A	B	C
1	Main
2		Brand	AAB-001, fka ELN115727
3		Generic	bapineuzumab
4		MOA	N-terminal specific for first 5 AA. Murine form binds fibrillar, oligomeric and monomeric forms. h3D6 antibody name, 1mg/kg was required to 'produce significant increase in synaptophysin, a marker of synaptic integrity' in mouse studies
5			3-5nM for AB, binds soluble AB. 89nM for AB40, biotinylated AB reduces affinity.
6		History	AAB-003 derivative reduces FC effector function went through FIH. Anti-ab murine 3D6.
7		Sequences	Light chain MESQTQVLMSLLFWVSGTCGYVVMTQSPLSLPVTPGEPASISCKSSQSLLDSDGKTYLNWLLQKPGQSPQRLIYLVSKLDSGVPDRFSGSGSGTDFTLKISRVEAEDVGVYYCWQGTHFPRTFGQGTKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
8			Heavy chain MGWSWIFLFLVSGTGGVLSEVQLLESGGGLVQPGGSLRLSCAASGFTFSNYGMSWVRQAPGKGLEWVASIRSGGGRTYYSDNVKGRFTISRDNAKNSLYLQMNSLRAEDTALYYCVRYDHYSGSSDYWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGGTAALGCLVKDYFPQPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCHHHHHH
9		Clinical Trials
10			Phase III "301" n=1121 mild-to-moderate Alzheimer's without APOE4 - NCT00575055 - NEJM 2014
11			placebo IV vs. 0.5mg/kg vs 1.0mg/kg vs. 2.0mg/kg?
12			Inclusion: MMSE 16-26
13			PE: Adas-Cog, DAD
14			ADAS-COG +7.1 (0.5mg/kg), +7.8 (+1.0mg/kg) vs. +7.4 for placebo
15
16
17			Phase III "302" n=1331 mild-to-moderate Alzheimer's with APOE4 - NCT00574132 - NEJM 2014
18			placebo IV vs. 0.5mg/kg
19			Inclusion: MMSE 16-26
20			PE: Adas-Cog, DAD
21			ADAS-COG +8.5 vs. +8.7 for placebo
22
23
24			Phase III "3001" carriers n=1100 cancelled - NCT00676143
25			Placebo+BAP 12.44 vs. BAP+BAP +10.38 in extension study with 0.5mg/kg dose
26			Placebo+BAP 10.52 vs. BAP+BAP +10.31 in extension study with 1.0mg/kg dose
27
28			Phase III "3000" non-carriers n=901 cancelled - NCT00667810
29			10.12 vs 10.11 in carrier study 3003 (extension)
30
31		Literature
32			Crespi et al. showed AA1-8 and 1-28 XRC. PDB: 4HIX, 4OJF
33
34
35
36
37		Literature
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57
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67		Magnetic Resonance Imaging and Spectroscopy. NMR Biomed. 2020 May;33(5):e4263.
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69
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78
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81		Spatial Memory in Young 3xTg-AD Mice by Reducing the Intracellular Amyloid-β
82		Burden. J Alzheimers Dis. 2019;70(4):1069-1091. doi: 10.3233/JAD-190484. PMID:
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86		mechanism of action of an efficient anti-Aβ single chain antibody fragment. PLoS
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107		Detection of amyloid β oligomers toward early diagnosis of Alzheimer's disease.
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119		Open-Label Extension Study. Curr Alzheimer Res. 2018;15(13):1231-1243. doi:
120		10.2174/1567205015666180821114813. PMID: 30129411.
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124		and apoJ mimetic peptides on the action of an anti-Aβ scFv in 3xTg-AD mice.
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127
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130		paradigm to assess potential anti-Aβ antibodies for Alzheimer's disease. Nat
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133
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135		Subcutaneous Bapineuzumab: A Single-Ascending-Dose Study in Patients With Mild
136		to Moderate Alzheimer Disease. Clin Pharmacol Drug Dev. 2019 Apr;8(3):326-335.
137		doi: 10.1002/cpdd.584. Epub 2018 Jun 19. PMID: 29920980.
