Actinium Pharmaceuticals (NYSE AMERICAN: ATNM) is forging its own pathway in treating underserved diseases. And, for cancer patients, especially those resistant to or untreatable by current regimens and therapeutics, ATNM's targeted radiotherapies could bring life-saving hope.
Moreover, given that a critical component of ATNM's mission is to commercialize treatments that address urgent unmet medical needs, excellent news for patients could also be great for investors. Better still, with accrued and encouraging clinical data already scored, Actinium is positioned to do more than save lives; it can become a leader in treating targeted indications needing improved standards of care.
With a recent corporate update showing that ATNM remains on schedule to release additional clinical trial updates in Q4 2022, the next step in meeting that mission is in the crosshairs.
ATNM Pivotal Iomab-B Phase 3 SIERRA Data Release
Last month's update from ATNM indeed puts potential catalysts into focus. Highlights included details from its ongoing late-stage clinical trials to treat patients resistant to particular cancer treatments. Of course, while impressive, accrued data won't be the value driver in Q4, adding to the cumulative total will. The best news- investors, and patients, won't need to wait long for a rally-igniting announcement.
Topline data from ATNM's Phase 3 SIERRA trial for Iomab-B is expected to be published by the end of 2022. And another round of positive data will be more than the next milestone reached; it could lead to expedited and life-saving therapeutics for patients with no current treatment options. Data to date indicate that's a likely proposition.
In fact, data shows the potential for Iomab-B to transform the standard of care for relapsed or refractory (r/r) acute myeloid leukemia (AML) patients with active disease. The difference and advantage of ATNM's candidate stem from Iomab-B's targeted radiotherapy, giving patients with active AML an opportunity to receive potentially curative bone marrow transplants (BMT) that would typically require the disease to be in remission. Even better, the therapy might lessen the adverse effects of conventional non-targeted chemotherapy, which can harm healthy tissues.
The Phase 3 SIERRA trial endpoints would be met from positive data comparing outcomes between elderly patients with active r/r AML who receive Iomab-B and subsequent BMT with those who receive a physician's choice of salvage therapy. The primary endpoint for the SIERRA trial is durable Complete Remission (dCR) of at least 180 days; secondary endpoints will examine Overall Survival and Event-Free Survival. Results to date are promising.
Positive Data Fuels Bullish Proposition
Earlier this year, ATNM presented trial data at the annual meetings of the American Society for Transplantation & Cellular Therapy and the Center for International Blood & Marrow Transplant Research. The presentation highlighted data indicating a 5x greater difference in the number of patients potentially evaluable for the dCR primary endpoint at 100-days post-BMT in the Iomab-B arm compared to the control arm at maximum enrollment. Most impressive, the data demonstrated that 100% (66/66) of patients receiving Iomab-B accessed BMT and engrafted without delay, and 100% (40/40) of patients crossing over to receive Iomab-B proceeded to BMT. Compared to the control arm, patients receiving Iomab-B also experienced 5% to 10% lower rates of 100-day, non-relapse transplant-related mortality.
Furthermore, Iomab-B patients experienced a sepsis rate of 5.3% compared to the control arm's rate of 23.7% - a statistically significant advantage with life-saving implications. Moreover, with Iomab-B being the only CD45-targeting drug candidate in Phase 3 clinical development, the treatment has received an Orphan Drug Designation from the U.S. Food and Drug Administration and the European Medicines Agency.
Importantly, Iomab-B may be the only route to a bone marrow transplant for patients with active disease. Although there are currently nine approved drugs for AML, none are curative. Therefore, a successful trial outcome could profoundly impact patients who need an alternative to current treatment options. It could also accelerate ATNM's intent to capitalize on a significant treatment opportunity and, as a result, drive shareholder value appreciably higher.
Additional Therapies Could Diversify Revenues
Still, the data release from the Phase 3 SIERRA Trial of Iomab-B isn't all that ATNM anticipates sharing before the year closes. According to its corporate update, overall survival data from its Actimab-A CLAG-M combination trial will also be released before the year's end.
