Pipeline

Status:

TG-1801 (NI-1701) Phase I - clinical trial ongoing

Ownership:

Shared program with TG Therapeutics

Format:

Kλ body

Indications:

B cell malignancies

Additional info:

TG-1801 (NI-1701) is a CD47/CD19 bispecific antibody that drives selective and effective CD47 blockade to CD19-positive B cells by pairing a high affinity anti-CD19 targeting arm to an anti-CD47 arm of optimized low affinity. As such, CD47 blockade is selective to CD19-bearing cells, thus avoiding unwanted CD47 blockade on other cell types (e.g., red blood cells and platelets). Due to its selectivity, the molecule contains a fully competent IgG1 Fc-domain allowing ADCC and ADCP effector functions. Currently, TG-1801 is being developed in Phase I clinical trials sponsored by our partner, TG Therapeutics.

Status:

Phase I - clinical trial ongoing

Ownership:

Light Chain Bioscience

Format:

Kλ body

Indications:

MSLN-positive solid tumors

Additional info:

NI-1801 is a CD47/MSLN bispecific antibody that drives selective and effective CD47 blockade to MSLN-positive cells by pairing a high affinity anti-MSLN targeting arm to an anti-CD47 arm of optimized low affinity. As such, CD47 blockade is selective to MSLN-bearing cells, thus avoiding unwanted CD47 blockade on other cell types (e.g., red blood cells and platelets). Due to its selectivity, the molecule contains a fully competent IgG1 Fc-domain allowing ADCC and ADCP effector functions. A first-in-human trial of NI-1801 in patients with solid cancers expressing MSLN was initiated in June 2022.

Status:

Phase I - clinical trial ongoing

Ownership:

LamKap Bio alpha

Format:

Kλ body

Indications:

CEA-positive solid tumors

Additional info:

NILK-2301 is a bispecific antibody that drives T-cell retargeting to tumor cells by pairing a high affinity anti-carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5, CEA)-targeting arm to an anti-CD3 arm of optimized low affinity. The Fc-domain of NILK-2301 has been modified to avoid FcγR-binding whilst maintaining neonatal fc receptor (FcRn) engagement. NILK-2301 is being developed the treatment of solid cancer for our partner LamKap Bio alpha AG and has advanced to Phase I in Q1/2024.

Status:

CTA submitted

Ownership:

LamKap Bio beta

Format:

Kλ body

Indications:

CEA-positive solid tumors

Additional info:

NILK-2401 is a bispecific antibody that drives selective and effective CD47 blockade to tumor cells expressing carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5, CEA) by pairing a high affinity anti-CEA targeting arm to an anti-CD47 arm of optimized low affinity. As such, CD47 blockade is selective to CEA-bearing cells, thus avoiding unwanted CD47 blockade on other cell types (e.g., red blood cells and platelets). Due to its selectivity, the molecule contains a fully competent IgG1 Fc-domain allowing ADCC and ADCP effector functions. NILK-2401 is being developed for our partner LamKap Bio beta AG and CTA has been filed in Q1/2024.

Status:

Discovery/early preclinical

Ownership:

LamKap Bio Gamma

Format:

Kλ body

Indications:

GPC3-positive solid tumors

Additional info:

NILK-2501 is a bispecific antibody that drives T-cell retargeting to tumor cells by pairing a high affinity arm targeting glypican-3 (GPC3) to an anti-CD3 arm of optimized low affinity. The Fc-domain of NILK-2301 has been modified to avoid FcγR whilst maintaining neonatal fc receptor (FcRn) engagement. NI-2501 is being developed for our partner LamKap Bio γ AG and is currently in discovery/early preclinical phase.

Status:

Discovery

Ownership:

Light Chain Bioscience

Format:

Kλ body

Indications:

Solid tumors

Additional info:

NI-2801 is a CD47/ HER2 bispecific antibody that drives selective and effective CD47 blockade to HER2-positive cells by pairing a high affinity anti-HER2 targeting arm to an anti-CD47 arm of optimized low affinity. As such, CD47 blockade is selective to HER2-bearing cells, thus avoiding unwanted CD47 blockade on other cell types (e.g., red blood cells and platelets). Due to its selectivity, the molecule contains a fully competent IgG1 Fc-domain allowing ADCC and ADCP effector functions. NI-2801 is currently in discovery phase.

