BrightPath Presents Preclinical Data and Phase 1 Trial Design for iPSC-Derived CAR-iNKT Therapy for Multiple Myeloma

Key Points

• BrightPath Biotherapeutics presented preclinical data and a Phase 1 trial design for BP2202, an iPSC-derived, BCMA-targeted cell therapy for multiple myeloma, at IMS 2026.
• BrightPath reported tumor growth inhibition with BP2202 in a multiple myeloma xenograft mouse model.
• Following FDA clearance of the investigational new drug application, BrightPath is activating US sites for the trial in patients who have received at least three prior lines of therapy.

BrightPath Biotherapeutics, a clinical-stage biopharmaceutical company focused on cancer therapies, presented preclinical data and the Phase 1 trial design for BP2202, a cell therapy for multiple myeloma, at the 23rd International Myeloma Society Annual Meeting (IMS 2026). The meeting runs from September 23 to 26, 2026, in Glasgow, United Kingdom. The poster was presented on September 23.

BP2202 is an allogeneic (donor derived), off-the-shelf therapy containing invariant natural killer T (iNKT) cells derived from induced pluripotent stem cells (iPSCs). The cells are engineered to express a chimeric antigen receptor (CAR) targeting B cell maturation antigen (BCMA). BrightPath says its manufacturing technology produces iPSC-derived iNKT cells in a homogeneous and scalable manner.

Following FDA clearance of the investigational new drug application, BrightPath is activating US clinical trial sites for the Phase 1 trial.

Preclinical findings

BrightPath reported the following preclinical and manufacturing findings:

• BP2202 demonstrated tumor growth inhibition in a multiple myeloma xenograft mouse model.
• A genomic safety assessment of the master iPSC bank, the starting material for manufacturing the investigational BCMA CAR-iNKT cells, confirmed chromosomal integrity, with no structural abnormalities of concern or notable off-target editing detected. The assessment included karyotyping, optical genome mapping, whole-genome sequencing and off-target analysis.
• The manufacturing process was highly reproducible, including consistent CAR expression.

Phase 1 trial design

The trial is designed for patients with relapsed or refractory multiple myeloma who have received at least three prior lines of therapy.

The open-label, multicenter trial consists of a dose-escalation part evaluating three dose levels (Part A), followed by a dose-expansion part at the recommended dose (Part B). Following lymphodepletion, patients will receive three doses of BP2202 at the same dose level on Day 0, Day 7 and Day 14.

The poster, “BP2202: An Off-the-Shelf iPSC-Derived BCMA-Targeted Cellular Therapy for Multiple Myeloma,” was presented as abstract PA-058 on September 23, 2026, at 12:00 p.m. BST (8:00 p.m. JST).

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