Targeted Immune Activation Cancer Therapy, Turning 'Cold' Tumors 'Hot'
Targeted Immune Activation Cancer Therapy, Turning 'Cold' Tumors 'Hot'
GDT-001 (IL12-FHAB)
GDT-001 (IL12-FHAB)
Home > PIPELINE > GDT-001 (IL12-FHAB)
Home > PIPELINE > GDT-001 (IL12-FHAB)
Guidant BioTherapeutics
Guidant BioTherapeutics
GDT-001 (Previously known as SON - 1010 ) is a candidate immunotherapeutic recombinant drug that links unmodified single-chain human IL-12 with the albumin-binding domain of the single-chain antibody fragment A10m3.
GDT-001 (Previously known as SON - 1010 ) is a candidate immunotherapeutic recombinant drug that links unmodified single-chain human IL-12 with the albumin-binding domain of the single-chain antibody fragment A10m3.
This was selected to bind the patient’s circulating albumin in the body, both at normal pH, as well as at the acidic pH typically found in the Tumor Microenvironment (TME).
The FHAB technology targets tumor and lymphatic tissue, and this navigated delivery(™) technology has demonstrated significant clinical benefit in clinical studies with sarcoma patients, without any signs of cytokine release syndrome or any adverse side effects. This validating asset will be further expanded through partnerships, while the learning from this clinical experience will help accelerate the clinical development for the exciting dual cytokine assets in the pipeline.
This was selected to bind the patient’s circulating albumin in the body, both at normal pH, as well as at the acidic pH typically found in the Tumor Microenvironment (TME).
The FHAB technology targets tumor and lymphatic tissue, and this navigated delivery(™) technology has demonstrated significant clinical benefit in clinical studies with sarcoma patients, without any signs of cytokine release syndrome or any adverse side effects. This validating asset will be further expanded through partnerships, while the learning from this clinical experience will help accelerate the clinical development for the exciting dual cytokine assets in the pipeline.
Key Details
Key Details
OVERVIEW
OVERVIEW
Indications
Indications
Current Stage
Current Stage
Soft-Tissue Sarcomas (STS) in combination with trabectedin (Yondelis®)
Soft-Tissue Sarcomas (STS) in combination with trabectedin (Yondelis®)
Solid Tumors
Solid Tumors
Phase 1
Phase 1
Interleukin-12 can orchestrate a robust immune response to many cancers and pathogens. Given specific proteins induced in the TME that actively accumulate, retain and bind albumin, such as the Secreted Protein and Rich in Cysteine (SPARC) and glycoprotein 60 (GP60), cancers such as non-small cell lung cancer, melanoma, head and neck cancer, sarcoma, and some gynecological cancers are particularly relevant for this approach.
GDT-001 is designed to deliver IL-12 to local tumor tissue, turning 'cold' tumors 'hot' by stimulating IFNγ, which activates innate and adaptive immune cell responses and increases the production of Programed Death Ligand 1 (PD-L1) on tumor cells.
Interleukin-12 can orchestrate a robust immune response to many cancers and pathogens. Given specific proteins induced in the TME that actively accumulate, retain and bind albumin, such as the Secreted Protein and Rich in Cysteine (SPARC) and glycoprotein 60 (GP60), cancers such as non-small cell lung cancer, melanoma, head and neck cancer, sarcoma, and some gynecological cancers are particularly relevant for this approach.
GDT-001 is designed to deliver IL-12 to local tumor tissue, turning 'cold' tumors 'hot' by stimulating IFNγ, which activates innate and adaptive immune cell responses and increases the production of Programed Death Ligand 1 (PD-L1) on tumor cells.
Mechanism of actions
Mechanism of actions
Demonstrated to Reduce Tumor Growth
Demonstrated to Reduce Tumor Growth
Targeted Delivery
Targeted Delivery
Advantage one
Advantage one
Advantage two
Advantage two
GDT-001 is approximately 35-fold more potent than IL-12 alone at Day 10, using a 1:30 ratio of IL-12, demonstrated in Mouse B16F10 Melanoma Model.
GDT-001 is approximately 35-fold more potent than IL-12 alone at Day 10, using a 1:30 ratio of IL-12, demonstrated in Mouse B16F10 Melanoma Model.
The FHAB technology targets tumor and lymphatic tissue, providing a mechanism for dose sparing and an improved safety and efficacy profile.
