Orca Bio CEO says Tregzi launch hinges on getting manufacturing right every time, at Meeting on the Mesa

Orca Bio is building the launch of its newly approved cell therapy Tregzi around making every personalized dose reliably, co-founder and CEO Nate Fernhoff said on a leadership panel at the Cell & Gene Meeting on the Mesa in Phoenix on Tuesday, October 6, 2026.

“I don’t expect launch to look like perhaps other launches in oncology,” Fernhoff said. Instead, Orca needs to establish Tregzi as “a product that can be relied upon, that we really get the logistics right every time, get the manufacturing right every time,” Fernhoff said. The FDA approved Tregzi, known in the clinic as Orca-T, on June 30, 2026.

The panel, “Leadership Perspectives: Beyond the Breakthrough”, was chaired by Tiffani Manolis of Thermo Fisher Scientific. Fernhoff was joined by Adriana Herrera, CEO of Pierre Fabre Pharmaceuticals, and Shankar Musunuri, chairman, CEO and co-founder of Ocugen.

Fernhoff said Orca ran all of its clinical trials out of a development facility of “around 10,000 square feet”, and now has “a purpose-built 100,000 square foot facility” for commercial production. Although Tregzi uses donor cells, manufacturing is personalized: “every patient we treat is a batch of medicine that we make for one dose.” Production must ramp responsibly, Fernhoff said, because “you don’t want to get out in front of your skis with production and then suddenly wind up with a bunch of out of specs”.

Orca sells directly to individual transplant hospitals, Fernhoff said, and sets up contracting with each one in a process the company calls site activation – “a really high-touch effort”. Fernhoff’s advice on planning a launch was that “you really start at treating that first patient,” working timelines back from there “rather than working forward from an approval day.”

Fernhoff said only around 10,000 of the roughly 40,000 to 50,000 people diagnosed each year in the US with acute leukemia and high-risk myelodysplastic syndromes receive a stem cell transplant, because of toxicity concerns. Orca’s development programs ask whether more of them, and people with autoimmune disease, could be treated, and what evidence is needed “in order to expand the label”, Fernhoff said.

Herrera said Pierre Fabre has resubmitted its BLA for tabelecleucel, which it licensed from the company that developed it. That partner is still “helping us through the regulatory process”, Herrera said. On donor-derived cell therapies, Herrera said: “I think allo is still complex. It’s just a different type of complexity,” with “the advantage of having inventory on the shelf, so to speak”.

Musunuri said Ocugen has “three programs in phase three” aimed at large populations with vision loss. “Reimbursement challenge is the one that keeps me up at night,” Musunuri said. If Ocugen can “easily treat 100,000 patients a year”, Musunuri said, the “government is not going to pay 30 billion dollars to one company.”

Musunuri argued for pay-over-time models, saying “you can’t price it into millions” and that “hospital systems can’t pay” up front for therapies for large diseases. Musunuri said the first approved gene therapies targeted small patient populations, and that the market now needs to understand there are “gene therapies for masses”.

About the panelists’ companies

Orca Bio is a privately held company based in Menlo Park, California. Tregzi is approved for matched-donor stem cell transplantation with myeloablative conditioning, to improve chronic graft-versus-host disease-free survival in adults with blood cancers, based on the Phase 3 Precision-T study.

Pierre Fabre Pharmaceuticals, of Secaucus, New Jersey, is the US subsidiary of Laboratoires Pierre Fabre and took over the tabelecleucel BLA from Atara Biotherapeutics in 2025. After a complete response letter in January 2026, the company said on October 14, 2026 that the FDA had accepted its resubmission in Epstein-Barr virus-positive post-transplant lymphoproliferative disease, with a target action date of March 31, 2027. The therapy is authorized in Europe as Ebvallo.

Ocugen, of Malvern, Pennsylvania, develops modifier gene therapies for blindness diseases and is targeting three BLAs by 2028. It expects top-line data for OCU400 in retinitis pigmentosa and OCU410ST in Stargardt disease in the first half of 2027, and started a Phase 3 trial of OCU410 in geographic atrophy this year.

Onyx previously covered the second complete response letter for tabelecleucel and Ocugen’s preliminary Phase 2 data for OCU410.

Sources: “Leadership Perspectives: Beyond the Breakthrough” panel, Cell & Gene Meeting on the Mesa, October 6, 2026; Cell & Gene Meeting on the Mesa agenda; Orca Bio press release, June 30, 2026; Pierre Fabre Pharmaceuticals press releases of October 14, 2026, September 30, 2026 and November 3, 2025, and statement of January 12, 2026; Ocugen corporate presentation, October 2026, and second-quarter 2026 results, August 6, 2026