ATNM – an NYSE Company making great strides

Hello, Fellow Trader,

Today we have Actinium Pharmaceuticals, Inc. (ATNM) on our radar.  The company is trading on the NYSE American and is currently priced at 0.43.

The global cancer therapy market has forecasted extensive growth due to higher prevalence and incidence of Cancer Worldwide. The US market is estimated to account for 46% of the global cancer cost.  The first targeted cancer therapy was tamoxifen approved in the 1970s.  Targeted cancer therapies are drugs that are actively involved in blocking the growth of cancer by interfering with specific molecules which are responsible for the growth, progression, and spread of cancerous cells. These therapies are also known as precision medicines. Targeted cancer therapy is different from standard chemotherapy treatment as these therapies target only cancerous cells without affecting the normal cells. Also targeted cancer therapy block tumor cell proliferation, whereas standard chemotherapy kills the tumor cells.

One NYSE Company is making great strides working on developing targeted therapies for patients with cancers who are lacking effective treatment options.  Early results are promising and both Wall Street and Cancer Patients are waiting to hear positive results.  In the meantime, this stock has been beaten up recently, and may very well be one to add to the watchlist.

Actinium Pharmaceuticals, Inc. (NYSE: ATNM), is a clinical-stage biopharmaceutical company focused on developing and commercializing targeted therapies for potentially superior myeloablation and conditioning of the bone marrow prior to a bone marrow transplant and for the targeting and killing of

 

Cancer cells. Their targeted therapies have demonstrated the potential to result in significantly improved access to bone marrow transplant with better outcomes, namely increased marrow engraftment and survival.

ATNM‘s proprietary technology platform utilizes monoclonal antibodies to deliver radioisotopes directly to cells of interest in order to kill those cells both safely and effectively. Actinium is currently progressing three drug candidates in clinical trials.

ATNM‘s lead product candidate, Iomab-B, is licensed from the Fred Hutchinson Cancer Research Center and is designed to be used, upon approval, in preparing patients for a hematopoietic stem cell transplant, commonly referred to as bone marrow transplant. A bone marrow transplant is often the only potential cure for patients with blood-borne cancers, but the current standard preparation for a transplant requires chemotherapy and/or total body irradiation that result in significant toxicities.

Iomab-b is currently in Phase 3 and is showing tremendous progress.

ATNM recently announced the successful activation of 16 clinical trial sites in the Phase 3 study.  With Stony Brook, New York-based Stony Book University, the sixteen clinical trial sites in the Phase 3 SIERRA trial represent over one-third of bone marrow transplant volume in the U.S., which bodes well for reaching the 150-patient enrollment goal.

Upon approval, Iomab-B is intended to prepare and condition patients for a bone marrow transplant also referred to as a hematopoietic stem cell transplant, which is often considered the only potential cure for patients with certain blood-borne cancers and blood disorders.

It has shown progress treating a number of blood cancer indications, including acute myeloid leukemia (AML), chronic myeloid leukemia (CML), acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), Hodgkin’s disease (HD), Non-Hodgkin lymphomas (NHL) and multiple myeloma (MM).

Iomab-B has been granted Orphan Drug Designation for relapsed or refractory AML in patients 55 and above by the U.S. Food and Drug Administration and the European Medicines Agency.

The Bone Marrow and Transplant Market is projected to expand at a steady CAGR of 3.9% over forecast period 2015–2021 and is expected to be valued at US$10.3 Billion by the end of 2021. Among other markets globally, the market in Europe is expected to remain dominant in terms of value and volume throughout the forecast period.

ATNM is also developing Actimab-A, its lead alpha-particle drug candidate. Actimab-A is currently in a multicenter open-label, 53-patient Phase 2 trial for patients newly diagnosed with AML age 60 and over. Actimab-A is being developed to induce remissions in elderly patients with AML who lack effective treatment options and often cannot tolerate the toxicities of standard frontline therapies.

Last but not least, ATNM has also has expanded its alpha-particle approach to include newly created drug candidate Actimab-M, which is being studied in patients with relapsed or refractory multiple myeloma in a Phase 1 clinical trial.

With all these drugs in various stages of the pipeline, ATNM has made great strides.  Recent developments include these 2017 Year-end Highlights with a positive 2018 Outlook

Year End 2017 Highlights:

