The clinical-stage drug development company focused on the treatment of cancer and cytokine release syndrome (septic shock) is going into the new financial year in a strong cash position, which will enable it to proceed with its exciting Four Pillars Oncology Program.
It is also expecting more developments from its subsidiary, Pharmorage, which deals with the growing collaboration with Hudson Institute of Medical Research, Australia’s pre-eminent research body in inflammatory diseases.
Chief executive officer and managing director Dr Graham Kelly said: “The major outcome from the past financial year has been a glimpse into the uniqueness and substantial potential of our isoflavonoid technology platform.
“From data showing us having what we believe could be the most effective means of turning tumours from ‘cold’ to ‘hot’, to the LuPIN data showing a strong enhancing effect of radioligand therapy, to what appears to be a successful anti-inflammatory effect in COVID-19 patients, to discovering molecules with the potential to block growth signals driving aggressive growth of cancers of the brain and pancreas.
“The progress in that year means we go into the current financial year with clear therapeutic and commercial strategies.
“Our IONIC trial has started to screen patients and DARRT-2 will be doing the same shortly. Our CEP-2 (sarcoma) study is scheduled to open Q4 2021.
“We are reviewing the clinical strategies for both a LuPIN-2 study and a Phase 2 NOXCOVID study with strong intentions of undertaking both this current financial year predominantly through non-dilutive funding.
“We also have an exciting anti-inflammatory drug discovery program underway with our subsidiary, Pharmorage. The 2020/2021 financial year was highly productive. The next financial year looks like being even more so.”
A wide range of pre-clinical collaborations and clinical trial read-outs this past reporting period led the company to realise the extent of opportunity it has in potentially meeting a range of urgent medical needs across the spectrum of human degenerative disease.
After considering the opportunities available, it has decided on the following strategies:
➢ The so-called ‘4 Pillars Oncology’ clinical development strategy for Veyonda based on the concept of using the broad anticancer properties of idronoxil to allow Veyonda to be used to enhance the effectiveness of other commonly-used anti-cancer treatments;
➢ The use of the unique anti-inflammatory/immune-sparing properties of idronoxil to position Veyonda as a treatment of early-stage COVID-19 disease;
➢ To use the drug technology platform to develop a pipeline of drugs that block ‘helper’ signals from healthy support cells to target those tumours such as brain and pancreatic cancers that display highly aggressive growth; and
➢ To use the drug technology platform to develop a pipeline of drugs with unique anti-inflammatory actions to target a range of inflammatory diseases, and to house this opportunity in the subsidiary, Pharmorage, in a partnership with Hudson Institute of Medical Research.
Market cap more than triples
At the beginning of the year, Noxopharm had a market capitalisation of around A$39 million and a share price of A$0.18.
At the close of the year on 30 June, the market capitalisation surged to around A$186 million, with the share price finishing at A$0.64.
Well-funded going forward
Noxopharm remains well-funded following a A$23 million capital raise in December 2020 and the exercise of $6 million in options in January 2021.
As at June 30, 2021, Noxopharm held A$26.8 million in cash.
Further, a Federal Government tax rebate of A$4.59 million was received in January 2021, with receipt of a formal notification of approval of the Advanced Overseas finding from the Department of Industry, Science, Energy and Resources.
The approval is that the company’s projected R&D expenditure over the 2020-2022 period both in Australia and overseas will be eligible for the AusIndustry R&D tax incentive program, returning 43% of approved funding back to the company.
Noxopharm remains in a strong financial position, with expenditure in line with forecasts.
In light of a rapidly expanding clinical program, the company remains confident of meeting anticipated business expenses over the FY22.
The LuPIN trial at St Vincent’s Hospital in Sydney in late-stage prostate cancer showed Veyonda plus Lutetium-PSMA-617 (LuPSMA) survival data providing a median overall survival (mOS) of 19.7 months at a major oncology conference, ASCOGU.
This was compared to other trials using LuPSMA alone with a mOS of 11.6 months (WARMTH trial) and 15.3 months (Novartis’ VISION trial).
Its DARRT-2 trial received Investigational New Drug (IND) approval by the US Food and Drug Administration (FDA) in late June.
The multinational trial Phase 2 study is being overseen by international contract research organisation (CRO) Parexel.
It is targeting around 100 patients with prostate, breast, lung cancers refractory to standard therapies.
It is undertaking IONIC-1 clinical trial planning, combining Veyonda® with checkpoint inhibitor Bristol Myers Squibb drug, Opdivo® (nivolumab).
The study will be conducted at multiple Australian sites under the supervision of eminent oncologist, Professor Paul de Souza.
Planning is well underway for the CEP-2 trial in soft-tissue sarcoma, which is built on the CEP-1 Phase 1a/1b trial findings of positive anti-cancer outcomes in patients with advanced breast, ovarian, lung and prostate cancer.
CRO Paraexel is completing site selection in the US for the CEP-2 study, building on the encouraging outcomes of CEP-1.
The Phase 1a/1b findings were published in the April edition of the peer-reviewed journal Current Therapeutic Research.
Recruitment into the NOXCOVID-1 study is complete and Veyonda® was determined to be well tolerated in the dose escalation phase of the study in patients with compromised lung function.
Phase 2 randomised controlled study is proposed for Veyonda, to be tested in hospitalized COVID-19 patients with mild hypoxia.
The anti-inflammatory drug offers broad-spectrum cytokine inhibition, but without immune suppression.
The Pharmorage collaboration is based on the identification of a new family of drug compounds with highly selective activity against cGAS-STING/TBK1 signalling.
STING/TBK1 antagonists are now the centre of major industry interest as a new drug class.
The anticipated newsflow in the next six months include:
➢ Progress in the IONIC-1, DARRT-2 & CEP-2 studies;
➢ Phase 2 COVID-19 clinical trial update;
➢ Oncology drug pipeline progress; and
➢ Pharmorage drug discovery progress.