BDC-4182 / Bolt Biotherapeutics - LARVOL DELTA

Preclinical Investigation of BDC-4182, a Claudin 18.2-targeting ISAC to Support Clinical Development (SITC 2025) - P1/2 | "Furthermore, we observed pharmacodynamic changes associated with the BDC-4182.S mechanism of action. Lastly, we provide supporting preclinical data supporting the use of BDC-4182 in combination with CPI in gastric cancer patients.Conclusions As the BDC-4182 clinical trial is enrolling patients (NCT06921837), we used preclinical models to help understand the activity across a range of CLDN18.2 expressing models, induction of immunologic memory with epitope spreading, favorable activity compared to cytotoxic CLDN18.2 ADCs, pharmacodynamic changes related to its mechanism and activity in combination with approved agents in gastric cancer."

IO biomarker • Preclinical • Gastric Cancer • Oncology • Solid Tumor • CLDN18

A phase I/II study of BDC-4182, a claudin18.2-targeting next generation immune-stimulating antibody conjugate (ISAC), in patients with advanced gastric and gastroesophageal cancer (ESMO 2025) - "Legal entity responsible for the study Bolt Biotherapeutics. Funding Bolt Biotherapeutics."

Clinical • IO biomarker • Metastases • P1/2 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CLDN18

Bolt Biotherapeutics…announced an update on the ongoing Phase 1 dose escalation study of BDC-4182… (GlobeNewswire) - "A strong immune response was observed at the initial dose levels and the Company is in the process of modifying the clinical trial protocol to allow for step-up dosing, which has been successfully used commercially for T-cell engagers....As a result of the update to the clinical trial protocol for BDC-4182, Bolt now expects to report initial clinical data in the third quarter of 2026."

P1 data • Trial status • Gastric Cancer • Gastroesophageal Cancer

Bolt Biotherapeutics…Provides Business Update (The Manila Times) - "In the second quarter we focused on advancing BDC-4182, the first next-generation Boltbody ISAC in our pipeline...We are now conducting a Phase 1 dose-escalation study for patients with gastric and gastroesophageal cancer in Australia, and will expand to other countries in the second half of 2025. We look forward to presenting initial data in the first half of 2026."

P1 data • Trial status • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

Bolt Biotherapeutics to Host KOL Conference Call and Webcast to Discuss BDC-3042 Phase 1 Results and Corporate Updates (GlobeNewswire) - "Dr. Dumbrava will discuss the results from the Phase 1 dose-escalation clinical study of BDC-3042 that were presented at the American Associates for Cancer Research (AACR) Annual Meeting that took place in April 2025. In addition, Bolt’s management team will discuss BDC-3042 partnering plans, present an update on BDC-4182 clinical development, and provide an update on first quarter 2025 financial results."

Clinical • P1 data • Non Small Cell Lung Cancer

A First-in-Human Study Using BDC-4182 as a Single Agent in Advanced Gastric and Gastroesophageal Cancer (clinicaltrials.gov) - P1/2 | N=122 | Recruiting | Sponsor: Bolt Biotherapeutics, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Oncology • Solid Tumor

A First-in-Human Study Using BDC-4182 as a Single Agent in Advanced Gastric and Gastroesophageal Cancer (clinicaltrials.gov) - P1/2 | N=122 | Not yet recruiting | Sponsor: Bolt Biotherapeutics, Inc.

New P1/2 trial • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Oncology • Solid Tumor

Bolt Biotherapeutics Reports Fourth Quarter and Full-Year 2024 Financial Results and Provides Business Update (GlobeNewswire) - "Finalizing preparations for the first-in-human trial of BDC-4182 in patients with gastric cancer:...BDC-4182 has advanced into IND-enabling activities, supported by in vitro and in vivo experiments demonstrating potent anti-tumor activity in multiple preclinical models....Key learnings were presented at SITC 2024 and the dose escalation trial is planned to start in Australia in the second quarter of 2025."

