NOVELTY NOBILITY Inc.

Program: NN2802

Modality: Monoclonal antibody targeting c-Kit

Indications: Mast Cell Diseases

Research
Preclinical
Phase I
Phase II/III

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Details: NN2802 is a fully human IgG1 monoclonal antibody discovered in-house by Novelty Nobility.

Clinical Status: A Phase 1a clinical study has been completed demonstrating pharmacological activity of NN2802 including more rapid reduction of the pharmacodynamic biomarker tryptase than other competitive therapeutic antibodies in clinical development.

Science: Mast cells are tissue-resident immune cells which mediate inflammatory responses such as hypersensitivity and allergic reactions. SCF/c-Kit signaling is required for the differentiation, tissue recruitment, activation and survival of mast cells. Mast cell activation plays a central role in the onset and progression of mast cell-driven diseases such as chronic urticaria. NN2802 specifically binds to c-Kit with picomolar binding affinity in competition with its natural ligand, SCF (stem cell factor), to potently inhibit the activation and pathobiology of mast cells.

Publications: [Mol. Cell. Biochem] A fully human anti‑c‑Kit monoclonal antibody 2G4 inhibits proliferation and degranulation of human mast cells (2022)

Program: NN3201

Modality: Antibody Drug Conjugate (ADC) targeting c-Kit (CD117, stem cell factor receptor)

Indications: Small Cell Lung Cancer (SCLC) and Gastrointestinal Stromal Tumor (GIST)

Research
Preclinical
Phase I
Phase II/III

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Details: NN3201 is a novel fully human IgG1 monoclonal antibody-drug conjugate (ADC) discovered, designed, and developed in-house by Novelty Nobility bearing an MMAE payload with a highly homogenous DAR of 4 conjugated via a proprietary site-specific cleavable linker technology.

Clinical Status: Our c-Kit ADC program is cleared by the U.S. FDA for Phase 1 clinical study in patients with c-Kit associated cancers including gastrointestinal stromal tumors (GIST), small cell lung cancer (SCLC), adenoid cystic carcinoma (ACC), uveal melanoma, neuroendocrine tumors (NET), and chromophobe and clear cell renal cell carcinomas.

Science: Developed to treat both c-Kit wildtype and activating mutation-driven cancers, NN3201 monotherapy exhibited complete remission in xenograft model studies of hard-to-treat cancers known to express c-Kit such as SCLC, GIST and AML. This novel ADC is powered by dual modalities that simultaneously induce tumor microenvironment (TME) amelioration via c-Kit pathway inhibition and cell cycle arrest-induced apoptosis in c-Kit positive tumors via ADC internalization. Further, strategic combination of our high specificity c-Kit antibody with the selected MMAE payload overcomes multidrug resistance concerns as c-Kit inhibition downregulates various key drug efflux pumps that could affect durability of MMAE cytotoxic effects in cancer cells. Thus, NN3201 has been carefully designed to demonstrate a superior preclinical efficacy and safety profile resulting in an expanded therapeutic index.

Publications

[Mol. Cancer Ther.] Preclinical Antitumor Efficacy of a Novel Anti-c-Kit Antibody-Drug Conjugate, NN3201, in c-Kit-Positive Tumors (2025)

[AACR poster] NN3201, A novel c-Kit targeting ADC, exhibits robust preclinical anti-tumor efficacy in SCLC and GIST models (2024)

[AACR poster] In vivo efficacy and preclinical safety profile of NN3201, an anti-cKIT antibody-drug conjugate, for treating SCLC and AML (2023)

[AACR poster] An Optimized Preclinical Antibody-Drug Conjugate Against Cancers with cKIT Overexpression or Activating Mutations (2022)

[Int. J. Mol. Sci.] Antibody-Drug Conjugate Targeting c-Kit for the Treatment of Small Cell Lung Cancer (2022)

[Mol. Oncol.] A novel anti-c-Kit ADC to treat wild-type and activating-mutant c-Kit-positive tumors (2021)

Program: NN3206

Modality: Antibody Drug Conjugate (ADC) targeting CDCP-1

Indications: Pan RAS-driven Cancers

Research
Preclinical
Phase I
Phase II/III

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Details: NN3206 is a first-in-class antibody-drug conjugate (ADC) designed and developed by Novelty Nobility with an undisclosed RAS correlate target and linker-payload system.

