Noxopharm Flags High Rates Of Response From LuPIN Trial Veyonda^® Dose-Finding Study

As per the latest announcements by Noxopharm Limited (ASX: NOX), the clinical-stage drug development company has now received positive interim results from its LuPIN trial Veyonda^® (NOX66) dose-finding study focused on investigating ¹⁷⁷Lu-PSMA-617 in combination with Veyonda^® in men with late-stage metastatic castration-resistant prostate cancer (mCRPC). The news sent the stock price to jump up by 18.182%, settling the day’s trading session at $0.650 as on 20 May 2019. A total of 978,385 shares changed hands as against an average volume of 109,447 (on a yearly basis), and this reflects a significant jump in terms of trading volume.

In the latest market announcement, clinical-stage drug development company, Noxopharm reported that interim results from LuPIN trial, an investigator-initiated trial, would be delivered by Associate Professor Louise Emmett in an oral presentation at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2019 Annual Meeting, scheduled to be held on 25 June 2019. However, an abstract of this data has already been published on the SNMMI website and will be published in the Journal of Nuclear Medicine in near future.

The trial results demonstrated an overall PSA (prostate-specific antigen) response rate of 69% across the 16 patients from the combination of ¹⁷⁷Lu-PSMA-617 (Lutetium-PSMA-617) and Veyonda^®, reportedly higher than that observed in studies of ¹⁷⁷Lu-PSMA-617 alone.

Background of the Study:

As indicated by the company, the LuPIN Study is a Phase 1b study in 32 men with mCRPC where the disease is end-stage and progressing, despite treatment with cabazitaxel, docetaxel, and either abiraterone or enzalutamide. Under this study, the company evaluates Veyonda^® (innovative dosage formulation of the experimental anti-cancer drug compound, idronoxil) for its ability to increase incidence, degree, and durability of a response to radioligand therapy, ¹⁷⁷Lu-PSMA-617. The men are receiving up to 6 courses of treatment with Veyonda^® and ¹⁷⁷Lu-PSMA-617 at six-weekly intervals.

It is worth noting that ¹⁷⁷Lu-PSMA-617 outlines a potential radioligand therapy that targets prostate-specific membrane antigen (PMSA) on the surface of prostate cancer cells. It has been assessed on an experimental basis over the past five years, mainly in Germany and Australia, in several thousand men with end-stage prostate cancer with no remaining treatment options, with Associate Professor Louise Emmett and St Vincent Hospital playing a key role.

LuPIN Study Details (Source: Company’s Website)

The objective of the study is to see if radio-enhancing and immuno-stimulatory properties of Veyonda^® could increase both the rate of response (more men able to complete the full course of treatment) and the durability of the response (longer time before disease progression) to ¹⁷⁷Lu-PSMA-617 in men with late-stage mCRPC. It, therefore, aims at evaluating safety and efficacy of combination of ¹⁷⁷Lu-PSMA-617 and NOX66 in men with mCRPC post-androgen signaling inhibition and 2 lines of taxane chemotherapy (LuPIN trial).

Latest interim results from the LuPIN trial

The latest interim report is based on first 16 subjects, all of whom were reportedly given ≥ 2 doses of ¹⁷⁷Lu-PSMA-617 with varied does of Veyonda^®. The data reported that the first eight men received 400 mg of Veyonda^®, and following a safety data review, the dose for patients 9-16 was escalated to 800 mg of Veyonda^®.

The effect of Veyonda^® was measured by its effect on the PSA response rate and its tolerability and safety profile. At the interim stage, the company received as high as 75% PSA response rates from 800mg (8 patients) dosages of Veyonda^®. The PSA response rates for 400mg (8 patients) was noted as 62.5%, taking the overall PSA response rate to 69% across the 16 patients. This achievement stands favourable when compared with PSA response rates of ¹⁷⁷Lu-PSMA-617 alone, (31% - 61%) in 10 published trials. The enhanced response rate has been achieved in a well-tolerated way, with only one severe adverse event (pneumonitis) being reported.

Greg van Wyk, company’s CEO and CMO, stated that the interim data has indicated positive results on the likely potential of Veyonda^® to increase the rate of responses to 177Lu-PSMA-617. The company now awaits results from the next 16 patients in the 800 mg dose expansion cohort to understand impact on these patients over the longer-term.

The trial underscores the company’s objective to develop Veyonda^® as an enhancer of radiotherapy across all its forms, including radiopharmaceuticals. The dual-acting cytotoxic drug candidate, Veyonda^®, is being developed to be used in combination with chemotherapy and radiotherapy for the treatment of prostate and other cancers in safe and well-tolerated way.

NOX is currently trading at $0.630,up 1.61% (as on 11:43 AM AEST, 22 May 2019).

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