December 31, 2018, and will take up his post from January 21, 2019. To this end, the Board of Directors appointed Fabienne François, currently Chief Financial and Administrative Officer at Theradiag, as interim Chief Executive Officer for the period from January 1 to January 20, 2019.

Aged 58, Bertrand de Castelnau has more than 25 years’ experience in the field of diagnostics. He began his career as a Commercial Attaché in Islamabad, Pakistan. He then joined Roche in Switzerland, as a Corporate Auditor before moving to the Diagnostics division and then taking charge of the Asia-Pacific region for Roche Diagnostics, based in Singapore. Bertrand went on to become Operations Manager at Guerbet for four years, before spending 10 years running the Horiba ABX Group and its Horiba Medical division. Finally he joined DiaSys as head of Marketing, Sales and Finance.

A fluent speaker of several languages, he holds an MBA from the Ecole des Hautes Etudes Commerciales (HEC) and a law degree from Paris.

Pierre Morgon, Chairman of the Board of Directors of Theradiag commented: "We are delighted to welcome Bertrand as Chief Executive Officer of Theradiag. His 25 years’ experience in the field of diagnostics and his track record of creating partnerships and developing international businesses will be key advantages for the expansion of Theradiag."

Bertrand de Castelnau, incoming Chief Executive Officer of Theradiag, added, "I am joining the Theradiag team with great enthusiasm and look forward to contributing my skills and experience to the growth and the expansion of the international reach of Theradiag and of biotherapy monitoring."

Changes to the Board of Directors

Following the resignation of Dominique Costantini from her position as Director, the Board of Directors is now as follows:

Pierre Morgon, Chairman of the Board of Directors
Sylvie Bratel, Independent Director
Vincent Fert, Independent Director
John Li, Director
Dominique Takizawa, Independent Director