Publications and Patents
Patents
Twilight Bioscience has filed seven provisional patents on Fc-fusion HERV-K vaccine constructs for the treatment of amyotrophic lateral sclerosis and HERV-K-related disorders. Twilight has also licensed the rights to develop and commercialize all clinical Fc protein vaccine candidates for infectious diseases and neurological disorders from Akston Biosciences, the company which invented the platform. This includes the AKS-452 vaccine for SARS-CoV 2. Twilight holds rights to patents from Akston for developing additional vaccines against exogenous and endogenous pathogens.
Selected Publications
1.TDP-43 proteinopathy in ALS is triggered by loss of ASRGL1 and associated with HML-2 expression. Garcia-Montojo M, Fathi S, Rastegar C, Simula ER, Doucet-O'Hare T, Cheng YHH, Abrams RPM, Pasternack N, Malik N, Bachani M, Disanza B, Maric D, Lee MH, Wang H, Santamaria U, Li W, Sampson K, Lorenzo JR, Sanchez IE, Mezghrani A, Li Y, Sechi LA, Pineda S, Heiman M, Kellis M, Steiner J, Nath A. Nat Commun. 2024 May 16;15(1):4163.
2.Human endogenous retrovirus K contributes to a stem cell niche in glioblastoma. Shah AH, Rivas SR, Doucet-O'Hare TT, Govindarajan V, DeMarino C, Wang T, Ampie L, Zhang Y, Banasavadi-Siddegowda YK, Walbridge S, Maric D, Garcia-Montojo M, Suter RK, Lee MH, Zaghloul KA, Steiner J, Elkahloun AG, Chandar J, Seetharam D, Desgraves J, Li W, Johnson K, Ivan ME, Komotar RJ, Gilbert MR, Heiss JD, Nath A. J Clin Invest. 2023 Jul 3;133(13):e167929.
3.Antibody Response to HML-2 May Be Protective in Amyotrophic Lateral Sclerosis. Garcia-Montojo M, Simula ER, Fathi S, McMahan C, Ghosal A, Berry JD, Cudkowicz M, Elkahloun A, Johnson K, Norato G, Jensen P, James T, Sechi LA, Nath A. Ann Neurol. 2022 Nov;92(5):782-792.
4.Human Endogenous Retrovirus K Envelope in Spinal Fluid of Amyotrophic Lateral Sclerosis Is Toxic. Steiner JP, Bachani M, Malik N, DeMarino C, Li W, Sampson K, Lee MH, Kowalak J, Bhaskar M, Doucet-O'Hare T, Garcia-Montojo M, Cowen M, Smith B, Reoma LB, Medina J, Brunel J, Pierquin J, Charvet B, Perron H, Nath A. Ann Neurol. 2022 Oct;92(4):545-561.
5.Retroviral Elements in Pathophysiology and as Therapeutic Targets for Amyotrophic Lateral Sclerosis. Li W, Pandya D, Pasternack N, Garcia-Montojo M, Henderson L, Kozak CA, Nath A. Neurotherapeutics. 2022 Jul;19(4):1085-1101.
6.SMARCB1 deletion in atypical teratoid rhabdoid tumors results in human endogenous retrovirus K (HML-2) expression. Doucet-O'Hare TT, DiSanza BL, DeMarino C, Atkinson AL, Rosenblum JS, Henderson LJ, Johnson KR, Kowalak J, Garcia-Montojo M, Allen SJ, Orr BA, Santi M, Wang T, Fathi S, Lee MH, Sampson K, Li W, Zhuang Z, Nath A.Sci Rep. 2021 Jun 18;11(1):12893.
7.Inhibition of HERV-K (HML-2) in amyotrophic lateral sclerosis patients on antiretroviral therapy. Garcia-Montojo M, Fathi S, Norato G, Smith BR, Rowe DB, Kiernan MC, Vucic S, Mathers S, van Eijk RPA, Santamaria U, Rogers ML, Malaspina A, Lombardi V, Mehta PR, Westeneng HJ, van den Berg LH, Al-Chalabi A, Gold J, Nath A. J Neurol Sci. 2021 Apr 15;423:117358.
