- BioSante Pharma, along with Aduro Biotech, a private company that has licensed certain rights to BPAX's cancer vaccine platform, presented at a Cancer Immunotherapy conference on 10/6
- Find more info and links on BPAX research page and Upcoming Events page.
- My notes from both companies are below-
- phase 2 cancer vaccine trials ongoing: pancreatic, AML/CML, multiple myeloma, breast, prostate
- phase 1: colorectal, melanoma (just begun, today was first announcement)
- based on cell genesys $CEGE "GVAX" platform- allogenic whole cell - goal was to maxmimize number of antigens [in contrast to approach like Dendreon $DNDN with patient-specific immunotherapy targeting one particular antigen]
- Now, 7-9 years after CEGE phase 3 VITAL1/2 trials began, we can tell they were destined to fail
- vital 1: pitted slow acting GVAX head to head vs fast acting chemotherapy
- vital 2: survival curves crossed - more deaths on GVAX arm at first but later showed benefit
- vital 1: effect depended on prognosis of patient-- halabi predicted survival <18 m, little benefit. dramamtic benefit >18m
- At the time, taxotere was just recentlyapproved, FDA demanded it be the control. Now can do placebo-controlled trials
- We now also know that appropriate combinations are critical
- new open label phase 2 prostate combo with immune checkpoint regulatory molecule, and treating at earlier stage. clinical hold on the program has been lifted, trial will start at Johns Hopkins in 2011
- There have been no controlled studies yet [hence, despite certain message board posters pleadings, there will be no substantive monetization of the platform anytime soon]
- pancreatic cancer-mutliple ongoing phase 2...trying to determine what is the best combo
- commercial strategy - apply for orphan drug desigation - get 7 years exclusivity regardless of patent estate
- orphan drug grants - may be able to get some funding next year
- one pancreatic cancer trial started already in 2011, another will start later in 2011
- Aduro (see more below) - give GVAX first, then boost with their platform. trial has initiated, targeting 90 patients
- Hussman Foundation - $10.9m commited phase 1/2 funding, they would then plan to out-license to larger company, which would trigger sublicense fees to BPAX. trial has initiated targeting 19 pts
- $19m series B to fund phase 2 trials closed 4/2011
- Have received $20m nondilutive government and other grant funding
- platform: listeria based immunotherapies
- Drew Pardoll is board member and JHU is a lead clinical site for phase 2
- "live attenuated double deleted" (LADD) platform...limit infection to phagocytic cells, and prevent spread to neighboring cells
- CRS-207 is lead program for pancreatic cancer- target mesothelin antigen (also found in ovarian, NSCLC, very low expression in normal tissue)
- 10^10 dose showed DLT of hypertension, so we will proceed with 10^9 dose
- phase 1: 17 pts who received up to 4 doses (pancretic, mesothelioma, ovarian, nsclc)
- we detected no shedding of organism into environment - important to FDA
- 6/17 had survival >15 months, 2 alive over 36 months after 1st dose
- 3/7 pancreatic patients had previously been treated with GVAX and these showed 17m vs 5m OS, no major difference in baseline criteria
- 2nd line salvage treatment trial started 2 weeks ago- GVAX 2 doses plus 4 doses boosts with CRS-207 vs GVAX alone 6 doses. 2:1 randomized to combo, OS is endpoint