Actinium is developing Actimab-A as a potential therapy for patients with advanced AML using the radioisotope's differentiated mechanism of action in combination with other therapeutic modalities. In line with the company's other candidates, Actimab-A is the only CD33-targeting radiotherapy under development. ATNM and investors have reasons to be encouraged about details in that update.
Data from the Phase 1 trial was impressive, showing a 72% MRD negativity rate in patients receiving Actimab-A + CLAG-M, a substantial improvement over the 39% MRD negativity rate in patients treated with CLAG-M alone. The trial reported no 30-day mortality, with an 80% overall response rate (CR/CRp/MLFS) in patients receiving less than four lines of prior therapy with 10 complete remissions across all four dose cohorts. If the data released in the coming weeks remains as potent as previous, it could position ATNM to bring multiple life-changing therapies to market.
Well-Capitalized And Deals Advance Its Mission
The better news is that ATNM is well-capitalized to advance its trials and ambitions. The company reported having roughly $116.3 million in cash and cash equivalents as of June 30, 2022 – an impressive amount for a small-cap biotech company. Better yet, new deals could strengthen that position.
For instance, Actinium licensing the EUMENA commercial rights for Iomab-B to Immedica AB brings significant revenue-generating potential. The licensing agreement, which included a $35 million upfront payment from Immedica, could be worth $417 million after sales milestones and mid-20% royalties. Immedica is an independent pharmaceutical company operating in Europe and the Middle East. Its main objective is to market treatments for rare diseases and specific niches in the healthcare industry, making the company a perfect fit for ATNM's offerings. The commercial licensing agreement offers a way for ATNM to build its international presence and treat a more significant proportion of the 21,000 patients diagnosed with AML each year.
Actinium added that its current cash and cash equivalents can sufficiently fund its operations through mid-2025, allowing the company to continue its research and seek out accretive partnerships.
There's still more to the story.
Patents, Partnerships, Profits
Capitalizing upon its proprietary technologies and clinical experience, ATNM is diligently working to bring additional and potentially unrivaled targeted radiotherapy treatments to the market. Its programs include evaluations of therapies that target and deplete specific cancer and immune cells to allow for a safe bone marrow transplant, among other gene and adoptive cell therapies. The company is a leading developer of Ac-225-based therapies and has amassed over 190 patents within its intellectual property portfolio. ATNM has presented considerable research regarding its Ac-225 therapies that target CD38 and HER3, as well as the first CD47 immune checkpoint targeted radiotherapy combinations with HER2 in solid tumors and CD33 in blood cancers.
Further, the versatility of ATNM's technologies and research candidates have led to multiple partnerships to accelerate the development of its innovative therapies. These collaborations include a partnership with AVEO Pharmaceuticals (NASDAQ: AVEO) on HER3-targeting radiotherapies for solid tumors, a collaboration with Astellas Pharma (TSE: 4503) focused on solid tumor theranostics, and studies with EpicentRx on CD47 immune checkpoint targeted radiotherapy combinations.
ATNM's partnerships and internal research projects have generated substantial momentum that could carry its transformative treatments to market. Also, given that major pharmaceutical companies like Pfizer (NYSE: PFE) and Bristol-Myers Squibb (NYSE: BMY) prefer to acquire rather than develop, even more deals could be on the horizon.
Q4 Data Update Could Kick Off Bull Run for ATNM
ATNM's efforts to bring curative therapies to cancer patients untreatable by current methods could lead to a winning proposition for all involved parties. The company's therapeutic candidates and research collaborations are rapidly moving through the development pipeline, and with substantial progress updates scheduled for Q4, its treatments could reach the market sooner than anticipated.
Undoubtedly, with potentially game-changing milestones in the year-end crosshairs, ATNM's current share price, even after a recent bullish move, may present a timely opportunity. Previous updates and data reads provide an excellent precedent to expect more of the same. Thus, additional confirmatory data in the coming weeks may more likely than not strengthen that record. If so, it could do more than accelerate ATNM to commercialize its revolutionary therapies for diseases with poor treatment availability; it could transform this "small-cap" biotech into a whole other league of valuation.
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