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GERMANTOWN, Md. , Dec. 21, 2018 /PRNewswire/ -- Precigen, Inc., a wholly-owned subsidiary of Intrexon Corporation (NASDAQ: XON ), and a biopharmaceutical company specializing in the development of innovative gene and cellular therapies to improve the lives of patients, today announced that the US Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for PRGN-3006, a first-in-class investigational therapy using Precigen's UltraCAR-T™ platform. PRGN-3006 UltraCAR-T is an autologous chimeric antigen receptor T-cell (CAR-T) therapy for treatment of patients with relapsed or refractory acute myeloid leukemia (AML) and higher risk myelodysplastic syndrome (MDS). PRGN-3006 utilizes Precigen's transformative UltraCAR-T platform, which reduces manufacturing time to less than two days following non-viral gene transfer.
Precigen's UltraCAR-T platform has the potential to disrupt the CAR-T treatment landscape by increasing patient access through shortening manufacturing time from weeks to days, decreasing manufacturing-related costs, and improving outcomes using advanced approaches for precise tumor targeting and control of the immune system. The platform brings several key advancements:
"With our first-in-human UltraCAR-T IND clearance from the FDA in about a year since our founding we have reached another critical milestone for patients and Precigen," said Helen Sabzevari , PhD, President of Precigen, "We are committed to developing the PRGN-3006 UltraCAR-T as quickly and as efficiently as possible with the goal of providing an effective treatment option for these patients with high unmet need."
Precigen will host a conference call on the morning of December 26 , 2018. Details to follow.
About Acute Myeloid Leukemia (AML) In 2018, nearly 20,000 new cases of AML will be diagnosed in the US, mostly in adults 1 . AML is among the most common types of leukemia in adults. AML is uncommon before the age of 45 and the average age of diagnosis is about 68 1 . The prognosis for patients with AML is poor with an average 5‐year survival rate of approximately 25 percent overall, and less than a 5 percent 5‐year survival rate for patients older than 65 2 . Amongst elderly AML patients (≥ 65 years of age) median survival is short, ranging from 3.5 months for patients 65 to 74 years of age to 1.4 months for patients ≥ 85 years of age 2 .
About Myelodysplastic Syndrome (MDS) MDS are diseases of the bone marrow generally found in adults in their 70s 3 . Incidence in the US is not known for sure, but estimates range from 10,000 each year and higher 3 . Using International Prognostic Scoring System (IPSS-R), median survival for MDS patients can vary from less than one year for the "very high" IPSS-R risk group to more than eight years for the "very low" IPSS-R group 3 .
1 American Cancer Society. Key Statistics for Acute Myeloid Leukemia (AML). Accessed December 2018 via ACS website . 2 Thein, M., et al., Outcome of older patients with acute myeloid leukemia: an analysis of SEER data over 3 decades. Cancer, 2013. 119(15): p.2720-7. 3 American Cancer Society. Key Statistics for Myelodysplastic Syndromes. Accessed December 2018 via ACS website .
Precigen Media Contact: Donelle M. Gregory [email protected]
SOURCE Precigen, Inc.