Clinical-stage oncology company PharmAust (ASX: PAA) could be set to upscale development of its flagship drug candidate ‘Monepantel’, a cancer drug that is potentially both applicable to humans as well as pets.
The drug is currently registered and marketed as a treatment for parasite infections in food chain animals, but PharmAust is confident it can repurpose the drug and develop an oncological platform that can be further harnessed to develop additional cancer treatments in future.
Earlier today, PharmAust announced that it had completed the development of a prototype Good Manufacturing Practice (GMP) method suitable for the scale-up manufacture of Monepantel for use in clinical trials, in collaboration with world-renowned manufacturing organisation Syngene International.
GMP is a recognised benchmark which must be met by any aspiring pharmaceutical manufacturer including rigorous processes to provide drugs with very high levels of purity for safe and effective use when administered to patients.
Completing development of a GMP method means PharmAust can now progress to the next stage of development – conducting more trials and upscaling its operations.
The overarching goal is to repurpose drugs such as Monepantel while lowering the risks and costs of development with the company’s efforts being actively supported by PharmAust’s subsidiary Epichem, a thriving medicinal chemistry company which generates around A$3 million in revenues in the 2018 financial year.
Hailing PharmAust’s “significant achievement”, the company’s chief scientific officer Dr Richard Mollard said the milestone “means that PharmAust has in principle secured a manufacturing capability of its aminoacetonitrile drug development pipeline,” and that the company would now “move forward with its preclinical programs knowing that in the future it can scale up and advance its novel anticancer candidates.”
According to PharmAust, it now possesses the technology to manufacture a range of drugs in its portfolio at an economical cost and to standards required for clinical trials in Australia, the US and Europe – the world’s largest pharma markets.
The GMP grant means its work alongside Syngene can now progress to the next stage with a view of establishing a “fully-proprietary oncology pipeline,” the company said.
PharmAust’s development partner Syngene provides what it calls “integrated services” to pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries all over the world with high-profile clients including Bristol-Myers Squibb, Baxter, Amgen, GSK, Zoetis, and Merck.
As a result of their collaboration, the duo has developed a safe and potent modulator of the “mTOR pathway”, which plays a pivotal role in driving many cancers. Furthermore, PharmAust has been granted multiple “methods of use” patents covering the novel anti-cancer activity of Monepantel.
The drug has already passed stage 1 clinical trials in both humans and dogs diagnosed with solid tumours. Additionally, PharmAust says all conducted trials achieved their primary clinical endpoints in terms of safety and reduction in key clinical biomarkers.
The combination of passing stage 1 trials and completing development of a GMP, means PharmAust is now well positioned to commercialise Monepantel for treatment of human and veterinary cancers as it advances the drug into phase 2 clinical trial in dogs and humans.
PharmAust has also confirmed that has initiated a phase 2 pilot study in dogs diagnosed with lymphoma.
Earlier this month, PharmAust said it completed testing of different Monepantel tablet prototypes in healthy Beagle dogs in collaboration with Canadian contract research organisation BRI Biopharmaceutical Research.
PharmAust reported that the data it collated was “better than expected” and provides a strong basis to build up its therapeutic Monepantel platform.
Achieving good palatability and absorption from the new tablet formulation is vital for the next stages as this is expected to be the product with which PharmAust will conduct its phase 2 efficacy study to start in Q1 2019.
PharmAust shares had added around 13% to trade at $0.044 per share by midday.