Orca Bio Inc.’s $192 million series D brings the company out of stealth and openly into the business of transforming allogeneic cell therapies. The new funding brings Orca’s total capital raised since 2016 to nearly $300 million.
The company’s cell therapies are designed to regenerate healthy blood and reboot an unhealthy immune system into a healthy one. The therapies are created by building individual doses cell by cell from another person’s blood. One application is the potential to eventually replace conventional bone marrow transplants.
The therapy can affect diseases beyond blood cancer, such as genetic blood disorders and beyond, Orca’s CEO, Ivan Dimov, told BioWorld.
“The next step up are autoimmune disorders,” Dimov said. “Diseases like Crohn’s disease and lupus, curing patients of HIV, as an unexpected secondary effect. It’s a broad and impactful therapeutic platform.”
In order to be able to deliver the therapy, Dimov added, the company needs its manufacturing platform to allow it to sort blood cells with high levels of purity and speed. The proprietary mix of cells is the recipe for success, he added.
The cell therapy field has grown quickly, Dimov said, saving people who would not have been alive without it, adding that the immune-oncology space is also a testament to rapid development.
“In the past, you’d think of this like science fiction and how startling the results are,” he added.
The global cell therapy market size is expected to reach $8.8 billion by 2027 at a CAGR of 5.4%, over the forecast period, according to Research and Markets.
The Menlo Park, Calif.-based company’s lead candidate is in a phase Ib trial of patients with blood cancers. TRGFT-201 is being used to evaluate a controlled T cells formulation that includes subsets of regulatory T cells. The open-label, multicenter trial focuses on patients with advanced hematologic malignancies undergoing allogenic hematopoietic cell transplantation. The primary outcome measures are the incidence of primary graft failure and the incidence of grade III-V acute graft-vs.-host disease. The study began in November and is set to conclude near the end of 2022.
Orca has another phase I underway, for OGFT-001, for recipients undergoing myeloablative allogeneic transplantation for hematologic malignancies. The interventional, single-group assignment, open-label study is a dose-escalation and expansion study of engineered donor grafts derived from mobilized peripheral blood with single-agent graft-vs.-host disease prophylaxis. The primary outcome measures are the incidence of dose-limiting toxicities and the incidence of primary graft failure.
Orca, an acronym for “Optical Retrieval from Cell Arrays,” hasn’t released any data from the studies but lauded the early safety and efficacy data as “stellar. … Anecdotally I can tell you we’ve seen terminal blood cancer patients getting well and leaving the hospital sooner than expected,” Dimov said.
Orca’s chief scientific officer, Nathan Fernhoff, is a co-founder along with Dimov. The two met at Stanford University, with Dimov studying bioengineering and Fernhoff specializing in immunology and therapeutics. In the past four years since the company began with three people, the company has expanded to around 40 people. Dimov said he will use some of the new funding for new hires.
The Orca advisory team includes Irving Weissman, a professor of pathology and developmental biology at Stanford. He is the director of the school’s Institute of Stem Cell Biology and Regenerative Medicine.
The company’s selected partners include Stanford, the National Marrow Donor Program and Be the Match.
Orca’s financing was co-led by Lightspeed Venture Partners and an undisclosed investor. New and existing investors Include 8VC, DCVC Bio, ND Capital, Mubadala Investment Co., Kaiser Foundation Hospitals, Kaiser Permanente Group Trust and IMRF.