I was asked for an opinion elsewhere. Reposting my response here.
I’m backing RAC due to the very, very low risk profile of Bisantrene:
- Was previously approved in France (1988)
- historically works very well for AML. Average Complete Response of 47% in 7 trials in 80s and 90s ( a 20% complete response would easily achieve FDA approval )
- In the big historic Breast Cancer trial achieved same overall survival as Doxorubicin, plus has much better safety ( Doxorubicin is the dominant chemo drug and Bisantrene has better heart safety ).
- History allows short runway to approval via a small Phase II trial in US and accelerated 505(b)(2) approval pathway
- Historically trialed in over 2,000 patients
- 46 historic trials which I estimate has an IP value of > USD $500M (cost of rerunning trials ). $ value aside, that’s immense value for optimising their clinical strategy
Incredible clinical history aside ( trials in patients), the preclinical results from 1983 are equally impressive.
In another clonogenic study of 989 human tumor samples, doxorubicin reduced tumor colony-forming units by 50% in 14% of samples, mitoxantrone had a 21% response rate, and bisantrene was effective against 31% of the samples.Response:
- Doxorubicin 14%
- mitoxantrone 21%
- Bisantrene 31%
Adriamycin = Doxorubicin ( the dominant drug in chemo today )
This is preclinical performance for various cancers.
View attachment 2489024Recent preclinical findings by City of Hope now also give Bisantrene Keytruda style potential ( that’s the biggest selling cancer drug in the world ). Places Bisantrene firmly in the immunoncology space. Works at high dose as a cancer killer and new findings show it works at low dose as a cancer inhibitor.
So a drug, previously approved, previously very successful in clinical trials is going up for approval in the next year or 2 ( IND is well-advanced ).
All that happened was that a chain of corporate takeovers in 1990s lead to drug being forgotten. The owners had financial problems and couldn’t afford to progress it ( had other priorities). Then it was forgotten.
New patents secured, FDA orphan drug designation and now new management has turned it around.
RAC was a hidden gem on the ASX until a successful investor who happens to run a DNA sequencing firm ( and knows something about cancer from his PHD ) went from A to Z through every ASX biotech and got to RAC and was stunned by what he found. He cornerstoned a placement and then joined the company and has been instrumental in turning it around.
(20min delay)