Imaging and AI for Temferon™ for Glioblastoma Trials | Genenta & IAG Partnership

Genenta and Image Analysis Group collaborate on the Phase I/IIa TEM‑GBM study of Temferon™ in glioblastoma multiforme, using advanced imaging and AI‑driven analysis to distinguish treatment effects from pseudo‑progression and generate more reliable early efficacy readouts.

Key Themes:

• Phase I/IIa TEM‑GBM trial support for Temferon™, an HSPC‑based immuno‑gene therapy in newly diagnosed glioblastoma patients.
  
• Centralized, quantitative MRI analysis and AI‑driven tumour volume assessment to differentiate true progression from treatment‑related inflammatory changes.
  
• Advanced imaging endpoints to complement standard criteria such as RANO and provide earlier insight into Temferon’s biological activity.
  
• Real‑time central reads and DYNAMIKA‑powered analytics to help Genenta de‑risk development and optimize decision‑making in this first‑in‑human program.

Discuss Imaging and AI Strategies for Your GBM Trial: contact@ia-grp.com

Partnership to optimize the TEM‑GBM clinical study

Genenta, a clinical‑stage biotechnology company developing hematopoietic stem cell immuno‑gene therapies for cancer, has partnered with Image Analysis Group to support its Phase I/IIa TEM‑GBM study of Temferon™ in glioblastoma multiforme. The collaboration focuses on using advanced imaging and AI‑based analysis to better understand how Temferon affects GBM tumors and surrounding brain tissue during early‑phase clinical development.

The TEM‑GBM study evaluates the safety and preliminary efficacy of autologous CD34+‑enriched hematopoietic progenitor cells, genetically modified with a lentiviral vector encoding human interferon‑α2, in patients with GBM who have an unmethylated MGMT promoter. IAG’s role is to provide centralised imaging expertise and quantitative analytics that can help Genenta interpret early response patterns with greater confidence.

Imaging Challenges in Glioblastoma Immunotherapy Trials

Immunotherapies such as Temferon™ can trigger inflammatory responses that mimic disease progression on conventional MRI, a phenomenon known as pseudo‑progression. In GBM, this can make it difficult to distinguish true tumor growth from treatment‑related changes when using routine clinical imaging and standard criteria alone.

To address this, Genenta selected IAG as its imaging partner for the TEM‑GBM study. By applying advanced, AI‑driven methods to brain MRI data, IAG aims to reduce ambiguity in response assessment, provide more nuanced views of tumor dynamics, and support better‑informed decisions on dose escalation, cohort expansion and overall development strategy.

Advanced imaging and AI‑driven tumor assessment

Using its proprietary DYNAMIKA™ platform, IAG performs central reading and quantitative analysis of imaging data generated in the TEM‑GBM trial. Non‑invasive, AI‑based methodologies are used to measure tumor volume within brain tissue, assess changes over time, and differentiate patterns consistent with pseudo‑progression from those indicating genuine tumor growth.

These imaging‑derived biomarkers complement established response criteria, such as RANO, by adding volumetric and texture‑based insights that can highlight early treatment effects. This helps Genenta monitor how patients react to Temferon™ in near‑real time and explore how the therapy influences both tumor and peritumoural tissue.

Benefits for early‑phase GBM development

For a first‑in‑human, Phase I/IIa study, early and accurate understanding of treatment effects is critical. IAG’s central imaging services and AI‑driven analytics provide Genenta with:

• More precise quantification of tumour burden and its evolution over time.
  
• A better ability to separate true progression from inflammatory changes associated with immunotherapy.
  
• Additional evidence to support safety and preliminary efficacy assessments in a complex GBM population.

These insights help de‑risk early development decisions, inform future trial design, and support discussions with investigators and regulators about how Temferon™ behaves in the brain microenvironment.

IAG’s broader role in oncology imaging and AI

Beyond this programme, IAG serves as an imaging CRO and scientific partner to biotech and pharma companies across oncology and immuno‑oncology. Leveraging its DYNAMIKA™ platform, central reading infrastructure and quantitative imaging capabilities, IAG designs and executes imaging strategies that align with each sponsor’s mechanism of action, trial phase and regulatory needs.

In the TEM‑GBM collaboration with Genenta, IAG’s work on AI‑driven, non‑invasive tumour assessment illustrates how advanced imaging can unlock more value from early‑phase glioblastoma trials. The same approach can be adapted to other solid tumour and immunotherapy programmes where pseudo‑progression and complex response patterns challenge conventional imaging assessments.

Exploring ways to de‑risk your glioblastoma development program with better imaging and response assessment?

Discover how advanced MRI, central reading and AI‑driven tumor analysis can help distinguish pseudo‑progression from true progression and support clearer early‑phase decisions in GBM trials.

Book a personalized DYNAMIKA™ demo today to see how our neuro‑oncology imaging and analytics can strengthen your Temferon‑style study design and help your teams act with greater confidence.

About Image Analysis Group (IAG)

Image Analysis Group (IAG) is a global imaging clinical research organization (iCRO) focused on de-risking and accelerating drug development through advanced imaging science and AI. IAG designs and runs imaging-centric clinical trials across oncology, immunology, neurology, rare diseases, musculoskeletal conditions, fertility and women’s health, partnering closely with biotech and pharma sponsors from early proof-of-concept through pivotal and real-world evidence studies.

Through its proprietary, cloud-native DYNAMIKA™ platform, IAG integrates centralized imaging workflows, blinded independent review, expert readers and AI-powered imaging biomarkers to deliver high-quality, regulator-ready imaging endpoints and decision-enabling insights that optimize trial design, reduce operational risk and unlock the full value of imaging data.

Media contact:

Marie Fussell
IAG Communications Lead
Press@ia-grp.com

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Read more about our partnership with Genenta here: https://ir.genenta.com/node/6341/pdf