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 updated Phase 1 study results of IBI343, an innovative anti-CLDN18.2 ADC, for the treatment of advanced pancreatic ductal adenocarcinoma (PDAC) during an oral presentation at the ESMO Asia Congress 2024. The results highlighted the excellent efficacy and favorable safety profile of IBI343 in an expanded cohort of CLDN18.2-positive patients with previously treated PDAC.

Pancreatic cancer is one of the most aggressive malignancies worldwide. Most patients are diagnosed in the middle and late stages and often develop resistance to standard chemotherapy, resulting in a 5-year survival rate of less than 10%1. According to the GLOBOCAN 2022 statistics2, there are approximately 510,000 new cases and 467,000 deaths globally from pancreatic cancer each year, with China accounting for 120,000 new cases and 110,000 deaths annually.

This Phase 1/1b study is a multi-regional, dose escalation and expansion clinical trial (NCT05458219). Preliminary data were presented at 2024 ASCO and the updated results from the study's dose-expansion cohort were presented at the 2024 ESMO Asia Congress as follows:

• As of September 6, 2024, a total of 43 patients with CLDN18.2-positive (≥60% tumor cells with membranous staining intensity ≥1+ by IHC) advanced PDAC received IBI343 6 mg/kg Q3W monotherapy. All participants had previously received at least 1 line of prior therapy, and 60.5% had received 2 or more lines of anticancer treatment.

• 43 patients were efficacy evaluable with overall objective response rate (ORR) of 32.6%, confirmed objective response rate (cORR) of 23.3%, and confirmed disease control rate (cDCR) of 81.4%.

• As the data cutoff date, 4 out of 10 cORR patients had progressed, the median duration of response (mDoR) was 7.0 (4.0-NC) months, and the 6-month DoR rate was 63%. 26 patients occurred PFS events, with a median progression-free survival (mPFS) of 5.3 (4.1-7.4) months, and OS data is not yet mature.

• The updated safety results demonstrated the favorable safety profile of IBI343 with a consistently low rate of gastrointestinal toxicity and no new safety signals. 97.7% of the participants experienced treatment-emergent adverse events (TEAEs), with the most common TEAEs being anemia, neutrophil count decreased, decreased appetite, nausea, and white blood cell count decreased. 51.2% of the participants experienced ≥ grade 3 TEAEs, and no ≥ grade 3 nausea and vomiting occurred. No TEAE led to death.

Professor Xianjun Yu from Fudan University Cancer Hospital, said, "Pancreatic cancer is one of the most malignant tumors of the digestive tract. Most patients are already in the advanced stage when diagnosed, and the 5-year survival rate is only about 10%1. Currently, chemotherapy is still the main first- and second-line treatment for advanced pancreatic cancer. The clinical options for second-line treatment are particularly limited, with a chemotherapy response rate of only 6-16%, median progression free survival of 2 to 5 months, and a median survival of approximately 6 to 9 months3, representing an urgent clinical need. After enrolling more advanced pancreatic cancer participants, the data update of IBI343 continued to show encouraging efficacy signals as well as manageable safety, and I hope its further development will eventually bring a breakthrough therapy in this difficult-to-treat cancer."

Dr. Hui Zhou, Senior Vice President of Innovent, said, "We are pleased to share the updated clinical data for IBI343. With the unique Fc-silent antibody design, stable linker and potent TOPO1i payload, IBI343 is the first ADC candidate globally to demonstrate encouraging efficacy and a favorable safety profile in the treatment of advanced pancreatic cancer. IBI343 offers a new direction and renewed hope for pancreatic cancer treatment. It is worth mentioning that, the FDA has approved IBI343's IND application for this indication and granted Fast Track designation, and we will initiate patient enrollment for IBI343's Phase 1 trial in the United States. We will continue to advance IBI343's clinical programs, hoping to bring breakthrough treatments to patients worldwide."

About IBI343（Anti-CLDN18.2 ADC）

IBI343 is a recombinant human anti-CLDN18.2 monoclonal antibody-drug conjugate (ADC) developed by Innovent Biologics. IBI343 binds to the CLDN18.2-expressing tumor cells, the CLDN18.2 dependent ADC internalization will occur and the drug is released resulting in DNA damage and eventually apoptosis of the tumor cells. The freed drug can also diffuse across the plasma membrane to reach and kill the neighboring cells, resulting in "bystander killing effect".

As an innovative TOPO1i ADC, IBI343 has demonstrated tolerable safety and encouraging efficacy signals in Phase 1 clinical studies. The therapeutic potential of IBI343 is currently being explored in tumor types such as gastric and pancreatic cancer.

In May 2024, China's National Medical Products Administration (NMPA) granted breakthrough therapy designation (BTD) to IBI343 for use as a single agent in patients with CLDN18.2–positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who experienced disease progression following two prior lines of systemic treatment. The Phase 3 trial (NCT06238843) of IBI343 for this indication is ongoing.

In June 2024, IBI343 received Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of advanced unresectable or metastatic pancreatic ductal adenocarcinoma (PDAC) that has relapsed and/or is refractory to one prior line of therapy. The multi-regional Phase 1 trial (NCT05458219) of IBI343 for previously treated PDAC is ongoing.

About Innovent Biologics

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 target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 11 products in the market. It has 5 new drug applications under regulatory review, 3 assets in Phase III or pivotal clinical trials and 17 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem 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: 

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

(2) Ramucirumab (Cyramza) and Selpercatinib (Retsevmo) were developed by Eli Lilly and Company.

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References

1 Siegel RL, Miller KD, Fuchs HE, et al. Cancer statistics, 2022. CA Cancer J Clin. 2022;72:7-33. doi: 10.3322/caac.21708.

2 Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263.

3 Jemal A, Bray F, Center MM, et al. Global cancer statistics. CA Cancer J Clin, 2011, 61(2): 69-90.