Cullinan Therapeutics gains FDA clearance for velinotamig blood-disorder trial

A blood-disorder trial can proceed after Cullinan Therapeutics, Inc. NASDAQCGEM reported U.S. and Australian regulatory clearance for velinotamig on Tuesday. The Phase 1b/2a study will test whether a course of four subcutaneous doses can help adults with relapsing and refractory autoimmune disease.

Cullinan said in its Oct. 27 announcement that the FDA and Therapeutic Goods Administration cleared the Phase 1b/2a trial in immune thrombocytopenia and warm autoimmune hemolytic anemia. The clearance permits clinical testing; the announcement supplies no efficacy or safety results from this study.

Cullinan is a small, clinical-stage drug developer based in Cambridge, Mass., developing T cell engagers for autoimmune diseases and cancer. Its approach recruits immune cells to eliminate other cells implicated in disease.

Cullinan shares NASDAQCGEM closed at US$14.54 on Nasdaq at 4:00 p.m. EDT on Oct. 26, according to Google Finance, before the clearance announcement. The next operational milestone is trial initiation, although the registry and earlier company guidance give different estimated start windows.

Trial Targets 72 Adults Across Two Blood Disorders

The ClinicalTrials.gov record, NCT07738822, gives an estimated enrolment of 72 participants. The record, last updated July 31, lists the study as not yet recruiting, with an estimated December 2026 start.

Cullinan's Aug. 6 financial update guided to initiation in early 2027. Tuesday's release says the clearances support initiation but gives no first-patient dosing date, so the older estimates do not establish when dosing will begin.

Part A will escalate doses before Part B expands selected regimens into separate disease groups. The registry describes an open-label, nonrandomized study with sequential experimental groups and no control arm. Its primary outcome is safety and tolerability over 48 weeks.

Cullinan also plans to evaluate disease activity, drug exposure and immune responses against the treatment. Without a control group, preliminary improvements will not establish superiority over existing care.

In immune thrombocytopenia, or ITP, the immune system destroys platelets needed for clotting. In warm autoimmune hemolytic anemia, or wAIHA, autoantibodies contribute to red blood cell destruction.

Velinotamig binds BCMA on antibody-producing plasma cells and CD3 on T cells, directing the latter toward those targets. Its design aims to reduce unwanted T cell activation and cytokine-related toxicity, an objective that still requires clinical testing.

“ITP and wAIHA are compelling settings for which targeting antibody-producing plasma cells with a defined course of velinotamig may deliver durable clinical benefit,” Cullinan chief medical officer Jeffrey Jones said in the release.

Autoimmune Developers Pursue Different Cell Targets

Climb Bio, Inc. NASDAQCLYM is testing the CD19-targeting antibody budoprutug in ITP. In its June 11 release, Climb reported durable platelet responses in four of six patients in the lowest-dose cohort, an early result rather than a comparison with velinotamig.

Read more: Climb Bio reports 38 per cent immunologic remission in kidney trial

Pfizer Inc. NYSEPFE provides an oncology counterpart: its April 29 release describes ELREXFIO as a BCMA-CD3 bispecific treatment for multiple myeloma. That shared target does not establish benefit in autoimmune blood disorders.

Read more: Pfizer's ELREXFIO beats standard regimens in Phase 3 myeloma trial

For sector context, the iShares Biotechnology ETF NASDAQIBB closed at US$208.69 at 4:00 p.m. EDT on Oct. 26, according to Google Finance. Cullinan's Aug. 6 update reported US$356 million in cash, cash equivalents, investments and interest receivable at June 30, with projected runway into 2029.

The next dated evidence point is Nov. 8, when Genrix Bio is scheduled to present velinotamig lupus data at ACR Convergence. Those results will inform its autoimmune development rationale, while efficacy in ITP and wAIHA remains for the newly cleared study to test.