HaemaLogiX origins go back to the discovery and characterisation of the Kappa Myeloma Antigens (KMA) and Lambda Myeloma Antigens (LMA).
The discovery of KMA and LMA on the cell surface of malignant (cancerous) B cells was completed at the University of Technology Sydney (UTS). These B cells in healthy people are responsible for fighting infection and aiding the human body's immune defense. When the antigens appear on the cell surface of these B-cells they can cause Multiple Myeloma (MM) and other related blood cancers. This discovery was the subject of a PhD thesis by Dr Rosanne Dunn who has remained associated with this project since that original discovery during her research and she is today a Director of HaemaLogiX and Vice President of Clinical Research and Product Development.
Following the original discovery at UTS, Pacmab Ltd was formed and "spun out" with this technology. Several iterations in the name & ownership of the company have subsequently occurred but throughout this the technology and Intellectual Property (IP) has been preserved, and is today held by HaemaLogiX Pty Ltd.
Following the completion of the Phase IIa clinical study in Multiple Myeloma (MM) (a form of blood cancer that impacts the bones and kidneys of patients with this disease), IST had sought funding for a global Phase IIb clinical study in MM. IST had also committed substantial funds toward the manufacture of the KappaMab antibody required for the clinical testing.
Though the Phase IIa study was successful in demonstrating safety and identifying patients who may best respond to this potential treatment, there was a remaining question of its value in patients who are experiencing "progressive disease". This question represents an important bridging step between the Phase IIa results and the next study, a Phase IIb/III clinical study.
With the cash on hand dwindling and new sources of capital not available, IST could not continue to fund the intended study and was placed into Administration by the IST Board of Directors.
Four individuals, who all had a prior association with IST, concluded they would acquire the assets and Intellectual Property of IST and develop these assets through a very focused approach aimed at proving effectiveness in patients with progressive MM who can be classified as high risk or have a form of MM that is poorly treated by the existing therapies available. These are the same patients in whom we have seen some responses in prior clinical trails.
With this approach we were able to raise the initial capital to acquire the IST assets and IP. We also created a new company, HaemaLogiX Pty Ltd, to take this project forward.
We believe the focused study (refer to question 2 & 3), can be best achieved by conducting a Phase II bridging clinical study, and is a key element of future success but beyond that there are several other factors. Unlike IST HaemaLogiX has no debt on it's balance sheet and so going forward all capital raised will be directed to further product development.
HaemaLogiX is also fortunate that during the months in which IST was under Administration, a new technology, called a CAR-T cell, has surged in terms of its potential importance in the treatment of blood cancers. HaemaLogiX collaborators, The Westmead Millennium Institute of Medical Research (WMI), (this collaboration was initiated by IST) have made significant progress toward development of a CAR-T cell treatment. Given the recent media coverage of Kite Pharmaceuticals and Juno in the US, we believe with our own CAR-T cell in development we have the ability to expand our future product offering into this exciting new field. These companies, Kite and Juno, have raised substantial capital on the basis of their CAR-T cell technology. We plan to follow suit though with more modest expectations.
HaemaLogiX has so far raised nearly $AUS2M through our Series A financing. This was more than enough to acquire all the IP and assets of IST and still have adequate funds in the bank to finance our on-going operations through to March 2016.
As indicated above, we have enough cash on hand to sustain our on-going status quo operations while we raise additional funds in a Series B financing which we hope to complete in the Oct/Nov 2015. It is not meaningful to disclose our actual cash at a given point in time as it fluctuates month to month. It has already benefited from a GST rebate and soon will gain further from an R&D tax rebate in the coming months.
Firstly, while our Series A fund raising has been successful, it is not adequate to start and complete the Phase II bridging clinical study (refer to question 2 & 3). Secondly with the new CAR-T technology we will need to complete further product development and fund a clinical study. Funding these two projects and achieving success in those studies has the potential to make our technology even more valuable and position us for discussions with major Pharmaceutical Companies to achieve a possible licensing deal or an option arrangement.
We have already begun to talk with potential investors in both Australia and the US. We are talking with a wide range of possible investors including Family Offices, High Net Worth individuals, Venture Capital companies and Brokers who may help us raise the funds.
The CAR-T cell technology provides another way to deliver the same KappaMab antibody to patients but does so using their own T-cells (immune cells that help defend our body from an attack by a virus, bacteria, cancer or other foreign material).
Recent results with CAR-T cells coded to produce other antibodies treating blood cancers, including in children who have proved to be resistant to all available therapies, have shown remarkable results. We are keen to test our Kappa CAR-T cell therapy first in mice and then in patients once WMI concludes the development program.
No, there will be no competition between these treatments in the market place. The KappaMab antibody will be used in patients in the earlier stages of their disease as a second or third line of treatment for MM. The Kappa CAR-T cell will be used in patients who have much more advanced disease and for whom the available therapies are no longer effective. As a result these two products will be complimentary and not competitive.
There are several CAR-T cell agents in development but most of these are not primarily focused on treating MM. Those that have chosen to target MM may have some important limitations but we will have to wait for the clinical results to validate these concerns. We believe that for many of the same reasons the KappaMab antibody represents a potential breakthrough in MM treatment so too will our Kappa CAR-T cell. Testing in patients will be critical to verify this.
HaemaLogiX has filed two new patents that build upon our underlying Intellectual Property for the Kappa and Lambda Myeloma Antigens and the associated antibodies. These new patents have also benefited from both the clinical and preclinical findings seen with both antibodies to date. This has prompted new concepts of treatments and new inventions that go beyond our prior patents. If approved these patents will provide exclusivity for many years to come.