Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) shares are in rally mode, surging 17% last Friday to $7.83. Why the surge in interest? ATNM announced it has completed enrollment for its pivotal Phase 3 SIERRA trial for Iomab-B. Better still, Iomab-B shows best-in-class results treating its targeted patient population. And for investors that have been around ATNM, that is welcome news.
Moreover, it could be better news for patients, especially with SIERRA the only trial showing effectiveness to facilitating bone marrow transplant to patients with active, relapsed or refractory acute myeloid leukemia (AML) age 55 and above. And the most significant attraction is that it may be the only curative treatment option for this patient population to date. Hence, while the two-day spike is impressive, the momentum is expected to build going forward.
Better news is that investors may hear results quickly, with Actinium telling the markets to expect data updates from its SIERRA trial in the fourth quarter of this year. And if as good as expected, it's likely shares could trade substantially higher ahead of its topline data for durable Complete Remission (dCR) expected in the first half of next year. Thus, potential catalysts are in sight. In fact, the company said to expect multiple updates in the coming weeks. And don't think ATNM lacks confidence. They already anticipate the data to support registration of a Biologics License Application (BLA) for Iomab-B. Hence, the clinical stars may be aligned to take ATNM from a clinical-stage to a commerical-stage company.
Iomab-B Shows Best-In-Class Treatment Potential
And it's not only ATNM showing confidence in Iomab-B. Dr. Sergio Giralt, Deputy Division Head, Division of Hematologic Malignancies; Melvin Berlin Family Chair in Multiple Myeloma, said,
"As an investigator in the SIERRA trial, I believe it is an important trial in the field of bone marrow transplant, as Iomab-B represents a potentially significant advancement for BMT conditioning. Having spent my career working to expand the use of transplant and improve patient outcomes, I know firsthand the value a targeted conditioning agent like Iomab-B can offer patients and transplant physicians. Given Iomab-B's targeted nature, it has demonstrated the ability to produce effective myeloablation, even in patients with high disease burden, while also being well-tolerated. This has shown to enable more patients, including those with significant comorbidities, to access bone marrow transplant and successfully engraft."
Know this, too. The data to date is outstanding. In fact, 100% of patients receiving Iomab-B accessed bone marrow transplants and engrafted without delay. That compared to only 18% of patients receiving salvage therapy on the control arm of the study through 75% of enrollment. That's a meaningful difference. Its safety profile is excellent as well.
There, significantly lower rates of serious adverse events, including febrile neutropenia, sepsis, and mucositis in patients receiving Iomab-B, were noted in comparison to the control arm. Of course, while that's great news for patients, it's also excellent news for shareholders. And with the SIERRA trial the only active randomized Phase 3 trial to facilitate bone marrow transplant as an option for patients with active, relapsed/refractory AML age 55 and above, its prospects to emerge as a blockbuster drug and the only curative treatment option for this patient population is in the crosshairs.
Meeting Unmet Need
Even better, with enrollment completed, getting that drug to market can happen sooner rather than later. And it's a drug that has a proven record of success, with ATNM showing an extraordinary amount of success in its evolution to this point. Foremost, Iomab-B targets the significant unmet need of patients, especially those who could possibly be cured of their blood cancer with a bone marrow transplant. It's strength lay in being potentially superior to non-targeted conditioning regimens that could not produce a remission or are too toxic in this patient population. In other words, patients could not even proceed to the life-saving bone marrow transplant procedure.
In contrast, Iomab-B's mechanism of action addresses that issue head-on through its targeted nature and ability to deliver high amounts of radiation directly to the bone marrow resulting in myeloablation while sparing healthy organs. Huge difference.
Moreover, the long-term benefits are what's important. In that respect, the SIERRA trial is evaluating the rate of durable Complete Remission of at least six months in patients receiving Iomab-B and a bone marrow transplant to those receiving salvage chemotherapy. And with already compelling data and enrollment complete, ATNM is proactively taking steps to prepare and submit its BLA to make Iomab-B available to the patients as soon as possible after positive topline results from the SIERRA trial. As noted, with trial results expected by mid 2022, commercialization could happen before the end of that year.
