Adcentrx Therapeutics announced that the US Food and Drug Administration (FDA) has granted clearance for its Investigational New Drug (IND) application for ADRX-0706.

ADRX-0706 will be evaluated for the treatment of specific advanced solid tumours. This IND clearance represents a crucial step in the drug’s clinical development journey, allowing Adcentrx Therapeutics to move forward with conducting clinical trials to assess its safety and efficacy in patients with these select advanced solid tumours.

This milestone signifies a significant achievement for Adcentrx Therapeutics as it progresses in its mission to revolutionize Antibody-Drug Conjugate (ADC) therapeutics for cancer and other life-threatening diseases, potentially providing novel treatment options for patients facing these challenging conditions.

Adcentrx founder and CEO Hui Li said: “The FDA’s acceptance of our IND application is an exciting milestone for Adcentrx.

“As our first programme to receive FDA clearance, we are one step closer to bringing our novel ADC technology to patients in need across the oncology landscape.”

Nectin-4 is an appealing target for Antibody-Drug Conjugates (ADCs) due to its notable presence in various solid tumours and its limited expression in normal tissues. The high expression of Nectin-4 in multiple cancerous tissues makes it a valuable focus for targeted therapies. Additionally, its crucial role in tumour progression and its association with poor prognosis and resistance to conventional treatments further underscore its significance as a therapeutic target.

With ADRX-0706, which specifically targets Nectin-4, there is the potential to achieve potent anti-cancer activity while maintaining a lower toxicity profile compared to conventional therapies. This selective targeting allows for more effective and precise treatment of cancer cells while sparing healthy tissues, reducing the side effects and complications associated with traditional treatments.

By leveraging the unique characteristics of Nectin-4 and its potential as a target for ADCs, ADRX-0706 offers a promising alternative to current therapeutic approaches. The hope is that this novel approach will bring about more effective and better-tolerated treatments for patients with solid tumours, improving their overall prognosis and quality of life.

Adcentrx chief scientific officer Pia Challita-Eid said: “ADRX-0706 demonstrated a remarkable efficacy and safety profile in preclinical studies.

“We are thrilled to be progressing our first program into the clinic as we continue to apply our optimised ADC platform on a robust and differentiated product pipeline.”

The upcoming Phase 1a/1b clinical trial of ADRX-0706 marks a significant milestone in its development. The trial will be the first time the drug is tested in humans, and it is designed as an open-label, multicentre study with a non-randomized dose escalation and dose expansion approach. Patients with specific advanced solid tumors will be enrolled in the trial.

The primary objectives of the study are twofold: first, to evaluate and characterize the safety and tolerability of ADRX-0706 in human patients, ensuring that the drug is well-tolerated and does not cause significant adverse effects. Second, the study aims to determine the optimal dose of ADRX-0706 for further development and potential future use in treating solid tumours effectively.

The company anticipates enrolling the first patient in the trial during the second half of 2023, marking the beginning of this critical clinical investigation. The initial data readout is expected to take place in the middle of 2024, providing initial insights into the drug’s safety, tolerability, and potential effectiveness in treating advanced solid tumours. This data readout will be a crucial step in shaping the drug’s further development and potential progression into later-stage clinical trials.