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, and Laekna Therapeutics Shanghai Co., Ltd., an emerging innovative pharma company based in China's "Zhangjiang Pharma Valley" and New Jersey in the U.S., focusing on developing new ground-breaking innovative therapies to treat cancer and liver diseases, today jointly announced they have entered into a collaboration agreement to evaluate the combination of Innovent's PD-1 inhibitor sintilimab and Laekna's pan-AKT kinase inhibitor afuresertib.

Under the agreement, the two companies will work together to conduct clinical studies assessing the combination of sintilimab and afuresertib (LAE002) in patients with multiple types of solid tumors that have been refractory – or failed to respond – to treatment with PD-1/PD-L1 inhibitors. The trials will evaluate the safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of the combination therapy. An investigational new drug (IND) application will soon be filed with the National Medical Products Administration (NMPA) in China.

Dr. Hui Zhou, Senior Vice President of Clinical Development of Innovent, said, "Since our inception in 2011, Innovent has built a robust pipeline of assets with five innovative drugs approved for marketing. Many unmet medical needs still exist for cancer patients around the world. To help address this, Innovent explores multiple indications and combinations of therapies when developing its existing and new drug candidates. At the same time, we seek to work together with additional collaborative partners as the Chinese biopharmaceutical industry continues to rapidly expand. Innovent is impressed with Laekna's R&D pipeline and research team, and we look forward to our close collaboration and future possibilities produced by this clinical development agreement."

Dr. Yue Yong, Chief Medical Officer of Laekna, stated, "We hope our leading pipeline candidate afuresertib can potentially become a first-in-class targeted treatment in multiple types of cancer by demonstrating improved efficacy and acceptable safety in clinical trials. Notably, sintilimab was included in China's National Reimbursement Drug List (NRDL) in 2019 as the first PD-1 inhibitor and the only PD-1 inhibitor to be included in the list that year. In addition, sintilimab, in combination with pemetrexed and platinum chemotherapy, is currently being reviewed by the U.S. FDA for a potential BLA approval in the first-line treatment of nonsquamous non-small cell lung cancer. We now have the opportunity to explore the combination therapy of afuresertib and sintilimab in multiple types of solid tumors, with a particular focus on cancers that have commonly shown to be refractory to treatment with PD-1/PD-L1 inhibitors. We hope this combination therapy demonstrates results that can ultimately lead to it becoming a new treatment option for people with these difficult-to-treat cancers."

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 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

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

Additionally, Innovent currently has a regulatory submission under review in China for sintilimab for the second-line treatment of squamous non-small cell lung cancer.

Innovent also has two clinical studies of sintilimab that have met their primary endpoints:

• In combination with cisplatin plus paclitaxel or cisplatin plus 5-fluorouracil for the first-line treatment of esophageal squamous cell carcinoma

• The second-line treatment of esophageal squamous cell carcinoma

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.

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 Afuresertib (LAE002)

Afuresertib (LAE002) is an oral, small molecule pan-AKT kinase inhibitor. It has been investigated in over 10 Phase 1/2 clinical trials, including ovarian cancer, gastric cancer, multiple myeloma, and melanoma. These studies have demonstrated that afuresertib has strong anti-cancer activities and a tolerable safety profile in these studies.

In recent years, AKT (a serine/threonine-protein kinase) has emerged as an important mechanism in oncology, as it plays an important role in regulating various cell functions such as metabolism, survival, proliferation, tissue invasion, and chemotherapy resistance. PTEN deletion and AKT/PIK3CA alteration may lead to excessive activation of the AKT signaling pathways, which is one of the key drivers for cancer growth. The increased activation of the AKT signaling pathway is particularly common in recurrent ovarian cancer, breast cancer, and prostate cancer.

The global randomized, open-label, multi-center Phase 2 PROFECTA-II clinical trial of afuresertib is the world's first registration-directed clinical study of a pan-AKT kinase inhibitor to treat platinum-resistant ovarian cancer. Laekna currently expects primary results of the endpoints will be available in 2022 and will discuss the data with regulatory authorities if the study outcome supports it.

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, 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. Leveraging the platform, the company has built a robust pipeline of 24 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, sintilimab's Biologics License Application (BLA) acceptance in the U.S., 5 assets in Phase 3 or pivotal clinical trials, and an additional 14 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. 

About Laekna Therapeutics

Founded in December 2016, Laekna Therapeutics is an emerging innovative pharmaceutical company based in China's "Zhangjiang Pharma Valley" and New Jersey in the U.S., focusing on developing new ground-breaking innovative therapies to treat cancer and liver diseases.

Laekna has a two-pronged strategy for new drug development. On the one hand, it is enriching its portfolio by acquiring rights to drugs that have a demonstrated clinical proof-of-concept. The company has obtained exclusive global rights to four new drug candidates from Novartis. On the other hand, Laekna is developing its own innovative drugs that will soon start entering early-stage clinical development.

Laekna has established a team of top global pharmaceutical talent and acquired key technologies. Its leadership team members have over 20 years of experience in new drug development in China and the U.S., with an exceptional track record in R&D, new drug approvals and commercialization. Laekna is committed to a science-based, innovation-driven approach to create a leading clinical research and development pipeline, and develop first-in-class and best-in-class innovative drugs. It has been developing an international leading platform for new drug research and development to benefit patients.

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)

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, S.A.R., China, Macau, S.A.R., China and Taiwan, China.