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Re: declaes post# 679

Wednesday, 10/18/2017 2:20:12 AM

Wednesday, October 18, 2017 2:20:12 AM

Post# of 1990
Rocapuldencel-T mRCC • Ongoing ADAPT trial; enrollment completed in July 2015; IDMC recommended study discontinuation; plan to continue until at least the pre-specified number of 290 events occurs, anticipated in the first half of 2018; plan to submit to the FDA a protocol amendment to increase the pre-specified number of events beyond 290 events; data analysis and discussions with the FDA ongoing

• Planned Phase 2 clinical trial, in combination with a checkpoint inhibitor, expected to open for enrollment in the second half of 2017 provided that financing is obtained

Early stage RCC (neoadjuvant) • Ongoing investigator-initiated Phase 2 clinical trial; initial data expected in 2017

Advanced solid tumors • Planned investigator-initiated Phase 2 clinical trial in muscle invasive bladder cancer, expected to open for enrollment in the second half of 2017 provided that financing is obtained

AGS-004 HIV • Ongoing second stage of investigator-initiated clinical trial in combination with vorinostat for HIV eradication

• Decision to open planned investigator-initiated Phase 2 clinical trial for long-term viral control in pediatric patients expected in 2017

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