Blue Earth portfolio expansion, strong performance

Syncona Ltd

Blue Earth portfolio expansion, strong in market performance

2 May 2018

• Syncona portfolio company Blue Earth signs exclusive worldwide license for radio-hybrid PSMA agent, rhPSMA-7, a novel, high potential cancer imaging agent

• The move extends Blue Earth’s leadership position in the radiopharmaceutical space; complementary to Axumin while offering the potential for further growth and expanded patient management options in biochemically recurrent prostate cancer

• Continued strong performance in the commercial launch of Axumin in the US with strong growth in unit sales in fifth and sixth trading quarters of 3700 and 5000 respectively

• Increase in Blue Earth valuation from £123.1m to £186.8m (9.7p per share uplift)  

rhPSMA-7 license

Syncona, a leading healthcare company focused on investing in and building global leaders in life science, is pleased to note that its portfolio company Blue Earth Diagnostics (Blue Earth) has signed a license for radiohybrid PSMA-targeted agent, rhPSMA-7, from Scintomics GmbH, Germany, a specialist in radiopharmaceuticals and radiopharmaceutical technologies.

The move expands Blue Earth’s oncology portfolio, representing an opportunity 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. PSMA agents are expected to play an important role in prostate cancer imaging in the future, possessing favorable clinical attributes that support broad application, and having the potential to support both diagnostic and therapeutic applications. If approved, these compounds would offer the possibility of ‘precision medicine’ for men with prostate cancer.

The license includes the exclusive worldwide rights to a high quality, broad family of Prostate Specific Membrane Antigen (PSMA)-targeted radiohybrid agents for prostate cancer imaging, together with an exclusive option to explore therapeutic uses. The license has been funded directly by Blue Earth. Syncona has not provided further funding to the business.

Blue Earth will be responsible for the further development of the lead imaging compound ¹⁸F-rhPSMA-7 in a diagnostic setting. It is currently in pre-clinical development, but has already been utilised clinically under a German compassionate use program in men with both primary and recurrent prostate cancer. Blue Earth will also collaborate with Scintomics to identify optimised therapeutic candidates for future development.

Blue Earth’s proven track record, and depth of expertise in the rapid development and global commercialisation of radiopharmaceuticals for cancer means it is very strongly placed to develop the compound. Having secured approval by the Food and Drug Administration (FDA) for Axumin in the United States of America in May 2016, 18 months ahead of plan, and by the European Medicines Agency in May 2017, the business has extensive commercial infrastructure and know-how which will optimise the speed of development and enhance commercial success.  

Axumin commercial launch progress and valuation update

Syncona also announces the continued strong performance of Blue Earth’s first prostate cancer diagnostic agent, Axumin, following its US commercial launch in August 2016. Since this time, it has performed strongly, with the clinical utility of fluciclovine (¹⁸F) demonstrated by positive change in patient management data.[1] Unit sales of Axumin in the US have steadily increased over the first six quarters since launch,[2] and were 3700 and 5000 in the last quarter of 2017 and the first quarter of 2018 respectively. As a result of strong growth, Blue Earth is now profitable.  

Following a review by Syncona and third parties, which took account of Axumin’s strong in-market performance and the licensing of rhPSMA-7, Blue Earth’s valuation as at 31 March 2018 has been increased from £123.1m to £186.8m (9.7 per share uplift) 

Iraj Ali, Syncona Partner and Director of Blue Earth, said, “We are very encouraged by the continued strong performance of Blue Earth and the momentum of Axumin which has now been dosed in over 15,000 patients globally and is showing clear patient utility. This performance demonstrates the success of the Syncona strategy to take a hands-on approach to developing high quality companies taking products all the way to market.

“The move to secure rhPSMA-7, a novel, high-potential PSMA agent with unique attributes, represents an exciting opportunity. We believe this is one of the leading assets in the space which gives Blue Earth the ability to extend its position in prostate cancer diagnostics.”

Jonathan Allis, D. Phil., CEO of Blue Earth Diagnostics, said, “This is a fantastic move for Blue Earth and a natural extension of the portfolio, as¹⁸F-rhPSMA-7 and Axumin have unique mechanisms that we believe may ultimately allow physicians and their patients to select the diagnostic agent most appropriate to each specific clinical situation. PSMA agents are innovative compounds which have potential utility in prostate cancer imaging and therapy. We expect PSMA to play an important role in patient management in the future.”

Syncona will report full year results on 14 June 2018.

[ENDS]

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Copies of this press release and other corporate information can be found on the company website at: www.synconaltd.com  

This announcement includes information that is inside information as defined in Article 7 of the Market Abuse Regulation (EU) No.596/2014. The person responsible for arranging for the release of this announcement on behalf of Syncona Ltd is [John Bradshaw, Chief Financial Officer], SIML.

