Clinical-stage biopharmaceutical company Actinium Pharmaceuticals Inc. (ATNM:NYSE.MKT), which is focused on developing targeted radiotherapies for patients with unmet needs, and Immedica Pharma AB, today announced that the two companies have "entered into 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."
"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."
—Anders Edvell, CEO, Immedica Pharma
The report indicated that Iomab-B is now being evaluated in the Phase 3 SIERRA study as a treatment for relapsed or refractory acute myeloid leukemia (AML) and said it expects to receive topline data from the trial in Q3/22. Actinium Pharmaceuticals pointed out that BMT is the only potentially curative treatment option for AML patients.
Actinium Pharmaceuticals' Chairman and CEO Sandesh Seth stated, "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."
Immedica Pharma's CEO Anders Edvell remarked, "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."
The agreement terms between the two firms stipulate that Immedica will pay Actinium $35 million upfront. In addition, the license and supply agreement calls for Actinium to receive additional payments totaling $417 million if certain regulatory and commercial milestones are achieved. If all goes as planned, Actinium will also be eligible to receive product royalties in the mid-twenty percent range on net sales.
In return for its investment and royalty payments, Immedica will be given commercialization rights for Europe and Middle East and North Africa (MENA) countries. The firms indicated that Actinium will maintain all rights pertaining to Iomab-B in the U.S. and globally except as noted above and will be in charge of manufacturing of Iomab-B and overseeing specific clinical and regulatory activities.
The company stated that, "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." The firm explained that "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."
The report noted that "lomab-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." The firm advised that Iomab-B has been issued Orphan Drug status from both the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).
Actinium mentioned that since the delivery mechanism carries iodine-131 directly to the bone marrow in a targeted action, it is believed that Iomab-B is capable of reducing or avoiding side effects and damage to healthy tissues incurred from traditional chemotherapy and external radiation treatments while at the same time effectively eliminating cancer cells.
The company advised that Iomab-B is presently being evaluated in a pivotal Phase 3 trial in relapsed or refractory acute myeloid leukemia (AML). The randomized, controlled SIERRA study includes 150 patients ages 55 and over. The primary objective of the study is "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."
Actinium is a clinical-stage biopharmaceutical firm based in New York City that is focused on antibody radiation-conjugates (ARCs), which combine the targeting ability of antibodies with the cell-killing ability of radiation. In its efforts to treat patients with needs not addressed by traditional cancer intervention therapies, the firm employs specific targeted radiotherapies that direct cancer radiation delivery with cellular level precision.
Immedica AB is a niche pharma group headquartered in Stockholm, Sweden which has solid experience in commercializing specialty care products throughout Europe and the Middle East. The company's management team was said to have an outstanding track record in international marketing of niche pharma products and is able to deliver optimal access of medicines to patients and maneuver through key distribution areas such as regulatory compliance, pharmacovigilance, quality assurance, product distribution, pricing and reimbursement.
Actinium Pharmaceuticals began the day with a market cap of around $117.1 million with approximately 22.14 million shares outstanding and a short interest of about 2.5%. ATNM shares opened 24% higher today at $6.59 (+$1.30, +24.57%) over yesterday's $5.29 closing price. The stock has traded today between $5.77 and $7.49 per share and is currently trading at $6.58 (+$1.29, +24.39%).
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