Watch: Our value inflection points between Q2 2023 and FY 2024
23 May 2023
More about the clinical studies we have planned to round out a KappaMab data package and advance our anti-KMA CAR-T, as explained by Dr Geoffrey Nichol, HaemaLogiX Non-executive director.
Intro: It is rare that you can spend maybe $20 million – this sounds a lot but in drug development terms it's just a drop in the bucket to spend 20 million and in 1-2 years essentially have all the answers that you need to determine whether you have what would then appear to be an enormously valuable asset.
Question: What do you foresee as some of the value inflection points for HaemaLogiX between now (Q2 2023) and FY2024?
The questions that we need to answer are twofold with the monoclonal antibody:
With KappaMab we need to see whether by raising the dose, which has increased efficacy with similar antibodies that have already gone into development, we can see even greater enhanced efficacy and we can do that in about 30 patients which in the grand scheme of drug development is quick and cheap process to get an answer that we anticipate having sometime in 2024.
The other question we would like to answer is - will the CAR-T data, that's been very positive in mice, be reproduced in people. The Peter Mac Institute is already planning to give a properly manufactured CAR-T to a group of patients and if our CAR-T is anything like other CAR-T’s, 6 to 12 patients is enough to see whether you're in the efficacy zone or not so that's another likely 2024 event.
If we have an active and effective CAR-T that will become an effective therapeutic, we know that from past experience, it almost certainly validates that a bispecific antibody, which sort of does the same thing in a different way as the CAR-T, is highly likely to be effective as well and obviously we will have the dispositive data on the antibody and at that point it's all downhill - it's just a matter of taking the time and spending the money to fulfill regulatory requirements. That does take time and it does take money, but you've written down almost all the risk so in drug development terms, this is almost a sort of perfect case that we have.
It is it is rare that you can spend maybe $20 million – this sounds a lot but in drug development terms it's just a drop in the bucket to spend 20 million and in 1 to 2 years essentially have all the answers that you need to determine whether you have what would then appear to be an enormously valuable asset.
Question: What are some of the benefits, from an investment point of view, of the design of HaemaLogiX’s clinical studies?
When I first joined the industry, the head of R&D at GlaxoSmithKline, at the time said the aim of drug development is to take the shortest route to the negative answer - get an answer as quick and as cheap as you can and that's not always possible. The checkpoint inhibitors that were in the balance for seven years and they were finally shown to work after a long expansive 5-year randomized placebo-controlled study in 750 patients. We had to wait that long to get an answer. That's completely different with HaemaLogiX’s - it's quick and in the grand scheme of drug development, it's dirt cheap.
There are some dis-positive studies in drug development which are blinded. No one knows what's going on. No one knows whether they're getting the active or the placebo treatment and you have to wait - sometimes years - to the end of that study before you actually know the results.
HaemaLogiX studies are different in that they are open label. We know what's happening with every patient as we go through the study for both the monoclonal antibodies and CAR-T studies so it is possible that we could see interesting activity early on. That being said, each study does have an element of starting at a somewhat lower dose and escalating the dose so you have to wait until that happens but there is still the opportunity to see some early data which does have the advantage, from the point of view of all of us investigating the drug, of having more or less, real-time evolving readout and if it's looking good you know that you have lead time to get the extra resources to exploit success.