Finally got around to watching the AGM. Below is a summary between the ClinicalTrials.gov listings and yesterday's AGM on the status of ongoing and planned clinical trials. Long story, short: A lot is going right now!!!!

Still ongoing and enrolling by invitation only: Continuation Protocol for ZEN003694 in Patients Experiencing Clinical Benefit While Enrolled in a ZEN003694 Protocol. This is the continuation of the original Phase 1/2 US-based ZEN-3694 plus enzalutamide prostate cancer trial. I don't think any additional info on this continuation trial was provided at the AGM. https://clinicaltrials.gov/ct2/show/NCT04145375

Newsoara (China) ZEN-3694 plus enzalutamide Phase 2/3 prostate cancer trial. Start as a Phase 2 then transition to a Phase 3. Paid for by Newsoara. Trial will start in China and then expand to US. Has anyone seen a trial listing for this one on any other sites that provides more info on trial status and timeline? I'm not sure if recruiting or dosing in this trial has started yet.

Recruiting: ZEN-3694, Enzalutamide, and Pembrolizumab for the Treatment of Metastatic Castration-Resistant Prostate Cancer. This is the Phase 2 UCSF/Merck Keytruda immuno-oncology and Pfizer enzalutamide combo prostate cancer trial. Don mentioned in the AGM that first dosing is expected in Q1 2021. https://clinicaltrials.gov/ct2/show/NCT04471974

Recruiting: A Study of ZEN003694 and Talazoparib in Patients With Triple Negative Breast Cancer (TNBC). This is the Phase 2 Pfizer PARP inhibitor breast cancer trial the was discussed at length in the AGM yesterday. Funded 50% by Pfizer. https://clinicaltrials.gov/ct2/show/NCT03901469. A recent poster had a lot more detail on this program. Key data on this trial expected by Q2 2021.

Exciting potential for the National Cancer Institute (NCI) CRADA (cooperative research and development agreement) program to explore combination drug strategies. I like how Don said during AGM that ZEN-3694 was the only BET inhibitor currently in the CRADA registry program. Don mentioned the NCI CRADA study with Bristol Meyers Squibb's nivolumab and ipilimumab in resistant ovarian cancer will be the first to launch. Don mentioned in AGM that first dosing is expected in Q1 2021. These drugs are in the immuno-oncology/immune checkpoint category. I don't see anything on ClinicalTrials.gov for this one yet.

Don mentioned many more of these types of CRADA sponsored trials to come in other cancers including ovarian cancer, breast cancer, colorectal cancer, prostate cancer and melanoma. These will be done in collaboration with MD Anderson, Harvard Dana-Farber, Cleveland Clinic that will use combinations of ZEN-3694 with PARP inhibitors, MEK inhibitors, CDK4/6 inhibitors, and other chemo agents. Not a lot of details on these other trials was provided but sounds like some, if not all, of these are CRADA programs and Don mentioned 4-5 more programs (trials) should be added on in the next 6 months. Importantly, these CRADA program are paid for by the sponsors. Zenith just provides their drug and pays a small annual fee to CRADA. 

Hold on to your butts! Happy holidays everyone.

BDAZ