AI/LLM & Data
Accelerate Your Path to Breakthrough Therapies with AI-Driven Antibody Design and Cutting-Edge Study Protocol Development
At WBR Lab, we are pioneers in leveraging advanced AI and machine learning technologies to revolutionize the field of antibody design and preclinical study development. Our mission is to accelerate the transition from discovery to preclinical drug candidates, providing you with a competitive edge in the fast-paced biopharmaceutical landscape.
AI-Powered Protein Design:
We specialize in the design and optimization of complex antibody structures, including bi-specific antibodies, nanobodies, and antibody fusion proteins. By integrating AI/ML technology into our design processes, we dramatically shorten the time required to develop high-affinity molecules. Our AI-generated structure-guided design approach harnesses vast datasets and predictive algorithms to identify the most promising candidates, ensuring that your therapeutic targets are optimized with precision.
Our High-Throughput Surface Plasmon Resonance (HT-SPR) screening platform complements our AI-driven design, allowing for rapid, high-throughput assessment of binding interactions. This synergy between AI and HT-SPR ensures that only the most potent and specific antibodies advance through the pipeline, minimizing costly delays and maximizing the likelihood of success in preclinical trials.
Transforming Study Protocol Design with LLMs:
In addition to our expertise in antibody design, we offer cutting-edge services in prompt engineering and study protocol development using the latest advancements in Large Language Models (LLMs). These models, powered by AI, are transforming the way we approach preclinical and clinical study design.
Our team of experts uses LLMs to craft data-driven, scientifically robust study protocols that align with your therapeutic goals. Whether you are in the preclinical phase, designing animal studies, or preparing for clinical trials, our LLM-driven approach ensures that every aspect of your study is meticulously planned and optimized. This includes:
Preclinical Study Design:
Utilizing LLMs to generate precise animal study protocols that account for all variables, from dosing regimens to endpoint analysis, ensuring that your studies yield meaningful, translatable results.
Clinical Study Protocol Development:
Leveraging AI to create comprehensive clinical study designs that meet regulatory standards and are tailored to your specific therapeutic objectives. Our protocols are designed to streamline the approval process and reduce time to market.
Why Choose Us?
Innovative AI/ML Solutions: We combine the latest AI/ML technologies with deep domain expertise to offer unmatched antibody design and study protocol services.
Speed and Efficiency: Our AI-driven approach significantly reduces the time needed to move from discovery to preclinical candidate, accelerating your drug development timeline.
Expertise in LLMs: Our prompt engineering services leverage LLMs to ensure your study protocols are optimized for success, whether in the preclinical or clinical phase.
Comprehensive Support: From molecule design to study protocol development, we provide end-to-end consulting services that are tailored to your unique needs.
Partner with WBR and let us help you bring your next breakthrough therapy to life, faster and more efficiently than ever before.
Localized RAG/LLM
We provide secure and entirely localized services for the construction, evaluation, and testing of Retrieval-Augmented Generation (RAG) assisted Large Language Models (LLMs), tailored specifically for the pharmaceutical industry.
Prompt engineering
We offer prompt engineering services for drug research and development, encompassing a comprehensive suite of offerings such as training, consulting, and tailored solution packages.
Case study 1
We are developing a blueprint for a Phase III clinical trial for a new drug, WBRmab, which is intended to treat wet age-related macular degeneration (wet-AMD). Our primary objective is to secure regulatory approval while minimizing risks associated with the trial. To inform our trial design, we conducted a thorough analysis of existing drugs currently approved for wet-AMD, focusing particularly on Lucentis (Ranibizumab) and Eylea (Aflibercept). This involved a detailed comparison of the design and outcomes of the Phase III studies for these two drugs, which have successfully navigated the regulatory process. This comparative analysis will help us align our trial design with proven successful strategies and improve our chances of achieving similar success.
