Noxopharm’s Veyonda® Granted IND for Sarcoma Patients.

Latest LuPIN Trial Interim Results and an Alliance with Oncology Services Provider, GenesisCare Further Enhance Veyonda®’s Potential Commercial and Shareholder Value

Australian clinical-stage drug development company Noxopharm Limited (ASX: NOX), with a commercial priority of bringing Veyonda® to market for late-stage prostate cancer, announced a landmark step regarding the Investigational New Drug (IND) application approval by the U.S. Food and Drug Administration (FDA), on the basis of the pre-clinical and clinical data presented to the FDA.

Noxopharm now proposes to explore available non-dilutive funding opportunities to enable the study to proceed.

NOX shares rose on the ASX after the encouraging update, trading as high as A0.365c on 21 February 2020.

Additionally, Noxopharm further aims to establish its potentially transformative and novel lead product candidate, Veyonda^®, as an essential adjunct to radiotherapy in the treatment of late-stage prostate cancer and mitigating portfolio risk by studying Veyonda^® in combination with external beam radiotherapy and intravenous radiopharmaceutical treatments.

Noxopharm took another step forward towards establishing Veyonda^®’s versatility in cancer treatments, as well as its potential to increase the commercial and shareholder value, by recently announcing positive interim results from its LuPIN Phase I/II clinical trial showing a pronounced survival benefit.

Additionally, a new clinical alliance with Australian oncology services provider, GenesisCare, was announced with an aim to offer a compassionate access program with Veyonda^®, for patients with advanced, treatment resistant, metastatic prostate cancer (mCRPC) undergoing treatment with a radiopharmaceutical.

Positive Interim Outcomes from LuPIN Phase I/II Clinical Trial; Pronounced Survival Benefit

Noxopharm recently reported promising interim data from its LuPIN phase I/II clinical trial from the first 32 patients with end-stage prostate cancer, receiving the combination treatment of Veyonda^® and ¹⁷⁷Lu-PSMA-617 - a radiopharmaceutical therapy, with Veyonda^® dosages of 400 mg (8 men) and 800 mg (24 men).

The results were presented by St Vincent’s Hospital, Sydney, during a poster presentation at the ASCO Genitourinary Cancers Symposium 2020, held in San Francisco, USA on 14 February.

Noxopharm is expecting to report further data on the final 24 men receiving 1200 mg Veyonda^® later in 2020, with the final read outs anticipated in mid-2021 for the Phase I/II LuPIN Study.

Patients Profile

The LuPIN study involves 56 patients with progressive mCRPC; all of whom had received and failed two prior lines of therapy (chemotherapy and androgen signaling inhibitors) and 90% of the patients had failed a 3^rd line of therapy before entering the trial. As well, 65% of patients had over 20 secondary tumours primarily in the bones and lymph nodes.

Key Efficacy/Safety Findings

The results also indicate a very good safety profile with approximately half the patients facing only mild adverse events, including dry mouth (17 of 32), fatigue (15 of 32) and anaemia (14 of 32). Higher grade side effects were minimal, and all the side effects were manageable.

Noxopharm and GenesisCare Collaboration

An alliance has been formalised by Noxopharm and GenesisCare to make the combination therapy of Veyonda® with ¹⁷⁷Lu-PSMA accessible in a compassionate use program for mCRPC patients who remain with limited treatment alternatives.

GenesisCare is one of the leading private providers of oncology services across Australia and Europe, offering a spectrum of treatments including radiation therapy, chemotherapy, palliative radiation and a new field of cancer management utilising nuclear medicine also known as theranostics.

According to Noxopharm, its lead product candidate, Veyonda^® has the potential to enhance the effects ¹⁷⁷Lu-PSMA in advanced prostate cancer patients.

¹⁷⁷Lu-PSMA has been used as compassionate treatment in over 3,000 patients in Europe and Australia in the last five years. It is being studied in several phase II and phase III trials in Australia and across the globe.

The potential of ¹⁷⁷Lu-PSMA-617 as an encouraging new treatment option for late-stage prostate cancer was recognised in 2018/19 by being the subject of a US$6 billion series of acquisitions by the Swiss drug maker, Novartis, expanding its radiopharmaceutical platform.

Disclaimer