BHV-1510 / GeneQuantum Healthcare, Biohaven - LARVOL DELTA

Biohaven Reports Recent Business Developments and Fourth Quarter and Full Year 2024 Financial Results (PRNewswire) - "Next Generation ADC Platform: Interim Phase 1 data with BHV-1510 and dose optimization as monotherapy and combination therapy with Libtayo in epithelial tumors in 2025. Initiate Phase 1 trial of BHV-1530 in 1H 2025. Advance Merus collaboration ADCs (undisclosed targets) and TopoIx ADCs in 2025."

Licensing / partnership • New P1 trial • P1 data • Oncology • Solid Tumor

A Study of GQ1010 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=220 | Recruiting | Sponsor: GeneQuantum Healthcare (Suzhou) Co., Ltd.

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

A Phase 1/2 Study of PBI-410 in Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=170 | Recruiting | Sponsor: Pyramid Biosciences | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Oncology • Solid Tumor

Biohaven Doses First Patient with its Novel Trop-2 Directed Antibody Drug Conjugate (ADC) BHV-1510 in Advanced or Metastatic Epithelial Tumors (PRNewswire) - "Biohaven...announced the first patient has been dosed in a first-in-human Phase 1/2 study of BHV-1510, a highly differentiated Trophoblast Cell Surface Antigen-2 (Trop-2) directed Antibody Drug Conjugate (ADC), and the lead ADC program to advance into clinical trials in Biohaven's growing oncology pipeline. The Phase 1/2 study of BHV-1510 is a multicenter, open-label study in subjects with select advanced or metastatic epithelial cell tumors. The trial consists of a dose-escalation phase, followed by a multicohort expansion phase....Biohaven also entered into a clinical supply agreement with Regeneron to study the combination of BHV-1510 with Regeneron's anti-PD-1 Libtayo (cemiplimab-rwlc) in the Phase 1/2 clinical trial."

Licensing / partnership • Trial status • Skin Cancer

A Phase 1/2 Study of PBI-410 in Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=170 | Not yet recruiting | Sponsor: Pyramid Biosciences

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

PBI-410 (GQ1010), A novel Trop-2-targeted ADC demonstrates a favorable safety and toxicokinetic profile in multiple preclinical assessments (AACR 2024) - "PBI-410 demonstrated a favorable and differentiated nonclinical safety profile and favorable TK relative to those reported to date for other Trop-2 ADCs in development. This profile, in addition to the potent anti-tumor response and synergistic activity in combination with anti-PD1 reported previously, position PBI-410 as a best-in-class potential Trop-2 ADC and partner of choice for anti-PD1 combination therapy. Additionally, TopoIx has displayed excellent properties among the TOP1 inhibitors, making it suitable for a broader therapeutic application based on exceptional potency while maintaining a favorable safety profile."

Preclinical • Oncology • TOP1

Potential 'Best-in-class'! Kai Tak Pharmaceutical's clinical application for TROP2-targeted ADC drug GQ1010 was accepted by CDE [Google translation] (163.com) - "On February 22, 2024, the clinical trial application for GQ1010 injection submitted by Kai Tak Pharmaceutical was officially accepted by the Drug Evaluation Center of the National Medical Products Administration (acceptance number: CXSL2400149)....GQ1010 is currently being developed for indications including non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC) and other solid tumors."

New trial • Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Advancing GQ1010: From Preclinical Development to Clinical Translation (ADC London 2024) - "• Discussing GQ1010’s efficacy in preclinical studies • Understanding the preclinical PK/PD relationship of GQ1010 • Sharing GQ1010 translation strategy"

Preclinical

Preclinical characterization of GQ1010, a next generation Trop2 ADC with the best-in-class potential against diverse Trop2+ solid tumors (AACR 2023) - "Toxicity study was performed in monkey, and clinical observation, body weight, food consumption, clinical pathology (hematology, coagulation, serum chemistry), and pathology were evaluated. GQ1010 demonstrated more potent in vitro cytotoxicity than DS1062 in diverse Trop2+ cancer cell lines tested. GQ1010 consistently demonstrate superior linker stability, in vitro and in vivo efficacies thanDS1062 and Trodelvy®, while maintaining excellent safety. These data suggest GQ1010 has the potential as the next generation Trop2 ADC that can address the critical unmet needs for diverse cancer patients."

Preclinical • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor • Triple Negative Breast Cancer

Pyramid Biosciences and GeneQuantum Healthcare Announce Preclinical Data for GQ1010, a Potential Best-In-Class TROP2-Targeted Antibody Drug Conjugate, at the 2023 AACR Annual Meeting (PRNewswire) - "Pyramid Biosciences, Inc...and its partner GeneQuantum Healthcare (Suzhou) Co. Ltd...announced data at the American Association for Cancer Research (AACR) Annual Meeting 2023 highlighting the preclinical efficacy and safety profile of GQ1010, a potential best-in-class antibody drug conjugate (ADC) targeting trophoblast cell surface antigen 2 (TROP2), across several in vitro and in vivo models....Specifically, in a mouse syngeneic MC38 colon cancer model, the combination of GQ1010 plus anti-PD-1 therapy showed compelling synergistic tumor growth inhibition, which was superior to DS-1062 plus anti-PD-1....In addition, GQ1010 showed more potent in vitro cytotoxicity and a superior bystander effect versus DS-1062, and increased in vivo tumor growth inhibition with GQ1010 monotherapy compared head-to-head with either DS-1062 or TRODELVY^® across multiple cancer models."

Preclinical • Colon Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Pyramid Biosciences Expands Oncology Pipeline with In-Licensing of GQ1010, a Potential Best-in-class TROP2 Targeted Antibody Drug Conjugate (ADC), from GeneQuantum Healthcare (PRNewswire) - "Pyramid Biosciences, Inc...today announced that it has entered into an exclusive license agreement with GeneQuantum Healthcare...to develop and commercialize GQ1010, a potential best-in-class antibody drug conjugate (ADC) targeting TROP2, worldwide except for Greater China (mainland China, Hong Kong, Macau, and Taiwan). GQ1010 has shown a highly differentiated preclinical profile, and is anticipated to enter a first-in-human trial within the next 12 months....Preclinical data suggests GQ1010 has a broader therapeutic margin compared to more advanced TROP2 ADCs, that may translate to an improved efficacy and safety profile for GQ1010. TROP2 is a cell surface glycoprotein that is highly expressed in a variety of tumors including breast, lung, pancreatic, ovarian, and prostate cancer, and plays a role in tumor cell proliferation."

Licensing / partnership • Breast Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Solid Tumor