Noxopharm Ltd (ASX:NOX) ended the September quarter in a strong financial position, well-funded with $23.6 million in cash to advance its “rapidly expanding” clinical program.
During the quarter, the company made strong progress with its oncology drug pipeline towards identifying three new first-in-class drugs.
Encouragingly, an expert medical advisory panel has recommended the development of Veyonda to provide a meaningful anti-inflammatory effect in patients with moderate COVID-19 disease.
DARRT, IONIC and CEP programs
Noxopharm’s cancer pipeline has three active programs, namely DARRT, IONIC and CEP, that involve executing clinical trials across three continents and engaging with dozens of hospitals.
The logistics in coordinating this level of clinical activity is considerable and the September quarter saw solid progress in the delivery of hospital contracts, obtaining ethics approvals, conducting site initiations and the shipment of the drug across multiple regions.
The COVID-19 pandemic has had a significant drag during the September quarter on the Sydney-centric IONIC study with its implementation coinciding with the outbreak of the Delta variant.
LuPIN Program
Developments in the Lupin program during the September quarter include
- The LuPIN phase 2 trial results were published in the Journal of Nuclear Medicine, confirming the median Overall Survival outcome of 19.7 months with the Veyonda/Lu-PSMA-617 combination;
- This effect also was confirmed in a recent animal study where the combination of Veyonda with LuPSMA showed a synergistic effect with sustained and almost complete regression of tumours; and
- A number of those enquiries have been the subject of ongoing discussions this quarter, all to act on what the company believes is a major opportunity for Veyonda to become a standard way of boosting the effectiveness of a range of radioligand products, including 177lutetium-PSMA.
Compassionate use program
Noxopharm makes Veyonda available under a compassionate use program with one of the main users being the theranostics division of GenesisCare, a major global radiology provider providing 177lutetium-PSMA treatment for men with late-stage prostate cancer.
More than 100 men now have been treated by GenesisCare in the program, including men with cancers refractory to 177lutetium-PSMA.
During the quarter, the company began working with GenesisCare to collate what is a considerable amount of data and is optimistic that it will further support the ability of Veyonda to overcome resistance to radioligand therapy.
Scaling up pipeline
As the company expands its clinical study sites in the US and Europe and responds to requests for access to Veyonda, it has focused on scaling up its manufacturing pipeline to supply this surge in demand.
Helping this situation, the company also was able to generate the supporting data required to increase the shelf-life of Veyonda to a minimum of 18 months.
Pack-and-label/distribution centres also were established in Melbourne, San Diego and Berlin that will warehouse and supply the drug.
Importantly, the pandemic has had little or no negative impact upon drug manufacture and supply.
Veyonda – Septic Shock
During the quarter, the headline findings of the NOXCOVID-1 trial were released, with the final data being assembled for publication and conference presentation.
The findings were viewed by the company as highly encouraging in terms of:
- The safety of the drug in patients hospitalised with COVID-19 disease; and
- The low rate of disease progression measured by clinical status and levels of blood biomarkers (cytokines) indicative of disease severity.
However, with the dynamics of the pandemic in such a state of flux, the company wanted expert advice on the merits of continuing with the NOXCOVID program and to this end assembled a panel of local medical and scientific experts.
Noxopharn wanted expert advice on the merits of continuing with the NOXCOVID program and to this end assembled a panel of local medical and scientific experts.
Consequently, the panel’s brief was to form an opinion on whether the NOXCOVID data showed that Veyonda had the potential to provide a meaningful anti-inflammatory effect in patients with moderate COVID-19 disease, and, if so, whether there was a need for such a treatment.
Cancer pipeline
Noxopharm continued to work on finalising its data package supporting the capacity of idronoxil to lower tumour resistance to immune cell infiltration, with the aim of submitting the first set of results to an international peer-reviewed journal by the end of December quarter of 2021
The company has conducted studies designed to acquire in-depth understanding of the role of idronoxil to act as a direct cell death agent in cancer cells, to block autophagy, and to lower resistance toward immune cell infiltration with existing collaborators in Australia, Germany and Hong Kong. A new and important academic collaboration also was established in the US.
A number of key collaborations were established with renowned academic collaborators in Australia and the US around the concept of blocking ‘helper’ growth signals sent by neighbouring stromal cells making major contributions to the aggressive growth of cancers such as brain and pancreatic cancers.
Encouragingly, Noxopharm identified lead molecules for both pancreatic and brain cancer programs and is planning to lodge a provisional patent around these compounds by the end of December quarter of 2021.
An additional important goal of this program is the development of high throughput drug screening assays that will allow for the identification of additional drug candidates in the future, providing Noxopharm with cutting-edge technology to support its mission of becoming a major drug discovery company.
Pharmorage
Noxopharm’s program of integrated studies is part of an ongoing collaboration with Hudson Institute of Medical Research, Monash Health, the Australian National University and the Centenary UTS Centre for Inflammation.
Studies confirmed the ability of idronoxil to:
- Block expression of STING induced inflammation genes;
- Block cytokine release syndrome triggered by influenza virus in mice;
- Decrease influenza viral loads in lungs of infected mice; and
- Decrease SARS-Co-V2 infection in a strain of mouse genetically modified to mimic human COVID-19 disease.
While the data from these studies serve to provide the scientific rationale for the development of Veyonda in the treatment of COVID-19 disease and sepsis, they also serve as a platform for the development of a new generation of idronoxil-like drugs as specific treatments for chronic inflammation including septic shock and autoimmune diseases.
Patent portfolio
During the reporting period, the following key patent developments occurred protecting the use of idronoxil as a suppository dosage form in combination with chemotherapy and radiation therapy:
- Isoflavonoid composition with improved pharmacokinetics - European application allowed (EP 17778482.4);
- Method of treating cancer using a combination treatment entitled 'Combination chemotherapy' - Japanese application allowed (JP 2018-555499); and
- Method of treating cancer by inducing an abscopal response entitled 'Radiotherapy improvements' - US application allowed (US 16/091706).