Thanks Tataki, for your calm and level-headed post. Also, may I say how sorry I am to hear about your daughter. I can’t comprehend how hard that must have been for you and your family, so please accept my condolences.
When working at the cutting edge, you step forward cautiously ...
There are actually many scientists that are working at the cutting edge of their science, but fewer are working in area where a single mis-step can cause disaster. Medical research is one of the areas where disaster can occur, either through significant harm (ie. death) to a patient or irreparable damage to the program itself. I’m sure I don’t have to expand on this aspect.
This is where Imugene (IMU) is working ... at the cutting edge, and very much in a ‘danger zone’, for patient and program. Throw in massive financial costs, regular trips to the FDA, along with shareholder expectations and you have a management team that is feeling the heat.
Further to the above we find that shareholder expectations often don’t align to the realities of clinical trials ... especially with the amount of time these trials actually take. These trials can be so complex ... endlessly evolving when you are blending the known with the unknown. Thank goodness we have our MAST study (or sandbox trial) to help the team ‘get it right’ in the expansion and possible registrational trials. Having said that, I must also note that company reps may have ‘over-promised’ on the timelines, due to enthusiasm driven by what they are witnessing in the trials. We are all human.
I still have not seen the science around the CF33 suite fall over, I am just waiting for more data. This new data may come from several trials, which should be encouraging for more the patient among us.
Personally, I think we are close to learning more about Cohort B in the Azer-Cel Allogeneic CD19 CAR T Phase 1b Trial in Blood Cancer (Diffuse Large B-Cell Lymphoma). Cohort B is the small group receiving azer-cel, chemotherapy, and interleukin 2 (IL-2).
Of the 3 evaluable patients in Cohort B we have ... 2 CRs so 67% CR and 1 Stable Disease (SD).
It’s a small sample, but by any standards this is amazing. To me the addition of a small dose of IL-2 (a protein that regulates the activities of white blood cells and plays a huge role in regulating the immune response) is a stroke of genius and could be the ‘game changer’. This addition will hopefully maximise the initial response rates and further extend the durability of response. IL-2 is mainly produced by CD4+ T lymphocytes after antigenic stimulation. We continue learn more about IL-2 every day, so watch this space.
Personally, I remain confident of the science and wait for further azer-cel results.
As always, the above is my opinion only.
(20min delay)