On August 29, 2024, Novatim Immune Therapeutics (Zhejiang) Co., Ltd. announced that the US Food and Drug Administration (FDA) has officially approved the phase I new drug clinical trial application (IND) for the monotherapy of KY-0118 injection and its combination with atezolizumab for the treatment of locally advanced or metastatic solid tumors. Clinical trials in the United States are about to commence. It is known that this is the first innovative drug project of Novatim to enter the clinical stage in the United States. This is also the FDA's approval of the clinical trial for KY-0118 injection after it received the clinical trial approval for monotherapy and combination with atezolizumab in China.
Dr. Wu Guoxiang, the founder and chairman of Novatim, stated: "KY-0118 is the first βγ-biased PD1/IL2 fusion protein in China developed by Novatim using its independent innovation technology platform. In the phase I clinical trial in China, significant and persistent anti-tumor effects as well as excellent safety have been preliminarily observed. The approval of this IND marks a major milestone for Novatim on its path to globalization."
Clinical data in China
The KY-0118 injection, when used as monotherapy, was tested in a phase Ia clinical trial for the treatment of various advanced solid tumors in 29 patients. Based on the current data, it appears to be safer while also being more beneficial for the long-term prognosis of the patients.
Regarding the data of the dose groups, a therapeutic signal was observed at the low dose (12 μg/kg). One patient with renal clear cell carcinoma in the 24 μg/kg dose group has been on treatment for more than 11 months and is currently in a stable disease state. The ORR in the 64 μg/kg dose group was 33.3% (1/3), and the DCR was 66.7% (2/3).
In terms of specific indications, the disease control rate (DCR) for melanoma was 3/3 (100%), with the longest progression-free survival (PFS) being 9 months; for renal clear cell cancer, the longest PFS was over 11 months; for triple-negative breast cancer, the first case had a clinical assessment showing a partial response (reduction of 56%). Other indications and therapeutic effects are still under continuous observation and exploration.
All patients were included in the safety analysis. The rate of grade 3 or higher drug-related TEAE was 4% (1 case), and the rate of grade 3 or higher drug-related SAE was also 4% (the same case). No DLT was observed in any of the dose groups, and further exploration of higher doses is currently underway.
Regarding KY-0118
The KY-0118 injection is a domestic first βγ-biased PD1/IL2 fusion protein designed based on the dual-function antibody platform independently developed by Novatim. It has a high affinity for binding and blocking PD-1, selectively delivering IL-2 to PD-1-positive T cells, thereby targeting and preferentially activating tumor-specific T cells, which is more conducive to long-term benefits for patients. Currently, the monotherapy clinical trial in China is at Phase Ib, and the monotherapy and combination with atezolizumab IND application in the US has been approved by the FDA. It is expected to bring revolutionary and rapid, in-depth and long-lasting effects to cancer treatment. After its future launch, it is also expected to become an innovative drug with annual sales of over 10 billion yuan.
About Novatim
Founded in 2018, Novatim Immune Therapeutics (Zhejiang) Co., Ltd. is a biotechnology company focused on innovative immuno-oncology drugs and clinical translation. Centered on unmet clinical needs and differentiated R&D, Novatim has built three core technology platforms: a bi-functional antibody platform, a nanobody bispecific ADC platform, and an enhanced dual-target CAR-T platform, with over ten potentially FIC/BIC programs. Representative assets include China’s first βγ-biased PD-1/IL-2 fusion protein, the world’s first nanobody bispecific ADC, and a parallel enhanced dual-target CAR-T.
