CBP-1008 / Coherent Biopharma - LARVOL DELTA

The world’s first! Tongyi Pharmaceutical’s dual-ligand conjugate drug CBP-1008 is granted fast track designation by the FDA [Google translation] (163.com) - "On October 10, 2024, Tongyi Pharmaceutical announced that the U.S. Food and Drug Administration (FDA) officially granted CBP-1008 Fast Track Designation (FTD) qualification for the treatment of platinum-resistant ovarian clear cell carcinoma (OCCC)."

Fast track • Ovarian Cancer

First-in-human, phase I study of CBP-1008, a first-in-class bi-specific ligand drug conjugate (Bi-XDC), in patients with advanced solid tumors (ESMO 2024) - P1 | "CBP-1008 demonstrated a good safety profile and promising anti-tumor activity in OC, especially OCCC pts, a rare population with lack of effective treatment. It has the potential to be a superior treatment option for OC, regardless of FRα/TRPV6 expression levels. Ning Li, Jifang Gong, Jian Zhang and Dan Liu contributed equally to this work."

Clinical • Metastases • P1 data • Breast Cancer • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Solid Tumor • Triple Negative Breast Cancer • FOLR1 • TRPV6

A Study of CBP-1008 in Patients With Advanced Solid Tumor (clinicaltrials.gov) - P1 | N=143 | Recruiting | Sponsor: Coherent Biopharma (Suzhou) Co., Ltd. | Phase classification: P1a/1b ➔ P1 | Trial completion date: Mar 2024 ➔ Sep 2024 | Trial primary completion date: Sep 2023 ➔ Sep 2024

Metastases • Phase classification • Trial completion date • Trial primary completion date • Breast Cancer • Colon Cancer • Colorectal Cancer • Endometrial Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

First-in-human, phase I study of CBP-1008, a first-in-class bispecific ligand drug conjugate (Bi-XDC), in patients with advanced solid tumors. (ASCO 2024) - P1a/1b | "The current result showed that CBP-1008 demonstrated manageable safety profile. Promising antitumor activity was observed in ovarian cancer patients at dose of 0.15mg/kg, especially in platinum-resistant HGSOC patients with ≤3 prior treatment regimens. CBP-1008 has the potential to provide a better treatment option for ovarian cancer patients regardless of FRα expression levels."

Clinical • Metastases • P1 data • Anemia • Breast Cancer • Hematological Disorders • Neutropenia • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Solid Tumor • Triple Negative Breast Cancer • FOLR1 • TRPV6

CBP-8008: A first-in-class targeted pan-Bet protein degradation therapy using bi-specific XDC (Bi-XDC) technology for TNBC and mCRPC (AACR 2024) - "Several anticancer Bi-ligand drug conjugates including CBP-1008, CBP-1018, and CBP-1019 have been brought into various clinical stages in China and US. CBP-8008 is currently in preclinical development as a potential first-in-class pan-Bet protein degradation therapy using Bi-XDC technology for TNBC and mCRPC"

Breast Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor • Triple Negative Breast Cancer • BRD2 • BRD3 • BRD4 • FOLR1

Bispecific-XDC: Novel First-in-Class Cancer Therapies From Concept to Clinical (ADC-USA 2023) - "Describing CBP-1008: a FR/ TRPV6 targeted drug conjugate in Phase II pivotal studies of advanced ovarian cancer treatment; Exploring CBP-1018: a FR/ PSMA targeted drug conjugate in Phase Ib for prostate cancer therapy; Highlighting CBP-1019: TOP1i payload drug conjugate for unmet medical needs"

Clinical • Genito-urinary Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Solid Tumor • TRPV6

Orphan Designation: Treatment of pancreatic cancer (FDA) - Date Designated: 09/19/2023

Orphan drug • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

First-in-human, phase I study of CBP-1008, a bi-specific ligand drug conjugate, in patients with advanced solid tumors. (ASCO 2023) - P1a/1b | "The current result showed that CBP-1008 has manageable safety profile. Antitumor activity was observed in PROC patients at dose of 0.15mg/kg or above, especially in PROC patients with FRα expression ≥25% and ≤3 prior treatment regimens. Jifang Gong, Jian zhang and Ning Li contributed equally to this work."

Clinical • Metastases • P1 data • Anemia • Breast Cancer • Colorectal Cancer • Diabetes • Febrile Neutropenia • Gastrointestinal Cancer • Hematological Disorders • Hepatology • HER2 Breast Cancer • Neutropenia • Oncology • Ovarian Cancer • Pancreatic Cancer • Renal Disease • Solid Tumor • Triple Negative Breast Cancer • ER • FOLR1 • HER-2 • TRPV6

A phase Ia/Ib study of CBP-1008, a bispecific ligand drug conjugate, in patients with advanced solid tumors. (ASCO 2022) - P1a/1b | "The preliminary results showed that CBP-1008 has manageable safety profile. Antitumor activity was observed in patients with FRα/TRPV6 receptor expression, especially in platinum-resistant OC cohort with high score of the two receptors."

Clinical • P1 data • Breast Cancer • Diabetes • Febrile Neutropenia • Gastrointestinal Cancer • Hematological Disorders • Hepatology • HER2 Breast Cancer • Lung Cancer • Neutropenia • Oncology • Ovarian Cancer • Pancreatic Cancer • Renal Disease • Solid Tumor • Triple Negative Breast Cancer • ER • FOLR1 • HER-2 • TRPV6

A Study of CBP-1008 in Patients With Advanced Solid Tumor (clinicaltrials.gov) - P1a/1b | N=143 | Recruiting | Sponsor: Coherent Biopharma (Suzhou) Co., Ltd. | Trial completion date: Dec 2022 ➔ Mar 2024 | Trial primary completion date: Sep 2022 ➔ Sep 2023

Metastases • Trial completion date • Trial primary completion date • Breast Cancer • Colon Cancer • Colorectal Cancer • Endometrial Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

"Coherent Biopharma CBP-1008 (anti-FRa TRPV6 bispecific ADC (?)) via L Wu. Seems pretty toxic. #ASCO22 $STRO" (@JacobPlieth)

TRPV6

CBP-1008 shows excellent efficacy and desirable drug safety profile in preclinical models (AACR 2022) - "Within the FRα+/TRPV6+ tumors, tumor growth inhibition well correlates with IHC score of FRα (R2=0.89).It is indicated that clinical trials in selected indications using biomarkers assay to screening patients will expedite the clinical development of CBP-1008. Initial clinical response has been observed in our Phase I trial."

Preclinical • Breast Cancer • Endometrial Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Solid Tumor • FOLR1

Bispecific XDC – A Versatile Drug Delivery Platform (ADC London 2022) - "Exploring design features of a bispecific XDC Providing a clinical overview of CBP-1008 Discussing bispecific XDC as a versatile drug delivery platform"

[VIRTUAL] Phase Ia study of CBP-1008, a bi-specific ligand drug conjugate targeting FRα and TRPV6, in patients with advanced solid tumors. (ASCO 2021) - "CBP-1008 has demonstrated acceptable safety profile . Tumor response correlating with dosing and FRα/TRPV6 receptor expression levels has been well observed."

Clinical • P1 data • Adrenal Cortex Carcinoma • Breast Cancer • Colorectal Cancer • Diabetes • Gastrointestinal Cancer • Genito-urinary Cancer • Hematological Disorders • Leukopenia • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Renal Disease • Sarcoma • Solid Tumor