BB-1701 / BlissBio, Eisai - LARVOL DELTA

Preclinical anti-tumor activity of BB-1701, a HER2-targeting eribulin conjugated ADC, in HER2-low breast cancer PDx models. (SABCS 2024) - P2 | "Recently, the clinical landscape of HER2-low BC has changed with the approval of a HER2 targeting antibody-drug conjugate (ADC), trastuzumab-deruxtecan (T-DXd). These results indicate that BB-1701 has the potential to provide clinical benefit to HER2-low BC patients. A phase 2 clinical trial in patients with HER2 positive or HER2-low unresectable or metastatic BC is ongoing (NCT06188559)."

Preclinical • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • CTSB • HER-2

Characterization and anti-tumor activity of BB-1701, a HER2-targeting eribulin-conjugated ADC, in preclinical models [WITHDRAWN] (SABCS 2024) - No abstract available

Preclinical • Breast Cancer • Oncology • HER-2

BB-1701-G000-205: A Study of BB-1701 in Previously Treated Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive or HER2-low Unresectable or Metastatic Breast Cancer (clinicaltrials.gov) - P2 | N=135 | Recruiting | Sponsor: Eisai Inc. | Trial completion date: Oct 2026 ➔ Mar 2026 | Trial primary completion date: Oct 2026 ➔ Mar 2026

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

An open-label, multicenter, phase II study to evaluate the safety and efficacy of BB-1701, a novel antibody drug conjugate (ADC) targeting HER2, in previously treated patients (pts) with HER2+ or HER2-low unresectable or metastatic (M) breast cancer (BC) (ESMO 2024) - P2 | "Background: Treatment options for pts with unresectable/MBC have improved with targeted therapies such as trastuzumab deruxtecan (T-DXd), a HER2-directed ADC...BB-1701 is a HER2-directed ADC with eribulin (microtubule inhibitor) as a payload...In both study parts, exploratory objectives will evaluate biomarkers expression and BB-1701 immunogenicity; other efficacy measures (ie, PFS on next-line of therapy) will be analyzed in the dose expansion only. As of April 30, 2024, 6 pts were screened; 4 have been randomized."

Clinical • Metastases • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

A phase II study to evaluate the efficacy and safety of BB-1701 in advanced or metastatic NSCLC patients with HER2 mutation/amplification (ESMO 2024) - "Background: BB-1701 is an antibody-drug conjugate (ADC) consisting of a humanized anti-HER2 antibody and eribulin. BB-1701 has demonstrated promising antitumor activity and a manageable safety profile in patients with HER2 mutant/amplified NSCLC."

Clinical • Metastases • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CTSB • HER-2

Eisai Accelerates Progress in Oncology Research with New Data at ESMO Congress 2024… (PRNewswire) - "Research from Eisai's pipeline includes a quality-of-life analysis from the Phase 3 EMERALD study in Japan evaluating either Eisai's eribulin mesylate (HALAVEN) or a taxane in combination with trastuzumab and pertuzumab in patients with HER2-positive, locally advanced or metastatic breast cancer (NCT03264547; Presentation: #373P); findings from a Phase 1b dose-expansion cohort evaluating E7386 (a CBP/β-catenin interaction inhibitor) in combination with lenvatinib in patients with advanced endometrial carcinoma with progression following prior anti-PD-(L)1 immunotherapy and platinum-based chemotherapy (NCT04008797; Presentation: #738P); as well as presentations for BB-1701...in previously-treated patients with HER2-positive or HER2-low unresectable or metastatic breast cancer (NCT06188559; Presentation: #437TiP) and non-small cell lung cancer patients with HER2 mutation/amplification (Presentation: #1296P; presented by Bliss Biopharmaceutical Co., Ltd), respectively."

Clinical data • Endometrial Cancer • HER2 Positive Breast Cancer • Non Small Cell Lung Cancer

Preclinical studies of BB-1701, a HER2-targeting eribulin-containing ADC with potent bystander effect and ICD activity. (PubMed, Antib Ther) - P1 | "The preclinical data support the test of BB-1701 in patients with various HER2-expressing cancers, including those resistant to other HER2-targeting ADCs. A phase I clinical trial of BB-1701 (NCT04257110) in patients is currently underway."

Journal • Preclinical • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Liposarcoma • Oncology • Sarcoma • Solid Tumor • HER-2

Updated safety and antitumor activity of BB-1701 from study 101 in the multiple dose level cohort of patients with locally advanced/metastatic HER2-low expressing breast cancer. (ASCO 2024) - P1 | "Background: BB-1701 is an antibody-drug conjugate (ADC) consisting of a humanized anti-HER2 antibody and eribulin. BB-1701 shows promising antitumor activity and a manageable safety profile in HER2 low-expressing breast cancer, including patients who received prior anti-HER2 ADCs."

