IMV Inc. (formerly ImmunoVaccine) reported updated results from DeCidE1, an ongoing study of its lead candidate, DPX-Survivac, in patients with advanced recurrent ovarian cancer. The new results show that DPX-Survivac immunotherapy is active and well-tolerated in patients with advanced ovarian cancer. This update marks DPX-Survivac as the first in-vivo T cell therapy to demonstrate clinical activity in hard-to-treat solid tumors.
DeCidE1 is a phase 1/2 multicenter, randomized, open-label study assessing DPX-Survivac with intermittent low dose cyclophosphamide (CPA). The phase 2 arm being reported on enrolled 22 patients with recurrent, advanced platinum-sensitive and –resistant ovarian cancer. Patients received 2 subcutaneous injections of DPX-Survivac 3 weeks apart and every eight weeks thereafter, and intermittent low dose CPA one week on and one week off for up to 1 year. Paired tumor biopsies were performed prior to treatment and on treatment. Primary endpoints of this study are overall response rate, disease control rate and safety.
At the time of reporting, 19 patients were evaluable for efficacy with six patients (31%) still receiving treatment. Key preliminary findings include the following:
- 15 patients (79%) achieved disease control, defined as Stable Disease (SD) or Partial Response (PR) on target lesions
- Tumor shrinkage of target lesions was observed in 10 patients (53%)
- Durable clinical benefits lasting ≥6 months were observed in seven patients (37%) so far:
- Four of these seven patients (21% of evaluable patients) achieved PR with tumor regression >30% on target lesions
- Three stable diseases were ongoing for > 6 months (range 7-9) including -29.5% and -12% tumor regressions
- Median duration not reached yet, with five of these seven (71%) patients still on treatment at > 6 months (range 7-10)
IMV plans to request a Type B meeting with the FDA to discuss these results, and to potentially reach an agreement on the design of a Phase 2b study with potential to support registration under accelerated approval in this indication.
DPX-Survivac has received Fast Track designation from the U.S. FDA as maintenance therapy in advanced ovarian cancer, as well as orphan drug designation status from the U.S. FDA and the European Medicines Agency (EMA) in the ovarian cancer indication.
DPX-Survivac is the lead candidate in IMV’s new class of targeted immunotherapies designed to elicit antigen-specific functional, robust and sustained de novo T cell response. IMV believes this mechanism of action (MOA) is key to generating durable solid tumor regressions. DPX-Survivac consists of five unique HLA-restricted survivin peptides formulated in IMV’s proprietary DPX drug delivery platform and known to induce a cytotoxic CD8+ T cell response against survivin expressing cancer cells.
Survivin, recognized by the National Cancer Institute (NCI) as a promising tumor-associated antigen, is broadly over-expressed in most cancer types and plays an essential role in antagonizing cell death, supporting tumor-associated angiogenesis and promoting resistance to chemotherapies. IMV has identified over 20 cancer indications in which survivin can be targeted by DPX-Survivac.