Among the programs involved are therapies for multiple myeloma and B-cell malignancies.
Roche is entering into a strategic global collaboration with Poseida Therapeutics focused on developing allogeneic CAR T-cell therapies for hematologic malignancies including multiple myeloma (MM) and various B-cell malignancies.1
Among the programs involved in the partnershipare P-BCMA-ALLO1, an allogeneic CAR-T for the treatment of MM, and P-CD19CD20-ALLO1, an allogeneic dual CAR-T for the treatment of B-cell malignancies.
"We are excited to partner and collaborate with Roche, one of the world's largest biotechnology companies, which has a successful track record in the discovery, development and commercialization of innovative medicines," Mark Gergen, chief executive officer, Poseida, said in a statement.1 "Roche is an ideal strategic partner for Poseida with its industry-leading R&D capabilities in oncology, complementary technologies and expertise, and global regulatory and commercial capabilities. Working together, we look forward to advancing novel allogeneic cell therapies based upon Poseida's technologies for patients battling cancer."
P-BCMA-ALLO1 is currently the focus of a phase 1 clinical trial (NCT04960579). The open-label, dose-escalation study is open to male and female patients aged 18 years and older who have a confirmed diagnosis of active relapsed or refractory MM. Patients must have previously received treatment with a proteasome inhibitor, an immunomodulatory agent, and anti-CD38 therapy. Participants must additionally be willing to practice birth control throughout the first year of the study after dosing, and female patients of childbearing potential must have a negative serum pregnancy test at screening. All participants must have adequate vital organ function and must have recovered from any toxicities from prior therapies. Patients who have an active second malignancy, an active autoimmune disease, or a history of significant central nervous system disease will be excluded from the study.
Participants in each of the dose escalation cohorts will receive P-BCMA-ALLO1 as a single dose administered intravenously after a conditioning chemotherapy regimen. The safety switch rimiducid may be administered if needed. The primary end point is the rate of dose-limiting toxicities in order to determine the maximum tolerated dose. Secondary end points include the incidence and severity of treatment-emergent adverse events, overall response rate, time to response, duration of response, progression free survival, overall survival, and the incidence and severity of cytokine release syndrome events. The study’s expected primary completion date is in June 2023.
P-CD19CD20-ALLO1 remains in the pre-clinical stage but is expected to have an investigational new drug application submitted in 2023.
"We are thrilled that Roche has embraced the opportunity to partner with us and use Poseida's unique allogeneic approach to develop CAR-T product candidates," Devon J. Shedlock, PhD, chief scientific officer of cell therapy, Poseida, added to the statement.1 "Using our proprietary technologies and manufacturing process including our booster molecule, we have the potential to develop and manufacture a product with high levels of stem cell memory T-cells, which are correlated with potent antitumor efficacy in the clinic, at a scale that can potentially reach more patients and enable broad commercial use."