Aprea did not meet in mds

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CKTC
Posts: 50
Joined: Sun May 31, 2020 4:26 am

Re: Aprea did not meet in mds

Post by CKTC » Wed Dec 30, 2020 2:42 pm

APRE is a cautionary tale for naïve biotech investors who become overly confident that a small Phase 2 trial's positive results will successfully translate to positive, statistically significant results in a more extensive Phase 3 trial.

CKTC
Posts: 50
Joined: Sun May 31, 2020 4:26 am

Re: Aprea did not meet in mds

Post by CKTC » Wed Dec 30, 2020 3:03 pm

BTW, Fenaux, Steensma, Komrokji, and the crew were all on board with APR-246 as the ability to reactivate p53 is a holy grail. PMVPharma (PMVP) is also working on targeting p53. The company has barely started Phase 1 and it’s already sporting a market cap north of $2 billion.

biopearl123
Posts: 1665
Joined: Fri Jul 20, 2018 5:13 pm

Re: Aprea did not meet in mds

Post by biopearl123 » Wed Dec 30, 2020 6:55 pm

CKTC, thanks for your post. One hopes Geron will not suffer a similar fate but I am heartened by the careful correlation of molecular end points (shortening of telomeres, direct measurable effects on hTERT, reduction in malignant molecular clones, measurable reductions in mutations etc) with clinical improvements in symptoms, spleen, OS and bone marrow fibrosis. The wisdom of Scarlett et al to establish Imetelstat as a single agent is apparent with failures such as Aprea in combination (azacitidine) and the newly initiated Constellation study (again with a combo arm) occurring. On YMB the cacophony is almost unbearable with a failure to understand the patient and painstaking approach Dr. Scarlett has taken to bring Imetelstat to market in two important indications with studies that have the blessing of the FDA and have the potential to present highly significant statistical data. Two (VERY) soft points on the curve as to what might be going on internally in Geron. One is the fact that the latest job posting (New Jersey) has not been filled and has prominently remained on the Geron site. The second is that when Dr. Scarlett assumed the helm at Geron he made a statement that the time to sell or partner was after good PII data. Take from this what you will but the ASH and EHA presentations received some very enthusiastic reviews by KOLs. A p53 activation drug in combination with Imetelstat could be a future course of research. At least on the surface, it appeared that promising combos with Rux or venetoclax not vigorously pursued perhaps because they are looking for just the right drug. Wishing Dr. Scarlett, Rizo and the entire Geron team a healthy happy and productive New Year. There seems little question that a lot is going on that you can't tell us about. Regards to all, bp

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