Highly technical presentation to specialist oligonucleotide audience

Having recently celebrated our 5^th anniversary is an appropriate time to look back on the Company’s beginnings and the path to the current.

This blog is in response to a note I received this week from a shareholder. I thought it would be useful to post my reply.

'Dear Prof. Kelly

I was reading this article from the Wall Street Journal .....

  https://www.wsj.com/articles/covid-arsenal-needs-pills-as-well-as-shots-11617567229#comments_sector

....and was wondering how Veyonda would fit into this picture.'

The LuPIN trial at St Vincent’s Hospital, Sydney

 Two matters were raised this week following the LuPIN data announcements at the 2021 ASCO Genitourinary Cancers Symposium. Both highly relevant.

In a nutshell we are testing an emerging theory that an over-exuberant response of an immune function known as the STING signalling pathway is a key cause of much death and disability of COVID-19 patients and that blocking this pathway will help reduce the need for hospitalisation and reduce the severity of the COVID-19 disease.

How do you interpret data from a single study using a single treatment arm? A fair question.

The answer is, cautiously. We have been cautious, and we still think the data is exciting.

¹⁷⁷Lu-PSMA-617 (¹⁷⁷Lu-PSMA) therapy suddenly has become a big talking point in prostate cancer circles. Delivering radiotherapy via injectable radiopharmaceuticals is being talked up as a coming mega trend in cancer therapy in general, but ¹⁷⁷Lu-PSMA and prostate cancer is where the big story lies at the moment.

The DARRT Program

The DARRT program aims to use Veyonda® to make radiotherapy more effective . It stands for Direct and Abscopal Response to RadioTherapy.

The IDX backstory (2009-2016). The birth of Noxopharm

Ironically, Noxopharm owes its existence to the failure of the OVATURE study.

I have been meaning for some time now to write a general blog about drug development and to put the Veyonda^(R)story into that context.

The ‘next big thing’ comes along about every 10-15 years in oncology. The last ‘big things’ were the so-called immuno-oncology drugs (or checkpoint inhibitors) – Yervoy and Opdivo (Bristol-Myers Squibb) and Keytruda (Merck). These drugs were expected to turn cancer therapy on its head based on some early dramatic responses in patients with melanoma and lung cancer, with annual sales of US$100+ billion being projected.

I understand the complexity around the DARRT concept, what we expect to come of the DARRT-1 study, and what the data means that we are reporting on as we move through the study. Boosting the effectiveness of radiotherapy with an immuno-oncology drug is an entirely new area of cancer therapy, so there are no yardsticks to measure us by. The only relevant yardstick is current therapeutic options and whether we can improve on them.

The stock market is on its longest bull run in modern history. The biopharma industry, in particular, is in the longest and most active financing window in its history.

Leerink Partners, a leading U.S.-based investment bank specializing in healthcare, recently published a report on the flow of public equity capital into U.S. biopharma stocks over the past 6 years, having analysed the performance[…]

We have been asked if the Company has dropped the CEP program from our list of clinical studies as it wasn’t mentioned in the latest Appendix 4C. The answer is, no, we haven’t. But it is not a priority. We have a busy clinical program using NOX66 in combination with radiotherapy, and we anticipate the […]

With NOX66 running in 3 separate clinical programs, there is considerable scope for priorities, commercial strategies, timelines etc to become blurred in shareholders’ minds. Hopefully this will make it clearer. …………………………………………………………………… In terms of priorities: The DARRT program in prostate cancer is #1. We regard this as our primary path to market approval and a […]

An  article appeared in the AFR this week. ‘Billion-dollar molecule’ may extend life in men with prostate cancer – Australian Financial Review, May 9 2018 It concerns a clinical trial being conducted in Australia of a promising experimental form of therapy for late-stage prostate cancer. I have been asked where our efforts with NOX66 in […]

Since Noxopharm’s ASX release last Wednesday about seeing abscopal responses in two patients receiving NOX66, some shareholders have asked me what it means to the future treatment of cancer. The short answer is, potentially a great deal. By any definition, it is ‘disruptive technology’ that has the potential to change the face of cancer therapy. […]

It’s been 9 months in the making, and a good deal of hard work, but finally our US subsidiary, Nyrada, Inc. is launched with the successful closing of a $4M capital raise. What does Nyrada mean to me as a NOX shareholder? As a NOX shareholder, through NOX, you now have a ‘stake’ in a […]

