BAT8006 / Bio-Thera Solutions - LARVOL DELTA

Safety and efficacy of BAT8006, a folate receptor α (FRα) antibody drug conjugate, in patients with platinum-resistant ovarian cancer: Update on the dose optimization/expansion cohort of BAT-8006-001-CR trial. (ASCO 2025) - P1 | "The safety profile is consistent with previous results, with no reports of ILD or ocular toxicity. The preliminary efficacy of BAT8006 appears promising in PROC patients with FRα expression ≥1%. On the basis of these findings, the target population, dose and schedule have been identified for a phase III trial of BAT8006 monotherapy in PROC patients."

Clinical • Platinum resistant • Anemia • Fallopian Tube Cancer • Interstitial Lung Disease • Leukopenia • Neutropenia • Oncology • Ovarian Cancer • Peritoneal Cancer • Pulmonary Disease • Respiratory Diseases • Solid Tumor • Thrombocytopenia • FOLR1

Phase 1 study of BAT8006, a folate receptor α antibody drug conjugate with strong bystander effect, in subjects with advanced solid tumors. (ASCO 2024) - P1 | "BAT8006 was well-tolerated with manageable toxicity and demonstrated preliminary antitumor activity in ovarian cancer."

Clinical • Metastases • P1 data • Anemia • Constipation • Fallopian Tube Cancer • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Leukopenia • Neutropenia • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • Thrombocytopenia • FOLR1

A Clinical Study to Observe How Well That BAT8006 Works on Patients With Platinum Resistance Ovarian Cancer (clinicaltrials.gov) - P1/2 | N=0 | Withdrawn | Sponsor: Bio-Thera Solutions | N=170 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Platinum resistant • Trial withdrawal • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

BAT-8006-001-CR: Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of BAT8006 for Injection (clinicaltrials.gov) - P1 | N=216 | Completed | Sponsor: Bio-Thera Solutions | Recruiting ➔ Completed | Trial primary completion date: Dec 2024 ➔ Dec 2025

Trial completion • Trial primary completion date • Breast Cancer • Endometrial Cancer • Lung Cancer • Non Small Cell Lung Cancer • Ovarian Cancer • Solid Tumor • FOLR1

Bio-Thera Solutions Announces First Patient Dosed in Phase 3 Clinical Trial for BAT8006, an Antibody Drug Conjugate Targeting Folate Receptor α for the Treatment of Platinum-Resistant Ovarian Cancer (PRNewswire) - "Bio-Thera Solutions...announced that dosing has begun in a phase 3 clinical study for BAT8006, an antibody drug conjugate targeting folate receptor α for the treatment of platinum-resistant ovarian cancer. The phase 3, randomized, open-label, parallel-group clinical trial (Clinical Trial Registration Number: CTR20251345) of BAT8006 is designed to assess the efficacy of BAT8006 versus investigator's choice of single-agent chemotherapy in patients with platinum-resistant high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer."

Platinum resistant • Trial status • Fallopian Tube Cancer • High Grade Serous Ovarian Cancer • Peritoneal Cancer

Bio-Thera Solutions Presents Clinical Data for multiple products at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting (PRNewswire) - "Bio-Thera Solutions Inc...will have an oral presentation in collaboration with medical centers at the 2025 ASCO Annual Meeting entitled 'Safety and efficacy of BAT8006, a Folate Receptor α (FRα) antibody drug conjugate (ADC), in patients with platinum-resistant ovarian cancer: Update on the dose optimization/expansion cohort of BAT-8006-001-CR trial'. Three posters will be also presented in the poster session, covering TROP2-ADC BAT8008, HER2-ADC BAT8010, BAT1006 (an ADCC-enhanced anti-HER2 mAb with a different epitope from BAT8010) , and a novel PD-1 mAb BAT1308 in various solid tumors."

