N4 Pharma achieves material advancements in the capabilities of Nuvec®

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N4 Pharma Plc (LON:N4P), the specialist pharmaceutical company developing Nuvec®, a novel delivery system for cancer treatments and vaccines, has announced its audited results for the year ended 31 December 2023.

Highlights:

Oncology

· In vitro results for Nuvec® loaded with two different clinically relevant siRNA, EGFR and BCL-2, show comparable cellular apoptosis to two commercially available products

· Further work has demonstrated that Nuvec® can bind not only single, but dual siRNAs aimed at simultaneously targeting pathways responsible for cancer progression and that there is an improved reduction in cell viability from treatment with dual loaded siRNA

· Results suggest that the dual loading of Nuvec® has the potential to be a hugely useful tool for combination therapy treatments

Oral Delivery

· Completion of in vivo studies demonstrating that Nuvec® loaded with OVA m-cherry DNA and encapsulated within an acid protective polymer can be dosed orally, penetrate the mucus layer, and successfully express the OVA m-cherry locally in the intestine epithelial cells

· Studies show that administering enteric coated PEGylated Nuvec® capsules with a subsequent dose 3 days later can produce and maintain protein expression

· Post period end, results of further testing show that administering enteric coated PEGylated Nuvec® capsules, on a staged basis over a period of 21 days, can maintain the protein expression for even longer and produce antibodies

Patents

· Patents on using Nuvec® to enhance the performance of viral vectors granted in Europe, Australia, Japan, China, the U.S. and India

Nanogenics

· Placing of £350,000 to fund the acquisition of a controlling stake in Nanogenics Limited, a company with a complementary lipid and peptide-based delivery system (Liptide®) that is developing a novel product (ECP105) for the prevention of scarring following surgery for the treatment of glaucoma

· Work underway with the University of Strathclyde on the formulation of the product needed to begin in vivo studies with Kings College London, studies expected to commence in May 2024

· Investigating potential for orphan drug designation for ECP105

· Non-viral, non-lipid delivery systems are high in demand in the gene therapy space and the Company now has two such delivery systems and expect considerable technical synergies in developing programmes using both Nuvec® and Liptide®

Collaborations

· Company continues to seek partners to develop its Nuvec® technology and is in the advanced stages of finalising a collaboration with an independent global R&D leader based in the US with the aim of securing a co-marketing agreement following initial studies

Financial

· Total comprehensive loss for the year was £1,276,778 (2022: £1,029,261)

· Cash at period end of approximately £1.0m (2022: £1.9m)

Nigel Theobald, Chief Executive Officer of the Company, commented:

“2023 was a year of good progress for the Company with material advancements in the capabilities of Nuvec® both in its ability to dual load and in its potential for oral delivery. We achieved our objective of expanding our portfolio through our interest in Nanogenics which brings us a clear path for taking a product to market and the potential for orphan drug designation.

“Our IP position has strengthened and we believe we are closer than ever before to agreeing a collaboration which would see Nuvec® being applied to other technologies with a view to co-marketing the resultant technology to big pharma and I look forward to making further announcements on this in the near future.

“We continue to manage our cash position tightly and look forward to the rest of 2024 with great optimism.”