Anisina (ATM-3507)

Anisina is a new approach to chemotherapy that targets the cancer cells' actin cytoskeleton. Anisina will be used with existing, widely-used chemotherapies, potentially reducing resistance and treatment toxicity levels. Anisina is at a pre-clinical development stage and a US IND is being prepared which will allow it to go into clinical trials.

  • Market Need

    The anti-tropomyosin (ATM) drug technology is a novel therapy that is based on 20 years of world-leading research into the actin cytoskeleton. Anisina (ATM-3507) belongs to a ‘first in class’ family of compounds that have been designed to target a core component of the microfilaments of cancer cells, Tropomyosin Tpm3.1. The ATMs work selectively against cancer cells as, unlike normal cells, cancer cells are highly dependent on Tpm3.1 for survival. Targeted inhibition of Tpm3.1 function results in the collapse of the cancer cells actin cytoskeleton, which ultimately leads to cell death.

    When used as an adjuvant treatment (treatment that is given in addition to the primary, main, or initial therapy to maximise its effectiveness), in pre-clinical studies, Anisina has been shown to enhance the anti-cancer activity commonly used chemotherapeutics agents such as the microtubule targeting compounds belonging to the taxanes and vinca alkaloid families.

    If proven to be effective in clinical trials, Anisina has the potential to deliver improved chemotherapy response across a broad range of cancer types including lung, prostate, colon, gastric, pancreatic and breast cancer, as well as childhood cancers such as neuroblastoma.

    The Science Behind It

    The cytoskeleton has a role in a number of biological functions that are hijacked by a cancer cell, including proliferation and survival. There are three components in the cytoskeleton, the microfilaments, the microtubules and the intermediate filaments. The novelty of the ATMS, is that by targeting the tropomyosin component (not the actin) treatment can selectively kill cancer cells over normal cells.

    The selectively of the ATMs is a huge step forward in terms of the development of compounds that target the cytoskeleton (with broader implications beyond the scope of oncology).

    The microtubules of cancer cells have been a successful therapeutic target for over four decades. The taxanes (paclitaxel, docetaxel) and vinca alkaloids (vincristine, vinblastine) continue to be among the most widely prescribed drugs in oncology, in many cases as first-line therapies of choice. However there are some clinical limitations with using microtubules targeting agents. Novogen believes that using the ATMs in combination with the microtubule targeting compounds has the potential of improving patient outcome on multiple fronts.

    • improved response to therapy
    • response at a lower dose of both chemotherapeutics (important in chemo sensitive patients and young children) and
    • restore sensitivity to patients that are resistance to standard of care microtubule inhibitors.

    In pre- clinincal studies, Novogen has observed in a 20-30 fold increase in the effectiveness in killing cancer cells when Anisina is used in combination compared to the microtubule targeting inhibitor alone.

    Novogen’s pre-clinical studies in a prostate cancer model have shown that Anisina can restore sensitivity of the prostate cancer to the standard of care microtubule targeting drug- docetaxel. Clinically that means that unresponsive patients, when treated with the Anisina/Docetaxel combination, may have a better response.

    Anisina is designed to enhance the activity of chemo agents such as taxanes and vinca alkaloids, which are widely used in cancer treatment

    Market Opportunity

    Anisina has international patent protection and has the potential to achieve a significant market value if development is successful. Taxanes and vinca alkaloids are very widely used components of the ‘backbone chemo’ routinely used in the treatment of cancer, even with targeted therapies, creating blockbuster potential for Anisina.

    Anisina is on a path to IND in 2017, after only three years of development in Novogen

    Focus on paediatric opportunity

    Young children treated for cancer with high doses of chemotherapy can experience significant impact on quality of life and some develop secondary cancers in adulthood.

    Through global collaborations, Anisina has been shown to work synergistically with existing chemotherapy agents. The synergy observed with Anisina (in combination with microtubule targeting drugs), may allow for a reduction in dosing and therefore and potential reduction in long term side effects.

    Global partners in the paediatric space include the Nationwide Children’s Hospital. Novogen’s Australian collaboration with The Kids Cancer Project will help to support the development of Anisina into Phase 1 trials in children. Studies have been extended to evaluate the effect of ATM in combination with microtubule targeting agents in hematological cancers.

    Timing and Market Implications

    Pending the outcome of the preclinical safety studies, we expect to start 'first people' studies in 2017.

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