Orca Bio | Our Pipeline

Our pipeline

Our pipeline of high-precision cell therapies is advancing. Our clinical program includes multicenter Phase 1, 2 and 3 studies in hematological malignancies and autoimmune diseases.

Therapeutic area	Candidate & Disease State(s)	Discovery	IND Enabling	Phase 1/2	Phase 3
Therapeutic area: Leukemia
Orca-T
Orca-T AML, MDS, ALL, MPAL Matched donors
Leukemia	Orca-T AML, MDS, ALL, MPAL Matched donors	Phase 3			Phase 3
	Orca-T
	Orca-T AML, MDS, MPAL Matched donors, RIC
	Orca-T AML, MDS, MPAL Matched donors, RIC	Phase 2		Phase 1/2
	Orca-Q
	Orca-Q AML, MDS, ALL, MPAL All donor types
	Orca-Q AML, MDS, ALL, MPAL All donor types	Phase 1		Phase 1/2
Orca-Q
Orca-Q AML, MDS, ALL, MPAL All donor types, pediatrics
Orca-Q AML, MDS, ALL, MPAL All donor types, pediatrics	Phase 1/2		Phase 1/2
Orca-T
Orca-T AML, MDS, ALL, MPAL Mismatched 7/8 donors
Orca-T AML, MDS, ALL, MPAL Mismatched 7/8 donors	Phase 1		Phase 1/2
Orca-T
Orca-T AML, MDS, ALL, MPAL All donor types, TMLI
Orca-T AML, MDS, ALL, MPAL All donor types, TMLI	Phase 1b		Phase 1/2
OrCAR Platform
OrCAR Platform B-ALL Matched donors
OrCAR Platform B-ALL Matched donors	Phase 1		Phase 1/2
Therapeutic area: Other Hematological Malignancies
OrCAR Platform
OrCAR Platform MM
Other Hematological Malignancies	OrCAR Platform MM	IND Enabling	IND Enabling
Other Hematological Malignancies	OrCAR Platform
OrCAR Platform NHL
OrCAR Platform NHL	IND Enabling	IND Enabling
Therapeutic area: Autoimmune Diseases
Orca-Q
Orca-Q PPMS Matched donors
Autoimmune Diseases	Orca-Q PPMS Matched donors	IND Accepted	IND Enabling
Therapeutic area: Solid Organ Transplantation
Orca-Q
Orca-Q All donor types
Solid Organ Transplantation	Orca-Q All donor types	Phase 1		Phase 1/2

Discovery	IND Enabling	Phase 1/2	Phase 3	Launch
Orca-T AML, MDS, ALL, MPAL Matched donors	Phase 3			Phase 3

Therapeutic Area:	Leukemia
Trial Characteristics:	Matched donors

Precision-T (NCT05316701) is a randomized, multicenter Phase 1b/3 study evaluating the safety, tolerability and efficacy of Orca-T, an allogeneic T-cell immunotherapy, in adult patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), high-risk myelodysplastic syndrome (MDS) and mixed-phenotype acute leukemia (MPAL) in a head-to-head comparison with a standard of care allogeneic hematopoietic stem cell transplant (alloHSCT).

Discovery	IND Enabling	Phase 1/2	Phase 3	Launch
Orca-T AML, MDS, MPAL Matched donors, RIC	Phase 2		Phase 1/2

Therapeutic Area:	Leukemia
Trial Characteristics:	Matched donors, RIC

A proposed multicenter single-arm Phase 2 study evaluating allogeneic T-cell immunotherapy, Orca-T, in the setting of reduced intensity conditioning (RIC), in adult patients with acute myeloid leukemia (AML), high-risk myelodysplastic syndrome (MDS) and mixed-phenotype acute leukemia (MPAL).

Discovery	IND Enabling	Phase 1/2	Phase 3	Launch
Orca-Q AML, MDS, ALL, MPAL All donor types	Phase 1		Phase 1/2

Therapeutic Area:	Leukemia
Trial Characteristics:	All donor types

A multicenter single-arm Phase 1 study (NCT03802695) evaluating the safety, tolerability and efficacy of allogeneic T-cell immunotherapy, Orca-Q, in patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), high-risk myelodysplastic syndrome (MDS) and mixed-phenotype acute leukemia (MPAL). The study is assessing patients with haploidentical donors, 7/8 matched donors and matched donors with and without the use of GvHD prophylaxis.

Discovery	IND Enabling	Phase 1/2	Phase 3	Launch
Orca-Q AML, MDS, ALL, MPAL All donor types, pediatrics	Phase 1/2		Phase 1/2

Therapeutic Area:	Leukemia
Trial Characteristics:	All donor types, pediatrics

An investigator-sponsored prospective Phase 1/2 study (NCT05322850) assessing the safety and efficacy of allogeneic T-cell immunotherapy Orca-Q in pediatric patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), high-risk myelodysplastic syndrome (MDS) and mixed-phenotype acute leukemia (MPAL). This study is evaluating pediatric patients with all donor types.