Clinical • Metastases • Anemia • Breast Cancer • Dyslipidemia • Hematological Disorders • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hypertriglyceridemia • Musculoskeletal Diseases • Oncology • Pain • Solid Tumor • CTSB • HER-2

An open-label, multicenter, phase 2 study to evaluate the safety and efficacy of BB-1701, a novel antibody drug conjugate (ADC) targeting human epidermal growth factor receptor 2 (HER2), in previously treated patients with HER2-positive (HER2+) or HER2-low unresectable or metastatic breast cancer (BC). (ASCO 2024) - P2 | "BB-1701 is an ADC consisting of a monoclonal antibody targeting HER2 with eribulin (microtubule inhibitor) as a payload that is capable of exerting a bystander effect...Randomization will be stratified by HER2 status (HER2+ vs. HER2-low) documented prior to T-DXd treatment...In both study parts, exploratory objectives will include evaluation of biomarkers of response to BB-1701 and BB-1701 immunogenicity; other efficacy measures (i.e., PFS on the next line of therapy) and population pharmacokinetics will be analyzed in the dose-expansion part only. Pt enrollment is currently open."

Clinical • Metastases • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

EISAI SHOWCASES ONCOLOGY PORTFOLIO AND PIPELINE AT ASCO 2024 (Eisai Press Release) - "Additional pipeline research to be presented in poster sessions include an overview of a Phase 2 study of BB-1701, an antibody drug conjugate targeting HER2, in previously treated patients with HER2-positive or HER2-low unresectable or metastatic breast cancer (NCT06188559; Abstract #TPS1122), findings from a Phase 1b trial of tasurgratinib (development code: E7090) with or without endocrine therapies for patients with ER-positive, HER2−negative recurrent/metastatic breast cancer after receiving a CDK4/6 inhibitor (NCT04572295; Abstract #3103), as well as the dose-expansion part of a Phase 1b global study of E7386 in combination with lenvatinib in patients with hepatocellular carcinoma and other solid tumors including endometrial cancer (NCT04008797; Abstract #TPS3169)."

P1 data • Trial status • Endometrial Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer

A Study of BB-1701 in Previously Treated Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive or HER2-low Unresectable or Metastatic Breast Cancer (clinicaltrials.gov) - P2 | N=135 | Recruiting | Sponsor: Eisai Inc. | Not yet recruiting ➔ Recruiting

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

Angle PLC - Contract announcement with Eisai Inc. (ACCESSWIRE) - "ANGLE plc...is delighted to announce that it has signed a contract with the global pharmaceutical company, Eisai Inc...Under the agreement, in a pilot study worth US $250,000 to ANGLE, ANGLE will provide CTC analysis with its Portrait HER2 assay to assess breast cancer patients' HER2 (human epidermal growth factor receptor 2) status in a Phase II study of the HER2 targeting antibody-drug conjugate (ADC) BB-1701. Success in the pilot study offers the potential for multiple large scale follow-up studies....ANGLE's Portrait HER2 assay enables quantitative assessment of both HER2 protein expression (via IF) and HER2/neu gene amplification (via FISH) to identify patients who could benefit from anti-HER2 ADC treatment."

Diagnostic • Licensing / partnership • Breast Cancer • Oncology • Solid Tumor • HER-2

A Study of BB-1701 in Previously Treated Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive or HER2-low Unresectable or Metastatic Breast Cancer (clinicaltrials.gov) - P2 | N=135 | Not yet recruiting | Sponsor: Eisai Inc.

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

Report on Cohort Expansion of Phase I Study to Investigate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of BB-1701 in Patients with Locally Advanced/Metastatic HER2 Low Breast Cancer (SABCS 2023) - "Background: BB-1701 is an antibody-drug conjugate (ADC) consisting of a humanized IgG1κ monoclonal anti-HER2 antibody with the same sequence as trastuzumab and eribulin linked together by a cathepsin-cleavable valine-citrulline linker...One patient who achieved PR was previously progressed on sacituzumab govitecan... BB-1701 has demonstrated promising preliminary antitumor activity in HER2 low breast cancer including patients who received prior anti-HER2 ADCs, and a manageable safety profile."

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

A First-in-human Study of Multiple Doses of BB-1701 in Subjects With Locally Advanced/Metastatic HER2 Expressing Solid Tumors (clinicaltrials.gov) - P1 | N=208 | Active, not recruiting | Sponsor: Bliss Biopharmaceutical (Hangzhou) Co., Ltd | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2023 ➔ Dec 2024 | Trial primary completion date: Aug 2023 ➔ Aug 2024

Enrollment closed • Metastases • Trial completion date • Trial primary completion date • Breast Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PGR

Development of BB-1701– A Differentiated Anti-HER2 Antibody Drug Conjugate With Eribulin Payload (ADC-USA 2023) - "Introducing BB-1701, an anti-HER2 ADC with Eribulin payload; Evaluating preclinical bioactivity and toxicity/pharmacokinetics; Discussing Phase 1 clinical data of BB-1701; Exploring the future of Bliss Bio's BB-1701"

Oncology

A first-in-human, open label, multiple dose, dose escalation, and cohort expansion phase I study to investigate the safety, tolerability, pharmacokinetics and antitumor activity of BB-1701 in patients with locally advanced/metastatic HER2-expressing solid tumors. (ASCO 2023) - P1 | "Background: BB-1701 is an antibody-drug conjugate consisting of a humanized IgG1κ monoclonal antibody and eribulin. BB-1701 was generally well tolerated up to 2.6 mg/kg dose levels and has shown promising antitumor activity in patients with HER2-overexpression solid tumors. Clinical trial information: NCT04257110."

