BDC-3042 / Bolt Biotherapeutics - LARVOL DELTA

BBI-20233042: Study of BDC-3042 as Single Agent and in Combination With Cemiplimab in Patients With Advanced Malignancies (clinicaltrials.gov) - P1 | N=17 | Terminated | Sponsor: Bolt Biotherapeutics, Inc. | N=147 ➔ 17 | Trial completion date: Mar 2028 ➔ Aug 2025 | Active, not recruiting ➔ Terminated | Trial primary completion date: Mar 2026 ➔ Aug 2025; Sponsor decision

Enrollment change • First-in-human • Platinum resistant • Trial completion date • Trial primary completion date • Trial termination • Breast Cancer • Clear Cell Renal Cell Carcinoma • Colorectal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor • Triple Negative Breast Cancer

BBI-20233042: Study of BDC-3042 as Single Agent and in Combination With Cemiplimab in Patients With Advanced Malignancies (clinicaltrials.gov) - P1 | N=147 | Active, not recruiting | Sponsor: Bolt Biotherapeutics, Inc. | Phase classification: P1/2 ➔ P1

Phase classification • Platinum resistant • Breast Cancer • Clear Cell Renal Cell Carcinoma • Colorectal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor • Triple Negative Breast Cancer

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

BDC-3042, a first-in-class Dectin-2 agonist, in patients with advanced malignancies: Results from the first-in-human dose-escalation study (AACR 2025) - "BDC-3042 was well tolerated up to 10 mg/kg and showed encouraging biological activity in a heavily pre-treated population with advanced cancers including 8 CRC pts. The favorable safety, PK, and immunostimulatory effects of BDC-3042 support its further study in selected indications and underscore its combination potential with immune checkpoint inhibitors and other therapies."

Clinical • IO biomarker • Metastases • P1 data • Clear Cell Renal Cell Carcinoma • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • PD-1

Bolt Biotherapeutics Presents Results from the Phase 1 Dose-Escalation Clinical Study of BDC-3042 at AACR Annual Meeting 2025 (GlobeNewswire) - P1/2 | N=147 | NCT06052852 | Sponsor: Bolt Biotherapeutics, Inc. | "Key Clinical Study Findings: Seventeen patients with six different tumor types and a median of four prior lines of therapy were enrolled across the seven dose cohorts. As of the April 7, 2025 data cut-off, results showed: BDC-3042 was well tolerated up to the highest dose level tested (10 mg/kg q2w), with no dose-limiting toxicities observed. Across all dose cohorts: No grade 4 or 5 drug-related adverse events (AEs) were reported; No drug-related serious adverse events (SAEs) were reported...BDC-3042 demonstrated favorable pharmacokinetics (PK) providing ample exposure and flexibility to widen the dosing interval....One NSCLC patient from the 10 mg/kg cohort had an unconfirmed partial response and remains on study beyond 18 weeks; 80% of evaluable patients (12/15) had SD or better as their best response; Four out of five patients who had progressed after previous treatment with PD-1/PD-L1 blockers had SD..."

P1 data • PK/PD data • Non Small Cell Lung Cancer

Bolt Biotherapeutics to Present Data from Phase 1 Dose-Escalation Clinical Study of BDC-3042 at AACR Annual Meeting 2025 (GlobeNewswire) - "Bolt Biotherapeutics...announced it will present data from the Phase 1 dose-escalation clinical study of BDC-3042 in patients with advanced cancers at the American Association for Cancer Research (AACR) Annual Meeting....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 solid tumors including non-small cell lung cancer (NSCLC). Bolt will also be presenting preclinical data from two of its pipeline programs, Boltbody ISACs targeting CEA and PD-L1."

P1 data • Preclinical • Colorectal Cancer • Non Small Cell Lung Cancer • Pancreatic Cancer

Bolt Biotherapeutics Reports Fourth Quarter and Full-Year 2024 Financial Results and Provides Business Update (GlobeNewswire) - "Completed enrollment of 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 solid tumors including non-small cell lung cancer (NSCLC). BDC-3042 has been well tolerated with no dose-limiting toxicities (DLTs) and evidence of biological activity. Results from the trial will be presented at an upcoming medical meeting in the second quarter of 2025."