Discovery	IND Enabling	Phase 1/2	Phase 3	Launch
Orca-T AML, MDS, ALL, MPAL Mismatched 7/8 donors	Phase 1		Phase 1/2

Therapeutic Area:	Leukemia
Trial Characteristics:	Mismatched 7/8 donors

An investigator-sponsored Phase 1 study (NCT06551584) evaluating allogeneic T-cell immunotherapy, Orca-T, in patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), high-risk myelodysplastic syndrome (MDS) and mixed-phenotype acute leukemia (MPAL) who have a mismatched 7/8 donor.

Discovery	IND Enabling	Phase 1/2	Phase 3	Launch
Orca-T AML, MDS, ALL, MPAL All donor types, TMLI	Phase 1b		Phase 1/2

Therapeutic Area:	Leukemia
Trial Characteristics:	All donor types, TMLI

An investigator-sponsored Phase 1b study (NCT06195891) evaluating allogeneic T-cell immunotherapy, Orca-T, with total marrow and lymphoid irradiation (TMLI) conditioning in patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), high-risk myelodysplastic syndrome (MDS) and mixed-phenotype acute leukemia (MPAL).

Discovery	IND Enabling	Phase 1/2	Phase 3	Launch
OrCAR Platform B-ALL Matched donors	Phase 1		Phase 1/2

Therapeutic Area:	Leukemia
Trial Characteristics:	Matched donors

An investigator-sponsored Phase 1 trial (NCT05507827) evaluating the safety and efficacy of administering allogeneic T-cell immunotherapy, Orca-T, with allogeneic CD19/CD22 CAR-T cells for the treatment of B-cell acute lymphoblastic leukemia (B-ALL).

Discovery	IND Enabling	Phase 1/2	Phase 3	Launch
OrCAR Platform MM	IND Enabling	IND Enabling

Therapeutic Area:

Other Hematological Malignancies

Orca Bio intends to develop a candidate that combines the Orca Bio high-precision approach with CAR-T technology for the treatment of multiple myeloma (MM).

Discovery	IND Enabling	Phase 1/2	Phase 3	Launch
OrCAR Platform NHL	IND Enabling	IND Enabling

Therapeutic Area:

Other Hematological Malignancies

Orca Bio intends to develop a candidate that combines the Orca Bio high-precision approach with CAR-T technology for the treatment of Non-Hodgkin’s lymphoma (NHL).

Discovery	IND Enabling	Phase 1/2	Phase 3	Launch
Orca-Q PPMS Matched donors	IND Accepted	IND Enabling

Therapeutic Area:	Autoimmune Diseases
Trial Characteristics:	Matched donors

A proposed multicenter Phase 1 clinical study evaluating allogeneic T-cell immunotherapy, Orca-Q, for the treatment of primary progressive multiple sclerosis (PPMS).

Discovery	IND Enabling	Phase 1/2	Phase 3	Launch
Orca-Q All donor types	Phase 1		Phase 1/2

Therapeutic Area:	Solid Organ Transplantation
Trial Characteristics:	All donor types

An investigator-sponsored Phase 1 trial (NCT01165762) evaluating how administering allogeneic T-cell immunotherapy, Orca-Q, following a living related one Haplotype match kidney transplantation may alter the need for immunosuppressive drugs.

AML = acute lymphoblastic leukemia, ALL= acute lymphoblastic leukemia, MDS = myelodysplastic syndrome, MPAL = mixed-phenotype acute leukemia, RIC = reduced intensity conditioning, TMLI = total marrow and lymphoid irradiation, B-ALL = B-cell acute lymphoblastic leukemia, MM = multiple myeloma, NHL = Non-Hodgkin’s lymphoma, PPMS = primary progressive multiple sclerosis

Orca-T, Orca-Q and OrCAR Platform are investigational agents that have not been approved by the FDA and their safety and effectiveness in these therapeutic areas have not been established

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Orca-T

Orca-T is our lead investigational allogeneic T-cell immunotherapy designed to treat hematological malignancies like acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL) and myelodysplastic syndrome (MDS).

Explore the trial details

Orca-Q

Orca-Q is our second-generation investigational allogeneic T-cell immunotherapy candidate being evaluated for the treatment of multiple hematological malignancies. Orca-Q is designed to deliver therapeutic benefits without the need for a fully matched donor.

Review the trial details

Our publications

We believe in transparency and sharing our findings with the scientific community. To help disseminate our results, we’ve presented our data at multiple national and international congresses.

View our data publications