Marker Therapeutics is perhaps one of the greatest anomalies on the market given they have clinical trials in an advanced stage, have shown long and durable complete responses in very refractory, post transplant relapsed patients (since 2012), yet their market cap is only 250 million.
Their Multi TAA therapy is an innovative platform whereby they take the patients own T-cells through a standard blood draw, expand them without genetic modification, and train them to attack antigens that are overexpressed in the cancer. Multi - TAA is also very versatile because it has the ability to attack up to 12 different antigen epitopes that are overly expressed on other cancers. To this date, no severe adverse effects have been experienced by any patient administered the treatment. They have treated almost 80 patients who have a history of being very refractory to their cancers including those with DLBCL, HL, Multiple Myeloma, AML, pancreatic and breast cancer.
Multi TAA is also very cost effective (<$8000) when compared to the exorbitant costs associated with other CAR-T such as Kymriah because there is no need for lymphodepletion or a safe room to administer the treatment. It essentially is an over the counter cancer treatment given its mechanism of action and safety profile.
Although the Multi TAA therapy has shown very compelling efficacy in post transplant relapse multiple myeloma as well (disease control rate of 70%), ALL and AML, it is their DLBCL lymphoma data that is particularly exciting.
Their data in DLBCL particular excites me (more so than any of their indications) because they have managed to put third and fourth line refractory patients in long, durable complete remissions who otherwise should have been deceased within a year.
Post transplant relapse in DLBCL is very dire and 80% of patients are deceased within a year. Of the 6 DLBCL patients they have treated, 3 have achieved complete responses that have been durable for as long as 5 years. These are in patients whe were heavily pre-treated and failed all other prior lines of therapy.
In total, they have treated 15 lymphoma patients since 2012 and have achieved a complete response in 40% of these patients (3 DLBCL and 3 HL). More importantly, none of these patients have relapsed which proves the durability and long term efficacy of their treatment. All these patients have complete responses between 3 and 5 years.
Given their DLBCL data and the very poor prognosis for post transplant relapse patients, I expect rapid approval in this indication. Their data is even more compelling when you look at the success of Multi TAA in very refractory patients who are currently in remission and being given the treatment in an adjuvant setting.
In Lymphoma, 15/17 patients who are in remission and were administered multi TAA to extend the length of their remission, remain cancer free. Prior to being administered the multi TAA treatment, the median length of time of these patients remissions were 4 months. Out of the 15 patients that were administered multi TAA while still in remission, 2 are still in remission after 4 years, 4 are still in remission after 3 years, and the rest have been in remission for a one and two year periods respectively. This is very impressive data.
Marker is an underappreciated biotech company that will eventually get the recognition they deserve. Although dilution is always a concern, the value is far too low to ignore and their clinical data to this date is a strong testament to the efficacy of this technology.
I am very long Marker.
Disclosure: I am/we are long MRKR.