Biotech company Immunovaccine, Inc. (IMV:CA)(IMMVF) said Wednesday that its ongoing Phase 1b clinical study of DPX-Survivac, in combination with epacadostat and low-dose cyclophosphamide to treat recurrent ovarian cancer produced positive interim data.
Specifically, analysis shows that of the first four evaluable patients in the trial, none have shown any serious adverse events from the triple combination, and the patient involved longest on the trial is starting to show a tumor shrinkage at day 140, which, according to the company, is at the beginning of the typical window of efficacy for immunotherapy.
Furthermore, the company says it has found evidence of T-cell infiltration following treatment, which is “the holy grail of combination immunotherapy.”
“All patients enrolled in the trial have active and progressing tumors and the fact that the treatment can have an impact in 3 out of 4 patients this early in the treatment is very promising,” Fred Ors, CEO of Immunovaccine, told Equities.com. “Generating T-cell infiltration is a key objective and prognosis factor for efficacy in Immunotherapy. DPX-Survivac was developed with this goal in mind, and having now made the demonstration of this mechanism of action is a very significant stepping stone for IMV on which we intend to build an ambitious development and commercial plan.”
DPX-Survivac is the company’s lead immune-oncology candidate based on its proprietary DepoVax platform, which works as a cancer vaccine delivery formulation that provides controlled and prolonged exposure of antigen adjuvant to the immune system. In September, Immunovaccine announced that the first patient of the recurrent ovarian cancer study, which is a collaboration with Incyte Corp. (INCY), had begun the triple combination treatment. The study plans to enroll up to 40 patients, all with recurrent ovarian cancer with evidence of progressive disease.
The recently released interim data analysis included results of blood tests, tumor biopsies and CT scans to assess safety, disease progression and T-cell response. According to Immunovaccine, the early data showed:
- The triple combination appears to be safe with no SAE to report.
- It is treating patients with active progressive disease and 3 out of the 4 are reported to have stabilized the disease.
- Signs of increased T cell activity in tumors in three of the four patients based on RNA sequencing.
- Stable disease with signs of tumor shrinkage in the patient who has been in trial for the longest duration thus far (based on CT scan at day 140).
- The company has also has seen evidence of an increase in checkpoint markers, which is an indication that the tumor is being primed to be more immuno-responsive and another key targeted mechanism of action for combination immunotherapy
“We are very encouraged by these early data, which are tremendously important to Immunovaccine, as they help to validate the underlying clinical potential of DPX-Survivac,” Ors stated in the announcement. “Research is consistently demonstrating that activating T cells is a crucial mechanism to improving tumor response rates. This desired mechanism of action is exactly what we have developed DPX-Survivac to address, and this data set has provided an encouraging first clinical demonstration of this effect.”
While Immunovaccine is developing DPX-Survivac, and its underlying DepoVax platform, to treat a number of different cancer types and infectious diseases, the company is focusing on treating ovarian cancer. DPX-Survivac has been granted Fast Track designation by the FDA as a maintenance therapy for advanced ovarian, fallopian tube, and peritoneal cancer. In February, Immunovaccine announced that a separate ovarian cancer combination treatment involving its DPX-Survivac cancer vaccine candidate, in combination with Merck’s (MRK) checkpoint inhibitor Pembrolizumab, will enter Phase 2 clinical trial. The study will be conducted by UHN’s Princess Margaret Cancer Centre (PM) and focus on patients with recurrent, platinum-resistant ovarian cancer.
Ovarian cancer ranks fifth in cancer deaths among women, according to the American Cancer Society (ACS), and is the seventh most common cancer in women worldwide, according to the World Cancer Research Fundiv.
“Ovarian cancer is a main focus for Immunovaccine as we continue to develop DPX-Survivac,” Ors said in February. “Combination therapies — particularly those with anti-PD-1 activity — are emerging as increasingly promising approaches for hard-to-treat cancers. We believe that the robust immunogenic and safety clinical profile for DPX-Survivac, along with its unique complementary activity to anti-PD-1 agents, which may boost their response rates, position our immuno-oncology candidate as an optimal co-therapy in this disease area.”
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