RE: What will the next SP moving News Be ?4 Feb 2021 23:13
Treeshaker - with regards to your comment;
"The exosome program is preclinical. The chance of even a small molecule preclinical drug making it to market is 1.in 5,000 and exosomes are a novel biologic which is riskier. Let's be generous and say they have 5 candidates - that"s a 0.1% chance of success."
Clearly, based on some of your postings, you are knowledgeable about biotech stocks, the risks, the FDA process etc. So perhaps you will offer comment on the following (which is a summary of my thoughts regarding exosomes - a subject up until about 8 months ago, I didn't really know or care about).
Codiak released an RNS today: https://www.globenewswire.com/news-release/2021/02/04/2169830/0/en/Codiak-Reports-Additional-Positive-Phase-1-Results-for-exoIL-12-Confirming-Local-Pharmacology-and-Dose-Selection-for-Safety-and-Efficacy-Trial-in-Early-Stage-Cutaneous-T-Cell-Lymph.html
In short summary, it is a follow-up study in relation to their testing of exoIL-12, which is the drug IL-12, loaded to exosomes and targeted to solid tumours.
IL-12 is a drug that was developed in 1986, and has been the subject of number trials due to it's promise as an immunoregulatory anti-cancer agent:
"Based on subsequent research studies, IL-12 seems to serve as an immunoregulatory anti-cancer agent for oncology patients. However, the adverse events related to IL-12, including fever, chills, decreased peripheral blood cells and organ dysfunction, have limited the clinical application of IL-12."
An RNS from Codiak a month or so ago discussed how the payload drug was tested phase 1, and the initial five cohorts of five patients displayed no observable side effects from the treatment. This despite the drug being delivered at equivalent levels that had previously shown severe adverse effects, when the drug has been administered via means other than exosomes. This is consistent with pre-clinical findings they presented from animal models (i.e. what Reneuron are currently pursuing).
The RNS today states "IL-12 was not detected in plasma at any dose of exoIL-12 tested and plasma IP-10 was only detectable at the highest, 12 µg dose. . . As previously described, no detectable IL-12 was present in plasma and no drug-related adverse events were observed across the entire dose range."
Codiak are in the process of validating a delivery programme for drugs that have been around a long time; drugs that are designed to target hard to reach/treat diseases. The drugs have previously been shown to be effective at treating the diseases, but have an intolerable safety profile, which is why the have not previously been approved.
Codiak and Rene are offering the potential means to load these drugs in a way that will target the disease, but potentially without the side-effects.
My question therefore is, in the context of what I've said above, do you truly believe that a 5 candidate programme would actually offer 'a 0.1% chance of success', as you state.