Actinium Expands Clinical Leadership Team to Support Key Development Programs for Iomab-B and Actimab-A
Actinium Pharmaceuticals, Inc. (NYSE: ATNM) announced a senior-level expansion of its clinical organization, strengthening its expertise in bone marrow transplant and acute myeloid leukemia. Key hires include Madhuri Vusirikala, MD, Akash Nahar, MD, Patrik Brodin, Ph.D., and Elaina Haeuber, enhancing the company's operational capabilities for pivotal programs Iomab-B and Actimab-A. Topline data from the Phase 3 SIERRA trial for Iomab-B is expected in Q4 2022. This expansion aims to advance clinical development and improve patient outcomes in hematological malignancies.
- Key hires enhance expertise in clinical development and operations.
- Strengthened leadership in hematological malignancies and bone marrow transplant.
- Anticipated topline data from the pivotal Phase 3 SIERRA trial supports investor confidence.
- No current revenue impact from management changes.
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- Key hires with proven expertise and track records in Bone Marrow Transplant, Acute Myeloid Leukemia, Radiation Sciences and Clinical Operations position Actinium well to drive key clinical programs forward
NEW YORK, Oct. 27, 2022 /PRNewswire/ -- Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a leader in the development of targeted radiotherapies, today announced a broad senior level expansion of its clinical organization. These key hires strengthen the Company's expertise in hematological malignancies, bone marrow transplant (BMT) and radiation sciences as well its operational capabilities. The addition of Madhuri Vusirikala, MD, Vice President of Clinical Development, BMT and Cellular Therapy, and Akash Nahar, MD, Vice President of Clinical Development, are complemented by the deep nuclear medicine and radiation science expertise with Patrik Brodin, Ph.D., Vice President of Radiation Sciences. Elaina Haeuber, Vice President, Head of Clinical Operations, will lead the clinical operations organization to further support the Company's clinical development plans for its pipeline products including Iomab-B and Actimab-A.
Dr. Avinash Desai, Chief Medical Officer at Actinium, said, "We are excited to add these talented and accomplished leaders to Actinium. This seasoned team bolsters our capabilities across the board as we advance our clinical development programs with Iomab-B, Actimab-A and Iomab-ACT. The expertise and contributions of these most recent additions to the team will be valuable as we continue the development of these highly differentiated product candidates in BMT, cell and gene therapy conditioning, as well as hematologic therapeutics. I look forward to working with our expanded team to unlock the full potential of our clinical portfolio."
Dr. Madhuri Vusirikala stated, "As a transplant physician, I know far too well the challenges in managing patients with relapsed or refractory AML and the frustration in not being able to offer potentially curative BMT to these patients. Iomab-B has the opportunity to significantly expand access to BMT for patients with AML and several other hematologic malignancies. This product candidate has the potential to shorten and improve the patient journey and the way we manage these patients in pursuit of increased survival and even curative outcomes. I am excited to bring to bear my expertise in the continued development and expansion of Iomab-B and Iomab-ACT". Dr. Akash Nahar added, "AML is an aggressive disease and despite 9 drug approvals since 2017, outcomes for relapsed or refractory patients remain dismal and a BMT remains the only curative option. As a hematologist, I believe both of Actinium's Iomab-B and Actimab-A clinical programs are highly differentiated. Having led many later stage development programs and regulatory filing efforts, I am excited by the opportunity to contribute my expertise as part of the Actinium team at this important point in the Company's evolution."
As previously announced, Actinium is preparing to report topline data from its pivotal Phase 3 SIERRA trial for Iomab-B in the fourth quarter of this year.
Madhuri Vusirikala, MD – Vice President, Clinical Development BMT and Cellular Therapy
Dr. Vusirikala is an accomplished bone marrow transplant physician and hematologist with over 20 years of clinical experience. She is board certified in internal medicine, hematology and oncology. Dr. Vusirikala joins Actinium from UT Southwestern Medical Center in Dallas, Texas, where she has been a Professor of Internal Medicine in the Division of Hematology/Oncology and Medical Director of the Adult Allogeneic Bone Marrow Transplant Program. She specialized in managing a variety of hematologic malignancies and performing allogeneic bone marrow transplants for these patients when indicated. She also served as primary investigator for most of the clinical trials at UT Southwestern related to BMT. Dr. Vusirikala earned her medical degree (M.B.B.S.) at India's Lady Hardinge Medical College before completing an internal medicine internship at Maulana Azad Medical College-Delhi University and an internal medicine internship and residency at The State University of New York, Syracuse. She also completed a hematology and oncology fellowship at the University of Pittsburgh and an advanced fellowship in bone marrow transplantation at Vanderbilt University Medical Center. Dr. Vusirikala is a member of the American Society of Hematology, American Society of Transplantation and Cellular Therapy. She serves as a member on the NCCN panels for Hematopoietic Cell Transplantation and Acute Lymphoblastic Leukemia committees.
