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Poster session 14

783TiP - Phase I study of HFB301001, a novel OX40 agonist monoclonal antibody, in patients with solid tumors selected via Drug Intelligence Science (DIS)


10 Sep 2022


Poster session 14


Tumour Immunology;  Immunotherapy

Tumour Site


Alexander Spira


Annals of Oncology (2022) 33 (suppl_7): S331-S355. 10.1016/annonc/annonc1058


A. Spira1, R. Mehra2, C. Mantia3, H. Babiker4, M. Borad5, A. Cervantes6, E. Garralda7, A. Mahipal8, L. Paz-Ares9, C. Hatzis10, A. Liu10, A. Raue10, J. Gan10, F. Adrian10, L. Manenti10, A.B. El-Khoueiry11

Author affiliations

  • 1 Research Institute, Virginia Cancer Specialist, 22031 - Fairfax/US
  • 2 Medicine, University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center, 21201 - Baltimore/US
  • 3 Genitourinary Oncology Department, Dana Farber Cancer Institute, 02215 - Boston/US
  • 4 Oncology/hematology, Mayo Clinic Cancer Center, 32224 - Jacksonville/US
  • 5 Oncology Department, Mayo Clinic Cancer Center, 85259 - Scottsdale/US
  • 6 Medical Oncology Department, Hospital Clinico Universitario de Valencia, 46010 - Valencia/ES
  • 7 Early Drug Development Group, Vall d'Hebron University Hospital, 8035 - Barcelona/ES
  • 8 Oncology, Mayo Clinic, 55905 - Rochester/US
  • 9 Medical Oncology Department - Edificio Maternidad 2ª Planta, Hospital Universitario 12 de Octubre, 28041 - Madrid/ES
  • 10 Clinical Development, HiFiBiO Inc., 02139 - Cambridge/US
  • 11 Medical Oncology Division, USC - University of Southern California - Keck School of Medicine, 90033 - Los Angeles/US


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Abstract 783TiP


OX40 agonist antibodies have shown promising preclinical activity but limited clinical success thus far, likely owing to a suboptimal pharmacological profile, inappropriate dosing regimen, and lack of a biomarker strategy for patient selection. HFB301001 is a novel human IgG1 agonist antibody that binds to a unique epitope on OX40 allowing for agonistic activity without competing with the endogenous OX40 ligand, inducing minimal OX40 downregulation upon co-stimulation of T cells. Also, HFB301001 can both enhance effector T cells and deplete regulatory T cells. It demonstrated more potent in vivo anti-tumor activity than a benchmark OX40 agonist, suggesting potentially superior patient benefit compared to first generation OX40 antibodies.

Trial design

HFB301001 is being evaluated in a first-in-human, open-label, multi-center, dose escalation and expansion study in adult patients with advanced solid tumors. It is hypothesized that high levels of OX40 expression associated with effector T cells or T regulatory cells in solid tumors may represent a tumor microenvironment more sensitive to OX40 agonism. Based on this, the following cancer indications have been prioritized using DIS (Drug Intelligence Science is a HiFiBiO Inc. trademark): soft tissue sarcoma (STS), uterine carcinosarcoma (UCS), renal cell carcinoma (RCC), head and neck squamous cell carcinoma (HNSCC), and hepatocellular carcinoma (HCC). The dose escalation portion of the study explores increasing doses in four cohorts of up to six patients, utilizing an mTPI-2 design to determine recommended dose(s) for expansion (RDE(s)). Once the RDE(s) is determined, expansion of up to 5 cohorts is planned to determine the recommended phase 2 dose (RP2D). The primary objective is to characterize safety and tolerability of HFB301001, and to determine RDE(s) and RP2D. Secondary objectives include pharmacokinetic parameters, preliminary evidence of anti-tumor efficacy, and pharmacodynamic evaluation in blood and tumor. Furthermore, a potential predictive biomarker signature derived based on the DIS™ single-cell immune profiling platform will be investigated.

