Syncona Share Discussion Threads

[alan@bj] 13/6/2019 08:10

Two press releases today, one about Quell Therapeutics appointing a new Chief Executive and the other about Freeline. To read them, go to:-

[ltinvestor] 13/6/2019 07:20

Excellent set of results and looking forward to an exciting year ahead.Blue Earth (89% owned by Syncona)t/o £83.9m and expected to rise this year with potential for further registrations.Autolus on the brink of 3 phase 2 trials....I can’t praise the management enough especially when one looks at the Woodford debacle.

[brexitplus] 13/6/2019 07:20

Excellent results. Just Woodford a fly in the ointment.

[luxaeterna1] 10/6/2019 13:53

Nightstar sale cheque should land with Syncona this week. Champagne all around?

[tiger blue] 07/6/2019 10:22

Autolus - good audio Q&A by CEO on the Autolus website from the Jefferies Healthcare Conference 5th June. You need to register and it's 25 minutes, but he addresses the share price & Woodford, calling it a price dislocation, implying technically weak on Woodford but no bearing on company progress. All of the Autolus programmes are covered, very promising so far with effectiveness as good as the best out there but with far lower toxicity and side effects, due to their engineered T-cells being given an 'off switch' once they have done their work. Worth a listen.

[tiger blue] 04/6/2019 18:38

it, sorry but I think you are just looking at one Woodfund fund, he holds it in both funds + patient capital. Just done a google search for Autolus shareholders and as of 14th May Woodford INV Mgmt as a whole has 12.04m Autolus which is 30.02%

Autolus currently down c 13% on Nasdaq, someone needs to buy his stock!

Best
Tiger

[ltinvestor] 04/6/2019 18:06

Woodford 12.8% not 30% holding in Autolus

[alan@bj] 04/6/2019 16:35

Good point, Dave. When I posted it was down to 222p.

[davemac3] 04/6/2019 13:56

what drop? ;-)

[alan@bj] 04/6/2019 12:24

Could this drop Woodford related, bearing in mind he has a 3% holding in autolus?

[luxaeterna1] 30/5/2019 10:59

My gut feeling is that SYNC is undervalued as a growth story, although the cash investments make it an interesting case for dividends etc. By simply taking Blue Earth’s quarterly profitability of £10.8m (£44m annually with 75+% sales growth), you can argue BED alone is worth £440m+ based on the 2018 profit levels! Clearly SYNC are going to plough additional revenue in extra treatments, but if AUTO and Freeline come online to the market we’re starting to see a roadmap to £4+ territory.

[ltinvestor] 28/5/2019 08:58

I believe that Syncona own 80% of Freeline?

[brexitplus] 28/5/2019 07:55

Freeline, a biotechnology company focused on developing curative gene therapies for chronic systemic diseases, presented pre-clinical data of FLT190, a novel proprietary AAV gene therapy to treat Fabry Disease at the 6th Update on Fabry Disease in Prague, Czech Republic.
Fabry mice (GLA knockout) received a single dose of ssAAV8-FRE1-GLAco (FLT190 pseudotyped with AA8 capsid). The first assessment of GLA levels made at four weeks after dosing showed levels up to 1061-fold higher compared to wild-type mice. These GLA levels were maintained throughout the follow up period, up to 98 days after dosing. Importantly, this single administration led to significant and durable reductions in Gb3 storage levels in the heart and kidney, thus demonstrating reduction of this toxic metabolite in important organs frequently affected by Fabry Disease. No adverse clinical signs or toxicity associated with high expression of α-GLA in the liver or increased plasma exposure to GLA were observed in the study.

Freeline also presented the study design for MARVEL1, the Phase 1/2 clinical study of FLT190 in patients with Fabry Disease. This study investigates the safety of FLT190, a new gene therapy using the Freeline proprietary AAVS3 capsid. In addition, the study will investigate the potential of FLT190 in treating the signs and symptoms of Fabry Disease following a single administration, including e.g. αGLA activity levels, Gb3/Lyso-Gb3 clearance, changes in Gb3 in renal and skin biopsies, renal and cardiac function, GLA immune response, viral shedding and quality of life. The study is currently recruiting at two sites in Europe.

