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That’s where the notion of the assist comes in.ĬIRM support led to the development of the JSP191 technology at Stanford. And while CIRM didn’t fund this clinical trial, it wouldn’t have happened without us paving the way for this research. None of the patients experienced serious side effects.Ĭlearly that’s really encouraging news. The patients were followed-up at 90 days and five of the six had no detectable levels of MDS/AML, and the sixth patient had reduced levels. In this Phase 1 study six patients, between the ages of 65 and 74, were given JSP191 – in combination with low-dose radiation and chemotherapy – prior to getting their transplant. In addition it also means the patients gets smaller doses of chemotherapy with lower levels of toxicity. JSP191 helps supplement the current treatment regimen by clearing all the remaining abnormal cells from the bone marrow and preventing relapse. Jasper has developed a therapy, JSP191, which is a monoclonal antibody, to address this issue. Even with a transplant there is often a high rate of relapse, because it’s hard for chemotherapy to kill all the cancer cells. The most effective way to treat, and even cure, MDS/AML is with a blood stem cell transplant, but this is often difficult for older patients, because it involves the use of toxic chemotherapy to destroy their existing bone marrow blood stem cells, to make room for the new, healthy ones. In about one in three patients, MDS can progress to acute myeloid leukemia (AML), a rapidly progressing cancer of the bone marrow cells. This is a group of disorders in which immature blood-forming cells in the bone marrow become abnormal and leads to low numbers of normal blood cells, especially red blood cells.
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They have just announced data from their Phase 1 clinical trial treating people with Myelodysplastic syndromes (MDS). The goal was scored by Jasper Therapeutics. Getting Orphan Drug Designation qualifies Immune-Onc for incentives including tax credits for clinical trials and the potential for seven years of market exclusivity if and when it is fully approved by the FDA. That’s defined as a therapy that’s intended for the treatment, prevention or diagnosis of a rare disease or condition, affecting less than 200,000 persons in the US. The FDA also granted IO-202 Orphan Drug Designation for treatment of AML in 2020. We look forward to working closely with the FDA to accelerate the clinical development of IO-202, which is currently being evaluated as a monotherapy and in combination with other agents in a Phase 1 dose escalation and expansion trial in patients with AML with monocytic differentiation and in chronic myelomonocytic leukemia (CMML).” “We are pleased that the FDA has granted IO-202 Fast Track designation in recognition of its potential to improve outcomes for people with relapsed or refractory AML.
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The antibody works by blocking a signal named LILRB4 which is associated with decreased rates of survival in AML patients. Paul Woodard and his team are treating patients with an antibody therapy called IO-202 that targets leukemic stem cells. Anywhere from 15-30 percent of CMML cases eventually progress into AML.ĭr. AML affects approximately 20,000 people in the United States each year and has a 5-year survival rate of about 25 percent. AML and CMML are both types of blood cancer. But for Immune-Onc Therapeutics the path to FDA approval may just have been shortened.īack in April of 2021 the California Institute for Regenerative Medicine (CIRM) approved investing $6 million in Immune-Onc to conduct a clinical trial for patients with acute myeloid leukemia (AML) and chronic myelomonocytic leukemia (CMML). People often complain about how long it can take to turn a scientific discovery into an approved therapy for patients.