Innovent Receives Fast Track Designation from the U.S. FDA for IBI363 (PD-1/IL-2α Bispecific Antibody Fusion Protein) as Monotherapy for Advanced Melanoma

Rhea-AI Summary

Innovent Biologics (HKEX: 01801) has received Fast Track Designation from the U.S. FDA for IBI363, a PD-1/IL-2α Bispecific Antibody Fusion Protein, for treating advanced melanoma. This designation applies to patients with unresectable locally advanced or metastatic melanoma who have progressed after at least one line of systemic therapy, including a PD-1/L1 inhibitor.

In ongoing Phase 1/2 trials, IBI363 has shown promising results: among 37 melanoma patients previously treated with immunotherapy, 11 achieved objective responses (1 CR, 10 PR), with an ORR of 29.7% and DCR of 73.0%. This is significant given the efficacy of current treatments for immunotherapy-resistant melanoma, which have an ORR of only 3.8% to 6.8%.

Positive

• Fast Track Designation granted by FDA for IBI363 in advanced melanoma
• Promising efficacy in melanoma patients who failed prior immunotherapy (ORR 29.7%, DCR 73.0%)
• Potential to address unmet medical need in immunotherapy-resistant melanoma
• Ongoing Phase 1/2 trials in China, U.S., and Australia

Negative

• None.

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SAN FRANCISCO and SUZHOU, China, Sept. 3, 2024 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, 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 (R&D code: IBI363) for the treatment of unresectable locally advanced or metastatic melanoma (except choroidal melanoma) in patients who have progressed after at least one line of systemic therapy, which must include a PD-1/L1 inhibitor. Phase 1/2 clinical trials are currently underway in China, the U.S., and Australia to assess IBI363's efficacy and safety in various advanced malignant tumors.

At the ESMO Plenary meeting on June 14, 2024, Innovent presented promising efficacy signals in melanoma patients who had previously undergone immunotherapy: 37 patients with melanoma who had previously received immunotherapy received 1mg/kg of IBI363 and underwent at least one tumor evaluation after baseline, and 11 patients achieved objective responses, including 1 CR and 10 PR, with ORR and DCR of 29.7% and 73.0%, respectively. (Link)

Dr. Hui Zhou, Senior Vice President of Innovent, said, "Melanoma is the most common fatal skin cancer in Europe and the United States. In China, while melanoma is a rare malignant tumor, it has a high fatality rate, and its incidence is steadily increasing each year. Despite the success of immune checkpoint inhibitors in the treatment of melanoma, there is currently no drug approved for immunotherapy failed melanoma around the world, and the ORR of traditional chemotherapy ± anti-vascular therapy for immunotherapy failed melanoma is only 3.8% to 6.8%, with a median PFS of less than 3 months, and the benefit is very limited^[1]-[2]. Therefore, there is an urgent clinical need for patients who have previously failed immunotherapy. As a First in-class PD-1/IL-2α-bias bispecific antibody fusion protein, IBI363 monotherapy has shown encouraging efficacy and a favorable safety profile in melanoma subjects who have previously received immunotherapy. We will continue to explore the efficacy and safety of IBI363 in melanoma to provide more effective clinical treatment for patients with immune-resistant melanoma."

Fast Track Designation (FTD) is a rapid review process designed to facilitate the clinical development of a drug that may treat serious conditions and fulfill an unmet medical need. According to regulations, drug candidates that obtain FTD qualifications will have more opportunities to communicate with the FDA during subsequent drug development and review processes, which will help speed up the clinical development and approval of the drug.

