CC yesterday was interesting. Sharing here some of the known and some of new info/clarification(s) for me.
NP did not do most of the talking (Sacha, Lalezari). Some important takeaways for me (please correct/elaborate as I am working out of my bad memory), again, the quotes are what I remember was said:
1) Colon cancer research is more advanced that I thought. "Very exiting animal data", going to new phase.
2) August 28 meeting with FDA regarding prognostic test
3) End of September for BLA approval possible (some IF's)
4) Face to face meeting for Monotherapy in September to discuss monotherapy protocol should Leronlimab have approval as a combination therapy
5) TNBC delay due to difficulty to get patients. New protocol will be tried as it is preferred to have Naïve patents, however Non-naïve will be injected (I think 5 patients) and then "go to the FDA".
6) Commercialization plan will be posted within couple of weeks in web site.
7) Back and forth for a license agreement has been ongoing for some time, we where "far away from each other" but "we believe we are very close to an agreement".
8) Exploring the Prev. properties of Leronlimab (work in Thailand), this can produce another revenue venue. Sacha thinks this is the best way to stop the HIV epidemic, that is, Prev(ention) and Cure.
9) CCR5 does not work in everybody, trying to understand why. CCR5 come in two forms and is highly regulated so it si important to know how much is expressed in the cells on a patient-by-patient basis.
10) The occupancy test are critical to "personalize" the dosage by optimizing treatment suites in an individual fashion.
11) There is another cancer mechanism that is being investigated (apart from the one from Dr. R. Pestell work).
12) Main investigator on monotherapy Dr. Jacob Lalezari says: "once-a-week will be a killer drug" and "life-changing".
13) The Receptor Occupancy Test is important because it will help with precise screening for Leronlimab monotherapy. Will tell when all the receptors are blocked.
14) Some patients are taking Leronlimab for more than 5 years now with no with no drug related SAEs Lalezari says "benefit without toxicity".
15) First TNBC patient injection is imminent (patient identified).
NP did not say why RP was fired (had some brief good words for him), also, no much time to answer questions which was disappointing.
In general got some takeaways from meeting and it seems there will be some milestones in the next few months. If only one of these work out the price should go north.
I liked Nader comment: "we are at a crucial position and too many people worked too hard and many shareholders have risked everything they had to fund us and we need to be very careful. Need to very honest, very transparent and clear about our goal and potential.". Well … I agree, so he is thinking on us bag-holders (finally, some would say).
AI
