Dyve Biosciences and Moffitt Cancer Center Report Promising Study Results for First-of-Its-Kind Topical Therapy Targeting Tumor Acidity

Novel therapy that works throughout the body boosted immune response and slowed tumor growth in early studies, pointing to a potential breakthrough treatment approach

CAMARILLO, Calif.--(BUSINESS WIRE)--Dyve Biosciences, in collaboration with Moffitt Cancer Center, today reported significant study results for a first-of-its-kind investigational therapy applied to the skin and designed to work throughout the body to target the tumor microenvironment, a key driver of treatment resistance and immune evasion.

The treatment, a novel transdermal therapy designed to modulate tumor pH, helped make tumors substantially less acidic, restore T-cell activity, slow tumor growth and improve survival in preclinical studies.

The findings were recently published in Frontiers in Immunology following studies conducted by researchers at Moffitt Cancer Center using animal models of bladder cancer. Known as DYV800, the treatment also demonstrated systemic effects, with activity beyond the site of application, and may have broader potential across multiple solid tumor types where tumor acidity plays a role.

Instead of attacking the tumor directly, this approach targets the conditions that help tumors survive. Tumor acidity may act as an upstream immune checkpoint and suppress immune response before traditional checkpoint pathways are engaged. Prior research has shown tumor-reactive CD8 T-cell responses can drop significantly in acidic conditions, reinforcing the role of pH in limiting immune activity.

Researchers have increasingly focused on the tumor microenvironment because it influences how tumors grow, evade the immune system and respond to treatment. One important factor is tumor acidity. Solid tumors often develop this acidic environment, typically ranging from pH 6.2 to 6.8 compared to a normal physiological pH of 7.4. This can suppress immune function and contribute to treatment resistance, making it a key focus of ongoing cancer research.

Modulating tumor pH and making tumors less acidic may help restore immune function and improve how some cancer treatments work. In these studies, DYV800 was associated with increased intratumoral pH, 4-1BB, TNF-α, IFN-γ, and antigen-specific CD8 responses, together with reduced tumor burden and prolonged survival. These findings reinforce the view that pH modulation may help improve immune activity within acidic tumor microenvironments.

Designed to Work Systemically

Dyve Biosciences’ transdermal platform delivers medicine through the skin, allowing it to circulate throughout the body. This enables the treatment to reach tumors beyond the site of application and influence the tumor microenvironment systemically.

In follow-on analyses, DYV800 increased tumor pH and helped restore T-cell activity suppressed in acidic environments. These findings were consistent with earlier observations of slower tumor growth, improved survival, and effects beyond the site of application.

In the published work, acidic conditions suppressed tumor-reactive T-cell function at multiple levels, including proliferation, migration, cytokine production, and antigen-specific reactivity, supporting the view that tumor acidity may act as an upstream immune checkpoint.

“Tumor acidity is a major barrier that can prevent the immune system from doing its job,” said Shari Pilon-Thomas, PhD, Co-Director, Center for Immunization and Infection Research in Cancer (CIIRC) at Moffitt Cancer Center and Corresponding Author. “By making tumors less acidic, we were able to restore immune activity and improve anti-tumor response in our preclinical models. We believe targeting tumor acidity could represent a potential breakthrough in cancer treatment, particularly when used in combination with immunotherapy, where raising tumor pH may help improve the effectiveness of checkpoint inhibitors.”

“We believe this approach represents a game-changing new way to treat cancer by targeting the tumor microenvironment,” said Dr. Ryan Beal, CEO of Dyve Biosciences. “Instead of going after the tumor directly, we’re changing the conditions that allow it to survive. That shift has the potential to improve how existing treatments work and expand what’s possible for patients.”

DYV800 is an investigational product. Safety and efficacy have not been established.

Long-Standing Cancer Challenge

Tumor acidity has long been recognized as a driver of immune suppression in cancer and may act as an upstream immune checkpoint, but delivering therapies that can safely and effectively change that environment remains a challenge.

Oral buffering approaches showed early promise but have been difficult to translate into clinical use due to dosing limitations, gastrointestinal side effects, and poor tolerability. This has limited the ability to consistently modulate tumor acidity in patients.

Dyve Biosciences’ approach delivers pH-modulating therapy through the skin, bypassing limitations associated with traditional oral delivery and eliminating the need for needles.

New Approach to Drug Delivery

Traditional methods for modulating tumor acidity, including oral buffering strategies, have faced challenges with dosing and tolerability.

DYV800 is designed as a non-invasive transdermal approach intended to address those translational barriers. If the underlying mechanism translates clinically, pH modulation may have broader relevance across solid tumors characterized by acidic tumor microenvironments, where acidity may act as an upstream immune checkpoint.

Preparing for Human Trials

Dyve Biosciences is working with Moffitt Cancer Center through a five-year, multi-trial strategic alliance to advance clinical development. First-in-human studies are expected to begin in 2026.

Early clinical studies are expected to evaluate safety, dosing, and how modulating tumor pH may affect the tumor microenvironment and immune response in patients.

This approach may have relevance across multiple cancers, particularly solid tumors where tumor acidity affects immune response. It may also warrant study alongside existing cancer treatments, including immunotherapy, where reducing tumor acidity may help improve T-cell activity and treatment response.

If supported in clinical trials, pH modulation could represent a new way to make certain cancers more responsive to treatment by changing the tumor environment.

About Dyve Biosciences

Dyve Biosciences is a clinical-stage biotechnology company developing therapies that can be delivered through the skin but work throughout the body. Using its proprietary transdermal delivery platform, Dyve is focused on medicines that target difficult-to-treat biological mechanisms, including pH modulation in the tumor microenvironment. The company’s programs focus on oncology and immunology, with research aimed at improving how existing treatments work and expanding treatment options for patients. For more information, visit DyveBio.com.

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Jamie Szwiec
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