HMBD-002 / Hummingbird Biosci, Percheron Therapeutics - LARVOL DELTA

A Study of HMBD-002, a Monoclonal Antibody Targeting VISTA, as Monotherapy and Combined With Pembrolizumab, in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=48 | Completed | Sponsor: Hummingbird Bioscience | Active, not recruiting ➔ Completed | N=313 ➔ 48 | Trial completion date: Jul 2025 ➔ Dec 2024

Enrollment change • Monotherapy • Trial completion • Trial completion date • Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ALK • EGFR • PD-1 • PD-L1

Phase I Data Expected in 4Q CY2025 - "Percheron anticipates releasing full data from the completed phase I study of HMBD002 in patients with advanced cancer in 4Q CY2025, and to provide an overview of its proposed phase II clinical trial design shortly thereafter."

New P2 trial • P1 data • Solid Tumor

RESEARCHERS AT UNIVERSITY OF TEXAS PUBLISH NEW PRECLINICAL DATA SHOWING ACTIVITY OF HMBD-002 IN TRIPLE-NEGATIVE BREAST CANCER - "The UTSW data suggests potent activity of HMBD-002 in TNBC. In the EO771 mouse model of TNBC, administration of HMBD-002 substantially blocked tumour growth entirely in VISTA+ animals (p < 0.0001)...Moreover, the data indicates that the activity of HMBD-002 is not purely immunedriven but may also derive from modulation of growth signals such as EGFR3 . This may be an important point of differentiation with existing immunotherapies such as Keytruda (pembrolizumab) which are though to act only via the immune system."

Preclinical • Triple Negative Breast Cancer

Percheron Therapeutics' antibody shows promise in enhancing radiotherapy for head and neck cancer (Proactiveinvestors) - "Percheron Therapeutics...has just received a major scientific boost, with new preclinical data showing that its antibody therapy, HMBD-002, significantly enhances the effects of radiotherapy in treating head and neck cancer. The study, led by Stanford University, used advanced patient-derived models — essentially implanting human tumours into mice — to replicate real-world cancer biology. When HMBD-002 was combined with radiotherapy, researchers saw powerful tumour suppression and a notable improvement in survival outcomes."

Preclinical • Head and Neck Cancer

Hummingbird Bioscience Licenses HMBD-002, Phase II-Ready Anti-VISTA Monoclonal Antibody to Percheron Therapeutics (GlobeNewswire) - "Hummingbird Bioscience...announced that it has granted Percheron Therapeutics Limited...an exclusive worldwide license to develop, manufacture, and commercialize HMBD-002 in all territories and indications. Under the terms of the agreement, Hummingbird Bioscience will be eligible to receive up to USD 290 million in upfront and milestone payments, plus royalties on net sales. HMBD-002 is a monoclonal antibody therapy targeting VISTA, a novel checkpoint involved in the body’s immune response to cancer....Percheron Therapeutics aims to continue clinical development of HMBD-002 in CY2026."

Licensing / partnership • Non Small Cell Lung Cancer • Triple Negative Breast Cancer

A Study of HMBD-002, a Monoclonal Antibody Targeting VISTA, as Monotherapy and Combined With Pembrolizumab, in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=313 | Active, not recruiting | Sponsor: Hummingbird Bioscience | Recruiting ➔ Active, not recruiting | Trial primary completion date: Mar 2025 ➔ Nov 2024

Enrollment closed • Trial primary completion date • Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ALK • EGFR • PD-1 • PD-L1

A Study of HMBD-002, a Monoclonal Antibody Targeting VISTA, as Monotherapy and Combined With Pembrolizumab, in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=313 | Recruiting | Sponsor: Hummingbird Bioscience | N=240 ➔ 313 | Trial completion date: Jan 2025 ➔ Jul 2025 | Trial primary completion date: Oct 2024 ➔ Mar 2025

Enrollment change • Metastases • Monotherapy • Trial completion date • Trial primary completion date • Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ALK • EGFR • PD-1 • PD-L1

The VISTA blocking antibody HMBD-002 promotes type-I interferon signaling and drives anti-tumor responses through macrophage reprograming and cytotoxic CD8+ T cell activation (AACR 2024) - "Moreover, blocking the type-I IFN signaling effectively impeded HMBD-002-induced TAM reprogramming and subsequent anti-tumor efficacy, thus confirming the pivotal roles of CD8+ T cells, TAMs, and type-I IFN signaling in driving the anti-tumor response to VISTA blockade. In conclusion, VISTA blockade with HMBD-002 promotes an anti-tumor response by type-I IFN mediated reprogramming of TAMs and activation of cytotoxic CD8+ T cells."

