Innovent Gets FDA Fast Track for IBI363 as Monotherapy for Advanced Melanoma

Innovent Biologics, Inc., a leading biopharmaceutical company based in San Francisco and Suzhou, China, has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its PD-1/IL-2α Bispecific Antibody Fusion Protein, known as IBI363, for the treatment of unresectable locally advanced or metastatic melanoma. This designation is specifically for patients who have progressed after at least one line of systemic therapy that must include a PD-1/L1 inhibitor. The company is currently conducting Phase 1/2 clinical trials in China, the U.S., and Australia to evaluate the efficacy and safety of IBI363 in various advanced malignant tumors.

At the ESMO Plenary meeting held on June 14, 2024, Innovent presented promising data from their trials, showing significant efficacy in melanoma patients who had previously undergone immunotherapy. Of the 37 patients treated with 1mg/kg of IBI363, 11 achieved objective responses, including one complete response and ten partial responses, resulting in an overall response rate (ORR) of 29.7% and a disease control rate (DCR) of 73.0%.

Dr. Hui Zhou, Senior Vice President of Innovent, highlighted the significance of these findings. He noted that melanoma remains the most fatal skin cancer in Europe and the United States and, although rare in China, it has a high fatality rate with increasing incidence rates each year. Despite the advancements in immune checkpoint inhibitors for melanoma treatment, there is still no approved drug for cases where immunotherapy has failed. Traditional chemotherapy combined with anti-vascular therapy has a very low ORR of 3.8% to 6.8% and a median progression-free survival (PFS) of less than three months. Thus, there is a significant unmet clinical need for new treatments.

IBI363, as a first-in-class PD-1/IL-2α bispecific antibody fusion protein, has shown encouraging results in its monotherapy trials, demonstrating both efficacy and a favorable safety profile in patients who had previously received immunotherapy. Innovent plans to continue exploring the potential of IBI363 to provide better treatment options for patients with immune-resistant melanoma.

The Fast Track Designation by the FDA is designed to expedite the development and review process of drugs that treat serious conditions and address unmet medical needs. This designation allows more frequent communication with the FDA, which can accelerate the clinical development and approval process for IBI363.

Melanoma, a malignant tumor arising from melanocytes, is the fifth most common cancer in the United States. Although it accounts for only 3% of all skin cancer cases, it has the highest mortality rate and is prone to metastasize. In China, both the incidence and mortality rates of melanoma have been steadily rising. Treatment options vary based on the type and mutation status of the melanoma. For instance, BRAF V600 mutation-positive cases are often treated with a combination of BRAF and MEK inhibitors, while other cases may receive chemotherapy combined with anti-angiogenic drugs. Immunotherapy is not typically a first-line treatment for advanced melanoma in China, leaving a gap in effective treatment options after initial therapies fail.

IBI363 is Innovent's pioneering drug candidate, developed to maximize efficacy while minimizing toxicity. It functions by blocking the PD-1/PD-L1 pathway and activating the IL-2 pathway, thereby enhancing the body's immune response against tumors. Preclinical and early clinical studies have demonstrated significant anti-tumor activity and favorable safety profiles.

Innovent Biologics, founded in 2011, is dedicated to delivering high-quality biopharmaceuticals to patients worldwide. The company specializes in innovative treatments for cancer, cardiovascular and metabolic diseases, autoimmune disorders, and eye diseases. With a commitment to integrity and action, Innovent continues to lead in the biopharmaceutical industry, aiming to make first-rate pharmaceutical drugs more accessible globally.

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