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Actinium Pharmaceuticals, Inc. (ATNM)

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Actinium Pharmaceuticals, Inc. (ATNM: NYSE MKT) is a public biopharmaceutical company specialized in the development of cancer drugs. The Company’s product candidates are based on its patented technology co-developed with Memorial Sloan Kettering Cancer Center (MSKCC) for combining the cancer targeting precision of monoclonal antibodies (mAb) for targeting specific types of cells with the power of alpha emitting radioisotopes, the most potent cancer killing agents in existence. ATNM’s first drug for the treatment of acute myeloid leukemia (AML) has been administered to 49 patients with promising results and the second generation drug candidate is currently in clinical trials with 28 patients treated to date. In addition to leukemia drugs, ATNM’s technology has been used to produce drug candidates for treatment of metastatic colorectal and prostate cancers, antiangiogenesis (prevention of blood supply to and growth of many solid cancers) and bone marrow ablation, part of a curative treatment for leukemias, lymphomas and multiple myeloma.

Company intends to develop its products through Phase II clinical trials and it then intends to partner each drug for completion of development and commercialization with an appropriate third party. ATNM expects that its revenues will be derived from upfront payments, milestone payments and royalty payments, which payments comprise a standard structure of such partnering deals. In some markets, ATNM may seek to retain commercial rights and derive additional revenue from sales of its products.

ATNM’s largest shareholder is AHLB Holdings, LLC, which is wholly owned by Memorial Sloan Kettering Cancer Center. ATNM’s second largest shareholder is a subsidiary of Merck and Co.

 

 


 

 

APIT Platform

 

ATNM TECHNOLOGY PLATFORM

ATNM’s Alpha Particle Immunotherapy (APIT) platform is a highly potent and selective form of targeted radiotherapy.  It is based on attaching powerful alpha emitting radioisotopes Actinium 225 or Bismuth 213 to monoclonal antibodies (mAbs) which are large molecules capable of binding specifically to cancer cells.  By virtue of carrying alpha emitters, mAbs bring them directly to cancer cells where alpha emitters can selectively kill the targeted cell.  Figure below presents a schematic of a drug based on the Company’s APIT technology.

APIT based drug construct and its components

 

APIT based drug construct and its components
 

 

The power of alpha emitters is best understood when compared to beta emitters, an alternative form of radioisotope used in cancer drugs.  The killing power of a radioactive particle is directly proportional to its energy and inversely proportional to its range.  Alpha particle carries the most energy but travels the shortest path, while beta particle has less energy but goes farther in the body.

Comparison between α and β irradiation’s effect
on cancer cells and healthy tissues

 

Comparison between a and ß irradiation’s effect on cancer cells and healthy tissues
 

 

Being 100 times more powerful than beta particles, alpha therapy is effective in cancers that are not sensitive to beta irradiation.  Prime examples are the past and current clinical trials in AML.  APIT has demonstrated extremely high cancer cell kill levels even though AML is not considered particularly radiosensitive and radiotherapy is not used in treating the disease.  Based on these inherent isotope traits, the Company and Dr. David Scheinberg, Chairman of the Molecular Pharmacology and Chemistry Program at Memorial Sloan Kettering Cancer Center (MSKCC), ATNM’s key scientific collaborator, developed alpha particles as an ideal payload for targeted cancer radiotherapy.  While their potency is 100-fold higher than beta’s and cytotoxins’ significantly increases the killing power of alpha particle drugs against targeted tumor cells, their extremely short range limits any damage inflicted on healthy tissues.

In addition to its potency and range of emission, there are other key considerations for evaluating the suitability of particular radioisotopes for medical use.  Among them are half-life of the isotope, which is an indication of the period over which it remains radioactive, and its pharmacokinetics, i.e. its distribution in the body and its eventual elimination from it.  For these reasons, Actinium 225 (Ac-225) and the isotope derived from it, Bismuth 213 (Bi-213), were selected as lynchpins of the Company’s technology.  Both isotopes have relatively short half-lives and favorable and controllable pharmacokinetics.  However, for efficacy, logistics and cost reasons ATNM has decided to focus its efforts on Actinium 225 which has a 10 day half life versus Bismuth-213’s half life of 46 minutes.

