pre|CISION Platform Update: AVA6103 Outperforms Leading ADC, Phase 1 Dosing Imminent

Since October 2025, when the pre|CISION platform first demonstrated its potential to deliver dual payloads like MMAE and exatecan from a single molecule in prostate cancer models, significant new data has emerged that strengthens its case as a next-generation targeted therapy.
The platform’s ability to exploit fibroblast activation protein (FAP) in the tumor microenvironment for precise payload release, achieving high tumor exposure with minimal systemic circulation, has now been validated through fresh preclinical pharmacology, AI-driven comparisons, and regulatory milestones.

The original reporting highlighted how pre|CISION conjugates showed 4-5x greater tumor cell killing than free payloads, strong bystander effects for heterogeneous prostate tumors, and durable responses in androgen-independent models, key for castration-resistant prostate cancer (CRPC).
​Building directly on this, December 2025 pharmacology data for AVA6103 (FAP-Exd), a single-payload exatecan derivative, confirmed sustained tumor payload release over five days versus just two hours in plasma, alongside complete responses in patient-derived xenograft (PDX) models including prostate.
This reinforces the platform’s tumor-selective advantage, with bystander killing ensuring efficacy even in FAP-heterogeneous lesions common in advanced prostate disease.

January 2026 brought FDA clearance of the investigational new drug application for AVA6103, paving the way for a Phase 1 trial in solid tumors starting as early as Q1 2026, the first clinical test of pre|CISION’s exatecan delivery.

​Then, in February 2026, innovative AI modeling created a synthetic comparator against a leading topoisomerase-I antibody-drug conjugate (Enhertu), revealing AVA6103’s superior profile: over 10-fold higher peak tumor payload concentration, nearly three-fold better tumor selectivity index (AUC tumor/plasma), and penetration within minutes rather than 24 hours.

​These metrics translate preclinical promise into higher clinical probability of success, especially since the comparator’s established efficacy benchmark underscores the platform’s edge in speed, magnitude, and specificity.

Source.