Bioanalytical Assays in Support of Tanezumab Developmental and Reproductive Toxicity Studies: Challenges and Learnings

References

• Mantyh PW , KoltzenburgM, MendellLM, TiveL, SheltonDL. Antagonism of nerve growth factor-TrkA signaling and the relief of pain. Anesthesiology115(1), 189–204 (2011).
   PubMed Web of Science ®Google Scholar
• Chang DS , HsuE, HottingerDG, CohenSP. Anti-nerve growth factor in pain management: current evidence. J. Pain Res.9, 373–383 (2016).
   PubMed Web of Science ®Google Scholar
• Abdiche YN , MalashockDS, PonsJ. Probing the binding mechanism and affinity of tanezumab, a recombinant humanized anti-NGF monoclonal antibody, using a repertoire of biosensors. Protein Sci.17(8), 1326–1335 (2008).
   PubMed Web of Science ®Google Scholar
• Lane NE , SchnitzerTJ, BirbaraCAet al. Tanezumab for the treatment of pain from osteoarthritis of the knee. N. Engl. J. Med.363(16), 1521–1531 (2010).
   PubMed Web of Science ®Google Scholar
• Schnitzer TJ , LaneNE, BirbaraC, SmithMD, SimpsonSL, BrownMT. Long-term open-label study of tanezumab for moderate to severe osteoarthritic knee pain. Osteoarthritis Cartilage19(6), 639–646 (2011).
   PubMed Web of Science ®Google Scholar
• Katz N , BorensteinDG, BirbaraCet al. Efficacy and safety of tanezumab in the treatment of chronic low back pain. Pain152(10), 2248–2258 (2011).
   PubMed Web of Science ®Google Scholar
• Brown MT , MurphyFT, RadinDM, DavignonI, SmithMD, WestCR. Tanezumab reduces osteoarthritic knee pain: results of a randomized, double-blind, placebo-controlled Phase III trial. J. Pain13(8), 790–798 (2012).
   PubMed Web of Science ®Google Scholar
• Spierings EL , FidelholtzJ, WolframG, SmithMD, BrownMT, WestCR. A Phase III placebo- and oxycodone-controlled study of tanezumab in adults with osteoarthritis pain of the hip or knee. Pain154(9), 1603–1612 (2013).
   PubMed Web of Science ®Google Scholar
• Brown MT , MurphyFT, RadinDM, DavignonI, SmithMD, WestCR. Tanezumab reduces osteoarthritic hip pain: results of a randomized, double-blind, placebo-controlled Phase III trial. Arthritis Rheum.65(7), 1795–1803 (2013).
   PubMedGoogle Scholar
• Kivitz AJ , GimbelJS, BramsonCet al. Efficacy and safety of tanezumab versus naproxen in the treatment of chronic low back pain. Pain154(7), 1009–1021 (2013).
   PubMed Web of Science ®Google Scholar
• Ekman EF , GimbelJS, BelloAEet al. Efficacy and safety of intravenous tanezumab for the symptomatic treatment of osteoarthritis: two randomized controlled trials versus naproxen. J. Rheumatol.41(11), 2249–2259 (2014).
   PubMed Web of Science ®Google Scholar
• Gimbel JS , KivitzAJ, BramsonCet al. Long-term safety and effectiveness of tanezumab as treatment for chronic low back pain. Pain155(9), 1793–1801 (2014).
   PubMed Web of Science ®Google Scholar
• Schnitzer TJ , EkmanEF, SpieringsELet al. Efficacy and safety of tanezumab monotherapy or combined with non-steroidal anti-inflammatory drugs in the treatment of knee or hip osteoarthritis pain. Ann. Rheum. Dis.74(6), 1202–1211 (2015).
   PubMed Web of Science ®Google Scholar
• US FDA . Assay development and validation for immunogenicity testing of therapeutic protein products: guidance for industry (2018). www.fda.gov/downloads/Drugs/Guidances/UCM192750.pdf
   Google Scholar
• Warnke C , HermanrudC, LundkvistM, Fogdell-HahnA. Antidrug antibodies. Drugs Ther. Studies2(e11), 56–63 (2012).
   Google Scholar
• Bowman CJ , EvansM, CummingsTet al. Developmental toxicity assessment of tanezumab, an anti-nerve growth factor monoclonal antibody, in cynomolgus monkeys (Macaca fascicularis). Reprod. Toxicol.53, 105–118 (2015).
   PubMed Web of Science ®Google Scholar
• Butt M , EvansM, BowmanCJet al. Morphologic, stereologic, and morphometric evaluation of the nervous system in young cynomolgus monkeys (Macaca fascicularis) following maternal administration of tanezumab, a monoclonal antibody to nerve growth factor. Toxicol. Sci.142(2), 463–476 (2014).
   PubMed Web of Science ®Google Scholar
• Ponce R , AbadL, AmaravadiLet al. Immunogenicity of biologically-derived therapeutics: assessment and interpretation of nonclinical safety studies. Regul. Toxicol. Pharmacol.54(2), 164–182 (2009).
   PubMed Web of Science ®Google Scholar
• Ballard O , MorrowAL. Human milk composition: nutrients and bioactive factors. Pediatr. Clin. North Am.60(1), 49–74 (2013).
   PubMed Web of Science ®Google Scholar
• Bauer J , GerssJ. Longitudinal analysis of macronutrients and minerals in human milk produced by mothers of preterm infants. Clin. Nutr.30(2), 215–220 (2011).
   PubMed Web of Science ®Google Scholar
• Kent JC , MitoulasLR, CreganMD, RamsayDT, DohertyDA, HartmannPE. Volume and frequency of breastfeedings and fat content of breast milk throughout the day. Pediatrics117(3), e387–e395 (2006).
   PubMed Web of Science ®Google Scholar
• Uniacke T , FoxPF. Milk: milk of primates. In:Encyclopedia of Dairy Sciences (2nd Edition).FuquayJW, FoxPF, McSweeneyPHL ( Eds). Academic Press, Cambridge, MA, USA, 613–631 (2011).
   Google Scholar
• Song S , YangL, TrepicchioWL, WyantT. Understanding the supersensitive antidrug antibody assay: unexpected high anti-drug antibody incidence and its clinical relevance. J. Immunol. Res. 2016, 3072586 (2016).
   Web of Science ®Google Scholar
• Covaceuszach S , KonarevPV, CassettaAet al. The conundrum of the high-affinity NGF binding site formation unveiled? Biophys. J. 108(3), 687–697 (2015).
   PubMed Web of Science ®Google Scholar
• Neubert H , ClarkTH, DengS, HurstSI. Serum β-nerve growth factor concentrations in pregnant female, nonpregnant female, and male cynomolgus monkeys. Neuroreport25(11), 829–832 (2014).
   PubMed Web of Science ®Google Scholar
• Zhong ZD , Clements-EganA, GorovitsBet al. Drug target interference in immunogenicity assays: recommendations and mitigation strategies. AAPS J.19(6), 1564–1575 (2017).
   PubMed Web of Science ®Google Scholar
• US FDA. Guidance document S6(R1) preclinical safety evaluation of biotechnology-derived pharmaceuticals (2012). www.fda.gov/regulatory-information/search-fda-guidance-documents/s6r1-preclinical-safety-evaluation-biotechnology-derived-pharmaceuticals
   Google Scholar