Actinium Offers Shareholders Several Interesting Near-Term Catalysts

TM editors' note: This article discusses a penny stock and/or microcap. Such stocks are easily manipulated; do your own careful due diligence.

Shares of Actinium Pharmaceuticals (ATNM) have performed nicely over the past month, driven by the achievement of several milestones, including the hiring of a new Chief Medical Officer and initiation of a new clinical trial with Actimab-M for multiple ATNM​myeloma. The company is executing well, and the upswing is likely to continue given the strong cash balance and incredible value at this level, along with several important catalysts on the near-term horizon. Cash and Catalysts, along with Credibility, are part of my 5 C's of Biotech Investing™.

In the article below, I take a look at some pending catalysts for Actinium in 2017.

Actimab-M Enters The Clinic

Earlier in February 2017, Actinium announced an exciting expansion of the pipeline by moving Actimab-M into a in Phase 1 proof-of-concept program in patients with multiple myeloma (MM). MM represents an interesting and sizable opportunity for Actinium. MM is incurable and has a 5-year survival rate less than 50%.

Actinium seems to have a strong scientific rationale with Actimab-M as it targets CD33, which has been found to be expressed in 25-35% of MM patients. This program builds on the company’s experience in the CD33 space from its Phase 2 Actimab-A program in AML. By targeting CD33, Actimab-M may be effective against mutated plasma cells resistant to standard-of-care chemotherapy. Independent work shows that CD33 positive expression is a predictor of poor response and lower overall survival.

Management believes that Actimab-M has the potential to improve outcomes for relapsed or refractory MM patients with limited treatment options available today. This is a very exciting opportunity for the company given the low response rates for existing medications like daratumumab and elotuzumab. It also presents Actinium with the opportunity to develop Actimab-M as both a monotherapy and combination therapy.

Updates from the recently initiated Phase 1 trial are expected during the second half of 2017. Complete data are expected during the first half of 2018. Management also plans to pursue Orphan Drug designation for Actimab-M in both the U.S. and EU.

Iomab-B Update

The Phase 3 SIERRA trial initiated in July 2016. SIERRA is a randomized, controlled, multi-center study with a target enrollment of 150 patients with refractory or relapsed AML over the age of 55. Enrollment is ongoing right now. Patients are being split equally between Iomab-B and (physician's choice) conventional conditioning prior to allogeneic hematopoietic stem cell transplantation, also known as bone marrow transplant (BMT). The primary endpoint of SIERRA is durable complete response (dCR) at six months post BMT. Secondary outcome measures include safety and overall survival (OS) at one-year.

An important aspect of the trial is that conventional chemotherapy failures (i.e. no CR) subjects can crossover back to Iomab-B. It provides investigators and patients an attractive option for enrollment. By enrolling in the trial, patients know they will either get the best available standard-of-care today or a potentially new breakthrough investigational medicine, and standard-of-care failures get to try the investigational medicine as a second-line option. Keep in mind, Iomab-B is both an induction and conditioning regimen all-in-one, which should be very attractive to physicians and patients alike.

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Disclosure: BioNap is party to a services agreement with the company that is the subject of this report pursuant to which BioNap is paid twenty-five hundred dollars per month by the company in ...

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