The Information Memorandum was released in November 2015, with first funding taking place in January 2016. Since then although the level of funding has been disappointing, with parent company support, and the support of certain shareholders of the parent company, the Company has been able to continue its research and development at a reasonable rate.
During the year it was found that the optical assay which formed the basis of the MiCK development was not performing with the reliability and reproducibility which is required of a diagnostic product and that a coefficient of variability (CV) of about 30% was being produced. For commercial acceptability through the FDA, a CV of about 8-12 is required at a minimum.
As a result, the Company decided that it would evaluate a number of molecular probes for direct measure of apoptosis hallmarks. We have incorporated 3 molecular probes for fluorescent imaging and the results have been excellent. Additionally, imaging provides morphologic characterization of nuclear changes. The assay as now configured produces a CV of about 4 (<5%). This is regarded as outstanding. Using the Company’s assay as currently configured should enable the medical profession to genuinely be able to look forward to a time when personalized cytotoxic therapy for cancer can be regarded as a reality.
One consequence of the significantly improved assay is that the Company’s previous clinical trial results must be revalidated using the updated assay. Because the assay is no longer solely an optical density assay based on the MiCK technology, it has been renamed ChemoINTEL.
During Q1-3 of 2017, the Company has continued optimizing and fine tuning the assay. We have initiated the final critical development studies to set cell number/well (Study 201600007) and the PDX study (Study 201700046) to gain confidence in response prediction and set drug concentration selection for the Training Study. The results of the PDX study should be available in mid-December. The team is confident that the assay is measuring drug induced cell apoptosis and is generating high quality, reproducible data required to support development of a predictive algorithm in the Training study. One drawback is that the large amount of data has required the Company to acquire additional bandwidth to handle all the data generated by the assay.
During Qs 1-4 of 2018, the Company will conduct a Training study and analytical validation. After a rigorous selection process, the Company selected Accelovance, Inc. as contract research organization (CRO) to manage and perform site coordination, site initiation, on-site and remote monitoring, patient assignment, site contracting and payment management, biostatistics/biometrics, clinical data management services with links to laboratory information management system, medical writing, and regulatory services. We will initially work with tissue samples from patients with ovarian cancer due primarily to biomass requirements, and optimise the analytical results over this period. The Company has been in contact with over ten (10) research institutions and a number of Key Opinion Leaders (KOL’s) that have expressed interest in participating in the Training Study. At the end of this period, the Company expects to have a substantial value inflexion, based on the demonstration of the assay’s predictive capabilities, which may or may not lead to a Liquidation Event at that time.
In the event there is no Liquidation Event in Q4 of 2018, a Clinical Validation study will be conducted starting in 1Q19. The patient population for the Clinical Validation study will include ovarian cancer and perhaps breast and/or NSCLC depending on a variety of factors. The Clinical Validation study is currently planned to be completed 2Q20. At this time the Company expects a strong inflexion point, which they hope will lead to a Liquidity Event. Additionally, at this time the Company will be able to launch an LDT and initiate collaborative agreements to generate a revenue stream.
If there has been no Liquidity Event at the end of the Clinical Validation Study, the Company will further develop the assay by conducting a Clinical Utility Study in ovarian cancer (and perhaps breast and NSCLC as well). The first Clinical Utility study is currently planned to be initiated 3Q20 and be completed 4Q21. FDA approval should follow 6 to 9 months later. A Liquidity Event could happen at any time after the end of the first Clinical Utilities study phase and some trading income from collaboration agreements could be expected at this time.
The work completed during 2016 and the first half of 2017 has resulted in a better and more reliable assay than was the case when the IM was published in November 2015. Management are confident that these changes of will lead to a technologically improved product, and to an earlier Liquidity Event than might have occurred under the original program, albeit at the expense of a narrower series cancers which have been tested. The cost to arrive at this result is expected to be significantly lower than was the projected in the Information Memorandum.
If the level of funding is improved and there are surplus funds after engaging in the basic program outlined above, Management intends first to reduce the time to complete the development program, and then to add further studies in additional cancer types. Management believes that with a rate of funding significantly above the minimum comfortably required to complete the above program, the time to completion can be reduced by 6 to 9 months, with proportionate time savings over the total time period of the studies to be completed.
As additional funds become available, the R&D team will continue the development of a new and exciting platform that we have named ImmunoINTEL. The platform is a multi-parameter flow cytometry-based immuno-oncology biomarker platform best positioned to (a) phenotypically characterize all cells present the tumor microenvironment and provide critical metrics to better stratify intra-tumoral immune responses, (b) to establish a systemic immunological profile of cancer patients as it relates to the planned tumor immunotherapy, and (c) to give a comprehensive and objective biomarker-based report to physician, a report that is tailored for a specific immunotherapy and patient. Additional information about the ImmunoINTEL platform will be available in future updates.
In summary, it remains the belief of Management that the Company has potentially world beating technology which will take 2 years to its first value inflection point and 4 years to its final inflection point, at a reduced cost as compared with the development program as originally envisaged n the Information Memorandum, and with a technologically improved assay, which will enable true personalized medicine for the first time in the field of chemotherapy. The addition of the ImmunoINTEL platform has already captured the attention of KOL’s and prominent research institutions and pharma companies.