NCP112 / DongKoo Bio & Pharma - LARVOL DELTA

DongKoo Bio & Pharma said Wednesday it will in-license technology for NCP112, a peptide-based drug candidate for atopic dermatitis it has been co-developing with Novacell Technology, a peptide R&D company affiliated with POSTECH, one of Korea’s leading science and engineering universities. (Korea Biomedical Review) - "The work has been backed by the Korea Drug Development Fund (KDDF)'s National New Drug Development Project, a pan-ministerial program designed to help Korea produce global “blockbuster” drugs by 2030."

Financing • Licensing / partnership • Atopic Dermatitis

[Bio Forum] Novacell Technology "Development of New Drug with FPR2 Target Peptide" [Google translation] (Hankyung) - "'The FPR2 target peptide new drug candidate we developed is a next-generation substance with dramatically improved activity and biostability.' said Lee Tae-hoon, CEO of Novacell Technology, at the ‘2025 Hankyung Bio Insight Forum’ held at Lotte Hotel Jeju on the 19th. Novacell Technology...Novacell Technology has exported the technology for its new immune disease drug candidate ‘NCP112’ to Huons. NCP112 targets FPR2 and is indicated for mild to moderate atopic dermatitis treatment....Currently, phase 2 clinical trials for NCP112 are about to begin."

Commercial • New molecule • New P2 trial • Dry Eye Disease

Huons applies for domestic phase 1 clinical trial IND for dry eye treatment [Google translation] (eDaily) - "Huons (243070) announced on the 29th that it had applied to the Ministry of Food and Drug Safety in Korea for approval of phase 1 clinical trial plan (IND) of NCP112 eye drops 'HUC1-394' for the treatment of dry eye syndrome."

New trial • Dry Eye Disease • Ophthalmology

FPR2- selective peptide ligand NCP112 ameliorates atopic dermatitis in preclinical models through inhibition of type 2 immune response and recovery of skin barrier function (EAACI 2023) - "Although recently approved biologic Dupixent has shown efficacy for patients with moderate-to-severe symptoms, there is still a high unmet medical need for an effective topical agent with long-term safety for patients with mild-to-moderate symptoms. Proteomic analysis of epidermis from capsaicin-induced animal shows that a wide range of proteins involved in innate immunity, wound healing, protease, and skin barrier which are affected by disease status are restored by topical treatment of NCP112. Conclusion These finding indicate that NCP112 has immunoregulatory activities to alleviate the skin manifestation of atopic dermatitis and it has the potential to be novel treatment option."

Preclinical • Allergy • Atopic Dermatitis • Dermatitis • Immunology • ANXA1 • FLG • FPR2 • IL13 • IL4

A Single-center, Randomized, Double-blinded, Placebo-controlled, Phase 1 Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of NCP112 (clinicaltrials.gov) - P1 | N=18 | Completed | Sponsor: NovaCell Technology Inc.

New P1 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Novacell Technology and the National New Drug Development Agency signed an R&D agreement for innovative new drugs [Google translation] (Pharm News) - "Novacell Technology...announced on the 16th that it had signed an R&D agreement with the National New Drug Development Agency for the innovative new external drug 'NCP112' being developed as a treatment for atopic dermatitis. Through this agreement, Novacell will receive R&D support from the National New Drug Development Agency for the development of domestic phase 1 clinical trials of NCP112 and entry into phase 2 clinical trials....With the research support of the National New Drug Development Project, NCP112 Phase 1 clinical trial Part B will be expanded to three institutions. The purpose of the phase 1 clinical trial design is to confirm safety in Part A, which is conducted on healthy volunteers, and to verify safety and explore effectiveness in Part B, which is conducted for patients with atopic dermatitis."

Licensing / partnership • New P1 trial • Atopic Dermatitis • Dermatology • Immunology

Novacell, Hits and Peptide Immunotherapy Joint Research [Google translation] (Yakup Shinmoon) - "Novacell Technology Co., Ltd., an affiliate of Donggu Biopharmaceuticals, a pharmaceutical and bio-specialized company and a peptide immunotherapy development company, signed a joint R&D contract with Hits, a company specializing in artificial intelligence-based new drug development, to develop effective substances for next-generation immunotherapeutic agents....Based on the results of structure-based R&D, Novacell and Hits will jointly develop a material to which peptidomimetics (mimicking peptide) is applied using artificial intelligence technology....PEPTIROID_AD, a treatment for atopic dermatitis, was approved for a clinical trial in January and is undergoing phase 1 clinical trials in Korea."

Licensing / partnership • Atopic Dermatitis • Dermatology

Nova Cell Technology enters clinical trial for atopic dermatitis treatment [Google translation] (Pharm News) - "Novasel Technology Co....announced on the 28th that it has received approval for a phase 1 clinical trial plan for atopic dermatitis treatment using NCP112...This two-stage clinical trial first evaluated the safety and tolerability of NCP112 as an external preparation applied to the skin in 18 healthy adults, and then evaluated the safety and tolerability of 45 patients with atopic dermatitis (a total of 3 trial groups)....Novacell has secured global patent rights for NCP112 along with the core technology for developing effective peptides."

New P1 trial • Atopic Dermatitis

New drug development company Novacell acquires U.S. patent for atopic dermatitis immunotherapeutics [Google Translation] (thereport.co.kr) - “NovaCell Technology…announced on October 10 that it had obtained a U.S. patent for ncp112, an innovative drug candidate being developed as an atopic dermatitis immunotherapeutic agent...focusing on the successful non-clinical completion and entry into clinical phase 1 in 2020….Meanwhile, NovaCell Technology is participating in the 2019 KDDF Investment Showcase, which will be held on October 14 to support subsequent investment in the Pan-Buddha New Drug Development Project.”

New P1 trial • Patent

Newly added product (The Report) - Preclinical, Atopic Dermatitis

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