2024-01-25On January 25, 2024, Genhouse Bio, a biotech company focusing on development of next-generation anti-cancer therapeutics, announced today that it has obtained IND clearance for its KIF18A inhibitor, GH2616, from the U.S. FDA. The IND of this program to China NMPA was cleared just two weeks ago. GH2616 is Genhouse’s third innovative drug that got approved for clinical development in the States, following its SHP2 inhibitor GH21 and ERK1/2 inhibitor GH55.
GH2616 is highly potent and selective. It has shown excellent monotherapy anti-tumor effect in several preclinical tumor models. The molecule has advantageous PK properties such as high oral bioavailability, and long half-life for sustained inhibition of this target, which is important for its efficacy. In addition, GH2616 is brain-penetrant and demonstrates good efficacy in preclinical intracranial models, offering the potential to treat brain tumors and tumor brain metastasis. So far, only two KIF18A inhibitors have entered the clinical trial worldwide. GH2616 is well positioned in the top tier of innovative cancer therapeutics targeting KIF18A.
Dr. Kuifeng Wang, CEO and founder of Genhouse, said: “Genhouse’s Pipeline 2.0 focuses on innovative synthetic lethality targets and tumor immunity. GH2616 is the first KIF18A inhibitor from China that got approved by the U.S. FDA to be tested in clinical trials, showing the global potential of Genhouse’s pipeline. Genhouse has always been committed to developing innovative drugs for cancer patients worldwide with unmet medical needs. With the encouraging preclinical data for GH2616, we are looking forward to its clinical development to provide clinical benefit for patients.”
Dr. Haidan Wang, CMO of Genhouse, said: “Preclinical studies have indicated that GH2616 has great anti-tumor activity, high oral bioavailability, good safety and metabolic stability. The Phase I trial in China will be initiated soon, and Genhouse team will work closely with global experts to provide more treatment options for cancer patients outside China.”
About GH2616
GH2616 targets the protein KIF18A which regulates chromosome positioning and spindle length during metaphase, and it is synthetic lethal with chromosome instability (CIN) and whole genome doubling (WGD+). The vast majority of human cells are diploid, and errors that lead to WGD+ may occur during cell division, transforming natural diploid cells into an unstable tetraploid state. WGD+ is a periodic event in cancer, and it will promote the formation of aneuploidy, CIN and eventually tumorigenesis. In the process of cell division, KIF18A plays a key role in the adjustment of mitotic spindle assembly and chromosome arrangement. The absence of KIF18A in WGD+ cells will prolong mitotic time or activate spindle checkpoint, blocking mitosis in G2/M phase, and thus achieving the effect of killing the tumor cell. GH2616 is a selective inhibitor targeting KIF18A with superior anticancer properties than leading competitors. Preclinically, it has shown significant inhibitory effect on tumors with TP53 mutation and WGD+ or CIN.
About Genhouse
Genhouse Bio is a clinical-stage biotech company focusing on the discovery and development of next-generation cancer therapeutics worldwide. Genhouse is committed on original innovation and overcoming those “undruggable” targets.
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