Redefining Solid Tumor Immunotherapy with QB-001 Platform
Overcoming Triple Tumor Microenvironment Barriers to Awaken Cold MSS-CRC Tumors through Next-Generation Bilayer Nanomedicine.
90%
Of cancers are solid tumors
3
Phase mechanism
Dual
Action platform
Creating a New Way of Therapeutic Adjuvants
Quillaya Biotech is an innovator in "Cell Therapy Support Agents," developing proprietary adjuvants to enhance the efficacy of immune therapies against solid tumors.
To overcome the physiological barriers of solid tumors using our proprietary QB-001 Bilayer Nanomedicine Platform—transforming cold tumor microenvironments and unlocking durable anti-tumor immunity.
William Feng
Founder / GM
Colin Teng
Founder
Nisha Chang
Founder
Ray Kuo
Consultant
QB-001 Next-Generation Bilayer Nanomedicine Platform
Overcoming Triple Solid Tumor Microenvironment Barriers to Awaken Cold MSS-CRC Tumors
QB-001 is Quillaya Biotech’s lead immunomodulatory drug candidate engineered to overcome the "immunologically cold tumor" barrier in microsatellite stable colorectal cancer (MSS-CRC)—enabling standard systemic intravenous delivery without the severe systemic toxicities of traditional immuno-agonists.
Pipeline Quick Facts: QB-001
Lead Therapeutic Asset Overview
Product Code
QB-001
Modality
Bilayer Nanomedicine Platform
Target Indication
MSS-CRC & Cold Solid Tumors
Route of Administration
Systemic I.V. Infusion
Clinical Strategy
Combination with PD-1 / PD-L1
Regulatory Path
FDA Fast Track & Priority Review
The Triple Solid Tumor Microenvironment Barriers
Colorectal cancer causes ~904,000 deaths annually. MSS-CRC accounts for 85% of cases, where immune checkpoint monotherapy is largely ineffective due to three biological defense rings:
Physical & Spatial Barrier
Dense fibrotic stroma and elevated interstitial fluid pressure severely impede the deep penetration of conventional therapeutics and circulating immune effector cells into tumor cores.
Physicochemical Microenvironment
Tumor glycolytic metabolism induces severe hypoxia and micro-acidification, which directly paralyzes effector T-cell cytotoxicity and accelerates metabolic exhaustion.
Immunosuppressive Cellular Shield
The tumor invasive margin is heavily occupied by tumor-associated macrophages (TAMs) polarized into pro-tumoral M2 phenotypes, forming an impenetrable immunosuppressive defense shield.
Intelligent Nano-De-cloaking & Macrophage Repolarization
Quillaya Biotech’s proprietary bilayer nanostructure design coordinates prolonged blood circulation, microenvironment-triggered de-cloaking, selective TAM targeting, and phenotypic reprogramming—turning immunosuppressive M2 macrophages into active M1 immune stimulators.
Bilayer Architecture & Systemic I.V. Delivery
Outer protective shell provides steric hindrance, preventing hepatic first-pass clearance and rapid RES uptake.
Enables standard systemic intravenous (I.V.) infusion, overcoming severe toxicities and operational constraints of intratumoral injections.
Facilitates preferential accumulation in primary and metastatic lesions via enhanced permeability and retention (EPR).
In Situ Vaccine Effect
Converts "cold" MSS-CRC into immunologically "hot" responsive tissue
Translational Strategy & Expedited Regulatory Pathways
Engineered to overcome therapeutic stagnation in late-stage oncology through targeted clinical trial design and international regulatory acceleration.
IO Combination Regimen
Synergy with Checkpoint Inhibitors
Pairs QB-001 with anti-PD-1/PD-L1 monoclonal antibodies to dismantle macrophage-driven immune brakes and reverse T-cell exhaustion.
