Radioligand Therapy & Theranostics Services

OVERVIEW

Radiopharmaceutical therapies represent an effective way to treat solid cancers by using tumor targeting small molecules, peptides or biologics to deliver a cytotoxic payload that induces DNA damage in tumor cells, while limiting damage to normal and healthy tissue.

Streamlined development, evaluation and clinical translation of radiopharmaceuticals requires a partner that has extensive scientific, regulatory and operational expertise. Working with a CRO that provides a complete solution ensures data is delivered in a timely manner to make a go/no-go decision on your imaging or
therapeutic candidates.

Services Include:

Single-site, first-in-human through multi-site, late phase clinical study support
Investigational New Drug (IND)/Clinical Trial Application (CTA) submission support with clinical protocol development
Preclinical and clinical dosimetry and advanced quantitative image analysis
Radiochemistry development – conjugation, radiolabeling, stability and immunoreactivity
Preclinical proof-of-concept studies – biodistribution, efficacy, toxicology
Good manufacturing practice (GMP) radiochemistry development and production support for imaging agents

Imaging/Theranostic Agent Development Process

Clinical Radiopharmaceutical Therapy Solutions

Seamless transition of your radiopharmaceutical into the clinic requires an imaging partner with experience supporting first-in-human, single-site and late phase, multi-site global clinical studies. Invicro has the unique blend of scientific expertise and operational experience to deliver on studies from Phase 0-III.

Clinical radiopharmaceutical therapeutic development services include:

First-in-human, single-site clinical trial support
Study design and consultation
Criteria-based centralized independent reviews and internal analysis
Late stage, global multi-center clinical trial support with response criteria reads
Advanced image analytics including dosimetry
Safety profile and therapeutic efficacy studies

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Dosimetry and Advanced Image Analytics

Our in-house image analytics team has experience supporting preclinical and clinical radiopharmaceutical therapy studies, spanning from customized and automated image processing techniques using deep learning to dosimetry analysis for safety profile analysis.

Some advanced image analytic techniques include:

Algorithms for automated and semi automated lesion identification
Image quality control and co-registration
Preclinical dosimetry safety studies and validated clinical workflows
Extrapolating dosimetry of therapeutics from imaging agents
Expertise across various species, radionuclides and novel administration routes

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Three-Dimensional Dosimetry for Radiation Safety Estimates from Intrathecal Administration

Radiochemistry - Radioisotopes for Targeted Radiotherapy

Our team has experience with novel and commercially available radioisotopes used for targeted radiotherapy. Our capabilities for novel radiotracers span preclinical to first-in-human clinical studies and GMP production with Invicro’s CMO partners.

Invicro has experience working with the following isotopes:

225Ac
177Lu
131I
111ln
68Ga/177Lu
111In/225Ac
203Pb/212Pb
67Cu/64Cu

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Preclinical Radiopharmaceutical Therapy Solutions

Bringing new therapeutic radiopharmaceuticals to the market is a complex and challenging process. When filing an Investigational New Drug (IND) or Clinical Trial Application (CTA) prior to the initiation of human trials, it is crucial to have strong non-clinical data to support a new candidate.

Invicro provides complete preclinical support of your project, including:

- Study design and consultation
- Radiolabeling/conjugation to support alpha, beta, and gamma emitting isotopes
- in vitro/ex vivo cell and tissue-based assays
- Primary pharmacology studies to demonstrate MOA
- in vivo Imaging model development to support theranostic imaging
- Advanced image analytics
- Dosimetry
- IND support
- Development of chemistry, manufacturing and controls package for imaging agents
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