Anne Prener, Chief Executive Officer of Freeline said:

“Our preclinical data are very encouraging, demonstrating clear evidence of the therapeutic potential of FLT190 in treating Fabry Disease.”

[luxaeterna1] 23/5/2019 11:46

Who is dumping stock today? Or just Brexit froth in the markets?

[brexitplus] 20/5/2019 07:06

Syncona founds Quell Therapeutics with GBP35 million Series A Financing


-- Foundation of a new Syncona company in an emerging area of cell therapy
-- Significant GBP34 million commitment from Syncona in line with its strategy of founding companies to become global leaders in life science

-- Syncona will have a 69.3 per cent stake(1) in the business with a holding value of GBP8.3 million(2)

London, 20 May 2019 - Syncona Ltd ("Syncona") announces the foundation of Quell Therapeutics (Quell), a new cell therapy company, with a GBP35 million commitment in a Series A financing of which Syncona has committed GBP34.0 million with a further GBP1.0 million being contributed by UCL Technology Fund. Syncona will have a 69.3 per cent stake(1) in the business, with the first tranche of the Series A commitment of GBP8.3m paid in March 2019.

Quell has been established with the aim of developing engineered T regulatory (Treg) cell therapies. Tregs are a subset of T cells with the potential to downregulate the immune system. Quell will seek to utilise the power of Treg cells to advance therapies for the management and treatment of a range of conditions such as solid organ transplant rejection, autoimmune and inflammatory diseases.

Syncona has significant domain expertise in the T-cell field, identifying Treg cells as an area of high interest in late 2017 and seeking to found a company with the potential to be a global leader in this emerging area. As part of the process, Syncona identified key opinion leaders and unified them behind a common goal of building a company to treat conditions of immune dysfunction utilising gene-modified cells. As a result, Quell has been founded in partnership with six leading experts in the Treg field, cell engineering, solid organ transplantation and autoimmune diseases from King's College London, UCL, and Hannover Medical School.

The GBP35 million financing will allow the company to initiate the development of its first programme. The Syncona team will work closely with Quell as it builds out its operations and management team. Syncona Chief Executive, Martin Murphy, has been appointed Chairman, whilst Elisa Petris and Freddie Dear, Syncona Partners, will be Director and Observer on the Board, respectively.

Elisa Petris, Partner of Syncona Investment Management Limited, said: "The foundation of Quell represents an exciting opportunity for Syncona to build the leading cell engineering company with the potential to develop a first-in-class therapy in an innovative field. Over the last year, we have worked to bring together a group of world-class leaders in their respective fields, developed a strategy for the business and funded the business to enable it to scale and succeed. We look forward to continuing to work in close partnership with them as we build out the company's management team and business plan to deliver their goal of becoming the leader in treating conditions of immune dysfunction utilising gene-modified cells."

Martin Murphy, Chief Executive of Syncona Investment Management Limited, said: "Quell is the tenth life science company to be founded by Syncona and clearly demonstrates our proactive model in areas of deep domain expertise. We identified an innovative area of science with the potential to deliver dramatic impact for patients and worked to build a company around it. It is an exciting addition to our cell therapy platform, where we are strategically and uniquely positioned with expertise across a range of modalities."

Professor Alberto Sanchez-Fueyo of Kings College London, Founding Partner, said: "We are delighted to partner with Syncona to found Quell and are excited to work with the team to develop the next generation of engineered Treg cell therapies. The founder team has a unique cross-section of expertise, built over decades of scientific research and we believe there is a significant opportunity to develop novel therapies for the treatment of solid organ transplant and autoimmune conditions. We share Syncona's vision to bring products to patients in areas of high unmet medical need and are looking forward to the journey ahead."

Hans Stauss, Professor of Tumour Immunology and Director of the Institute of Immunity and Transplantation at UCL, said: "Quell brings together the expertise in clinical trials, regulatory T cell biology and gene engineering at UCL, King's College London and Hannover Medical School. It is exciting to have the backing of Syncona to develop a new class of living medicine to avoid transplant rejection and treat autoimmune diseases."

