Immunotherapy Start-Up Juno Therapeutics: FDA Orphan Drug Designation For Acute Lymphoblastic Leukemia
Juno Therapeutics, a Seattle-based clinical-stage start-up biotechnology company, is developing novel cellular immunotherapies to treat cancer based on “two distinct and complementary platforms”:
• Chimeric Antigen Receptors (CARs)
• T Cell Receptors (TCRs).
CAR T-cell therapy, “re-engineers” or “reprograms” a patient’s immune system to recognize and attack cancer cells – immunotherapy. Immunotherapy is well represented and talked about at this year’s American Society of Clinical Oncology (ASCO).
In July 2014, the FDA gives Novartis’ CAR T-cell therapy a Breakthrough Therapy Designation (BTD) for its personalized cell therapy CTL019, for relapsed/refractory Acute Lymphoblastic Leukemia (r/r ALL). CTL019 also receives FDA Orphan Drug Designation (ODD) in January 2014. Novartis is one of Juno Therapeutics’ competitors in the CAR T-cell therapy space. Novartis’ CTL019:
“ … uses CAR technology to reprogram a patient’s own T cells to “hunt” cancer cells that express specific proteins, called CD19. After they have been reprogrammed, the T cells (now called CTL019) are re-introduced into the patient’s blood; they proliferate and bind to the targeted CD19+ cancer cells and destroy them.”
Since the creation of Juno Therapeutics a year ago, the start-up company raises more than $300 million. Juno Therapeutics is created in December 2013 with an initial investment of $120 million in Series A investments. Three US cancer research centers team up to launch Juno Therapeutics :
• Fred Hutchinson Cancer Research Center (Seattle)
• Memorial Sloan-Kettering Cancer Center (New York)
2014 Juno Therapeutics News
• April 2014, completion of $176 million Series A round
• August 2014, close of $134 million Series B round
• September 2014, named one of FierceBiotech’s 2014 Fierce 15.
FDA Orphan Drug Product Database Record For Juno Therapeutics
On November 13th, the FDA grants Juno Therapeutics ODD for its product candidate JCAR015, a chimeric antigen receptor product, for ALL:
|Generic Name:||Autologous CD3+ T cells transduced with retroviral vector containing a chimeric antigen receptor directed against CD19 (Autologous CD3+ T cells containing CD19 chimeric antigen receptor)|
|Orphan Designation:||Acute Lymphoblastic Leukemia (ALL)|
|Orphan Designation Status:||Designated|
|FDA Orphan Approval Status:||Not FDA Approved for Orphan Indication|
|Sponsor:||Juno Therapeutics, Inc. 307 Westlake Ave. N., St. 300 Seattle, WA|
Juno Therapeutics Pipeline.
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