FDA Approves IND for Selected Advanced Solid Tumors Using ADRX-0706

FDA Approves IND for Selected Advanced Solid Tumors Using ADRX-0706

Source – Adcentrx Therapeutics

The FDA has granted clearance to Adventrx Therapeutics’ IND application for ADRX-0706, a promising treatment for select advanced solid tumors. ADRX-0706 is an antibody-drug conjugate (ADC) designed to target Nectin-4, an attractive candidate for ADCs due to its high expression in multiple solid tumors and limited presence in normal tissues. Targeting Nectin-4 with ADRX-0706 offers potential as an alternative therapeutic option with potent anti-cancer activity and a lower toxicity profile compared to current approaches. Moreover, ADRX-0706 has been associated with poor prognosis and resistance to conventional therapies.

Previous studies in clinical models demonstrated that ADRX-0706 has a favorable pharmacokinetic and safety profile, along with significant efficacy across various tumor types.

“The FDA’s acceptance of our IND application is an exciting milestone for Adcentrx. 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.”

– Hui Li, Ph.D., Founder and Chief Executive Officer of Adcentrx

With the IND clearance, ADRX-0706 will undergo evaluation in a first-in-human, open-label, multicenter, non-randomized Phase Ia/Ib clinical trial. The study will include both dose-escalation and dose-expansion phases, enrolling patients with select advanced solid tumors.

The primary endpoints of the trial will focus on characterizing the safety and tolerability of ADRX-0706 and determining the optimal dose for different patient populations.

Enrollment of the first patient is expected to begin in the latter half of 2023, and initial data from the trial is anticipated to be announced in mid-2024.

Adcentrx Therapeutics is also actively working on developing additional candidates, aiming to advance at least one new therapy into clinical trials each year.

“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 optimized ADC platform on a robust and differentiated product pipeline.”

– Pia Challita-Eid, PhD, chief scientific officer of Adcentrx

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