After reviewing its portfolio of technology products following recent discoveries from preclinical technology platforms - Chroma™ and Sofra™ - Noxopharm Ltd (ASX:NOX) (Noxopharm Ltd (ASX:NOX)) has decided to prioritise allocation of resources to these two assets.
On the other hand, two Veyonda® trials - DARRT-2 and CEP-2 - are to be discontinued due to protracted timelines, low patient acceptance of suppositories and predicted cost increases.
The review is part of the board and management team’s continual operational risk and cost profile evaluation – an effort to use existing resources, the company’s cash balance prudently to maximise shareholder value.
Profound anti-cancer treatment
In September 2022, Noxopharm released initial preclinical data from a proprietary novel ‘dual-cell’ therapy drug developed under its Chroma™ platform, which is effective in killing both pancreatic cancer cells and their barrier cells to achieve a more profound anti-cancer treatment outcome.
In the studies, conducted using a cutting-edge model developed by UNSW Sydney, tumour cells decreased by up to 85% and barrier cells were reduced by up to 87%.
The company is now working with its partners to accelerate this research into the next phase of studies and build its data package.
There is a large global need for new pancreatic cancer treatments, which is predicted to be a US$4 billion market.
The company’s Sofra™ platform is also delivering encouraging early results.
Noxopharm recently announced the development of a proprietary mRNA vaccine enhancer technology called SOF-VACTM, which has demonstrated strong activity against inflammation and the potential to make mRNA vaccines – including those targeting COVID-19 – safer, better tolerated by patients and more cost-effective to manufacture.
The company is generating further data to explore the full capacity of this technology and its relevance to an mRNA market that is growing rapidly and expected to reach US$128 billion by 2030 at a compound annual growth rate of 13%.
Veyonda program
The DARRT-2 and CEP-2 Veyonda trials have experienced slow patient recruitment compared to the numbers provided by the trial sites in pre-trial commitments.
These trials are being conducted mainly at US hospitals with very experienced teams and track records, but ongoing pressures on the US healthcare system from COVID-19 have meant that participating hospitals are operating at reduced staffing capacity, leading to delays.
Over the course of the trials, it has also become apparent that Veyonda’s rectal route of administration is not widely accepted by patients, with recruitment numbers and feedback from clinical staff at sites suggesting that patients are preferring to participate in other available oncology trials where suppositories are not required.
Idronoxil was reformulated as a suppository and branded as Veyonda at the time of the company’s foundation, following historical explorations with intravenous and oral formulations.
A range of factors has seen the two trials continue to experience protracted patient recruitment and therefore longer projected readout timelines.
Expectations for significant cost increases and extended reporting timeframes in the two company-sponsored trials have resulted in the board deciding to discontinue DARRT-2 and CEP-2.
This has resulted in the "difficult but necessary decision" to reduce employee headcount by disbanding Noxopharm’s clinical trials team.
Veyonda manufacturing will also be wound down, further reducing ongoing costs. Noxopharm will continue to supply Veyonda in order to support currently enrolled and potential future patients in the investigator-initiated IONIC trial led by Professor Paul de Souza.
Improved cash runway
The removal of the direct costs of paying suppliers and the clinical site hospitals, along with the reduction in associated clinical trial staff, results in sizeable cost savings to Noxopharm that will allow the company to focus on the potential of its Chroma™ and Sofra™ assets.
"The board’s decision to discontinue the two company-sponsored trials and disband the clinical team has not been made lightly,” said chairman Fred Bart.
“We firmly believe investment into the preclinical pipeline is a prudent and lower-risk strategy while being more likely to deliver shareholder returns in the future.
“Our proprietary preclinical assets are being built from the ground up with novel characteristics, robust IP and encouraging commercial potential.
“As we position ourselves for the future, we also acknowledge the role played by our departing staff members.
“The board and management team recognise the valuable work these diligent and talented colleagues have performed over the past few years, often in trying circumstances due to the impact of the pandemic and wish them all the best in their future careers.”