BL-M07D1 / Biokin Pharma - LARVOL DELTA

A breast cancer neoadjuvant drug from Baili Tianheng was approved for Phase II/III clinical trial [Google translation] (Sina Corp) - "On the evening of February 18, Baili Tianheng...announced that it had recently received the 'Notice of Approval for Drug Clinical Trial' officially approved and issued by the National Medical Products Administration. The Phase II/III clinical trial of the company's independently developed innovative biological drug BL-M07D1 (HER2-ADC) for injection was approved. 'After review, it is agreed that this product will be used for joint exploratory research in neoadjuvant patients with HER2-positive breast cancer'."

Trial status • HER2 Positive Breast Cancer

A Study of BL-M07D1 Versus T-DM1 in the Adjuvant Treatment of HER2-positive Breast Cancer With Residual Invasive Cancer After Neoadjuvant Therapy (clinicaltrials.gov) - P3 | N=1450 | Not yet recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.

New P3 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

A Study of BL-M07D1 in Patients With Locally Advanced or Metastatic HER2 Positive/Low Expression Breast Cancer and Other Solid Tumors (clinicaltrials.gov) - P1 | N=26 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Dec 2024 ➔ Dec 2025 | Trial primary completion date: Dec 2024 ➔ Jun 2025

Metastases • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Phase I Clinical Study of BL-M07D1 in Locally Advanced or Metastatic Digestive Tract Tumors and Other Solid Tumors (clinicaltrials.gov) - P1 | N=26 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Jan 2025 ➔ Dec 2025 | Trial primary completion date: Jan 2025 ➔ Jun 2025

Metastases • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Oncology • Solid Tumor • HER-2

A Study of BL-M07D1 in Patients With HER2-expressing Recurrent or Metastatic Gynecologic Malignancies (clinicaltrials.gov) - P1/2 | N=138 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | N=58 ➔ 138

Enrollment change • Metastases • Gynecologic Cancers • Oncology

BL-M07D1-206: A Study of BL-M07D1 Combination Therapy in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov) - P2 | N=46 | Not yet recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | N=120 ➔ 46 | Trial completion date: Jun 2026 ➔ Oct 2026 | Initiation date: Jul 2024 ➔ Oct 2024 | Trial primary completion date: Jun 2026 ➔ Oct 2026

Combination therapy • Enrollment change • Metastases • Trial completion date • Trial initiation date • Trial primary completion date • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

A Study of BL-M07D1 in Patients With Locally Advanced or Metastatic HER2 Positive/Low Expression Breast Cancer and Other Solid Tumors (clinicaltrials.gov) - P1 | N=26 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Aug 2024 ➔ Dec 2024 | Trial primary completion date: Aug 2024 ➔ Dec 2024

Metastases • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

BL-M07D1-206: A Study of BL-M07D1 Combination Therapy in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | N=86 ➔ 120

Combination therapy • Enrollment change • Metastases • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

BL-M07D1-205: A Study of BL-M07D1, BL-M07D1+Pertuzumab and BL-M07D1+Pertuzumab+Docetaxel in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

A Study of BL-M07D1, BL-M07D1+Pertuzumab and BL-M07D1+Pertuzumab+Docetaxel in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.

Metastases • New P2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Sichuan Baili Tianheng Pharmaceutical Co., Ltd. Voluntarily Discloses Announcement on the Completion of the First Subject Enrollment in the Phase III Clinical Trial of BL-M07D1 (HER2-ADC) for Injection for Locally Advanced or Metastatic HER2-Positive Breast Cancer [Google translation] (Shanghai Securities News) - "Sichuan Baili Tianheng Pharmaceutical Co., Ltd...has recently completed the first patient enrollment in the Phase III clinical trial of the innovative biopharmaceutical BL-M07D1 (HER2-ADC) for injection for locally advanced or metastatic HER2-positive breast cancer."

Enrollment open • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

A Study Comparing BL-M07D1 With T-DM1 in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer (clinicaltrials.gov) - P3 | N=268 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

A Study of BL-M07D1 in Patients With HER2-mutated, Locally Advanced or Metastatic Non-small-cell Lung Cancer (clinicaltrials.gov) - P1/2 | N=58 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HER-2

A Study of BL-M07D1+PD-1 Monoclonal Antibody and BL-M07D1+PD-1 Monoclonal Antibody+Capecitabine in Patients With Locally Advanced or Metastatic HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov) - P2 | N=86 | Not yet recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.

New P2 trial • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

Baili Tianheng: "BL-M07D1 + PD-1/PD-L1 monoclonal antibody ± chemotherapy" and "BL-M07D1 + pertuzumab ± chemotherapy" received phase II clinical trial approval notices [Google translation] (Daily Economic News - NBD) - "According to AI News, Baili Tianheng announced that the company's independently developed innovative biological drug BL-M07D1-related combination drugs 'BL-M07D1+PD-1/PD-L1 monoclonal antibody ± chemotherapy' and 'BL-M07D1+Pertuzumab 'Monoclonal Antibody ± Chemotherapy' recently received the 'Drug Clinical Trial Approval Notice' officially approved and issued by the National Medical Products Administration (NMPA)."

