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Bolt Biotherapeutics to Present Data from Phase 1 Dose-Escalation Clinical Study of BDC-3042 at AACR Annual Meeting 2025

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Bolt Biotherapeutics (BOLT) announced it will present data from its Phase 1 dose-escalation clinical study of BDC-3042 at the AACR Annual Meeting in Chicago (April 25-30, 2025). BDC-3042 is a pioneering agonist antibody targeting dectin-2, specifically designed for patients with advanced cancers including non-small cell lung cancer (NSCLC).

The company will showcase three poster presentations: the first-in-human dose-escalation study results of BDC-3042, presented by Dr. Ecaterina Dumbrava from MD Anderson Cancer Center, and two preclinical studies featuring their Boltbody™ ISAC technology targeting CEA and PD-L1. These presentations will highlight advancements in their immunotherapy pipeline for treating various cancers including colorectal, pancreatic, and lung tumors.

Bolt Biotherapeutics (BOLT) ha annunciato che presenterà i dati del suo studio clinico di fase 1 di escalation della dose di BDC-3042 durante l'incontro annuale dell'AACR a Chicago (25-30 aprile 2025). BDC-3042 è un anticorpo agonista innovativo che mira al dectin-2, progettato specificamente per pazienti con tumori avanzati, inclusi il cancro polmonare non a piccole cellule (NSCLC).

L'azienda presenterà tre poster: i risultati dello studio di escalation della dose di BDC-3042, presentati dalla Dr.ssa Ecaterina Dumbrava del MD Anderson Cancer Center, e due studi preclinici che mostrano la loro tecnologia Boltbody™ ISAC mirata a CEA e PD-L1. Queste presentazioni metteranno in evidenza i progressi nel loro pipeline di immunoterapia per il trattamento di vari tumori, inclusi quelli colorettali, pancreatici e polmonari.

Bolt Biotherapeutics (BOLT) anunció que presentará datos de su estudio clínico de escalación de dosis de fase 1 de BDC-3042 en la Reunión Anual de la AACR en Chicago (25-30 de abril de 2025). BDC-3042 es un anticuerpo agonista pionero que se dirige a dectin-2, diseñado específicamente para pacientes con cánceres avanzados, incluido el cáncer de pulmón de células no pequeñas (NSCLC).

La empresa mostrará tres presentaciones en póster: los resultados del estudio de escalación de dosis en humanos de BDC-3042, presentados por la Dra. Ecaterina Dumbrava del MD Anderson Cancer Center, y dos estudios preclínicos que presentan su tecnología Boltbody™ ISAC dirigida a CEA y PD-L1. Estas presentaciones destacarán los avances en su pipeline de inmunoterapia para tratar diversos cánceres, incluidos los tumores colorrectales, pancreáticos y pulmonares.

볼트 생명공학(BOLT)BDC-3042의 1상 용량 증량 임상 연구 데이터를 2025년 4월 25일부터 30일까지 시카고에서 열리는 AACR 연례 회의에서 발표할 것이라고 발표했습니다. BDC-3042는 비소세포 폐암(NSCLC)을 포함한 진행성 암 환자를 위해 특별히 설계된 데크틴-2를 표적으로 하는 혁신적인 작용제 항체입니다.

회사는 세 가지 포스터 발표를 진행할 예정입니다: MD 앤더슨 암 센터의 에카테리나 둠브라바 박사가 발표하는 BDC-3042의 첫 번째 인체 용량 증량 연구 결과와 CEA 및 PD-L1을 표적으로 하는 Boltbody™ ISAC 기술을 특징으로 하는 두 개의 전임상 연구입니다. 이러한 발표는 대장암, 췌장암 및 폐종양을 포함한 다양한 암 치료를 위한 면역요법 파이프라인의 발전을 강조할 것입니다.

Bolt Biotherapeutics (BOLT) a annoncé qu'il présentera des données de son étude clinique de phase 1 sur l'escalade de dose de BDC-3042 lors de la réunion annuelle de l'AACR à Chicago (du 25 au 30 avril 2025). BDC-3042 est un anticorps agoniste novateur ciblant le dectin-2, conçu spécifiquement pour les patients atteints de cancers avancés, y compris le cancer du poumon non à petites cellules (NSCLC).

L'entreprise présentera trois présentations sous forme de posters : les résultats de l'étude d'escalade de dose chez l'homme de BDC-3042, présentés par Dr. Ecaterina Dumbrava du MD Anderson Cancer Center, et deux études précliniques mettant en avant leur technologie Boltbody™ ISAC ciblant le CEA et le PD-L1. Ces présentations mettront en lumière les avancées de leur pipeline d'immunothérapie pour le traitement de divers cancers, y compris les tumeurs colorectales, pancréatiques et pulmonaires.

Bolt Biotherapeutics (BOLT) gab bekannt, dass es Daten aus seiner klinischen Phase-1-Dosiserhöhungsstudie zu BDC-3042 auf dem AACR-Jahrestreffen in Chicago (25.-30. April 2025) präsentieren wird. BDC-3042 ist ein wegweisender Agonisten-Antikörper, der auf Dectin-2 abzielt und speziell für Patienten mit fortgeschrittenen Krebserkrankungen, einschließlich nicht-kleinzelligem Lungenkrebs (NSCLC), entwickelt wurde.

Das Unternehmen wird drei Posterpräsentationen zeigen: die Ergebnisse der ersten Dosiserhöhungsstudie am Menschen zu BDC-3042, präsentiert von Dr. Ecaterina Dumbrava vom MD Anderson Cancer Center, sowie zwei präklinische Studien, die ihre Boltbody™ ISAC-Technologie zur Zielgerichtetheit auf CEA und PD-L1 vorstellen. Diese Präsentationen werden Fortschritte in ihrem Immuntherapie-Pipeline zur Behandlung verschiedener Krebserkrankungen, einschließlich kolorektaler, pankreatischer und Lungen-Tumoren, hervorheben.