ATNM's prospects with the drug get even better, with ATNM expecting to expand the use of Iomab-B in other indications to support its targeted conditioning abilities. Boosting confidence there is that Iomab-B is the only CD45 targeting agent in clinical development. And, with CD45 expressed in all blood cancers, it could expose massive marketing opportunities. Moreover, ATNM has said that the drugs multi-indication opportunity could help accelerate its commercialization efforts by targeting a concentrated number of transplant centers and physicians that could provide significant marketing leverage.
That makes sense after knowing the potential of Iomab-B.
Trial Data Showed 100 Access To BMT
Through 75% of trial enrollment, data presented at the 2021 Transplantation and Cellular Therapy Annual Meeting attracted significant attention. And deservedly so. The data showed a 100% (49/49) BMT access and engraftment rate for patients receiving a therapeutic dose of Iomab-B compared to 18% (10/57) of patients receiving physician's choice of salvage therapy on the control arm. Here's an even better stat.
Of all the patients enrolled in the trial up to that point, 79% (89/113) could proceed to a bone marrow transplant. Put into better perspective, that included a patient population not considered eligible for the procedure with standard approaches due to cross-over. Thus, it gives a substantial number of patients a more than excellent chance to receive potentially life-saving treatment.
Better still, Iomab-B delivers high amounts of targeted radiation to the bone marrow with minimal impact on other organs resulting in lower rates and severity of adverse events. And this is happening at the cell level, which makes the drug attractive to researchers. In other words, it does not deliver a massive dose of radiation to places other than its targeted cancer cell.
That happens by Iomab-B, via the monoclonal antibody apamistamab, targeting only the CD45, an antigen widely expressed on leukemia and lymphoma cancer cells, immune cells, and bone marrow stem cells. Once apamistamab is linked to the radioisotope iodine-131 and attached to its target cells, it emits energy that can travel about 100 cell lengths, destroying a patient's cancer cells and ablating their bone marrow. However, by carrying iodine-131 directly to the bone marrow in a targeted manner, Actinium believes Iomab-B can avoid the side effects of radiation on most healthy tissues while effectively killing the patient's cancer cells. And that includes those in bone marrow niches due to the "crossfire" effect enabled by the I-131 radioisotope. The bottom line- it's showing itself as an effective treatment solution.
Catching The Value Proposition
Still, while investors need to understand the drugs they are backing, at the end of the day, investing is more about making money. And for ATNM, patients, and investors, Iomab-B presents a win-win-win proposition. Also, Iomab-B has been studied in nearly 300 patients for at least six blood cancer indications in multiple trials. And its profile is always best-in-class.
That profile is expected to bode well for patients, especially with the SIERRA trial planning to meet a high bar for its primary and secondary endpoints, including durable Complete Remission at six months and a secondary endpoint of overall survival. Of course, some will say that many drug trials are designed with similar endpoints in mind. While true, others don't own the compelling track record supported by a durable and overlapping data set.
And specific to its targeted indications, Iomab-B shows a potentially safer and more efficacious method of action compared to non-targeted intensive chemotherapy conditioning currently the standard of care in bone marrow transplant conditioning. Keep in mind, too, at this stage in patients treatment, a bone marrow transplant is often considered the only potential cure for certain blood-borne cancers and blood disorders. Thus, not only is Iomab-B a potential blockbuster drug for ATNM, but it could also present the last chance for survival among a particular patient population.
Here's another critical point. Despite the nine current AML drug approvals, none are curative. That sets up Iomab-B to have a clear competitive advantage in targeted patient populations. It also creates a compelling value proposition to ATNM investors by being the only path to a potentially curative bone marrow transplant in relapsed/refractory AML.
Transformative Data As Early As Q4 2021
If so, its 17% surge last week would be the launchpad of what could be exponential gains upon presentation of positive topline data in 2022. Still, the updates expected by Q4 of this year could light the fuse to start that rally. And that makes ATNM a compelling investment proposition ahead of expected news. Moreover, as a late-stage drug development company, ATNM deserves more share price appreciation at this point anyway.
With that said, markets do have a way of catching up quickly for undervalued stocks. That could be happening now. In that respect, two things make sense for investors at this point. First, being short the shares may be not be wise. And, second, despite taking years to get here, ATNM is on the verge of delivering multiple catalysts that could send its share price soaring.
Hence, don't ignore the obvious. More importantly, recognize the promise of Iomab-B and its billion-dollar market opportunity. Both suggestions could lead to capitalizing on a tremendous investment opportunity.
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