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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."
RNS Number : 7157B
Evgen Pharma PLC
14 June 2021
14 June 2021
Evgen Pharma plc
("Evgen" or the "Company")
Progress with Glioma/Glioblastoma programme
Evgen Pharma plc (AIM: EVG), a clinical stage drug development company, announces further progress and an update on clinical trial plans for SFX-01 in glioblastoma ("GBM").
Glioma is the most common form of brain tumour affecting around 5 per 100,000 people. The more severe, grade IV classification, glioblastoma, is a very serious form of brain tumour representing 45% of all cases and has a poor prognosis with median survival of around 14 months. Together with neuroblastoma, GBMs now account for more deaths in the under 40s than any other tumour.
Previously the Company reported that these data generated by Dr Claudio Festuccia at University L'Aquila showed that with in vivo pre-clinical subcutaneous and orthotopic models (where glioma cells are implanted in brain tissue representing a more disease-relevant model), SFX-01 produced tumour shrinkage and significantly extended survival times. SFX-01 was also found to potentiate (i.e. substantially increase) the therapeutic effect of radiotherapy in these models.
Evgen now report that the in vitro these data from these experiments have been reproduced with very similar results at the University of Auckland using cells generated from freshly extracted patient GBM tissue, rather than the standard GBM cell lines established many decades previously. Further in vivo work has commenced at a contract research organisation to build upon the subcutaneous GBM tumour model experiments conducted by Dr Festuccia.
Plans for a Phase II GBM clinical trial with an adaptive design are progressing with a scheduled start in the first half of 2022. In tandem work has started with regulatory advisers on preparation of an Investigational New Drug application for submission to the US Food and Drug Administration in Q4/2021.
The therapeutic options for GBM are limited to surgery, radiotherapy and the one drug widely available, temozolomide. There is a clear unmet need for more treatments for use in conjunction with the current standard of care.
Dr Huw Jones, Evgen CEO, commented: "Building on this data set generated by Dr Festuccia is a key step in the pathway to commencement of a clinical trial, and we are delighted that the work done at Auckland University has produced such consistent positive results. We are excited by this compelling new data set in a type of cancer which has severely limited therapeutic options for the patient and thank Professor Bruce Baguley and Dr Euphemia Leung for their advice and insightful experiments. We have started the planning for the Phase II trial and are pleased to report the GBM programme is proceeding exactly to plan."