In November, Nanoform filed to FIMEA a notification of an update to our manufacturer’s authorisation. This relates to additional API and manufacturing lines
On October 25, Nanoform and TargTex, a European biotech company, presented highly promising in-vivo data, enabled by a nanoformed drug product for the treatment of glioblastoma multiforme (GBM), at the PODD Conference in Boston, USA.
The data was generated for a planned Phase 1/2a clinical trial, due to commence in early 2024. Nanoform will deliver GMP grade nanoformed material to TargTex for the clinical trial. The drug is a selective Ca2+ channel blocker delivered by implantation at the site of the resected tumor in the brain. Nanoform and TargTex have collaborated in the optimisation of a hydrogel formulation enabled by nanoformulation of the drug.
The study was conducted in a rat model for GBM in which tumor cells are injected into the brain. After 2-3 weeks, the nanoformulated hydrogel was delivered locally in the brain of the animal, on top of the tumor. The study results showed long term survival of 40 per cent of the treated animals and no microscopic tumor cells were detected in these animals at sacrifice.
The nanoformed drug product provided a controlled release and deep drug diffusion across the brain parenchyma. The data showed no systemic exposure, and the drug was not toxic at maximum loading concentration. The study was performed at a sub-therapeutic dose that can be increased by at least 2-fold. Future studies are planned to be performed at increased drug concentrations with the goal to further improve long term survival.
In November, Nanoform filed to FIMEA a notification of an update to our manufacturer’s authorisation. This relates to additional API and manufacturing lines.
Another quarter of solid progress at Nanoform, despite the ongoing macroeconomic turbulence. We’ve continued to invest in and execute on our main tasks; client relationships & brand recognition, line capacity, IT & automation, processes, facilities, preparing for the US and the ability to help our clients generate positive data in biology, with the ultimate goal to help patients. Not forgetting our main 2025 target of becoming cashflow positive.
Speaking of biological data and the potential of helping patients in the future, I’m very pleased with the progress we’ve made with TargTex, where we jointly in Boston presented highly promising in-vivo data, enabled by a nanoformed drug product for the treatment of glioblastoma multiforme. Even though it is still early days, the fact is that nanoforming enabled a sufficient drug load where other technologies had failed, and as a result this promising API – the study showed long term survival of 40% of the treated animals – is on its way towards the clinic. Small is indeed a powerful ingredient in formulation work.
I’m also pleased to announce that after a year of extensive preclinical work with a European headquartered international company, two privately held European pharmaceutical development and manufacturing organisations have decided to join the drug development program. Together with Nanoform, the four parties will in equal shares fund the development and commercialisation of a more patient centric version of a current blockbuster drug.
There are many headwinds impacting the global economy; the war in Ukraine, the continued covid shutdowns in China, the rapidly rising cost of capital and in some cases even the complete lack thereof
Related to our substantial ongoing investments, I am happy to inform you that we have completed the first runs on both our GMP2 line and on our Biologics pilot line for GMP. The clean room for GMP3 line is finished and the line equipment and main isolator have arrived. Our ERP project, evident in the IT costs during 2022, has progressed well and we will go live with SAP after closing the books for this financial year.
Our preparation for GMP manufacturing in the US has progressed well during the last months. After dozens of meetings with state representatives - including one governor, municipalities, real estate companies, developers, advisors, and life science companies that have set up manufacturing in different parts of the US, we have now chosen a leading diversified professional services and investment management company, to help us find and establish the manufacturing site in the US.
About the macroeconomic situation. There are many headwinds impacting the global economy; the war in Ukraine, the continued covid shutdowns in China, the rapidly rising cost of capital and in some cases even the complete lack thereof. While our brand recognition and service offering continue to grow stronger and the client response to that keeps growing, it is clear that higher interest rates and tighter financial conditions are impacting investment decisions, especially among small biotech companies with limited resources.
Nevertheless, the problem with bioavailability is enormous in the pharma industry, the R&D budgets of large pharma companies are huge, the amount of money raised by biotech companies and life science funds during 2020-21 was record-breaking so we expect the interest in our technology to continue to grow. Naturally, the strong dollar and significant price increases in the global CDMO industry help us as our cost base is mostly in euros. It’s also clear that our strong balance sheet is a positive aspect when partners evaluate us.
All in all, I look with confidence and excitement forward to the coming quarters and years. We’ll continue to work relentlessly towards our 2025 mid-term business targets, while executing as fast as possible on our near-term targets. None of this can be done without our amazing employees and great partners. My sincere THANK YOU to you all for your continued dedication to Nanoform and for the inspiring and innovative work for which we’re known.
Prof. Edward Hæggström, CEO Nanoform