Actinium Pharmaceuticals is a biopharma developer focused on the oncology space, primarily leveraging their extremely potent selective radiotherapy platform, Alpha Particle Immunotherapy (APIT), which functions by attaching radioisotopes (actinium-225/bismuth-213) to large molecules that bind specifically to cancer cells (monoclonal antibodies, or mAbs) and pump out alpha emissions at around 1k times the energy of typical beta irradiation, but over a much shorter range, making the platform ideal for handling cancer cells that are not sensitive to beta irradiation.
Intense, focused energy over the shortest distance represents a powerful alternative to beta emitters, and the company has carefully selected the bismuth-213 isotope of actinium-225 for its superior pharmokinetic properties and radioactive half-life. These are key elements of any such therapy and ATNM was very adept in emphasizing a target that will be readily taken up and distributed/eliminated from the body, as well as having a relatively short half-life. Currently, the company is focused on utilizing the more broad-spectrum approach of actinium-225 despite its considerably longer half-life over bismuth-213 (10 days compared to only 46 minutes), but this is primarily for the purposes of overall efficacy in the run up to fully demonstrating the technology, as well as for cost and logistical concerns.
The company has demonstrated extremely high cancer cell kill levels in AML (Acute Myeloid Leukemia) with this selective, targeted radiotherapy, flooring sector leaders due to AML’s reputation for being resistant to radiotherapy and the subsequent lack of current use to treat the disease. The company has drawn some serious attention of late for their technological proficiency, with the Targeted Alpha Therapy International Symposium presentation (early June) of the their clinical programs in AML, focusing on their lead drug candidates Actimab-A™ and Bismab-A™, being quite well received within the industry and garnering ATNM more international attention.
These targeted payload immunotherapeutics went on to be presented before the prestigious and highly influential International Atomic Energy Agency technical team meeting at the UN HQ in Vienna (reported July 9). Interim Director of the Sloan-Kettering Institute (Memorial Sloan-Kettering Cancer Center research division), Dr. David Scheinberg, went over the merits of the company’s leading AML indications and of alpha particle therapy itself in some detail, spurred on by the mounting attention from all levels of the sector. Clinicians, government agencies, isotope producers, and scientists are all chomping at the bit over this technology and the potential for ANTM’s proprietary, patented platform solutions using monoclonal antibodies to do high-precision delivery of extremely powerful alpha emitters nail all the fundamentals perfectly.
The potential of the company’s pipeline is immense, with Iomab™-B representing a lifeline option across five Phase I and Phase II clinical trials as an effective cure for patients whose backs are truly against the wall, with no other options left available to them. This established clinical track record in over 250 patients suffering from incurable blood cancers, where Iomab-B made possible pre-bone marrow transplant conditioning for previously ineligible patients, is of tremendous significance to investors. For the many patients over 50 where bone marrow transplant is generally not an option due to a whole host of concomitant factors, Iomab-B offers a profound developmental pathway and this technology has the potential to strike across multiple other patient categories as well. With the monoclonal antibody targeting a widely expressed antigen for hematopoietic cells (and not other tissues) known as CD45, Iomab-B (a BC8-I-131 construct) has the ability to punch well above its weight in Myelodysplastic Syndrome, Acute Lymphoblastic Leukemia, Hodgkin’s Disease and also in Non-Hodgkin Lymphoma. BC8-I-131 has been used to prep patients for bone marrow transplant with great success and a pivotal registration trial in AML for refractory and relapsing patients could grant ATNM an extremely short time to market.
The underlying monoclonal antibody technology, which was originally in-licensed from Fred Hutchinson Cancer Center in June of 2012 (PDF), has rapidly transformed ATNM from a tech company to a biopharma developer with multiple product vectors. They have the targeted payload platform and have recently made key appointments to management as well, bringing in the big guns with Kaushik J. Dave, Ph.D., MBA., taking up the President and CEO job last month (Sept 16). Dr. Dave now also sits on the Board of Directors and comes to the role from Exec. VP of Product Development over at Antares Pharmaceuticals Inc., where he spearheaded the product revamp around their compelling medical device technology, leading to the NDA on OTREXUP™ and taking Antares from $40M market cap to around half a billion during his time with them. Actinium Pharmaceuticals also tapped biotech industry accounting, finance, IR and public reporting ace Corey Sohmer for VP of Finance and Business Development last month (Sept 18). Sohmer brings a ton of leadership experience to the role from his work in core finance and business development, spanning more than a decade at some other top NASDAQ-listed biopharmas like Cyclacel Pharmaceuticals, where he was Director Corporate Finance.
Strong tech pipelines with demonstrable effective products that are in dire need of coming to market always move and ATNM is one to keep a close eye on, especially as the global oncology space wises up to the inherent potential of their targeted payload alpha particle platform.
More info on Actinium Pharmaceuticals, Inc. is available at www.ActiniumPharmaceuticals.com
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