The FHAB technology targets tumor and lymphatic tissue, providing a mechanism for dose sparing and an improved safety and efficacy profile.
Key advantages
Key advantages
Related Programs
Related Programs
First in class dual-cytokine IL-12 + IL-15 candidate ready for IND and clinical trials.
First in class dual-cytokine IL-12 + IL-15 candidate ready for IND and clinical trials.
GDT-002 (IL12-FHAB-IL15)
GDT-002 (IL12-FHAB-IL15)
Phase 1 | Solid Tumors
Phase 1 | Solid Tumors
First in class dual-cytokine IL-12 + IL-18 candidate in early preclinical development.
First in class dual-cytokine IL-12 + IL-18 candidate in early preclinical development.
GDT-003 (IL12-FHAB-IL18)
GDT-003 (IL12-FHAB-IL18)
Read More
Read More
Phase 1 | Solid Tumors
Phase 1 | Solid Tumors
Interested in GDT-001?
Interested in GDT-001?
Partnerships Inquiry
Partnerships Inquiry
Guidant BioTherapeutics is actively engaging with potential partners and licensees interested in leveraging the strength of our proprietary FHAB technology platform.
Guidant BioTherapeutics is actively engaging with potential partners and licensees interested in leveraging the strength of our proprietary FHAB technology platform.
Partner With Us
Partner With Us
Guidant BioTherapeutics
Guidant BioTherapeutics
© 2026 Sonnet BioTherapeutics, Inc. All Rights Reserved.
© 2026 Sonnet BioTherapeutics, Inc. All Rights Reserved.
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CONTACT
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GDT-002 (IL12-FHAB-IL15)
Advancing for treatment of non muscle invasive bladder cancer (NMIBC) and other solid tumors
Home > PIPELINE > GDT-002 (IL12-FHAB-IL15)
Guidant Biotherapeutics
GDT-002 is an immunotherapeutic bifunctional drug candidate that links unmodified single-chain human IL-12 and human IL-15 with the albumin-binding domain of the single-chain antibody fragment FHAB, separating the two cytokines with linkers to avoid steric hindrance.
The FHAB single chain was selected to bind well at normal pH, as well as at an acidic pH that is typically found in the tumor microenvironment (TME). The FHAB technology targets tumor and lymphatic tissue, providing lowered dose, enhanced PK, and an opportunity to improve the safety and efficacy profile of not only IL-12 and IL-15, but a variety of other potent immunomodulators using the platform.
Key Details
OVERVIEW
Mechanism of actions
Related Programs
Indications
Current Stage
Solid Tumors
Soft-Tissue Sarcomas (STS) in combination with trabectedin (Yondelis®)
Phase 1
Interleukin-12 can orchestrate a robust immune response to many cancers and pathogens. Given specific proteins induced in the TME that actively accumulate, retain and bind albumin, such as the Secreted Protein and Rich in Cysteine (SPARC) and glycoprotein 60 (GP60), cancers such as non-small cell lung cancer, melanoma, head and neck cancer, sarcoma, and some gynecological cancers are particularly relevant for this approach.
GDT-001 is designed to deliver IL-12 to local tumor tissue, turning 'cold' tumors 'hot' by stimulating IFNγ, which activates innate and adaptive immune cell responses and increases the production of Programed Death Ligand 1 (PD-L1) on tumor cells.
Key advantages
Advantage one
Demonstrated to Reduce Tumor Growth
GDT-001 is approximately 35-fold more potent than IL-12 alone at Day 10, using a 1:30 ratio of IL-12, demonstrated in Mouse B16F10 Melanoma Model.
Targeted Delivery
Advantage two
The FHAB technology targets tumor and lymphatic tissue, providing a mechanism for dose sparing and an improved safety and efficacy profile.
First in class dual-cytokine IL-12 + IL-15 candidate ready for IND and clinical trials.
GDT-002 (IL12-FHAB-IL15)
Read More
Phase 1 | Solid Tumors
First in class dual-cytokine IL-12 + IL-18 candidate in early preclinical development.
GDT-003 (IL12-FHAB-IL18)
Read More
Phase 1 | Solid Tumors
Interested in GDT-001?
Guidant BioTherapeutics is actively engaging with potential partners and licensees interested in leveraging the strength of our proprietary FHAB technology platform.
Partner With Us
Partnerships Inquiry