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Entitlement Offer Prospectus
May/June 2020

    Clinical Overview

    The primary objective of our clinical development program is to establish Veyonda® as an essential adjunct to radiotherapy in the treatment of prostate cancer,

    Two separate prostate cancer programs are currently underway:

    • DARRT program
    • LuPIN program.

    Veyonda® and the DARRT program

    DARRT stands for Direct and Abscopal Response to RadioTherapy.

    DIRECT response refers to the effect of radiotherapy on the tumours being exposed to radiation.
    An ABSCOPAL response refers to the effect of radiotherapy on the tumours outside of the field of radiation.

    The typical patient is one with late-stage cancer who has run out of conventional treatment options and is presenting for palliative radiotherapy. In this situation, 1 or 2 tumours might be causing symptoms (pain or pressure on vital organs such as the spinal cord) and the radiotherapy is being used to shrink those tumours to provide temporary, symptomatic relief.

    We are exploring two key hypotheses:

    1. that Veyonda®will lead to a better DIRECT response to radiotherapy by holding cancer cells in a state in which they are more vulnerable to damage by radiation (G2M stage of cell division )and then by blocking the cancer cell’s ability to repair this damage.
    2. that Veyonda®will lead to tumour responses outside of the field of radiation – potentially ABSCOPAL

    FAQs about Veyonda® and DARRT 

    1. What cancers are suitable for this approach?
      Veyonda® targets proteins that to date have been identified on all forms of cancer. We are focusing our initial clinical studies on prostate cancer, lung cancer and sarcomas, but we expect eventually to see the DARRT approach being used across a broad range of cancers.
    2. What does the DARRT program entail ?
      Veyonda® is given twice daily for 14 days. Sequential (prior-to radiotherapy) and concurrent (overlapping with radiotherapy) strategies are being explored. In both instances, Veyonda® therapy begins prior to radiotherapy to maximise the number of cancer cells being blocked in their G2M stage of cell division. Palliative, low-dose radiotherapy (25 Gy of either external beam radiotherapy or stereotactic body radiotherapy) is then given to a single tumour over 5 days. Giving subsequent cycles of Veyonda® may also be feasible and is being actively considered for applicable future studies.
    3. Safety profile
      Veyonda® targets proteins generally not found in healthy cells and no adverse effects on healthy cells are known. Over 70 patients have been treated in clinical trials to-date and Veyonda® has generally been well tolerated with few serious side effects. Our ongoing and planned clinical program are designed to confirm and expand on these findings.
    4. How is Veyonda®given?
      Veyonda® is self-administered as a suppository, twice daily.

    Veyonda® and the LuPIN program

    The LuPIN (Lu-PSMA IN Conjunction with Veyonda®) involves men with late-stage metastatic prostate cancer where the radiotherapy is injected intravenously, in conjunction with Veyonda® treatment.

    The radiation is in the form of the radionuclide, 177-lutetium, attached to the peptide, PSMA-617. The peptide is the delivery vehicle and the 177-lutetium is the payload. The PSMA-617 seeks out the protein, PSMA, which is found mainly on prostate cells (cancerous and non-cancerous), but also salivary glands, kidneys and stomach cells. Once attached to the prostate cancer cells, the 177-lutetium emits radiation from a location close to the nucleus, such that damage to the cancer cell is achieved with little or no damage to surrounding healthy tissues.

    Lu-PSMA-617 is injected intravenously on 6 occasions, 6 weeks apart (= total 36 week treatment course). The rationale for using Veyonda® in conjunction with Lu-PSMA-617 is to hold cancer cells in a state in which they are more vulnerable to damage by radiation and then to blocking the cancer cell’s ability to repair this damage.

    Lu-PSMA-617 therapy is an experimental therapy for late-stage, metastatic, castrate-resistant prostate cancer that is attracting considerable attention globally.

    FAQs about Veyonda® and LuPIN 

    1. How is this approach being tested?
      Veyonda® and Lu-PSMA-617 currently are being tested in a Phase 1b investigator-initiated study in Australia. It is a dose-finding study using both 400mg and 800 mg Veyonda® dosages.
    2. What does the program entail ?
      A treatment cycle is Veyonda® daily for 10 days starting 1 day prior to receiving an intravenous injection of Lu-PSMA-617. Each patient receives 6 treatment cycles.
    3. What end-points are being looked at?
      The two key end-points are safety and clinical response being monitored on the basis of PSA levels, radiographic changes and other measures such as quality of life, at 3, 6 and 12 months