Pipeline

Status:

Phase I - clinical trial completed

Ownership:

Light Chain Bioscience

Format:

Kλ body

Indications:

B cell malignancies

Additional info:

NI-1701 is a CD47×CD19 bispecific antibody engineered to deliver selective CD47 blockade to CD19-positive B cells by pairing high-affinity CD19 targeting with optimized low-affinity CD47 binding. This design spares non-B cells (e.g., RBCs, platelets) and enables a fully active IgG1 Fc for ADCC and ADCP. In Phase I, NI-1701 showed a favorable safety profile with minimal hematologic toxicity. Clinical activity included 23% partial responses on monotherapy and 44% responses (1 CR, 6 PR) in combination with ublituximab in DLBCL and FL.

Status:

Randomized Phase II trial against SOC

Ownership:

Light Chain Bioscience

Format:

Kλ body

Indications:

MSLN-positive solid tumors

Additional info:

NI-1801 is a CD47×mesothelin bispecific antibody designed to deliver selective CD47 blockade to mesothelin-positive tumor cells by combining high-affinity tumor targeting with optimized low-affinity CD47 binding. This tumor-restricted approach spares healthy cells and enables an active Fc domain to promote immune-mediated tumor cell killing. Clinical data generated predominantly in heavily pre-treated platinum-resistant ovarian cancer (PROC) patients show a favorable safety and pharmacokinetic profile, evidence of single-agent and combination activity, and durable clinical benefit with a well-tolerated, chemotherapy-free regimen. The profile to date supports clear differentiation from earlier CD47-targeting approaches.

Status:

Phase I - clinical trial ongoing

Ownership:

LamKap Bio alpha

Format:

Kλ body

Indications:

CEA-positive solid tumors

Additional info:

NILK-2301 is a CEA×CD3 bispecific antibody that retargets T cells to CEA-expressing tumor cells by combining high-affinity CEA binding with optimized low-affinity CD3 engagement. Its Fc domain is engineered to avoid FcγR binding while preserving FcRn-interaction. NILK-2301 is being developed for the treatment of solid tumors in partnership with LamKap Bio alpha AG. Light Chain Bioscience is the clinical trial sponsor. The program has completed dose escalation and is currently in expansion cohorts as monotherapy and in combination with an immune check point inhibitor.

Status:

Phase I - clinical trial ongoing

Ownership:

LamKap Bio beta

Format:

Kλ body

Indications:

CEA-positive solid tumors

Additional info:

NILK-2401 is a CD47×CEA bispecific antibody designed to deliver selective CD47 blockade to CEA-expressing tumor cells by combining high-affinity CEA targeting with optimized low-affinity CD47 binding. This tumor-restricted approach limits CD47 engagement on healthy cells and enables a fully active IgG1 Fc to support immune-mediated tumor cell killing. NILK-2401 is being developed for the treatment of solid tumors in partnership with LamKap Bio alpha AG. Light Chain Bioscience is the clinical trial sponsor. The program has completed dose escalation and is currently in expansion cohorts as monotherapy and in combination with an immune checkpoint inhibitor.

Status:

Preclinical

Ownership:

Light Chain Bioscience

Format:

Kλ body

Indications:

HER2-positive solid tumors

Additional info:

NI-2801 is a CD47×HER2 bispecific antibody designed to deliver selective CD47 blockade to HER2-expressing tumor cells by combining high-affinity HER2 targeting with optimized low-affinity CD47 binding. This tumor-restricted approach minimizes CD47 engagement on healthy cells and enables a fully active IgG1 Fc to support immune-mediated tumor cell killing. NI-2801 is currently in the preclinical phase

Status:

Clinical ready

Ownership:

Light Chain Bioscience

Format:

Kλ body

Indications:

PD-L1-positive solid tumors

Additional info:

NI-3201 is a PD-L1×CD28 bispecific antibody designed to deliver a conditional costimulatory signal to T cells through co-engagement of PD-L1 in the tumor microenvironment and CD28 on T cells. CD28 engagement is monovalent and PD-L1–dependent, focusing activity to the tumor site. Its Fc domain is engineered to avoid FcγR binding while preserving FcRn-mediated half-life. NI-3201 is designed to show single-agent activity and to synergize with CD3 T-cell engagers. The program has completed preclinical development, including GMP manufacturing, and is CTA-ready.

Status:

Preclinical

Ownership:

Light Chain Bioscience

Format:

Kλ body

Indications:

CEA-positive solid tumors

Additional info:

NI-3301 is a CEA×CD28 bispecific antibody designed to provide a conditional costimulatory signal to T cells through co-engagement of CEA on tumor cells and CD28 on T cells. CD28 engagement is monovalent and CEA-dependent, focusing activity to the tumor site. Its Fc domain is engineered to avoid FcγR binding while preserving FcRn-mediated half-life.NI-3301 is intended to enhance the efficacy of T-cell-retargeting bispecifics and to synergize with checkpoint inhibitors such as PD-1/PD-L1 blockers. The program is in preclinical development, with a clonal CHO cell line established for GMP manufacturing.

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:

Preclinical

Ownership:

Discoveric Bio Alpha

Format:

Kλ body

Indications:

Alzheimer's disease

Additional info:

NIDB-3101 is a novel antibody-based therapeutic being developed by discoveric bio alpha to slow the progression of neurodegenerative diseases. The program leverages bispecific and biparatopic antibody designs to capture a broad range of pathological protein species, including truncated forms, with the aim of improving disease modification in disorders such as Alzheimer’s and Parkinson’s disease. A clinical candidate has been selected for NIDB-3101 and advancing into GMP manufacture and IND/CTA-enabling studies.

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.