BPT567 / Bright Peak Therap - LARVOL DELTA

The first-in-class PD1-IL18 conjugate BPT567 induces potent anti-tumor immunity by preferentially activating PD1+IL18R+ intratumoral effector T cells in cis (AACR 2024) - "Strikingly, despite addressing overlapping epitopes in PD-1, even a 200-fold excess of pembrolizumab has no impact on the in vitro potency of BPT567. In an effort to confirm findings generated in murine models in relevant human ex vivo systems, we analyzed the release of cytokines and chemokines in dissociated cells isolated from primary human tumor explants. Also in this human model, BPT567 is able to induce significantly stronger IFNγ release compared to either single agents or the combination of untargeted IL-18 and an anti-PD1 Ab, thus confirming the unique MoA of the PD1-IL18 conjugate triggering superior TIL activation in cis."

Oncology • CD4 • CD8 • IFNG • IL18 • PD-1

SUMMIT-1: A Study to Evaluate Safety and Tolerability of BPT567 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=20 | Terminated | Sponsor: Bright Peak Therapeutics Inc | N=100 ➔ 20 | Trial completion date: Dec 2028 ➔ Mar 2026 | Active, not recruiting ➔ Terminated | Trial primary completion date: Dec 2027 ➔ Jan 2026; Sponsor decision

Enrollment change • First-in-human • Trial completion date • Trial primary completion date • Trial termination • Oncology • Solid Tumor

SUMMIT-1: A Study to Evaluate Safety and Tolerability of BPT567 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=100 | Active, not recruiting | Sponsor: Bright Peak Therapeutics Inc | Recruiting ➔ Active, not recruiting

Enrollment closed • First-in-human • Oncology • Solid Tumor

Bright Peak Therapeutics Announces Dosing of First Patient in Phase 1/2a Clinical Trial of BPT567, a First-in-Class Bifunctional PD1-IL18 Immunoconjugate (GlobeNewswire) - "Bright Peak Therapeutics...today announced that the first patient was dosed in its Phase 1/2a trial evaluating BPT567, an investigational bifunctional PD1-IL18 immunoconjugate."

Trial status • Oncology • Solid Tumor

Bright Peak Therapeutics Announces $90 Million in Series C Financing to Advance First-in-Class PD1-IL18 Immunoconjugate Program Into Clinical Trials (GlobeNewswire) - "Bright Peak Therapeutics...announced that it raised $90 million in a Series C financing. The round was led by Johnson & Johnson Innovation – JJDC, with participation from additional new investors Venrock, KB Investment, and Northleaf Capital Partners. Existing investors participating in the round include founding investor Versant Ventures along with Fidelity Management & Research Company, RA Capital Management, Qatar Investment Authority, Invus, Alexandria Venture Investments, and an undisclosed leading healthcare investment fund. Proceeds from the Series C financing will be used to advance BPT567 into a Phase 1/2a clinical trial and accelerate a pipeline of next-generation immunotherapies."

Financing • Oncology • Solid Tumor

Bright Peak Therapeutics Presents New Data at the 2024 American Association for Cancer Research (AACR) Annual Meeting (GlobeNewswire) - "Bright Peak Therapeutics...today announced the presentation of new data characterizing the mechanisms of action, and potent preclinical antitumor activity of BPT567, a cis-signaling, PD1-IL18 immunoconjugate, at the American Association for Cancer Research (AACR) Annual Meeting being held on April 4-10, 2024, in San Diego, CA....'Characterization of the biological activity of BPT567 in preclinical tumor models has demonstrated that BPT567 indeed can more selectively target the potent proinflammatory effects of IL-18 to the tumor.'"

Preclinical • Oncology

A first-in-class PD1-IL18 immunocytokine (BPT567) targets PD-1+ IL18R+ CD8+ T effector cells enriched in the tumor microenvironment and exhibits potent antitumor efficacy with excellent tolerability (AACR 2023) - "Hence, we developed a PD1-IL18 IC to specifically target and activate intratumoral IL-18R-expressing PD-1+ CD8+ T cells.We engineered a conjugatable variant of human IL-18 with enhanced potency and significant resistance to IL-18 binding protein (IL-18BP) and utilized this enhanced IL-18 payload to create a PD1-IL18 IC (BPT567) via site-specific chemical conjugation to a defined lysine residue within the heavy chain of an anti-human PD-1 antibody (Ab)...Our evidence suggests that the strong in vivo efficacy observed is attributed to a preferential activation of PD-1+ tumor-infiltrated immune cells. The excellent tolerability and large therapeutic window observed in mice may be driven by less potent immune cell activation in the periphery."

Biomarker • Clinical • IO biomarker • Tumor microenvironment • Oncology • CD8 • IL18

Bright Peak Presents New Data at AACR: BPT567 A First-in-Class Multifunctional PD1-IL18 Immunocytokine (GlobeNewswire) - "Bright Peak Therapeutics...announced the presentation of new data characterizing the highly targeted biological and therapeutic effects of BPT567 that contribute to its potent single agent anti-tumor activity at the American Association for Cancer Research (AACR) Annual Meeting being held on April 14-19, 2023, in Orlando, FL....In preclinical tumor models, administration of BPT567 mediated synergistic antitumor activity that was superior to anti-PD-1 alone, a control non-targeted HER2 IL-18 IC, or the combination of anti-PD-1 and non-targeted IL-18 IC. All mice that were cured of their initial tumors rejected rechallenge with MC38 implantation, confirming the development of long-term immunologic memory induced by BPT567."

Preclinical • Oncology