drugset / Press release

New Independent Trial Data Supports Potential of Veyonda

2021-05-31 · Noxopharm Limited · original noxopharm.com ↗

Noxopharm Limited. ABN 50 608 966 123 Suite 3, Level 4, 828 Pacific Highway, Gordon NSW 2072 AUSTRALIA Noxopharm Limited (ASX:NOX) | ASX Announcement | 31 May 2021 New Independent Trial Data Supports Potential of Veyonda as Major New Anti-Cancer Drug • New independent clinical trial supports Company’s aim for Veyonda to become a standard companion drug for major anti-cancer therapies • WARMTH study is first reported large-scale multi-national study of Novartis experimental drug, 177lutetium-PSMA-617, in late-stage prostate cancer and showed a median overall survival (mOS) of 11.6 months • This compares to the LuPIN trial (Veyonda + 177lutetium-PSMA-617) which achieved an mOS of 19.7 months, a 71% increase over the WARMTH trial • Patient disease status similar between both studies • LuPIN trial part of the Noxopharm ‘Four-Pillars’ oncology program. Sydney 31 May 2021: Australian clinical -stage drug development company Noxopharm Limited (ASX:NOX) is pleased to report on the recent publication of independent clinical trial data involving the experimental radiopharmaceutical drug, 177lutetium-PSMA-617 (Lu-PSMA) owned by Novartis. Known as the WARMTH (World Association of Radiopharmaceutical and Molecular Therapy) study, it is an 18-centre, multi-national, retrospective trial reviewing the experience of 319 men with late -stage progressive metastatic castrate -resistant prostate cancer (mCRPC) receiving Lu-PSMA following prior therapies. The trial data was published on-line last week in the European Journal of Nuclear Medicine and Molecular Imaging.1 The key outcome of the WARMTH study is a median overall survival (mOS) outcome of 11.6 months. Given that both WARMTH and LuPIN studies involved men with similar disease status (end-stage , progressive) and similar pre-treatment histories, the Company believes that the WARMTH trial provides meaningful context for the LuPIN trial . That context is that the combination of Veyonda and Lu-PSMA in LuPIN delivered a median overall survival outcome of 19.7 months,2 a 71% increase in survival outcome over the WARMTH trial. Note: median Overall Survival is the time after the start of treatment when half the patient population has died and half remains alive. Noxopharm Limited. ABN 50 608 966 123 Suite 3, Level 4, 828 Pacific Highway, Gordon NSW 2072 AUSTRALIA Comparison of patient details: WARMTH v LuPIN WARMTH LuPIN Number of patients 319 56 Patients with bone metastases 94% 88% Patients with >20 lesions 57% 73% Prior therapies*: Abiraterone/enzalutamide 100% 100% Docetaxel 76% 100% Cabazitaxel 23% 95% Dr Graham Kelly, Noxopharm CEO and Managing Director, said, “This result further supports the Company’s belief that Veyonda  has the potential to become a standard of care drug to be used in combination with the most common forms of anti-cancer treatments. In this instance, Veyonda is being combined with the Novartis radioligand, 177lutetium-PSMA- 617, for the treatment of metastatic prostate cancer. This particular combination is one of our so-called 4-Pillars oncology program where we are looking to use Veyonda to improve survival prospects across a range of cancer treatments and forms of cancer. Based on early data from our CEP-1 and DARRT-1 clinical studies, we believe that the unique multiple anti-cancer actions of Veyonda have the potential to produce meaningful survival benefits as a combination treatment across multiple treatment combinations. The striking difference in mOS outcomes between the LuPIN and WARMTH trials serves to further support that belief.” LuPIN Study The LuPIN study completed the final treatment of the last (56 th) patient in October 2020 and will conclude formally in October 2021 , after which the final data, including the final mOS outcome, will be announced. The LuPIN trial involved Veyonda doses 400-1200 mg. Since then, Noxopharm has established in its NOXCOVID trial that a 1800 mg dosage is well tolerated with the potential for an even greater anti-cancer effect. A larger Phase 2 LuPIN study is under consideration in light of the anticipated pending marketing approval of 177lutetium-PSMA-617 and its likely adoption as a standard treatment. References 1. Ahmadzadehfar H et al (2021) Eur J Nuc Med Mol Imaging. https://doi.org/10.1007/s00259-021-05383-3 2. Pathmanandavel S et al (2021) ASCO G-U Conference 2021 Abstract #103 *Lack of standardised treatment regimens means comparisons with other studies have limitations which need to be considered Noxopharm Limited. ABN 50 608 966 123 Suite 3, Level 4, 828 Pacific Highway, Gordon NSW 2072 AUSTRALIA About the 4-pillars oncology program The 4-pillars oncology program is the Company’s signature program, testing the ability of Veyonda to boost survival outcomes in the following 4 combinations: • chemotherapy CEP Program doxorubicin • radiotherapy DARRT Program standard radiotherapy • checkpoint inhibitor therapy IONIC Program nivolumab • radioligand therapy LuPIN Program 177Lu-PSMA-617 Noxopharm believes this highly ambitious objective is possible through the action of idronoxil (the active ingredient of Veyonda) as a unique highly selective inhibitor of sphingosine -1-phosphate production, resulting in a wide range of oncolytic and immunostimulatory outcomes. The aim is to improve survival prospects for cancer patients and to provide a significant boost to global sales of anti-cancer treatments, with chemotherapy and checkpoint inhibitor therapy sales currently estimated by the Company at $70 billion USD p.a. About Radioligand therapy A radioligand comprises a compound (ligand) that searches out and attaches to a cancer target, combined with a radioisotope that emits radiation to kill the cancer cell. Radioligand therapy is emerging as a major new form of cancer therapy, offer ing the ability to deliver radiation , usually intravenously, in a highly targeted manner. Current use largely is limited to the treatment of neuroendocrine tumours and late-stage prostate cancer. 177lutetium-PSMA-617 involves an antibody fragment attached to the isotope lutetium-177. The antibody fragment (peptide) identifies prostate -specific membrane antigen, a surface protein highly expressed by prostate cancer cells. Swiss pharmaceutical company, Novartis, acquired 177lutetium-PSMA-617 as part of a series of US$6 billion transactions in 2018. About Noxopharm Noxopharm Limited (ASX:NOX) is an Australian clinical -stage drug development company focused on the treatment of cancer and septic shock. Veyonda® is the Company’s first pipe -line drug candidate currently in Phase 2 clinical trialling. Veyonda® has two main drug actions – a moderating effect on the ceramide/sphingosine -1-phosphate balance and inhibition of STING signalling. Activity against the former target contributes to its dual-acting oncolytic and immunostumulatory functions designed to enhance the effectiveness and safety of standard oncology treatments, i.e., chemotherapies, radiotherapy and immune checkpoint inhibitors. Activity against the latter target provides an anti -inflammatory effect, also contributing to an anti -cancer action, but also potentially blocking septic shock. Noxopharm also is the major shareholder of US biotechnology company Nyrada Inc (ASX:NYR). To learn more, please visit: noxopharm.com END Graham Kelly, CEO and Managing Director of Noxopharm, has approved the release of this document to the market on behalf of the Board of Directors. Noxopharm Limited. ABN 50 608 966 123 Suite 3, Level 4, 828 Pacific Highway, Gordon NSW 2072 AUSTRALIA Investor, Corporate & Media enquiries: Company Secretary: Prue Kelly David Franks M: 0459 022 445 T: +61 2 8072 1400 E: [email protected] E: [email protected] Forward Looking Statements This 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 (including but not limited to the COVID-19 pandemic) that could cause the actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statement.

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