Very informative conference. Hope it becomes a regular event for CLDX.
Lots of positive comments from the panelists- prospects look solid for rindo, 011 and 1127. I'll post more detailed notes tomorrow, but my expectation is for more upgrades, increased institutional buying and strong partnering interest from big pharma.
There was a lot of good information presented, and the panelists covered the slides thoroughly, so I will focus more on what I think were novel pieces of information (and my take in parentheses):
1. CDX-1127 (Weber)
- Weber stated that in preclinical studies, 1127 is more potent than ipi (Yervoy), and it also has a better safety profile. (1127 is an early stage drug, and ipi is a quirky drug, so it's too early to put too much stock in non-human data).
- I was struck by the sheer number of indications where 1127 could play a role, either as monotherapy in several cancers, or as an immunomodulator, in combination with chemo and immunotherapy. It will be interesting to see how the 1127 story unfolds.
2. CDX-011 (Vahdat)
- Vahdat mentioned that targeted cancer drugs are the future in BC therapy. She stated that GPNMB is a valid target in BC, and that in addition to E, P and Her2, breast cancer pts will be routinely tested for GPNMB expression. (In the Q&A there was a question on a diagnostic for GPNMB, and Davis stated that one will be available).
- The threshold for a successful outcome for the 011 PIIb trial is a lot less stringent than we have discussed on this MB; she said that as long as 011 shows the same efficacy as the investigator's choice arm, 011 is moving to the next stage. (I think this is influenced by the fact that 011 is targeted, and also has a mild AE profile. If 011 shows a robust effect, with statistically significant differences, eg in triple negative disease, then an NDA is possible for that indication. If 011 goes on to a PIII, either in GPNMB pts as a whole, or in particular subgroups, then it will likely be partnered).
- She mentioned that secondary aspects of the trial, such as stable disease and rate of tumor shrinkage will also be important. (011 has shown robust efficacy for both of these endpoints.)
3. Rindo (Sampson)
- The PediACT trial in pediatric pontine glioma pts at Stanford could lead to early approval for Rindo because there is a severe unmet need for this indication (this was a surprise because this is an early stage trial- however, there may be sufficient evidence from all the other rindo trials re safety, and there is a critical need for an effective drug in this indication)
- Sampson described the case study of a patient who had recurrent glioblastoma, was given rindo, and the imaging showed the tumor totally disappear- very convincing (this would increase the patient population for rindo significantly).
- Results from the Avastin + Rindo trial could lead to early approval (the sooner, the better...some pts who were expected to live 1 year on SOC are alive and well after >7 years on rindo)
Congrats to CLDX for organizing and putting on this conference- it really brought into focus the great science and oncology pipeline at CLDX, and the compelling investment prospects for this biotech.
Great presentations. Two things that jumped out at me:
-Confirmation of DDD trial 2H of 2012 with CDX-1135. This would be a very small indication that Celldex could keep in house. It has a great safety profile from past trials (I counted close to 1,000 participants in past TP10 trials without serious AE.) So this drug, if it ultimately proves successful, could generate sales in the 10's of millions but still be 100% owned by Celldex with a very small sales force (similar to what they want to do with CDX-110.)
-Absolutely zero mention of CDX-1401 under 2012 Anticipated Milestones (slide 112) even though the final collection data points were moved up to February 2012. So either this drug was a flop and they're downplaying or they're in serious partnership discussions and can't mention for obvious reasons. I believe and hope that it's the latter. I can't think of too many other reasons they'd go dark on this one.
Agree. CDX-1135(sCR1,TP10) has a very good safety profile, and is also an effective complement inhibitor at both C3 and C5. The development path that they have chosen shows that they thought about the best way forward. One of 2 complement inhibitor currently on the market, Soliris, has done very well in an ultra-orphan indication.
CDX-1401 has a lot of potential and I believe CLDX will continue its development.
Look forward to your analysis and opinion.
This has got to be one of the best buys in biotech:
1) maturing pipeline with outstanding clinical trial results, 100% owned by CLDX
2) company is at the vanguard of cancer immunotherapy, the next wave of cancer treatment
3) low number of shares outstanding
4) extremely large number of shorts that will have to cover
5) increasing institutional interest
6) ripe for partnership on highly favorable terms
7) ridiculously undervalued market capitalization
Put numbers 1-7 together, and what have you got? A recipe for a rapid increase in share price!