On May 10, 2017 Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, reported that the first patient has been enrolled in the Phase 1 clinical trial of LOXO-292, an investigational, highly potent and selective RET inhibitor (Press release, Loxo Oncology, MAY 10, 2017, View Source [SID1234518973]). RET gene alterations are thought to play a key role in the development of certain cases of lung, thyroid, colon and other cancers.

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"We are excited to put a second, purpose-built precision medicine into clinical development," said Josh Bilenker, M.D., chief executive officer of Loxo Oncology. "We believe that patients with RET-altered lung, thyroid and other cancers have highly actionable genetic events that are not well addressed by existing therapies. LOXO-292 was designed to deliver potent RET inhibition, while avoiding off-target activities that can compromise dose intensity and contribute to toxicity. If our hypothesis is correct, LOXO-292 could have meaningful single agent anti-tumor activity in RET-altered cancers, and the ability to address key resistance mutations that could otherwise limit the clinical potential of RET inhibition in affected patients. In advancing our larotrectinib program, we have worked closely and creatively with patients and their doctors to deliver on the promise of precision medicine. We hope that LOXO-292 opens a new and exciting chapter in this story."

This first-in-human, global, multi-center Phase 1 trial will evaluate LOXO-292 as a single agent in patients with advanced solid tumors. The primary objective of the trial is to determine the maximum tolerated dose or recommended dose for further study. Key secondary objectives include measures of safety, pharmacokinetics, and anti-tumor activity (i.e. Objective Response Rate and Duration of Response, as determined by RECIST v1.1). The trial includes a dose escalation phase and dose expansion phase. During the dose escalation phase, up to 30 patients with advanced solid tumors may be enrolled to inform the selection of a dose and schedule for the expansion phase. In the expansion phase, five cohorts are planned to allow for the characterization of preliminary activity of LOXO-292 in the following genetically-defined populations: 1) RET-fusion lung cancer patients with prior RET inhibitor experience; 2) RET-fusion lung cancer patients with no prior RET inhibitor experience; 3) RET-mutant medullary thyroid cancer patients with prior RET inhibitor experience; 4) RET-mutant medullary thyroid cancer patients with no prior RET inhibitor experience; and 5) other RET-altered solid tumors. Loxo Oncology anticipates that approximately 15 patients will be enrolled to each of the expansion cohorts.

About LOXO-292
LOXO-292 is a potent, oral and selective investigational new drug in clinical development for the treatment of patients with cancers that harbor abnormalities in the rearranged during transfection (RET) kinase. RET fusions have been identified in approximately 2% of non-small cell lung cancer, 10-20% of papillary thyroid cancer, and a subset of colon and other cancers. RET point mutations account for approximately 60% of medullary thyroid cancer. Both RET fusion and select RET mutated cancers are primarily dependent on this single activated kinase for their proliferation and survival. This dependency, often referred to as "oncogene addiction," renders such tumors highly susceptible to small molecule inhibitors targeting RET. LOXO-292 was designed to inhibit native RET signaling as well as anticipated acquired resistance mechanisms that could otherwise limit the activity of this therapeutic approach. LOXO-292 is currently being studied in a Phase 1 trial. Interested patients and physicians can contact the Loxo Oncology Physician and Patient RET Clinical Trial Hotline at 1-855-RET-4-292 or email [email protected].

On May 10, 2017 Actinium Pharmaceuticals, Inc. (NYSE MKT:ATNM) ("Actinium" or "the Company"), a biopharmaceutical Company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers, reported that the Company received clearance from Health Canada to initiate the pivotal Phase 3 SIERRA Trial of Iomab-B at Canadian based clinical trial sites (Press release, Actinium Pharmaceuticals, MAY 10, 2017, View Source [SID1234518969]). Iomab-B is Actinium’s lead asset that upon approval, is intended to prepare and condition patients for a bone marrow transplant (BMT), also referred to as a hematopoietic stem cell transplant (HSCT), which is often considered the only potential cure for patients with certain blood-borne cancers and blood disorders. The SIERRA trial is a 150-patient, randomized, multicenter pivotal study evaluating Iomab-B followed by an HSCT in patients with relapsed or refractory acute myeloid leukemia (AML) who are age 55 and above compared to physician’s choice of chemotherapy that patient’s in the control arm will receive.

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According to the Canadian Blood and Marrow Transplant Group (CBMTG), there are approximately 15 centers in Canada that perform blood and marrow transplants who participate in the CBMTG’s registry. In CBMTG’s 2015/2016 annual report, it reported that there were 7,693 allogeneic transplants performed in Canada including 2,417 for patients with AML.

Dr. Mark Berger, Chief Medical Officer of Actinium said, "The clearance to initiate the SIERRA trial in Canada is an exciting milestone for Iomab-B as it offers us the opportunity to make Iomab-B available to more patients in need. We are expecting to open 15-20 clinical trial sites in the SIERRA trial and we are excited to begin to have participation from sites in Canada. The promise of Iomab-B is that it will enable a bone marrow transplant and long term survival for these patients that have few options for treatment."

About Iomab-B

Iomab-B is Actinium’s lead product candidate that is currently being studied in a 150-patient, multicenter pivotal Phase 3 clinical trial in patients with relapsed or refractory acute myeloid leukemia who are age 55 and above. Upon approval, Iomab-B is intended to prepare and condition patients for a bone marrow transplant, also referred to as a hematopoietic stem cell transplant, which is often considered the only potential cure for patients with certain blood-borne cancers and blood disorders. Iomab-B targets cells that express CD45, a pan-leukocytic antigen widely expressed on white blood cells with the monoclonal antibody, BC8, labeled with the radioisotope, iodine-131. By carrying iodine-131 directly to the bone marrow in a targeted manner, Actinium believes Iomab-B will avoid the side effects of radiation on most healthy tissues while effectively killing the patient’s cancer and marrow cells. In a Phase 2 clinical study in 68 patients with advanced AML or high-risk myelodysplastic syndrome (MDS) age 50 and older, Iomab-B produced complete remissions in 100% of patients and patients experienced transplant engraftment at day 28. Iomab-B was developed at the Fred Hutchinson Cancer Research Center where it has been studied in almost 300 patients in a number of blood cancer indications, including acute myeloid leukemia (AML), chronic myeloid leukemia (CML), acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), Hodgkin’s disease (HD), Non-Hodgkin lymphomas (NHL) and multiple myeloma (MM). Iomab-B has been granted Orphan Drug Designation for relapsed or refractory AML in patients 55 and above by the U.S. Food and Drug Administration and the European Medicines Agency.