Clinical-stage drug development company, Noxopharm Limited (ASX: NOX) has released its updated corporate presentation for June 2019. The company, with offices in Sydney, New York and Hong Kong, is developing its leading drug candidate, Veyonda® as a universal treatment of metastatic disease.
Metastatic disease is a disease caused by spreading of cancer cells within a body and typically involves multiple tumours. In the clinical arena, it has been observed that metastatic disease is rarely curable once established due to several challenges including extensive tumour load, eventual resistance to standard chemotherapy/radiotherapy and elimination of immune cells. Noxopharm is addressing this issue by a proprietary dose formulation of Veyonda® (formerly known as NOX66), that delivers idronoxil continuously over 12 hours to enable prolonged anti-cancer activity.
Developed over 20 years of pre-clinical and clinical research, idronoxil enhances the DNA-damaging effects of both cytotoxic chemotherapy and radiotherapy, but with thus far, noticeably fewer side-effects and appearing to activate the body’s innate immune system.
History of Veyonda® (Source: Company Presentation)
Let us have a look at what’s latest with Noxopharm’s Clinical programs:
Four Clinical Programs of Noxopharm to attack metastatic disease (Source: Company Presentation)
DARRT (Direct and Abscopal Response to Radiotherapy) Program: DARRT-1 is an ongoing Phase 1b multi-centre clinical study that uses Veyonda® in combination with low dose external beam radiotherapy for the treatment of men with metastatic Castrate Resistant Prostate Cancer (mCRPC). This study, being conducted in Georgia and Australia, has been divided into two stages- Dose Escalation Stage (400mg/800mg/1200mg Veyonda®) and Dose Expansion Stage (1200mg Veyonda®), both covering 12 subjects.
NOX Dose Escalation Program included three groups of 4 men who were given 400mg, 800mg and 1200mg Veyonda® each on a daily basis for 15 days along with low-dose radiotherapy to a single lesion. The assessment of the patients at 6 months without treatment delivered favourable results in terms of safety & tolerability, pain relief and stabilization of tumour volume, as per the company’s May 2 release.
Noxopharm recently announced that it has enrolled the 12th patient into the dose expansion category. This enrolment of the final patient announced on May 30, 2019 marked the completion of enrolment in DARRT-1 study’s dose expansion phase, as planned. Noxopharm has selected 1200 mg Veyonda® dose for this phase, under which it aims to assess the dose response in all 12 subjects at regular intervals to mainly measure pain levels and PSA (prostate-specific antigen) levels. The interim results of this study are expected for release in August 2019.
LuPIN Program: It is a radiotherapy enhancing program that focuses on evaluating ability of Veyonda® to increase the rate and durability of response to Lutetium-177 (177Lu) labelled PSMA-617 (referred to as 177Lu-PSMA-617) in men with late-stage metastatic castrate resistant prostate cancer (mCRPC). It is an open label study that has enrolled 56 patients for evaluation. Dose-escalation under this program initially comprised of 8 men evaluated on 400 mg of Veyonda®, 24 patients evaluated on 800 mg of Veyonda® and the remaining 24 receiving 1200 mg Veyonda®.
PSA response for LuPIN Program (Source: Company Presentation)
As per the excerpt of interim results on the program based on an analysis of 16 subjects, there was an encouraging overall prostate-specific antigen (PSA) response rate of 69%. Some interim results on the study are expected to be released at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2019 Annual Meeting, due on 25 June 2019.
CEP Program: Chemotherapy Enhancement Program (CEP) aims at the enhancement of chemotherapy effects in patients whose late-stage cancers have stopped responding to standard chemotherapy. For this, the program is testing the ability of Veyonda® to restore sensitivity of cancer cells to carboplatin via a combination of Veyonda® with cytotoxic chemotherapy as a treatment for late-stage metastatic disease.
CEP-1 Study- Data of patients evaluable after 3 and 6 cycles (Source: Company Presentation)
The company has successfully completed Phase 1b of CEP-1 Study which registered 19 patients with end-stage solid cancers (breast, lung, prostate, ovarian). This phase confirmed the safety and tolerability of Veyonda® in these patients with just one serious adverse event. As per Noxopharm, out of the 9 patients allocated to the 800 mg dosage of Veyonda®, 56% displayed stable disease with no tumour growth and no new tumours, or a partial response after 6 cycles.
Of interest is that this study tested Veyonda® in four different types of solid tumour cancers.
The company has scheduled to initiate the CEP-2 study by 4Q 2019. The CEP-2 phase 1b open- label study, combining Veyonda® and doxorubicin in the treatment of metastatic soft tissue sarcomas, will reportedly include a Dose Escalation arm (varied dosages of Veyonda®, up to 30 patients) and a Dose Expansion arm (MTD Veyonda® dose, 16 patients).
“Noxopharm believes CEP offers an expedited means of obtaining a New Drug Approval and potentially coming to market.”
IONIC Program: This is an Immuno-Oncology program in combination with NOX66; planning to use Veyonda® and a checkpoint inhibitor (PD-1 or PD-L1) with or without low-dose EBRT as the likely preferred regimen. This study is currently at pre-clinical level with Phase 1b study scheduled to commence by Q2 2020.
Together these clinical programs target to establish Veyonda® as a key, versatile treatment in the lucrative cancer market. The company believes that Veyonda® has the potential to become a first-in-class activator, having multiple anti-cancer biologies with the ability to attack metastatic disease.
Noxopharm operates non-oncology research through its majority-owned subsidiary Nyrada Inc. which is registered in the United States. Nyrada was established by Noxopharm to house a number of non-oncology drug assets with Noxopharm currently owning 67.7% of Nyrada. The remaining 33.3% shareholding in Nyrada is owned by Altnia Holdings Pty Ltd. The subsidiary mainly focuses on four pre-clinical programs including the areas of anti-neuroinflammation, neuroprotection, and anti-hypercholesterolaemia.
As per the announcement dated 7 June 2019, Nyrada Inc, has received a cash rebate of $486.338K under the Australian Government’s Research and Development Tax Incentive Scheme which reimburses companies for 43% of approved R&D expenditure. This tax incentive relates to its three leading R&D programs that includes PCSK9 inhibitor, Neuroprotectant, and Peripheral neuropathic pain.
The company intends to add this amount of cash rebate to the $4 million raised through Convertible Notes with the objective of ramping up these three programs through to potential first-in-human studies in 2020.
With the market capitalisation of $62.53 million, NOX is trading at $0.510 on 18 June 2019 (12:37 PM AEST). The stock has posted positive YTD return of 24.39% with an upside of 20% in the past three months.
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