Altor currently has three products in clinical development. Our lead product ALT-801, a T-cell receptor-targeted immunotherapeutic developed from the STAR™ platform technology for cancer, concluded a Phase I/IIa clinical trial in patients with metastatic malignancies in 2009 (Fishman, et al. 2011 Clin Cancer Res 17:7765 - Pubmed Link) and a Phase II trial for ALT-801 in combination with cisplatin for patients with metastatic melanoma in 2Q-2012. A second Phase II trial for ALT-801 in combination with gemcitabine and cisplatin is enrolling patients with locally advanced or metastatic urothelial carcinomas of the bladder, ureter, urethra and renal pelvis. A third Phase II trial is underway for ALT-801 in combination with gemcitabine for patients with non-muscle invasive bladder cancer who have failed BCG treatment. A fourth Phase II trial for ALT-801 is also enrolling patients with refractory multiple myeloma. ALT-801 is also being evaluated in a trial in combination with donor lymphocyte infusion in patients with acute myeloid leukemia. (More on ALT-801 - PDF...)
Altor’s second product ALT-836, a monoclonal antibody-based tissue factor antagonist, completed a second 90-patient, multi-center, randomized, placebo-controlled, Phase II trial for treatment of patients with Acute Respiratory Distress Syndrome and Acute Lung Injury, life-threatening, systemic inflammatory diseases. A dose-escalating Phase I/IIa clinical trial for ALT-836 in combination with gemcitabine has been completed for treatment of patients with solid tumors who failed the standard-of-care treatments. (More on ALT-836 - PDF...)
The newest product to enter clinical development is Altor’s ALT-803, a novel IL-15 superagonist protein complex, initiating first-in-human Phase I clinical trials for treatment of metastatic melanoma, refractory multiple myeloma and relapse of hematologic malignancy after allogeneic stem cell transplantation. The primary objective of these trials is to evaluate the safety and biological effects of ALT-803 in a dose escalating design using a weekly dosing regimen. Patient enrollment is anticipated in the late third quarter of 2013. Furthermore, Altor is actively engaged in multiple promising research collaborations with leading U.S. institutes and universities to explore the effects of ALT-803 against various diseases including cancer and viral indications. (More on ALT-803 - PDF...)
Numerous product candidates that have completed proof-of-principle studies in animal models are in pre-clinical development for treatment of cancer, infection, inflammatory and autoimmune diseases.