On August 17, 2023 NovaRock Biotherapeutics Ltd, announced today that the U.S. Food and Drug Administration (FDA) issued a "study may proceed" letter for its investigational new drug (IND) application for NBL-028, a CLDN6-CD137 BsAb T Cell Engager (Press release, NovaRock Biotherapeutics, AUG 17, 2023, View Source [SID1234634476]). The company plans a Phase I clinical study to evaluate the safety, tolerability, and pharmacokinetics of NBL-028 in patients with CLDN6 expressing advanced tumors, including but not limited to testicular cancer, ovarian cancer, non-small cell lung cancer (NSCLC) and endometrial cancer.

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About NBL-028

Claudin 6 is a member of the claudin family of tight junction (TJ) proteins and is expressed at high levels in multiple human malignancies but has little to no expression in normal tissues. CD137, or 4-1BB, a member of the superfamily of tumor necrosis factor receptors (TNFR), is an inducible co-stimulatory receptor that plays a key role in T cell proliferation, survival, cytolytic activity, and memory formation as well as modulating other immune cell functions. NBL-028 targets both human CLDN6 and human CD137. It is designed to selectively activate the CD137 co-stimulatory pathway in T cells and other immune cells upon binding to the tumor cell surface CLDN6 in TME, resulting in conditional redirected tumor cell killing. NBL-028 has demonstrated superior efficacy and safety in preclinical studies.

NBL-028 is the first program entering clinical phase from NovaRock’s proprietary T cell engager platform NovaTE. NovaTE is a next-generation T cell engager platform for treating cancer, especially solid tumors. NovaTE is designed and optimized to induce sustainable T effector cell activation, lift immune suppression in the TME, while minimizing the risk of systemic toxicity, including CRS, ICANS and hepatotoxicity. NBL-028 offers a potential advantage in the efficacy and safety for patients with CLDN6-expressing tumors.

NovaRock also filed an IND application to National Medical Products Administration (NMPA) in PRC in July 2023.