Clinical data • Platinum resistant • Cervical Cancer • Ovarian Cancer • Solid Tumor

A Clinical Study to Observe How Well That BAT8006 Works on Patients With Platinum Resistance Ovarian Cancer (clinicaltrials.gov) - P1/2 | N=170 | Not yet recruiting | Sponsor: Bio-Thera Solutions | Initiation date: Sep 2024 ➔ Jan 2025

Trial initiation date • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

Bio-Thera: BAT8006 clinical trial application approved [Google translation] (Eastmoney.com) - "Southern Finance, August 27, Bio-TheraAccording to the announcement, the company recently received the 'Notice of Approval for Drug Clinical Trial' approved and issued by the National Medical Products Administration, and the clinical trial application for the investigational drug BAT8006 combined with bevacizumab for the maintenance treatment of patients with platinum-sensitive recurrent ovarian cancer was approved."

New trial • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

A Clinical Study to Observe How Well That BAT8006 Works on Patients With Platinum Resistance Ovarian Cancer (clinicaltrials.gov) - P1/2 | N=170 | Not yet recruiting | Sponsor: Bio-Thera Solutions

New P1/2 trial • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

Bio-Thera Solutions Presents Clinical Data for BAT8006 (Folate Receptor-alpha-ADC) at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting (PRNewswire) - P1 | N=216 | NCT05378737 | Sponsor: Bio-Thera Solutions | "Bio-Thera Solutions Inc...will present a poster at the 2024 ASCO...that highlights clinical data for the potential best-in-class efficacy and safety of BAT8006 as a potential treatment for ovarian cancer patients and other patients with tumors that express Folate Receptor-alpha...To the date of data cut-off, 54 subjects with platinum refractory or platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer were treated with BAT8006 doses of 1.8~2.4 mg/kg and 84/93mg/m² and have received at least one tumor assessment. Among these patients, 38.9% (21/54) of them had undergone＞3 lines prior systemic treatment. Regardless of the FRα expression, the ORR including unconfirmed partial response (PR) is 37.0% (20/54)....The safety of BAT8006 is favorable with manageable toxicity."

P1 data • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

Biotech’s BAT1308 (PD-1) combined with BAT8006 (ADC-FRα) has received clinical approval for the treatment of advanced solid tumors [Google translation] (Bio-thera Press Release) - "Biotech Biopharmaceutical...The company announced today that it has received the 'Drug Clinical Trial Approval Notice' approved and issued by the National Medical Products Administration, and the company's clinical trial application for the company's research drug BAT1308 combined with BAT8006 for the treatment of advanced solid tumors has been approved."

New trial • Solid Tumor

Bio-Thera Solutions Receives IND Clearance From US FDA to Initiate a Phase II Study for BAT8006, an Innovative Antibody Drug Conjugate Targeting Folate Receptor α (PRNewswire) - "Bio-Thera Solutions...today announced receiving IND clearance from the US FDA for a phase II Study for BAT8006, an innovative Antibody Drug Conjugate (ADC) targeting Folate Receptor α (FRα). The phase II study will investigate the use of BAT8006 for the treatment of subjects with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer....Currently, a phase I study of BAT8006 is ongoing in China...Updated clinical data will be presented at future academic conference."

IND • New P2 trial • P1 data • Fallopian Tube Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

BAT8008, A Novel Trop-2 ADC With Potent Bystander Effect to Treat Solid Tumours (ADC London 2024) - "• Providing an Overview of Bio-Thera Solutions’ ADC technology • Understading the preclinical in vitro and in vivo analysis of BAT8008 • Sharing the BAT8008 phase I trial result and clinical validation of our ADC technology using BAT8006 (folate receptor ADC)"

Oncology • Solid Tumor

Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of BAT8006 for Injection (clinicaltrials.gov) - P1 | N=216 | Recruiting | Sponsor: Bio-Thera Solutions | Trial completion date: Dec 2024 ➔ Dec 2025 | Trial primary completion date: Dec 2023 ➔ Dec 2024