LLM answer
| Drug type | Anti-VEGF (Ranibizumab) | Anti-VEGF (Aflibercept) |
| Study Type | Randomized, multicenter, double-blind study | Randomized, multicenter, double-blind study |
| Primary Endpoint | Change in BCVA (Best-Corrected Visual Acuity) | Proportion of patients who maintained vision (loss of fewer than 15 ETDRS letters) at 52 weeks |
| Secondary Endpoints | Included secondary endpoints such as anatomical changes measured by OCT | Included secondary endpoints such as improvement in BCVA and anatomical outcomes measured by OCT |
| Control Group | Photodynamic therapy (Verteporfin) | Ranibizumab, providing direct drug comparison |
| Focus | Focused specifically on predominantly classic CNV lesions | Included a broader range of wet AMD types, not limited to specific lesion types |
| Population | 423 patients | 1,217 patients |
| Study Duration | Primary and secondary efficacy endpoints measured over various points, focus on up to 24 months | Primary efficacy measured at 52 weeks, with additional long-term follow-up |
| Patient Numbers | Comparatively fewer patient numbers | Larger patient numbers, enhancing statistical power |
Now we ask the LLM to compare the Vabysmo (Fricimab) with Eylea (Aflibercept) phase III studies
LLM answer
| Comparison Aspect | VIEW 1 Trial (Eylea - Aflibercept) | TENAYA Trial (Vabysmo - Faricimab) |
|---|---|---|
| Enrollment | Approximately 1,217 patients with wet AMD | Approximately 1,200 patients with wet AMD |
| Location | Multinational across various countries | Multinational across various countries |
| Dosing Regimen | Initial: 3 monthly injections of 2 mg Maintenance: Every 8 weeks |
Initial: Monthly injections for the first four doses Flexible Extended: Up to 16 weeks based on response |
| Study Duration | Primary Endpoint: 52 weeks Long-term follow-up beyond 52 weeks |
Primary Endpoint: 52 weeks Long-term monitoring for additional data |
| Control Group | Ranibizumab (Lucentis), 0.5 mg every 4 weeks | Aflibercept (Eylea), 2 mg every 8 weeks after initial phase |
| Primary Outcome | Proportion of patients maintaining vision, losing fewer than 15 ETDRS letters |
Proportion of patients maintaining vision, losing fewer than 15 ETDRS letters |
| Secondary Outcomes | Gaining at least 15 ETDRS letters Changes in central retinal thickness Safety outcomes |
Gaining at least 15 ETDRS letters Anatomical improvements via OCT Safety evaluations |
Finally we ask LLM to design a phase III study for us.
LLM answers
Proposed Phase III Clinical Trial Design
Study Objective
Primary Objective: To demonstrate the superiority of the new drug (let's call it NeoVab) over Vabysmo in improving and maintaining visual acuity in patients with wet AMD.
Secondary Objectives: To evaluate the safety profile, dosing flexibility, and impact on quality of life compared to Vabysmo.
Study Design
Type: Randomized, double-blind, multicenter, active-controlled superiority trial.
Population: Approximately 1,200 patients diagnosed with wet AMD, including a diverse demographic to ensure generalizability.
Enrollment Criteria
Inclusion Criteria: Diagnosis of wet AMD, age 50 and above, active choroidal neovascularization (CNV), baseline visual acuity between 20/40 and 20/320 on the ETDRS chart.
Exclusion Criteria: Previous treatment with anti-VEGF therapies within the last 6 months, any concurrent intraocular condition, or uncontrolled systemic diseases that might affect visual outcomes.
Intervention
Test Group: NeoVab administered intravitreally.
Control Group: Vabysmo administered as per the regimen used in the TENAYA trial.
Dosing Regimen
Initial Phase: Monthly injections for the first 3 months for both groups.
Maintenance Phase: Extend the interval based on treatment response, with a minimum interval aim of 12 weeks for NeoVab, compared to the 16-week interval potential of Vabysmo, to test if a shorter interval could yield superior results.
Duration
Follow-Up: Primary endpoint assessed at 1 year; extended follow-up for 2 years to evaluate long-term efficacy and safety.
Endpoints
Primary Endpoint: Proportion of patients gaining ≥15 letters at 52 weeks.
Secondary Endpoints: Change in central retinal thickness as measured by OCT, safety profile, including all adverse events and serious adverse events, quality of life assessments using NEI VFQ-25, proportion of patients maintaining dosing interval extension beyond 12 weeks without loss of efficacy.
Statistical Analysis
Sample Size Calculation: Based on achieving adequate power (90%) to detect a clinically significant difference with a significance level (alpha) of 0.05.
Interim Analysis: Conducted at 6 months to allow for possible adjustments in study design or early stopping for efficacy or futility.
Alternative Design Consideration
Head-to-Head Comparison with Different Dosing Frequencies: An alternative study could explore varying dosing intervals for NeoVab compared to a fixed regimen of Vabysmo, to directly compare the effects of more frequent vs. less frequent dosing on patient outcomes.
Add a Placebo Group: While ethical considerations need to be addressed (as withholding effective treatment for wet AMD might not be justifiable), including a placebo group could help delineate the baseline progression of the disease against treatment effects.