Updates from Syncona and our portfolio companies
Achilles Therapeutics (“Achilles””), a biopharmaceutical company developing personalised cancer immunotherapies, today announces that its Clinical Trial Application (CTA) to conduct a Phase I/II study with its lead product, a tumour-derived T cell therapy targeting clonal neoantigens, in development for the treatment of advanced Non-Small Cell Lung Cancer (NSCLC), has been approved by the UK regulatory authority, the Medicines and Healthcare products Regulatory Agency (MHRA). The study, an open-label, multi-centre Phase I/II trial evaluating the safety and clinical activity of clonal neoantigen T cells (cNeT) in patients with advanced NSCLC, is expected to enrol the first patient in 2H 2019.
Autolus Therapeutics plc (NASDAQ: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announced that it has signed a long-term, full-building lease with Alexandria Real Estate Equities, Inc. (NYSE: ARE) for the construction and development of an 85,000 square foot build-to-suit facility to be located in the Shady Grove Life Sciences Center in Rockville, Maryland. The new facility will house offices for Autolus’ U.S.-based research and development, commercial and corporate functions and serve as its first full commercial-scale manufacturing center, with a planned capacity to produce 5,000 T cell therapies annually. In addition, Autolus has established a temporary U.S. headquarters in Rockville until the new facility is ready for occupancy, which is currently expected to occur in 2021.
Blue Earth Diagnostics, a leading molecular imaging diagnostics company, today announced that the first commercial production of Axumin® (fluciclovine (18F)) in France occurred recently, with the first French patients being dosed. Axumin is a novel molecular imaging agent approved in the European Union for use in PET imaging to detect and localize prostate cancer in men experiencing suspected recurrence based on elevated blood prostate specific antigen (PSA) levels after primary curative treatment. Axumin is the first and only PET imaging agent approved by the European Commission for use in men with suspected recurrent prostate cancer in all European Union member states as well as in Iceland, Liechtenstein and Norway. Axumin is commercially available in France, Norway, the Czech Republic, The Netherlands, United Kingdom and Austria with further European countries set to follow soon.
Stevenage, UK 10 December 2018 – Achilles Therapeutics (“Achilles” or “the Company”), a biopharmaceutical company using neoantigens to develop personalised cancer immunotherapies, today announces that it has appointed Dr Edwin Moses as Chairman of its Board of Directors. In addition, Dr Iraj Ali, currently Interim CEO, will become the permanent, full-time CEO of the Company.
Blue Earth Diagnostics, a molecular imaging diagnostics company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) for the expanded use of Axumin® (fluciclovine F 18) in adults for the detection and continuing assessment of glioma.
OMass Therapeutics (“OMass”), a biotechnology company using structural mass spectrometry to discover novel medicines, today announced the expansion of its senior leadership team with the appointments of Dr Ali Jazayeri as Chief Scientific Officer; Dr Giles Brown, VP, Medicinal Chemistry; and Dr Hsin Loke, VP, Head of Finance and Strategy. These appointments come shortly after the completion of a £14 million Series A financing from Syncona Ltd and Oxford Sciences Innovation.
Developing novel medicines using structural mass spectrometry
Blue Earth Diagnostics, a molecular imaging diagnostics company, today announced results from an investigational Phase 3 blinded image evaluation (BIE) study of the diagnostic efficacy of 18F-fluciclovine positron emission tomography (PET) imaging, as an adjunct to magnetic resonance imaging (MRI), in adults with glioma.
Freeline is pleased to announce the appointment of Brian M. Silver as Chief Financial Officer and Head of Corporate Development. Brian will be based in New York, as the Company establishes offices in the United States.
Gyroscope Therapeutics (Gyroscope) and Freeline Therapeutics (Freeline) are partnering with two research organisations, NHSBT's Clinical Biotechnology Centre (CBC) and the Centre for Process Innovation (CPI), to develop and design a manufacturing platform to produce novel (adeno-associated virus) AAV gene therapies. The consortium has been awarded £1.1m funding by Innovate UK over a period of 2 years.