- Superior efficacy and favorable tolerability in animal models support the potential of ARR-002 to overcome limitations of single-target approaches
- Phase 1 initiation expected in the second half of 2026
NEWTOWN SQUARE, Pa., May 07, 2026 (GLOBE NEWSWIRE) -- ArriVent BioPharma, Inc. (Company or ArriVent) (Nasdaq: AVBP), a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, today announced clearance of an investigational new drug (IND) application by the United States Food and Drug Administration (FDA) for ARR-002, a potential first-in-class MUC16/NaPi2b targeting tetravalent antibody-drug conjugate (ADC) with an initial focus in ovarian and endometrial cancers and broader therapeutic potential across solid tumors.
"We are pleased to advance ARR-002 into the clinic as the second next-generation ADC from our portfolio," said Stuart Lutzker, MD, Ph.D., President of Research and Development of ArriVent. "At AACR, compelling preclinical data was presented demonstrating ARR-002's potential to improve safety and efficacy over conventional single-target and bivalent bispecific ADCs in ovarian and endometrial cancers. ARR-002's dual-target approach is designed to improve delivery and reduce off-tumor toxicity to overcome key limitations of single-target ADCs, including limited internalization, suboptimal payload delivery, and heterogeneous target expression. We expect to initiate a Phase 1 trial and dose the first patient in the second half of the year."
MUC16 and NaPi2b are highly expressed on ovarian and endometrial cancers with limited expression in normal tissues, making them strong co-targets. Select preclinical data included in the IND submission of ARR-002 was presented at the 2026 American Association for Cancer Research (AACR) Annual Meeting in a joint presentation with Aarvik Therapeutics demonstrating:
- Effective binding to individual targets, simultaneous engagement of both targets, and enhanced internalization vs. single-target antibody controls
- Superior in vivo efficacy vs. single-target ADCs in the OVCAR-3 xenograft model
- The potential for a wider therapeutic window based on a favorable tolerability profile in cynomolgus monkeys, consisting of reversible hematologic findings at a higher maximum tolerated single dose vs. other approaches in development
About ArriVent
ArriVent is a clinical-stage biopharmaceutical company dedicated to the identification, development, and commercialization of differentiated medicines to address the unmet medical needs of patients with cancers. ArriVent seeks to utilize its team's deep drug development experience to maximize the potential of its lead development candidate, firmonertinib, and advance a pipeline of novel therapeutics, such as next-generation antibody drug conjugates, through approval and commercialization.
About ARR-002
ARR-002 (also known as AV-P138-ADC) is a first-in-class, Mucin-16 (MUC16) and sodium-dependent phosphate transport protein 2b (NaPi2b) dual-target, tetravalent (2+2 format) ADC, with site-specific conjugation to vcMMAE at a drug-to-antibody ratio (DAR) of 4. Both these cell surface antigens are expressed in ovarian and endometrial cancers with limited expression in normal tissues, making them strong co-targets.
Forward-Looking Statements
This press release includes certain disclosures that contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 about us and our industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this press release, including statements regarding our future results of operations or financial condition, business strategy and plans, estimates of our addressable market, activity and safety of ARR-002 compared to available therapies, anticipated clinical milestones, including the timing of, and results of global development of ARR-002 including initiating a Phase 1 trial and dosing the first patient, and objectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements because they contain words such as "anticipate," "believe," "contemplate," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," or "would" or the negative of these words or other similar terms or expressions. Forward-looking statements are based on ArriVent's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, risks and uncertainties that are described more fully in the section titled "Risk Factors" in our annual report on Form 10-K for the fiscal year ended December 31, 2025, filed with the Securities and Exchange Commission on March 5, 2026 and our other filings with the Securities and Exchange Commission. Forward-looking statements contained in this press release are made as of this date, and ArriVent undertakes no duty to update such information except as required under applicable law.
Contact:
Joyce Allaire
LifeSci Advisors, LLC
jallaire@lifesciadvisors.com