Positive
  • First-in-class dectin-2 agonist antibody advancing through clinical trials
  • Multiple pipeline programs progressing simultaneously (BDC-3042 and two Boltbody™ ISACs)
  • Expanding therapeutic reach across multiple cancer types (NSCLC, colorectal, pancreatic, lung)
Negative
  • None.

REDWOOD CITY, Calif., March 25, 2025 (GLOBE NEWSWIRE) -- Bolt Biotherapeutics (Nasdaq: BOLT), a clinical-stage biopharmaceutical company developing novel immunotherapies for the treatment of cancer, today 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, taking place April 25-30, 2025, in Chicago, Illinois.

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.

Details about the poster presentations can be found below and on the AACR website. Additionally, a copy of each poster will be available on the Publications page of the Bolt Biotherapeutics website at the start of each poster session.

Title: BDC-3042, a first-in-class Dectin-2 agonist, in patients with advanced malignancies: Results from the first-in-human dose-escalation study
Presenter: Ecaterina E. Dumbrava, M.D., The University of Texas MD Anderson Cancer Center
Poster Session: First-in-Human Phase I Clinical Trials 2
Session Date and Time: Tuesday, April 29, 2025, 9:00 a.m. – 12:00 p.m. CDT
Location: Poster Section 48
Poster Number: 20
Abstract Number: CT154

Title: A highly efficacious next-generation CEACAM5 (CEA)-targeted Boltbody™ ISAC for the treatment of colorectal, pancreatic and lung tumors
Presenter: Paul D. Ponath, Ph.D., Bolt Biotherapeutics
Poster Session: T Cell Engagers and Novel Antibody-Based Therapies
Session Date and Time: Wednesday, April 30, 2025, 9:00 a.m. – 12:00 p.m. CDT
Location: Poster Section 40
Poster Number: 25
Abstract Number: 7399

Title: PD-L1-directed ISACs target host immune cells to drive powerful antitumor immune responses in a manner distinct from conventional PD-1/PD-L1 blockade
Presenter: Justin A. Kenkel, Ph.D., Bolt Biotherapeutics
Poster Session: T Cell Engagers and Novel Antibody-Based Therapies
Session Date and Time: Wednesday, April 30, 2025, 9:00 a.m. – 12:00 p.m. CDT
Location: Poster Section 40
Poster Number: 19
Abstract Number: 7333

About the Boltbody™ Immune-Stimulating Antibody Conjugate (ISAC) Platform
Bolt Biotherapeutics’ Boltbody ISAC platform harnesses the precision of antibodies with the power of the innate and adaptive immune system to generate a productive anti-cancer response. Each Boltbody ISAC candidate comprises a tumor-targeting antibody, a non-cleavable linker, and a proprietary immune stimulant. The antibody is designed to target one or more markers on the surface of a tumor cell and the immune stimulant is designed to recruit and activate myeloid cells. Activated myeloid cells initiate a positive feedback loop by releasing cytokines and chemokines, chemical signals that attract other immune cells and lower the activation threshold for an immune response. This increases the population of activated immune system cells in the tumor microenvironment and promotes a robust immune response with the goal of generating durable therapeutic responses for patients with cancer.

About Bolt Biotherapeutics, Inc.
Bolt Biotherapeutics is a clinical-stage biopharmaceutical company developing novel immunotherapies for the treatment of cancer. Bolt Biotherapeutics’ pipeline candidates are built on the Company’s deep expertise in myeloid biology and cancer drug development. The Company’s pipeline includes BDC-3042, a first-in-class agonist antibody that activates macrophages by targeting dectin-2, and BDC-4182, a next-generation Boltbody™ Immune-Stimulating Antibody Conjugate (ISAC) clinical candidate targeting claudin 18.2. BDC-3042 is currently in a Phase 1 dose escalation trial that includes patients with any of seven different solid tumor types. BDC-4182 is supported by strong in vitro and in vivo data demonstrating potent anti-tumor activity, and activities are underway to support the initiation of clinical trials in second quarter 2025. Bolt Biotherapeutics is also developing additional Boltbody™ ISACs in strategic collaborations with leading biopharmaceutical companies. For more information, please visit https://www.boltbio.com/.

Investor Relations and Media Contact:
Matthew DeYoung
Argot Partners
(212) 600-1902
boltbio@argotpartners.com


FAQ

What is the significance of Bolt Biotherapeutics' BDC-3042 Phase 1 trial presentation at AACR 2025?

BDC-3042 is BOLT's first-in-class dectin-2 agonist antibody being tested in patients with metastatic or unresectable solid tumors, including NSCLC. The Phase 1 results will provide important initial safety and efficacy data.

What types of cancer is BOLT's BDC-3042 targeting in clinical trials?

BDC-3042 is being evaluated in patients with metastatic or unresectable solid tumors, specifically including non-small cell lung cancer (NSCLC).

What additional pipeline programs will BOLT present at AACR 2025?

BOLT will present preclinical data on two Boltbody™ ISAC programs: one targeting CEA for colorectal, pancreatic and lung tumors, and another targeting PD-L1 for antitumor immune responses.

When and where will BOLT present its BDC-3042 clinical trial data?

The data will be presented on Tuesday, April 29, 2025, from 9:00 a.m. to 12:00 p.m. CDT at the AACR Annual Meeting in Chicago, in Poster Section 48.
Bolt Biotherapeutics, Inc.

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