Clinical trial identification


Editorial acknowledgement

Legal entity responsible for the study

HiFiBiO Inc.


HiFiBiO Inc.


A. Spira: Financial Interests, Personal, Consulting or Advisory Role: Incyte, Mirati Therapeutics, Gritstone Oncology, Jazz Pharmaceuticals, Janssen Research & Development, Mersana, Gritstone Bio, Daiichi Sankyo/AstraZeneca, Array Biopharma, Blueprint Medicines; Financial Interests, Personal, Consulting or Advisory Role / Honoraria: Amgen, Novartis, Takeda, AstraZeneca/MedImmune, Merck, Bristol Myers Squibb; Financial Interests, Personal, Honoraria: CytomX Therapeutics, Janssen Oncology, Bayer; Financial Interests, Institutional, Officer, CEO: NEXT Oncology Virginia; Financial Interests, Personal, Stocks/Shares: Eli Lilly; Financial Interests, Institutional, Invited Speaker: LAM Therapeutics, Roche, AstraZeneca, Boehringer Ingelheim, Astellas Pharma, MedImmune, Novartis, Newlink Genetics, Incyte, AbbVie, Ignyta, Trovagene, Takeda, Macrogenics, CytomX Therapeutics, Astex Pharmaceuticals, Bristol Myers Squibb, Loxo, Arch Therapeutics, Gritstone, Plexxikon, Amgen, Daiichi Sankyo, ADCT, Janssen Oncology, Mirati Therapeutics, Rubius, Synthekine, Mersana, Blueprint Medicines. R. Mehra: Financial Interests, Personal, Advisory Board: Rakuten Medical, Coherus; Financial Interests, Institutional, Invited Speaker: Merck, Innate Pharma, Ayala, Merck, Iovance, Seattle Genetics, Kura, Astra Zeneca, Pfizer, Astellas, Incyte; Financial Interests, Institutional, Funding: AstraZeneca; Non-Financial Interests, Advisory Role, uncompensated advisory board: AstraZeneca; Non-Financial Interests, Member: ASCO, AACR; Non-Financial Interests, Leadership Role: ECOG-ACRIN. C. Mantia: Financial Interests, Institutional, Invited Speaker, Institutional funding for research: Bristol Myers Squibb. H. Babiker: Financial Interests, Personal, Advisory Role: Endocyte, Celgene, Idera, Myovant Sciences, Novocure; Financial Interests, Personal, Speaker’s Bureau: Guardant Health. M. Borad: Financial Interests, Personal, Advisory Role: G1 Therapeutics, Inspyr Therapeutics, Immunovative Therapies, Exelixis, Lynx Group, Genentech, Western Oncolytics, Klus Pharma, De Novo Pharmaceuticals, Merck, Imvax; Financial Interests, Institutional, Advisory Role: Fujifilm, Agios, Insys Therapeutics, Novartis, ArQule, Celgene, Halozyme, Pieris Pharmaceuticals, Taiho Pharmaceutical; Financial Interests, Personal: ArQule, Celgene, AstraZeneca; Financial Interests, Personal, Stocks/Shares: Gilead Sciences, AVEO, Intercept Pharmaceuticals, Spectrum Pharmaceuticals; Financial Interests, Institutional, Funding: Boston Biomedical, miRNA Therapeutics, Senhwa Biosciences, MedImmune, BiolineRx, Agios, Halozyme, Celgene, Threshold Pharmaceuticals, Toray Industries, Dicerna, Sillajen, Eisai, Taiho Pharmaceutical, EMD Serono, Isis Pharmaceuticals, Incyte, Sun Biopharma, ARIAD, ImClone Systems, QED Therapeutics, Puma Biotechnology, Adaptimmune, Merck Serono, RedHill Biopharma, Basilea, AstraZeneca; Financial Interests, Institutional, Sponsor/Funding: HiFiBiO Inc.. A. Cervantes: Financial Interests, Institutional, Advisory Board: