IPG7236 / Immunophage Biotech - LARVOL DELTA

Phase1/2a Study for IPG7236 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=34 | Completed | Sponsor: Nanjing Immunophage Biotech Co., Ltd | Recruiting ➔ Completed | N=196 ➔ 34 | Trial primary completion date: Sep 2025 ➔ Feb 2026

Enrollment change • First-in-human • Trial completion • Trial primary completion date • Breast Cancer • Melanoma • Oncology • Solid Tumor • Triple Negative Breast Cancer

IPG7236 Combined With Toripalimab in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=52 | Recruiting | Sponsor: Nanjing Immunophage Biotech Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor • CCR8

IPG7236 Combined With Toripalimab in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=52 | Not yet recruiting | Sponsor: Nanjing Immunophage Biotech Co., Ltd

New P1/2 trial • Oncology • Solid Tumor • CCR8

Integrative multi-omics stratification and translational evaluation of Treg-targeted combination immunotherapy in breast cancer. (PubMed, Front Oncol) - "In vivo efficacy studies were conducted using the EMT6 syngeneic breast tumor model, characterized by an immunosuppressive tumor microenvironment, assessing the antitumor effects of a CCR8-targeted small molecule (IPG7236) as monotherapy or in combination with anti-PD-L1 treatment...This study identifies Treg-enriched and immunosuppressive breast cancer subtype through integrative multi-omics analysis and demonstrates, through both in-silico and in-vivo approaches, the therapeutic potential of combining Treg-targeted and PD-L1 blockade therapies. These findings highlight Treg-mediated immunosuppression as a key determinant of therapeutic responsiveness, providing a biological rationale for patient stratification and guiding the development of personalized combination strategies for clinical translation."

Journal • Breast Cancer • Oncology • Solid Tumor • CCR8

A Study of Orally Administered IPG7236 in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=63 | Terminated | Sponsor: Nanjing Immunophage Biotech Co., Ltd | Trial completion date: Nov 2022 ➔ Nov 2025 | Not yet recruiting ➔ Terminated; Sponsor decision

Trial completion date • Trial termination • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Phase1/2a Study for IPG7236 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=196 | Recruiting | Sponsor: Nanjing Immunophage Biotech Co., Ltd | Phase classification: P1 ➔ P1/2

Phase classification • Melanoma • Oncology • Solid Tumor • Triple Negative Breast Cancer

AIMEFIE and Shanghai Gaobo Cancer Hospital jointly promote the Phase II clinical trial of IPG7236 [Google translation] (bydrug.pharmcube.com) - "AIMFIB Pharmaceuticals announced that it has reached a comprehensive strategic cooperation with Shanghai Gaobo Cancer Hospital affiliated to China Pharmaceutical University on IPG7236, the world's first small molecule antagonist targeting CCR8, which it independently developed. According to the agreement, Shanghai Gaobo Cancer Hospital will continue to promote the Phase II clinical trial of IPG7236 based on the existing clinical trials. Professor Li Jin, President, Chief Scientist and Chief Physician of Shanghai Gaobo Cancer Hospital affiliated to China Pharmaceutical University, will serve as the PI and be fully responsible for the Phase II clinical trial of IPG7236."

Licensing / partnership • Solid Tumor

Phase1/2a Study for IPG7236 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=196 | Recruiting | Sponsor: Nanjing Immunophage Biotech Co., Ltd | Trial completion date: Dec 2024 ➔ Dec 2025 | Trial primary completion date: Dec 2024 ➔ Sep 2025

Metastases • Trial completion date • Trial primary completion date • Melanoma • Oncology • Solid Tumor • Triple Negative Breast Cancer

IPG7236 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=196 | Recruiting | Sponsor: Nanjing Immunophage Biotech Co., Ltd | Trial completion date: Mar 2024 ➔ Dec 2024 | Trial primary completion date: Dec 2023 ➔ Dec 2024

Metastases • Trial completion date • Trial primary completion date • Melanoma • Oncology • Solid Tumor • Triple Negative Breast Cancer

Discovery of a Potent and Selective CCR8 Small Molecular Antagonist IPG7236 for the Treatment of Cancer. (PubMed, J Med Chem) - "IPG7236 alone or in combination with PD-1 antibody exhibited significant tumor suppression effects in the mouse xenograft model of human breast cancer. IPG7236 is a promising clinical candidate that targets CCR8 with excellent in vitro ADMET properties, pharmacokinetics, safety profiles, and in vivo efficacy."

Journal • Breast Cancer • Oncology • Solid Tumor • CCR8

A Study of Orally Administered IPG7236 in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=86 | Not yet recruiting | Sponsor: Nanjing Immunophage Biotech Co., Ltd

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