Enrollment closed • P1 data • Non Small Cell Lung Cancer • Solid Tumor

BBI-20233042: Study of BDC-3042 As Single Agent and in Combination with Cemiplimab in Patients with Advanced Malignancies (clinicaltrials.gov) - P1/2 | N=147 | Active, not recruiting | Sponsor: Bolt Biotherapeutics, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Breast Cancer • Clear Cell Renal Cell Carcinoma • Colorectal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor • Triple Negative Breast 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

Bolt Biotherapeutics Reports Second Quarter 2024 Financial Results and Provides Business Update (GlobeNewswire) - "Recent Highlights and Anticipated Milestones - Advanced to cohort 6 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."

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

A phase 1/2 study of BDC-3042, a novel dectin-2 agonistic antibody, in patients with advanced cancers. (ASCO 2024) - P1/2 | "A phase 1/2, first-in-human, dose-escalation and dose-expansion study of BDC-3042 as a single agent and in combination with a cemiplimab in subjects with advanced cancers has been initiated. J Immunother Cancer. 2021."

Clinical • IO biomarker • Metastases • P1/2 data • Breast Cancer • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor • Triple Negative Breast Cancer • CD8

Bolt Biotherapeutics Reports First Quarter 2024 Results, Announces Strategic Pipeline Prioritization and Changes to Leadership Team (GlobeNewswire) - "BDC-3042 Phase 1 dose escalation continues to advance....Bolt anticipates providing an update on enrollment and safety in the second half of the year; Discontinued development of trastuzumab imbotolimod (BDC-1001). Following a strategic review, Bolt has determined that the program will not meet its pre-defined success criteria, and Bolt will therefore be focusing resources on its next-generation ISAC programs."

Discontinued • Enrollment status • P1 data • Oncology • Solid Tumor

Bolt Biotherapeutics Reports Fourth Quarter and Full-Year 2023 Financial Results and Provides Business Update (GlobeNewswire) - "We have now administered BDC-1001, which we have renamed trastuzumab imbotolimod, to patients in all five of the Phase 2 cohorts. BDC-3042 also continues to advance, and has now entered the fourth dose escalation cohort without a dose-limiting toxicity. Both clinical programs are on track and we look forward to providing updates later this year."

P1/2 data • P2 data • Trial status • Colorectal Cancer • Endometrial Cancer • Gastroesophageal Cancer • HER2 Positive Breast Cancer

A phase 1/2 study of BDC-3042, a novel Dectin-2 agonistic antibody, in patients with advanced cancers (SITC 2023) - "Exploratory analyses will also be conducted to assess BDC-3042’s ability to reprogram TAMs and identify biomarkers associated with BDC-3042 biological activity with and without pembrolizumab. This study is being conducted in the US and is currently recruiting patients."

Clinical • IO biomarker • Metastases • P1/2 data • Breast Cancer • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor • Triple Negative Breast Cancer • CD8

Bolt Biotherapeutics to Present Data at the Society for Immunotherapy of Cancer’s 2023 Annual Meeting (GlobeNewswire) - "Bolt Biotherapeutics...announced that it will present four posters at the Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting. The conference is being held at the San Diego Convention Center in San Diego, Calif. and virtually from November 1-5, 2023....'Our research team has made significant progress across our portfolio, highlighting our commitment to generate breakthroughs for patients. In addition to clinical-stage data that further validate our Boltbody™ ISAC technology, we are excited to show at SITC for the first time our preclinical work with a trastuzumab ISAC and pertuzumab and how the combination augments anti-tumor efficacy in multiple HER2+ tumor models relative to trastuzumab plus pertuzumab'."

Preclinical • Trial status • Colorectal Cancer • Endometrial Cancer • Gastroesophageal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Head and Neck Cancer • Kidney Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor

Bolt Biotherapeutics Announces First Patient Dosed in Phase 1/2 Study of BDC-3042 in Patients with Advanced Cancers (GlobeNewswire) - "Bolt Biotherapeutics...announced that the first patient has been dosed with BDC-3042 in the single-agent dose-escalation portion of this first-in-human Phase 1/2 clinical study. The study will evaluate 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), or ovarian cancer."

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

Study of BDC-3042 as Single Agent and in Combination With Pembrolizumab in Patients With Advanced Malignancies (clinicaltrials.gov) - P1/2 | N=167 | Recruiting | Sponsor: Bolt Biotherapeutics, Inc.

