FDA Clears IND of ADRX-0706 for Select Advanced Solid Tumors

• In preclinical models, the antibody drug conjugate (ADC) ADRX-0706 revealed promising efficacy, safety, and pharmacokinetics in multiple solid tumors.

• With this investigational new drug (IND) application clearance, Adcentrx Therapeutics is closer to bringing their novel ADC technology to a variety of patient populations.

• A phase 1a/1b clinical trial will further evaluate ADRX-0706 in patients with select advanced solid tumors.

The FDA has cleared the IND application of ADRX-0706 for the treatment of patients with select advanced solid tumors, according to Adcentrx Therapeutics.¹

ADRX-0706 is an ADC which targets Nectin-4. For ADCs, Nectin-4 is an attractive target as it has high expression in multiple solid tumors, limited expression in normal tissues, and is crucial in tumor progression.

Image credit: © Helmut - Adobe Stock

Through the targeting of Nectin-4 with ADRX-0706, experts believe there is potential for an alternative option over current therapeutic approaches due to its potent anti-cancer activity that can be reached with a lower toxicity profile. Additionally, ADRX-0706 has been associated with poor prognosis and resistance to conventional therapies.

Previously in clinical models, ADRX-0706 has shown to have a favorable pharmacokinetic and safety profile and has also demonstrated significant efficacy across a variety of tumor indications.

"The FDA's acceptance of our IND application is an exciting milestone for Adcentrx," said Hui Li, PhD, founder, and chief executive officer of Adcentrx, in a press release. "As our first program to receive FDA clearance, we are one step closer to bringing our novel ADC technology to patients in need across the oncology landscape."

Following the clearance of the IND, ADRX-0706 will be evaluated in a first-in-human, open-label, multicenter, non-randomized phase 1a/1b clinical trial. The study will include a dose-escalation and dose-expansion portion and plans to enroll patients with select advanced solid tumors.

The primary end points being assessed in the study will characterize the safety and tolerability of ADRX-0706 and determine the optimal dose of the ADC among various patient populations.

The first patient is expected to be enrolled in the study in the second half of 2023. Additionally, an initial data readout is anticipated to be announced in the middle of 2024.

In addition to ADRX-0706, Adcentrx Therapeutics is working on the development of additional candidates with the goal of advancing at least 1 into the clinic each year.²

"ADRX-0706 demonstrated a remarkable efficacy and safety profile in preclinical studies," added Pia Challita-Eid, PhD, chief scientific officer of Adcentrx, in the press release.¹ "We are thrilled to be progressing our first program into the clinic as we continue to apply our optimized ADC platform on a robust and differentiated product pipeline."

REFERENCES:

1. Adcentrx Therapeutics announces FDA clearance of investigational new drug application for ADRX-0706, a novel ADC targeting nectin-4 for the treatment of advanced solid tumors. News release. Adcentrx Therapeutics. July 17, 2023. Accessed July 17, 2023. https://tinyurl.com/3ymn5jx6
2. Pipeline. Adcentrx Therapeutics. Accessed July 17, 2023. https://www.adcentrx.com/pipeline/