Tallac Therapeutics has dosed the first participant in a Phase I/II clinical trial of its lead clinical candidate, TAC-001, to treat advanced or metastatic solid tumours.

The multicentre, open-label, dose-escalation and expansion INCLINE-101 study will assess the pharmacokinetics, safety, as well as preliminary anti-tumour activity of TAC-001 administered intravenously in patients with select advanced or metastatic solid tumours.

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TAC-001 is said to be the company’s first candidate developed from its new Toll-like Receptor Agonist Antibody Conjugate (TRAAC) Platform and to enter the clinic.

It includes a potent toll-like receptor 9 agonist (T-CpG) conjugated to an antibody against CD22.

The drug candidate is designed to deliver T-CpG to B cells systemically by attaching to CD22, leading to TAC-001 internalisation, B cell activation, TLR9 signalling, along with a cascade of immune reactions.

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Tallac Therapeutics president, CEO and co-founder Hong Wan said: “The initiation of the first-in-human study for our lead therapeutic candidate represents a major milestone for Tallac as we work to advance our differentiated pipeline of immunotherapy candidates derived from our TRAAC platform.

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“As this study advances, we are also progressing additional assets in our pipeline and plan to file an investigational new drug application (IND) at the beginning of next year for our Phase 1 study in partnership with ALX Oncology Holdings for ALTA-002.”

Preclinical studies showed that the innate and adaptive immune responses triggered by TAC-001 lead to potent anti-tumour activity.

This data supported the development of TAC-001 to treat a wide range of solid tumour malignancies, mainly in tumour types with the involvement of B cell/TLS.