About Melanoma

Melanoma is a malignant tumor that develops from melanocytes and is the fifth most common cause of cancer in the United States^[3]. Although melanoma represents only 3% of all skin cancer cases, it has the highest mortality rate and is the most prone to metastasize. In China, both the incidence and mortality rates of melanoma have been steadily rising over the years. According to the classification of the disease site, melanoma is mainly divided into skin melanoma, acral and mucosal melanoma. Chinese melanoma differs greatly from European and American Caucasian melanoma in pathogenesis, biological behavior, histological morphology, treatment and prognosis^[4]. For advanced cutaneous and acral melanomas, for those carrying BRAF V600 mutation, BRAF inhibitor combined with MEK inhibitor is the preferred molecular targeted therapy. For patients without a BRAF V600 mutation, comination of chemotherapy and anti-angiogenic drugs may be considered as the first-line treatment. Immunotherapy has not been approved as the first-line treatment indication for advanced melanoma in China. For second-line treatment, therapies not used in the first-line are recommended. If a PD-1 monoclonal antibody was not administered initially, it can be selected for the second-line. In advanced mucosal melanoma, chemotherapy or a combination of PD-1 monoclonal antibody and anti-angiogenic drugs may be considered as first-line options. For patients with BRAF V600 mutation, a BRAF inhibitor ±MEK inhibitor can be chosen. Currently, posterior treatment options for melanoma are very limited^[5].

About IBI363 (PD-1/IL-2α)

IBI363 is a first-in-class drug candidate independently developed by Innovent Biologics. Its active ingredient is PD-1/IL-2 bispecific antibody fusion protein. The IL-2 arm of IBI363 has been engineered to maximize efficacy and reduce toxicity, whereas the PD-1 binding arm achieves PD-1 blockade and selective IL-2 delivery. Therefore, IBI363 functions by simultaneously blocking the PD-1/PD-L1 pathway and activating the IL-2 pathway, enabling more precise and efficient targeting and activation of tumor specific T cells. IBI363 has demonstrated notable anti-tumor activity across various tumor-bearing pharmacological models and showed significant antitumor efficacy in both PD-1 resistant and metastatic models. Additionally, IBI363 exhibited a favorable safety profile in preclinical models. Clinical studies of IBI363 are currently underway in China, the United States, and Australia to evaluate its safety, tolerability and preliminary efficacy in subjects with advanced malignancies.

About Innovent

Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that treat some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has 11 products in the market, 3 new drug applications under the NMPA review, 4 assets in Phase III or pivotal clinical trials and 18 more molecules in early clinical stage. Innovent partners with over 30 global healthcare leaders, including Eli Lilly, Roche, Sanofi, Adimab, Incyte and MD Anderson Cancer Center.

Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit www.innoventbio.com, or follow Innovent on Facebook and LinkedIn.

Statement: Innovent does not recommend the use of any unapproved drug (s)/indication (s).

Forward-Looking Statements

This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly.

These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions.

Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect.

References:

[1] Wang X, Xu W, Chi Z, et al. Chemotherapy combined with antiangiogenic drugs as salvage therapy in advanced melanoma patients progressing on PD-1 immunotherapy. Transl Oncol. 2021;14(1):100949.

[2] European Journal of Cancer 162 (2022) 22e33；

[3] National Cancer Institute Melanoma of the Skin-Cancer Stat Facts:

https://seer.cancer.gov/statfacts/html/melan.html.

[4] Melanoma Diagnosis and Treatment (2022).

[5] Chinese Society of Clinical Oncology (CSCO) Melanoma Diagnosis and Treatment Guidelines (2022).

 

FAQ

What is the Fast Track Designation for Innovent's IBI363 (IVBIY)?

The FDA granted Fast Track Designation to IBI363 for treating unresectable locally advanced or metastatic melanoma in patients who progressed after at least one line of systemic therapy, including a PD-1/L1 inhibitor.

What are the clinical trial results for IBI363 (IVBIY) in melanoma patients?

In Phase 1/2 trials, IBI363 showed an ORR of 29.7% and DCR of 73.0% in 37 melanoma patients previously treated with immunotherapy. 11 patients achieved objective responses, including 1 CR and 10 PR.

How does IBI363 (IVBIY) compare to current treatments for immunotherapy-resistant melanoma?

IBI363 shows promising results with an ORR of 29.7%, compared to current treatments for immunotherapy-resistant melanoma which have an ORR of only 3.8% to 6.8% and median PFS of less than 3 months.

What type of drug is Innovent's IBI363 (IVBIY)?

IBI363 is a PD-1/IL-2α Bispecific Antibody Fusion Protein, classified as a First in-class treatment for melanoma patients who have previously failed immunotherapy.