8.Safety and tolerability of Triumeq in amyotrophic lateral sclerosis: the Lighthouse trial. Gold J, Rowe DB, Kiernan MC, Vucic S, Mathers S, van Eijk RPA, Nath A, Garcia Montojo M, Norato G, Santamaria UA, Rogers ML, Malaspina A, Lombardi V, Mehta PR, Westeneng HJ, van den Berg LH, Al-Chalabi A. Amyotroph Lateral Scler Frontotemporal Degener. 2019 Nov;20(7-8):595-604.
9.Technical considerations in detection of HERV-K in amyotrophic lateral sclerosis: selection of controls and the perils of qPCR. Garcia-Montojo M, Li W, Nath A. Acta Neuropathol Commun. 2019 Jul 3;7(1):101
10.Human endogenous retrovirus-K (HML-2): a comprehensive review. Garcia-Montojo M, Doucet-O'Hare T, Henderson L, Nath A. Crit Rev Microbiol. 2018 Nov;44(6):715-738.
11.Safety, tolerability, immunogenicity, and efficacy of UB-311 in participants with mild Alzheimer's disease: a randomised, double-blind, placebo-controlled, phase 2a study. HJ Yu, SP Dickson, PN Wang, MJ Chiu, CC Huang, CC Chang, H Liu, SB Hendrix, JC Dodart, A Verma, CY Wang, J Cummings. EBioMedicine. 2023 Aug;94:104665.
12.Extracellular vesicles for treating neurological disorders. A Verma, T Soos, N Ross, C Mccoy, J Finn, S Sathyanarayanan, S Patel, K Xu, RE McConnell, KP Dooley. Patent App. US17/906,177
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14.Extracellular vesicle-nlrp3 antagonist LIM Joanne, K Kirwin, W Broom, S Sathyanarayanan, A Verma. US Patent App. 17/635,311
15.Immunisation with UB-312 in the Thy1SNCA mouse prevents motor performance deficits and oligomeric α-synuclein accumulation in the brain and gut JT Nimmo, H Smith, CY Wang, JL Teeling, JAR Nicoll, A Verma, ...Acta Neuropathologica 143 (1), 55-73, 2022
16.Novel modification of Luminex assay for characterization of extracellular vesicle populations in biofluids OV Volpert, E Gershun, K Elgart, V Kalia, H Wu, AA Baccarelli, A Verma, E Eren, ...bioRxiv, 2022
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18.Immunotherapy with UB-312 in the Thy1-SNCA mouse improves motor performance and reduces oligomeric α-synuclein in the brain and gut J Nimmo, H Smith, J Teeling, J Nicoll, A Verma, JC Dodart, CY Wang, ...Acta Neuropathologica, 2021
19.Amyloid-β and α-synuclein immunotherapy: from experimental studies to clinical trials JT Nimmo, L Kelly, A Verma, RO Carare, JAR Nicoll, JC Dodart. Frontiers in Neuroscience, 2021
20.Novel antibodies detect additional α-synuclein pathology in synucleinopathies: potential development for immunotherapy JT Nimmo, A Verma, JC Dodart, CY Wang, J Savistchenko, R Melki, ... Alzheimer's Research & Therapy 12 (1), 1-16, 2020
21.New directions in clinical trials for frontotemporal lobar degeneration: Methods and outcome measures AL Boxer, M Gold, H Feldman, BF Boeve, SLJ Dickinson, H Fillit, A Verma, C Ho, ...Alzheimer's & Dementia, 2019
22.A Phase IIA, Randomized, Double-Blind, Placebo-Controlled, 3-ARM Parallel-Group, Multicenter Study with Active Immunotherapeutic Vaccine UB-311 in Patients with Mild Alzheimer … A Verma, HJ Yu, PN Wang, MJ Chiu, CC Huang, CC Chang, HC Chen, ...NEUROTHERAPEUTICS 15 (3), 833-834, 2018
23.Skeletal muscle oxidative capacity in amyotrophic lateral sclerosis TE Ryan, ML Erickson, A Verma, J Chavez, MH Rivner, KK Mccully. Muscle & nerve 50 (5), 767-774, 2014.