Combination therapy • Metastases • New P1/2 trial • Breast Cancer • Clear Cell Renal Cell Carcinoma • Colorectal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor • Triple Negative Breast Cancer

Bolt Biotherapeutics Announces Issuance of U.S. Patent Covering Dectin-2-Targeting Agonist Antibodies, Including BDC-3042 (GlobeNewswire) - "Bolt Biotherapeutics, Inc...announced today the issuance of the first and foundational patent covering BDC-3042. The U.S. Patent and Trademark Office (USPTO) issued U.S. Patent 11,753,474 titled 'Anti-Dectin-2 Antibodies,' on September 12, 2023....The claims of the patent will be valid through May 2041, excluding any patent term adjustments or extensions which may provide additional protection."

Patent • Oncology • Solid Tumor

Bolt Biotherapeutics Reports Second Quarter 2023 Financial Results and Provides Business Update (GlobeNewswire) - "FDA clears IND for BDC-3042 in July 2023. BDC-3042 is a proprietary agonist antibody that targets Dectin-2, an immune-activating receptor expressed by tumor-associated macrophages (TAMs). The Company remains on track to initiate a Phase 1 clinical study of BDC-3042 in solid tumors later in 2023."

IND • New P1 trial • Oncology • Solid Tumor

Targeting tumor-associated macrophages to enhance anti-tumor immunity with the Dectin-2 agonistic antibody BDC-3042 (AACR 2023) - "Systemically administered BDC-3042 mediates anti-tumor efficacy as a monotherapy, and combination with checkpoint blockade therapy enhances anti-tumor efficacy. The data presented demonstrate the therapeutic potential of targeting Dectin-2 expressed by TAMs with the agonistic antibody BDC-3042 as a novel pan-cancer approach for myeloid cell-directed tumor immunotherapy."

IO biomarker • Oncology • Solid Tumor • CD8

Bolt Biotherapeutics to Present Preclinical Data for BDC-3042, a Dectin-2-Targeting Agonistic Antibody, at 2023 AACR Annual Meeting (GlobeNewswire) - "Bolt Biotherapeutics...announced that it will present a poster with new preclinical data for BDC-3042, a Dectin-2-targeting agonistic antibody, at the upcoming American Association of Cancer Research (AACR) Annual Meeting 2023. The conference is being held at the Orange County Convention Center in Orlando, Fla. from April 14-19, 2023."

Preclinical • Oncology

BDC-3042: A Dectin-2 agonistic antibody for tumor-associated macrophage-directed immunotherapy (SITC 2022) - "Systemically administered BDC-3042 activates TAMs and mediates anti-tumor efficacy in mice with humanized immune systems. Conclusions The data presented demonstrate the therapeutic potential of targeting Dectin-2 expressed by TAMs with the agonistic antibody BDC-3042 as a novel pan-cancer approach for myeloid cell-directed tumor immunotherapy."

IO biomarker • Colon Cancer • Lung Cancer • Oncology • Solid Tumor • CCL3 • CD34 • IL1B • TNFA

Bolt Biotherapeutics Reports Third Quarter 2022 Financial Results and Provides Business Update (GlobeNewswire) - "BDC-1001 – Monotherapy and combination dose-escalation trial is on track to complete enrollment by year-end 2022. Topline data, the recommended Phase 2 dose (RP2D) and the Phase 2 dose-expansion study design are expected during the first quarter of 2023, with full data to follow later in 2023 at a scientific conference; BDC-3042 on track to enter the clinic in 2023 – Investigational New Drug (IND)-enabling activities for BDC-3042...are on track to support an IND filing and initiation of clinical development in 2023."

Clinical protocol • Enrollment status • IND • P2 data • Oncology • Solid Tumor

Bolt Biotherapeutics to Present Preclinical Data on BDC-3042, Dectin-2 Targeting Agonistic Antibody, at the SITC Annual Meeting (GlobeNewswire) - "Bolt Biotherapeutics...announced that it will be presenting a poster with new preclinical data on BDC-3042, a Dectin-2 targeting agonistic antibody, at the 2022 Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting....BDC-3042 exhibits minimal binding to and activation of peripheral leukocytes. BDC-3042 repolarizes TAMs toward an immunostimulatory phenotype and mediates anti-tumor activity in tumor-bearing humanized mice."

Preclinical • Oncology • Solid Tumor

Bolt Biotherapeutics Reports Second Quarter 2022 Financial Results and Provides Business Update (GlobeNewswire) - "Clinical data and recommended Phase 2 dose (RP2D) expected in the second half of 2022 from BDC-1001 monotherapy and combination dose-escalation study....Bolt is currently conducting IND-enabling studies for BDC-3042 and is on track to initiate clinical development of BDC-3042 in 2023."

Clinical • P2 data • Oncology • Solid Tumor