Science: An undruggable target from a traditional antibody perspective, RAS mutations regulate the induction of a certain membrane protein, our undisclosed target. Pan RAS mutations and overexpression of our undisclosed target are found to be highly correlated in various RAS-driven tumors including pancreatic ductal adenocarcinoma (PDAC) and colorectal cancer (CRC).

NN3206 is designed to demonstrate superb RAS subtype- or mutation-agnostic pharmacological activities utilizing a linker-payload system with high potency balanced to enable a broader therapeutic index. Accordingly, our novel pan RAS correlate-targeting ADC program is expected to overcome the structural issues that have hindered capitalization of RAS as a promising oncology target while utilizing the precision of antibody drug delivery.

Publications: [MTO] CDCP1-targeting ADC outperforms standard therapies in Ras-mutant pancreatic cancer (2025)

Program: NN4101

Modality: Bispecific antibody targeting VEGF and c-Kit

Indications: Neovascular Retinal Diseases

Research
Preclinical
Phase I
Phase II/III

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Details: NN4101 is a first-in-class bispecific antibody connecting a fully human anti-c-Kit monoclonal antibody discovered by Novelty Nobility with a VEGF trap.

Science: Unlike most investigational retinal therapies currently participating in the race to increase the durability of anti-VEGF therapies, we focus on the fundamental mechanism of retinal diseases: hypoxia. Hypoxia-inducible factor-1α (HIF-1α) is a transcription factor stabilized by hypoxia, playing a pivotal role in the onset and development of retinal diseases.

Our c-Kit inhibiting antibody regulates angiogenic factors including VEGF, vascular permeability factors such as Ang-2, and multiple inflammatory cytokines (IL-6, IL-8) simultaneously by modulating stabilized HIF-1α and resolving hypoxia. To enhance durability, we introduced the validated sequence of the VEGF trap for additional VEGF inhibition resulting in a 2x2 format bispecific antibody, NN4101.

Publications

[iOVS] Intraocular Concentration of Stem Cell Factor/c-KIT and Galectin-1 in Retinal Diseases (2024)

[Cardiovasc Res.] Stem cell factor and cKIT modulate endothelial glycosis in hypoxia (2024)

[ARVO Poster] The novel function of NN2101, an anti-c-kit antibody, as an inhibitor of HIF via c-kit regulation in retinal neovascularization and neurodegeneration (2022)

[Pharmaceutics] A Fully Human Monoclonal Antibody Targeting cKIT Is a Potent Inhibitor of Pathological CNV in Mice (2021)

[ARVO Poster] A Fully Human Monoclonal Antibody Targeting c-KIT is a Potent Inhibitor of Choroidal Neovascularization in a Murine Model (2021)

[IJBIOMAC] Development and characterization of a fully human antibody targeting SCF/c-kit signaling (2020)

[ATVB] SCF (Stem Cell Factor) and cKIT Modulate Pathological Ocular Neovascularization (2019)

[Mol Vis.] Src tyrosine kinase regulates the stem cell factor-induced breakdown of the blood-retinal barrier (2016)

[ATVB] Stem Cell Factor Is a Potent Endothelial Permeability Factor (2014)

[Cardiovasc Res.] Direct and Differential Effects of Stem Cell Factor on the Neovascularization Activity of Endothelial Progenitor Cells (2011)

Program: NN4103

Partnership

Modality: Bispecific antibody targeting c-Kit and an undisclosed target

Indications: Geographic Atrophy (GA)

Research
Preclinical
Phase I
Phase II/III

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Details: NN4103 is a first-in-class bispecific antibody designed by Novelty Nobility to target both c-Kit and an undisclosed target for the treatment of geographic atrophy (GA).

Science: GA is the progressive, irreversible, advanced form of dry age-related macular degeneration (AMD) that can lead to permanent central vision loss over time. We hypothesize that mast cells are activated under hypoxic conditions in AMD. Upon activation and degranulation of mast cells, tryptase is released into the choroidal stroma and Bruch’s membrane. Tryptase can degrade choroidal stroma and Bruch’s membrane resulting in thinning of the choroid and degeneration of the retinal pigment epithelium (RPE), both key features of GA. c-Kit signaling is well known for controlling mast cell differentiation, tissue recruitment, survival and activity. Our research focuses on uncovering the fundamental role mast cells play in the development of GA to provide a new therapeutic option for patients in the form of NN4103, a bispecific antibody utilizing c-Kit inhibition and an undisclosed target pathway.

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