Juno Therapeutics, Inc. announced that it has voluntarily placed a phase II trial of its lead pipeline candidate, JCAR015 on hold after two patients suffered cerebral edema earlier in the week. One of the patients died and the other has very low chances of recovery.
The ROCKET trial was evaluating patients with relapsed or refractory B cell acute lymphoblastic leukemia (ALL).
Share price of the company plunged more than 24% following the disappointing news.
The company has notified FDA regarding the hold. Juno is working with the agency and the Data and Safety Monitoring Board to decide the next course of action.
Earlier in July, the FDA placed a clinical hold on the same study as two patients had died within a week due to severe neurotoxicity after the addition of fludarabine to the pre-conditioning regimen. The FDA had asked the company to submit, as a complete response to the clinical hold, a revised patient informed consent form, a revised investigator brochure, a revised study protocol, and a copy of the presentation made to the agency.
Later in the month, the FDA lifted the clinical hold on the study and it continued under a revised protocol using JCAR015 with cyclophosphamide pre-conditioning alone.
Juno was earlier looking to gain accelerated FDA approval of JCAR015 in 2017 but timelines were pushed back with the announcement of the clinical hold in July to the first half of 2018. However, now that the study is again on hold, the regulatory filing timeline could be shifted further.
Per the company’s press release, its studies and plans for its other CD19-directed CAR T cell pipeline candidates, with JCAR017, have not been affected.
Juno is looking to revolutionize cancer treatments by engaging the body’s immune system to treat cancer. It is developing cell-based cancer immunotherapies based on CAR and high-affinity TCR technologies – the goal is to activate a patient’s own T-cells to recognize and kill cancer cells. JCAR015 is Juno’s one of the most advanced pipeline candidates, which use CAR T-cell technology to target CD19. With the key candidate in trouble again this year, the stock price might suffer further. Share price has decreased 48.69% year to date for the company.
Juno is a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the healthcare sector include Heska Corporation (HSKA - Free Report) , Arbutus Biopharma Corporation (ABUS - Free Report) and Anika Therapeutics Inc. (ANIK - Free Report) . Heska and Anika sport a Zacks Rank #1 (Strong Buy) while Arbutus carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
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