About
Early Phase Strategy for a First-in-Class Bispecific Antibody-Drug Conjugate Asset
YEAR: 2026
SKILLS: Market Analysis | Competitive Landscape | Data Visualization | Python | AI API Deployment
PURPOSE: Independent extension of a project from the “Industry Case Study Program” at University of Toronto; originally contributed as part of the intellectual property (IP) team
LINKS: Github | Final Recommendation
Background:
NEOK001 is a bispecific antibody-drug conjugate developed by NEOK Bio that targets ROR1 and B7-H3, two surface antigens broadly overexpressed across solid tumors. Following FDA IND clearance in January 2026, this project explores how a data-driven framework could be used to prioritize initial clinical indications across thoracic, gastrointestinal, and gynecological cancers.
This work was conducted as an independent case study using publicly available information to simulate early-phase clinical development decision-making and strategy.
Methods & Approach:
Built a two-axis scoring model evaluating 12 candidate indications on medical fit (ROR1×B7-H3 expression, unmet need, biomarker tractability) and commercial opportunity (US incidence, competitive density). The results were visualized as a 2×2 indication prioritization quadrant. Sized the PDAC opportunity with a Trodelvy-anchored TAM/SAM/SOM projection. Lastly, mapped the competitive IP landscape through sequential CPC-based filtering of Lens.org records, AI-classified per-patent target flags, and analysis of NEOK001's own patent portfolio.
Strategic Recommendation:
Initiate Phase 1 in pancreatic ductal adenocarcinoma (PDAC) as primary, with NSCLC (Lung Squamous) and gastric/GEJ as the secondary and tertiary indication, respectively.
PDAC ranked #1 using the second expression method, had the highest unmet need of the 12 indications evaluated, faces the cleanest competitive ADC landscape and addresses a ~$3.2B near-term US 2L+ market with a with a ~$320M–$480M base-case peak annual revenue (Year 4 post-launch).
In terms of IP, the asset's bispecific ADC composition is not directly protected by a granted or pending composition patent. Family 24 (ROR1 bispecific format) is the most important pending filing in the portfolio and warrants prosecution focus and continuation strategy ahead of Phase 1 readout.
Group Project Foundation
This project began as a team deliverable for the Industry Case Study Program at the University of Toronto, where I contributed as part of the intellectual property (IP) team advising NEOK Bio on patent strategy for NEOK001. The independent extension, presented above, was developed afterward to deepen the strategic analysis beyond the original scope.
PUBLISHED GROUP ABSTRACT:
Read full abstract →
Final presentation delivered at the ITCS showcase, May 2026. The deck covered a comprehensive go-to-market strategy for NEOK001, spanning indication selection (TNBC, with a focus on 2+ mTNBC), US market sizing, IP strategy, competitive landscape, market exclusivity, pricing, pre-launch advocacy (FDA Breakthrough, EAP, KOL engagement), Target Product Profile, and an integrated launch roadmap. My contributions focused on IP portfolio analysis and the US expiry timeline of NEOK001-relevant patents.
IP Team: YuYing Fan, May Nguyen, Phoebe Wang, Manjula Kamath
Advised by Stacey Ivanchuk
Medical Affairs Team: Vineeth Raveendran, Shana Alexander, Karida Liu
Advised by Heather VanSeggelen
Consulting Team: Maye Cheng, Ishnoor Singh
Advised by Katie Lye