Status:

Preclinical

Ownership:

Light Chain Bioscience

Format:

Kλ body

Indications:

PD-L1-Positive

Additional info:

NI-3201 is a bispecific antibody that provides a costimulatory signal to T cells via the co-engagement of PD-L1 and CD28. The goal is to provide a specific signal 2 to T-cells via the co-engagement of a PD-L1 in the tumor microenvironment (TME). Importantly, CD28 engagement is monovalent and is restricted by PD-L1 expression in the TME. The Fc-domain of NI-3201 has been modified to avoid FcγR-binding whilst maintaining neonatal Fc receptor (FcRn) engagement. NI-3201 can be used to enhance anti-tumor effect driven by T-cell retargeting CD3 bispecific antibodies or synergize with PD-1 checkpoint inhibitors. NI-3201 is currently in early pre-clinical phase of development.

Status:

Preclinical

Ownership:

LamKap Bio alpha

Format:

Kλ body

Indications:

CEA-positive solid tumors

Additional info:

NILK-3301 is a bispecific antibody that provides a costimulatory signal to T cells via the co-engagement of carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5, CEA) and CD28. Importantly, CD28 engagement is monovalent and is restricted by CEA present on tumor cells. The Fc-domain of NILK-3301 has been modified to avoid FcγR-binding whilst maintaining neonatal Fc receptor (FcRn) engagement. NILK-3301 can be used to enhance anti-tumor efficacy driven by T cell retargeting bispecific antibodies or synergize with e.g., checkpoint inhibitors PD-1/PD-L1. It is currently in preclinical development.

Status:

Discovery/early preclinical

Ownership:

LamKap Bio Gamma

Format:

Kλ body

Indications:

GPC3-positive solid tumors

Additional info:

NILK-3801 is a bispecific antibody that provides a costimulatory signal to T cells via the co-engagement of glypican-3 (GPC3) and CD28. Importantly, CD28 engagement is monovalent and is restricted by GPC3 present on tumor cells. The Fc-domain of NILK-3301 has been modified to avoid FcγR-binding whilst maintaining neonatal Fc receptor (FcRn) engagement. NILK-3801 can be used to enhance anti-tumor efficacy driven by T cell retargeting bispecific antibodies or synergize e.g., with checkpoint inhibitors PD-1/PD-L1 and is currently in discovery/early preclinical phase of development.

Status:

Discovery

Ownership:

Discoveric Bio Beta

Format:

Kλ Multispecific

Indications:

Infectious diseases

Additional info:

Using the Kλ body platform, mixtures of bispecific antibodies are being developed to target antibiotic resistant bacteria. The NI-3001 program is in partnership with Discoveric bio beta and is currently in discovery phase of development.

Status:

Discovery

Ownership:

Discoveric Bio Alpha

Format:

Kλ Multispecific

Indications:

Alzheimer's disease

Additional info:

Using the Kλ body platform, mixtures of bispecific antibodies are being developed to target key drivers of Alzheimer's disease. The NI-3101 program is in partnership with Discoveric bio alpha and is currently in discovery phase of development

Status:

EB05 Phase III clinical trial ongoing

Ownership:

Edesa Biotech

Format:

Monoclonal antibody

Indications:

Acute respiratory distress syndrome (ARDS)/other

Additional info:

NI-0101 (EB05) is a humanized antibody targeting Toll-like Receptor 4 (TLR4). The Fc-domain of NI-0101 has been modified to increase binding toFcγR32a (FcγRRIIa) affording an increased binding and functional activity to the molecule. Edesa Biotech, Inc. has licensed NI-0101 and is being studied in Phase 3 clinical trial as a single-dose therapy for hospitalized COVID-19 patients.

Status:

Phase II

Ownership:

Edesa Biotech

Format:

Monoclonal antibody

Indications:

Acute respiratory distress syndrome (ARDS)/other

Additional info:

NI-0801(EB06) is a fully human monoclonal antibody directed against chemokine (C-X-C motif) ligand 10 (CXCL10). Edesa Biotech, a clinical-stage biopharmaceutical company, has obtained an exclusive worldwide license to develop and commercialize NI-0801.

Status:

IKS03 Phase I clinical trial ongoing

Ownership:

Partnered to IKSUDA Therapeutics

Format:

Antibody Drug Conjugate (ADC)

Indications:

B cell malignancies

Additional info:

NI-2201 is a CD19-targeted Antibody Drug Conjugate (ADC) monoclonal antibody. Light Chain Bioscience, LegoChem Biosciences & Iksuda have a Licensing Agreement for the development and commercialization of NI-2201 (LCB73, IKS03) for CD19+ B cell hematological tumors. NI-2201 was generated in a partnership by combining LegoChem Biosciences ‘cancer-selectively activated next-generation linker and toxin platform with Light Chain Bioscience’s proprietary antibody targeting CD19. Preclinical data of LCB73 along with clinical outcome of other CD19-targeted therapies suggest that this ADC may be an effective treatment option for various B-cell hematological cancers including diffuse large B-cell lymphoma (DLBCL) and Burkitt lymphoma.