We’re Shaping the Future of Immunotherapy by Unlocking the Power of Granzyme B
to Tackle Cancer & Autoimmune Diseases.[I]Illustrative concept; not actual patient data unless explicitly stated.
Why CytoSite Bio
World-Renowned Leaders in Immunotherapy
Co-founders Benjamin Larimer, PhD, Eric Wehrenberg-Klee, MD, and Umar Mahmood, MD, PhD, three of the top global researchers in granzyme B, built CytoSite Bio. They developed the foundational technology for our platform and continue to provide unparalleled scientific and clinical leadership, ensuring our solutions are grounded in cutting-edge research. Their combined vision delivers a unique and powerful solution for the future of immunotherapy.
Benjamin Larimer, PhD
Umar Mahmood, MD, PhD
Trusted by Industry Giants
The potential of our granzyme B platform has earned the confidence of industry-leading companies, a powerful testament to the strength of our science. We have partnered with Lantheus, a global leader in precision diagnostics and radiopharmaceuticals, through a licensing agreement for our radiodiagnostic agent. This collaboration validates the clinical value of our technology.[VIII]Collaboration scope is governed by definitive agreements; collaboration does not guarantee regulatory approval, commercialization, or clinical success. Furthermore, our pipeline is advancing with the support of major global pharmaceutical companies and strategic partnerships that underscore the potential of our next-generation approach to precision immunotherapy.
First-in-Class Granzyme B Targeting Platform
Our platform is the first of its kind[III]“First-in-class” is based on CytoSite’s internal assessment of publicly available information as of the publish date; not independently verified. to harness the power of granzyme B, a functional biomarker that directly signals immune-mediated cancer cell death. While other approaches look at static markers or general metabolic activity, our technology provides a real-time, actionable roadmap[II]Describes intended use and investigational objectives; clinical utility and outcomes remain under evaluation and are not guaranteed. of where the body is actively fighting a disease. By leveraging this single biological signal for both our diagnostic and therapeutic programs, we are pioneering a unique, integrated approach. Our imaging agent provides a clear picture of immune activity, while our therapeutic agent utilizes the same granzyme B pathway for precision-guided targeting and tumor destruction.[VI]Mechanistic description based on investigational design and preclinical/early data; benefit-risk has not been established in humans. This seamless connection is what makes our platform truly first-in-class.[III]“First-in-class” is based on CytoSite’s internal assessment of publicly available information as of the publish date; not independently verified.
Impressive Early Clinical Results— >95% Sensitivity/Specificity Across Multiple Cancer Types
Our diagnostic platform’s capabilities are supported by robust clinical data, demonstrating high clinical value with a sensitivity and specificity of over 95% across multiple cancer types to date.[IX]Performance metrics reflect early, limited-size studies with protocol-specific endpoints; not validated for all populations, indications, or settings; results may vary. These metrics aren’t just numbers; they represent the accuracy that is our goal to empower confident decision-making. The high sensitivity of our test will enable us to reliably detect when a patient’s immune system is actively fighting cancer. Conversely, our high specificity will ensure we can correctly identify when a therapy is not working, preventing patients from enduring ineffective and costly treatments. This high degree of accuracy and reliability is a critical differentiator, and will provide clinicians and drug developers with the certainty they need to guide patient care and accelerate the development of new drugs.
Ready-to-Deploy Infrastructure – GMP Manufacturing Complete, Active INDs, Established Clinical Sites
We’ve built the operational and regulatory infrastructure needed to accelerate clinical partnerships. Our platform is ready for immediate deployment, featuring a completed GMP manufacturing process to ensure a reliable supply of our radiopharmaceuticals. We have active INDs with a flexible, modular design that streamlines regulatory submissions for collaborators. Furthermore, our established network of clinical sites is prepared to conduct trials. This complete, pre-established framework eliminates the typical barriers to entry, enabling our partners to quickly and efficiently advance their clinical programs without delay.[X]GMP refers to clinical-trial manufacturing readiness; INDs authorize specified studies and do not imply approval. Site readiness and timelines are subject to various factors, including regulatory, operational, and contractual considerations.