Metastases • Trial completion date • Trial primary completion date • Breast Cancer • Endometrial Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor

Bio-Thera Solutions Announces Positive Phase 1 Clinical Data for BAT8006 (Folate-Receptor-α-ADC) and Presents Phase 1 Dose Escalation Study at the Bethune Obstetrics and Gynecology Forum (PRNewswire) - P1 | N=216 | NCT05378737 | Sponsor: Bio-Thera Solutions | "Bio-Thera Solutions...today announced positive Phase 1 clinical data for BAT8006 (Folate-Receptor-α-ADC) as part of a presentation of the clinical results of a Phase 1 dose escalation study evaluating the safety and efficacy of BAT8006 at the Bethune Obstetrics and Gynecology Forum in China...July 6, 2023 served as the cut-off date for the data presented at the conference. At that time twenty-nine (29) subjects with advanced solid tumors were recruited...All twenty-nine (29) subjects enrolled in the study (regardless of tumor type) had at least one tumor assessment with an Overall Objective Response Rate (ORR) of 31.0% and a Disease Control Rate (DCR) of 86.2%...BAT8006 demonstrated a manageable safety profile with the main treatment related adverse events (TRAEs) being hematological toxicity..."

P1 data • Breast Cancer • Endometrial Cancer • Gynecologic Cancers • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor

BAT8006, a novel FRα ADC with strong bystander effect, for the treatment of advanced solid tumor (SABCS 2022) - "In addition, BAT8006 showed favorable pharmacokinetic and safety profiles in cynomolgus monkeys with the highest non-severely toxic dose (HNSTD) of 30 mg/kg when dosed once every three weeks for 3 times. Together these results indicate that BAT8006 could potentially provide a therapeutic benefit to treat FRα-positive tumors including breast cancer in clinical trial."

Breast Cancer • Endometrial Cancer • Lung Cancer • Neuroendocrine Tumor • Oncology • Ovarian Cancer • Small Cell Lung Cancer • Solid Tumor • FOLR1

Bio-Thera Solutions Announces BAT8006 (Folate-Receptor-α-ADC) and BAT8008 (Trop2-ADC) Poster Presentations at the 2022 San Antonio Breast Cancer Symposium (Businesswire) - "Bio-Thera Solutions...announced the company will present two posters at the 2022 San Antonio Breast Cancer Symposium (SABCS) taking place December 6 - 10, 2022 in San Antonio, Texas. The first poster...will present preclinical data and initial phase 1 clinical data that highlight advantages demonstrated by BAT8006 as a potential treatment for patients with solid tumors, such as ovarian cancer and breast cancer....The second poster, entitled...will present preclinical data that highlight advantages demonstrated by BAT8008 as a potential treatment for Trop-2 positive cancer patients."

P1 data • Preclinical • Breast Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of BAT8006 for Injection (clinicaltrials.gov) - P1 | N=216 | Recruiting | Sponsor: Bio-Thera Solutions | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor

Bio-Thera Solutions Announces First Patient Dosed in Phase 1 Study for BAT8006, an Antibody Drug Conjugate Targeting Folate Receptor α for the Treatment of Advanced Solid Tumors (Businesswire) - "Bio-Thera Solutions, Ltd...announced that dosing has begun in a Phase 1 clinical study evaluating BAT8006, an antibody drug conjugate (ADC) that targets folic acid receptor α (FRα). The clinical trial is a multicenter, open-label Phase 1 clinical study in patients with advanced solid tumors to evaluate the safety and tolerability of BAT8006 and to determine the recommended phase 2 dose."

Trial status • Oncology • Solid Tumor

Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of BAT8006 for Injection (clinicaltrials.gov) - P1 | N=216 | Not yet recruiting | Sponsor: Bio-Thera Solutions

New P1 trial • Oncology • Solid Tumor