Hengyu Bio Congratulates Keyi Pharma on FDA Approval of KY-0118, China's First PD-1/IL-2v Fusion Protein, as Monotherapy and in Combination with Atezolizumab for Phase I Clinical Trials
Novatim
Innovative Drug Developer for Tumor Immunotherapy
On August 29, 2024, Novatim Immune Therapeutics (Zhejiang) Co., Ltd. announced that the U.S. Food and Drug Administration (FDA) had officially approvedKY-0118 Injection Monotherapy and Combination with AtezolizumabPhase I New Drug Clinical Trial Application (IND) for the treatment of locally advanced or metastatic solid tumors is about to initiate clinical trials in the United States.
It is reported that,This isNovatim's First Innovative Drug Project to Enter Clinical Stage in the United States，It is also the clinical trial approval obtained by KY-0118 injection from the US FDA after receiving the clinical trial approval for monotherapy and combination with atezolizumab in China.
HENGYU BIOTECHProvided in this project are compliant with the dual-reporting requirements of China and the US.Cell Bank Testing (CLC）Bio-safety testing services, with internationally compliant quality and technical systems, rapid delivery, and professional project management, safeguard the overseas launch of innovative drugs.
KY-0118 Injection is the first βγ-biased PD1/IL2 fusion protein in China, developed based on Novatim's independently researched and developed bifunctional antibody platform. It binds with high affinity and blocks PD-1 while selectively delivering IL-2v to PD-1-positive T cells, thereby achieving targeted and biased activation of tumor-specific T cells, which is more beneficial for long-term patient outcomes. Currently, the monotherapy clinical trial in China is in Phase Ib, and the IND application for monotherapy and combination therapy with Atezolizumab has been approved by the FDA in the United States. This drug is expected to bring about rapid, profound, and durable effects in cancer treatment and, after its future market launch, has the potential to become an innovative drug with annual sales exceeding 10 billion yuan.
Dr. Guoxiang Wu, founder and chairman of Novatim, stated:KY-0118 is the first domestically produced βγ-biased PD1/IL2 fusion protein developed by Novatim using its self-innovated technology platform. In a Phase I clinical trial in China, it has preliminarily demonstrated significant and durable anti-tumor effects as well as excellent safety. The approval of this IND represents a major milestone for Novatim in advancing towards globalization.
Clinical Data in China
1. KY-0118 Injection Monotherapy in the Phase Ia Clinical Trial for End-of-Line Treatment of Various Advanced Solid Tumors Enrolled 29 Patients, and Current Data Suggests It Is Safer While Being More Beneficial for Long-Term Patient Outcomes.
2. In terms of dose group data, efficacy signals have been observed at the low dose (12 μg/kg). One patient with clear cell renal carcinoma in the 24 μg/kg dose group has been on medication for over 11 months and remains in a stable disease state. In the 64 μg/kg dose group, the ORR is 33.3% (1/3), and the DCR is 66.7% (2/3).
3. Specific indications show that the DCR for melanoma is 3/3 (100%), with the longest PFS of 9 months; the longest PFS for renal cell carcinoma exceeds 11+ months; the first case of triple-negative breast cancer achieved PR (56% reduction) at the initial clinical evaluation. Other indications and efficacy are still under continuous observation and exploration.
4. All patients were included in the safety analysis, with ≥3 grade drug-related TEAEs at 4% (1 case) and ≥3 grade drug-related SAEs at 4% (the same case). No DLT was observed in any of the dosing groups, and higher dose exploration is currently ongoing.
*Source: Novatim WeChat Official Account
About Novatim
Based on the bispecific antibody platform, independently developed by the companyChina's First βγ-Biased PD1/IL2 Fusion ProteinCurrently, the single drug is in Phase Ib clinical trials in China, and the combination with Atezolizumab has obtained clinical approval in both China and the US; based on the nano-bispecific ADC platform, the company has independently developed.World's First Nano Bispecific ADC, which is about to obtain IND approvals in both China and the U.S.; based on an enhanced dual-target CAR-T platform, independently developed by the company.World's First CAR-T Therapy Specifically Targeting rrMM (with Extramedullary Involvement) and POEMS Syndrome, currently in clinical PhaseⅠ/Ⅱa.