Akash Nahar, MD – Vice President, Clinical Development
Dr. Nahar brings over 15 years of hematology-oncology research and development experience in academia and industry. Previously, Dr. Nahar held positions of increasing responsibilities, most recently serving as Global Product Development Lead for hematology programs at Merck. In this role, he led a team of six physicians responsible for the development of the PD-1 inhibitor Keytruda® in Hodgkin's lymphoma along with other developmental products for hematological malignancies. Dr. Nahar successfully led the filing of two indications for Keytruda®. He made impactful contributions cross-functionally, including clinical research, strategy, and regulatory, spanning multiple hematological indications. He also brings experience from all phases of drug development, successfully executing programs from early phase 1 through approval. Dr. Nahar is board certified in pediatrics and hematology/oncology. He is a faculty member in oncology at St. Christopher's Hospital for Children in Philadelphia and an Associate Professor in pediatrics at Drexel University. He has authored multiple papers and book chapters and have published several papers in peer reviewed journals. Dr. Nahar received his Bachelor of Medicine and Bachelor or Surgery (MBBS) from Mahatma Gandhi Memorial Medical College, Indore, India and his MPH in Epidemiology from the State University of New York at Albany.
Patrik Brodin, MSc, PhD – Vice President, Head of Radiation Sciences
Patrik is a board certified Medical Physicist, and a Diplomat of the American Board of Radiology in the discipline of Therapeutic Medical Physics, and previously, was an Assistant Professor and Senior Physicist at the department of Radiation Oncology at Montefiore/Einstein. By combining his expertise in radiation physics and data analysis with biology-based research methods, he spearheaded the development of new approaches in radiation-driven immunotherapy, and solutions for reducing the risk of severe treatment complications associated with receiving high-dose radiation therapy. Patrik has experience and expertise in clinical medical physics, biostatistics and advanced analytical methods including quantitative image analysis, and novel experimental design. He has authored more than 60 peer-reviewed publications and presented at national and international meetings including oral presentations at the ESTRO, ASTRO, AAPM and PTCOG annual meetings. Patrik trained in Medical Physics at Lund University, Sweden, followed by a PhD at the Niels Bohr Institute at the University of Copenhagen, Denmark, and received his M.Sc. in Clinical Research Methods from Yeshiva University upon coming to the United States.
Elaina Haeuber, MS – Vice President, Head of Clinical Operations
Elaina brings more than 20 years of clinical research operations and project management experience in the biopharmaceutical industry. Most recently, she was Vice President, Operations at WCG, a global organization supporting various aspect of clinical trials where she was responsible for overseeing data safety monitoring boards and independent event adjudication for numerous clinical studies. Prior to this, she was Executive Director, Operations Management for oncology and hematology trials at Syneos Health. Elaina has overseen regional and global project and clinical management teams of up to 300 staff and managed a strategic biopharma portfolio at PPD, which included more than 60 studies in multiple therapeutic areas. Her oncology experience includes all phases of studies across multiple indications, cell and gene therapy, immuno- and targeted therapies. She has supported programs leading to marketing approval in both the US and EMA including PD-L1 inhibitor Tecentriq approved in non-small cell lung cancer, small cell lung cancer, triple negative breast cancer and other indications, Zynteglo, the first cell-based gene therapy approved for patients with beta-thalassemia, and Skysona, a gene therapy for patients with early, active cerebral adrenoleukodystrophy (CALD). While at PPD, she supported the merger of two independent business units (Acurian and Synexus) into an integrated business unit called Accelerated Enrollment Solutions, as well as played a key role in designing a decentralized clinical trial model to better manage their large clinical trial operations. She has a BA from Boston University and an MS from the University of Illinois.
About Actinium Pharmaceuticals, Inc.
Actinium Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing targeted radiotherapies to deliver cancer-killing radiation with cellular level precision to treat patients with high unmet needs. Actinium's clinical pipeline is led by radiotherapies that are being applied to targeted conditioning, which is intended to selectively deplete a patient's disease or cancer cells and certain immune cells prior to a bone marrow transplant (BMT), gene therapy or adoptive cell therapy, such as CAR-T, to enable engraftment of these transplanted cells with minimal toxicities. Our lead product candidate, I-131 apamistamab (Iomab-B) has been studied in over four hundred patients, including the pivotal Phase 3 Study of Iomab-B in Elderly Relapsed or Refractory Acute Myeloid Leukemia (SIERRA) trial for BMT conditioning. Topline data from the SIERRA trial are expected in the fourth quarter of 2022. Iomab-ACT, low dose I-131 apamistamab, is being studied as a targeted conditioning agent in a Phase 1 study with a CD19 CAR T-cell Therapy with Memorial Sloan Kettering Cancer Center with NIH funding. Actimab-A, our second most advanced product candidate has been studied in approximately 150 patients with Acute Myeloid Leukemia or AML, including in ongoing combination trials with the chemotherapy regimen CLAG-M and with venetoclax, a targeted therapy. Actimab-A or lintuzumab-Ac225 is an Actinium-225 based antibody radiation conjugate targeting CD33, a validated target in AML. Actinium is a pioneer and leader in the field of Actinium-225 alpha therapies with an industry leading technology platform comprising over 190 patents and patent applications including methods of producing the radioisotope AC-225. Our technology and expertise have enabled collaborative research partnerships with Astellas Pharma, Inc. for solid tumor theranostics, with AVEO Oncology Inc. to create an Actinium-225 HER3 targeting radiotherapy for solid tumors, and with EpicentRx, Inc. to create targeted radiotherapy combinations with their novel, clinical stage small molecule CD47-SIRPα inhibitor. More information is available on Actinium's website: https://www.actiniumpharma.com/.
Investors:
Hans Vitzthum
LifeSci Advisors, LLC
Hans@LifeSciAdvisors.com
(617) 430-7578
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SOURCE Actinium Pharmaceuticals, Inc.
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