Innovent Announces Updated Data of Phase 1 Clinical Trial for IBI351 (KRAS[G12C] Inhibitor) as Monotherapy for Solid Tumors at the AACR Annual Meeting 2023

ROCKVILLE, Md. and SUZHOU, China, April 17, 2023 /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, autoimmune, metabolic, ophthalmology and other major diseases, today announced the updated results of IBI351 (GFH925) (KRAS^G12C inhibitor) from a phase 1 clinical trial (NCT05005234) in an oral presentation at the 2023 American Association for Cancer Research (AACR) Annual Meeting.

Topic: Phase I study of IBI351 (GFH925) monotherapy in patients with advanced solid tumors: updated results
Main Researcher: Prof. Qing Zhou, Prof. Yi-Long Wu, Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital
Abstract Number: CT030
Presentation Date/Time: Monday Apr 17, 20232:30 PM - 4:30 PM

IBI351(GFH925) is a novel, irreversible covalent inhibitor of KRAS^G12C mutation. The NCT05005234 study presented was a first-in-human study conducted in China to evaluate the safety, tolerability and efficacy of IBI351 monotherapy in patients with advanced solid tumors who failed or intolerant to standard of care treatment. As data cutoff date (30 November 2022), 74 subjects were enrolled in the study, including 67 patients with non-small cell lung cancer (NSCLC), 6 colorectal cancer (CRC) and 1 pancreatic cancer. In the presentation, we updated safety and efficacy of NSCLC subjects. Approximately 38.8% of NSCLC patients had brain metastases at baseline. The highlights of the study results were as follows:

• As of February 10, 2023, of the 67 evaluable NSCLC patients, 41 achieved partial response (PR), with investigator assessed ORR 61.2% and DCR 92.5%. Most patients remained on treatment.
• Of 30 patients with NSCLC treated at 600mg BID (the recommended phase 2 dose), better efficacy signal was observed, with investigator assessed ORR 66.7% (confirmed ORR 53.3%) and DCR 96.7%. The mDOR was not reached yet, the 6m DoR rate was 74.5%（95% CI, 39.8-91.7）. The mPFS was 8.2m (PFS events 46.7%), the data is immature yet. The 6m and 9m PFS rate were 58.9%（95% CI, 39.0-74.3） and 47.3%（95% CI, 26.1-65.8, respectively, with a median follow-up of 8.1 months.
• As of 30 November 2022, IBI351 was well tolerated. No DLT was reported and MTD was not reached. Treatment-related adverse events (TRAEs) occurred in 94.0% (63/67) patients and the most common TRAEs were anemia, pruritus, transferase increased, asthenia, protein urine present and bilirubin increased. The majority of the TRAEs were grade 1-2 with 31.3% of patients reporting ≥grade 3 TRAEs. There were no TRAEs led to treatment discontinuation or death.

Favorable safety and tolerability and promising antitumor activity of IBI351 monotherapy were observed in previously-treated advanced NSCLC harboring KRAS^G12C mutation. A single-arm registrational trial of IBI351 monotherapy in previously-treated advanced non-small cell lung cancer is ongoing.

Professor Yi-Long Wu from Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, stated: "KRAS mutation as the "undruggable" target for decades has become one of the most popular direction for clinical development recently. IBI351 is a novel, irreversible covalent inhibitor of KRAS^G12C mutation, whose preliminary data of safety and efficacy was reported at 2022 ASCO and CSCO. The update data shows the favorable safety and promising activity of IBI351 (GFH925) monotherapy in KRAS G12C mutated advanced NSCLC. Median duration of response (DOR) was not reached and the data of median progression free survival (PFS) was immature. We look forward to more positive clinical data from this study. "

Dr. Hui Zhou, Senior Vice President of Innovent, stated: "We are pleased to present our clinical development updates at the 2023 AACR, and that IBI351 monotherapy demonstrated encouraging efficacy and safety data in phase I study. A single-arm registrational trial of IBI351 monotherapy in previously-treated advanced NSCLC is ongoing.  We are working to advance into late stage clinical development to explore the potential of IBI351 as monotherapy and in combo-therapy. We are actively exploring next-generation cancer therapies, hoping to benefit more cancer patients."

About IBI351/GFH925 (KRAS^G12C Inhibitor)

Discovered by GenFleet Therapeutics, GFH925 (Innovent R&D code: IBI351) is a novel, orally active, potent KRAS^G12C inhibitor designed to effectively target the GTP/GDP exchange, an essential step in pathway activation, by modifying the cysteine residue of KRAS^G12C protein covalently and irreversibly. Preclinical cysteine selectivity studies demonstrated high selectivity of IBI351 towards G12C. Subsequently, IBI351 effectively inhibits the downstream signal pathway to induce tumor cells' apoptosis and cell cycle arrest. In September 2021, Innovent and GenFleet Therapeutics entered into an exclusive license agreement for the development and commercialization of IBI351 in China (including mainland China, Hong Kong, Macau and Taiwan) with additional option-in rights for global development and commercialization.

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 in the fields of oncology, metabolism, autoimmunity, ophthalmology 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 35 valuable assets in the fields of cancer, metabolic disorder, autoimmune disease and other major therapeutic areas, with 8 approved products on the market. These include:  TYVYT^® (sintilimab injection), BYVASDA^® (bevacizumab biosimilar injection), SULINNO^® (adalimumab biosimilar injection), HALPRYZA^® (rituximab biosimilar injection) , Pemazyre^® (pemigatinib oral inhibitor), olverembatinib (BCR-ABL TKI) , Cyramza^® (ramucirumab) and Retsevmo^® (selpercatinib). An additional 3 assets are under NMPA NDA review, 5 assets are in Phase 3 or pivotal clinical trials, and 19 more molecules are 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, Sanofi, Adimab, Incyte, MD Anderson Cancer Center 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:

TYVYT^® (sintilimab injection) is not an approved product in the United States.

BYVASDA^® (bevacizumab biosimilar injection), SULINNO^®, and HALPRYZA^® (rituximab 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.

CYRAMZA^® (ramucirumab, Eli Lilly). CYRAMZA^® was discovered by Eli Lilly and licensed to Innovent for commercialization in Mainland China.

Retsevmo^® (Selpercatinib, Eli Lilly). Retsevmo^® was discovered by Eli Lilly and licensed to Innovent for commercialization in Mainland China.

Disclaimer: This indication is still under clinical study, Innovent does not recommend any off-label usage.

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.

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