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Actinium Pharmaceuticals, Inc. (ATNM)

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Last Post: 9/27/2016 12:09:51 PM - Followers: 86 - Board type: Free - Posts Today: 9

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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News News Alert: Actinium Announces Initiation of Phase 2 Clinical Trial of Actimab-A in Patients Newly Diagnosed with Acute Myeloid Leukemia ... 09/27/2016 07:00:00 AM
PostSubject
#995  Sticky Note $ATNM recent news/filings stocktrademan 03/22/16 11:04:55 AM
#1095   Dipped right back to support. Howabout that. BooDog 09/27/16 12:09:51 PM
#1094   I'm looking for this to start building into BooDog 09/27/16 11:13:42 AM
#1093   would be nice if they could just transfer blackbandit 09/27/16 11:01:04 AM
#1092   So what is the ETA for lomab coming Monroe1 09/27/16 10:17:02 AM
#1091   If I remember they had about 4.5M shares BooDog 09/27/16 10:11:51 AM
#1090   possibly, aren't they about done? blackbandit 09/27/16 10:09:24 AM
#1089   My guess would be that Sloan is taking BooDog 09/27/16 09:48:50 AM
#1088   NEWS -- Actinium Announces Initiation of Phase 2 Paulness 09/27/16 09:36:41 AM
#1087   Going up, up up today!! JMO winemeup 09/27/16 09:23:51 AM
#1086   based on your DD, what do you think raptors1994 09/26/16 08:42:50 PM
#1085   NEWS -- Actinium Pharmaceuticals to Sponsor and Participate Paulness 09/26/16 08:58:08 AM
#1084   ATNM my #1 pick for the next 2 blackbandit 09/22/16 11:10:04 AM
#1083   maybe we are finally seeing the start of blackbandit 09/21/16 01:07:35 PM
#1082   NEWS -- Actinium Pharmaceuticals to Host Webinar to Paulness 09/21/16 09:03:53 AM
#1081   docroc, you are right about this heating up blackbandit 09/20/16 01:56:35 PM
#1080   NEWS -- Actinium Pharmaceuticals Selects Vector Oncology as Paulness 09/20/16 09:47:15 AM
#1079   I'm watching for them to report once they're BooDog 09/20/16 06:27:38 AM
#1078   BooDog, what does below 10% mean? ANESRI 09/20/16 12:36:03 AM
#1077   NEWS -- Actinium Pharmaceuticals to Present at Ladenburg Paulness 09/19/16 09:00:00 AM
#1076   MSKT now under the 10% mark. Now BooDog 09/16/16 05:50:35 AM
#1075   NEWS -- Actinium Pharmaceuticals Presenting at Rodman & Paulness 09/13/16 09:20:41 AM
#1074   Only a matter of time before this one docoroc2 09/10/16 05:10:37 PM
#1073   NEWS -- Actinium Pharmaceuticals Presenting at the BioCentury Paulness 09/09/16 09:25:37 AM
#1072   NEWS -- Actinium Enhances Capabilities with Hiring of Paulness 09/07/16 07:43:12 AM
#1071   Craig Sager’s cancer fight continues with rare third ANESRI 08/31/16 08:56:12 PM
#1070   Craig Sager clarifies his 3-6 months to live ANESRI 08/31/16 08:54:00 PM
#1069   Increases in recent volume increasing, but relatively subtle. docoroc2 08/31/16 03:13:24 PM
#1068   Close at/above 1.80 today very bullish, IMHO. docoroc2 08/30/16 02:54:43 PM
#1067   $ATNM does have a squeezy look to it BooDog 08/30/16 01:52:36 PM
#1066   Moving now. Not much volume, but should see docoroc2 08/30/16 01:23:22 PM
#1065   2 presentations in a row. BooDog 08/30/16 09:10:37 AM
#1064   NEWS -- Actinium to Present at Rodman & Paulness 08/30/16 09:04:31 AM
#1063   Headed past resistance. Clear sailing to 2 bucks docoroc2 08/29/16 03:05:04 PM
#1062   Coverage initiated per Roth at 5.50, I think. docoroc2 08/25/16 01:14:31 PM
#1061   NEWS -- Actinium Pharmaceuticals to Present at the Paulness 08/23/16 08:16:56 AM
#1060   when ATNM breaks above the current range of blackbandit 08/19/16 12:01:13 AM
#1059   Pressure on the sector imo. News today BooDog 08/10/16 03:36:47 PM
#1058   All this good news I don't know why MrMr1 08/10/16 02:06:53 PM
#1057   NEWS -- With Impressive Data in Tow, Actinium Paulness 08/10/16 08:54:13 AM
#1056   NEWS -- Actinium Pharmaceuticals Granted SME Status by Paulness 08/09/16 08:49:26 AM
#1055   Almost at entry point again and ride the Popeye 08/08/16 10:03:51 PM
#1054   a little surprised the shareholder update didn't spark blackbandit 08/05/16 01:26:08 PM
#1053   shhh, quiet, longs loading the boat here for blackbandit 08/04/16 02:17:52 PM
#1052   NEWS -- Actinium Pharmaceuticals Issues Mid-Year Letter to Paulness 08/04/16 07:29:59 AM
#1051   And there's 1.65 lol BooDog 07/20/16 03:11:32 PM
#1050   Filled 1.67. We'll see if Memorial Sloan-Kettering Cancer BooDog 07/20/16 03:11:03 PM
#1049   I like the way you think. Like the BooDog 07/20/16 11:40:27 AM
#1048   LOADING Runners123 07/20/16 09:50:57 AM
#1047   Thanks Paul. Awesome! eom BooDog 07/20/16 08:34:30 AM
#1046   NEWS -- Actinium Pharmaceuticals Highlights Successful Investigator Meeting Paulness 07/20/16 07:27:24 AM
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