Colon Cancer • Colorectal Cancer • Oncology • Solid Tumor • CD4 • CD8

Hummingbird Bioscience to Present Two Posters on Anti-HER3 and Anti-VISTA Antibody Therapeutics at American Association for Cancer Research (AACR) Meeting 2024 (PRNewswire) - "Hummingbird Bioscience...announced two upcoming poster presentations at the American Association for Cancer Research (AACR) Meeting 2024....Presentations will highlight the broad potential treatment opportunities for its clinical-stage targeted therapeutics HMBD-001 (anti-HER3 mAb) and HMBD-002 (anti-VISTA mAb) with further demonstrations of their pre-clinical efficacy in additional indications and deeper studies of their underlying therapeutic mechanisms."

Preclinical • Oncology

A phase 1 first-in-human clinical trial of HMBD-002, an IgG4 monoclonal antibody targeting VISTA, in advanced solid tumors. (ASCO 2023) - P1 | "HMBD-002, a non-depleting, high-affinity IgG4 monoclonal antibody against VISTA, has demonstrated significant inhibition of tumor growth in preclinical studies, both as a monotherapy and in combination with pembrolizumab. Biomarker correlations with clinical outcomes may lead to the identification of predictive markers of response to HMBD-002. Clinical trial information: NCT05082610."

Clinical • IO biomarker • Metastases • P1 data • Breast Cancer • Immune Modulation • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • VSIR

Hummingbird Bioscience Announces HMBD-002 Trials in Progress Poster at ASCO Annual Meeting 2023 (PRNewswire) - "Hummingbird Bioscience...announced a Trials in Progress poster presentation for HMBD-002, a unique anti-VISTA antibody, at the American Society of Clinical Oncology (ASCO) Annual Meeting being held 2-6 June, 2023 in Chicago. The poster will summarize the Phase 1 clinical trial design for HMBD-002 (NCT05082610)....The study will be conducted under a clinical trial collaboration and supply agreement with Merck & Co., Inc...Monotherapy escalation cohorts 1-4 have been completed without dose-limiting toxicities, and the trial is currently enrolling cohort 5. Combination escalation is projected to begin in the second half of 2023."

Clinical protocol • Trial status • Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer • Triple Negative Breast Cancer

A Phase 1 First in Human Study of HMBD-002, an IgG4 Monoclonal Antibody Targeting VISTA, as a Monotherapy and Combined with Pembrolizumab in Patients with Advanced Solid Malignancies (SITC 2021) - "Safety, efficacy, pharmacokinetic, and pharmacodynamic endpoints will be monitored and reported. Correlative studies will assess pre- and post-treatment markers of immune activity in the periphery and the tumor microenvironment."

Clinical • Monotherapy • P1 data • Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Trial in Progress: A phase 1 first-in-human study of HMBD-002, an IgG4 monoclonal antibody targeting VISTA, as a monotherapy and combined with pembrolizumab in patients with advanced solid malignancies (SITC 2022) - P1 | "Exploratory correlative analyses with clinical outcomes may lead to the identification of predictive biomarkers of clinical benefit with HMBD-002. Clinical trial information NCT05082610"

Clinical • IO biomarker • Monotherapy • P1 data • Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • VSIR

Anti-VISTA antibody HMBD-002 reprograms tumour associated macrophages and promotes cytotoxic T cell response (SITC 2022) - "Further, combining anti-VISTA with other immune checkpoint inhibitors that can reprogram exhausted T cells has the potential for synergistic activity. Ethics Approval The study was approved by the Institutional Animal Care and Use Committee, approval number 2021/SHS/1660"

IO biomarker • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • CD8 • GZMB • TNFA • VSIR

