Research and development

MFA-370 is a novel treatment that aims to eliminate cancer tumors, that will first be trialed for the treatment of metastatic urothelial bladder cancer. In preclinical studies MFA-370 has, apart from urothelial bladder cancer cells, shown promising, positive results in treating breast, colorectal and prostate cancer cells.

Medicine not ‘miracle’

When clinical urologist Dr Christer Edlund witnessed the complete remission of terminal urothelial bladder cancer in a 65-year-old patient many described it as a “medical miracle”. For Ectin Research it was the beginning of its research journey towards MFA-370 – a novel therapy for eliminating cancer tumors.

Repurposing tried and tested drugs

Research revealed that the patient had earlier been prescribed a standard medication for a parasitic infection, on top of his regular treatments. Built on extensive in vitro research MFA-370 is a combination of a medication from that substance family, together with one other standard, well-established pharmaceutical drug.

Positive preclinical results
for bladder cancer

Preclinical in vitro cell proliferation studies show that the two substances in combination act synergistically to deliver an anti-cancer effect by dampening the cell proliferation at very low concentrations of the respective substance, reducing the risk of unwanted potential side effects in the final formulation.

In cell morphology studies the combined treatment demonstrated not only that it halted cell proliferation, but also that it induced cell death.

This supports the finding in ’patient zero’, our original 65-year-old patient, where tumorous cell growth was not just stopped, or halted – it was actively reduced, due to induced cell death.

Positive preclinical results for breast, colorectal and prostate cancer cells

Preclinical studies also demonstrate a positive anti-cancer effect in the cell models of other large oncology indications. The combined MFA-370 decreased proliferation rates in cell lines for breast, colorectal and prostate cancer cells.

Histological studies of prostate cancer cells show that this combination treatment also impacts the morphology of the cell lines, with cells releasing from the surface of the culture plate, indicating cell death.

Clinical pathway

MFA-370 comprises two standard tried-and-tested substances, both with excellent safety profiles. It will proceed to a Phase I/II clinical study.

Phase I/ II milestones

  • Scheduled to initiate phase I during H2 2021
  • Expected study result for phase I – H2 2022
  • Scheduled to begin phase II during H1 2023
  • Expected study result for phase II – H2 2024, survival data H1 2025

The power of two:
fixed dose combination (FDC) therapy

Ectin will formulate MFA-370 as a Fixed Dose Combination (FDC) therapy. FDC formulation is expected to increase patient compliance and strengthen each substances’ respective anti-cancer effect. Ultimately this could make administration and treatment for both patients and care team easier.

Exploratory formulation work will aim to explore and define solubility, release rate and other key formulation parameters for an oral FDC treatment.

Simple oral FDC tablet

A simple, oral tablet formulation for an end-stage oncology treatment is unusual – and highly beneficial, for patients, who do not need to make repeated clinical visits for grueling injected treatments, and for healthcare providers, who can offer patients simpler treatments with fewer potential side effects that can be taken in the comfort of their own home – a critical factor at this stage of treatment.

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