The company plans for a Phase I dose-escalation and dose-expansion study with CLN-619. Credits: Lightspring/Shutterstock.com

Cullinan Oncology is gearing up to advance one of its lead drugs CLN-619 into a Phase I clinical study for multiple myeloma following US Food and Drug Administration (FDA) clearance of its Investigational New Drug (IND).

According to the 1 March press release, the planned Phase I study will comprise of a dose escalation and dose expansion phase testing CLN-619 as a potential treatment for relapsed or refractory multiple myeloma.

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CLN-619, an intravenously administered anti-MICA humanized IgG1 monoclonal antibody, is designed to inhibit MHC class I polypeptide related sequence A (MICA) and MHC class I polypeptide related sequence B (MICB) to induce activation of natural killer group 2D (NKG2D) receptors. In engaging these receptors, CLN-619 is hypothesised to promote the cytotoxicity and lysis of NK-mediated tumour cells. As per Cullinan CMO Dr. Jeffrey Jones, CLN-619 is capable of restoring MICA/B expression on tumor cells and enabling immune recognition.

The Phase I study will be the first MICA/B antibody clinical study in hematologic malignancies, according to the company.

The Cambridge, Massachusetts-based biotech is also evaluating CLN-619 as a monotherapy and in combination with MSD’s Keytruda (pembrolizumab) in a Phase I study (NCT05117476) for advanced solid tumours. Cullinan expects “updated” clinical data in Q2 2024.

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Cullinan is far from being the only company playing in the multiple myeloma space. Last month, Starton Therapeutics announced that it had activated another site for its Phase Ib STAR-LLD study (NCT06087653) that is evaluating a continuous subcutaneous low-dose lenalidomide in combination with dexamethasone and Takeda’s Velcade (bortezomib).

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Also in February, GSK published interim results from the Phase III DREAMM-7 study assessing a combination treatment comprised of its antibody drug conjugate Blenrep (belantamab mafodotin) alongside bortezomib and dexamethasone (BorDex) in a head-to-head comparison against a combination with Janssen Oncology’s Darzalex (daratumumab). The study reported that it found significant improvements in progression free survival (PFS) in patients with relapsed or refractory multiple myeloma.