izalontamab brengitecan (BL-B01D1) / Biokin Pharma, BMS - LARVOL DELTA

Phase I study of iza-bren (BL-B01D1), an EGFR x HER3 bispecific antibody-drug conjugate (ADC), in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with driver genomic alterations (GA) outside of classic EGFR mutations. (ASCO 2025) - P1 | "Clinical Trial Registration Number: NCT05194982 The abstract will be released to the public on May 22, 2025 at 4:00 PM"

Clinical • Metastases • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Phase I study of iza-bren (BL-B01D1), an EGFR x HER3 bispecific antibody-drug conjugate (ADC), in patients with locally advanced or metastatic small cell lung cancer (SCLC). (ASCO 2025) - P1 | "Clinical Trial Registration Number: NCT05194982 The abstract will be released to the public on May 22, 2025 at 4:00 PM"

Clinical • Metastases • P1 data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

A Study of BL-B01D1+PD-1/PD-L1 Monoclonal Antibody in Patients With Advanced Biliary Tract Cancer (clinicaltrials.gov) - P2 | N=46 | Not yet recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.

New P2 trial • Biliary Cancer • Biliary Tract Cancer • Oncology • Solid Tumor

Phase II Study of BL-B01D1 and Almonertinib for EGFR+ Stage II-IIIB NSCLC (clinicaltrials.gov) - P2 | N=40 | Not yet recruiting | Sponsor: Sichuan University

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Phase I study of iza-bren (BL-B01D1), an EGFR x HER3 bispecific antibody-drug conjugate (ADC), in patients with locally advanced or metastatic breast cancer (BC) (ESMO-BC 2025) - P1 | "In heavily pre-treated locally advanced or metastatic HER2- BC, iza-bren has demonstrated encouraging efficacy with a manageable safety profile, including in pts with HER2 zero expression."

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

SystImmune, Inc. to Present Updated izalontamab brengitecan (iza-bren) Data in Locally Advanced or Metastatic Breast Cancer at ESMO Breast 2025 (PRNewswire) - "SystImmune, Inc...announced that one abstract on izalontamab brengitecan (iza-bren), a potentially first-in-class EGFRxHER3 bispecific antibody drug conjugate (ADC) will be presented at the European Society for Medical Oncology (ESMO) Breast Cancer 2025 Annual Congress taking place May 14 – May 17 in Munich, Germany....Data will be presented at the meeting from an ongoing Ph1 clinical trial of iza-bren in patients with locally advanced or metastatic HER2- Breast Cancer."

P1 data • HER2 Negative Breast Cancer

Preclinical studies of BR-2302: A HER3xEGFR bi-specific Exd-containing ADC (AACR 2025) - "To combat this issue, novel HER3-targeting therapies are under investigation, including antibody-drug conjugates (ADCs) such as Patritumab Deruxtecan (U3-1402), which have shown encouraging results in clinical trials, underscoring the potential of HER3 targeting to overcome resistance...Izalonatamab brengitecan (BL-B01D1), an ADC designed for simultaneous targeting of EGFR and HER3, has demonstrated substantial clinical benefits in heavily pretreated patients with EGFR-mutant non-small cell lung cancer (NSCLC)...Collectively, our findings indicate that BR-2302 possesses promising anti-tumor properties. This innovative therapeutic approach has the potential to improve treatment outcomes for patients with solid tumors expressing both HER3 and EGFR, warranting further clinical exploration."

Preclinical • Colon Cancer • Colorectal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ERBB3

A Study of BL-B01D1 in Patients With Multiple Solid Tumors, Including Locally Advanced or Metastatic Urinary System Tumors (clinicaltrials.gov) - P2 | N=76 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Apr 2025 ➔ Dec 2025 | Trial primary completion date: Apr 2025 ➔ Dec 2025

Trial completion date • Trial primary completion date • Solid Tumor

CS5007: A novel EGFR and HER3 dual-targeted antibody-drug conjugate (ADC) with potent antitumor activity in preclinical studies (AACR 2025) - "For instance, MRG003, an EGFR-targeted ADC, has shown encouraging clinical outcomes in NPC and HNSCC...Daiichi's HER3-ADC, U3-1402, has shown promising clinical results in advanced EGFR-mutant NSCLC, confirming HER3 as a valid therapeutic target for ADC. Additionally, BL-B01D1, an EGFR/HER3 bispecific ADC, has shown encouraging phase 1 data in advanced cancers... CS5007 is a promising dual-targeted ADC that demonstrates potent antitumor efficacy with a favorable safety and PK profile. These preclinical findings support its further IND-enabling studies and clinical investigations for the treatment of various advanced solid tumors."

Preclinical • Colorectal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • ERBB3

A Study of BL-B01D1 + Axitinib Without or With Pembrolizumab in Patients With Locally Advanced or Metastatic Renal Cancer (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.

New P2 trial • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

DB-1418, a bispecific antibody-drug conjugate (ADC) targeting EGFR and HER3, demonstrates superior and broad antitumor efficacy and favorable safety in preclinical models (AACR 2025) - "Notably, in an osimertinib-resistant NSCLC xenograft model with the C797S mutation, DB-1418 induced tumor regression with a TGI of 98% at a dose of 6 mg/kg Q3W, significantly higher than the BL-B01D1 analog at 6 mg/kg Q3W (TGI of 68%, p<0.01). DB-1418 has shown promising pharmacological and pharmacokinetic properties, differentiated from the current clinical trial bispecific ADC targeting EGFR and HER3, with a broader therapeutic window. DB-1418 offers additional treatment options for patients who have developed resistance to EGFR tyrosine kinase inhibitors (TKIs) and addresses other unmet medical needs."

