Evgen Pharma Regulatory News (EVG)

14 June 2021

Evgen Pharma plc

 ("Evgen" or the "Company")

Progress on metastatic breast cancer programme

Evgen Pharma plc (AIM: EVG), a clinical stage drug development company, announces new preclinical data which shows SFX-01 may be of benefit to metastatic breast cancer ("mBC") patients who have become resistant to CDK4/6 inhibitors.

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). 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's collaborators at the Manchester Breast Centre, the University of Manchester, are conducting further in vitro preclinical work to assess the impact of SFX-01 in CDK4/6 resistance models. An increasing body of in vitro data from there shows that in these models 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 ability of palbociclib-resistant cells in vitro.

Palbociclib is the leading CDK4/6 inhibitor. Marketed by Pfizer, it had sales of circa $5bn in 2019. Mammospheres are colonies of primary tumour cells which represent a disease-relevant model to study drug effectiveness.

Should these data be reinforced with in vivo work, the Company will pursue a Phase II placebo-controlled study a in second line ER+ve mBC treatment of patients who have failed on CDK4/6 inhibitors. Such a trial could commence in 2022.

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

Dr Huw Jones, CEO of Evgen, commented: "It is exciting that the preliminary data set generated by our colleagues at the Manchester Breast Centre suggests SFX-01 may have a valuable role in the treatment of patients who have developed CDK4/6 resistance patients. We will soon be proceeding with the in vivo work and we are working up the design of the next trial."

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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 has its headquarters at Alderley Park, Cheshire, and its registered office is at the Liverpool Science Park, Liverpool. It is listed on the AIM market of the London Stock Exchange and trades under the ticker symbol EVG.  

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

For research on the Company, please visit: http://evgen.com/investors/analyst-coverage/