[brexitplus] 10/5/2019 14:05

Freeline, a biotechnology company focused on developing curative gene therapies for chronic systemic diseases, has secured a collaborative grant of £1.3 million from Innovate UK to lead a supply chain model and delivery development project in partnership with Symbiosis Pharmaceutical Services (Symbiosis) and the Cell and Gene Therapy Catapult (CGTC). The project is intended to create a UK based novel viral vector supply chain and to increase the speed of the Freeline production cycle by over 25%.

The Innovate UK grant will allow the consortium to collaboratively optimise quality systems and operating processes aligned for the supply chain platform. Symbiosis, a contract manufacturing organisation (CMO) specialising in sterile fill finish, alongside CGTC, will develop an innovative UK-based Drug Substance/Drug Product supply chain solution optimised for the Freeline Adeno Associated Virus (AAV) manufacturing platform to accelerate the progression of its therapies into the clinic.

Jan Thirkettle, Chief Development Officer at Freeline said: “At Freeline we have developed a state-of-the-art AAV drug substance manufacturing process. With the launch of this collaboration, and the access to dedicated funding, we and our partners will be able to accelerate delivery of our portfolio and deliver high quality gene therapy products more rapidly to the clinic.”

Colin MacKay, Chief Executive of Symbiosis, added: “We have invested heavily to establish viral vector manufacturing capabilities with the aim of developing a UK-based supply chain to both facilitate and accelerate the successful clinical and commercial manufacture of viral vectors. Our well-established track record in viral vector fill finish for clinical trials positions Symbiosis perfectly to work with Freeline and CGTC on this project and help grow the UK’s expanding capabilities in the field of advanced therapy manufacturing.”;

Keith Thompson, Chief Executive Officer, CGT Catapult commented: “There has been a significant increase in the use of adeno-associated virus (AAV) vectors in gene therapy trials; however, producing these vectors at the required scale and throughput is still a barrier to industry growth. We are proud to support and accelerate the development of these exciting next generation therapies by working with Freeline and Symbiosis at the CGT Catapult manufacturing centre, providing access to our knowledge and expertise in viral vector manufacturing and the associated supply chain.”

[brexitplus] 09/5/2019 09:17

Blue Earth Diagnostics, a leading molecular imaging diagnostics company, today announced expanded access to Axumin® (fluciclovine (18F)) in Europe. The first commercial production of Axumin in Belgium occurred recently, with the first Belgian patients being dosed. This follows the first administration of Axumin in Luxembourg earlier this year. Axumin is the first and only PET imaging agent approved in the European Union for use in in men with suspected recurrent prostate cancer. Axumin is commercially available in Belgium, Luxembourg, Italy, France, Norway, the Czech Republic, The Netherlands, United Kingdom and Austria with further European countries set to follow soon.

Prostate cancer is a leading cause of cancer death in men. While most primary prostate cancer can be successfully treated, recurrence occurs in up to one-third of patients. Recurrent disease is typically detected by a rise in PSA levels but often the location and extent of the disease cannot be detected by conventional imaging. Of those who suffer biochemical recurrence, approximately one-third develop metastatic prostate cancer. Axumin was developed to target the increased amino acid transport that occurs in many cancers, including prostate cancer. It is labelled with the radioisotope (18F), enabling it to be visualized in the body with PET imaging.

Dr. Jonathan Allis, Chief Executive Officer of Blue Earth Diagnostics said, “Detection and localization of recurrent prostate cancer is a significant unmet medical need, and we’re delighted to announce another significant step in our mission of making Axumin commercially available to clinicians and their patients across Europe.”

[brexitplus] 08/5/2019 14:46

WALTHAM, Mass. and LONDON, May 08, 2019 (GLOBE NEWSWIRE) -- Nightstar Therapeutics plc ("Nightstar") is pleased to announce that, at the General Meeting and the Court Meeting held earlier today in connection with the recommended acquisition of the entire issued and to be issued share capital of Nightstar by Tungsten Bidco Limited, a newly-incorporated company and wholly-owned indirect subsidiary of Biogen Inc., all resolutions proposed were passed by the requisite majorities and accordingly the Scheme was approved. Details of the resolutions passed are set out in the notices of General Meeting and Court Meeting at pages ix to xiii and vi to viii respectively of the combined circular and proxy statement dated 9 April 2019 (the "Scheme Document").

