On April 12, 2022 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company) a leader in the development of targeted radiotherapies for patients with unmet needs, and Immedica Pharma AB ("Immedica") reported entering 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 (Press release, Immedica Pharma, APR 12, 2022, View Source [SID1234612057]). 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).
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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 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.
Shadow Lake Group (SLG) served as the advisor to Immedica.
About Iomab-B
Iomab-B (I-131 apamistamab), via the monoclonal antibody apamistamab, targets CD45, an antigen widely expressed on leukemia and lymphoma cancer cells, immune cells and bone marrow stem cells. Apamistamab is linked to the radioisotope iodine-131 (I-131) and once attached to its target cells emits energy that travels about 100 cell lengths, destroying a patient’s cancer cells and ablating their bone marrow. By carrying iodine-131 directly to the bone marrow in a targeted manner, Iomab-B may avoid the side effects of non-targeted chemotherapy and external radiation on most healthy tissues while effectively killing the patient’s cancer (induction) and marrow cells (myeloablation) including those in bone marrow niches due to the "crossfire" effect enabled by the I-131 radioisotope.
Iomab-B was licensed from the Fred Hutchinson Cancer Research Center where it was studied in nearly 300 patients, in multiple clinical trials in 6 blood cancer indications. Iomab-B is being studied in the pivotal Phase 3 SIERRA (Study of Iomab-B in Relapsed or Refractory AML) trial, a 150-patient, randomized controlled clinical trial in patients with active, relapsed or refractory Acute Myeloid Leukemia (AML) who are age 55 and above.. If granted approval, Iomab-B is intended to prepare and condition patients for a bone marrow transplant, also referred to as a hematopoietic stem cell transplant, in a potentially more efficacious manner and with a more beneficial safety profile than the non-targeted intensive chemotherapy conditioning that is the current standard of care in bone marrow transplant conditioning. A bone marrow transplant is often considered the only potential cure for patients with certain blood-borne cancers and blood disorders. Iomab-B has been granted Orphan Drug Designation from the U.S. FDA and the European Medicines Agency (EMA). Iomab-B is covered by patents having terms extending to at least 2036/2037 in Europe and the US. In addition, Actinium received positive Scientific Advice from the Committee for Medicinal Products for Human Use (CHMP) of the EMA indicating that the Phase 3 SIERRA trial design, primary endpoint and planned statistical analysis are acceptable as the basis for a Marketing Authorization Application.
About the SIERRA Phase 3 Trial
The SIERRA trial is a 150-patient, randomized clinical trial, studying Iomab-B compared to physician’s choice of salvage therapy in patients with active, relapsed or refractory acute myeloid leukemia (r/r AML) age 55 and above. The SIERRA trial completed enrollment in the third quarter of 2021 with the last patient receiving a BMT in the fourth quarter of 2021. Topline data from the SIERRA trial is expected in the third quarter of 2022. In SIERRA, patients receiving Iomab-B, those achieving a remission after salvage therapy or those patients not achieving remission after salvage therapy that crossed over to receive Iomab-B were offered a BMT, which is the only treatment option with curative potential for patients with active r/r AML. The SIERRA trial is the only randomized Phase 3 trial to offer BMT to this patient population. The control arm of SIERRA included over 20 single agents or combination treatment options based on physician’s choice, including salvage chemotherapy and recently approved targeted agents including Bcl-2 inhibitor (Venetoclax), FLT3 inhibitors and IDH 1/2 inhibitors as there is no standard of care for this patient population. The SIERRA trial enrolled patients at 24 leading transplant centers in the United States and Canada.