 


Overview

Actinium Pharmaceuticals Drug Development Status

 

Product Pipeline V2

 

  1. HSCT stands for Hematopoietic Stem Cell Transplantation, a procedure in which cells capable of reconstituting normal bone marrow function are transplanted to a patient.
    ATNM has decided to discontinue development of Bismab-A at this time for supply, logistics and cost reasons. Actimab-A is the second generation drug of Bismab-A.
    Properties of Actinium 225 are uniquely suited for Antiangiogenesis and API is considering options for further development in that area.
    Antiangiogenesis therapies starve cancerous tumors by choking off blood supply to them.

 

 


Development Plan & Market Potential

Breakthrough Therapy Potential in Multiple Billion Dollar Markets

Over time, the biggest market potential for Actinium lies in the fact that its highly patented platform technology could be used to target a wide variety of cancers. Preclinical and clinical work has already focused on Non-Hodgkin Lymphoma (NHL), brain cancer, bladder cancer, ovarian cancer, breast cancer, prostate cancer, and a number of other cancer related indications.

Actinium intends to develop its product candidates through phase 2 clinical trials, and then plans to partner each drug for completion of development and commercialization with an appropriate third party. Revenues will be derived from upfront payments, milestone payments and royalty payments, which payments comprise a standard structure of such partnering deals. In some markets, Actinium may seek to retain commercial rights and derive additional revenue from sales of its products.

The compelling advantages of the Actinium's platform should continue to draw attention from the healthcare and investor communities. The company’s technology further illustrates the immense licensing and acquisition potential inherent in the company's high-momentum product pipeline. In fact its closest technology competitor, Algeta, which is about 3-4 years ahead from a market perspective, was just acquired by Bayer for $2.9 billion.

 


Market Potential of Product Pipeline


Actimab-A

 

Phase I Trial with single dose of Actimab-A

In collaboration with Memorial Sloan Kettering Cancer Center (MSKCC) we are conducting a first-in-man Phase I dose escalation trial to determine the safety, pharmacology, and biological activity of Actimab-A in Acute Myeloid Leukemia (AML).  Eighteen patients (median age, 64 yrs; range, 45–80 yrs) with relapsed/refractory AML were treated to date.  Patients received a single infusion of Actimab-A at doses of 0.5, 1, 2, 3, or 4 µCi/kg (µCi –microCurie; total dose, 23–390 µCi).  No acute toxicities were seen.  Dose limiting toxicity (DLT) was suppression of the entire bone marrow lasting over 35 days and consequent death due to sepsis.  It occurred in one patient treated with 3 µCi/kg and in both patients receiving 4 µCi/kg.  Toxicities outside of the target organ (bone marrow) were limited to transient grade 2/3 liver function abnormalities.  With follow-up from 1–24 months (median, 2 months), no evidence of damage to kidneys due to radiation was seen.  Peripheral blood blasts (leukemia cells) were eliminated in 10 of 16 evaluable patients who received a full treatment dose.  Bone marrow blast reductions of over 33% were seen in 10 of 15 evaluable patients at 4 weeks, including 3 patients with 5 percent or fewer blasts.  Actimab-A is tolerable at doses less than 4 µCi/kg and has antileukemic activity.

Acute Myeloid Leukemia is characterized by very high numbers of immature cancerous white blood cells of certain kind that are similar to normal young blood cells and all immature white blood cells are called blasts.  It is not normal for a person to have any blasts circulating in peripheral blood (peripheral blasts) and to have more than 5 percent of blasts in the bone marrow.

Phase I/II AML Trial with two consecutive fractionated doses of Actimab-A

After receiving clearance from the FDA the Company started Phase I/II multi-center AML trial with fractionated doses of Actimab-A.  ATNM has concluded contracts with and provided training to 6 participating trial centers (Baylor University Medical Center, MSKCC, Johns Hopkins Medicine, University of Pennsylvania Health System, Fred Hutchinson Cancer Center and University of MD Andersen Cancer Center).  The Phase I (dose escalating) portion of the trial is ongoing. The Company estimates that it will take approximately 3-6 months to complete the Phase I portion of the trial and an additional 1- 1.5 years to complete the Phase II portion of the trial.  For the proposed Phase I/II study, patients are eligible if they have previously untreated newly diagnosed acute myeloid leukemia according to World Health Organization criteria, are age 60 years or older, and are unfit for or decline intensive chemotherapy, or are 70 years or older with newly diagnosed AML.  This target population has had better outcomes than relapsed and refractory patients who have been most of the patients in ATNM’s previous trials.

Maximum enrollment in the Phase I portion of the trial is 21 patients in dose escalating cohorts of 3 patients each with the goal of determining the maximum tolerated dose (MTD) for Actimab-A.  There is a six week interval between dose levels.  Once MTD has been determined, it will be used as the dose level for the Phase II portion of the trial which will enroll up to 53 patients.  There are 4 planned dose levels in the Phase I portion of the trial.








