Actinium Pharmaceuticals, Inc. (ATNM) is “One to Watch”

Actinium Pharmaceuticals, Inc. is an extremely attractive, rapidly developing biopharma with arguably the most compelling technology platform in the oncology space today for alpha particle radioimmunoconjugates. Their Alpha Particle Immunotherapy Technology (APIT) platform uses large molecules that bind to specific cancer cell types and affixed radioisotopes in order to deliver targeted decimation to cancer cells via massively powerful alpha radiotherapy in a highly-localized fashion that doesn’t damage other tissues.

The Nov 25 move by sector giant Bayer to do a $2.4B buyout on the only other real player in the space, Bayer’s Norwegian partner Algeta, whose Xofigo for prostate cancer was approved by the FDA back in May, is extremely telling of ATNM’s true value in an increasingly M&A-focused sector. The announcement just this morning (Dec 19) that Bayer has now closed the Algeta deal with a reported sticker price of $2.9B in cash says it all frankly.

The fact that Bayer’s takeover bid on Algeta is merely the latest in a series of oncology deals by this juggernaut, combined with the 37% premium to share price Algeta rallied together pre-bid and a forward consensus on Xofigo sales (indicated for castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease) of approximately $1B in 2018, collectively spells out huge opportunities for ATNM’s APIT platform, especially considering the wide-ranging implications of the technology, which has the potential to cut across a broad array of cancer types. Sector M&A dynamics are also strongly characterized by the Amgen purchase of their partner Onyx back in October for $9.7B, with powerhouse AMGN scooping up Nexavar (Sorafenib, for primary kidney and advanced primary liver cancer, as well as radioactive iodine-resistant advanced thyroid carcinoma) and Stivarga (Regorafenib, the oral multi-kinase inhibitor with multi-tumor capability). The compelling advantages of the APIT platform compared to products like Xofigo (the first alpha particle-emitting radiotherapy agent approved by FDA) should really throw a spotlight on ATNM for investors and a closer look at their technology will further illustrate the immense licensing and acquisition potential inherent in the company’s high-momentum product pipeline.

Whereas Algeta is focused on radium-223 dichloride as the primary vector (as well as thorium-227), keen on the calcium-like properties of radium-223 for targeting the secondary bone metastases associated with late-stage prostate cancer (remainder is generally excreted via the gut), ATNM has carefully selected actinium-225 and its bismuth-213 isotope for their superb pharmokinetic properties, as well as short radioactive half-life. The short half-life of ATNM’s primary weapons, actinium-225 (10 days) and iodine-131 (8 days), as well as the exceptionally short half-life of bismuth-213 (only 46 minutes), represent a laser-precision cancer destruction technology that effectively weaponizes monoclonal antibody carriers into smartbombs.

A proven track-record for their lead candidate Iomab™-B in realizing effective cures for subjects with otherwise incurable blood cancers, via Phase 1/2 trials in over 250 subjects, has positioned ATNM for a direct path to market in AML (Acute Myeloid Leukemia ) refractory/relapsing patients, where Iomab-B has become a clear choice for its demonstrated capacity in prepping such patients before bone marrow transplant and where no other treatment is currently indicated. This is a life-saver technology and thanks to the broad expression of the Iomab-B target antigen, CD45 (pan-leukocytic antigen widely expressed on white blood cells), by hematopoietic cells and not other tissues, the implications for Acute Lymphoblastic Leukemia, Hodgkin’s Disease and Non-Hodgkin Lymphoma, as well as Myelodysplastic Syndrome and similar diseases are quite exciting. Iomab-B uses the novel murine monoclonal antibody BC8 (developed by Fred Hutchinson Cancer Research Center) with iodine-131 and can achieve amazingly precise results when labeled with radioactive isotopes. The typical consensus of AML not being particularly radiosensitive and the noticeable absence of radiotherapy applications in this disease as a result, makes the extremely precise monoclonal antibody targeting approach developed by ATNM a serious contender that investors need to keep an eye on.

The recent announcement of successful End of Phase 2 with the FDA on Iomab-B initiated a Phase 3 ramp towards a Biologics License Application. This FDA approval trajectory will not only fundamentally validate the company’s underlying technology, it will be a grand-slam homerun for the pipeline’s star candidate. The single, pivotal Phase 3 clinical study is mapping the previous Phase 1/2 AML and myelodysplastic syndrome work and its associated, 6-month, 100% complete remission rate targets for primary endpoint, here prepping aged 55-plus AML patients for bone marrow transplant in a patient class where there are currently no FDA approved treatments or a defined standard of care.

ATNM has slated its Annual Shareholders’ Meeting for Monday of next week (Dec 23) and news is breaking just this morning that the company intends to scale-up and launch into a full IND application to the FDA on Iomab-B, moving into their pivotal Phase 3 clinical trialing straight away next year. With radiolabeling, testing and evaluation processes for validating Iomab-B stability now well established, ATNM is planning to advance into large-scale manufacturing and has also acquired a considerable inventory of BC8 in preparation. FDA approval of Iomab-B means solid confirmation of their targeted payload immunotherapeutics for advanced cancers strategy and the technology platform itself, and would become a significant revenue generator as well, making ATNM even more attractive as they march steadily towards a registration trial that is already eagerly anticipated by top minds in the leukemia field.

This is all extremely good news for the company’s next most advanced clinical stage product, Actimab-A™, which saw some nice exposure recently (Dec 9) at the high-profile American Society of Hematology’s 55th Annual Meeting and Exposition in New Orleans, as the company touted their proprietary patented monoclonal antibody (in this case Lintuzumab) armament technology using actinium-225 and bismuth-213 as short range, high-intensity alpha emitters. The data presented was very clear, with the antileukemic impact of this high precision delivery system showing efficacy in 67% of evaluable patients and 47% across the dosage spectrum in newly-diagnosed AML cases where prognosis, or inability/unwillingness to undergo chemo were factors. The decay properties of actinium-255, which produces an effective series of daughter atoms capable of generating their own cancer cell-killing alpha particle, enhances the Actimab-A profile nicely and the precision strike capability profile (Lintuzumab targets CD33, found on myeloid leukemia cells) of this product is further reinforced by Actimab-A essentially being the humanized equivalent of the antibody that was initially developed at Memorial Sloan Kettering Cancer Center by Dr. David Scheinberg, M195, back in the 90′s.

To learn more about Actinium Pharmaceuticals, visit www.ActiniumPharmaceuticals.com

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