Rigor-led Discovery

Rigor-led development of next-generation therapeutics for HIV and cancer. At Masinova, we combine Quality-by-Design (QbD) execution with modality innovation—spanning next-generation CAR T-cell engineering and AI-integrated nanomedicine (including targeted nanoparticle approaches). Our goal is to build reproducible, safety-informed, development-ready programs that can progress efficiently from preclinical milestones toward clinical evaluation.

 

Beyond the ordinary: Our Core Technology Building

This is where our journey begins.

TPP-defined HIV program.
Our lead HIV program is guided by a defined Target Product Profile (TPP) and a structured development plan designed to support Phase I readiness.

Early oncology programs in development.
We are advancing early-stage oncology programs using the same rigor-led, QbD-driven framework.

Driven by passion: Next-Gen CAR T cell

Next-Generation CAR T-Cell

Engineering durable cellular therapies for HIV and oncology.
Masinova designs next-generation CAR T-cell strategies to address key biological barriers such as persistence, specificity, and escape/heterogeneity. In HIV, we focus on durable immune control and resistance to viral diversity; in oncology, we focus on overcoming antigen heterogeneity and tumor microenvironment suppression. Program-level construct details are available under NDA.

Design priorities

 

  • Multi-parameter specificity and functional potency

  • Persistence and controlled activation

  • Escape-resilience and safety logic

 

 

Focus on Medical Needs: NanoParticle

AI-Integrated Nanomedicine (Targeted Nanoparticles)

Precision delivery to improve tissue access and therapeutic index.
We develop targeted nanomedicine strategies using nanoparticle design principles to optimize biodistribution, target engagement, and exposure in hard-to-reach tissues. Our development work is guided by structured criteria (e.g., size/charge/stability, targeting ligand design, release kinetics) and evaluated using reproducible test frameworks aligned to translational endpoints.

What we optimize

 

  • Delivery precision and tissue penetration

  • Stability, release kinetics, and PK/PD alignment

  • Safety-informed design and developability

 

 

Quality and Speed

Translational Intelligence Framework

Connecting preclinical signals to clinical readiness with QbD discipline.
Masinova applies structured translational thinking tools—including simulation-driven and decision frameworks—to connect TPP-defined goals to qualified assays, biomarkers, and development gates. This framework supports clear go/no-go criteria, early risk identification, and partner-ready packages that improve efficiency from preclinical development toward Phase I readiness.

How it shows up

 

  • TPP → assays → biomarkers → decision gates

  • Safety-by-design and risk mitigation planning

  • Partner-evaluable preclinical package (under NDA)

 

 

Our Scientific Approach

Masinova’s R&D is built to withstand real-world development pressure: clear hypotheses, measurable endpoints, and decision-quality data.

Reproducibility

SOP-driven workflows and qualified/robust assays to support confident decisions.

Safety-by-Design

Early safety and developability considerations integrated into program strategy.

Efficient Translation

milestone-driven plans aligned with preclinical and IND-enabling expectations.

Partner-Ready Preclinical Package

Masinova has built a complete, QbD-driven preclinical package for our lead HIV/oncology program. This package links a clear Target Product Profile (TPP) to qualified assays, defined go/no-go criteria, and an IND-enabling plan. Potential partners can confidently evaluate our assets under NDA.

Partner-Ready Preclinical Package (Under NDA)

Masinova prepares partner-evaluable packages that connect:

  • TPP → qualified assays → go/no-go criteria → IND-enabling plan

  • Clear milestones, risks, and mitigation strategies

  • Documentation structure designed for efficient collaboration

 

Let’s Talk

We welcome discussions with biopharma partners and investors interested in HIV and oncology therapeutic programs.