A Randomized Phase 1 Safety, Pharmacokinetic and Pharmacodynamic Study of the Novel Myostatin Inhibitor Apitegromab (SRK-015): A Potential Treatment for Spinal Muscular Atrophy von Barrett, Doreen, Bilic, Sanela, Chyung, Yung, Cote, Shaun M., Iarrobino, Ryan, Kacena, Katherine, Kalra, Ashish, Long, Kimberly, Nomikos, George, Place, Amy, Still, James Gordon, Vrishabhendra, Leela

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Spatial transcriptomics reveals discrete tumour microenvironments and autocrine loops within ovarian cancer subclones von Denisenko, Elena, de Kock, Leanne, Tan, Adeline, Beasley, Aaron B., Beilin, Maria, Jones, Matthew E., Hou, Rui, Muirí, Dáithí Ó, Bilic, Sanela, Mohan, G. Raj K. A., Salfinger, Stuart, Fox, Simon, Hmon, Khaing P. W., Yeow, Yen, Kim, Youngmi, John, Rhea, Gilderman, Tami S., Killingbeck, Emily, Gray, Elin S., Cohen, Paul A., Yu, Yu, Forrest, Alistair R. R.

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Bioanalysis of Antibody–Drug Conjugates: American Association of Pharmaceutical Scientists Antibody–Drug Conjugate Working Group Position Paper von Gorovits, Boris, Alley, Stephen C, Bilic, Sanela, Booth, Brian, Kaur, Surinder, Oldfield, Phillip, Purushothama, Shobha, Rao, Chetana, Shord, Stacy, Siguenza, Patricia

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Transcriptomic analysis of patient plasma reveals circulating miR200c as a potential biomarker for high-grade serous ovarian cancer von Hannan, Natalie J., Cohen, Paul A., Beard, Sally, Bilic, Sanela, Zhang, Bonnie, Tong, Stephen, Whitehead, Clare, Hui, Lisa

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801 PRIME™ IL-15 (RPTR-147): Preliminary clinical results and biomarker analysis from a first-in-human Phase 1 study of IL-15 loaded peripherally-derived autologous T cell therapy... von Hamilton, Erika, Nikiforow, Sarah, Bardwell, Philip, McInnis, Christine, Zhang, Jeffrey, Blumenschein, George, Cristea, Mihaela, Osman, Keren, Shields, Anthony, Motta, Marlyane, Bilic, Sanela, Schoenborn-Kellenberger, Oliver, Rakestraw, James, Carey, Shawn, Geretti, Elena, Sauer, Karsten, Harris, Tim, Maniar, Tap, Hewes, Becker, Andresen, Thomas, Fitzgerald, Jonathan, Kluger, Harriet

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Whole–genome characterization of chemoresistant ovarian cancer von Patch, Ann-Marie, Christie, Elizabeth L., Etemadmoghadam, Dariush, Garsed, Dale W., George, Joshy, Fereday, Sian, Nones, Katia, Cowin, Prue, Alsop, Kathryn, Bailey, Peter J., Kassahn, Karin S., Newell, Felicity, Quinn, Michael C. J., Kazakoff, Stephen, Quek, Kelly, Wilhelm-Benartzi, Charlotte, Curry, Ed, Leong, Huei San, Hamilton, Anne, Mileshkin, Linda, Au-Yeung, George, Kennedy, Catherine, Hung, Jillian, Chiew, Yoke-Eng, Harnett, Paul, Friedlander, Michael, Quinn, Michael, Pyman, Jan, Cordner, Stephen, O’Brien, Patricia, Leditschke, Jodie, Young, Greg, Strachan, Kate, Waring, Paul, Azar, Walid, Mitchell, Chris, Traficante, Nadia, Hendley, Joy, Thorne, Heather, Shackleton, Mark, Miller, David K., Arnau, Gisela Mir, Tothill, Richard W., Holloway, Timothy P., Semple, Timothy, Harliwong, Ivon, Nourse, Craig, Nourbakhsh, Ehsan, Manning, Suzanne, Idrisoglu, Senel, Bruxner, Timothy J. C., Christ, Angelika N., Poudel, Barsha, Holmes, Oliver, Anderson, Matthew, Leonard, Conrad, Lonie, Andrew, Hall, Nathan, Wood, Scott, Taylor, Darrin F., Xu, Qinying, Fink, J. Lynn, Waddell, Nick, Drapkin, Ronny, Stronach, Euan, Gabra, Hani, Brown, Robert, Jewell, Andrea, Nagaraj, Shivashankar H., Markham, Emma, Wilson, Peter J., Ellul, Jason, McNally, Orla, Doyle, Maria A., Vedururu, Ravikiran, Stewart, Collin, Lengyel, Ernst, Pearson, John V., Waddell, Nicola, deFazio, Anna, Grimmond, Sean M., Bowtell, David D. L.

