Innovent Biologics, Inc., a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, announced that the results of the Phase Ia/Ib study of IBI110 were released today in a poster presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting 2021 (Abstract #2589).

The phase 1 study of IBI110 is a dose-escalation trial evaluating IBI110, an anti-LAG-3 monoclonal antibody, as a single agent and in combination with sintilimab in patients with advanced solid tumors refractory to standard of care therapy. The study is comprised of Phase Ia, an IBI110 single-drug dose-escalation phase, and Phase Ib, the dose-escalation phase of IBI110 in combination with sintilimab (200mg). At disease progression, cross over from IBI110 monotherapy to combo (IBI110+ sintlilimab) was allowed at the investigators' discretion. At data cutoff (February 9, 2021), 40 patients were enrolled and received treatment. 22 subjects were assigned in dose groups of 7 (0.01mg/kg~20mg/kg) in Phase Ia, the prespecified dose escalation had been completed and no dose-limited toxicity (DLT) was observed. No adverse event (AE) led to discontinuation of IBI110 or sintilimab and no treatment-related death was reported. In terms of efficacy, a subject with advanced ovarian cancer who progressed on multiple prior systemic therapies achieved partial response after IBI110 monotherapy treatment and was still in the study for more than 6 months. 18 subjects were assigned in dose groups of 5 (0.3mg/kg~5mg/kg) in Phase Ib of IBI110 in combination with sintilimab, the prespecified dose escalation had been completed and no dose-limited toxicity (DLT), adverse events leading to discontinuation or death was observed. At data cutoff (April 26, 2021), three subjects had achieved partial response with an objective response rate of 16.7% (3/18) in phase 1b, demonstrating a synergistic anti-tumor activity of IBI110 and sintilimab.

"The efficacy signal and safety profile we see with IBI110 in this study is exciting," said Dr. Hui Zhou, Senior Vice President of Clinical Development, Innovent Biologics. "The single-drug efficacy demonstrated in the trial suggested a huge anti-tumor potential of this target. As we move ahead with the study, we look forward to greater clinical benefits of IBI110 in combination with sintilimab in patients in this trial. We are committed to innovation and relentless pursuit of breakthroughs for cancer patients. Aside from IBI110, we are also initiating phase 1 clinical trial on IBI323, a LAG-3/PD-L1 bispecific antibody, to fully investigate therapeutic value of LAG-3. "

Professor Caicun Zhou from Shanghai Pulmonary Hospital said: "IBI110's good safety and preliminary efficacy data support the further exploration of this molecule in a variety of tumor types, including non-small cell lung cancer, small cell lung cancer, melanoma, etc. LAG-3 is the third validated immune-related target after PD-1 and CTLA-4. We look forward to seeing more positive results from the upcoming trials of IBI110."

About the Study

This study is a phase Ia/Ib open label, dose escalation and expansion study to evaluate the safety, tolerability and efficacy of IBI110, an anti-LAG-3 monoclonal antibody, as a single agent and in combination with sintilimab in advanced solid tumors. The study follows a classic 3+3 design. Patients received escalating doses of IBI110 once every 3 weeks in phase Ia and escalating doses of IBI110 in combination with TYVYT? (sintilimab injection) 200 mg once every 3 weeks in phase Ib until disease progression, unacceptable toxicity, or withdrawal of consent.

Primary objectives of the trial were to evaluate the safety, tolerability and the antitumor activity of IBI110 monotherapy and in combination with sintilimab.

About LAG-3

Lymphocyte activation gene-3 (LAG-3) (CD223) is a novel 498-amino acid type I transmembrane protein identified on activated human NK and T-cell lines. LAG-3 (CD223) is a potential cancer immunotherapeutic target due to its negative regulatory role on T cells and its capacity, in combination with PD-1, to mediate a state of exhaustion.

About TYVYT? (sintilimab Injection)

TYVYT? (sintilimab injection) is an innovative PD-1 inhibitor with global quality standards jointly developed by Innovent and Lilly. Sintilimab is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1 / PD-Ligand 1 (PD-L1) pathway, and reactivates T-cells to kill cancer cells. Innovent is currently conducting more than 20 clinical studies of sintilimab to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registrational or pivotal clinical trials.

In China, TYVYT? (sintilimab Injection) has been approved for two indications, including:

• The treatment of relapsed or refractory classic Hodgkin's lymphoma after two lines or later of systemic chemotherapy

• In combination with pemetrexed and platinum chemotherapy, for the first-line treatment of nonsquamous non-small cell lung cancer

• In combination with gemcitabine and platinum chemotherapy, for the first-line treatment of squamous non-small cell lung cancer

Additionally, Innovent currently has regulatory submissions under review in China for TYVYT? (sintilimab Injection):

• In combination with BYVASDA? (bevacizumab injection) for the first-line treatment of hepatocellular carcinoma

• The second-line treatment of squamous non-small cell lung cancer

In May 2021, the U.S. FDA accepted for review the Biologics License Application (BLA) for sintilimab in combination with pemetrexed and platinum chemotherapy for the first-line treatment of nonsquamous non-small cell lung cancer.

TYVYT? (sintilimab Injection) was included in China's National Reimbursement Drug List (NRDL) in 2019 as the first PD-1 inhibitor and the only PD-1 included in the list in that year.

About Innovent 

Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to develop, manufacture and commercialize high-quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high quality innovative medicines for the treatment of cancer, autoimmune, metabolic diseases, and other major therapeutic areas. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong, S.A.R., China Limited with the stock code: 01801.HK.

Since its inception, Innovent has developed a fully integrated multi-functional platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. By leveraging this platform, the company has built a robust pipeline of 24 valuable assets in major therapeutic areas, with 4 products officially approved for marketing in China - TYVYT? (sintilimab injection), BYVASDA? (bevacizumab biosimilar injection), SULINNO? (adalimumab biosimilar injection) and HALPRYZA? (rituximab biosimilar injection), one Biologics License Application (BLA) submission for sintilimab accepted by the U.S. FDA, six assets in Phase 3 or pivotal clinical trials, and 14 more molecules in clinical trials. TYVYT? (sintilimab injection) was included in the National Reimbursement Drug List (NRDL) in 2019 as the historically first PD-1 inhibitor entering in NRDL and the only PD-1 included in the list in that year.

Innovent has built an international team of advanced talented professionals in high-end biopharmaceutical development and commercialization, including many overseas experts. The company has also entered into strategic collaborations with Eli Lilly and Company, Adimab, Incyte, MD Anderson Cancer Center, Hanmi and other international partners. Innovent strives to work with all relevant parties to help advance China's biopharmaceutical industry, improve drug availability to ordinary people and enhance the quality of the patients' lives.