KY-0118 / Novatim Immune Therap - LARVOL DELTA

The first PD1-IL2v fusion protein monotherapy and combined with atezolizumab in China have been approved by the FDA for clinical trials [Google translation] (bydrug.pharmcube.com) - "On August 29, 2024, Keyi (Zhejiang) Pharmaceutical Technology Co., Ltd. announced that the U.S. Food and Drug Administration (FDA) has officially approved the phase I new drug clinical trial application (IND) for KY-0118 injection monotherapy and combined with atezolizumab for the treatment of locally advanced or metastatic solid tumors, and will soon conduct clinical trials in the United States."

Trial status • Solid Tumor

Dose escalation of KY-0118, PD-1, and IL-2v due-target fusion protein in patients with advanced renal clear cell carcinoma, urothelial carcinoma, and malignant melanoma. (ASCO 2024) - P1 | "The preclinical data shows higher antitumor activity in several CDX models compared with nivolumab and IL2wt. These preliminary data suggest that KY-0118 demonstrated a manageable safety profile and encouraging early evidence of activity has been observed in locally advanced and/or metastatic solid tumors. Enrollment is ongoing, further results are forthcoming. Pts: 21; AEs: 399; TEAEs: 289 (100%); AESI: 13; sAEs: 8."

Clinical • Metastases • Cardiovascular • Clear Cell Renal Cell Carcinoma • Fatigue • Melanoma • Oncology • Pulmonary Embolism • Renal Cell Carcinoma • Respiratory Diseases • Solid Tumor • Urothelial Cancer • CD8 • IL2

Phase I Dose Escalation/Expansion Study of KY-0118 in Subjects With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=189 | Recruiting | Sponsor: Novatim Immune Therapeutics (Zhejiang) Co., Ltd.

New P1 trial • Oncology • Solid Tumor