Our Leadership
Our Leadership
Benjamin Larimer, PhD
Umar Mahmood, MD, PhD
Eric P. Wehrenberg-Klee, MD
Colin Miller, PhD
Geoffrey Bilcer, PhD
Ellen Cordo, CPA
Kimmai Phan
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I
Illustrative concept; not actual patient data unless explicitly stated.
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II
Describes intended use and investigational objectives; clinical utility and outcomes remain under evaluation and are not guaranteed.
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III
“First-in-class” is based on CytoSite’s internal assessment of publicly available information as of the publish date; not independently verified.
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IV
Potential process benefits are investigational and depend on study design, regulatory guidance, and sponsor practices; not guaranteed.
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V
Investigational; not approved for commercial use. The safety and efficacy of this product have not been established.
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VI
Mechanistic description based on investigational design and preclinical/early data; benefit-risk has not been established in humans.
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VII
Preclinical model results; not necessarily predictive of human outcomes.
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VIII
Collaboration scope is governed by definitive agreements; collaboration does not guarantee regulatory approval, commercialization, or clinical success.
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IX
Performance metrics reflect early, limited-size studies with protocol-specific endpoints; not validated for all populations, indications, or settings; results may vary.
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X
GMP refers to clinical-trial manufacturing readiness; INDs authorize specified studies and do not imply approval. Site readiness and timelines are subject to various factors, including regulatory, operational, and contractual considerations.
From Diagnostics to Therapeutics
Company Founded
Developed first-in-class Granzyme B PET imaging
- Developed first-in-class[III]“First-in-class” is based on CytoSite’s internal assessment of publicly available information as of the publish date; not independently verified. granzyme B PET imaging
- Built a world-class team
- Secured Series A Funding
- Awarded multiple grants and patents
First Human Granzyme B PET Image
First to image granzyme B in humans via a PET scan.
- Iterated CSB-111 and CSB-221 to the final CSB-321 design for PET imaging of granzyme B.[V]Investigational; not approved for commercial use. The safety and efficacy of this product have not been established.
- Validated clinical effectiveness of CSB-321 granzyme B PET imaging in melanoma and NSCLC in humans.[V]Investigational; not approved for commercial use. The safety and efficacy of this product have not been established.
CSB-321 PET Imaging Diagnostic Clinical Trials Initiated
- Completed successful Phase I trial with CSB-221 and next-gen CSB-321.[III]“First-in-class” is based on CytoSite’s internal assessment of publicly available information as of the publish date; not independently verified.
- Validated targeting in multiple cancers, including melanoma, kidney, head and neck, mesothelioma, and colorectal cancer.
- Established GMP manufacturing for CSB-321[V]Investigational; not approved for commercial use. The safety and efficacy of this product have not been established. ligand.
- Strategic decision to expand to radiotherapeutics.
- Preclinical therapeutic success.[VII]Preclinical model results; not necessarily predictive of human outcomes.
CSB-321 Diagnostic Human Dosimetry Completed
- First in-Human CSB-321[V]Investigational; not approved for commercial use. The safety and efficacy of this product have not been established. clinical trial.
- Demonstrated optimal clinical pharmacokinetics for the platform
Pioneered granzyme B radiotherapeutic for immunotherapy.
First-in-class preclinical granzyme B radiotherapeutic for immunotherapy.
- 100% complete radioimmunotherapy response in preclinical efficacy studies.[VII]Preclinical model results; not necessarily predictive of human outcomes.
Lantheus Licensing Deal
Phase I CSB-321[V]Investigational; not approved for commercial use. The safety and efficacy of this product have not been established. trials continue.
- Phase I CSB-321[V]Investigational; not approved for commercial use. The safety and efficacy of this product have not been established. trials continue.
- Lantheus partnership validates radiodiagnostic platform.[VIII]Collaboration scope is governed by definitive agreements; collaboration does not guarantee regulatory approval, commercialization, or clinical success.
- CSB-421[V]Investigational; not approved for commercial use. The safety and efficacy of this product have not been established. therapeutic IND submission.
- Multiple cancer indications for CSB-421[V]Investigational; not approved for commercial use. The safety and efficacy of this product have not been established. radiotherapeutic.
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