An FDA oncology analysis of immune activating products and first-in-human dose selection

Regulatory Toxicology and Pharmacology

Volumn 81, Issue , 2016, Pages 448-456

  Saber, Haleh ^a   Gudi, Ramadevi ^a   Manning, Michael ^a   Wearne, Emily ^a   Leighton, John K ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

First in human dose; Immune oncology; MABEL

Indexed keywords

CD3 ANTIBODY; GAMMA INTERFERON; IMMUNOGLOBULIN ANTIBODY; IMMUNOGLOBULIN FC FRAGMENT; IMMUNOGLOBULIN G1 ANTIBODY; IMMUNOGLOBULIN G2; IMMUNOGLOBULIN G4; IMMUNOMODULATING AGENT; INTERLEUKIN 10; INTERLEUKIN 2; INTERLEUKIN 6; TUMOR NECROSIS FACTOR; MONOCLONAL ANTIBODY;

APOPTOSIS; ARTICLE; BINDING AFFINITY; CONTROLLED STUDY; CYTOKINE RELEASE; CYTOLYSIS; DRUG APPROVAL; DRUG DOSE REGIMEN; FIRST IN HUMAN DOSE SELECTION; IMMUNOMODULATION; IN VITRO STUDY; LYMPHOCYTE PROLIFERATION; MOLECULAR WEIGHT; NO-OBSERVED-ADVERSE-EFFECT LEVEL; NONHUMAN; ONCOLOGICAL PROCEDURE; PRIORITY JOURNAL; RETROSPECTIVE STUDY; STUDY DESIGN; T LYMPHOCYTE ACTIVATION; ANIMAL; DOSE RESPONSE; FOOD AND DRUG ADMINISTRATION; HUMAN; IMMUNOLOGY; NEOPLASM; UNITED STATES;

ANIMALS; ANTIBODIES, MONOCLONAL; DOSE-RESPONSE RELATIONSHIP, DRUG; HUMANS; NEOPLASMS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84991608471     PISSN: 02732300     EISSN: 10960295     Source Type: Journal    
DOI: 10.1016/j.yrtph.2016.10.002     Document Type: Article

References (22)

1. Brennan, F.R., et al. Safety and immunotoxicity assessment of immunomodulatory monoclonal antibodies. Monoclon. antibodies 2 (2010), 233–255.
2. Couzin-Frankel, J., Cancer immunotherapy. Science 342 (2013), 1432–1433.
3. Doessegger, L., Banholzer, M.L., Clinical development methodology for infusion-related reactions with monoclonal antibodies. Clin. Transl. Immunol., 4, 2015, e39.
4. EMA, Guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products. 2007, European Medicines Agency.
5. EMA, Guideline on the evaluation of anticancer medicinal products in man. 2013, European Medicines Agency.
6. FDA, Immunogenicity assessment for therapeutic protein products. 2014, Food and Drug Administration.
7. Goutelle, S., et al. The Hill equation: a review of its capabilities in pharmacological modelling. Fundam. Clin. Pharmacol. 22 (2008), 633–648.
8. Grimaldi, C., et al. Cytokine release: a workshop proceedings on the state-of-the-science, current challenges and future directions. Cytokine 85 (2016), 101–108.
9. ICH S9, Nonclinical Evaluation for Anticancer Pharmaceuticals. 2010.
10. Kircheis, R., et al. Correlation of ADCC activity with cytokine release induced by the stably expressed, glyco-engineered humanized Lewis Y-specific monoclonal antibody MB314. Monoclon. antibodies 4 (2012), 532–541.
11. Li, F., Ravetch, J.V., Inhibitory fcγ receptor engagement drives adjuvant and anti-tumor activities of agonistic CD40 antibodies. Science 333 (2011), 1030–1034.
12. Lowe, P.J., et al. On the anticipation of the human dose in first-in-man trials from preclinical and prior clinical information in early drug development. Xenobiotica 37 (2007), 1331–1354.
13. Mellman, I., et al. Cancer immunotherapy comes of age. Nature 480 (2011), 480–489.
14. Muller, P.Y., Brennan, F.R., Safety assessment and dose selection for first-in-human clinical trials with immunomodulatory monoclonal antibodies. Clin. Pharmacol. Ther. 85 (2009), 247–258.
15. Römer, P.S., et al. Preculture of PBMCs at high cell density increases sensitivity of T-cell responses, revealing cytokine release by CD28 superagonist TGN1412. Blood 118 (2011), 6772–6782.
16. Saber, H., Leighton, J.K., An FDA oncology analysis of antibody-drug conjugates. Regul. Toxicol. Pharmacol. 71 (2015), 444–452.
17. Satoh, M., et al. Non-fucosylated therapeutic antibodies as next-generation therapeutic antibodies. Expert Opin. Biol. Ther. 6 (2006), 1161–1173.
18. Stebbings, R., et al. After TGN1412: recent developments in cytokine release assays. J. Immunotoxicol. 10 (2013), 75–82.
19. Stebbings, R., et al. “Cytokine storm” in the Phase I trial of monoclonal antibody TGN1412: better understanding the causes to improve PreClinical testing of immunotherapeutics. J. Immunol. 179 (2007), 3325–3331.
20. Stopforth, R.J., et al. Regulation of monoclonal antibody immunotherapy by FcγRIIB. J. Clin. Immunol. 36 (2016), 88–94.
21. Suntharalingam, G., et al. Cytokine storm in a Phase 1 trial of the anti-CD28 monoclonal antibody TGN1412. N. Engl. J. Med. 355 (2006), 1018–1028.
22. Vatsan, R.S., et al. Regulation of immunotherapeutic products for cancer and FDA's role in product development and clinical evaluation. J. Immunother. Cancer 1 (2013), 1–16.