TPST-2003 / Novatim Immune Therap, Tempest Therap, Vrise Therap - LARVOL DELTA

In the POEMS-1 trial, as of the January 31, 2026 data cutoff, all five evaluable patients had achieved a CRVEGF within two months of being administered TPST-2003 (GlobeNewswire) - "No dose-limiting toxicities were observed in any of the treated patients."

P1 data • Multiple Myeloma

Tempest Presents Clinical Update at ISCT 2026 Annual Meeting (GlobeNewswire) - "Updates include the latest data from the ongoing REDEEM-1 Phase 1/2a trial evaluating TPST-2003, as well as progress in Tempest’s other dual-targeting CAR-T pipeline programs....All 10 CAR-T-naïve patients currently evaluable for efficacy in the REDEEM-1 trial – three treated at dose level 1 (1 x 106 cells/kg), three at dose level 2 (2 x 106 cells/kg), and four at dose level 3 (3 x 106 cells/kg) – achieved a CR according to the IMWG uniform response criteria. A single patient, who had previously received a BCMA-targeting CAR-T, did not respond....The observed safety profile (no Grade >3 CRS or ICANS), together with the consistency of responses observed in the REDEEM-1 trial continue to support Tempest’s plan to pursue its objective of meeting with the FDA to discuss initiating a U.S. registrational study later this year."

FDA event • P1/2 data • Multiple Myeloma

Tempest to Advance Dual-Targeting CAR-T Platform with Clinical Update at ISCT 2026 Annual Meeting (GlobeNewswire) - "Updates will include the latest data from the ongoing REDEEM-1 Phase 1/2a trial evaluating TPST-2003, as well as progress in Tempest’s other dual-targeting CAR-T pipeline programs."

Clinical data • P1/2 data • Multiple Myeloma

Tempest Announces Key Manufacturing Milestone for TPST-2003 Dual-Targeting CD19/BCMA CAR-T (GlobeNewswire) - "Tempest’s dual-targeting CD19/BCMA CAR-T therapy under development for the treatment of relapsed/refractory multiple myeloma ('rrMM'). Earlier this month, Tempest’s manufacturing partner, Cincinnati Children’s Applied Gene and Cell Therapy Center ('AGCTC'), took delivery of the TPST-2003 lentiviral vector, a critical component used in the manufacturing of TPST-2003. This milestone supports Tempest’s plans to initiate the first potentially registrational study to evaluate a dual-targeting CAR-T therapy in patients with rrMM, including patients who are experiencing extramedullary disease ('EMD'), later this year."

New trial • Multiple Myeloma

First in India, phase 1/2 study of an indigenously adapted, cost-efficient autologous dual-target BCMA/CD19 CAR T-cell therapy for relapsed or refractory multiple myeloma (AACR 2026) - P1, P1/2 | "This study represents first-in-India clinical evaluation of VL-2511 with an objective to assess efficient, cost-conscious, local manufacturing and delivery of clinically promising Dual CAR T. This approach has the potential to meaningfully expand access to advanced cellular therapies in India and other resource-constrained settings. Beyond R/R MM, and B-cell NHL, the dual-targeted VL-2511 has broader applicability across additional immune-mediated and plasma cell-driven disorders, including POEMS syndrome (NCT06518876), systemic lupus erythematosus, myasthenia gravis, and AL amyloidosis."

CAR T-Cell Therapy • P1/2 data • Hematological Malignancies • Multiple Myeloma • Oncology

Announced positive interim results from the ongoing REDEEM-1 Phase 1/2a trial of TPST-2003 in patients with rrMM, which is being sponsored and conducted by Tempest’s partner, Novatim Immune Therapeutics (GlobeNewswire) - "100% complete response (CR) rate among all six efficacy evaluable patients as of the January 31, 2026 data cutoff; Favorable safety profile with no Grade >3 cytokine release syndrome ('CRS') or immune effector cell-associated neurotoxicity syndrome ('ICANS') appears to be emerging as a potentially differentiating attribute in its class; Prior investigator-initiated trial ('IIT') reached median progression free survival (PFS) of 23.1 months, including in patients with extramedullary disease; 36 patients with rrMM treated to date across two studies."

P1/2 data • Multiple Myeloma

Potential Future Milestones (GlobeNewswire) - "TPST-2003: Present results from the ongoing Phase 1/2a REDEEM-1 study, as well as updated data from the Phase 1/2 IIT, in 2026; Submit a U.S. IND application and, subject to clearance, initiate a Phase 2b U.S. registrational study of TPST-2003 in patients with rrMM in 2026."

IND • New P2b trial • P1/2 data • Multiple Myeloma

Novatim and ERIGEN Ink Licensing Pact for Dual-Target CAR-T Therapy KQ-2003 (flcube.com) - "Novatim Immune Therapeutics...announced a strategic cooperation with US-based biopharmaceutical company ERIGEN LLC. The partnership involves an exclusive overseas licensing agreement for Novatim’s self-developed KQ-2003, the world’s first parallel-enhanced dual-target CAR-T cell therapy targeting BCMA/CD19. This collaboration grants ERIGEN exclusive rights to develop, register, and commercialize the product globally, excluding Greater China, India, Turkey, and Russia....Under the agreement, ERIGEN will have exclusive rights to develop 'off-the-shelf CAR-T cell therapies' using the key patent structures and sequences of KQ-2003. Novatim retains complete rights to the off-the-shelf product within Greater China, setting the stage for future joint development and regional commercialization. Novatim will receive an initial milestone payment of $15 million and is eligible for up to $1.32 billion in development, registration, and commercialization milestones."

Licensing / partnership • Multiple Myeloma

A Study of KQ-2003 CAR-T Cell Therapy for Patients With Relapsed or Refractory POEMS Syndrome (clinicaltrials.gov) - P1 | N=21 | Not yet recruiting | Sponsor: Novatim Immune Therapeutics (Zhejiang) Co., Ltd.

CAR T-Cell Therapy • New P1 trial • Rare Diseases

A Study of KQ-2003 CAR-T Cell Therapy for Patients With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P1/2 | N=29 | Recruiting | Sponsor: Novatim Immune Therapeutics (Zhejiang) Co., Ltd.

CAR T-Cell Therapy • New P1/2 trial • Hematological Malignancies • Multiple Myeloma • Oncology