Forward-looking statements – this announcement contains certain forward-looking statements with respect to the portfolio of investments of Syncona Ltd. These statements and forecasts involve risk and uncertainty because they relate to events and depend upon circumstances that may or may not occur in the future. There are a number of factors that could cause actual results or developments to differ materially from those expressed or implied by these forward-looking statements and forecasts. Nothing in this announcement should be construed as a profit forecast. 

About Syncona:

Syncona is a leading FTSE250 healthcare company focused on investing in and building global leaders in life science. Our vision is to deliver transformational treatments to patients in truly innovative areas of healthcare while generating superior returns for shareholders. Our current investment portfolio consists of seven high quality companies in life science and a leading range of fund investments. 

We seek to partner with the best, brightest and most ambitious minds in science to build globally competitive businesses. We are established leaders in gene therapy, cell therapy and advanced diagnostics, and focus on delivering dramatic efficacy for patients in areas of high unmet need.

Our fund investments represent a productively deployed evergreen funding base which enables us to take a long term approach to investing in life sciences as we target the best new opportunities and support our existing portfolio companies to grow and succeed.

Syncona is aligned with two of the premium charitable funders in UK science, the Wellcome Trust, original founder of Syncona, and Cancer Research UK, both of which are significant shareholders in our business.  We make a donation of 0.3% of Net Asset Value to a range of charities each year.

About Blue Earth Diagnostics

Blue Earth Diagnostics is a molecular imaging diagnostics company focused on the development and commercialisation of novel PET imaging agents to inform clinical management and guide care for cancer patients in areas of unmet medical need. Formed in 2014, Blue Earth Diagnostics is led by recognised experts in the clinical development and commercialisation of innovative nuclear medicine products.

Blue Earth Diagnostics’ first approved and commercially available product is Axumin^® (fluciclovine ¹⁸F), a novel molecular imaging agent approved in the United States and Europe for use in PET imaging to detect and localize prostate cancer in men experiencing suspected biochemical recurrence. Blue Earth Diagnostics is funded by Syncona Limited, an investment company listed on the London Stock Exchange (LON: SYNC). For more information, visit: www.blueearthdx.com.

About rhPSMA-7

rhPSMA-7 was invented at the Technical University of Munich, Germany, where it has been utilized clinically in the diagnostic imaging of men with both primary and recurrent prostate cancer. ¹⁸F-rhPSMA-7 consists of a prostate-specific membrane antigen (PSMA) receptor ligand, which attaches to and is internalized by prostate cancer cells, and is labeled with the 18F radioisotope for PET imaging. rhPSMA-7 and other “rh” compounds, can also be labeled with the radioisotope 177Lu for therapeutic use.

Scintomics’ unique theranostic “rh” technology allows for the efficient labelling of PSMA-targeted agents with imaging radioisotopes, such as 18F or 68Ga, or therapeutic radioisotopes such as 177Lu. Depending on the type of radioisotope attached, the resulting radiopharmaceutical may be used either as an imaging agent to locate prostate cancer cells in the body or as a therapeutic which targets cancer cells with high energy radiation. These innovative compounds offer the possibility of “precision medicine” for men with prostate cancer.

About Axumin^® (fluciclovine (¹⁸F))

Axumin (fluciclovine (¹⁸F)) injection is a novel product indicated for use in positron emission tomography (PET) imaging to identify suspected sites of prostate cancer recurrence in men. Recurrence of prostate cancer is suspected by an increase in prostate specific antigen (PSA) levels following initial therapy. PET imaging with Axumin may identify the location and extent of such recurrence.

Axumin was developed to enable visualisation of the increased amino acid transport that occurs in many cancers, including prostate cancer. It consists of a synthetic amino acid that is preferentially taken up by prostate cancer cells compared with surrounding normal tissues, and is labeled with the radioisotope ¹⁸F for PET imaging.

Fluciclovine ¹⁸F was invented at Emory University in Atlanta, Ga. USA, with much of the fundamental clinical development work carried out by physicians at Emory University’s Department of Radiology and Imaging Sciences.

Axumin is the first product commercialised by Blue Earth Diagnostics. The molecule is being investigated by Blue Earth Diagnostics for other potential cancer indications, such as glioma.

[1] FALCON Change in Management study demonstrated that 61.2% of patients had their treatment path changed following an Axumin scan.

[2] First 6 quarters of units sold respectively are: 200, 800, 1800, 2500, 3700 and 5000 to March 31 2018.