$heff's $tation of $tocks & $olid DD

[BiotechValues]

From "Let Your Biotech Winners Ride into Orbit: Jason Napodano of BioNap"

JN: Actinium Pharmaceuticals Inc. (ATNM:OTCQB) has a platform for acute myeloid leukemia (AML). It has two drugs, one of which is called Iomab-B, a conditioning regimen for really sick patients who may not be able to withstand standard conditioning for bone marrow transplant. The other drug, Actimab-A, is earlier stage, and is for elderly patients with AML who cannot tolerate standard of care.

Iomab-B, a radioactive iodine on a targeted monoclonal antibody, is in Phase 3, and it's like SEAL Team 6. It's a very interesting approach that delivers radiation to the bone marrow cells in a more targeted way to obliterate it without too much toxicity to the rest of the body, to avoid treatment-related mortality.

Standard conditioning often includes some combination of total body irradiation and chemotherapy, and is designed to knock out all of the bone marrow ahead of a hematopoietic stem cell bone marrow transplant. If you have AML, you are producing cancerous blast cells that are not maturing to full white blood cells. The goal is to wipe out the bone marrow, which wipes out all the cancerous cells. With a transplant of healthy marrow from a matched donor, you could potentially cure the AML. In fact, AML is a curable cancer if the treatment option works.

However, standard conditioning is difficult to tolerate if you are elderly or you have comorbidities. It's a balancing act between enough radiation and enough chemotherapy to kill the bone marrow and prevent post-transplant graft rejection, but not so powerful that the patient dies.

TLSR: To be fair, a lot of small-cap biotechs are down from a year ago, but the market doesn't seem to have appreciated Actinium. With a $76M market cap it is large enough for some small-cap institutions to own, but it hasn't gotten Wall Street's attention. Is there an issue you can pinpoint?

JN: Actinium isn't the first company to develop a targeted monoclonal antibody with radioisotopes attached. There have been other drugs, and there have also been a lot of failures in the AML space. Pfizer Inc. (PFE:NYSE) had a drug that came with its Wyeth acquisition called Mylotarg (gemtuzumab ozogamicin), but it was pulled from the market. Bexxar (tositumomab + iodine I 131 tositumomab/ GlaxoSmithKline [GSK:NYSE]) was on the market and just didn't sell, so GSK discontinued it. Zevalin (ibritumomab tiuxetan) from Spectrum Pharmaceuticals Inc. (SPPI:NASDAQ) is still on the market but doesn't do very well. Each of these drugs has specific issues: They are too toxic, or they are too difficult to prepare, or they don't have centralized manufacturing.

Actinium's drug, and specifically Actimab, which is going to be a first-line therapy for elderly patients with AML, has certain advantages over these failed drugs. The market just hasn't caught on yet. It's possible the market is not giving Actinium enough credit for the changes it has made and the improvements in strategy. That would be a guess.

I really like Actinium's platform. I think radiolabeled immunotherapies have a place in the future treatment of hematological cancers. Everyone is excited about the chimeric antigen receptor (CAR) T cells being developed for leukemias and lymphomas by companies like Juno Therapeutics (JUNO:NASDAQ), Kite Pharma (KITE:NASDAQ) and bluebird bio Inc. (BLUE:NASDAQ), and these companies have market caps that are tenfold Actinium's just because of that excitement. But I think an effective, radiolabeled, targeted monoclonal antibody will be met with enthusiastic response by the oncologist community, as long as it has improvements and advantages over the older drugs. I think Actinium has the right strategy.


http://www.thelifesciencesreport.com/pub/na/let-your-biotech-winners-ride-into-orbit-jason-napodano-of-bionap-consulting