BDC-2034 / Bolt Biotherap - LARVOL DELTA

Bolt Hones in on ISAC programs as Toxicities Claim Preclinical Hopeful (BioSpace) - "Immuno-oncology company Bolt Biotherapeutics announced it is dropping its preclinical BDC-2034 program and shifting its focus to prioritize two other immune-stimulating antibody conjugates (ISAC) programs: BDC-1001 and BDC-3042. The decision to discontinue BDC-2034 was based on off-target toxicity related to the targeting antibody. The company stated that with its current cash flow position and new strategy, it can keep its doors open through 2025."

Discontinued • Oncology

The CEA-targeted ISAC, BDC-2034, shows preclinical efficacy associated with innate immune activation, phagocytosis, and myeloid reprogramming (AACR 2022) - "These preclinical findings demonstrate the potential of BDC-2034 to generate anti-tumor activity in CEA-expressing cancers through direct innate immune activation and the induction of adaptive anti-tumor immunity."

IO biomarker • Preclinical • Oncology • Solid Tumor • CD40 • CEACAM5 • CXCL10 • TNFA

Bolt Biotherapeutics Reports Four Quarter and Full Year 2021 Financial Results and Provides Business Highlights (GlobeNewswire) - "BDC-1001 for the treatment of patients with HER2-expressing solid tumors on track for recommended Phase 2 dose identification later in 2022; BDC-1001 combination study arm with OPDIVO® (nivolumab) progressing well; Preclinical data on multiple pipeline programs will be presented at AACR 2022, including BDC-2034, BDC-3042, and a PD-L1 ISAC."

Preclinical • Trial status • Oncology • Solid Tumor

Bolt Biotherapeutics to Present Updates for Three Preclinical Immuno-Oncology Pipeline Programs at AACR Annual Meeting 2022 (GlobeNewswire) - "Three of Bolt Biotherapeutics’ preclinical programs will be featured in poster presentations: (1) BDC-2034, a CEA-targeting immune-stimulating antibody conjugate (ISAC) expected to enter clinical development in the second half of 2022, (2) BDC-3042, a Dectin-2-targeting, myeloid-modulating antibody anticipated to enter clinical development in 2023, and (3) a PD-L1-targeting ISAC. These posters will highlight updates on preclinical research for each of the programs, demonstrating anti-tumor activity and supporting future clinical development for all three programs."

Preclinical • Oncology

BDC-2034: Discovery of a CEA-targeting immune-stimulating antibody conjugate (ISAC) for solid tumors (SITC 2021) - "Results Antibody CEA1 binds to the CEA protein with high affinity (EC50 = 0.25 nM), binds selectively to CEA-positive tumor cell lines, and mediates ADCP more efficiently than a reference anti-CEA antibody, labetuzumab (figure 1). Conclusions These pre-clinical data demonstrate the potential of BDC-2034 to treat CEA-expressing human cancers. Most importantly, the antigen-dependent induction of immune-stimulating cytokines promises a robust immune response that combines the activation of innate and adaptive arms."

Oncology • Solid Tumor • CEACAM5 • CXCL10 • TLR8 • TNFA

Bolt Biotherapeutics Presents New Preclinical Data on Three Pipeline Programs at Society for Immunotherapy of Cancer (SITC) Annual Meeting (GlobeNewswire) - "Bolt Biotherapeutics...announced the company will be presenting posters with new data from three of its pipeline programs on Saturday, Nov. 13, at the 2021 Society for Immunotherapy of Cancer (SITC) Annual Meeting, being held virtually and in person in Washington, D.C. from Nov. 10-14. Each presentation highlights the progress made in preclinical studies to demonstrate the potential for each pipeline candidate as a novel approach for the treatment for cancer....Bolt Biotherapeutics designated BDC-2034 as a clinical candidate and is currently conducting IND-enabling studies with the expectation to initiate BDC-2034 clinical development in 2022."

IND • Preclinical • Oncology • Solid Tumor

Bolt Biotherapeutics Reports Third Quarter 2021 Financial Results and Provides Business Highlights (GlobeNewswire) - “Progress in the BDC-1001 Phase 1/2 trial in HER2-expressing solid tumors, with a monotherapy interim update in Q4 2021: Interim data from more than 50 patients treated at increasing exposure levels will be presented in December at the ESMO Immuno-Oncology Congress 2021….The positive data support continued investigation of an optimal dosing regimen and Phase 2 initiation in 2022….Clinical collaboration and supply agreement with Bristol Myers Squibb to investigate BDC-1001 in combination with Opdivo® (nivolumab)…The combination dose escalation and combination dose expansion portions of the Phase 1/2 clinical trial in patients with HER2-expressing solid tumors, including breast, gastroesophageal and colorectal. The combination portion of the trial is expected to start in the fourth quarter of 2021….IND-enabling studies with BDC-2034 (CEA-targeting ISAC) remain on track. GLP toxicology studies are expected to commence in first quarter of 2022 and IND filing in mid-2022.”

IND • New P2 trial • P1/2 data • Trial status • Breast Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Bolt Biotherapeutics to Present Updates on Three Pipeline Programs at the 2021 Society for Immunotherapy of Cancer Annual Meeting (SITC) (GlobeNewswire) - “Bolt Biotherapeutics, Inc….announced that it will be presenting three abstracts at the 2021 Society for Immunotherapy of Cancer’s (SITC) 36th Annual Meeting, which is being held from Nov. 10-14, both virtually and in person in Washington, D.C....The three poster presentations highlight assets in Bolt’s preclinical pipeline, including two Boltbody™ immune stimulating antibody conjugate (ISAC) candidates and an agonist antibody. BDC-2034 is a Boltbody ISAC targeting CEA, and the other Boltbody ISAC program targets PD-L1. The company’s proprietary agonist antibody targets Dectin-2 (also known as TAM1).”

Preclinical • Oncology • Solid Tumor

Bolt Biotherapeutics Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Business Highlights (GlobeNewswire) - “We plan to advance our second Boltbody ISAC BDC-2034, which targets the cancer antigen CEA, into the clinic in 2022…Later this year, Bolt plans to advance to part 3 of the trial, monotherapy Phase 2 dose expansion cohorts, and part 2, BDC-1001 dose escalation in combination with an anti-PD-1 antibody…Manish R. Sharma, M.D. of START Midwest, a principal investigator in Bolt’s ongoing BDC-1001 Phase 1/2 trial, will present a trial-in-progress e-poster entitled ‘CT218 - Phase 1/2 study of a novel HER2 targeting TLR7/8 immune-stimulating antibody conjugate (ISAC), BDC-1001' in the session ‘PO.CT08.01 - Phase I Clinical Trials in Progress” at AACR on Saturday, April 10, 2021, from 8:30 AM - 11:59 PM ET.”

Clinical • Trial status • Breast Cancer • HER2 Breast Cancer • Oncology