New Hope for Advanced Prostate Cancer: SYNC-T SV-102 Immunotherapy Approved by FDA

Introduction to SYNC-T SV-102 Immunotherapy

Syncromune Inc., a clinical-stage biopharmaceutical company, has received FDA clearance for their innovative SYNC-T SV-102 therapy for treating metastatic castrate-resistant prostate cancer. This approval marks a significant step forward in the fight against this aggressive form of cancer.

How SYNC-T SV-102 Works

SYNC-T SV-102 is a unique therapy that combines partial tumor oncolysis with a fixed-dose combination multi-target biologic drug. First, a procedure is performed to freeze part of the tumor, causing it to break down and release cancer-specific signals. These signals activate the body's immune system, creating an in situ vaccine right at the site of the tumor.

After this initial oncolysis, the SV-102 drug is directly infused into the tumor. This biologic drug further stimulates the immune system while blocking mechanisms that suppress it. By doing so, the therapy enhances the body's ability to recognize and fight the cancer cells.

Clinical Trials and Efficacy

In a Phase 1 trial involving patients with metastatic castrate-resistant prostate cancer, SYNC-T SV-102 demonstrated promising results. The objective response rate was 85%, with five patients showing complete responses and six showing partial responses out of the 13 evaluated. The treatment also led to a complete resolution of bone metastases in 54% of the patients.

The therapy was well-tolerated, with minimal and manageable side effects. These results highlight the potential of SYNC-T SV-102 to improve outcomes for patients with this challenging form of cancer.

The LEGION-100 Phase 1b Trial

Syncromune plans to begin enrolling patients for the LEGION-100 Phase 1b trial in the latter half of 2024. This trial aims to further assess the safety and efficacy of SYNC-T SV-102 in a larger patient population. It marks the next critical step in bringing this innovative therapy to more patients.

The Future of Prostate Cancer Treatment

The approval of SYNC-T SV-102 underscores the potential of combination immunotherapy in treating metastatic castrate-resistant prostate cancer. By harnessing the body's immune system, the therapy offers a personalized and targeted approach that could revolutionize prostate cancer treatment.

With its ability to activate T cells and stimulate an immune response, SYNC-T SV-102 could also have broader applications in treating other types of metastatic solid tumors.

About Syncromune

Syncromune is focused on developing innovative therapies for solid tumor cancers. Their leading platform, SYNC-T, aims to create personalized in situ vaccines that synchronize the release of tumor antigens with immune system activation. This approach has shown high response rates and has the potential to significantly improve patient survival.

Looking Ahead

The FDA clearance of SYNC-T SV-102 is a promising development for patients with advanced prostate cancer. As Syncromune gears up for the LEGION-100 trial, there is growing optimism about the future of cancer immunotherapy and its potential to offer new hope to patients.

Summary

Syncromune Inc.'s FDA-cleared SYNC-T SV-102 is a groundbreaking combination immunotherapy showing promise in treating metastatic castrate-resistant prostate cancer, with high response rates and minimal side effects.