On May 9, 2017 Kymab Group Limited ("Kymab"), a leading human monoclonal antibody biopharmaceutical group, reported the appointment of Dr Sonia Quaratino as its first Chief Medical Officer (Press release, Kymab, MAY 9, 2017, View Source [SID1234537009]). Dr Quaratino will manage the clinical development of the Group’s expanding therapeutic antibody portfolio.

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Dr Quaratino is an immunologist and joins Kymab from Novartis, where she has served as Global Clinical Program Leader – Transitional Clinical Oncology, responsible for the clinical development of proprietary therapeutic antibody programmes in immuno-oncology.

Prior to her role with Novartis, Dr Quaratino was Senior Medical Director and Immunology Advisor at Merck Serono, where she was responsible for the clinical development of various immunomodulators. Dr Quaratino also has over 20 years of professional experience in biomedical research in UK academic institutions including Imperial College London and the University of Southampton.

"I am delighted to welcome Sonia to Kymab," says Dr David Chiswell, CEO of Kymab, on the appointment. "With her demonstrated track record in clinical development and medical affairs, Sonia is a superb addition to Kymab‘s management team as we prepare for our first clinical trials. Sonia’s deep understanding of the global environment in clinical research complement those of Dr Arndt Schottelius, our new Executive VP of R&D who recently joined us from Morphosys.

"These two key appointments add a high calibre of depth and provide further validation to our burgeoning and advancing R&D pipeline."

Dr Sonia Quaratino, newly appointed Chief Medical Officer of Kymab added: "Kymab’s emerging human antibody pipeline provides great potential to improve patient treatment options in our four main therapeutic areas of focus: immuno-oncology; auto-immunity; haematology and infectious disease. The Kymouse technology that underpins the company contains a full set of human immunoglobulin light and heavy chain genes that can produce 10 trillion different antibodies, thus significantly increasing the chances of finding new best-in-class antibodies. I am pleased and proud to be joining the Kymab team."

Dr Quaratino has an extensive professional background which includes a Medical Degree and a Doctorate in Hematology-Oncology from the University of Palermo, Italy and a Ph.D. in Immunology from Imperial College London, UK. For a number of years Sonia was a Professor of Immunology at the University of Southampton, a leading institution for innovative research. During her time in Southampton her focus was on the pathogenic mechanisms underlying chronic inflammatory diseases and the interface between autoimmunity and cancer.

Notes to Editors
Issued 9 May, 2017

Kymab
David Chiswell, Chief Executive Officer

Anne Hyland, Chief Financial Officer

Tel: +44 (0)1223 833 301

Email: [email protected]

Don Powell
Email: [email protected]

Tel: +44 (0)1223 515436

Mob: +44 (0)778 6858220

Consilium Strategic Communications
Mary-Jane Elliott/Jessica Hodgson/Suki Virji/Laura Thornton

Tel: +44 (0) 20 3709 5700

Email: [email protected]

Valeant has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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Akebia has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Akebia, 2017, MAY 9, 2017, View Source [SID1234521594]).

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Aclaris Therapeutics has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Aclaris Therapeutics, 2017, MAY 9, 2017, View Source [SID1234521538]).

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On May 9, 2017 EUSA Pharma reported that the European Commission (EC) has approved the antibody ch14.18/CHO, dinutuximab beta, for the treatment of high-risk neuroblastoma in patients aged 12 months and above.1 Today’s announcement makes dinutixumab beta the only approved immunotherapy in Europe for high risk neuroblastoma and an important tool in the fight against the condition (Press release, EUSA Pharma, MAY 9, 2017, View Source [SID1234527666]).

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Neuroblastoma, is the second most common solid tumour in childhood, following brain tumours2, and predominantly affects children under five years old3. Every year in Europe, around 1,200 children are diagnosed with neuroblastoma4, a rare cancer arising from neural crest cells, which are involved in the foetal development of the nervous system and other tissues.2 Because neuroblastoma can spread very quickly, almost half of children are initially diagnosed at an advanced stage of their disease and are recognised as ‘high-risk’ and with a poor prognosis. Approval of dinutuximab beta brings new hope to these ‘high-risk’ children who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and stem cell transplantation, as well as those with history of relapsed or refractory neuroblastoma, with or without residual disease.1

"Today’s announcement is a leap forward for the children and families affected by neuroblastoma, particularly those who have keenly followed the positive clinical trial results for dinutixumab beta and long anticipated its approval in Europe," commented Dr Juliet Gray, Associate Professor and Consultant in Paediatric Oncology at University of Southampton, UK. "As a clinician working in a highly specialised disease area with limited treatment options, I greatly welcome the availability of this targeted immunotherapy treatment that offers improved results for high-risk neuroblastoma patients used alone or in combination with existing therapies."

Steve Richards, CEO of the neuroblastoma charity Solving Kids’ Cancer Europe, added: "In the absence of any other targeted immunotherapy for children with high-risk neuroblastoma, the European regulatory body that approves medicines to be marketed in Europe, expedited the review of dinutuximab beta. Today’s approval means that EUSA Pharma who manufactures dinutuximab beta is able to make it available for use by hospitals across Europe, improving access for thousands of children and their families to this new treatment, with proven improved survival rates. The next challenge will be for EUSA Pharma to engage with relevant access bodies throughout Europe, including NICE in the UK, to ensure timely review through the new drugs processes and secure access to this medicine for patients. The young innocent victims of this cruel and devastating disease deserve nothing less."

Lee Morley, CEO of EUSA Pharma, commented, "We are delighted that the EC has recognised the urgent need to accelerate approval of dinutuximab beta in order to provide an effective and targeted treatment for this debilitating disease. EUSA Pharma in partnership with Apeiron and SIOPEN has believed strongly in the potential of this treatment throughout the clinical trial process and today’s announcement is final acknowledgement of its value to address the serious unmet need of children and their families affected by high-risk neuroblastoma."

-ENDS-

NOTES TO EDITORS

About dinutuximab beta

Dinutuximab beta is a monoclonal chimeric antibody developed to target a specific antigen, GD2, on neuroblastoma cells. It has been investigated in clinical trials for high-risk neuroblastoma, with more than 1000 patients having received treatment to date. Dinutuximab beta has orphan drug designation in the US and EU, and EUSA plans to file the product for approval in the United States in 2017.