Preclinical • Bladder Cancer • Genito-urinary Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Prostate Cancer • Solid Tumor • EGFR • ERBB3

Izalontamab brengitecan: Data readout from P1 LUNG-101 trial (NCT05983432) for 1L NSCLC and advanced solid tumors in H2 2025 (Bristol-Myers Squibb) - Q1 2025 Results: Data readout from P1/2 trial (NCT06618287) for advanced solid tumors in 2026

P1 data • P1/2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Izalontamab brengitecan: Data readout from P2/3 IZABRIGHT-Breast01 trial (NCT06926868) for 1L TNBC in 2028 (Bristol-Myers Squibb) - Q1 2025 Results

P2/3 data • Breast Cancer • Oncology • Triple Negative Breast Cancer

A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Recurrent or Metastatic Urothelial Carcinoma (clinicaltrials.gov) - P3 | N=674 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor • Urothelial Cancer

A Study of Izalontamab Brengitecan Versus Chemotherapy in Participants With Previously Untreated, Locally Advanced, Recurrent Inoperable, or Metastatic Triple-negative Breast Cancer Ineligible for Anti-PD(L)1 Drugs (IZABRIGHT-Breast01) (clinicaltrials.gov) - P2/3 | N=560 | Not yet recruiting | Sponsor: Bristol-Myers Squibb

New P2/3 trial • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Leading the frontline of lung cancer, opening a new chapter: The world's first EGFR×HER3 dual-antibody ADC first-line treatment of non-small cell lung cancer Phase III completed the first patient enrollment [Google translation] (bydrug.pharmcube.com) - "Recently, the first subject has been enrolled in the Phase III clinical trial of BL-B01D1 (EGFR×HER3 dual-antibody ADC) combined with osimertinib for first-line EGFR mutation-type locally advanced or metastatic non-small cell lung cancer....This time, BL-B01D1 combined with osimertinib is expected to become a new solution for changing the first-line treatment of non-small cell lung cancer with EGFR mutations."

Enrollment open • Non Small Cell Lung Cancer

A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Recurrent or Metastatic Urothelial Carcinoma (clinicaltrials.gov) - P3 | N=674 | Not yet recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.

New P3 trial • Oncology • Solid Tumor • Urothelial Cancer

A Study of BL-B01D1 in Combination With Osimertinib Versus Osimertinib as First-Line Treatment in Patients With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov) - P3 | N=696 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study of BL-B01D1 in Combination With Osimertinib Versus Osimertinib as First-Line Treatment in Patients With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov) - P3 | N=696 | Not yet recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.

New P3 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Baili Tianheng initiates Phase III clinical trial for first-line NSCLC with EGFR mutation [Google translation] (bydrug.pharmcube.com) - "On February 17, Baili Tianheng registered a Phase III clinical trial of BL-B01D1+osimertinib for a head-to-head comparison of osimertinib monotherapy as the first-line treatment for locally advanced or metastatic non-small cell lung cancer with EGFR mutations on the 'Drug Clinical Trial Registration and Information Disclosure Platform' website."

New P3 trial • Non Small Cell Lung Cancer

A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Chordoma (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.

New P2 trial • Chordoma • Solid Tumor

The 5th time! Baili Tianheng's EGFR/HER3 dual-antibody ADC is planned to be included in the breakthrough therapy [Google translation] (Sohu.com) - "On December 24, the CDE official website showed that Baili Tianheng's BL-B01D1 for injection is planned to be included in the breakthrough therapy category for the treatment of patients with recurrent small cell lung cancer who have failed previous platinum-containing chemotherapy and anti-PD-1/PD-L1 monoclonal antibody treatment."

Breakthrough therapy • Small Cell Lung Cancer

BL-B01D1, a first-in-class EGFRxHER3 bispecific antibody-drug conjugate, in patients with Locally Advanced or Metastatic Breast Cancer and other Solid Tumor: Updated results from a phase 1 study (SABCS 2024) - P1 | "BL-B01D1 has demonstrated encouraging efficacy in previously treated patients with metastatic and locally advanced breast cancer subtypes, particularly in earlier lines of therapy. The safety and tolerability of BL-B01D1 are consistent with previously published data."

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

A Study to Evaluate the Safety, Tolerability, Drug Levels, and Preliminary Efficacy of BMS-986507 Combinations in Adult Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=218 | Recruiting | Sponsor: Bristol-Myers Squibb | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Lung Cancer • Oncology • Solid Tumor

SystImmune, Inc. to Present Updated BL-B01D1 Data in Breast Cancer at SABCS Congress 2024 (PRNewswire) - "SystImmune, Inc...announced that a poster for BL-B01D1, a potentially first-in-class EGFRxHER3 bispecific antibody drug conjugate (ADC) will be presented at the San Antonio Breast Cancer Symposium (SABCS) 2024, taking place on December 10-13 in San Antonio, Texas....Updated results from clinical trials of BL-B01D1 will include data from patients with advanced stage triple-negative, HR-positive / HER2-negative, and HER2-positive breast cancer."

P1 data • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Triple Negative Breast Cancer