Actinium to Host KOL Call on November 11th Featuring Actimab-A AML Combination Trials

Rhea-AI Summary

Actinium Pharmaceuticals, Inc. (NYSE: ATNM) will host a CD33 program update event featuring key opinion leaders on November 11, 2020, at 4:15 PM ET. Dr. Ehab Atallah will present data from the Actimab-A CLAG-M trial, revealing a 100% remission rate in its final dose cohort. Dr. Gary Schiller will discuss the Actimab-A venetoclax trial, emphasizing the lack of options for relapsed or refractory acute myeloid leukemia (R/R AML). Both trials have promising results and will be discussed further at the upcoming ASH Annual Meeting.

NEW YORK, Nov. 11, 2020 /PRNewswire/ -- Actinium Pharmaceuticals, Inc.  (NYSE AMERICAN: ATNM) ("Actinium") today announced that it will host a CD33 program update featuring two key opinion leaders (KOLs) today, November 11^th at 4:15 PM ET.  The event will feature KOLs Dr. Ehab Atallah from the Medical College of Wisconsin, the senior investigator of the Actimab-A CLAG-M combination trial and Dr. Gary Schiller from the University of California Los Angeles Health, the principal investigator for the Actimab-A venetoclax combination trial as well as members of Actinium's management team.  Both KOL's will review data that was included in abstracts accepted for presentation at the 62^nd American Society of Hematology (ASH) Annual Meeting.  They will also provide their perspectives on the treatment landscape and medical need each trial potentially addresses. 

Actimab-A AML Combinations Update Call Details
Webcast link: https://ir.actiniumpharma.com/presentations-webinars
Date: November 11, 2020
Time: 4:15 PM ET

Dr. Ehab Atallah, MD, is a Professor of Medicine and Section Head of Hematological Malignancies at the Medical College of Wisconsin Division of Hematology and Oncology, specializing in leukemia and myelodysplastic syndromes at Froedtert Hospital. Dr Atallah, as senior investigator, will review the Phase 1 data from the Actimab-A CLAG-M combination trial in relapsed or refractory acute myeloid leukemia (R/R AML) that demonstrated 100% remission in the third and planned final dose cohort.  Further, 83% of patients (10/12) who received 3 or fewer prior lines of treatment achieved CR or CRi.  Notably, 70% of CR/CRi patients (7/10) were MRD negative indicating a deep remission with no detectable disease.  Dr. Atallah will also discuss the trial data in the context of data available for other treatment options, including recently approved and novel agents in development, in the fit R/R AML population.

Dr. Gary Schiller, MD, is the Director of Bone Marrow/Stem Cell Transplantation and Professor of Hematology-Oncology at UCLA.  Dr. Schiller, a well-published clinical investigator in acute and chronic leukemias and other hematologic malignancies, is the principal investigator on the Phase 1/2 clinical trial of Actimab-A and venetoclax.  Dr. Schiller will discuss the lack of viable treatment options for R/R AML and the available opportunity for combination regimens such as Actimab-A plus venetoclax.  Last week, the company announced that first-in-human data in this combination trial had been accepted for poster presentation at ASH in December.  The trial is in the dose escalation phase with proof of concept data expected in 2021.

CD33 Program ASH Abstract Links

Oral Presentation Title: A Phase I Study of Lintuzumab Ac225 in Combination with CLAG-M Chemotherapy in Relapsed/Refractory AML
Publication Number: 165
Link: https://ash.confex.com/ash/2020/webprogram/Paper137218.html

Poster Title: Lintuzumab-225Ac in Combination with Venetoclax in Relapsed/Refractory AML: Early Results of a Phase I/II Study
Publication Number: 2875
Link: https://ash.confex.com/ash/2020/webprogram/Paper141132.html

About Actinium's CD33 Program

Actinium's CD33 program is evaluating the clinical utility of Actimab-A, an ARC comprised of the anti-CD33 mAb lintuzumab linked to the potent alpha-emitting radioisotope Actinium-225 or Ac-225. CD33 is expressed in the majority of patients with AML and myelodysplastic syndrome, or MDS, as well as patients with multiple myeloma. The CD33 development program is driven by data from over one hundred and twenty-five treated patients, including a Phase 1/2 trial where Actimab-A produced a remission rate as high as 69% as a single agent.  This clinical data is shaping a two-pronged approach for the CD33 program, where at low doses the Company is exploring its use for therapeutic purposes in combination with other modalities and at high doses for use for targeted conditioning prior to bone marrow transplant. Actinium currently has multiple clinical trials ongoing including the Phase 1 Actimab-A CLAG-M and Phase 1/2 Actimab-A venetoclax combination trials and is exploring additional CD33 ARC combinations with other therapeutic modalities such as chemotherapy, targeted agents or immunotherapy.

