Georgiamune has launched a clinical trial of its second oncology drug candidate. Image credit: Crystal Eye Studio / Shutterstock

Georgiamune has dosed the first patient in a Phase I/II trial of its second oncology drug to progress to trials.

CEO Dr. Samir Khleif told the Clinical Trials Arena that the drug candidate GIM-531 addresses an unmet need in the oncology space of cold tumours and patients who have developed either primary or acquired resistance to PD1 inhibitors.

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The Phase I/II trial of GIM-531 is investigating the candidate in 84 patients with advanced solid tumours, with an additional focus on cold tumours.

Cold tumours are tumours that are unlikely to trigger a strong immune response including cancers of the breast, ovary, prostate, pancreas, and brain (glioblastoma).

The Phase I portion of the trial (NCT06425926) will evaluate the safety profile, pharmacokinetics (PK), and pharmacodynamic (PD) effects; as well as inform the dose, schedule, and early anti-tumour activity of GIM-531.

Following the completion of the dose escalation, the Phase II portion will enrol an additional two study cohorts with the first investigating the candidate as a single agent in tumours with selective inhibition of T-regs and the second cohort investigating the candidate as a rescue for patients who have become unresponsive to anti PD-1 therapies.

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GIM-531 is a first-in-class, oral cancer immunotherapy that is a selective T regulatory (T-reg) cell inhibitor and spares other immune effector cells.

Khleif said: “The novel mechanism of action of GIM-531 can finally address one of the key challenges and limitations that has been facing the field in developing drugs selectively targeting suppressor immune cells like T-reg and sparing other important immune cells. This builds on Georgiamune’s ability to translate innovative research into novel therapies for patients with high unmet needs.”

This news comes on the heels of the Maryland-based company announcing it will progress to the Phase II portion of a Phase I/II trial of its lead candidate GIM-122- a G1 kappa dual functioning monoclonal antibody (mAb). The drug acts by overcoming cancer-mediated immune suppression and stimulates activated T cells.

In December 2023, Georgiamune initiated the first-in-human trial (NCT06028074) of GIM-122 in adult patients with advanced malignancies. The Phase I portion of the study was a dose-escalating trial, evaluating the safety, pharmacokinetics, and pharmacodynamics of the candidate.

The Phase II portion trial will be a dose expansion study. Primary endpoints include safety, tolerability, overall response rate (ORR), anti-tumour and activity. The trial plans to enrol 111 patients.

Last year, the biotech announced it had raised $75m in Series A financing.

In October 2023, Georgiamune and Verily entered a strategic collaboration to advance new cancer treatments.