Maveropepimut-S: Our Most Advanced Cancer Vaccine
Maveropepimut-S (MVP-S, formerly named DPX-Survivac) is a DPX-enabled therapeutic cancer vaccine. MVP-S is comprised of immunogenic peptides from the cancer antigen, survivin, as well as a universal T helper peptide, and an innate immune activator, packaged within our proprietary DPX lipid-in-oil delivery platform. Together, these components generate a strong, and persistent stimulation of survivin-specific cytotoxic T cells and antibody-producing B cells that roam the body to target and destroy cancer cells that express survivin.
MVP-S, administered alone or in combination with other agents, has shown robust, persistent immune responses to the cancer antigen survivin. We saw defined, durable clinical benefits in patients with hematologic or solid cancer. Ongoing clinical studies are evaluating MVP-S alone and in combination with low-dose cyclophosphamide and/or pembrolizumab in patients with late-stage cancers like Diffuse Large B Cell Lymphoma (DLBCL) and ovarian cancer,. MVP-S is also being evaluated in earlier-stage trials in a neoadjuvant setting in non-muscle invasive bladder cancer (NMIBC) and breast cancer.
About Survivin
Survivin is a tumor-associated antigen (TAA) that is overexpressed in most solid and hematologic tumors, and rarely in normal, terminally differentiated adult tissues. Survivin supports the tumors’ ability to grow and metastasize by protecting cancer cells from apoptosis, conferring resistance to chemotherapy and radiotherapy. Survivin expression is correlated with tumor aggressiveness and poor prognosis in multiple cancers.
Ongoing Clinical Studies with MVP-S
The VITALIZE clinical study is a company-sponsored, multi-center phase 2b trial in patients with recurrent, refractory diffuse large B cell lymphoma (r/r DLBCL). This study is an open-label, randomized, parallel group, Simon two-stage study designed to assess the combination of MVP-S and Merck’s checkpoint inhibitor (pembrolizumab) with or without intermittent, low-dose CPA. In the first stage of this study, our lead compound is being evaluated in up to 30 subjects, with r/r DLBCL who have received at least two prior lines of systemic therapy and who are ineligible or have failed ASCT or CAR-T therapy.
Market landscape in DLBCL1
- +140,000 new cases in Western Europe and the USA each year,
- Approximately 20% to 50% of patients develop relapsed/refractory (R/R) disease,
- Recent approvals for DLBCL treatment have primarily occurred in the relapsed setting, including CAR-T therapies, but the number of incidents and prevalent cases of the third line plus (3L+) eligible DLBCL patients is expected to increase by 56% and 53% respectively,
- Once a patient reaches the third line few treatments have been available historically and overall survival is less than 7 months,
- 3-4 months is the life expectancy of r/rDLBCL if left untreated.
The AVALON clinical study is an open label, company-sponsored phase 2b, single arm trial evaluating the efficacy and safety of MVP-S and intermittent low-dose cyclophosphamide (CPA) in patients with platinum-resistant ovarian cancer. The study is a Simon two-stage design where up to 41 subjects will be evaluated in stage one, with the option to expand to up to a total of 73 patients in stage two. Patients participating in the trial will receive two doses of subcutaneous MVP-S once every three weeks, followed by an MVP-S dose once every eight weeks, plus low-dose oral CPA on a repeating cycle of one week on/one week off.
Market landscape in ovarian cancer2
- 314,000 new cases and 207,000 deaths worldwide each year,
- 70% patients will relapse within 3 years of first line therapy,
- Less than 30% of women will with advanced endothelial ovarian cancer survive 5 years,
- Chemotherapy regimens remain the standard of care.
2. https://www.cancer.org/cancer/ovarian-cancer/about/key-statistics.html
The basket Phase 2 study was an open-label, multi-center study to evaluate the safety and efficacy of MVP-S and intermittent, low dose CPA in combination with Merck’s checkpoint inhibitor (pembrolizumab) in patients with various solid cancers. This study is now completed.
This investigator-led three-arm phase 1B trial is designed to assess the combination of MVP-S plus standard-of-care aromatase inhibitor with/without radiotherapy or intermittent, low-dose CPA prior to surgery. Across the three arms of this study, MVP-S is evaluated for the first time as a neoadjuvant in 18 subjects with resectable, non-metastatic HR+/HER2- breast cancer.
This phase 1 clinical trial is designed to evaluate the safety and the efficacy of MVP-S, and DPX-SurMAGE in two separate arms, each with or without intermittent low-dose CPA.