New P2 trial • Oncology • Solid Tumor

A Study of BL-M07D1 in Patients With HER2-expressing Recurrent or Metastatic Gynecologic Malignancies (clinicaltrials.gov) - P1/2 | N=58 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Gynecologic Cancers • Oncology

A Study Comparing BL-M07D1 With T-DM1 in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer (clinicaltrials.gov) - P3 | N=268 | Not yet recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.

Metastases • New P3 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

A Study of BL-M07D1 in Patients With a Variety of Solid Tumors Including Locally Advanced or Metastatic HER2-positive/Low-expressing Urinary and Gastrointestinal Tumors (clinicaltrials.gov) - P1/2 | N=42 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Biliary Tract Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Oncology • Solid Tumor • HER-2

Open Label Study to Evaluate BL-M07D1 in HER2 Expressing Malignant Solid Tumors (clinicaltrials.gov) - P1 | N=280 | Recruiting | Sponsor: SystImmune Inc.

Metastases • New P1 trial • Biliary Cancer • Cervical Cancer • Endometrial Cancer • Gastrointestinal Cancer • Hepatology • Oncology • Ovarian Cancer • Solid Tumor • Urothelial Cancer

A Study of BL-M07D1 in Patients With a Variety of Solid Tumors Including Locally Advanced or Metastatic HER2-positive/Low-expressing Urinary and Gastrointestinal Tumors (clinicaltrials.gov) - P1/2 | N=42 | Not yet recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Nov 2025 ➔ Mar 2026 | Initiation date: Nov 2023 ➔ Mar 2024 | Trial primary completion date: Nov 2025 ➔ Mar 2026

Metastases • Trial completion date • Trial initiation date • Trial primary completion date • Biliary Tract Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Oncology • Solid Tumor • HER-2

A Study of BL-M07D1 in Patients With HER2-mutated, Locally Advanced or Metastatic Non-small-cell Lung Cancer (clinicaltrials.gov) - P1/2 | N=58 | Not yet recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Dec 2025 ➔ Mar 2026 | Initiation date: Dec 2023 ➔ Mar 2024 | Trial primary completion date: Dec 2025 ➔ Mar 2026

Metastases • Trial completion date • Trial initiation date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HER-2

A Study of BL-M07D1 in Patients With HER2-expressing Recurrent or Metastatic Gynecologic Malignancies (clinicaltrials.gov) - P1/2 | N=58 | Not yet recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.

Metastases • Trial completion date • Trial initiation date • Trial primary completion date • Gynecologic Cancers • Oncology

BL-M07D1, an antibody-drug conjugate directed to HER2 in patients with locally advanced or metastatic Breast Cancer with HER2-positive/low-expression and other solid tumors: Results from a first-in-human phase 1 study (SABCS 2023) - P1 | "BL-M07D1 demonstrated encouraging efficacy in heavily pretreated HER2 expressing cancers, especially in HER2+ BC. The safety profile showed adequate safety and tolerability. Clinical trial identification: NCT05461768."

Clinical • Metastases • P1 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • CTSB • HER-2

SystImmune, Inc. Announces the Presentation of Breast Cancer Clinical Trial Results at the 2023 San Antonio Breast Cancer Conference and US Clinical Trial Developments (PRNewswire) - P1 | N=26 | NCT05461768 | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | "Updated analysis from an ongoing phase 1 study of the HIRE platform HER2-specific ADC, BL-M07D1 in the trial registered as NCT05461768, continues to demonstrate impressive results in patients with breast cancer. Reported are response rate of 80%, confirmed responses over 60%, and disease control rate of 100% in 50 patients with HER2+ metastatic breast cancer. Prior treatment with HER2 ADCs did not prevent responses to BL-M07D1, as 18 subjects who had received prior ADC therapies showed similar overall response. Preliminary results from the same study demonstrated an overall response rate of 50%, confirmed responses in 28.9% and disease control rate of 86% in an analysis of 38 heavily pretreated patients with HER2 low-expressing metastatic breast cancer."

P1 data • HER2 Positive Breast Cancer

SystImmune, Inc. Announces the Presentation of Breast Cancer Clinical Trial Results at the 2023 San Antonio Breast Cancer Conference and US Clinical Trial Developments (PRNewswire) - "SystImmune...announced that the U.S. Food and Drug Administration (FDA) authorized the company to proceed with the planned clinical study of the HER2-specific HIRE platform ADC, BL-M07D1, in the Investigational New Drug (IND) application on November 28, 2023. This milestone paves the way for the multicenter Phase 1 study evaluating the safety, tolerability, pharmacokinetic profile, and initial efficacy of BL-M07D1 in subjects with metastatic or unresectable HER2 expressing cancers in the United States."

IND • Solid Tumor