Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) continues to move higher, adding another 9% to its gains on Tuesday. The bulls took charge after ATNM announced it completed enrollment for its pivotal Phase 3 SIERRA trial for Iomab-B. Already, data shows Iomab-B to have best-in-class potential in treating its targeted patient population. Even better, it could be the only drug available to treat its focused indications.
And that's great news for patients as well as ATNM. Moreover, with SIERRA the only trial showing effectiveness in facilitating bone marrow transplant to patients with active, relapsed, or refractory acute myeloid leukemia (AML) age 55 and above, the market opportunities after approval can be tremendous. Best of all, with Iomab-B in line to become the only curative treatment option for this patient population, the news can be great for investors as well.
Also, for investors that prefer short-term trades with potential catalysts in sight, ATNM fits the mold. Actinium told the markets that data updates from its SIERRA trial could be expected in Q4 of this year. And supposing they add to an already impressive set, it's likely shares could bounce substantially higher ahead of its final topline data for durable Complete Remission (dCR) expected in the first half of 2021. Thus, while milestones can be reached in the coming weeks, the potentially company-changing catalyst is only about two quarters away.
Thinking on the bright side, ATNM is already preparing to leverage what they expect to be excellent data from the trial.
Accelerating Development Plans
Exuding confidence, ATNM is already working to support the registration of a Biologics License Application (BLA) for Iomab-B. And while it took some years of trial and research to get to this point, ATNM is indeed on the doorstep of a transformative development. In fact, positive data in Q4 takes this clinical-stage company substantially closer to becoming a commercial-stage drug company. That could happen in a matter of months. And, as noted, by being positioned as a front-line treatment, the revenues from commercialization could be significant.
Lead investigators are confident as well. Dr. Sergio Giralt, Deputy Division Head, Division of Hematologic Malignancies; Melvin Berlin Family Chair in Multiple Myeloma, noted,
"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 transplants 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."
His confidence comes after reviewing compelling data. To date, 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 more than a meaningful difference; it can become a statistical one. Moreover, the treatment is supported by an excellent safety profile.
In that respect, significantly lower rates of serious adverse events, including febrile neutropenia, sepsis, and mucositis in patients receiving Iomab-B, were noted compared to the control arm. While that's great news for patients, it's also excellent news for shareholders ahead of a planned FDA submission.
With efficacy and safety impressive, 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, many of the potential hurdles are already cleared. Better still, meeting an unmet medical need, the drug could earn expedited approval and/or compassionate use designations.
Even if it doesn't, though, ATNM, through its SIERRA trial, can deliver a blockbuster drug to market and stand alone as the only curative treatment option for this patient population. Hence, it's understandable why investors are bidding the stock higher.
Full Enrollment And All Systems Go
And the trend may continue. With enrollment completed, getting that drug to market is well within the crosshairs. That presumption comes from more than overzealous optimism.
It's supported by a drug that has a proven record of success. Part of the attraction is that Iomab-B targets the significant unmet need of a particular set of patients, especially those who could possibly be cured of their blood cancer with a bone marrow transplant.
Iomab-B's promise is enhanced by 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, without an effective Iomab-B treatment, getting a life-saving bone marrow transplant may not even be possible.
ATNM is expecting to change that landscape. They are banking on Iomab-B's mechanism of action to address that competitor shortfall 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. More than a significant difference, it's a potential life-saver.
Moreover, the long-term benefits are just as significant. Included its endpoint targets, the SIERRA trial evaluates 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, as noted, ATNM expects to meet its primary and secondary points setting into action steps to prepare and submit its BLA to make Iomab-B available to the patients as soon as possible after positive topline SIERRA trial results. That could happen before the end of 2022.
Keep this in mind, too. ATNM expects that Iomab-B can be helpful in other indications needing its targeted conditioning abilities. Thus, don't consider the drug a "one and done" no matter how big the market can be. In fact, boosting confidence in the ATNM camp is that Iomab-B is the only CD45 targeting agent in clinical development. And, with CD45 expressed in all blood cancers, it could bring massive additional treatment opportunities.
Better yet, ATNM believes that the drug's multi-indication opportunity could help accelerate its commercialization efforts by targeting a concentrated number of transplant centers and physicians already familiar with Iomab-B's benefits.
They are already working with several to potentially expedite the review and implementation process.
Unrivaled 100% Access To Bone Marrow Transplant
The excellent news- enrollment is now complete, which is the spark that ignited the current rally. Still, the data presented through 75% of trial enrollment at the 2021 Transplantation and Cellular Therapy Annual Meeting could fuel additional gains in the near term.
ATNM presented data showing a 100% (49/49) BMT access and engraftment rate for patients receiving a therapeutic dose of Iomab-B. That compared to 18% (10/57) of patients receiving physician's choice of salvage therapy on the control arm. Results got more impressive.
Of all the patients enrolled in the trial up to that point, 79% (89/113) could proceed to a bone marrow transplant. And that number included a patient population not considered eligible for the procedure with standard approaches due to cross-over. Thus, data overwhelmingly supports that a substantial number of patients can be provided a more than excellent chance to receive potentially life-saving treatment after an FDA approval of Iomab-B.
Further, it can treat patients safely, with Iomab-B delivering high amounts of targeted radiation to the bone marrow with minimal impact on other organs resulting in lower rates and severity of adverse events. Moreover, this is happening at the cell level, making the drug attractive to researchers since it does not deliver a massive radiation dose to places other than its targeted cancer cell.
Of course, that's by design. Iomab-B, via the monoclonal antibody apamistamab, targets 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, ATNM has found that by carrying iodine-131 directly to the bone marrow in a targeted manner, Iomab-B can avoid the side effects of radiation on most healthy tissues while effectively killing the patient's cancer cells.
Thus, the drug does its job and nothing more. When dealing with radiation, that's optimal.
ATNM Earns Its Attractive Presence
Indeed, it's taken a number of years for ATNM to get to this inflection point. However, taking cautious steps could lead to Iomab-B's near-term approval. And that would be potentially great news for investors ahead of FDA submissions. Remember, too, Iomab-B has been studied in nearly 300 patients for at least six blood cancer indications in multiple trials. And by always showing best-in-class potential, investors should enjoy the privilege to stay on the optimistic side of the trade.
Furthering that sentiment 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 potentially transformative drug for ATNM, but it could also present the last chance for survival among a particular patient population.
Transformative Data As Early As Q4 2021
If it becomes the go-to drug, ATNM stock could be positioned for considerably more upside. And the update expected in Q4 might be the fuse. If the data again impresses, then the ultimate catalyst isn't far behind, with topline data expected roughly two quarters later. In the world of biotech investment, that makes ATNM a compelling investment proposition ahead of expected news.
Hence, the obvious is in play. Actinium Pharmaceuticals is on the verge of a long-awaited transformative event. The better news is that investors will get an update on that status only weeks from now.
More importantly, the promise of Iomab-B and its billion-dollar market opportunity is attracting attention because of its expected ability to save lives. That's the big story. But, at the end of the day, it may do wonders for investor's portfolios as well.
With updates expected only weeks from now, ATNM deserves quick consideration.
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