On July 9, 2023 RemeGen Co., Ltd. ("RemeGen" or "the Company") (HKG: 9995, SHA: 688331), a fully-integrated commercial-stage biotechnology company, reported a clinical research and supply agreement with Innovent Biologics ("Innovent") (HKEX: 01801) (Press release, RemeGen, JUL 9, 2023, https://www.prnewswire.com/news-releases/remegen-and-innovent-collaborate-on-clinical-trials-to-evaluate-the-potential-of-rc88-and-rc108-combined-with-pd-1-therapy-for-advanced-solid-tumors-301872574.html [SID1234633146]). This collaboration will focus on conducting clinical trials exploring combination therapies of the novel antibody-drug conjugates (ADCs), RC88 (targeting MSLN) and RC108 (targeting c-MET), along with the PD-1 inhibitor sintilimab injection (TYVYT).
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According to the agreement, Innovent will supply clinical drug supplies of sintilimab during the clinical trial collaboration, while RemeGen will conduct Phase I/IIa clinical studies in China. The trials will assess the safety, tolerability, and preliminary efficacy of RC88 or RC108 combined with sintilimab in Chinese cancer patients.
RemeGen’s independently developed ADC, RC88, targets mesothelin (MSLN) and was approved for Phase I clinical trials in China in November 2018. Preliminary results show that RC88 monotherapy exhibits anti-tumor activity against MSLN-expressing solid tumors and demonstrates manageable safety. The combined use of RC88 with immune checkpoint inhibitors (ICIs) such as PD-1/PD-L1 can induce immunogenic cell death (ICD), releasing a series of signaling molecules to further activate T cells, and enhancing the tumor immune response.
Similarly, RC108, another ADC independently developed by RemeGen targeting c-MET, was approved for Phase I clinical trials in November 2020. The ongoing trials indicate the potential of RC108 monotherapy against c-MET-expressing solid tumors, with manageable safety. Preclinical research suggests that RC108 induces tumor-specific adaptive immunity and increases T cell infiltration in the tumor microenvironment, while PD-1 monoclonal antibodies activate T cells, enhancing the anti-tumor immune response. Therefore, it is expected that the combination therapy of RC108 and TYVYT can enhance both the presentation of tumor antigens by dendritic cells and the killing of tumor cells by T cells, resulting in enhanced tumor suppression.
TYVYT, a PD-1 inhibitor developed collaboratively by Innovent and Eli Lilly and Company (NYSE: LLY), has been approved for seven indications, six of which have been included in China’s National Reimbursement Drug List (NRDL). It is the only PD-1 inhibitor to include first-line treatment for the five major high-incidence solid tumors (non-squamous non-small cell lung cancer, squamous non-small cell lung cancer, liver cancer, gastric cancer, esophageal cancer), and also the first and only immunotherapy drug in the field of gastric cancer to be included in the NRDL.
"The alliance with Innovent is a critical step forward in the research and commercialization strategy of combination therapies with RC88 and RC108," said Su Na, Senior Vice President of RemeGen. "By combining these therapies with sintilimab, we offer innovative treatment plans that target two pathways. These mechanisms are complementary, potentially helping to overcome or delay treatment resistance and provide an effective solution to unmet clinical needs."
"We are thrilled to join forces with RemeGen to unlock the potential of combining sintilimab injection with novel ADCs," added Dr. Zhou Hui, Senior Vice President of Innovent. "Preclinical studies have suggested that combining ADCs with an anti-PD-1 monoclonal antibody may improve patient outcomes and overcome drug resistance. As immunotherapy advanced into the next era of development, we hope to strengthen the leading position of sintilimab as a backbone immunotherapy as well as investigate the new opportunities of combination therapies, and provide better treatment options for more cancer patients."