 


Iomab-B

 

Iomab-B for Hematopoietic Stem Cells Transplantation:

Iomab-B (BC8-I-131 construct) has already been successfully used as a myeloconditioning/myeloablative agent in over 250 patients with incurable blood cancers. In both Phase I and Phase II trials Iomab-B has led to effective cures in patients with no options left. The only potentially curative treatment option for those patients is bone marrow transplantation (BMT), also known as a hematopoietic stem cell transplant (HSCT), but vast majority of patients over the age of 50 are either ineligible for myeloablative conditioning due to concomitant conditions or have a high burden and/or very resistant disease that makes reduced dose conditioning futile.

BC8-I-131 has demonstrated ability to successfully prepare such patients for bone marrow transplants when no other treatment was indicated. ATNM intends to develop Iomab-B through a regulatory approval via a pivotal registration trial in AML refractory/relapsing patients. That would allow for a relatively quick path to the market and provide a potentially curative treatment to patients who currently have little or no chance of achieving even a temporary remission, let alone a cure.

The targeting part of the Iomab-B construct is a monoclonal antibody that targets CD45, an antigen widely expressed on hematopoietic cells but not other tissues. Due to this broad expression, Iomab-B has demonstrated utility in other groups of patients and other indications as well, including Myelodysplastic Syndrome, Acute Lymphoblastic Leukemia, Hodgkin’s Disease and Non-Hodgkin Lymphoma. These are follow-on indications which could be pursued simultaneously or delayed, for cash conservation, and financed from commercial revenues.

The company is already preparing a program for replacing iodine 131 with Actinium 225 to create a second generation drug that would enable a significant expansion of use, described below as Actimab-B, Iomab-B was invented by researchers at the Fred Hutchinson Cancer Research Center (FHCRC), ATNM’s key collaborator on this program from whom ATNM obtained rights for all the commercial uses. FHCRC played a pivotal role in developing the entire field of bone marrow transplantation and the lead Hutchinson researcher, Dr. E. Donnall Thomas received the 1990 Nobel Prize in physiology/medicine for work in this area.

iomabbgraphnew

Iomab-B

  • The $1.3 billion Bone Marrow Transplant (BMT) market in the U.S. is largely unaddressed by novel pharmaceutical drug companies
    BMT is the fastest growing hospital procedure in the US
    • ~20,000 of the ~60,000 BMTs in 2010 were performed in the U.S.

    Sustained growth in patients treated over 55 years old
    • 8% in 2000 to 21% in 2005 and 27% in 2007

 


Management Team

http://www.actiniumpharma.com/about/senior-management/
Kaushik J. Dave, Ph.D., M.B.A.
President & CEO

Dragan Cicic, M.D., M.B.A.

COO and CMO

Dennis Earle, M.S., M.B.A., P.M.P.

Senior Vice President of Clinical Operations

David Gould, M.D.

Senior Vice President of Finance and Corporate Development

Corey Sohmer, M.B.A.

Vice President of Finance and Business Development
 


 

Actinium Pharmaceuticals, Inc.
501 Fifth Ave.
New York, NY 10017
646-459-4201
www.actiniumpharmaceuticals.com
CSohmer@actiniumpharmaceuticals.com

MissionIR
3645 Marketplace Blvd.
Suite 130-280
Atlanta, GA 30344
Phone: (404) 941-8975
www.MissionIR.com
Editor@MissionIR.com

 

Investors
http://www.actiniumpharma.com/investors/investor-relations/

SEC Filings
http://www.sec.gov/cgi-bin/browse-edgar?action=getcompany&CIK=0001388320&owner=exclude&count=40&hidefilings=0

 

