Noxopharm’s clinical programs aiming to unveil a potential blockbuster drug in the cancer treatment spectrum

Clinical stage drug development company, Noxopharm Limited (ASX: NOX) aims to bring hope to cancer patients who have reached the end of their treatment journey and have no standard treatment options remaining, except palliative therapy for pain-relief. The current focus is on prostate cancer, with trials for other cancers planned.

In the world of cancer, there are a number of developments taking place frequently, but not all could make a long-term impact on the overall survival and disease progression of the patients. Australian company Noxopharm is currently trialling its lead drug candidate Veyonda^® at the end of the prostate cancer treatment spectrum, where the only remaining treatment option is palliative care therapy. That means the Company’s current trials are testing to treat trial patients who have passed through all the stages of standard treatments and that have now failed and their cancer remains progressive, which leaves them to palliative therapy essentially for pain relief, as the last resort for treatment. Importantly, so far, the clinical trials are showing Veyonda^® to be well-tolerated and with minimal side effects.

The two current prostate trials aim to shrink some of the tumours of patients to provide pain relief; or perhaps put the disease into dormancy so that the men will live longer with a reasonable quality of life, largely free of pain; with hopes that some men may even be in a longer-lasting remission from their disease.

The company has also developed a diverse pipeline in its clinical and pre-clinical programs to investigate Veyonda^® under different settings for its potential to enhance the cancer-killing effect of both standard radiotherapy and chemotherapy in different cancers, but again, aiming to have reduced side-effects during treatment.

For investors, the Company believes this strategy not only widens the possibilities for Veyonda^®’s path to market approval, but also provides portfolio risk mitigation.

It is important to note that the subject of two current studies (prostate cancer) shows the company’s objective of making an important change in the biopharmaceutical industry. Prostate cancer, one of the most common cancers, ultimately spreads to the skeleton, with end stage disease that can involve dozens, or even hundreds of tumours scattered in the pelvis, ribs, skull, arm and leg bones, once the disease has progressed and is what is termed “end-stage”. Moreover, tumours in bones in the spine are characteristically very painful and can also cause paralysis and spinal compression.

Under radiotherapy, Noxopharm is currently using Veyonda^® in combination with radiotherapy in two different studies involving men with late-stage prostate cancer. One of those studies is called DARRT-1, where DARRT stands for Direct and Abscopal Response to RadioTherapy. This study uses Veyonda^® with External Beam Radiation Therapy (EBRT).

While some biotech companies are trialling anti-cancer therapies which are associated with significant side-effects and extended treatment courses, Noxopharm has designed its DARRT treatment regimen as short (15 days), minimally invasive, well-tolerated course to provide a significant therapeutic outcome for men with late-stage, metastatic, castration-resistant prostate cancer (mCRPC), who have no remaining treatment options than palliative therapy.

Planning is also underway to take the DARRT regimen into earlier stage prostate cancer in the hope of delaying or even avoiding the need for therapies such as chemical castration with its attendant side- effects.

NOX Executive Chairman, Dr Graham Kelly, explained that in the DARRT program, Veyonda^® is given to the patient at the same time that a single tumour receives radiotherapy. This is happening in patients with advanced prostate cancer, which means that the patients typically have dozens of tumours, some large but most small, all around the body. All tumours are getting Veyonda^®, but only one of those tumours is receiving radiation.

It is thought that Veyonda^® can activate the body’s immune system and that radiotherapy can do that as well in the tissue receiving the radiation. It is thought that what is happening in DARRT is that by putting the two treatments together, an immune response is happening in the tumour receiving the radiation, to the extent that that immune response spreads out to involve all other tumours throughout the body.

The success of clinical trials undertaken in many anti-cancer drug development program is evaluated on the basis of end points that include:

• Progression-free survival (PFS)- Stopping tumour growth, determined by the number of subjects at a particular time-point to have had no disease progression
• Overall survival- Determined by number of subjects that are still alive at the end of the study.

Measurements including PSA Response, Pain Response and Quality of Life, are taken to assess secondary end points in determining the effectiveness of the treatment. As per the company, the DARRT programme aims to include a combination of above end points. Noxopharm was recently encouraged by the results reported in 6-month interim data of NOX ongoing DARRT study.

Under the interim data, DARRT-1 involving 14 men in its dose-escalation arm, reported durable anti-cancer response rate, lasting at least 6 months in the men with mCRPC. And six months after the company gave these 14 men a single course of treatment (15-day course of Veyonda^® + low-dose radiotherapy to a single lesion), it was reportedly recorded that cancer in 8 of those 14 men (57%) remained progression-free at 6 months.

The company believes that so far, this longer-lasting durable response possibly represents an immunological effect of Veyonda^® in combination with radiation that was previously seen in the Company’s pre-clinical research. Given that the radiation was only applied to a single lesion, NOX believes that the general anti-cancer effect involving responses in non-targeted lesions, indicates a potential immunological response.

On comparing the interim results of DARRT-1 with historical experiences, NOX determined the encouraging progress at end points, that include:

• The PSA response rate (proportion of subjects experiencing a reduction of 50% or more in PSA levels) was 36%, versus reported rates of between 5-9% with low-dose radiotherapy alone.
• 5 of 14 subjects reported experiencing a significant reduction in their pain at 6 months, including 2 men reporting to be free of pain. The company’s expectation is that palliative care with low-dose radiation would provide only minimal rates of improvements in pain levels this long after treatment.
• Having 8/14 patients with progressive disease showing no disease progression at 6 months, suggests that this could have a significant effect on a mean progression-free survival outcome.

DARRT-1 is now in its dose-expansion arm which is fully enrolled with its final 12th patient being enrolled recently. The company informed that patients in the second arm of the study are receiving the highest (1200 mg) dose of Veyonda^® versus the three varied dosages (400, 800, 1200 mg) given at dose-escalation arm. The results from its second arm, dose-expansion, are expected to be released by the company in the second half of 2019.

NOX is currently trading at $0.420 on 15 July 2019 (01:35 PM AEST).

Also Read: Potential ground-breaking outcomes for Veyonda® at SNMMI 2019 Conference

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