Cell therapy has become an established treatment option for certain blood cancers, but solid tumors remain elusive. Oricell Therapeutics aims to bring cell therapy to solid tumors and it has raised $110 million to take its lead program into pivotal testing in the most common type of liver cancer.
The Oricell cell therapy, Ori-101, is designed to treat advanced cases of hepatocellular carcinoma. It’s an autologous CAR T-therapy, made by harvesting a patient’s immune cells and engineering them in a lab to become targeted cancer fighters. The target of Ori-101 is Glypican-3, or GPC3, a protein that’s highly expressed by liver cancer cells but less so by healthy cells of the organ.
One reason it’s difficult for cell therapies to treat solid tumors is that the tumor microenvironment contains many immunosuppressive components that effectively protect a cancer from the immune system. Shanghai-based Oricell describes its treatments as next-generation cell therapies that come from its proprietary technology platforms for antibody discovery, T cell enhancement, and rapid manufacturing.
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Ori-101 is currently being evaluated in an open-label Phase 1 study. Preliminary results from 10 patients were presented last year during the American Society of Clinical Oncology (ASCO) annual meeting. Of the nine patients evaluable for efficacy, six achieved disease control at dose level 2 or higher; all patients at dose level 3 achieved an objective response. One patient who achieved a complete response showed encouraging durability and no signs of relapse at nine months. Investigators said the preliminary data indicate Ori-C101’s safety profile is manageable.
There are currently no FDA-approved therapies that target GPC3. While Oricell claims its therapy offers best-in-class efficacy and safety, it’s a class with competition. Privately held Eureka Therapeutics is evaluating a T cell therapy called ECT204 in a Phase 1/2 study enrolling adults with advanced hepatocellular carcinoma. AstraZeneca is developing a GPC3-targeting CAR T-therapy now called AZD7003. Earlier this year, the pharmaceutical company acquired AbelZeta’s 50% share of the rights to this therapy in China, securing sole global rights to the asset. AstraZeneca’s pipeline lists AZD7003 in Phase 1 testing in hepatocellular carcinoma and squamous non-small cell lung cancer.
Meanwhile, Zymeworks is going after GPC3 with an antibody drug conjugate, ZW251. This program is currently enrolling patients for a global Phase 1 study in advanced solid tumors, including hepatocellular carcinoma.
Oricell is developing therapies for both liquid and solid tumors. The company is also developing in vivo cell therapies that avoid the multiple steps required for autologous cell therapies. Oricell’s next most advanced program is the autologous cell therapy OriCAR-017, a potential treatment for multiple myeloma. This cell therapy is designed to target GPRC5D, which has clinical and regulatory validation from Johnson & Johnson’s Talvey, a bispecific T cell engager that is the only FDA-approved multiple myeloma therapy for this protein. Bristol Myers Squibb is in pursuit with a dual-targeting CAR T-therapy targeting GPRC5D and BCMA; this multiple myeloma therapy is in early clinical testing.
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Oricell said it will use its new capital to accelerate global expansion and clinical development. The cash will go toward strengthening the company’s technological capabilities. The new capital announced late Thursday is what Oricell describes as a pre-IPO financing round. It follows $70 million raised in January, which it said at the time was the initial closing of a Series C round.
The latest financing was co-led by Vivo Capital, Beijing Medical and Health Care Industry Investment Fund, Qiming Venture Partners, and a leading global healthcare fund that was not disclosed. Other participants include an unidentified international sovereign wealth fund, E-Town Capital, Luxin Venture Capital, NGS Super, Elikon Investment, and Talon Capital.
“As we approach key inflection points in our clinical programs, our priority is clear: Expedite the global development of our core assets and deepening our research into revolutionary technologies, including in vivo CAR T and solid tumor CAR T,” Oricell Chairman and CEO Huanfeng Yang said in a prepared statement. “We are committed to delivering transformative therapies that offer real hope to cancer patients worldwide, positioning Oricell as a dominant force in the global immunotherapy arena.”
Image by Flickr user Ed Uthman via a Creative Commons license