CStone Pharmaceuticals has enrolled the first patient in China for CS5001-101, which is a multi-regional Phase I clinical trial of CS5001, an antibody-drug conjugate (ADC) targeting receptor tyrosine kinase-like orphan receptor (ROR1).

Designed to assess the safety, tolerability and pharmacokinetics of CS5001, the study will evaluate preliminary anti-tumour activity of CS5001 in advanced lymphomas and solid tumours.

CStone CEO Dr Jason Yang said: “This marks another milestone in our Pipeline 2.0 strategy. With the addition of the China investigational centres, the pace of this important programme will be further accelerated.

“We will rapidly promote the global development of CS5001 in all aspects and look forward to bringing more quality treatment options to patients soon.”

In comparison to a standard ROR1 ADC, CS5001 demonstrated potential in mantle cell lymphoma and triple-negative breast cancer xenograft models.

CStone chief scientific officer Dr Archie Tse said: “It consists of a fully human antibody backbone conjugated site-specifically to prodrugs of pyrrolobenzodiazepine (PBD) via a proprietary tumour-cleavable linker, all of which aim to widen the therapeutic window of the ADC.

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“Results from the preclinical studies of CS5001 already showed its therapeutic potential in ROR1-expressing haematological and solid malignancies.”

Demonstrating a bystander impact amid in vitro co-culture systems, CS5001 may also benefit solid tumour patients with heterogeneous/low expression of ROR1.

The licensing agreement to develop and commercialise CS5001 was signed between CStone and LegoChem Bioscience in October 2020.

CS5001 was initially developed in partnership with both South Korea-based companies LCB and ABL Bio.

According to the agreement, CStone has exclusive global rights for developing and marketing CS5001 outside South Korea.

Advancing the trial with multiple dose levels of CS5001 in the US and Australia, the dose escalation Phase I trial also demonstrated good safety and tolerability.