Noxopharm registered drug Veyonda® Granted 1st Allowed Patent Application, Advancing on Commercialisation Strategy

Australian clinical stage drug development company Noxopharm Limited (ASX:NOX) recently announced a significant milestone, that its potentially transformative anti-cancer drug candidate Veyonda^® has been awarded first allowed patent application (No. 2016401508) by the Australian Patent Office, with a term through to July 2036.

Post the announcement, NOX shares rose by 9.7% on 17 March 2020. The stock was trading at A$0.110 as at 26 March 2020 (12:00 PM AEDT).

The allowed patent claims underpin Noxopharm’s proprietary ownership of Veyonda^® and provide a strong platform for comprehensive exposure of Veyonda^® as a therapeutic with what the Company believes is a considerable potential commercial value, backed by the strength of the recent clinical outcomes.

The patent claims address a suppository dosage formulation including idronoxil which is a first-in-class inhibitor of sphingosine-1-phosphate (S1P).

Noxopharm’s Broad Patent Strategy for Veyonda^®

Aiming at its focused strategy to secure Veyonda^® in major drug territories by building as many patent boundaries as possible around Veyonda^®, Noxopharm has lodged five families of patents, with a 6^th family currently in the pipeline to ensure a further improvement to the bio-active form of idronoxil in Veyonda^®. All patent applications relating to method of administration & various clinical uses of Veyonda^® are now in the national phase of examination and were filed under the Patent Cooperative Treaty scheme.

Collectively, these six patent families are designed to build an extensive IP portfolio that will boost the commercial opportunity and industry attractiveness of Veyonda^® for clinical use. This portfolio plays an important part of expected forthcoming partnership negotiations, while the Company is confident of securing allowance of commercially relevant patent claims.

The recent patent allowance has been granted for the most fundamental patent application the Company has lodged for its first family. This patent application is also being pursued in several other countries.

Veyonda^® Commercial strategy

While Noxopharm’s strategy remains concentrated on the role Veyonda^® plays in re-establishing the body’s immune function to tumours in combination with radiotherapy, the Company will continue to embrace broader applications of the product where suitable. The main opportunity for Veyonda^® lies in two core areas:

• A standard combination therapy for low-dose radiotherapy, signifying a major opportunity considering the extensive use of low-dose radiotherapy in palliative treatment.

• Restoring immune function to so-called ‘cold’ tumours; Given the recently growing prominence of immuno-oncology therapy, this represents a major area of interest in the global pharma industry.

Veyonda^® Supply Chain

Noxopharm’s foremost priority is to maintain the supply of Veyonda^® to the increasing number of patients dependent on treatment, with ample quantities available for the immediate future.

Ahead of its DARRT-2 study including the growing compassionate use program being conducted in collaboration with GenesisCare, Noxopharm is currently taking all necessary measures to ensure the Veyonda^® production pipeline involving supply of raw materials, synthesis of drug & final product manufacture remains secure.

Update on DARRT-2 Study

• To accelerate the proposed Veyonda^® registration pathway, Noxopharm has commenced the process of strategic planning for DARRT-2 Phase 2 study.
• To efficiently address regulatory affairs matters, Noxopharm has appointed a suitably qualified and experienced research organisation on contract basis.
• Access to a global medical advisory board comprising of main opinion leaders in the field of prostate cancer.
• With the necessary approvals expected to be obtained in 2H 2020 ahead of a multi-national study initiation in early-2021, the final clinical protocol is targeted for finalisation in mid-2020.

Robust Clinical Results

Noxopharm is advancing its clinical agenda backed by encouraging clinical data. Noxopharm reported a strong safety profile for both its completed DARRT-1 study (Phase 1b) and the currently ongoing LuPIN (Phase 1b/2a) trial. Trial results also indicate that Veyonda^® delivers a meaningful anti-cancer response in nearly 50% of patients, a figure that Noxopharm believes would position Veyonda^® as an important and very valuable new therapy in the field of prostate cancer, if the efficacy results are repeated or possibly exceeded in the DARRT-2 study.

Noxopharm has initiated the strategic planning process for its DARRT-2 Phase 2 study to expedite the proposed Veyonda® registration pathway.

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