KyYi Pharma Announces FDA IND Approval for KY-0301, the World’s First Nanobody-Based Bispecific ADC

Dec 05, 2024 13:11 CST Updated 13:11

Novatim

Innovative Drug Developer for Tumor Immunotherapy

On December 5, 2024, Novatim Immune Therapeutics (Zhejiang) Co., Ltd. announced that the U.S. Food and Drug Administration (FDA)Officially Approved the IND Application for KY-0301, the World's First Nano Bispecific ADC.This is the 8th clinical trial approval received by Novatim, and also the 2nd innovative drug pipeline from Novatim to enter the clinical stage in the United States.

AboutKY-0301

KY-0301 is Novatim's nano bispecific ADC platform based on independent innovation.The world's first nano bispecific ADC developed by "TPEBEN".By simultaneously targeting the c-MET (cellular-mesenchymal epithelial transition) factor and EGFR (epidermal growth factor receptor), the development of bispecific nanobody-drug conjugates (BsNb-ADC) can deliver drugs to tumor tissues more effectively and address toxicity caused by prolonged drug retention in the bloodstream, with an added layer of original and unique safety design.，Thereby making the drug safety much higher than that of similar bispecific ADC products currently on the market.At the same time, systematically optimize the nano bispecific ADC process to address product homogeneity issues.Increase the purity of DAR4 products to the highest level in the industry (98%).。

In preclinical studies, KY-0301 demonstrated more effective tumor tissue penetration, higher anti-tumor activity, and better safety compared to traditional bispecific antibody-drug conjugates (ADCs).The experimental results of four CDX animal models and two PDX animal models all showed,KY-0301 can rapidly suppress the growth of various solid tumors, almost all reaching a state of complete regression.And within the same time frame, it demonstrated nearly double the drug delivery capability compared to traditional dual-antibody ADCs. Its toxicology data also showed better safety results than traditional dual-antibody ADCs, laying a solid foundation for its clinical research with these positive outcomes.

About Novatim

Novatim Immune Therapeutics (Zhejiang) Co., Ltd.Founded in 2018, Novatim Immune Therapeutics (Zhejiang) Co., Ltd. is a biopharmaceutical technology enterprise focused on the research and development of innovative drugs for tumor immunotherapy and their clinical applications. Based on clinical needs and differentiation, the company is committed to efficient and groundbreaking R&D innovation by establishing three major R&D platforms:Bifunctional AntibodyPlatform, Nano Bispecific ADC Platform, Enhanced Dual-Target CAR-T Platform. Independently developed from scratch over 10 novel, differentiated potential FIC/BIC pipelines.

Based on the bifunctional antibody platform, the company has independently developed the first βγ-biased PD1/IL2 fusion protein in China. Currently, it is in Phase Ib clinical trials in China as a monotherapy or in combination with PD-L1 monoclonal antibody, and has also obtained IND approval in the United States; based on the nano bispecific ADC platform, the company has independently developed the world's first nano bispecific ADC, which has already received U.S. clinical trial approval, and Chinese approval is soon to follow; based on the enhanced dual-target CAR-T platform, the company has independently developed the world’s first dual-target CAR-T with a parallel enhanced structure, which is currently in clinical PhaseⅠ/Ⅱa.

As a strategic partner of Novatim, Kelle BiotechIn this projectAssist NovatimAdvance the World's First Nano Bispecific ADC-CMC Development and Registration Submission for KY-0301, Including Antibody, Conjugation, and Payload-Linker.Novatim's World-First Nano Bispecific AntibodyFDA IND Clinical Approval for ADC ProjectOf milestone significance!

Cayman Bio, empowered by Cayman Pharmaceutical Group's toxin-linker business capabilities, possesses a one-stop CDMO service capability for ADCs, covering multiple aspects such as antibodies, toxin-linkers, and conjugation, fully empowering globally.InnovativeThe Rapid Development of Conjugated Drugs.