Clinical • Metastases • P1 data • PK/PD data • Anemia • Breast Cancer • Colorectal Cancer • Dyslipidemia • Esophageal Cancer • Gallbladder Cancer • Gastric Cancer • Gastrointestinal Cancer • Hematological Disorders • Hepatology • HER2 Breast Cancer • Hypertriglyceridemia • Infectious Disease • Interstitial Lung Disease • Oncology • Ovarian Cancer • Pain • Pulmonary Disease • Respiratory Diseases • Septic Shock • Solid Tumor • CTSB • HER-2

Eisai Delivers New Data and Highlights Continued Progress of Oncology Portfolio and Pipeline at ASCO 2023 (PRNewswire) - "Eisai announced today the presentation of research across various types of cancer from its oncology portfolio and pipeline during the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting (#ASCO23), which is taking place virtually and in-person in Chicago, Illinois from June 2 to 6....Furthermore, Bliss Biopharmaceutical Co., Ltd. (BlissBio) will present a poster at the conference with results from the first-in-human study of BB-1701, a HER2-targeting ADC."

P1 data • Oncology • Solid Tumor

BLISS BIOPHARMACEUTICAL ENTERS INTO A CLINICAL TRIAL COLLABORATION AGREEMENT WITH AN OPTION OF STRATEGIC COLLABORATION WITH EISAI FOR BB-1701 (PRNewswire) - "Bliss Biopharmaceutical (Hangzhou) Co., Ltd...announced a clinical trial collaboration agreement with option for strategic collaboration with Eisai Co., Ltd. ('Eisai'), for BB-1701, eribulin-payload based ADC directed against Human Epidermal Growth Factor Receptor 2 (HER2) for the treatment of cancers. This collaboration with Eisai is an important advancement in BlissBio's corporate development plan to further develop BB-1701 globally and help advance BB-1701 toward late stage of development....Under the terms of the agreement, BlissBio will receive upfront and milestone payments, and BlissBio and Eisai will conduct co-development activities related to BB-1701 through an option period....Upon the exercise of the option, Eisai will receive worldwide (excluding Greater China) rights to develop and commercialize BB-1701."

Licensing / partnership • Oncology • Solid Tumor

Preclinical development of BB-1701, a HER2-tageting eribulin-containing ADC with potent bystander effect and ICD activity (AACR 2023) - "BB-1701 also showed effective tumor suppression in models insensitive to T-DM1 or T-Dxd. In conclusion, these comprehensive preclinical data have strongly supported BB-1701 as a potent antitumor agent to cancers including HER2-low expressing and/or cancers insensitive to other HER2-targeting ADCs. A phase I clinical study of BB-1701 in those patients is ongoing."

Preclinical • Breast Cancer • HER2 Breast Cancer • Liposarcoma • Oncology • Sarcoma • Solid Tumor • CALR • HER-2

"BB-1701https://www.adcreview.com/drugmap/bb-1701/" (@OncoZine)

Review

"BB-1701 ADChttps://www.adcreview.com/drugmap/bb-1701-adc/" (@OncoZine)

Review

A First-in-human Study of Multiple Doses of BB-1701 in Subjects With Locally Advanced/Metastatic HER2 Expressing Solid Tumors (clinicaltrials.gov) - P1 | N=208 | Recruiting | Sponsor: Bliss Biopharmaceutical (Hangzhou) Co., Ltd | N=88 ➔ 208 | Trial completion date: Feb 2022 ➔ Dec 2023 | Trial primary completion date: Feb 2022 ➔ Aug 2023

Enrollment change • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PGR

Bliss Bio’s ADC development backed by USD 62.3m Series B (GBI Health) - "Hangzhou-based oncology-focused clinical stage biotech Bliss Biotechnology Co., Ltd (GBI translation) reportedly raised upwards of RMB 400 million (USD 62.3 million) in a Series B financing round...Proceeds will go towards a global multi-center clinical study for lead candidate BB-1701, pre-clinical studies and regulatory filings for other products in its pipeline, as well as the construction of research and development facilities."

Financing • Oncology

A First-in-human Study of Multiple Doses of BB-1701 in Subjects With Locally Advanced/Metastatic HER2 Positive Solid Tumors (clinicaltrials.gov) - P1; N=88; Recruiting; Sponsor: Bliss Biopharmaceutical (Hangzhou) Co., Ltd; Initiation date: Mar 2020 ➔ Jul 2020

Clinical • Trial initiation date • Oncology • Solid Tumor • HER-2