Hummingbird Bioscience Announces Two HMBD-002 Poster Presentations at the Society for Immunotherapy of Cancer 2022 Annual Meeting (PRNewswire-Asia) - "Hummingbird Bioscience...announced two poster presentations for HMBD-002, a unique anti-VISTA antibody, at the 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) being held November 10-12, 2022 in Boston....The first poster describes the Phase 1, open-label, multi-center, first-in-human trial evaluating HMBD-002 as a monotherapy and in combination with the anti-PD-1 therapy KEYTRUDA® (pembrolizumab)....The second poster shares preclinical data demonstrating that VISTA blockade with HMBD-002 reprograms tumor-associated macrophages to an inflammatory phenotype and promotes cytotoxic T-cell response. HMBD-002 in combination with anti-PD-1 treatment shows enhanced anti-tumor efficacy compared to monotherapy arms."

Clinical protocol • Preclinical • Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer • Triple Negative Breast Cancer

Hummingbird Bioscience Chief Scientific Officer Jerome Boyd-Kirkup to Present at the 2nd Annual VISTA Virtual Symposium (PRNewswire) - "Hummingbird Bioscience...announced that Jerome Boyd-Kirkup, Ph.D., Hummingbird Bioscience's Chief Scientific Officer, will present at the 2nd Annual VISTA Symposium on September 23, 2022....'I am excited to join the symposium to discuss the potential of anti-VISTA therapies alongside leading researchers and clinicians in immunology. Our differentiated, clinical-stage, anti-VISTA antibody HMBD-002 has potential as an important new therapy that may address VISTA-mediated immunosuppression across a broad range of tumors'....The symposium will focus on VISTA's function and applicability in cancer immunology, as well as the latest research and development in programs targeting VISTA."

Clinical data • P1 data • Oncology

Rationally targeted anti-VISTA antibody that blockades the C-C' loop region can reverse VISTA immune suppression and remodel the immune microenvironment to potently inhibit tumor growth in an Fc independent manner. (PubMed, J Immunother Cancer) - "In conclusion, we have shown that VISTA-induced immune suppression can be reversed by blockade of the functional C-C' loop region of VISTA with a first-in-class rationally targeted and non-depleting IgG4 isotype anti-VISTA antibody, HMBD-002. This antibody represents a highly promising novel therapy in the VISTA-suppressed ICT non-responder population."

IO biomarker • Journal • Breast Cancer • Colorectal Cancer • Immune Modulation • Inflammation • Lung Cancer • Oncology • Solid Tumor • VSIR

Hummingbird Bioscience Publishes Preclinical Data Demonstrating Therapeutic Potential of HMBD-002 in VISTA-expressing Cancers (PRNewswire) - "Hummingbird Bioscience...announced the publication of preclinical data for HMBD-002, a novel anti-VISTA antibody therapeutic, in the Journal for ImmunoTherapy of Cancer, a peer-reviewed journal of the Society for Immunotherapy of Cancer...The data demonstrate that HMBD-002 inhibits VISTA binding to key partners, including VSIG3, to release suppression of T cell activity, and that HMBD-002 treatment results in remodeling of the tumor microenvironment in murine models towards an anti-tumor phenotype."

Preclinical • Oncology

A Study of HMBD-002, a Monoclonal Antibody Targeting VISTA, as Monotherapy and Combined With Pembrolizumab (clinicaltrials.gov) - P1; N=240; Recruiting; Sponsor: Hummingbird Bioscience, Inc.; Not yet recruiting ➔ Recruiting

Enrollment open • Monotherapy • Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ALK • EGFR • PD-1 • PD-L1

Hummingbird Bioscience Announces Trials in Progress Poster Presentation at the Society for Immunotherapy of Cancer 2021 36th Annual Meeting (PRNewswire) - “Hummingbird Bioscience…announced a Trials in Progress poster presentation outlining the Phase 1 clinical trial design for HMBD-002, a unique anti-VISTA antibody developed using Hummingbird's Rational Antibody Discovery platform to address VISTA-mediated suppression of anti-tumor immune responses, at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC). The meeting will be held in Washington, D.C. and virtually from November 10 to 14, 2021….‘We are excited to present our Phase 1 clinical strategy for HMBD-002 at SITC and discuss our longer-term clinical development plans with the wider immuno-oncology community…We look forward to continued collaboration with Merck to advance HMBD-002 through clinical trials’…Hummingbird Bioscience currently plans to dose the first patient in Q4 2021 and expects to have clinical data from the Phase 1 clinical trial in the second half of 2023.”