In response to shareholder enquiry, this is a clarifying note about the agreement recently entered into between NOX and KZA. The agreement represents a commercial decision reached by both parties that provides NOX with the certainty it needs as it prepares to enter a Phase 2/Phase 3 clinical program for its lead drug candidate, NOX66. […]

  The two key tests in being awarded a patent over any intellectual property (IP) are novelty and inventiveness. In the drug development world, proving both is much easier where there is no pre-existing IP…. For example, no-one had described the new molecule before (known as a New Chemical Entity), so it is novel; or […]

A short note on the clinical data we presented at ESMO. This is early data from our first-in-human clinical study, so it is important to keep that perspective. Over the course of the next 6 months we plan on reporting on this and other clinical studies at various international and local oncology conferences. Progressively, the […]

Is it possible that Noxopharm can do something meaningful for patients with brain cancer, where so many others have failed? We believe so, with our recent announcement going some way to justifying that belief. Yes, what we have just announced is laboratory data. And, yes, we have a long way to go before we can […]

Unless you have had prostate cancer, or graduated in medicine, or hold a PhD in physics, chances are you have never heard of the terms radiotherapy brachytherapy and 177-lutetium-PSMA peptide complex. So here goes with an explanation…an easy one first and then a more in-depth explanation if you are up to it. Simple explanation: a […]

The following are some questions generated by last Thursday’s announcement. Q: Why are we planning on running 7 clinical studies? A: Because we want to be in a Phase 3 registration study in 2019, and that means knowing by the end of 2018 what that study will look like. We also want that Phase 3 […]

Our last announcement (27th March) reported on two developments. Both relating to some research being done under contract for Noxopharm by Monash University and partially funded by the Federal Government. First development:   idronoxil-C  Q. What is idronoxil-C? A.  Idronoxil-C is an exciting development that we believe has increased very considerably the value of the Company’s […]

Our primary focus remains to bring NOX66 to market to make both chemotherapy and radiotherapy work better and at lower, safer dosages. However, we now can reveal a tantalizing opportunity that is being incorporated into our trials for minimal additional cost. Last Friday’s announcement introduced that opportunity, as well as a new word for most […]

We have yet to treat our first patient with NOX66, but the clinical program has started. Splitting hairs? Perhaps, but starting any first-in-man study is an exercise in logistics. Getting a program of 5 clinical studies up and running is a considerable task. We have cleared the major hurdles on all 5 studies: viz. manufacture […]

The results of a recent study endorse the approach being taken by Noxopharm in using NOX66 to allow low dosages of chemotherapy to be used…much lower than currently in general use. The obvious advantage we are pursuing with NOX66 is that chemotherapy potentially could be used at levels unlikely to cause any side-effects, making life […]

Our AGM last Wednesday in Melbourne and General Briefing last Friday in Sydney brought out some questions from the floor that I thought it worthwhile mentioning for those not able to attend.   Q.Are we looking to raise capital? No. We have sufficient funds to take us through to 2018. If we are successful in […]

The details about the Phase 1 study announced yesterday are available at: https://clinicaltrials.gov/show/NCT02941523 Our main objective in this study is to see if NOX66 can make tumours respond to chemotherapy once they have become fully drug-resistant, and to do so using low dosages of chemotherapy. That’s an ambitious and novel objective, but one that in […]

It’s been 2 months since the listing and IPO. The first few months in the life of a drug development company is all about laying foundations. Everyone is looking for news flow as evidence of activity, but that requires first building the platforms that will deliver the news flow.  As the platforms are progressively built, […]

In a recent ASX announcement, we made mention of opening up a second clinical front for NOX66, that being to use it in conjunction with radiotherapy.   Our objective is to open up two Phase 1 studies of NOX66 + radiotherapy over the next 6 months. These will complement the NOX66 + chemotherapy study we […]

SEPTEMBER 5, 2016:   NOX66 TECHNOLOGY EXPLAINED       by Dr Graham Kelly   Here is an obvious question: Idronoxil was tested in over 400 cancer patients over a 10-year period. In the end, it didn’t work in enough patients to warrant the investment to continue to bring it to market. So why do we think we can […]

Welcome to this first blog, which I will use to expand on the details of our upcoming clinical study. It’s a somewhat unusual design, so worth a moment or two to look at in some detail. The first thing to comment on is why we are conducting the study in Eastern Europe and not Australia. […]