Notes on CLDX presentation at Leering 2/14/13 (From YMB)
(Any comments appreciated.)
Some of the highlights:
1. Rindo PIII:
- accrual will be complete at YE'14
- 50% of events determination by IDMB in 3Q'14
- 75% of events in 4Q'14
- 100% of events in 1Q'15
- Keler confirmed that Rindo produces a potent immune response against EGFRvIII
2. REACT PII with Rindo+AVastin combo:
- expect results this year
- if positive results obtained, CLDX will discuss with FDA registrational trial by either extending pt numbers in that are, or initiating new trial
3. CDX-011 Accelerated Approval trial
- trial will be randomized in pts with high GPNMB/TNBC
- surrogate marker, likely PFS, will be used as end-point
- pt accrual will be completed in 12-15 months ( add about 6 months for follow-up, plus a few months for the FDA decision: approval sometime in mid to 2H'15)
4. CDX1127 PI two arm study:
- solid tumor arm: dose escalation completed, trial will be expanded into 2 indications
- lymphoid tumor: dose escalation ongoing
- results will be reported YE'13
- Keler indicated that 1127 safety profile looks very good; efficacy in preclinical trials similar to PD1 agent developed by K. at Medarex
5. CDX1135 complement inhibitor:
- inhibits all complement activation pathways and this differentiates it from Soliris which is limited to C5 complement pathway
My own 2 cents worth on 1135 in DDD:
- since this is an ultra-orphan indication, initial trial will be in less than a dozen pts
- if initial trial positive, 1135 will go into an Accelerated Approval trial (this is similar to the development pathway for Soliris)
Looks to me like CLDX is firing on all cylinders. Although they didn't tip their hands, my impression based on what Marucci and Keler said- or sometimes implied- was that the trials are going well and we can look forward to a steady stream of positive news. This personal impression is consistent with market sentiment, which has been unwaveringly positive since the EMERGE trial results were reported in Dec '12.
Bladerunner
