Australia headquartered clinical stage drug development company, Noxopharm Limited (ASX: NOX) has been in the spotlight for its potentially transformative therapy in late-stage prostate cancer where few or no standard therapy exists currently.
Noxopharm recently released a corporate presentation to its shareholders and the market, providing a general outlook with an update on its clinical strategy as well as commercialisation and funding strategies.
VeyondaÂ® - first-in-class S1P inhibitor
Noxopharm believes that its lead drug candidate VeyondaÂ® (NOX66) has the potential to become a commonly used anti-cancer drug within a few years.
A novel patented formulation of idronoxil, VeyondaÂ® is a first-in-class, sphingosine-1-phosphate inhibitor (S1P) that reinstates the ability of the bodyâs immune system to fight and eliminate cancer.
The inhibitory effect of VeyondaÂ® is on an oncogene upstream of S1P which makes it unique from any other S1P inhibitor. Another distinctive feature of VeyondaÂ® is that it only blocks S1P in cancer cells and some high-turnover cells.
Bringing VeyondaÂ® to Market
During its journey so far, Noxopharm remained engaged in determining the most assured path to market for VeyondaÂ®, with three potential methods of use including, monotherapy, combination therapy and immunotherapy in the first three years.
The company selected DARRT based on following considerations-
- Encouraging positive clinical outcomes in DARRT-1;
- Absence of disease progression at 6-months in more than 50% of men, indicating its potential to possibly achieve OS (Overall Survival) outcome;
- No noteworthy safety issues;
- Ability to cater to large unmet need;
- Guidance received from Noxopharm's U.S. Prostate Cancer Med Advisory board;
- Prospects to apply for FDA expedited review;
- Opportunity for Phase 2 adaptive design;
- Only one competitive technology known till now (PSMA + radionuclide).
With the promising data of DARRT-1 study, Noxopharm is planning for DARRT-2 multi-national study next year across Australasia, North America, and Europe.
Noxopharmâs Clinical Development Program at a Glance
Source: NOX Investor Presentation
Both DARRT and LuPIN (Lu-PSMA in conjunction with VeyondaÂ®) trials to date have been well-tolerated and have shown promising results in terms of tumour response, PSA, RECIST criteria and pain reduction.
A major differentiator to the standard cancer treatments is the fact that VeyondaÂ® is very well tolerated.
Breaking down Frontiers - A future beyond VeyondaÂ®
The convincing signal that Noxopharm is pushing the boundaries with a vision to become a major drug development and drug discovery player comes from the strategic planning of a new clinical pipeline.
The inclusion of other solid cancer types in the existing programs is expected to support Noxopharmâs intention in securing marketing approvals for VeyondaÂ® for its successful commercialisation.
The Company is strategically planning new clinical programs including-
- Glutamate receptor inhibitor for Glioblastoma multiforme- Noxopharm recently updated the market about the commencement of novel research program leveraging its world-leading glutamate-inhibition technology for treating glioblastoma multiforme (GBM), aiming to become first glutamate-inhibitor in the clinic for GBM, bringing a fundamental transformation in brain cancer treatment.
- NOX66 for Nasopharyngeal cancer - Noxopharm entered into a collaboration with Hong Kong University with the aim to underpin future clinical study or strategic partnership in China. Moreover, the Company recently received a $50,000 bridging grant from Australian Academy of Technology and Science.
- Cancer stem cell cytotoxic for various cancers
- IRAK4 inhibitor for various cancers
Lens over Noxopharmâs Commercialisation and Funding Strategies
Noxopharmâs commercial and financial perspective was unveiled by Companyâs Chief Commercial Officer, Mr. Alexander Hunter as follows â
- Finessing commercial structure and business systems to support growth;
- Securing necessary funding;
- Building suitable banking and commercial US relationships;
- Execution of clinical development plan and other commercialization pathways.
Noxopharmâs Critical Business Plan
With a goal to revolutionise cancer treatment, Noxopharm continues to develop research-oriented clinical programs and commercial opportunities in its quest of bringing to the market VeyondaÂ® - a versatile therapy that could be a game-changer in the existing cancer treatments.
NOX last traded at $0.325 on 27 November 2019. The stock is currently placed on a trading halt (as on 28 November), pending the release of an announcement pertaining to DARRT-1 results.
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