  • Announced Actimab-MDS, a new clinical initiative focused on improving transplant outcomes as measured by 1-year overall survival for patients with high-risk myelodysplastic syndrome with a p53 genetic mutation.  We intend to begin a Phase 2 trial with Actimab-MDS that will be led by principal investigator Dr. Gail Roboz of Weill-Cornell and the MDS Clinical Research Consortium that is comprised of the Cleveland Clinic, Dana-Farber Cancer Institute, Johns Hopkins, MD Andersen Cancer Center, Moffitt Cancer Center.
  • Presented Phase 2 data at ASH from our Actimab-A clinical trial showing a 69% overall response rate in patients with AML who are older and unfit for induction chemotherapy.  Actimab-A produced these results as a single agent that is administered via two infusions on day 1 and day 8.
  • Launched the AWE Program that is focused on creating ARCs or antibody radio-conjugates or biobetters utilizing actinium-225 in partnership or collaboration with biopharmaceutical companies.
  • Presented preliminary preclinical data from our AWE Program at ASH where we showed an up to ten-fold increase in the cell-killing ability of daratumumab, a blockbuster CD38 antibody therapy for patients with multiple myeloma that is marketed by Johnson & Johnson.
  • An abstract was published in the ASH volume of blood®confirming the expression of CD33 in patients with multiple myeloma from a large U.S. patient database, providing further validation for our Actimab-M clinical trial in refractory multiple myeloma patients, which is the first CD33 targeted therapy for this patient population.
  • Announced that the independent data monitoring committee reviewed initial data from the first 20 patients in the pivotal Phase 3 SIERRA trial for Iomab-B and recommended that the trial continue as planned.

2018 Outlook:

Unlocking Significant Value in Myeloablation for Bone Marrow Transplant

With the announcement of Actimab-MDS, Actinium is now the only company with a multi-disease, multi-product pipeline focused on improving bone marrow transplant access and outcomes via improved myeloablation.  Bone marrow transplant is a potentially curative treatment option for patients with blood cancers and diseases such as leukemias, lymphomas, and myelodysplastic syndromes.  A majority of bone marrow transplants are performed in fifty leading hospitals in the U.S., which is where Actinium will initially focus and build on its existing presence in leading centers that account for over 35 percent of transplant volume.  Actinium is committed to building a franchise serving the bone marrow transplant market and expects to achieve the following milestones in 2018 and beyond for Iomab-B as it strives to be the leader in the field:

Iomab-B:

  • Complete enrollment of the pivotal Phase 3 SIERRA trial for Iomab-B by the end of 2018
  • Have successful DMC safety analyses when 25%, 50% and 75% of patients have been enrolled and potential interim analyses when 70 and 110 patients have reached the primary endpoint
  • Report topline data results in the second half of 2019
  • Prepare for a BLA filing to obtain FDA approval
  • Scale up for commercial operations

Actimab-MDS:

  • Have a meeting with the FDA in the first half of 2018 to set a regulatory pathway
  • Initiate Phase 2 clinical trial in the second half of 2018

Building an Industry Leading CD33 Program with Multiple Shots on Goal

The Company is developing a potentially leading CD33 targeting program in the industry with clinical programs in three indications. Actinium is the only commercial sponsor to have a clinical trial in multiple myeloma that is focused on targeting CD33.  In addition, Actinium is the only commercial sponsor to utilize an alpha particle payload in these radiation sensitive cancers.  Actinium believes the following programs are best-in-class and/or first-in-class:

  • Actimab-A for unfit elderly AML patients in Phase 2
  • Actimab-M for refractory multiple myeloma in a proof of concept Phase 1 trial
  • Actimab-MDS for BMT conditioning in high-risk MDS patients with a planned Phase 2

Actinium expects numerous milestones from these programs in 2018 including:

Actimab-A:

  • Complete enrollment of the Phase 2 trial in the first half of 2018
  • Report top-line data in the second half of 2018

Actimab-M:

  • Complete enrollment of the Phase 1 trial in second half of 2018
  • Report top-line data by the end of 2018

Actimab-MDS:

  • Have a meeting with the FDA in the first half of 2018 to set a regulatory pathway
  • Initiate Phase 2 clinical trial in the second half of 2 clinical trial

Leading Innovation Via the AWE Technology Platform

Actinium announced its Actinium Warhead Enabling or AWE Technology Platform to capitalize on the utilization of actinium-225 to enhance the cell-killing power of targeting agents such as antibodies, peptides, Fab fragments and other modalities.  Using the AWE program, Actinium intends to create ARCs or antibody radio-conjugates and biobetters in collaboration or partnership with biopharmaceutical companies.  In January, Actinium announced that Dr. Dale Ludwig was appointed Chief Scientific Officer and would be tasked with managing the AWE Technology Platform. In 2018, Actinium expects to achieve the following with its AWE Program:

  • Present additional data from its work with labeling daratumumab with actinium-225
  • Label additional targeting agents with actinium-225
  • Secure a collaboration based on the AWE Technology Platform

The Company reiterates its intent to build upon the promise of both the CD45 and CD33 programs over the next three to five years by gaining approval and commercializing multiple product candidates based on these programs to enhance access to bone marrow transplant with improved outcomes via its improved myeloablation approach and to partner strategically to enhance the value of its programs and technology platforms.

If you are still reading this, then you see the value that ATNM has to offer.  Positive Phase 3 announcements have been known to launch biotechs into the stratosphere.  Results are due shortly, and this is one company worth watching very closely.

For now, it is worth adding ATNM to the watchlist and carefully observing for an ideal entry.


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