NOX Noxopharm Limited

Noxopharm Limited (ASX: NOX) (‘Noxopharm’ or the ‘Company’) is pleased to provide an update on results from a series of key proof-of-principle experiments in mice that are exploring the interaction between Veyonda® and radiotherapy in a novel and potentially transformative treatment regimen known as DARRT (Direct and Abscopal Response to Radiotherapy).

An abscopal response is where radiation directed at a tumour in one part of the body leads to an anti-cancer response both in the irradiated tumour as well as in tumours elsewhere in the body. An abscopal response offers the opportunity to take a typical course of radiotherapy being used for palliative treatment, and to convert it into a treatment offering substantially greater pain relief and survival benefit through shrinkage of tumours generally throughout the body. An abscopal response has come to be regarded as a potentially transformative method of cancer therapy, offering the prospect of a significant anti-cancer effect with a minimally intrusive, well-tolerated treatment regimen. Noxopharm believes it is well-positioned to develop a world-leading position in this important and emerging field.

The DARRT regimen involves dosing the patient with Veyonda® with the aim of achieving drug presence in all tumours, and then directing a low dosage of radiotherapy at 1 or 2 individual tumours. The rationale is that the combination of Veyonda® and radiotherapy in the irradiated tumours sets up inflammatory and immune responses that then spread throughout the body, leading to a general anti-cancer response throughout the body.

The Company is undertaking pre-clinical (animal) studies with a variety of local and international collaborators to better understand the mechanisms behind this effect of Veyonda®. This information will form an important part of submissions to various partners including clinical investigators, regulators and future strategic partners.

Together with Australian academic collaborators, the Company has developed a bi-flank mouse model in which tumours are grown on both sides of a mouse, allowing radiation to be delivered in an isolated way to one side only.  This model now has confirmed the following expected findings that:

• Veyonda® alone has an anti-cancer effect on both tumours, and
• radiotherapy alone has an anti-cancer effect on the irradiated tumour only, with no effect on the non-irradiated tumour.

But the model also yielded the following two breakthrough proof-of-principle findings that:

• a combination of Veyonda® plus radiotherapy to one side delivered a potent anti-cancer effect on both sides, consistent with an abscopal effect.

This pre-clinical news comes at an important time for the Company as it prepares for the release to the market next week of the next round of interim clinical data from its DARRT-1 study concerning the 12 patients in the second arm of the study. That report will outline the impact 3 months following DARRT treatment on

• PSA response (aim to achieve at least a 50% PSA reduction)
• Pain levels
• Tumour response (changes in tumour numbers and size measured by radiology).

Noxopharm CEO, Dr Greg van Wyk, said, “Veyonda® is being developed as a versatile therapy to enhance the effects of existing cancer treatments including chemotherapy, radiotherapy and immuno-oncology drug therapy. The DARRT program is the Company’s lead effort because it underpins the Company’s aspiration to make Veyonda® an essential adjunct to radiotherapy in prostate cancer. Achieving clinically meaningful abscopal effects, particularly with a single short course of Veyonda® and radiotherapy would provide compelling evidence of a treatment effect that the Company believes could transform the treatment of prostate cancer.”

“Our work to date corroborates our belief that Veyonda® is enabling radiotherapy to kill more cancer cells. One of the reasons that advanced prostate cancer is so debilitating is that the cancer generally spreads to the bones resulting in significant pain. If we can help shrink tumours throughout the body via the abscopal effect, we will be able to substantially alleviate the pain these men suffer.  This is an exciting aspect of Veyonda® that we are exploring in our drive to deliver effective therapies for people living with cancer.”

About Noxopharm Noxopharm is a clinical-stage Australian drug development company with offices in Sydney and New York. The Company has a primary focus on the development of Veyonda®. Noxopharm also is the major shareholder in Nyrada Inc, a spin-off company developing a pipeline of non-oncology drugs.

About Veyonda®Veyonda® (previously known as NOX66) is a suppository dosage formulation of the experimental anti-cancer drug, idronoxil, that leads in the body to the formation of a proprietary pro-drug form. Idronoxil specifically inhibits the ability of cancer cells to respond to stress, such as that induced by radiation, leading to loss of pro-survival signaling via sphingosine-1-phosphate. One of the outcomes is to augment the STING response in tumours, activating the body’s innate and adaptive immune system in response to cancer.

www.noxopharm.com
Investor & Corporate Enquiries:	Company Secretary:
Prue Kelly	David Franks
M: 0459 022 445	T: +61 2 9299 9690
E: info@noxopharm.com	E: David.Franks@automicgroup.com.au
Media Contacts:
Frank de Maria  USA
Purposeful Communications
T: +1 347 647 0284
E: frank.demaria@purposefulcommunications.com
Marianne Gould   Australia
Noxopharm Limited
T: +61 2 91442223
E: Marianne.Gould@noxopharm.com

Forward Looking StatementsThis announcement may contain forward-looking statements. You can identify these statements by the fact they use words such as “aim”, “anticipate”, “assume”, “believe”, “continue”, “could”, “estimate”, “expect”, “intend”, “may”, “plan”, “predict”, “project”, “plan”, “should”, “target”, “will” or “would” or the negative of such terms or other similar expressions. Forward-looking statements are based on estimates, projections and assumptions made by Noxopharm about circumstances and events that have not yet taken place. Although Noxopharm believes the forward-looking statements to be reasonable, they are not certain. Forward-looking statements involve known and unknown risks, uncertainties and other factors that are in some cases beyond the Company’s control that could cause the actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statement. No representation, warranty or assurance (express or implied) is given or made by Noxopharm that the forward-looking statements contained in this announcement are accurate and undue reliance should not be placed upon such statements.