Advanced & Metastatic MSS-CRC
85% of Colorectal Cancer Patients
Targets 2nd and 3rd line metastatic patients who have exhausted chemotherapy and anti-angiogenic therapies with zero effective options.
Expedited Regulatory Pathways
Accelerating Time to Market
Qualify for early applications for U.S. FDA Fast Track Designation, Priority Review, and Accelerated Approval.
Disrupting a Multi-Billion-Dollar Oncology Segment
With 1.9M annual CRC cases worldwide and the second- and third-line MSS-CRC market valued at $6B–$8B, current chemotherapy and anti-angiogenic options yield poor survival and high toxicity. Successful clinical validation of QB-001 expands the total addressable market beyond USD 20 billion while delivering transformative survival benefits.
1.6M
Annual MSS-CRC Patients
85% of all global colorectal cancer cases
$20B+
Total Addressable Market
Expanded oncology market upon overcoming immune resistance
800K+
Metastatic mCRC Volume
Annual advanced cohort needing innovative microenvironment remodelers
25K–150K
Direct Lives Impacted
Estimated annual patients receiving direct survival improvements
Beyond Single-Pathway Inhibitors
While competitors focus on single-pathway inhibitors such as LILRB2 antagonists or CpG-A oligonucleotides, the QB-001 Bilayer Platform enables standard systemic intravenous delivery with tumor-localized de-cloaking and comprehensive macrophage repolarization.
Higher Precision
TME-triggered activation ensures the payload is released only where needed.
Lower Systemic Toxicity
Stealth delivery minimizes off-target effects on healthy tissue.
Comprehensive Remodeling
Multi-pathway approach prevents antigen escape and tumor recurrence.
Matrix One eQMS
A Cloud-Based eQMS Solution From Germany Tailored for Life Sciences and MedTech
Matrix Quality (formerly Simploud) is an all-in-one electronic Quality Management System (eQMS) engineered specifically for biotechnology, pharmaceutical, and medical device companies. Built on the secure enterprise-grade Salesforce cloud platform, it empowers organizations to streamline compliance with FDA, EMA, ISO 13485, and GxP standards.
Rapid Deployment & High ROI
Pre-configured, validation-ready workflows allow implementation in as little as a few weeks, significantly reducing Total Cost of Ownership (TCO).
Proven Regulatory Compliance & Security
Fully aligned with FDA 21 CFR Part 11 and EU Annex 11 requirements, featuring comprehensive audit trails and role-based access control. Successfully proven through multiple FDA inspections.
Scalability & Seamless Integration
Designed with high configurability and robust APIs to integrate effortlessly with existing ERP, CRM, and requirements management tools.
Quality Events & CAPA Management
Centralized tracking for Deviations, Non-conformances (NC), Customer Complaints, CAPA, and Change Controls, and Audit management.
Document & Training Management
Full document lifecycle control, versioning, and collaborative review. Automates role-based training assignments and tracks completion via Training Matrix.
Risk Management
Supports ISO 14971 and GxP-compliant risk assessments, operating either standalone or seamlessly integrated into CAPA and Change Control workflows.
Manufacturing & Batch Records
Manages material tracking, usage, shipments, and related batch records to ensure complete operational traceability.
Trial Master File (TMF) & Regulatory Submissions
Manages compliant, stress-free Trial Master File workflows and centralizes product registrations, and variations.
New Advanced AI Tool
Automates compliance documentation, risk assessments, and traceability for user while maintaining strict human-in-the-loop validation.
Ready to Work Together?
We're actively seeking strategic partners, collaborators, and investors who share our vision of overcoming solid tumor resistance. Let's discuss how the QB-001 Platform can advance your therapeutic pipeline.
info@quillayabiotech.com
Location
Hsinchu, Taiwan
Industry
Biotechnology & Cell Therapy
Partnership Inquiries
Whether you're a pharmaceutical company, research institution, or investor, we'd love to explore how the QB-001 platform can complement your efforts in advancing immuno-oncology therapies.