Marker Therapeutics: Phenomenal Data In Lymphoma And Other Indications, Yet Little Recognition From The Street

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About: Marker Therapeutics, Inc. (MRKR)
by: Daniel Waserman
Summary

DLBCL data was particularly impressive. Patients who were third and fourth line refractory and relapsed post-transplant are experiencing durable and long responses with some now five years in remission.

80% of DLBCL patients who relapse after transplant die within one year which makes data particularly more impressive. NO Serious Adverse Effects and cost is 1/10th that of Kymriah.

Marker has breadth to their pipeline but is underappreciated given that they were private and taken over by a public company (Tapimmune) and did not formally IPO on the market.

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Marker Therapeutics (MRKR) 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. Most impressive is patient 6 who suffers from refractory DLBCL and relapsed within one month after ASCT. This person has now been in complete response for longer than 4 years when they otherwise should have been deceased within 6 months.

Given their phase 1 clinical 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.

The following picture demonstrates the results of the ongoing phase 1 lymphoma trials taken from the corporate presentation:

Active Lymphoma Phase 1 Clinical Data

Figure 1: Active Lymphoma Clinical Data from Phase 1 (40% CR, 67% Disease Control Rate) Figure 2: Patient Profiles for Active Lymphoma Trial

There is also a Phase 1 Lymphoma trial for those in remission. 15/17 patients who are in remission were administered multi TAA to determine whether the treatment can extend the length of their remission and still remain cancer free to this day. 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.

Figure 3: Phase 1 Results from Patients in Adjuvant Lymphoma Setting (15/17 patients remain in remission)

Figure 4: Clinical Profiles from Patients in Adjuvant Lymphoma Setting

These are just the results from the Lymphoma Trial which I found particularly intriguing. The technology has also shown promise in very refractory Multiple Myeloma and Post Transplant Relapse AML. When all their clinical data is considered, 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.

They currently have approximately $65 million in the bank, excluding warrants which could bring in another $80 million. Fully diluted, the company is only worth $340 million which I believe is very low given the breadth of its clinical data. The burn rate should be relatively low (estimated at $6/7 million per quarter) given the strong ties with the integrated Baylor healthcare system and the low cost associated with the treatment. Given that they have only been on the market for 4 months, they are yet to release an earnings report but this is expected to be released near the end of month.

At this point, given the breadth of their data and large patient population that has been administered the treatment, I do not see downside other than the normal dilution that comes with the territory of owning any small cap bio tech. Compared to other names such as Allogene, Iovance, Atara, and Ziopharm, Marker holds far more compelling value given that their treatment is affordable, not MHC class restricted, and has no serious adverse effects.

Marker is a very promising stock that is well worth the wait. I am very long Marker.

Disclosure: I am/we are long MRKR. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

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