Press release

Menlo Park, CA

April 25, 2022

Orca Bio Presents Positive Data Reinforcing Clinical Profile and Manufacturing Reliability of Orca-T at 2022 Transplantation & Cellular Therapy ASTCT and CIBMTR Tandem Meetings

Pooled data from 137 patients show Orca-T high-precision cell therapy improved overall survival and reduced chronic graft versus host disease compared to standard of care

Orca-T was well-tolerated and resulted in engraftment with regression of marrow fibrosis in patients with myelofibrosis

Manufacturing reliability analysis found vein-to-vein times for all grafts were under 72 hours regardless of donor collection site and transplant center locations

The Precision-T Phase 3 randomized registrational study of Orca-T versus standard of care is now open

MENLO PARK, CA, Apr. 25, 2022 – Orca Bio, a clinical-stage biotechnology company developing purified, high-precision cell therapies for the treatment of cancer, genetic blood disorders and autoimmune diseases, today announced that positive new data were presented at the 2022 Transplantation & Cellular Therapy ASTCT and CIBMTR Tandem Meetings in Salt Lake City, Utah.

The new data on Orca Bio’s lead investigational high-precision cell therapy, Orca-T, include updated results from 137 patients with hematologic malignancies, which continued to show an increase in overall survival rates and a reduction of acute and chronic graft versus host disease (GvHD) compared to standard of care; positive outcomes in a subset of patients with myelofibrosis who received Orca-T; and new analyses demonstrating Orca Bio’s manufacturing platform is reliable, robust and scalable.

"These data from an expanded group of patients are very encouraging and demonstrate that Orca-T appears to improve survival while reducing GvHD. This could be a compelling option for patients battling serious hematological malignancies who currently face devastating transplant-related risks," said Everett Meyer, M.D., Ph.D., primary investigator. "These results, combined with the reliable and centralized Orca-T manufacturing, could potentially transform treatment options for patients and physicians.'

Orca Bio presented pooled data from 137 patients in the single-center Phase 2 and multi-center Phase 1b trials of Orca-T with acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL) and myelodysplastic syndromes (MDS), with at least 100 days of follow-up and a median of 341 days. For comparison purposes, an independent CIBMTR-based control arm was identified, consisting of similar patients with hematologic malignancies who received a standard of care allogeneic hematopoietic stem cell transplant (“alloHSCT”) over a similar timeframe. Results demonstrated that:

  • Rates of moderate-to-severe chronic GvHD were low among Orca-T recipients, occurring in only 5% of patients at one year compared to 38% who received a standard alloHSCT.
  • GvHD-free, relapse-free survival (GRFS) was 71% at one year for Orca-T patients compared to 21% in the CIBMTR-based control arm.
  • The overall survival for patients who received Orca-T was 90% at one year compared to 68% in the CIBMTR-based control arm.

Additionally, Orca Bio presented findings from a manufacturing reliability analysis of 100 Orca-T products in the Phase 1b trial. All investigational cell therapies were manufactured at Orca Bio’s cGMP facility in Sacramento, CA, and transplant centers and donor sites were located across the U.S. All products were successfully delivered and infused to patients within 72 hours or less.

"We produce a unique batch of drug for each patient who receives an Orca-T product, and this drug is made up of fresh, living cells that need to be infused on an extremely rapid timeline," said Nate Fernhoff, Ph.D., co-founder and chief scientific officer at Orca Bio. "Reliable and scalable manufacturing have been integral to the development of our therapies since day one. These results not only show that Orca-T continues to reduce GvHD and improve survival rates over time, but that we have maintained the ability to reliably manufacture, deliver and infuse all patients in a timely manner regardless of donor and patient location. This is an important indication of our ability to potentially deliver this therapy urgently and seamlessly to patients in need."

In a separate poster, Orca Bio presented updated data on the treatment impact of Orca-T in 12 patients with myelofibrosis compared to nine patients who received a standard of care alloHSCT. Orca-T recipients had lower incidence of acute and chronic GvHD (33% with Orca-T versus 100% with alloHSCT) and the data suggest Orca-T was well-tolerated. Treatment with Orca-T resulted in engraftment with regression of marrow fibrosis, indicating potential efficacy for the treatment of myelofibrosis.

Based on the favorable results of the Phase 1b and 2 clinical trials, a randomized registrational Phase 3 trial evaluating Orca-T against standard of care alloHSCT, named Precision-T, is now open. More details will be announced in the coming weeks.

Links to the abstracts follow:

“These data from an expanded group of patients are very encouraging and demonstrate that Orca-T appears to improve survival while reducing GvHD.”

Everett Meyer, MD, Ph.D., primary investigator

About Orca-T

Orca-T is an investigational high-precision allogeneic cellular therapy consisting of infusions containing regulatory T-cells, conventional T-cells and CD34+ stem cells derived from peripheral blood from either related or unrelated matched donors. Orca-T has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration and is being studied to treat multiple hematologic malignancies.

About Orca Bio

Orca Bio is a clinical-stage biotechnology company developing purified, high-precision cell therapies for the treatment of cancer, autoimmune diseases and genetic blood disorders. Our investigational therapies are designed to deliver better survival rates with dramatically fewer risks than standard allogeneic stem cell transplants, like graft versus host disease and other debilitating transplant-related toxicities. At Orca Bio, we hope to not only replace patients' blood and immune systems with healthy ones, but restore their quality of life. For more information, visit www.orcabio.com and follow Orca Bio on Twitter: @orcabio.

Contact:

Corporate Communications

Kelsey Grossman

media@orcabio.com