CVM Ph3 Trial Uncertainty

CVM's pending Phase 3 report out of its long term head & neck cancer study of its immuno-oncology reagent multikne (see image for mechanism of action) is getting lots of attention, especially given the length of time of the study and that it is taking for data report-out. Today, STAT news/Adam Feuerstein published an article that is very negative on CVM and their current trial, which follows another STAT article from May 5, which discussed some of the negative history with CVM and this trial. Many of these issues were raised in a previous Seeking Alpha article. Regarding the latest accusations by STAT of CVM, it seems very possible that CVM does NOT have overall survival data yet, but they know that there is a reasonable chance that the trial will not hit its primary endpoint. However, they are trying to convince investors that even some of the secondaries could be a win for them.

The intent of this post, or our accompanying much more extensive forum post on BPIQ.com, is NOT to defend CVM or STAT. As investors we are often caught in the middle of CEOs, who by their job description are excellent salespeople for their company. And journalists, who make a living on hyping up issues. The purpose of this post is to announce that we are pushing out our estimated date for data readout to July 31, 2021, and to provide more information regarding the timing of this readout and its likelihood of success. Keep in mind that our updated July 31, 2021 date is a very rough estimate date. It is mainly based on the fact that another long-term cancer trial in our database, with a data lock 2 months before CVM's Ph3 data lock, has not yet reported out.

The other very long-term cancer trial that is pending data readout, that we find in our database is the following: The NWBO Phase 3 trial for its cell therapeutic product - DCVax-L in glioblastoma (For BPIQ subscribers see IQ card HERE). In Amp Biotech Research's full forum post on BPIQ.com, they provide a detailed table comparing the CVM trial to NWBO's Phase 3 trial, as well as to a 3rd long-term cancer trial looking at overall survival. Furthermore, Amp's forum post provides a detailed table comparing CVM's phase 3 trial design and endpoints, to the design and results of a phase 1/2 and phase 2 trial of Multikine to attempt to determine likelihood of success. Finally, Amp provides its conclusion regarding whether it is investing in a bullish or bearish manner, in CVM currently.

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Multikine mechanism of action