MerckSerono, Amgen, Roche, Transgene; Financial Interests, Institutional, Invited Speaker: Amgen, Roche, Merck Serono, Foundation Medicine; Financial Interests, Personal, Associate Editor: Annals of Oncology, ESMO Open; Financial Interests, Personal, Editor: Cancer Treatment Reviews; Financial Interests, Institutional, Research Grant, Principal Investigator: Actuate Therapeutic, Amgen, Astellas Pharma, Beigene, Bayer, AstraZeneca, BMS, Amcure, FibroGen, Lilly, Genentech, MedImmune, Merck Serono, Novartis, Natera, MSD, Servier, Sierra Oncology, Adaptimmune, Takeda; Non-Financial Interests, General and Scientific Director: INCLIVA Biomedical Research Institute. E. Garralda: Financial Interests, Personal, Advisory Board: Genentech, F.Hoffmann/La Roche, Neomed Therapeutics1 Inc, Boehringer Ingelheim, Janssen Global Services, Alkermes, Thermo Fisher, MabDiscovery, Anaveon, Lilly; Financial Interests, Personal, Invited Speaker: Ellipses Pharma, Seattle Genetics, Bristol Myers Squibb, MSD; Financial Interests, Personal, Expert Testimony: TFS; Financial Interests, Institutional, Funding: Novartis, Roche, Thermo Fisher, AstraZeneca, Taiho; Institutional Travel Grant: Bristol Myers Squibb, MSD, Menarini, Glycotope. A. Mahipal: Financial Interests, Personal, Advisory Board: Taiho, Incyte. L. Paz-Ares: Financial Interests, Personal, Advisory Board: Roche, MSD, Merck Serono, BMS, AZ, Lilly, Pfizer, Pharmamar, Bayer, Amgen, Janssen, GSK, Novartis, Takeda, Sanofi, Mirati; Financial Interests, Personal, Board member: Genomica, Altum sequencing; Financial Interests, Personal, Invited Speaker: Altum sequencing, Amgen; Financial Interests, Institutional, Invited Speaker: Daiichi Sankyo, AstraZeneca, Merck Sharp & Dohme corp, BMS, Janssen-cilag international NV, NOvartis, Roche, Sanofi, Tesaro, Alkermes, Lilly, Takeda, Pfizer, Pharmamar. C. Hatzis: Financial Interests, Personal, Full or part-time Employment: HifiBiO Therapeutics; Financial Interests, Personal, Stocks/Shares: Bristol Myers Squibb. A. Liu: Financial Interests, Personal, Full or part-time Employment: HiFiBiO Inc.. A. Raue: Financial Interests, Personal, Full or part-time Employment, Employee and share holder: HiFiBiO Therapeutics; Financial Interests, Personal, Stocks/Shares, Option shares: HiFiBiO Therapeutics. J. Gan: Financial Interests, Personal, Full or part-time Employment: HiFiBiO Therapeutics; Financial Interests, Personal, Stocks/Shares: HiFiBiO Therapeutics. F. Adrian: Financial Interests, Personal, Full or part-time Employment: HiFiBiO Inc.. L. Manenti: Financial Interests, Personal, Full or part-time Employment: HiFiBiO; Financial Interests, Personal, Stocks/Shares: HiFiBiO; Non-Financial Interests, Member: ASCO. A.B. El-Khoueiry: Financial Interests, Personal, Advisory Board: Bayer, Exelixis, AstraZeneca, BMS, Genentech, Agenus, Servier, QED, Tallac, ABL Bio, Senti Biosciences, Qurient; Financial Interests, Institutional, Funding: Fulgent, Astex, AstraZeneca; Financial Interests, Personal, Invited Speaker: Merck; Non-Financial Interests, Principal Investigator: Agenus, Affimed, Bayer.

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