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#995  Sticky Note $ATNM recent news/filings stocktrademan 03/22/16 11:04:55 AM
#1190   NEWS -- Actinium Further Strengthens Clinical Development Team Paulness 11/29/16 09:04:15 AM
#1189   News: Most recently, Mr. Bergonio worked at Novartis BooDog 11/29/16 07:24:01 AM
#1188   Actinium Issues Letter to Shareholders Highlighting 2016 Accomplishments Paulness 11/22/16 09:37:23 AM
#1187   NEWS -- Actinium Pharmaceuticals to Present at LD Paulness 11/21/16 08:45:54 AM
#1186   I agree with you - lots of new ANESRI 11/18/16 09:33:13 PM
#1185   Awesome. Be nice to see ATNM recover BooDog 11/15/16 02:08:27 PM
#1184   Trump just dropped a big hint to the ANESRI 11/15/16 12:52:44 PM
#1183   NEWS -- Actinium Announces Notice of Allowance for Paulness 11/14/16 08:17:14 AM
#1182   healthcare / bio sector should climb as a blackbandit 11/10/16 03:16:12 PM
#1181   Does anyone know cash on hand will they stockweiser 11/08/16 06:42:54 PM
#1180   Why would anyone sell at this level? < namretloh 11/08/16 01:08:19 PM
#1179   How many cash has the company?Thank you harmsen 11/08/16 12:06:55 PM
#1178   Pinch baby Actinium! You can do it! BooDog 11/08/16 10:04:35 AM
#1177   Agree winemeup 11/01/16 12:18:29 PM
#1176   you may have sold the bottom. Selling volume blackbandit 11/01/16 10:22:27 AM
#1175   On the old AMEX so don't see the BooDog 10/31/16 07:16:23 PM
#1174   Hope so. It is in dangerous territory now. MontanaState83 10/31/16 06:58:29 PM
#1173   From 9/15/16 BooDog 10/31/16 01:02:03 PM
#1172   wow - what the heck is going on here?? Atlanta1 10/31/16 12:58:46 PM
#1171   I'm out at .95 from 1.07,took a loss Ominous 10/31/16 12:57:01 PM
#1170   New 52 week lows on a weekly basis. rnoutlaw21 10/31/16 12:29:15 PM
#1169   Why is this one going down on what Ominous 10/31/16 12:27:16 PM
#1168   NEWS -- Actinium Pharmaceuticals Announces Key Hire in Paulness 10/31/16 08:29:12 AM
#1167   Very interesting - ANESRI 10/28/16 11:19:33 PM
#1166   Factsheet Oct 2016 ANESRI 10/28/16 11:10:14 PM
#1165   pg 15 ANESRI 10/28/16 10:58:45 PM
#1164   pg 6 (broadening the use of Ac225!) ANESRI 10/28/16 10:57:38 PM
#1163   Pg 6 ANESRI 10/28/16 10:48:19 PM
#1162   pg 26 ANESRI 10/28/16 10:33:51 PM
#1161   Today's filing pg22 ANESRI 10/28/16 10:28:05 PM
#1160   NEWS -- Actinium Pharmaceuticals Announces New Hires As Paulness 10/26/16 09:07:52 AM
#1159   Actinium Pharmaceuticals Announces New Hires As Supply Chain BooDog 10/26/16 08:21:13 AM
#1158   NEWS -- Actinium Pharmaceuticals Initiates Pursuit of Scientific Paulness 10/25/16 09:01:23 AM
#1157   Actinium Pharmaceuticals Initiates Pursuit of Scientific Advice for BooDog 10/25/16 07:15:35 AM
#1156   Other than a few presentations here and there BooDog 10/24/16 11:15:10 AM
#1155   Thanks for your reply MR 1955 DOUBLE DIE 10/24/16 11:00:34 AM
#1154   just read their last few press releases and blackbandit 10/24/16 10:29:55 AM
#1153   Hi. Can you tell me what the near MR 1955 DOUBLE DIE 10/21/16 06:14:06 PM
#1152   its practically at 52wk low, normally a great blackbandit 10/21/16 02:58:15 PM
#1151   I feel the same way. I keep winemeup 10/20/16 08:47:17 PM
#1150   I don't know what to do with is Brian56 10/20/16 05:37:01 PM
#1149   Thank you. Sure looks tempting at current levels. MR 1955 DOUBLE DIE 10/20/16 04:34:39 PM
#1148   On or about the 4th the shares were BooDog 10/20/16 03:20:27 PM
#1147   Anyone know when the offering ends? The closing MR 1955 DOUBLE DIE 10/20/16 01:23:42 PM
#1146   The Orphan Drug Designation program provides orphan status LGL8054 10/19/16 11:14:30 PM
#1145   NEWS -- Actinium Announces Acceptance of Actimab-A Data Paulness 10/19/16 09:08:53 AM
#1144   They are shaking out retail, they know this poonch1ne 10/18/16 02:39:31 PM
#1143   it's time for cooler heads to prevail here. Atlanta1 10/18/16 02:38:42 PM
#1142   this just makes no sense at all. Atlanta1 10/18/16 01:56:08 PM
#1141   Crazy 8 ball says "very likely" if it BooDog 10/18/16 01:35:53 PM
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