Evgen Pharma announces progress on two separate cancer programmes
Evgen Pharma PLC (LON:EVG) has announced progress on two separate cancer programmes.
The AIM-listed firm is developing SFX-01 for glioblastoma (GBM), which is the most severe classification of glioma, the most common form of brain tumour affecting around five per 100,000 people.
GBM represents 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.
Evgen previously reported that studies at University L’Aquila showed that with in vivo models, SFX-01 produced tumour shrinkage and significantly extended survival times.
It was also found to substantially increase the therapeutic effect of radiotherapy in these models.
The group said 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 as established decades ago.
Further in vivo work has commenced at a contract research organisation to build upon the subcutaneous GBM tumour model experiments conducted by the University L’Aquila.
Plans for a Phase II GBM clinical trial with an adaptive design are progressing with a scheduled start in the first half of 2022. Work has also started with regulatory advisers on preparation of an Investigational New Drug application for submission to the US Food and Drug Administration in the fourth quarter, Evgen said.
The therapeutic options for GBM are limited to surgery, radiotherapy and the one drug widely available, temozolomide, so there is need for more treatment, the firm added.
In a separate update, the clinical stage drug development company announced 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.
The latter is standard of care as the first line mBC treatment for the large group of patients who are estrogen receptor-positive.
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, Evgen said.
Researchers at 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, Evgen said.
Should these data be reinforced with in vivo work, the company will set up a phase II placebo-controlled study in 2022.