Innovent and NeoCura Announce Strategic Collaboration to Study the Combination Therapy of Sintilimab and Neoantigen Vaccine NEO_PLIN2101 for Cancer Treatment in China

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SAN FRANCISCO and SUZHOU, China, Oct. 27, 2021 /PRNewswire/ -- Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, and NeoCura Bio-Medical Technology Co., Ltd. ("NeoCura"), a leading AI-enabled RNA precision medicine biotech company committed to building a global top RNA innovative drug platform, today jointly announced that they have entered into a strategic collaboration agreement to carry out a clinical study in China on the combination therapy of sintilimab from Innovent and individualized neoantigen vaccine NEO_PLIN2101 from NeoCura.

Innovent will collaborate with NeoCura in China to assess the safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of the combination therapy using sintilimab from Innovent and NEO_PLIN2101 from NeoCura in cancer patients, to advance the clinical development of combination immunotherapy for multiple solid tumors, and prepare to submit the Investigational New Drug (IND) application to the National Medical Products Administration (NMPA) in the near future.

Dr. Liu Yongjun, President of Innovent, stated: "We are impressed by NeoCura's differentiated R&D pipeline and international research team, and we are pleased to enter into this strategic collaboration to explore the clinical value of sintilimab in combination with neoantigen vaccines for solid tumors. Innovent has a robust pipeline with strong capabilities in immunology and cancer biology. Currently, we have five innovative drugs approved and launched in China and will have more than 10 innovative drugs to be launched in the next 2-3 years. Our fully integrated platform has accumulated strong R&D, clinical development and commercialization capabilities and is ideal for partners at home and abroad. We also hope to further explore the new opportunities in expanding indications and enhancing therapeutic efficacy of sintilimab in combination with novel therapies. We look forward to wider and in-depth collaboration between the two parties in the future. "

Dr. Wang Yi, founder of NeoCura, stated: "At present, neoantigen vaccines are a revolutionary emerging therapeutic approach worldwide. NeoCura has been focusing on the R&D of tumor neoantigen vaccines since its establishment, hoping to overcome the challenges of existing immunotherapy in the treatment of solid tumors through the application of new technologies. The collaboration with Innovent will play a synergistic role of personalized neoantigen vaccines and monoclonal antibody drugs and jointly explore the clinical effect of the combination therapy in the treatment of solid tumors, which is expected to improve the objective response rate of cancer immunotherapy and bring new opportunities for cancer combination regimens."

About Sintilimab

Sintilimab, marketed as TYVYT® (sintilimab injection) in China, is an innovative PD-1 inhibitor with global quality standards jointly developed by Innovent and Eli Lilly and Company. Sintilimab is an 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, sintilimab has been approved for four 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 non-squamous non-small cell lung cancer

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

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

Additionally, Innovent currently has one regulatory submission under review in China for sintilimab, for the first line treatment of esophageal squamous cell carcinoma.

Additionally, four clinical studies of sintilimab have met their primary endpoints:

  • Phase 3 study in combination with oxaliplatin and capecitabine for the first-line treatment of unresectable, locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma

  • Phase 2 study as second-line treatment of esophageal squamous cell carcinoma

  • Phase 3 study as second-line treatment for squamous NSCLC with disease progression following platinum-based chemotherapy

  • Phase 3 study in combination with BYVASDA® (bevacizumab biosimilar injection) and chemotherapy (pemetrexed and cisplatin) for EGFR-mutated non-squamous NSCLC following EGFR-TKI treatment

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 non-squamous non-small cell lung cancer.

Sintilimab 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 NEO_PLIN2101

NEO_PLIN2101 is a personalized neoantigen vaccine developed by NeoCura, which can be custom made according to the unique tumor gene mutation of each patient. Through high-throughput sample sequencing and AI algorithm epitope prediction, high-quality neoantigen fragments that can be efficiently presented by tumor cells and elicit a potent immune response are selected from patient's tumor sample. The mRNA vaccine encoded corresponding neoantigen is synthesized in vitro, vaccinated into patients to activate tumor-specific T cells to control tumor growth and reduce tumor burden. Compared to conventional approach, NEO_PLIN2101 has stronger specificity and immunogenicity that can induce anti-tumor immune response in cancer patients.

