A Lens On Noxopharm’s June 2019 Quarterly Results

Noxopharm Limited (ASX: NOX) has recently released its quarterly report for the three months ended 30 June 2019, covering updates from both Noxopharm and its majority-owned subsidiary, Nyrada Inc.

Let us travel through the chief developments of the Company in light of encouraging interim clinical outcomes of two current clinical trials of the drug candidate, Veyonda® and the successful fundraising completed in July 2019, obtaining flexible financial security if required, through to a proposed intended secondary listing on a US securities exchange.

Panoramic View of Noxopharm Limited with a focus on latest updates and future plans

Noxopharm Limited is a clinical-stage drug development company that is presently listed on the Australian Securities Exchange. Current efforts and resources of Noxopharm Limited are primarily directed towards the development of its first clinical-stage asset, Veyonda® and simultaneously creating the potential commercial value of this asset for Noxopharm shareholders.

Veyonda® represents an innovative dosage formulation of anti-cancer drug compound, idronoxil, which is being investigated by Noxopharm for the treatment of late-stage prostate cancer and is also in planning for a clinical trial for the treatment of sarcoma, for which there are currently limited treatment options.

Noxopharm’s quarterly report explains how a range of lethal effects of Veyonda® within cancer cells and the surrounding cancer microenvironment may mean a potential to add-to or enhance the efficacy of different types of anti-cancer treatments. The three clinical studies conducted to-date have shown an encouraging tolerability profile when combining Veyonda® with one of two forms of radiotherapy, and a standard -of-care chemotherapy. It strengthens the company’s confidence in Veyonda® for its potential to become a versatile cancer treatment.

Noxopharm is presently focused on accelerating its drug discovery initiatives with the Veyonda® program now well-advanced. This outlines the company’s ultimate objective to evolve into a biopharmaceutical company possessing a strong pipeline of anti-cancer drug candidates, owned and developed by Noxopharm.

The idea behind the clinical strategy of Noxopharm has been summarised by the company under three action statements: a focus on one cancer with a huge unmet medical need e.g prostate cancer; a focus on a cancer such as  sarcoma with too few treatment options and, by focusing on these two cancer types, follow the most recent advancements in radiotherapeutics and immuno-oncology.

Quarterly Update and Future Outlook of Noxopharm’s Ongoing Clinical Programs

Noxopharm’s current clinical programs involve using Veyonda® to enhance other treatments.

These include two ongoing trials, namely DARRT-1, LuPIN-1, and two in planning: the larger DARRT-2 prostate cancer trial with low-dose radiotherapy; and CEP-2 which is Veyonda® with another chemotherapy (the approved cancer drug doxorubicin) for adult metastatic soft-tissue sarcomas.

The CEP-1 trial was completed late in 2018 with encouraging results. This Phase 1 trial looked at combining Veyonda® with the approved cancer drug, carboplatin, in the treatment of prostate cancer, breast cancer, lung and ovarian cancer.

(Source: Official website of the company)

Clinical progress of the ongoing trials and the company’s guidance for the next 12 months are as follows:

DARRT-1 (Radiotherapy Enhancing Program)

During the June quarter, Noxopharm announced that ‘The Direct and Abscopal Response to RadioTherapy’ (DARRT-1) has delivered a long-lasting disease control, with 57% of the 14 patients recruited in the first phase of the trial remaining cancer progression free over six months. The interim results also reported that the responses in pain relief were encouraging, with two patients reporting being completely free of pain at six months post-treatment.

This component of the trial treatment regime included different doses of Veyonda® in combination with low-dose, external beam radiotherapy to treat men with late-stage metastatic castration-resistant prostate cancer (mCRPC).

In May, the company announced enrolment of 12th and final patient in the second cohort of the study, that led to the completion of enrolments at the dose expansion phase of 1200mg of Veyonda®. Subsequently, Noxopharm expects the top-line 12-week and 24-week follow-up result for this cohort to be released in August and November 2019, respectively. Noxopharm aims to release the complete results of the trial at an international scientific congress in the first half of 2020.

DARRT-2 (Radiotherapy Enhancing Program)

In the quarterly report, Noxopharm stated that the planning is well underway for a larger Phase 2 trial of the DARRT regimen in mCRPC. This program plans to use Veyonda® again with low-dose External Beam Radiotherapy. The company plans to discuss many potential trial designs with globally-recognised oncologists and nuclear medicine physicians in Australia and the USA at upcoming advisory boards planned for the third quarter of 2019.

