N4 Pharma plc (AIM: N4P), the specialist pharmaceutical company developing Nuvec®, a novel delivery system for cancer treatments and vaccines, is pleased to provide an update on its current work streams.
As announced on 20 May 2021, the Company has been working on two Material Transfer Agreements ("MTAs") to assess how well Nuvec® can bind and be optimised for transfection with two different proprietary nucleic acid products. The first agreement is with a major international company working in the gene therapy space and the second is with a UK based pharmaceutical company developing its its own proprietary vaccine for Covid-19 using a DNA plasmid.
Both projects have progressed well and in each case the Company has been able to successfully load and well disperse Nuvec® with the proprietary products at different doses. This will allow the testing of a wide range of options with the MTA partners and each company is now undertaking its own tests with Nuvec® and their respective products. Timing of such work will be dependent on each party but the Company remains in regular contact whilst the work continues.
In vivo studies
As announced on 20 May 2021, the Company received good results from the in vivo pilot dosage study undertaken by Nanomerics using an OVA plasmid. As a consequence of this study, and the work being undertaken under the MTA in respect of a plasmid DNA for Covid-19, the Company took the opportunity to review the scope of the in vivo work planned at Evotec and to assess other Covid-19 plasmid DNAs for use with Nuvec®. The Company has now successfully completed the amplification and initial testing of a new Covid-19 plasmid at Evotec and finalised the scope of the in vivo study. This proof of concept study is now scheduled to start around the middle of September and is expected to last approximately three months.
Dosage follow-on study
Nanomerics' wider in vivo study will seek to validate the results seen from the pilot dosage study which, if consistent, would demonstrate a significant improvement through the use of this newly formulated Nuvec®. This follows 18 months of optimisation and formulation work which has been finalised. Analysis is ongoing and expected to be completed next month.
In addition to the work above, Nanomerics has been working with Nuvec® in respect of the delivery of TNFalpha in the treatment of cancer. The initial pilot study to assess the tolerance of different doses has been concluded successfully and the second pilot study looking at tumour models will commence shortly and conclude around the end of next month. After this, the main study will begin and take a further ten weeks including analysis at which time the Company will provide an update.
At Medicines Discovery Catapult the Company is undertaking studies to analyse how Nuvec® behaves with mRNA both in vitro (binding, dispersion, stability) and in vivo after subcutaneous injection.
Finally, in conjunction with the University of Queensland, following the receipt of a grant from the Australian Government, the Company is to commence a more substantive study into the oral application of Nuvec®. This will be a three-year programme and is fully funded under the grant.
Nigel Theobald, Chief Executive Officer of the Company, commented:
"It has been a busy and productive period for the Company across our different work streams. All studies have progressed well to the point where we now have visible timelines for their conclusion throughout the fourth quarter of this year and I look forward to providing further updates as and when we are able."