ACTINIUM PHARMACEUTICALS: Actinium's Leading Clinical, Preclinical, Production and IP Efforts Related to Actinium-225 Highlighted at Preeminent Targeted Alpha Therapy International Symposium


Actinium Pharmaceuticals issued the following announcement on April 8.

Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) today highlighted its broad presence at the 11th Targeted-Alpha-Therapy International Symposium (TAT) that was held on April 1 – 4, 2019 in Ottawa, Canada. Two oral and four poster presentations related to Actinium's AWE or Antibody Warhead Enabling technology platform and clinical programs were featured at the symposium while Actinium's Chief Scientific Officer, Dr. Dale Ludwig, participated in a panel titled, "The Renaissance of Radio Pharmaceuticals – A Commercial Perspective". Actinium has extensive experience with targeted alpha therapy including clinical data in over 100 patients from four clinical trials and extensive intellectual property, know-how and trade secrets related to Ac-225 or Actinium-225 applications and manufacturing.

Actinium utilizes Ac-225, a potent alpha-particle emitting isotope, for generating ARCs or Antibody Radiation Conjugates used in several clinical trials including its pivotal Actimab-MDS program and combination trials of Actimab-A with venetoclax. In addition, Ac-225 is an important radionuclide warhead used in Actinium's AWE technology platform that is being utilized in an ongoing collaboration research partnership with Astellas Pharma, Inc.

In the poster presentation at TAT, Actinium highlighted several studies that evaluated the feasibility of accelerator produced Ac-225 in comparison to "thorium cow" generator produced Ac-225 that is used most commonly today. Studies demonstrated that labeling efficiency for the anti-CD33 monoclonal antibody lintuzumab was comparable between accelerator and generator produced Ac-225. Further, radiochemical purity was determined to be comparable, at 98.5% for accelerator produced material and 98.7% for generator produced material. In addition to radiochemical purity, accelerator produced Ac-225 demonstrated comparable immunoreactivity, a critical quality attribute, to that of generator produced Ac-225. Finally, comparable levels of anti-leukemic cell killing were observed irrespective of the Ac-225 source. Actinium has filed intellectual property related to the utilization of Ac-225 produced by an accelerator, which is in addition to granted patents related to the production of Ac-225 in a cyclotron.

Research commissioned by Actinium to evaluate the biodistribution of accelerator produced Ac-225 was presented in a separate poster presentation. The results of these studies using pharmacokinetic models determined that accelerator produced Ac-225 labeled to lintuzumab had a negligible impact in the context of therapy compared to generator produced Ac-225. In addition, an oral presentation highlighted Ac-225 labeled daratumumab, a CD38 antibody blockbuster therapy for patients with multiple myeloma that is marketed by Johnson & Johnson as Darzalex®. The studies featured in the oral presentation observed enhanced potency, cell killing and tumor control with Ac-225 labeled daratumumab compared to naked daratumumab alone.

Dr. Dale Ludwig, Actinium's Chief Scientific Officer, said, "It was exciting to have such broad representation of Actinium's alpha therapy efforts at TAT, as it is the leading conference for alpha particle-based therapies. Leveraging our AWE platform, we have significantly increased our research and development efforts and have worked to rapidly translate this work into the clinic as we have done with our combination trials with venetoclax and targeted Ac-225. As we look to the future, we are delighted to have the opportunity to work with next-generation Ac-225 from the DOE and demonstrate its feasibility for ARC applications. We plan to continue advancing the field of Ac-225 research and clinical development in several strategic areas including next-generation ARC's and combinations with other therapeutic modalities while continuing to expand our intellectual property estate in these applications."

Actinium recently announced that its patent portfolio now consists of 111 issued and pending patents in the U.S. and internationally, contained within 28 patent families, that cover key areas of Actinium's business including ARC generation, composition of matter, formulations, methods of administration for solid and liquid cancers and radionuclide production including the manufacturing of Ac-225.

Sandesh Seth, Actinium's Chairman and CEO, said, "Our broad presence at this year's TAT is emblematic of Actinium's commitment to leading the field of Actinium-225 based targeted alpha therapy. Recognizing the potential of alpha therapies, we strategically apply our research and development activities around our AWE technology platform and clinical development capabilities to advance novel ARC's for indications with unmet needs. Leveraging our extensive clinical experience with Ac-225, we are excited to have crafted an ARC pipeline encompassing targeted conditioning, combinations and targeted therapeutics across multiple patient populations. As a result, we are addressing a large cumulative patient population that we see as unmatched by other therapies. With our strong and growing IP portfolio, enhanced capabilities and integrated research and development capabilities I am confident in our ability to continue to build our leadership position in Ac-225 based therapies."

Original source can be found here.

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