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Feeedback from Yahoo Board January 16, 2020 BIOTECHNOLOGY Yun Zhong, Ph.D. 212-888-2359 yzhong@janney.com Important Updates From Meetings With Marker And Selecta Marker management provided us with an update on the clinical hold on the IND application for the AML program and the company is still in active dialogue with the FDA. We believe Marker is actively addressing the FDA's requests. The process has taken longer than we had expected likely due to the administrative procedure that the company has to follow in submitting new information to the FDA and the time spent waiting for the agency's feedback. The lack of a definitive answer from the FDA is the the reason why management has not provided an update for investors. Management believes that there could be two possible pathways but is conservatively preparing for the unfavorable scenario, which could potentially take another several months to resolve. However, the more favorable scenario could allow the clinical hold to be lifted any day. Selecta management confirmed to us that there will not be an interim analysis in the ongoing Phase II COMPARE study so the full statistical data in mid-2020 will be the next data readout. Management continues to expect Phase III protocol finalization based on the discussion with the FDA at the end-of-Phase II meeting in January. Management reiterated guidance on one gene therapy program to enter the clinic in 2020 and we believe initial clinical data could unlock ImmTOR's strong potential. Marker Therapeutics (MRKR, Buy, FV $10) ● Recall the clinical hold on Marker's IND filing for MultiTAA T cell therapy for AML was due to two reagents supplied by third party vendors that are used in the manufacturing process. Management disclosed that one reagent is a recombinant cytokine and the other reagent is a biological product. Since the original manufacturers were not able to provide the information/materials that the FDA requested, Marker has identified a second manufacture for both reagents. According to management, the rate limiting factor now is the Certificate of Analysis (CoA), which is not available yet. Marker's most recent document submission was made on January 3 and the company is waiting for the FDA's response, which can take up to 30 days every time. The FDA may decide to lift the clinical hold and allow preparation activities to be initiated without the CoA, and allow the CoA to be submitted 30 days prior to patient treatment. Alternatively, the FDA may require the CoA to be ready before lifting the clinical hold. According to management, five clinical centers, all major centers of expertise for transplantation (Memorial Sloan Kettering Cancer Center, MD Anderson, Mass General Hospital, University of Chicago Medical Center, and Moffitt Cancer Center), are willing to initiate the preparation activities at risk without waiting for the clinical hold to be lifted. ● Management disclosed that the pancreatic study has completed patient enrollment and management plans to provide an update at a medical conference in 2020. |
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Msg # | Subject | Author | Recs | Date Posted |
504 | Re: Feeedback from Yahoo Board | CHM_760 | 0 | 1/17/2020 1:14:16 PM |
509 | Re: Feeedback from Yahoo Board | luckijack | 0 | 2/3/2020 10:09:57 AM |