About Actinium Pharmaceuticals, Inc. (NYSE: ATNM)

Actinium Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing ARCs or Antibody Radiation-Conjugates, which combine the targeting ability of antibodies with the cell killing ability of radiation.  Actinium's lead application for our ARCs is targeted conditioning, which is intended to selectively deplete a patient's disease or cancer cells and certain immune cells prior to a BMT or Bone Marrow Transplant, Gene Therapy or Adoptive Cell Therapy (ACT) such as CAR-T to enable engraftment of these transplanted cells with minimal toxicities.  With our ARC approach, we seek to improve patient outcomes and access to these potentially curative treatments by eliminating or reducing the non-targeted chemotherapy that is used for conditioning in standard practice currently.  Our lead product candidate, I-131 apamistamab (Iomab-B) is being studied in the ongoing pivotal Phase 3 Study of Iomab-B in Elderly Relapsed or Refractory Acute Myeloid Leukemia (SIERRA) trial for BMT conditioning.  The SIERRA trial is over seventy-five percent enrolled and positive single-agent, feasibility and safety data has been highlighted at ASH, TCT, ASCO and SOHO annual meetings.  More information on this Phase 3 clinical trial can be found at sierratrial.com. I-131 apamistamab will also be studied as a targeted conditioning agent in a Phase 1 study with a CD19 CAR T-cell Therapy and Phase 1/2 anti-HIV stem cell gene therapy with UC Davis.  In addition, we are developing a multi-disease, multi-target pipeline of clinical-stage ARCs targeting the antigens CD45 and CD33 for targeted conditioning and as a therapeutic either in combination with other therapeutic modalities or as a single agent for patients with a broad range of hematologic malignancies including acute myeloid leukemia, myelodysplastic syndrome and multiple myeloma.  Ongoing combination trials include our CD33 alpha ARC, Actimab-A, in combination with the salvage chemotherapy CLAG-M and the Bcl-2 targeted therapy venetoclax.  Underpinning our clinical programs is our proprietary AWE (Antibody Warhead Enabling) technology platform.  This is where our intellectual property portfolio of over 100 patents, know-how, collective research and expertise in the field are being leveraged to construct and study novel ARCs and ARC combinations to bolster our pipeline for strategic purposes.  Our AWE technology platform is currently being utilized in a collaborative research partnership with Astellas Pharma, Inc. Website: https://www.actiniumpharma.com/

Forward-Looking Statements for Actinium Pharmaceuticals, Inc. 

This press release may contain projections or other "forward-looking statements" within the meaning of the "safe-harbor" provisions of the private securities litigation reform act of 1995 regarding future events or the future financial performance of the Company which the Company undertakes no obligation to update. These statements are based on management's current expectations and are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with preliminary study results varying from final results, estimates of potential markets for drugs under development, clinical trials, actions by the FDA and other governmental agencies, regulatory clearances, responses to regulatory matters, the market demand for and acceptance of Actinium's products and services, performance of clinical research organizations and other risks detailed from time to time in Actinium's filings with the Securities and Exchange Commission (the "SEC"), including without limitation its most recent annual report on form 10-K, subsequent quarterly reports on Forms 10-Q and Forms 8-K, each as amended and supplemented from time to time.

Contacts:

Investors:
Clayton Robertson
Actinium Pharmaceuticals, Inc. 
crobertson@actiniumpharma.com

Hans Vitzthum
LifeSci Advisors, LLC
Hans@LifeSciAdvisors.com
(617) 430-7578

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SOURCE Actinium Pharmaceuticals, Inc.

FAQ

What will be discussed at the Actinium Pharmaceuticals KOL call on November 11, 2020?

The call will feature updates on the Actimab-A CLAG-M trial and the Actimab-A venetoclax trial, focusing on remission rates and treatment options for R/R AML.

What are the key results from the Actimab-A CLAG-M trial?

The trial showed a 100% remission rate in its final dose cohort, with 83% of patients achieving complete remission or complete remission with incomplete recovery.

Who are the key opinion leaders addressing the clinical updates on November 11, 2020?

Dr. Ehab Atallah and Dr. Gary Schiller will present during the KOL call, sharing insights on the Actimab-A trials.

What is the significance of the upcoming ASH Annual Meeting for Actinium Pharmaceuticals?

Actinium will present data from its trials at the ASH Annual Meeting, highlighting its advancements in treating R/R AML.

What is the stock symbol for Actinium Pharmaceuticals?

The stock symbol for Actinium Pharmaceuticals is ATNM.