LuPIN (Radiotherapy Enhancing Program)

The LuPSMA and IdroNoxil trial, investigating the combination of Veyonda® and the radiopharmaceutical  177Lu-PSMA-617, in June  2019 reported interim results showing high response rates of Prostate-specific antigen (PSA) in the first set of 16-patients trial, with 69% of patients achieving a response and 81% of the first 16 patients still alive after a median follow-up of 12 months, thereby reflecting encouraging survival trends. The study’s interim data also reported that 56% of the patients (9/16) were able to complete their full course of treatment over the 36 weeks without any relapse, which was also encouraging.

LuPIN Trial PSA Response Rate (Source: St Vincent’s LuPIN trial Presentation SNMMI 2019)

The trial included up to six, 42-day treatment cycles in which patients with late-stage metastatic prostate cancer were given intravenous injections of 177Lu-PSMA-617 on day 1 of the cycle and daily administration of Veyonda® on days 1-10. Initially, the trial included 16 patients, but subsequently expanded to include another 16 patients and is now expanded further by recruiting another 24 patients, driven by the company’s desire to study the 1200 mg target dose of Veyonda® based on earlier encouraging interim results.

It is worth noting that the principal investigator of the study, Dr Louise Emmett is Associate Professor and Director of Theranostics and Nuclear Medicine at St Vincent’s Hospital, and the radiopharmaceutical used in this study, 177Lu-PSMA-617, is licensed to US biotech company, Endocyte Inc., which was acquired by Swiss pharmaceutical giant, Novartis, in a USD$2.1 billion deal last year.

CEP-2 (Chemotherapy Enhancement Program)

The Chemotherapy Enhancement Program – 2 trial is designed to treat adult patients with metastatic soft tissue sarcomas (mSTS), which is a rare but devastating group of over 70 different subtypes of cancers which has seen minor advances in the pharmaceutical sphere in the last five decades.

Noxopharm has worked with internationally acclaimed clinical experts in the US to develop the protocol for this trial (combining Veyonda® with doxorubicin) that will be conducted in the United States. As of now, the company is reportedly in talks with the US FDA, seeking to secure Investigational New Drug (IND) status in the US before end-2019.

The company is also preparing to apply for Orphan Drug Designation status from the FDA in second half of this year, which if successful, would open access to a range of financial and regulatory benefits that would greatly assist in the development of Veyonda® for sarcoma treatment.

Non-clinical Programs:

At a preclinical level, Noxopharm is further exploring the anti-cancer effects announced in April 2019.

Noxopharm’s preclinical studies with idronoxil, the active ingredient in Veyonda®, are also exploring the possible role and use of STING (Stimulating Interferon Genes) mechanism that may potentially boost the overall low response rates to immuno-oncology drugs.

During the June quarter, the company also discovered that idronoxil has the potential to activate NK (natural killer) cells and increase the numbers of CD8 and CD4 lymphocytes, thereby reflecting effects associated with activation of STING pathway.

Nyrada Inc.

Noxopharm owns the majority interest in its subsidiary company, Nyrada Inc., which is registered in the United States. As per the company, Nyrada is currently in the process of moving to independence from the parent, Noxopharm. During the quarter, the preparation of Prospectus had been undertaken to get Nyrada ready for a proposed listing on the Australian Securities Exchange in 2H FY19.

Nyrada Inc. was established to house Noxopharm’s non-oncology drugs and related intellectual properties. It currently focusses on 3 small molecule R&D programs; (i) a PCSK9 inhibitor to help lower blood cholesterol, (ii) a neuroprotectant drug potentially for concussion or stroke, (iii) an anti-inflammatory drug for peripheral nerve crush injury in conditions such as sciatica. The company has made important laboratory progress across its three main R&D programs, including the identification of lead drug candidates in its neuroprotectant program and the PCSK9 inhibitor program.

Funding Facility

In mid-July, Noxopharm secured a A$26 million funding facility from two New York-based institutional investors – CST Investment Funds and Lind Global Macro Fund, LP. In addition to the immediate injection of A$4 million, the funding facility provides Noxopharm the ability to place up to A$2 million value of shares each month for a period of further one year, should this be required.

The company also anticipates a reimbursement of a minimum of approximately AU$3 million by the third quarter of this year through the R&D Rebate Scheme of the Federal Government.

Noxopharm’s stock price surged up 4.878% to trade at $0.430 on 19 August 2019, 1:16 PM AEST.


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