Orca Bio and Lyell Immunopharma Announce Research Partnership

The partnership promotes complementary scientific technologies to develop next-generation cell-based therapies for patients with solid cancers

MENLO PARK, CA, and SOUTH SAN FRANCISCO, CA, September 2, 2020 – Orca Bio and Lyell Immunopharma today announced a research partnership to jointly identify next-generation T cell therapies that will combine the high-precision purification T cell technologies from Orca Bio with the scientific expertise in T cell biology from Lyell to generate potentially synergistic therapeutic solutions for solid tumors.

Lyell Immunopharma has brought together an unrivaled scientific team focused on advancing the science of therapeutic T cells, including the role of T cell differentiation. Orca Bio has developed T cell therapies for patients with blood diseases while also streamlining the commercial manufacture of high-precision cell therapies using OrcaSort™, an ultra-fast, clinically compatible cell sorter.

The ability to produce optimal starting-cell populations is one of many continuing challenges in the development of curative T cell therapies. Evidence from current generation cell therapies suggest that the proportion of cell types and their stages of differentiation may impact the safety and efficacy of T cell therapies. Together, the companies aim to mitigate this challenge by utilizing their proprietary technologies to effectively treat solid tumor cancers.

“Lyell Immunopharma is focused on developing curative T cell therapies for solid tumor cancers by defining starting-cell preparations and modulating T cells, so they are functional in the immunosuppressive tumor microenvironment,” said Nick Restifo, MD, Executive Vice President of Research for Lyell Immunopharma. “This collaboration with Orca Bio provides the potential to more efficiently define starting-cell preparations, which I believe could lead to more effective T cell therapies.”

“Orca Bio has developed extremely pure doses of stem and immune cells that can be precisely formulated to treat cancers,” said Ivan Dimov, PhD, cofounder and CEO of Orca Bio. “By combining our scientific expertise with that of Lyell Immunopharma, and by applying our specialized manufacturing platform, we aim to create the scalable production of adoptive T cell therapies that can reach patients with unprecedented speed.”

Orca Bio and Lyell Immunopharma will each continue to pursue programs independently and through their other partnerships.

Orca Bio Emerges With Nearly $300 Million to Transform Allogeneic Cell Therapy

Company aims to safely and effectively regenerate a healthy blood and immune system for patients with hematological malignancies, genetic diseases and autoimmune disorders

High-precision cell therapies manufactured by Orca Bio have the potential to replace conventional bone marrow transplants and expand the eligible patient population

$192 million Series D financing strengthens the company with resources to propel lead product candidate to completion of clinical development

MENLO PARK, CA, June 17, 2020 – Orca Bio, a clinical-stage biotechnology company developing high-precision allogeneic cell therapies, today announced a Series D financing that brings its total capital raised since its 2016 launch to nearly $300 million. The company creates precisely controlled cell therapies by building each dose cell-by-cell from another person’s blood. Each therapy is constructed by formulating a proprietary mixture of cells that aims to cure the patient’s disease and eliminate dangerous side effects.

Orca Bio’s $192 million Series D financing was co-led by Lightspeed Venture Partners and an undisclosed investor. Other new and existing blue-chip investors also participated in the latest round, including 8VC, DCVC Bio, ND Capital, Mubadala Investment Company, Kaiser Foundation Hospitals, Kaiser Permanente Group Trust and IMRF.

The financing will support the continued advancement of Orca Bio’s cell therapy pipeline and its novel manufacturing platform, which sorts blood with single-cell precision and a high level of purity and speed to create optimal therapeutic mixtures of immune and stem cells. These proprietary mixtures have the potential to revolutionize allogeneic cell therapy for hematological and other cancers, as well as many other diseases and disorders.

A conventional bone marrow transplant relies on naturally occurring T cells. However, the uncontrolled cellular composition often results in life-threatening complications. The company’s most advanced program, TRGFT-201, is evaluating a highly controlled formulation of T cells that includes subsets of regulatory T cells, in a phase I/II clinical study in patients with certain blood cancers. The company’s second program, OGFT-001, is evaluating a fully controlled cell product candidate that contains a next-generation formulation of T cells, in a phase I study, also in patients with blood cancers. Orca Bio’s 2 ongoing clinical studies are among the largest phase I cell therapy trials ever conducted. Each product candidate has the potential to deliver curative outcomes for the initial indications Orca Bio is pursuing, as well as the promise to significantly expand the eligible patient population by substantially reducing the severe toxicities associated with conventional bone marrow transplants.

“The capital we have raised has formed the launchpad for a world-class, fully integrated allogeneic cell therapy company differentiated from all others,” said Ivan Dimov, PhD, Cofounder and Chief Executive Officer of Orca Bio. “Replacing bone marrow transplants is a logical first step in next-generation allogeneic cell therapy. While a conventional bone marrow transplant administers an uncontrolled cell product, Orca Bio has been the first to deliver a high-precision cell therapy. We are initially focused on two clinical programs in patients with blood cancers and have successfully treated the largest-ever number of patients with a high-precision cell therapy. We believe our approach has the potential to transform allogeneic cell therapy, and thus the treatment of not only blood cancer, but also many other diseases with significant unmet need, such as a variety of genetic diseases and autoimmune disorders.”

“With precise reconstitution using highly defined cell preps and a swift reboot of the patient’s immune system, Orca Bio’s product candidates have the potential to eliminate fatal side effects, such as graft-versus-host disease, and infections commonly associated with bone marrow transplants while maintaining or enhancing antitumor efficacy,” said Rick Klausner, MD, an investor and member of Orca Bio’s advisory board. “The possibility of improving cure rates and minimizing toxicity holds the promise of expanding the eligible patient population for successful bone marrow transplantation in cancer.”

“Orca Bio’s visionary leadership team, seasoned advisors, solid financial foundation, and novel technology make the company uniquely suited to develop truly differentiated, scalable allogeneic cell therapies,” said Jonathan MacQuitty, PhD, Venture Partner at Lightspeed Venture Partners. “I look forward to the Orca Bio team’s continued development and commercialization of revolutionary allogeneic cell therapies.”

Internationally Recognized Experts and Leaders

Orca Bio’s leadership, Ivan Dimov, PhD, Chief Executive Officer, Nate Fernhoff, PhD, Chief Scientific Officer, and Jeroen Bekaert, PhD, Chief Operating Officer, met at Stanford University and launched the company in 2016. Orca Bio’s board of directors and advisory board are comprised of renowned scientific leaders and seasoned biotech executives with extensive experience in drug discovery and cell-based therapeutics, including: