Actinium Pharmaceuticals (NYSE AMERICAN: ATNM) is doing things differently. And that's potentially excellent news for cancer patients, who may soon benefit from ATNM's advancing development of targeted radiotherapies for cancer patients who cannot be treated by currently available solutions.
Great news for patients may be excellent for investors, too, considering that part of ATNM's mission is to bring to market treatments serving underserved medical needs. Actinium wins, too, by securing its place as a niche provider in markets needing a better standard of care.
However, the best news for all is that an update from Actinium Pharmaceuticals indicated that operational and cinical momentum is at its back, with not only milestones reached expected but catalysts as well.
Iomab-B Phase 3 SIERRA Trial Drives Investor Interest
In an update released last month, ATNM showed how both can be reached sooner than later. Information regarding its ongoing clinical trials is of particular interest, with data supporting ATNM's mission to become an integral part of the cancer treatment landscape. But there's better news on that front.
One of the biggest takeaways from the update is that ATNM remains on track to publish topline data from its Phase 3 SIERRA trial for Iomab-B by the end of 2022, putting a significant value driver in the near-term crosshairs. Moreover, it's a shot on goal from a respected clinical candidate.
Iomab-B has the potential to revolutionize the way relapsed or refractory (r/r) acute myeloid leukemia (AML) patients with the active disease get treated. That results from 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. Better yet, the treatment may reduce the side effects caused by traditional non-targeted chemotherapy, which can damage healthy tissues.
The Phase 3 SIERRA trial endpoints will be generated from 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.
The excellent news so far is that initial data are positive. Earlier in the year, ATNM presented its findings 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.
Though there are 9 approved drugs for AML, none are curative, making Iomab-B potentially the only path to a curative BMT for patients with active disease. Therefore, a successful trial could prove transformative for ATNM and, better still, life-saving for patients needing an alternative to available treatment options.
Other Corporate Update Highlights
Iomab-B's Phase 3 SIERRA Trial isn't the only data ATNM expects to release in Q4. The ATNM update also confirmed its plans to release overall survival data from its Actimab-A CLAG-M combination trial by the end of the year.
As the only CD33-targeting radiotherapy in development, Actinium is developing Actimab-A as a potential therapy for patients with advanced AML using the radioisotope's differentiated mechanism of action in conjunction with other therapeutic modalities. ATNM plans to publish its combination trial results in Q4 2022, an announcement met with enthusiasm from investors expecting the company to add to the positive data published from earlier studies.
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 expected in Q4 remains positive, share prices may again respond favorably, with another potentially life-saving therapy from ATNM serving as an additional catalyst.
That's not all. Investors liked hearing that ATNM has the resources to continue its clinical missions, inclusive to the data that could help secure potential and additional research partnerships. As of June 30, 2022, the company had cash and cash equivalents of approximately $116.3 million, and deals could enhance that position.
Actinium's licensing of the EUMENA commercial rights for Iomab-B to Immedica AB is an example. The deal, which also gave ATNM an upfront payment of $35 million, is valued at a potential $417 million following sales milestones and mid-20 % royalties. Immedica is an independent pharmaceutical company with commercial activity in Europe and the Middle East whose primary goal is to bring treatments to market for rare diseases and niche healthcare markets. The commercial licensing agreement provides a pathway for ATNM's innovation to capitalize on a strengthening overseas presence and treat a more significant number of the 21,000 patients per year who are diagnosed with AML.
Actinium anticipates that its current cash and cash equivalents will be sufficient to fund operations through mid-2025, which is impressive for a small-cap biotech and indicates ATNM has no intentions of slowing down. Favorable Q4 data could even accelerate the clinical ambitions.
There's more to like.
Unique Portfolio and Accretive Collaborations
Utilizing its proprietary technological foundation and substantial clinical experience, ATNM is advancing several other projects and partnerships to bring additional targeted radiotherapy treatments to the market. Those programs include evaluations of therapies that target and deplete specific cancer and immune cells to allow for a safe bone marrow transplant or other gene and adoptive cell therapies. By the way, ATNM is already an established leader in the space by developing Ac-225-based therapies and earning more than 190 patents supporting its intellectual property portfolio. ATNM has presented considerable research regarding their 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, ATNM's diversified research and technological advances and applications have led to multiple partnerships helping to accelerate the development of its innovative therapies. These collaborations include a partnership with Astellas Pharma (TSE: 4503) focused on solid tumor theranostics, work with AVEO Pharmaceuticals (NASDAQ: AVEO) on HER3-targeting radiotherapies for solid tumors, and studies with EpicentRx on CD47 immune checkpoint targeted radiotherapy combinations.
These collaborations, alongside its internal research initiatives, such as the Iomab-ACT program for cell and gene therapy conditioning, generate substantial momentum for ATNM going forward. And with big pharma giants like Pfizer (NYSE: PFE) and Bristol Myers Squibb (NYSE: BMY) liking to acquire instead of developing from a pre-clinical perspective, future partnerships could be in the queue.
Bullish Sentiment Into Q4 And 2023
Undoubtedly, ATNM's focus on filling the gaps left unaddressed by traditional cancer therapies is an effort that could transform the company from a small-cap biotech player into a commercial-stage juggernaut. And with its research and collaborations with industry partners showing curative promise to patients with limited, if any, treatment options, that could happen faster than many expect.
So, pay attention. Actinium plans to update investors on several late-stage clinical trials by the end of this quarter. And if history is a guide, it could help fuel another share price rally. Thus, while the window of investment opportunity is open now, with data imminent, it could close quickly.
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