Zenith AGM thoughts
posted on
Nov 28, 2017 03:59PM
Zenith's BET Inhibitor ZEN-3694 is Currently Being Evaluated in Multiple Oncology Clinical Trials
AGM 2 weeks away. I compiled a few questions in advance of the AGM. Please edit/add on as you see fit.
ZEN-3694 single agent trial: This trial is listed a now completed. What was the maximum tolerated dose? Was the recommended Phase 2 dose every day dosing or intermittent dosing? Plans for publication/presentation? Any follow up single agent trials planned for breast cancer or immunooncology or will these future trials be combination therapy trials?
ZEN-3694/enzalutamide combo trial (also see patient update below): When is the estimated completion date? Has the maximum tolerated dose been reached yet or is the trial still in dose escalation stage? Is the recommended Phase 2 dosing everyday or intermittent dosing? At what point is this deemed a success? The graphs state that the standard of care is 18 weeks progression free survival. Is the “target line” 32 weeks or 36 weeks (it changed between the two recent presentations)? Will there be a dose confirmation/expansion stage in this Phase 1 trial?
ZEN-3694 breast cancer/immuno-oncology trial(s): In the October 17, 2017 presentation, pre-clinical data for a triple-negative breast cancer model was shown, in which ZEN-3694 in combo with other drugs worked very well in various breast cancer models. In this webcast, DM mentioned "In breast cancer we'd probably start with ER-positive breast cancer. Our data in that area is actually even better." What is the study design, timeline, patient population (i.e. type of breast cancer), and combo drugs for the upcoming breast cancer trial(s)? When is this trial anticipated to occur? What is the plan and timeline for any ZEN-3694 immuno-oncology trials?
Zenith financials: In both October 2017 and November 2017 slides, it was stated “10MM additional shares will be sold shortly.” Has this occurred yet? If not, what is the timeline? What is the price per share for these 10M shares….how much will this share sale raise? How does Zenith plan to fund future prostate cancer trials, breast cancer trials, and immuno-oncology trials? Will current cash on hand and funds raised from the 10M share sale be sufficient for 2018 activities?
Status of patents: Zenith previously indicated that US fast track patent approach was being undertaken to expedite approval of current patent. It was also suggested that a published patent is needed to get a licensing deal over the finish line in China and that once the fast track patent is approved, the follow on patents in other countries can happen very fast. Please provide an update on Zenith patents.
Other Zenith compounds: Aside from ZEN-3694, what other molecules are lead candidates for Zenith and for what indications? What are the properties of these other lead molecules?
Patient update in ZEN-3694/enzalutamide combo trial as of data updated ~10/11/17
Cohort 1 (four patients) started at the lowest dose and 3 of the 4 patients are no longer ongoing due to withdrawl of consent, radiographic progression or clinical progression. The one remaining patient ongoing w/o disease progression for 42 weeks as of the data updated ~10/11/17 and theoretically will be at ~51 weeks as of AGM 12/12/17.
Cohort 2 (six patients) is the most informative group. Three of this cohort have been ongoing for 29-32 weeks as of data updated ~10/11/17 and theoretically will be at 38-41 weeks as of AGM 12/12/17. These three patients also show robust suppression of the PSA response and have maintained this low PSA level for beyond the 18 week standard of care mark (20-24 wks as of data updated 9/20/17). The other three Cohort 2 patients were added later and were at 6-9 weeks as of data updated ~10/11/17 and will theoretically be at 15-18 weeks as of AGM 12/12/17.
Cohort 3 (3 patients): 1 of the 3 Cohort 3 patients is at week 12 as of data updated ~10/11/17 and will theoretically be at week 21 as of AGM 12/12/17. However, the other two patients had clinical progression or adverse event (anorexia/fatigue/nausea) necessitating termination in trial at week 10 or 11.
Cohort 4 (2 patients) just started (week 1 and 4) as of data updated ~10/11/17 and will theoretically be at week 10 and 13 as of AGM 12/12/17.