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Wednesday, March 1, 2017

Actinium's Iomab-B Excited KOL's at BMT Tandem

Last week, the combined meeting of the Center for International Blood & Marrow Transplant Research (CIBMTR) and the American Society for Blood and Marrow Transplantation (ASBMT) held their annual meeting in Orlando, Flordia. The "BMT Tandem" meeting is an opportunity for clinical research professionals, nurses, pharmacists, administrators, and other health professional to come together and benefit from the full scientific program that addresses the most timely issues in hematopoietic cell transplantation.

Over the past several months, I've been updating investors on the recent progress at Actinium Pharmaceuticals (ATNM). I published an article last week noting some important catalysts on the near-term horizon for the company. I wanted to do a follow-up based on what looks to be an impressive showing by the company at BMT Tandem, specifically with respect to KOL interest in Iomab-B.

KOL's Mention Iomab-B

In the past, I've compared Actinium to Celator, the small-cap biopharma company developing an improved formulation of cytarabine + daunorubicin, called Vyxeos®, for patients with high-risk (secondary) acute myeloid leukemia (AML). Celator shares went from less than $2 per share in March 2016 to over $30 per share after getting acquired by Jazz Pharmaceuticals in June 2016 (see pic) all based on the success of Vyxeos in a Phase 3 trial.

I noted at the time of Vyxeos success that this was good news for Actinium because the greater number of patients that can be helped by Vyxeos (vs. standard 7+3), the greater the patient population eligible for a bone marrow transplant and the use of a conditioning agent like Iomab-B. Quite simply, Vyxeos makes the market bigger for Iomab-B.

At BMT Tandem, Dr. Jeffrey Lancet, MD of the Moffitt Cancer Center presented results from the Vyxeos Phase 3 trial. Dr. Lancet was a principal investigator (PI) during the Vyxeos Phase 3 program. The picture below shows Dr. Lancet discussing Iomab-B and the Phase 3 SIERRA trial being conducted by Actinium. I think this is interesting because it seems to validate what I've said in the past about the market opportunity for Iomab-B subsequent to the impressive Vyxeos data.


Dr. Sergio Giralt is the Chief, Adult Bone Marrow Transplant Service at Memorial Sloan Kettering Cancer Center (MSKCC). The two photos below show Dr. Giralt discussing Iomab-B at BMT Tandem last week. The first slide shows Dr. Giralt highlighting the previous data from Iomab-B. The website OncLive posted an article after interviewing Dr. Giralt talking about the previous Iomab-B data.


The second picture below shows Dr. Giralt discussing Actinium's Phase 3 SIERRA trial.


Dr. Partow Kebriaei, MD is an Associate Professor in the Department of Stem Cell Transplant and Cellular Therapy at the MD Anderson Cancer Center in Houston, Texas. OncLive also conducted an interview with Dr. Kebriasei at BMT Tandem during which the professor discussed the Phase 3 SIERRA trial and the utility of reduced-intensity conditioning and Iomab-B in elderly patients with AML. The video with OncLiveTV can be seen below.


Background on Iomab-B

Actinium's Iomab-B (BC8-I131) was invented by researchers at the Fred Hutchinson Cancer Research Center (FHCRC). The drug is a combination monoclonal antibody that targets a common lymphocyte antigen, CD45, and radioactive iodine-131. CD45 plays a crucial role in the function of hematopoietic cell activation and differentiation. By specifically targeting CD45, a cell surface antigen widely expressed on hematopoietic (myeloid and lymphoid) cells, but not other tissues, Iomab-B can effectively offer target-specific ablation as a conditioning regimen prior to hematopoietic stem cell transplantation (HSCT) with the potential for improved efficacy, safety and tolerability. And, because expression of CD45 is found on both normal and leukemic cells, it can be used to target marrow in both remission and relapsed patients.

The Phase 3 SIERRA trial initiated in July 2016. SIERRA is a randomized, controlled, multi-center study with a target enrollment of 150 patients with refractory or relapsed AML over the age of 55. Enrollment is ongoing right now. Patients are being split equally between Iomab-B and (physician's choice) conventional conditioning prior to allogeneic hematopoietic stem cell transplantation, also known as bone marrow transplant (BMT). The primary endpoint of SIERRA is durable complete response (dCR) at six months post BMT. Secondary outcome measures include safety and overall survival (OS) at one-year.

An important aspect of the trial is that conventional chemotherapy failures (i.e. no CR) subjects can crossover back to Iomab-B. It provides investigators and patients an attractive option for enrollment. By enrolling in the trial, patients know they will either get the best available standard-of-care today or a potentially new breakthrough investigational medicine, and standard-of-care failures get to try the investigational medicine as a second-line option. Keep in mind, Iomab-B is both an induction and conditioning regimen all-in-one, which should be very attractive to physicians and patients alike. Based on a strong showing at BMT Tandem, it seems like leading KOLs agree.

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2 comments:

  1. Hi Jason, what the docs say about the odds of ATNM phase 3 study showing a doubling in PFS vs control arm given that all the data is from single arm studies

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    1. Not sure about PFS endpoint. The primary endpoint of the study is dCR at 6-months and I think they have excellent odds at beating SoC based on the previous data. Hopefully, that leads to an increase in PFS and OS, but I can't really say what those odds are.

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