Bio, CH and other knowledgeable board members: Is there anything worth worrying about re toxicity concerns some twitter guy has been fanning? I read the CC transcript, and noticed that dosing was changed. The twit has been going off on the subject with the fearsome AF joining in. Trying to avoid another VICL and AEZS and SPPI debacle, where AF proved correct on all three pans, and hold on to my ONXX gains. BTW, CRIS starting to slowly come to life. CH talked me into it.
This to me seems like an old issue. Did this guy just read about it or something. The toxicity that I believe they are referring to here is for their 901 conjugate. What really happened was that the patient was able to tolerate one or two (maybe more?) doses at the higher concentrations tested. What they found as time progressed was that the patients developed peripheral neuropathy with repeated dosing. A set back for IMGN as they had to reduce the dosing and essentially start the trial over with a new protocol. They are still seeing the same efficacy at the lower dosing, and that is much more tolerable for the patients.
These are relatively new moieties (ADCs') that these folks are still learning about. Getting the dosing in just the right window to sneak a very potent drug through a person's system and into a target cancer cell is not a simple task. I for one am giving Immunogen a pass on this one, its a very reasonable issue to run into during initial clinical trials. After all, this is part of the whole reason we do clinical trials.
Small cell lung cancer is one of the holey grails of the biotech industry, and the landscape is littered with failed drugs aiming to treat this disease. They have a long road ahead of them on this drug, but it certainly has the potential to be a winner. I think Endocyte looks like a more elegant and potential winner in this disease indication with their folate conjugate. They are looking primarily at Vintafolide in ovarian cancer as their lead indication, but they also have a phase II trial ongoing in lung cancer.
I don't think they did enough dose ranging testing with chemo for 901 and IMO, that lead to the toxic response. I recall CEGE had an issue with their immunotherapy, it worked fairly well on its own, then they added chemo and it was too toxic for end-stage patients (stupid Stephen Sherwin cost me a bundle on that mistake). IMGN should have done more testing before trying the combo in phase II and someone should have been fired. It makes no sense to say ADC's are "too toxic", look at Kadcyla and the SGEN drug, they are amazing in efficacy and far les toxic than chemo. IMO, AF is a short tool, pun intended. I am not concerned, they just have to find the right dosing levels and schedules, etc. Maybe that's why phase I takes so long.
Thanks Bio, helpful as always. Good luck to you, and us. Beware of the tool Adam. I'm neither fan nor foe, but he is very smart and often right. BTW, I caught that falling knife at 15.65, and am bleeding already.