HONG KONG – South Korean biotech Bioleaders Co. Ltd., headquartered in Yong-in city, Gyeonggi-do, and Israel's Weizmann Institute of Science, based in Rehovot, recently founded a joint venture in Israel. With the new entity, they will accelerate the R&D of a Weizmann-developed approach targeting p53, a strong tumor suppressor that has proved difficult to drug.

The Korean firm said it finalized all legal contracts for the joint entity. The new company, to be named Quintrigen, awaits the Israeli government's final approval of p53 technology transfer, as the technology R&D has been supported by the Israel Innovation Authority (IIA). After the approval, the new office will be set up either in the Weizmann Institute or at the Rabin Science Park in Rehovot.

In March, Bioleaders signed a strategic partnership agreement with Yeda Research and Development Co. Ltd., a technology transfer company belonging to Weizmann. Under the agreement, Bioleaders will invest $10 million and Yeda will invest technology in the new venture. The two entities will own 70% and 30% of Quintrigen's shares, respectively. Weizmann has also licensed out its p53 platform technology to Bioleaders. The cost of the deal has not been disclosed.

"We aim to proceed with the R&D to the clinical trial stage through Quintrigen. The joint venture will optimize Bioleaders' new drug candidates, determine drug indication and conduct toxicity test to enter clinical trial phase I. We plan to apply for IND status from the FDA soon and expect to kick off the clinical trials by next year," a spokesman at Bioleaders told BioWorld.

The p53 R&D will be led mainly by Varda Rotter and Moshe Oren, Weizmann's two professors in the Molecular Cell Biology Department. The two researchers discovered the function of the p53 protein, also called "the guardian of the genome." The protein is known to be mutated or dysfunctional in around 70% of human cancers, and such malfunctions possibly let the cancer spread fast.

The two professors recently developed a peptide that can restore p53 function. The peptide is combined with the mutated or malformed p53 when it enters the cell and binds to the protein. The Israeli Institute has said that when mice carrying human tumors were treated with the peptide, tumors were observed to shrink and disappear, in some cases without significant side effects. Weizmann announced the preclinical trial results at the American Association for Cancer Research meeting in March.

"The two researchers at Weizmann have secured certain peptides as a drug library, and these will be Quintrigen's drug candidates," the spokesman said. "Restored p53 is especially effective in treating ovarian cancer, colon cancer and breast cancer in preclinical trials. Weizmann's technology for restoring mutated p53 has great potential to expand its indications to various kinds of cancers, and the new joint venture will further develop the drug optimization and diversify its administration methods."

"The joint venture will be a huge project for growing Bioleaders' potential. The clinical trial overseas will spur the company's core substances and technology," Taegi Ha, senior analyst at Sangsangin Investment and Securities Co. Ltd. in Korea, told BioWorld.

Founded in 2000, Bioleaders has focused on developing biopharmaceuticals and platform technology. Its main substance, poly-gamma-glutamic acid, serves to increase immunity in the human body, and the company secures a massive production system for the substance.

The company uses the acid to develop treatments for cervical dysmorphia based on a new drug platform technology called Humamax. Based on poly-gamma-glutamic acid's immunoregulatory effects, it induces innate immunity, strengthens adaptive immunity and improves the tumor microenvironment. The company will start the phase III trial in cervical intraepithelial neoplasia (CIN) 1 in Korea using Humamax soon and will complete that study by next year.

Another platform technology, Mucomax, induces antigen-specific immunities by absorbing antigens, either as entire proteins or as peptides, into a body with lactic acid bacteria as its transporter. The technology neutralizes or eliminates target proteins and ultimately removes heteromorphic cells by increasing the activation of cytotoxicity.

Weizmann is one of the world's top basic research institutions in the natural and exact sciences. Founded in 1934, the institute consists of 250 research groups across five faculties such as biology, biochemistry, chemistry, mathematics and computer science, and physics. The institute has invented blockbuster drug substances, nanomaterials for industrial and medical uses, and advanced computer technology.

The institute has registered about 5,000 patents worldwide through Yeda. The institute's technology transfers make sales of around $35 billion every year. Humira (adalimumab, Abbvie Inc.), Copaxone (glatiramer, Teva Pharmaceutical Industries Ltd.) and Erbitux (cetuximab, Merck & Co. Inc.) have all been developed through Weizmann's technology transfer.

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