New trial • Gastric Cancer

Bolt Biotherapeutics Reports Third Quarter 2024 Financial Results and Provides Business Update (GlobeNewswire) - "Recent Highlights and Anticipated Milestones:...(i) BDC-4182 on track to start clinical trial in second quarter 2025; (ii) Advanced to cohort 7 (10 mg/kg) in the Phase 1 study of BDC-3042 in patients with advanced cancers. BDC-3042 is a proprietary agonist antibody that targets Dectin-2, an immune-activating receptor expressed by tumor-associated macrophages (TAMs). This single-agent, dose-escalation Phase 1 clinical study is evaluating BDC-3042 in patients with metastatic or unresectable triple-negative breast cancer (TNBC), colorectal cancer, clear cell renal cell carcinoma, head and neck cancer, non-small cell lung cancer (NSCLC), ovarian cancer, or melanoma."

New trial • Trial status • Clear Cell Renal Cell Carcinoma • Colorectal Cancer • Head and Neck Cancer • Melanoma • Non Small Cell Lung Cancer • Ovarian Cancer • Triple Negative Breast Cancer

Preclinical activity of BDC-4182, a claudin 18.2-targeting ISAC with enhanced potency and an encouraging safety profile (SITC 2024) - "Conclusions BDC-4182, a CLDN18.2-targeted ISAC, demonstrates potent antigen dependent activation of the immune system, compelling anti-tumor activity, induction of immunologic memory with epitope spreading, favorable activity compared to cytotoxic CLDN18.2 ADCs and an acceptable safety profile in preclinical studies. BDC-4182 is expected to begin FIH trials in 2025."

IO biomarker • Preclinical • Oncology • Pancreatic Cancer • Solid Tumor • CLDN18 • TNFA

Preclinical activity of BDC-4182, a claudin 18.2-targeting ISAC with enhanced potency and an encouraging safety profile (SITC 2024) - "Conclusions BDC-4182, a CLDN18.2-targeted ISAC, demonstrates potent antigen dependent activation of the immune system, compelling anti-tumor activity, induction of immunologic memory with epitope spreading, favorable activity compared to cytotoxic CLDN18.2 ADCs and an acceptable safety profile in preclinical studies. BDC-4182 is expected to begin FIH trials in 2025."

IO biomarker • Preclinical • Oncology • Pancreatic Cancer • Solid Tumor • CLDN18 • TNFA

Bolt Biotherapeutics Presents Updated Preclinical Data...at SITC 39th Annual Meeting (GlobeNewswire) - "The tolerability of BDC-4182 was also tested in non-human primates (NHPs)....BDC-4182 demonstrated superior efficacy compared to cytotoxic claudin 18.2 ADCs; BDC-4182 demonstrated anti-tumor activity in a wide range of tumor models and elicits immunological memory; BDC-4182 has an acceptable safety profile in NHPs with findings consistent with TLR7/8 activation and claudin 18.2 targeting; BDC-4182 toxicology profile may enable combinations with checkpoint inhibitors, chemotherapy and anti-angiogenesis agents used in first-line and second-line treatments."

Preclinical • Oncology • Solid Tumor

Bolt Biotherapeutics Reports Second Quarter 2024 Financial Results and Provides Business Update (GlobeNewswire) - "Recent Highlights and Anticipated Milestones:...Preparing BDC-4182 to start clinical trials in 2025. BDC-4182 is a next-generation Boltbody ISAC clinical candidate targeting claudin 18.2, a novel, clinically validated target in oncology with expression in gastric/gastroesophageal junction cancer, pancreatic cancer, and other tumor types. BDC-4182 has advanced into IND-enabling activities, supported by in vitro and in vivo experiments demonstrating potent anti-tumor activity in multiple preclinical models. A poster on BDC-4182 will be presented at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting, which will take place from November 6-10, 2024, in Houston, Texas."

New trial • Preclinical • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Pancreatic Cancer