Effective Date and Timetable

The outcome of the General Meeting and Court Meeting means that Conditions A(i) and (ii) (as set out in Part III of the Scheme Document) have been satisfied. The Scheme remains subject to sanction by the Court at the Court Hearing, which is to take place on 6 June 2019, and the delivery of a copy of the Court Order to the Registrar of Companies. Nightstar expects that the Scheme will become effective on 7 June 2019.

[brexitplus] 08/5/2019 07:26

OMass Therapeutics (“OMass”), a drug discovery company using structural mass spectrometry to discover novel medicines, today announced the appointment of Rosamond Deegan MBA, as Chief Executive Officer. Ros brings more than 20 years’ experience in drug discovery and development leadership in the biotechnology and pharmaceutical industry, both in the UK and the US.

We have made great progress since the formation of OMass and are delighted to welcome Ros to our leadership team at this important time in the Company’s development,” said Professor Dame Carol Robinson, Founder & Scientific Advisor, OMass Therapeutics. “Ros brings proven experience in leading corporate development, strategy, operations and commercial development, all of which will be invaluable as we leverage and expand our core capability in proprietary high-resolution mass spectrometry to build an exciting portfolio of therapeutics.”

Ros Deegan, Chief Executive Officer, OMass Therapeutics commented:

“OMass Therapeutics is pioneering the use of structural mass spectrometry for drug discovery that has the capability to identify novel drugs to precisely target large protein complexes. I am very excited to be joining this accomplished team and look forward to working with my new colleagues to create an industry-leading pipeline of therapeutics that offer new treatment options for patients.”

Dr Edward Hodgkin, Executive Chairman, OMass Therapeutics and Partner at Syncona Investment Management Limited, added: “We are delighted to have appointed someone of Ros’ calibre to lead OMass, which we believe is a testament to the company’s unique proposition, following its re-launch as a drug development business last year. Ros is a highly experienced leader and will bring important corporate and commercial expertise to the business, which will be a great complement to the leadership team’s pharmaceutical and technological capabilities.”

Ros joined OMass Therapeutics from Bicycle Therapeutics where she served as President, Chief Business Officer and a Director of the US subsidiary of the Company. Ros established the company’s Boston-based subsidiary and over a three-year period led three major transactions and grew the US organisation to more than 20 employees. Prior to that she served as Senior Vice President, Business Development and Operations at Trevena, Inc, where she had previously held the role of Head of Finance and Operations. During Ros’ tenure at Bicycle and Trevena, the companies moved four programmes into the clinic, and raised over $300 million in private and public financings. In her earlier career, Ros was Director of Business Development at GSK in the US and, prior to that, she served as Director of Operations for GSK’s Centre of Excellence for External Drug Discovery (CEED) and as Marketing Manager for GSK’s UK launch of Bonviva for post-menopausal osteoporosis. Ros is a graduate of Cambridge University and received her MBA with distinction from INSEAD.

OMass Technologies was formed in 2016 as a spin-out from the University of Oxford then completed a £14 million Series A financing in 2018 from Syncona and Oxford Science Innovation. OMass applies structural mass spectrometry technology developed in the laboratory of Prof. Dame Carol Robinson to the discovery of novel therapeutics against complex protein targets, including membrane proteins.

[ltinvestor] 07/5/2019 09:44

Blue Earth looking good....

[brexitplus] 07/5/2019 08:23

Syncona Limited

07 May 2019

Syncona Limited

Blue Earth announces results from initial clinical experience of PSMA

07 May 2019

Syncona Ltd, a leading healthcare company focused on founding, building and funding global leaders in life science, is pleased to note that its portfolio company, Blue Earth Diagnostics (Blue Earth), has announced results from early clinical experience in an academic setting with its radiohybrid PSMA-targeted agent, rhPSMA-7 in high-risk primary and recurrent prostate cancer. Blue Earth acquired rhPSMA-7 in 2018 to extend its leading position in prostate cancer imaging, including potential new areas of high unmet need, such as early stage primary prostate cancer patients.

