1. This was initial testing for extending CDX-011 treatment to GPNMB+ pediatric cancers.
2. There was a 50% complete response rate in osteosarcoma cancer model.
3. Response strongly correlated with GPNMB+ expression.
These results are consisted with, and validate in a pediatric cancer setting, the efficacy results demonstrated by CDX-011 in adult breast cancer.
Initial testing (stage 1) of glembatumumab vedotin (CDX-011) by the pediatric preclinical testing program.
Kolb EA1, Gorlick R, Billups CA, Hawthorne T, Kurmasheva RT, Houghton PJ, Smith MA.
1A.I. duPont Hospital for Children, Wilmington, Delaware
2The Children's Hospital at Montefiore, Bronx, New York
3St. Jude Children's Research Hospital, Memphis, Tennessee
4Celldex Therapeutics, Needham, Massachusetts
5Nationwide Children's Hospital, Columbus, Ohio
6Cancer Therapy Evaluation Program, NCI, Bethesda, Maryland
Glembatumumab vedotin is an antibody-auristatin conjugate that targets cells expressing the transmembrane glycoprotein NMB (GPNMB, also known as osteoactivin). It has entered clinical evaluation for adult cancers that express GPNMB, including melanoma and breast cancer.
Glembatumumab vedotin was administered intravenously at a dose of 2.5 mg/kg using a weekly × 3 schedule, and its antitumor activity was evaluated against selected Pediatric Preclinical Testing Program (PPTP) solid tumor xenografts using standard PPTP response metrics.
Sentiment: Strong Buy
For those who are interested;
"Osteosarcoma is not a common cancer. Each year, about 800 new cases of osteosarcoma are diagnosed in the United States. About 400 of these are in children and teens.
Most osteosarcomas occur in children and young adults between the ages of 10 and 30. Teens are the most commonly affected age group, but osteosarcoma can occur in people of any age. About 10% of all osteosarcomas occur in people over the age of 60.
Osteosarcomas account for about 3% of childhood cancers, but they make up a much smaller percentage of adult cancers."
longvrts2, With a 50% complete response, how fast can we expect to go to market?
You shorts out there had better pay attention to what is actually happing at Celldex.
800 new cases annually ? it doesn't sound right to me.. bio companies complaining about high cost of developing new drugs and this drug is targeting 800 new patients ? how long would it take to get their ROI, or CLDX just focusing on building a pipeline of quantity rather quality of drugs...
the economic business model telling me that treating the largest pool of cancer patients makes more sense than going after the rare of the rarest cancers.. resource is limited and they should focusing on the largest ROI projects instead of targeting cancer treatment for 800 patients..
They are making good progress with the accelerated approval PIII in TNBC, so I think they will push through for approval in TNBC first, and then expand to other indications. As I mentioned in the initial post, it is reassuring- and it bodes well for the TNBC trial- that they are seeing strong a correlation between GPNMB expression and response to 011 in osteosarcoma.
Sentiment: Strong Buy
rays this could be one of those ORPHAN LIKE INDICATIONS that gets 011 on the market faster while we cont to pursue other indications that will require further validation like BC!
EXEL did this w/ Cabo and MTT although Prostate Ca is the main driver!
if Im not mistaken was not Ed Kennedy, Teds son.. DXd w/osteosarcoma in 1973 and lost a leg..his dad had GBM too but may have been too old to enter our trials back than!
011 could be a great OSTEOSARCOMA treatment where GPNMB is implicated and save limbs!
Fraz, I am a chicken sheeeet. Last week, I told Rays that cldx will head to 20s, but I didn't buy. Now it is too late to catch another big move. This stock needs to breath for a while. I guess Friday it may drop back to $15, then it will be my turn to load more. Let see if I am correct.
Thanks. This brings to mind, whatever happen to the CDX-110 trial specifically targeted for the pediatric population I believe at Cincinnati Children's hospital? I believe that was discontinued a few years ago. But why?
What is so positive if we continue to see GPNMB show response in those with high expressions this could lead to shorter trials and quicker approval. Essentially we are identifying a paradigm shift.