Noxopharm Limited (ASX: NOX) is an Australian clinical-stage drug development company, which recently marked its third anniversary on the Australian Securities Exchange since its listing in August 2016. The company is primarily focused on the development of its key drug candidate Veyonda®, with later generation drug candidates under development. Veyonda® is a first-in-class, dual-acting cytotoxic and immuno-oncology molecule in a novel proprietary formulation.
Noxopharm aims to establish Veyonda® as an essential adjunct to radiotherapy in the treatment of prostate cancer as well as to broaden its clinical value by improving outcomes in sarcoma and increasing response-rates with immuno-oncology agents. The company is currently in different stages (planning, conducting and supporting) of its four clinical trials.
Promising 3-month Results for DARRT-1 Dose Expansion Stage
Noxopharm recently revealed encouraging interim 3 months results from the second stage (Dose Expansion) of the DARRT-1 (Direct and Abscopal Response to RadioTherapy) study in late-stage prostate cancer patients treatment combining its proprietary treatment Veyonda® with radiotherapy.
Outcomes have been recorded in 11* patients with progressive, metastatic late-stage prostate cancer in this short, easily dosed & well-tolerated proprietary treatment regimen of a single course of low dose RT + 1200 mg Veyonda® given for 15 consecutive days. The results indicated that 45% (5 out of 11) of men showed clinically significant decrease in pain (>30% falls), 55% (6 out of 11) of these men displayed PSA response (>50% fall) and overall 80% of all evaluable patients (6 patients) had stable tumour size, while the remaining 20% had reduced tumour size. The two patients showed a partial response (as per RECIST criteria) by exhibiting remarkable tumour size reduction – signifying a very positive result for the subjects in a palliative set up.
*A total of 12 men were enrolled for the study; however, 11 underwent treatment as one patient withdrew before the procedure on account of personal reasons.
With good tolerability reported to date, Veyonda®’s safety profile continues to be promising. Presently, this study is progressing as planned, with anticipated interim six months clinical report expected to be announced in late November 2019.
Noxopharm’s Intentions to Draft the Future
Noxopharm plans continued monitoring of DARRT-1 patients with the next set of data to be collected at 24 weeks (post-treatment) in late Nov 2019. Data from all participants in the trial will be presented at an International Scientific Congress in early 2020. Additionally, a manuscript submission to a peer-reviewed journal is planned for H1 2020. Completion of the DARRT-1 study, followed by its review by an independent committee to fully-characterize the abscopal effects (the reductions in the sizes of non-irradiated tumours) is also expected to be published in H1 2020. Moreover, long-term data on the patients, including overall survival, is also being investigated in the DARRT-1 study and planned to be reported in late 2020.
Noxopharm is currently planning to move ahead with the next phase of the DARRT program in prostate cancer, DARRT-2, to involve an even greater number of subjects and hospitals with a multi-national study scheduled to commence in 2020.
Talking about this recently released data, CEO and Chief Medical Officer of Noxopharm, Dr Greg van Wyk, stated that these results positively add to the previously achieved results from the first cohort of mCRPC (metastatic Castrate-Resistant Prostate Cancer) patients. He added, ‘this kind of response in men with terminal disease is very encouraging’, specially referring to the fact that in standard palliative RT, the advantages are usually restricted to reduction in symptoms like pain relief; however, in this well-tolerated combination treatment, a pronounced improvement in the patients’ condition was observed not only in pain relief but also in tumour size and PSA (prostate specific antigen) response.
He was pleased to state that the overall 55% PSA response rate with only a single course of Veyonda® + low dose RT is very promising , especially when compared to low PSA response rate (only 5-9% as per published scientific data) in end-stage mCRPC patients at any given time after RT treatment alone.
Dr van Wyk also mentioned that clinicians, patients and their families would welcome this treatment to be able to enhance the RT response in advanced metastatic prostate cancer patients, who are generally living with extreme pain and have limited life expectancy because presently the therapeutic options for this terminal disease at such an advanced stage are very limited. Radiation Oncologist from GenesisCare & Principal Investigator on the DARRT-1 trial, Dr Anne Capp, further confirmed the above-stated facts.
Noxopharm’s DARRT Program is testing the ability of Veyonda® to increase the tumour response to radiotherapy in prostate cancer. Through this clinical study, Noxopharm aims to demonstrate that Veyonda®, in combination with low-dose radiation therapy, achieves higher and/or equivalent efficacy in comparison to published results for palliative radiation therapy alone. The DARRT treatment regimen, initially tested in prostate cancer, would be extended over time to other solid cancer types that the company believes will assist in the Veyonda® marketing approval process.
The DARRT treatment regimen includes a 5-day course of radiotherapy with Veyonda® administered daily for up to 2 weeks. The treatment regimen in DARRT-1 is divided into two stages, with 14 patients with late stage mCRPC administered with 400mg/800mg/1200mg Veyonda® coupled with low dose RT in the Dose Escalation Stage. While 11 patients were given 1200mg Veyonda® in the Dose Expansion Stage.
Interim 6-month results for DARRT-1 Dose Escalation Arm
According to the 2nd May release, Noxopharm reported the interim data on the long-lasting responses from DARRT-1 treatment in the first group of late-stage prostate cancer patients. This minimally intrusive, well-tolerated regimen delivered durable anti-cancer response rate in terms of tumour size, pain and PSA at 24 weeks in a high proportion (57%) of men with mCRPC.
On 21 August 2019, the Company announced confirmation of abscopal effects by Veyonda® as evidenced through pre-clinical studies. These studies demonstrated the potential of Veyonda® to generate an abscopal response, which is an off-target response, whereby a single cancer tumour is irradiated but an anti-cancer effect is seen in other, distant tumours. In a clinical patient setting this potentially places DARRT as a revolutionary and transformative cancer therapy. As described earlier, the DARRT-1 study is minimally intrusive, and the treatment has been well-tolerated.
Noxopharm’s clinical agenda for 2020 includes a promising and suitably ambitious plan to progress the commercialization of Veyonda® to the market in the shortest possible time frame.
NOX is currently trading at A$0.400, up 9.6% as on 3 September 2019 (12:23 PM AEST).
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