The Technical University at Munich (TUM) has utilised the agent in early clinical experience[1] in men with both primary and recurrent cancer. These retrospective analyses were presented at the Annual Urological Association's 2019 Annual meeting:

-- A retrospective analysis of 58 patients with high risk primary prostate cancer indicated that 18F-rhPSMA-7 PET/CT demonstrated sensitivity of 72% (13/18), specificity of 93% (37/40) and diagnostic accuracy 86% (50/58), when compared to histopathological findings.

-- A retrospective analysis of 261 patients with biochemically recurrent prostate cancer in which 18F-rhPSMA-7 PET/CT demonstrated a detection rate of 81% (211/261) at a median PSA level of 0.96 ng/mL

Blue Earth expects to launch its own phase I/II clinical trial in 2019 calendar year.

Martin Murphy, Chief Executive of Syncona Investment Management Limited, said: "We are encouraged by these results, which provide further evidence to support the potential clinical utility of rhPSMA-7 in both high-risk primary and recurrent prostate cancer. While Blue Earth will next look to test this hypothesis in its own clinical trial, this data reinforces our belief that this PSMA agent is one of the leading assets in the space and should enable Blue Earth to extend its leading position in prostate cancer diagnostics."

Blue Earth Chief Executive, Jonathan Allis, said: "We are very pleased that TUM is able to share the results of this initial clinical experience with the prestigious urology community at AUA 2019. Blue Earth Diagnostics acquired rhPSMA-7 last year as part of our mission to develop and commercialize innovative PET imaging agents for cancer. rhPSMA-7 is a strategic expansion of our technologically advanced imaging portfolio, and a complement to approved, commercially available Axumin."

Syncona has an 89.0 per cent stake in the business with a holding value of GBP229.6 million.[2]

[brexitplus] 30/4/2019 07:36

Freeline announced today it has signed a multi-year agreement with Brammer Bio (Brammer), a leading gene therapy contract development and manufacturing organisation, to secure a dedicated AAV manufacturing suite in Brammer’s state-of-the-art Cambridge, MA facility. This agreement will allow Freeline to meet the commercial demand of the FLT180a program for Haemophilia B. Freeline has now deployed its iCELLis®-based mammalian cell manufacturing at three separate locations, including Brammer, the Cell and Gene Therapy Catapult outside of London, UK, and at a European CMO.

“We invested early in CMC, manufacturing and analytics, and have built our own robust and flexible manufacturing platform focused on quality at scale,” said Jan Thirkettle, Chief Development Officer, Freeline. “The impressive commercial-supply capabilities of Brammer Bio’s Cambridge US facility, alongside our existing suppliers, secures our commercial supply for Haemophilia B, as well as our future development pipeline.”

"Brammer Bio and Freeline have been working closely together since 2017 to establish the Freeline iCELLis based manufacturing platform in readiness for late-phase clinical studies, and we are delighted to expand our strong relationship through this agreement,” said Mark Bamforth, president and CEO, Brammer Bio. “It is an exciting time for us as we look forward to joining Thermo Fisher Scientific and leveraging their industry-leading scale and capabilities to support the growth of gene therapy companies like Freeline."

Brammer Bio operates with extensive experience and expertise in the supply of gene therapy products for clinical trials and the establishment of commercial-ready processes. As a leader in viral vector manufacturing for gene and cell therapies, the Company will play a key role in the progression of the Freeline lead programme towards market supply. Brammer offers a wide range of viral vector manufacturing platforms to translate genes into vectors and to purify these vectors for eventual clinical distribution and patient delivery.

[luxaeterna1] 29/4/2019 11:31

So we have a nice week of medical presentations @ conferences to keep the newsflow running in the background.

[brexitplus] 29/4/2019 07:33

Freeline, a biotech company focused on developing curative gene therapies for chronic systemic diseases, together with Pall Corporation (Pall), a leading manufacturer of advanced biopharmaceutical processing technology, are pleased to announce the completion of the first full-scale run in Freeline’s newly commissioned Good Manufacturing Practice (GMP) facility located at the Cell and Gene Therapy Catapult (Catapult) facility in Stevenage, UK. The Freeline proprietary adeno-associated virus (AAV) manufacturing platform uses Pall’s iCELLis bioreactor system to achieve commercial scale and quality production of AAV gene therapy vectors. The two companies have now announced the extension of their partnership in order to accelerate in-house production of Freeline products.