Pipeline Overview

DEVELOPMENT PIPELINE

Pipeline Overview

Turning research findings into diagnostic and therapeutic technologies.

Biozipcode, Inc. aims to develop findings from basic research into diagnostic technologies, therapeutic candidates, cell-targeted drug candidates, and medical materials that can be put to practical use.

In diabetes, our R&D focuses on therapeutic candidates aimed at complete remission, biomarkers associated with diabetes stem cells, and cell-targeted drug candidates using Biozipcode™.

We also aim to apply Biozipcode™ cell-recognition technology to cancer-cell targeting and tissue regeneration. For each program, we are working toward development stages spanning basic and preclinical research, clinical application, and commercialization.

The pipeline shown here includes programs in basic, exploratory, preclinical, and translational research. The research topics, therapeutic and diagnostic candidates, and Biozipcode™ candidates listed have not necessarily been shown to be effective or safe in humans. They do not represent approved medicines, diagnostic methods, or medical devices.

The development stage, strategy, target indication, and candidate treatments for each program may change as research, partnerships, preclinical and clinical studies, and discussions with regulators progress.

Medical & Scientific Disclaimer

Basic Research

Biozipcode™ Cell-Targeted Diabetes Therapy

We are developing an investigational cell-targeted diabetes therapy by combining Biozipcode™ candidates that recognize diabetes stem cells with existing HDAC inhibitors, with a cure as a long-term research goal.

Basic Research

Cell-Targeted Tissue Regeneration

We are developing investigational materials designed to integrate with tissue when placed at the site, potentially avoiding transplantation or suturing. One focus is regenerative approaches for skin damage, including burns.

Basic Research

Preclinical (Animal) Research

Diabetes Stem Cell Biomarker

We are exploring a companion diagnostic candidate based on detecting cells consistent with the research concept of diabetes stem cells in peripheral blood to help assess diabetes.

Preclinical / Clinical POC

Cell-Targeted Oncology Therapeutics

We are investigating whether Biozipcode™ candidates that recognize features shared by cancer cells could deliver new anticancer agents and enable the reconsideration of drugs previously limited by side effects.

Preclinical / Clinical POC

Diabetes Remission Therapy Candidate

We are researching a treatment approach combining an existing HDAC inhibitor (or a drug with HDAC-inhibiting activity) with insulin. The aim is to evaluate whether repurposing existing medicines could benefit people with type 2 diabetes.

Preclinical / Clinical POC

Phase I: Safety and Dose

Phase II: Efficacy and Side Effects

Phase III: Confirmatory Studies

Understanding the Pipeline Stages

Basic Research

Basic research lays the foundation for drug discovery by investigating the biology and chemistry of disease at the molecular level. It helps identify potential drug targets and understand disease mechanisms, providing a basis for future treatments.

Key Points:

Identify and validate potential drug targets.
Use advanced methods to study disease mechanisms.
Review the literature, model biological processes, and run laboratory experiments.
Examine how potential therapeutic compounds interact with biological systems.
Form hypotheses about how a new medicine might affect disease processes.

Preclinical (Animal) Research

Preclinical research tests drug candidates in laboratory and animal models before human trials. These studies examine safety, pharmacokinetics, pharmacodynamics, and potential efficacy. The results help determine whether a candidate has an acceptable basis for entering clinical studies.

Key Points:

Assess toxicity, metabolism, and pharmacological effects in animal models.
Determine dose ranges and identify potential side effects.
Examine effects on biological systems and possible mechanisms of action.
Generate data to inform clinical trial design, including dosing plans.
Regulators review preclinical data before allowing human studies to begin.

Phase I: Safety and Dose

Phase I studies are usually the first tests of an investigational medicine in humans. They focus on safety, tolerability, pharmacokinetics, and pharmacodynamics, and help determine a dose range suitable for further study.

Key Points:

Assess safety and determine appropriate doses.
Studies may enroll approximately 20–100 healthy volunteers or patients.
Examine how the medicine is absorbed, metabolized, and eliminated.
Identify side effects as doses increase.

Phase II: Efficacy and Side Effects

Phase II studies further evaluate an investigational medicine in people with a specific condition, often in larger groups of around 100–300 participants. They begin gathering preliminary evidence of effectiveness while continuing to monitor safety, including short-term side effects.

Key Points:

Further assess potential efficacy and safety.
Include larger groups of people with the condition.
Help identify a dose that balances potential benefit and side effects.
Provide additional safety data and early evidence of efficacy.

Phase III: Confirmatory Studies

Phase III studies evaluate an investigational medicine in larger populations, sometimes 1,000–3,000 participants. They seek to confirm efficacy, monitor side effects, compare the treatment with standard care, and gather information for safe use. Their results may support an application for regulatory approval.

Key Points:

Confirm efficacy on a larger scale and assess the overall balance of benefits and risks.
Include large patient groups.
Compare the investigational medicine with standard treatment.
Provide important evidence for review by regulators such as the FDA.

Phase IV: Postmarketing Studies

Phase IV studies take place after a medicine is approved for marketing. They gather further information about its effects across different populations and about possible side effects with long-term use. They may also examine other potential uses and refine guidance for treatment.

Key Points:

Begin after marketing approval.
Monitor long-term effects and safety.
May investigate additional uses, benefits, and dosing strategies.
Can involve thousands of people using the medicine.