Cellectar Biosciences Inc (NASDAQ: CLRB) released some big news today. A cancer pateint enrolled in the company’s Phase 2 clinical trial of CLR 131 showed incredible progress when it comes to reduction of tumor burden. On the other hand, biotechnology companies release data all the time, what’s the big deal about a single patient sample size producing positive data? Let’s dig in!

What Is CLR 131?

CLR-131 is Cellectar Bioscience’s flagship treatment candidate. The candidate is a radioiodinated PDC therapy that has shown the ability to exploit the tumor-targeting properties of the company’s proprietary phospholipid ether, or PLE, ass well as PLE analgs. In doing so, the treatment selectively delivers radiation to malignant tumor cells, ultimately reducing the radiation exposure to normal tissues.

At the moment, CLRB is in the midst of Phase 2 clinical trials. During the trial, the company is assessing CLR 131 as a treatment for relapsed or refractory MM and a range of B-cell malignancies. The company is also in the midst of a Phase 1 clinical study, assessing CLR 131 as a treatment for pediatric solid tumors and lymphoma. Finally, the company is currently planning a second Phase 1 clinical study in combination with external beam radiation for head and neck cancer.

Today’s News Was Overwhelmingly Positive¬†

Early this morning, CLRB released news surrounding a patient in the Phase 2 clinical trial mentioned above. The patient, a 67-year-old woman, was diagnosed with Waldenstrom Macroglobulinemia, a rare type of cancer that begins in the white blood cells.

Patients with Waldenstrom macroglobulinemia typically have bone marrow that produces too many abnormal white blood cells. As a result, health blood cells end up being crowded out.

These abnormal white blood cells produce a protein that accumulates in the blood, imparing circulation and causing complications. Often times, Waldenstrom macroglobulinemia is called lyphoplasmactic lympoma or LPL as it is considered to be a type of non-Hodgkin’s lymphoma.

The patient that today’s press release was centered around received two lines of multi-drug therapy after being diagnosed. The second of these lines achieved the best response of disease progression, however, the cancer remained persistent.

Soon, the patient was enrolled in the Phase 2 clinical study being performed by CLRB. In the study, the patient has received two doses of CLR 131. The first dose 25mCi/m2 dose of CLR 131, which was administered over a 30-minute infusion period, showed incredible efficacy. In fact, on day 52 following the infusion, a CT scan showed a more than 50% reduction in tumor volume. As a result, the reduction was classified as a partial response.

From there, on day 123, the patient another dose of CLR 131 was administered by Dr. Sikander Ailawadhi of The Mayo Clinic. 64 days after the second dose was administered, yet another CT scan was taken. This scan showed a 94% overall reduction in tumor burden and complete resolution of 4 out of 5 targeted tumor masses. In fact, the company said that the total targeted tumor mass shrank from approximately 4700mm2 prior to infusion to approximately 500mm2 at the last reading.

Why This Is Such A Big Deal

At the end of the day, investing in clinical-stage biotechnology companies can be a scary concept. Anything can go wrong in clinical studies, and when this happens, investments tend to shrink dramatically. So, when data is released, showing strong efficacy of a clinical-stage treatment, we tend to see growth.

However, in the case of Cellectar Biosciences, the excitement goes further than that. The reality is that¬†Waldenstrom’s macroglobulinemia is a very difficult disease to treat. Early lines of therapy often include combination treatments that come with some serious side effects. However, in this patient, no serious adverse events have been observed and efficacy is high, with 94% tumor burden reduction. Considering this, it’s hard to argue that CLRB isn’t onto something here!

The Potential Here Is Incredible

If all goes well with the rest of the Phase 2 clinical trial, the potential for growth in CLRB stock is incredible. After all, the company is targeting multiple cancer types through the study, including multiple myeloma, chronic lyphocytic leukemia.small lymphocytic lymphoma (CLL/SLL), lymphoplasmacytic lymphoma (LPL), marginal zone lymphoma (MZL), mantie cell lymphoma (MCL), and potentially diffuse large B-cell lymphoma (DLBCL). Should the Phase 2 trial lead to positive results across all indications, it will be headed into pivotal trials and one step closer to the market as a multiple-indication commercial-stage oncology treatment. Of course, this would lead to strong financial support for the company, partnership demand, and potential takeover interest with an incredible premium.

Consider The Risks

Any time an investment is made, the investor assumes the risk associated with the investment. It’s just the name of the game! In the case of Cellectar Biosciences, some of the larger risks to consider include:

Currently, CLRB is a clinical stage biotechnology company. This means that the company doesn’t currently have any approved treatments under its belt and therefore cannot earn revenue from the sale of their treatments. Therefore, the company’s financial stability is ultimately at the mercy of investors and institutions. There’s also a possibility that clinical studies may fail. In the event of a clinical failure, we could see a drastic reduction of value. Finally, the company had just under $7 million in cash on hand at the end of the first quarter of 2018. With multiple clinical trials taking place, CLRB is burning cash and may need to look to the market to raise funds in the next 12 months.

Final Thoughts

While any investment comes with risk, the news today further validated Cellectar Biosciences’ work with CLR 131. With just two doses, a response of tumor burden reduction of 94% is an incredible one. This combined with the absense of serious adverse events shows that the company’s proprietary PLE being used in CLR 131 is a promising candidate that could become a first-line therapy in various cancer indications. With that said, I believe that the potential benefit outweighs the risk associated with investing in CLRB.


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