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 and other major diseases. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong 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. Leveraging the platform, the company has built a robust pipeline of 26 valuable assets in the fields of cancer, metabolic, autoimmune disease and other major therapeutic areas, with 5 products – TYVYT® (sintilimab injection), BYVASDA® (bevacizumab biosimilar injection), SULINNO® (adalimumab biosimilar injection), HALPRYZA® (rituximab biosimilar injection) and Pemazyre® (pemigatinib oral inhibitor) – officially approved for marketing in China, 1 asset's NDA under NMPA review, sintilimab's Biologics License Application (BLA) acceptance in the U.S., 5 assets in Phase 3 or pivotal clinical trials, and an additional 15 molecules in clinical studies.

Innovent has built an international team with advanced talent in high-end biological drug development and commercialization, including many global 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 many collaborators to help advance China's biopharmaceutical industry, improve drug availability and enhance the quality of the patients' lives. For more information, please visit: www.innoventbio.com. and www.linkedin.com/company/innovent-biologics/.

Note:

Sintilimab is not an approved product in the United States.

BYVASDA® (bevacizumab biosimilar injection), HALPRYZA® (rituximab biosimilar injection), and SULINNO® (adalimumab biosimilar injection) are not approved products in the United States.

TYVYT® (sintilimab injection, Innovent)

BYVASDA® (bevacizumab biosimilar injection, Innovent)

HALPRYZA® (rituximab biosimilar injection, Innovent)

SULINNO® (adalimumab biosimilar injection, Innovent)

Pemazyre® (pemigatinib oral inhibitor, Incyte Corporation). Pemazyre® was discovered by Incyte Corporation and licensed to Innovent for development and commercialization in Mainland China, Hong Kong, Macau and Taiwan.

Disclaimer:

1. This indication hasn't been approved in China.
2. Innovent does not recommend any off-label usage.
3. For medical and healthcare professionals only.

About NeoCura

Founded in 2017, NeoCura is committed to building a global top RNA innovative drug platform. NeoCura has built a multi-omics data collection platform and corresponding omics database, empowered by AI and bioinformatics technology for target deep mining and automated drug design for innovative RNA medicine research and development, and built a leading RNA drug manufacturing center in China to support pipeline research and development as well as clinical needs.

NeoCura brings together the world's top scientists, senior industry experts and international first-class academic consultant teams. The core R&D team includes dozens of doctoral/postdoctoral fellows from prestigious schools such as Harvard, Cambridge, Cornell, Peking University, Tsinghua University and Chinese Academy of Sciences. The professional fields cover multiple disciplines including genomics sequencing, AI algorithm, bioinformatics, onco-immunology, vaccine design and drug delivery. Team members have held core R&D positions in top international research institutions or enterprises such as Harvard Medical School, Dana-Farber Cancer Institute, Brigham and Women's Hospital, Boston Children's Hospital, and the research results have been published on hundreds of articles in international high-portfolio journals such as Nature, Science, and Cell.

NeoCura has independently developed AI bioinformatics platform for deep target mining, RNA medicine platform, automated drug design platform, multi-omics big data collection and analysis platform and target validation platform, aiming to promote RNA drug clinical research in combination with artificial intelligence algorithm plus real-world data validation. Its proprietary NeoCuraTM AI ALPINE tumor neoantigen prediction algorithm has the highest prediction accuracy in the world. Relying on its own R&D expertise and technical advantages, NeoCura has carried out in-depth studies in the tumor neoantigen vaccine, tumor microenvironment modulations, etc., developed personalized neoantigen vaccine for different individuals, established a public neoantigen pool for the high incidence of cancers in China, significantly reduced the cost of neoantigen drug treatment and shortened the preparation cycle. At present, NeoCura has jointly carried out clinical trials with many leading hospitals and will become a new landmark in the field of cancer treatment. With its cutting-edge AI technologies, outstanding innovation capability and robust oncology pipelines, NeoCura is recognized as one of the Most Promising Enterprise in China and Top 10 China AI/Algorithm Pharmaceutical Innovative Enterprise in 2021.

Company website: www.neocura.com.cn.

Innovent 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.

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