EVG.L Regulatory News (EVG)

Evgen Pharma plc

 ("Evgen" or the "Company")

Expansion of collaboration with the Manchester Breast Centre

Evgen Pharma plc (AIM: EVG), a clinical stage drug development company, announces an expansion of its collaboration with the Manchester Breast Centre at the University of Manchester's School of Medical Sciences, in a continued drive to establish the optimum clinical positioning for lead asset SFX-01 in metastatic breast cancer ("mBC").

Since the STEM open-label Phase II trial of SFX-01 in mBC trial concluded, CDK4/6 inhibitors have become standard of care as the first line mBC treatment for the large group of patients who are estrogen receptor positive (ER+ve), human epidermal growth factor receptor 2 negative ("HER-2 negative''). These drugs provide an extended period of progression-free survival, but invariably patients' tumours become resistant to them. Options for such patients are limited, especially since drugs used in this setting are poorly tolerated.

Accordingly, Evgen is expanding its work with Professor Rob Clarke at the Manchester Breast Centre with in vitro preclinical work to assess the impact of SFX-01 in CDK4/6 resistance models. An increasing body of in vitro data from these models shows that SFX-01 may suppress tumour growth and metastasis in patients who have become resistant to CDK4/6 inhibitors. In particular, SFX-01 reduces the viability and mammosphere colony formation of palbociclib-resistant tumour cell lines in vitro.

In addition, the extended collaboration will include in vivo models to provide the optimum support for clinical trial design and/or licensing in patients with HER-2 negative, ER+ve breast cancer, where CDK4/6 inhibitors such as palbociclib are showing weakening effectiveness. Evgen anticipates data from both in vitro and in vivo work later in the year.

Palbociclib, marketed by Pfizer, is the leading CDK4/6 inhibitor; in 2019 it had sales of circa $5bn.

Dr Huw Jones, Evgen CEO, commented: "We are delighted to expand this collaboration with Rob and Dr Bruno Simões and the team, and we remain passionate about optimising the use of SFX-01 to improve patient outcomes. Breast cancer remains our top priority alongside brain cancer, and we hope ultimately to provide an effective treatment for these patients as the current options for treatment become more limited."

Prof Rob Clarke, Professor of Breast Biology at the University of Manchester, added: "We look forward to working closely with the Evgen Pharma team to advance our work on SFX-01 in breast cancer, and to demonstrate its effectiveness in patients who are resistant to the current standard of care treatments."

The Company's previous open-label STEM trial in patients who had not received CDK4/6 inhibitors demonstrated:

• Evidence of anti-cancer activity via objective responses (tumour shrinkage)

• 24% of patients showed a durable clinical benefit for at least six months, despite the late stage of disease and patients' established resistance to hormone therapy. Of these, five patients were still receiving SFX-01 at 12 months and one patient remained on SFX-01treatment for 18 months

• A mild and favourable side effect profile for an anti-cancer drug.

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About Evgen Pharma plc 

Evgen Pharma is a clinical stage drug development company developing sulforaphane based medicines for the treatment of multiple diseases. The Company's core technology is Sulforadex®, a method for synthesising and stabilising the naturally occurring compound sulforaphane and novel proprietary analogues based on sulforaphane. The lead product, SFX-01, is a patented composition of synthetic sulforaphane and alpha-cyclodextrin.

Clinical data from the Company's open-label Phase II STEM trial has shown that SFX-01 can halt the growth of progressing tumours in patients with oestrogen-positive (ER+) metastatic breast cancer, and in some cases significantly shrink the tumour, whilst causing very few side effects.

The Company commenced operations in January 2008 and has its headquarters at The Colony, Wilmslow, Cheshire, and its registered office is at the Liverpool Science Park, Liverpool. It joined the AIM market of the London Stock Exchange in October 2015 and trades under the ticker symbol EVG.  

For further information, please visit: www.evgen.com