138
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141		Follow Up of Patients with Mild-to-Moderate Alzheimer's Disease Treated with
142		Bapineuzumab in a Phase III, Open-Label, Extension Study. J Alzheimers Dis.
143		2018;64(3):689-707. doi: 10.3233/JAD-171157. PMID: 29914022.
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157		astrocytes are precluded by an anti-Aβ single chain variable fragment in
158		combination with an apoE mimetic peptide. Mol Cell Neurosci. 2018 Jun;89:49-59.
159		doi: 10.1016/j.mcn.2018.03.015. Epub 2018 Apr 3. PMID: 29625180.
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164
165		34: Liu E, Wang D, Sperling R, Salloway S, Fox NC, Blennow K, Scheltens P,
166		Schmidt ME, Streffer J, Novak G, Einstein S, Booth K, Ketter N, Brashear HR;
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168		in phase 3 randomized clinical trials with bapineuzumab. Neurology. 2018 Mar
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176
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180		Induced by Human CSF. Cell Rep. 2017 Dec 12;21(11):3310-3316. doi:
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186
187		38: Martens RM, Bechten A, Ingala S, van Schijndel RA, Machado VB, de Jong MC,
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189		of subtraction MRI in detection of amyloid-related imaging abnormalities with
190		oedema or effusion in Alzheimer's patients: An interobserver study. Eur Radiol.
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192		PMID: 28956123; PMCID: PMC5811582.
193
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196		Accumulation in Advanced Aged Tg2576-AβPPswe Mice Without Inducing
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201		improvement in stability of an anti-Aβ single-chain variable fragment,
202		scFv-h3D6, as a way to enhance its therapeutic potential. Amyloid. 2017
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205
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208		randomized controlled trials. BMC Neurol. 2017 Apr 4;17(1):66. doi:
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210
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213		Phase III Clinical Trials of Bapineuzumab in Mild-To-Moderate Alzheimer's
214		Disease Patients. J Alzheimers Dis. 2017;57(2):557-573. doi: 10.3233/JAD-160216.
215		PMID: 28269765.
216
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220		Bapineuzumab in Patients with mild to moderate Alzheimer's disease. J Alzheimers
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225		tolerability of bapineuzumab in patients with Alzheimer's disease in two phase 3
226		extension studies. Alzheimers Res Ther. 2016 Jun 23;8(1):24. doi:
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228
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230		of disease modifying therapies in Alzheimer's disease suggesting a new
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233
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236		I, Booth K, Luscan G, Wyman BT, Hua L, Yang L, Brashear HR, Black RS;
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238		to moderate Alzheimer's disease in two global, randomized, phase 3 trials.
239		Alzheimers Res Ther. 2016 May 12;8(1):18. doi: 10.1186/s13195-016-0189-7. PMID:
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241
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244		Moderate Alzheimer's Disease Trials of Bapineuzumab. J Alzheimers Dis. 2016 May
245		3;53(2):535-46. doi: 10.3233/JAD-151065. PMID: 27163805.
246
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250
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252		S, Kupiec JW. First-In-Human safety and long-term exposure data for AAB-003
253		(PF-05236812) and biomarkers after intravenous infusions of escalating doses in
254		patients with mild to moderate Alzheimer's disease. Alzheimers Res Ther. 2016
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256		PMC4772335.
257
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262
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265		Volume with Bapineuzumab in Mild to Moderate Alzheimer's Disease. J Alzheimers
266		Dis. 2016;49(4):1123-34. doi: 10.3233/JAD-150448. PMID: 26639957.
267
268		53: Bouter Y, Lopez Noguerola JS, Tucholla P, Crespi GA, Parker MW, Wiltfang J,
269		Miles LA, Bayer TA. Abeta targets of the biosimilar antibodies of Bapineuzumab,
270		Crenezumab, Solanezumab in comparison to an antibody against N‑truncated Abeta
271		in sporadic Alzheimer disease cases and mouse models. Acta Neuropathol. 2015
272		Nov;130(5):713-29. doi: 10.1007/s00401-015-1489-x. PMID: 26467270.
273
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275		Brashear HR, Styren S, Hu C. Alzheimer's disease assessment scale-cognitive
276		11-item progression model in mild-to-moderate Alzheimer's disease trials of
277		bapineuzumab. Alzheimers Dement (N Y). 2015 Oct 9;1(3):157-169. doi:
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279
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