Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) and Immedica Pharma AB (“Immedica”)have entered a license and supply agreement for Iomab-B, an Antibody Radiation Conjugate comprised of apamistamab, a CD45 targeting antibody, and the radioisotope iodine-131 that is being developed for targeted conditioning to facilitate bone marrow transplant (BMT) and other cell and gene therapies.
A pivotal Phase 3 trial, Study of Iomab-B versus Conventional Care in Elderly, Relapsed or Refractory Acute Myeloid Leukemia (SIERRA), of Iomab-B completed patient enrollment in the third quarter of 2021 with topline data expected in the third quarter of 2022. BMT is the only potentially curative treatment option for patients with active, relapsed or refractory acute myeloid leukemia (AML), Actinium said.
Sandesh Seth, Actinium’s Chairman and CEO, said, “Immedica has established a strong team and impressive capabilities to commercialize specialty products in Europe, the Middle East and North Africa. Europe and the MENA countries are key commercial markets for Iomab-B, with a large addressable AML patient population and access to a strong BMT community that is highly concentrated with select leading centers performing a majority of the BMT procedures. Despite multiple drug approvals for patients with AML in recent years, curative outcomes and access to potentially curative BMT are severely lacking, particularly for patients with active, relapsed or refractory disease. We are excited to partner with Immedica to work to bring Iomab-B to patients with AML in Europe, the Middle East and North Africa who may benefit from a potentially curative transplant.”
“We are excited about the opportunity to make Iomab-B accessible for patients in Europe, the Middle East and North Africa. It is clear there is a large medical need for these AML patients, which we believe will be addressed by this new innovative treatment. We also look forward to deepening our collaboration with Actinium to bring the best possible support to AML treatment centers and health care professionals in Europe, the Middle East and North Africa”, says Anders Edvell, CEO at Immedica.
Under the terms of the agreement, Actinium said that it will receive an upfront payment of $35 million and will be eligible to receive an additional $417 million in regulatory and commercial milestones as well as royalties in the mid-twenty percent range on net sales. Immedica receives commercialization rights in Europe and MENA countries. Actinium retains all rights related to Iomab-B in the United States and the rest of the world, and will be responsible for certain clinical and regulatory activities and the manufacturing of Iomab-B.