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CD70-Targeted Allogeneic CAR T-Cell Therapy for Advanced Clear Cell Renal Cell Carcinoma.
Pal SK, Tran B, Haanen JBAG, Hurwitz ME, Sacher A, Tannir NM, Budde LE, Harrison SJ, Klobuch S, Patel SS, Meza L, Dequeant ML, Ma A, He QA, Williams LM, Keegan A, Gurary EB, Dar H, Karnik S, Guo C, Heath H, Yuen RR, Morrow PK, Agarwal N, Srour SA. Pal SK, et al. Among authors: karnik s. Cancer Discov. 2024 Jul 1;14(7):1176-1189. doi: 10.1158/2159-8290.CD-24-0102. Cancer Discov. 2024. PMID: 38583184 Free PMC article. Clinical Trial.
Safety and activity of CTX130, a CD70-targeted allogeneic CRISPR-Cas9-engineered CAR T-cell therapy, in patients with relapsed or refractory T-cell malignancies (COBALT-LYM): a single-arm, open-label, phase 1, dose-escalation study.
Iyer SP, Sica RA, Ho PJ, Prica A, Zain J, Foss FM, Hu B, Beitinjaneh A, Weng WK, Kim YH, Khodadoust MS, Huen AO, Williams LM, Ma A, Huang E, Ganpule A, Nagar SD, Sripakdeevong P, Cullingford EL, Karnik S, Dequeant ML, Patel JN, He XS, Li Z, He QA, Mendonez JH, Keegan A, Horwitz SM. Iyer SP, et al. Among authors: karnik s. Lancet Oncol. 2024 Nov 28:S1470-2045(24)00508-4. doi: 10.1016/S1470-2045(24)00508-4. Online ahead of print. Lancet Oncol. 2024. PMID: 39617017
Agonist antibody to guanylate cyclase receptor NPR1 regulates vascular tone.
Dunn ME, Kithcart A, Kim JH, Ho AJ, Franklin MC, Romero Hernandez A, de Hoon J, Botermans W, Meyer J, Jin X, Zhang D, Torello J, Jasewicz D, Kamat V, Garnova E, Liu N, Rosconi M, Pan H, Karnik S, Burczynski ME, Zheng W, Rafique A, Nielsen JB, De T, Verweij N, Pandit A, Locke A, Chalasani N, Melander O, Schwantes-An TH; Penn Medicine Biobank; Baras A, Lotta LA, Musser BJ, Mastaitis J, Devalaraja-Narashimha KB, Rankin AJ, Huang T, Herman G, Olson W, Murphy AJ, Yancopoulos GD, Olenchock BA, Morton L. Dunn ME, et al. Among authors: karnik s. Nature. 2024 Sep;633(8030):654-661. doi: 10.1038/s41586-024-07903-1. Epub 2024 Sep 11. Nature. 2024. PMID: 39261724 Free PMC article. Clinical Trial.
Gut microbe-generated phenylacetylglutamine is an endogenous allosteric modulator of β2-adrenergic receptors.
Saha PP, Gogonea V, Sweet W, Mohan ML, Singh KD, Anderson JT, Mallela D, Witherow C, Kar N, Stenson K, Harford T, Fischbach MA, Brown JM, Karnik SS, Moravec CS, DiDonato JA, Naga Prasad SV, Hazen SL. Saha PP, et al. Among authors: karnik ss. Nat Commun. 2024 Aug 6;15(1):6696. doi: 10.1038/s41467-024-50855-3. Nat Commun. 2024. PMID: 39107277 Free PMC article.
Ammonia transporter RhBG initiates downstream signaling and functional responses by activating NFκB.
Mishra S, Welch N, Singh SS, Singh KD, Bellar A, Kumar A, Deutz LN, Hanlon MD, Kant S, Dastidar S, Patel H, Agrawal V, Attaway AH, Musich R, Stark GR, Tedesco FS, Truskey GA, Weiner ID, Karnik SS, Dasarathy S. Mishra S, et al. Among authors: karnik ss. Proc Natl Acad Sci U S A. 2024 Jul 30;121(31):e2314760121. doi: 10.1073/pnas.2314760121. Epub 2024 Jul 25. Proc Natl Acad Sci U S A. 2024. PMID: 39052834
2023 White Paper on Recent Issues in Bioanalysis: Deuterated Drugs; LNP; Tumor/FFPE Biopsy; Targeted Proteomics; Small Molecule Covalent Inhibitors; Chiral Bioanalysis; Remote Regulatory Assessments; Sample Reconciliation/Chain of Custody (PART 1A - Recommendations on Mass Spectrometry, Chromatography, Sample Preparation Latest Developments, Challenges, and Solutions and BMV/Regulated Bioanalysis PART 1B - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV, Biomarkers/IVD/CDx/BAV, Immunogenicity, Gene & Cell Therapy and Vaccine).
Baratta M, Jian W, Hengel S, Kaur S, Cunliffe J, Boer J, Hughes N, Kar S, Kellie J, Kim YJ, Lassman M, Mehl J, Morgan L, Palandra J, Sarvaiya H, Zeng J, Zheng N, Wang J, Yuan L, Ji A, Kochansky C, Tao L, Huang Y, Maes E, Barbero L, Contrepois K, Ferrari L, Fu Y, Johnson J, Jones B, Kansal M, Lu Y, Post N, Shen HH, Xue YY, Zhang YC, Biswas G, Cho SJ, Edmison A, Benson K, Abberley L, Azadeh M, Francis J, Garofolo F, Gupta S, Ivanova ID, Ishii-Watabe A, Karnik S, Kassim S, Kavetska O, Keller S, Kossary E, Li W, McCush F, Mendes DN, Abhari MR, Scheibner K, Sikorski T, Staack RF, Tabler E, Tang H, Wan K, Wang YM, Whale E, Yang L, Zimmer J, Bandukwala A, Du X, Kholmanskikh O, Gijsel SK, Wadhwa M, Xu J, Buoninfante A, Cludts I, Diebold S, Maxfield K, Mayer C, Pedras-Vasconcelos J, Abhari MR, Shubow S, Tanaka Y, Tounekti O, Verthelyi D, Wagner L. Baratta M, et al. Among authors: karnik s. Bioanalysis. 2024;16(9):307-364. doi: 10.1080/17576180.2024.2347153. Epub 2024 May 27. Bioanalysis. 2024. PMID: 38913185
16th GCC Closed Forum: ICH M10 implementation; NGS, qPCR/dPCR, flow cytometry validation; tissue biomarkers; IS response; immunogenicity harmonization; bioanalytical industry status.
Zimmer J, Hays A, Lester T, Diaz M, Thomas E, O'Dell M, Hyer E, Tangri S, Dakappagari N, Yuan M, Lavelle A, Karnik S, Liu A, Xu B, Sales K, Gorityala S, Reynolds G, Sangster T, Franckaert D, Love I, Patel V, Roberge M, Lin J, Jerks E, Xu T, Garofolo W, Nadarajah S, Kernstock R, Dufield D, Ambrose D, Warrino D, Luna M, Marco CD, Tudoroniu A, Iordachescu A, Sanghvi M, Barton H, Brown M, Hoffpauir B, Rocha A, Dong K, Yamashita J. Zimmer J, et al. Among authors: karnik s. Bioanalysis. 2024 Jun 2;16(11):505-517. doi: 10.1080/17576180.2024.2342691. Epub 2024 Jun 12. Bioanalysis. 2024. PMID: 38864397
241 results