Clinical • New P1 trial • P1 data • Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Hummingbird Bioscience to Collaborate with Merck on Clinical Trial of Anti-VISTA Antibody HMBD-002 in Combination with KEYTRUDA (Pembrolizumab) for Treatment of Cancer (PRNewswire) - “Hummingbird Bioscience…announced it has entered into a clinical trial collaboration agreement with Merck. Under this collaboration, Hummingbird will evaluate the safety, tolerability, and anti-tumor activity of its novel anti-VISTA antibody, HMBD-002, in combination with KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in patients with triple negative breast cancer (TNBC), non-small cell lung cancer (NSCLC) and other cancers with high VISTA expression. HMBD-002 is anticipated to enter a Phase 1 clinical trial in 2021….‘Our preclinical studies have shown that VISTA in combination with PD-1 therapy can enhance anti-tumor activity.’”

Licensing / partnership • New P1 trial • Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Triple Negative Breast Cancer

A Study of HMBD-002, a Monoclonal Antibody Targeting VISTA, as Monotherapy and Combined With Pembrolizumab (clinicaltrials.gov) - P1; N=240; Not yet recruiting; Sponsor: Hummingbird Bioscience, Inc.

Clinical • Monotherapy • New P1 trial • Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ALK • EGFR • PD-1 • PD-L1

Hummingbird Bioscience Announces US FDA Clearance of IND for First-in-Human Phase 1 Trial of HMBD-002 in Patients with Advanced Solid Tumors (PRNewswire) - “Hummingbird Bioscience…announced that the U.S. Food and Drug Administration (FDA) has approved the initiation of a Phase 1 clinical trial of HMBD-002, Hummingbird's anti-VISTA neutralizing antibody. HMBD-002 is being developed for the treatment of cancers with VISTA-mediated immune suppression, including triple negative breast cancer (TNBC) and non-small cell lung cancer (NSCLC)....The Phase 1, multi-center, open-label trial will evaluate HMBD-002, as a monotherapy and in combination with pembrolizumab.”

IND • Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Hummingbird Bioscience and MD Anderson Announce Strategic Research Collaboration To Advance Innovative Immunotherapies (PRNewswire) - “Hummingbird Bioscience…and The University of Texas MD Anderson Cancer Center today announced the launch of a multi-year strategic research collaboration to investigate and evaluate HMBD-002, Hummingbird's VISTA antagonist antibody. Under the agreement, MD Anderson and Hummingbird will collaborate on the design and execution of clinical and translational research studies to better understand how HMBD-002 modulates the anti-tumor immune response, both as a monotherapy and in combination with other checkpoint inhibitors. Working with MD Anderson's immunotherapy platform and its experts in comprehensive immunoprofiling, the teams will seek to identify biomarkers that may be used to predict clinical outcomes and adverse events.”

Licensing / partnership • Oncology

Hummingbird Bioscience to Speak at 2021 Virtual Symposium: “VISTA: A New Immune Checkpoint in Cancer, Autoimmunity and Beyond“ (PRNewswire) - “Hummingbird Bioscience…announced that its Chief Scientific Officer and co-founder, Dr Jerome Boyd-Kirkup, will be speaking at the 2021 virtual symposium ‘VISTA: A New Immune Checkpoint in Cancer, Autoimmunity and Beyond’, taking place on June 18, 2021…Hummingbird's rationally targeted anti-VISTA neutralizing antibody, HMBD-002, is the only IgG4 isotype anti-VISTA neutralizing antibody that is currently in development for the treatment of cancers with VISTA-mediated immune suppression, including triple negative breast cancer and non-small cell lung cancer. Pre-clinical studies have shown that HMBD-002 as a monotherapy inhibits tumor growth and significantly prolongs survival, with no observed toxicity. It has also shown synergy when used in combination with anti-PD-1 therapy."

Clinical • Preclinical • Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Triple Negative Breast Cancer