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First Section Of Marketplace Article (This article piece was originally written on December 16, 2021)
For this Biotech Analysis Central Update Series I wanted to go over a biotech by the name of Checkmate Pharmaceuticals (CMPI). The reason why I want to go over this biotech again is because it had recently reported some pretty good results from its phase 1b study, using its drug vidutolimod alone and in combination with Keytruda for the treatment of patients with PD-1 refractory melanoma. These results are important because it will set up top-line results from the phase 2 study which is ongoing and expected to be released 2nd half of 2023. Then, it has an ongoing phase 2 study which is using vidutolimod in combination with Keytruda for the treatment of patients with head and neck squamous cell carcinoma (HNSCC). There will be data that is expected on a subset of patients in the 2nd half of 2022. Lastly, Checkmate has also started exploring its drug vidutolimod with a partnered drug from Regeneron Pharmaceuticals (REGN) known as cemiplimab in patients with non-melanoma skin cancer. Such cancers are cutaneous squamous cell and Merkel cell carcinomas being evaluated in phase 2 studies. These studies are expected to report results in the 2nd half of 2022. Speaking of partners, the company is also partnered with Bristol-Myers Squibb (BMY) to run phase 2 studies in multiple combinations in patients with melanoma.
Conclusion Of Marketplace Article
The Final Verdict is that Checkmate Pharmaceuticals is a good speculative biotech to look into. I can't yet fully endorse it, because while the phase 1b results were good, I have yet to see it fully succeed in a phase 2 study. Also, I still think it's a wait and see approach for the most part. Worth a small gamble, but not an all in thing. That's because another bitoech which uses a different type of TLR9 drug known as tilsotolimod has failed in a phase 3 study with Opdivo in melanoma. Can Checkmate's drug vidutolimod achieve a different outcome? Possibly, if the drugs composition is slightly different to that of tilsotolimod. Keep in mind that there is always a risk for failure and as such I still believe it is speculative. However, the preliminary results that were released from the phase 1b study using vidutolimod plus Keytruda in patients with PD-1 refractory melanoma were pretty good. Achieving a 23.5% objective response rate (ORR) for this patient population who has already failed on prior PD-1 therapy is not that bad. In addition, as I highlighted above there is potential in possibly achieving accelerated approval in the PD-1 refractory melanoma indication. That's because both studies will have data released by 2nd half of 2023. If either one is successful, it may be possible for Checkmate to receive accelerated FDA approval for vidutolimod for the treatment of patients with PD-1 refractory melanoma. It is said that the global melanoma therapeutics market is expected to be worth $12.4 billion by 2025. This is the main indication for the biotech but not the only one. The other indication that is in phase would be the use of vidutolimod for the treatment of patients with HNSCC. However, the use of Checkmate's TLR9 drug for this patient population is being combined with another PD-1 inhibitor known as Keytruda (pembrolizumab). Whereas all the ongoing melanoma studies are using vidutolimod together with Opdivo (Bristol-Myers Squibb's PD-1 inhibitor). As you can see there are two indications using vidutolimod in combination with two different checkpoint inhibitors (Opdivo and Keytruda). What I like about this company is that it is trying a 3rd approach. Meaning, that is is combining vidutolimod with cemiplimab for the treatment of patients with non-melanoma skin diseases. A partnership allowing the use of cemiplimab for these patients was made with Regeneron. While all these partnerships are very early, I believe there is potential for larger deals to be established should positive results be achieved.
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