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Clinical Pharmacology Tools and Evaluations to Facilitate Comprehensive Dose Finding in Oncology: A Continuous Risk‐Benefit Approach von Bullock, Julie M., Lin, Tiffany, Bilic, Sanela

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A Phase IB multicentre dose‐determination study of BHQ880 in combination with anti‐myeloma therapy and zoledronic acid in patients with relapsed or refractory multiple myeloma and... von Iyer, Swaminathan P., Beck, Joseph Taddeus, Stewart, A. Keith, Shah, Jatin, Kelly, Kevin R., Isaacs, Randi, Bilic, Sanela, Sen, Suman, Munshi, Nikhil C.

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Unexpected hepatotoxicity in a phase I study of TAS266, a novel tetravalent agonistic Nanobody® targeting the DR5 receptor von Papadopoulos, Kyriakos P., Isaacs, Randi, Bilic, Sanela, Kentsch, Kerstin, Huet, Heather A., Hofmann, Matthias, Rasco, Drew, Kundamal, Nicole, Tang, Zhongwhen, Cooksey, Jennifer, Mahipal, Amit

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Prognostic gene expression signature for high-grade serous ovarian cancer von Intermaggio, M.P., Leong, H.S., Chen, S., Elatre, W., Gilks, B., Volchek, M., Wang, C., Mackenzie, R., George, J., Bowtell, D., Chenevix-Trench, G., Green, A., Gertig, D., Fereday, S., Moore, S., Hung, J., Harrap, K., Malt, M., Robertson, R., Maidens, J., Jayde, V., Mamers, P., Schmidt, T., Ball, C., Bilic, Sanela, Stuart-Harris, R., Clingan, P., Glasgow, A., Shannon, J., Young, B., Robertson, G., Carter, J., Dalrymple, C., Russell, P., Links, M., Jaworski, R., Crandon, A., Horwood, K., Obermair, A., Wyld, D., Davy, M., Dodd, T., Healy, T., Pittman, K., Henderson, D., Pierdes, J., Brown, B., Hyde, S., Healy, D., McNealage, J., Simpson, I., Fox, S., Lade, S., Loughrey, M., Neesham, D., Bell, R., Ng, L.F., Whiteman, D., Fereday, S., Steed, H., Koziak, J.M., Goranova, T., Silva De Silva, D., Ramón y Cajal, T., García-Donas, J., Rodriguez, G.C., Harris, H.R., Greene, C.S., Zelaya, R.A., Sinn, P., Menkiszak, J., Pearce, C.L., Rhenius, V., Piskorz, A.M., Sharma, R., Johnatty, S.E., Larson, M.C., Luk, H., Hernandez, B.Y., Thompson, P.J., Sherman, M.E., Bodelon, C., Lewsley, L.A., Banerjee, S.N., Stronach, E.A., Haluska, P., Ray-Coquard, I., Winterhoff, B., Slamon, D., Levine, D.A., Menon, U., Goodman, M.T., Schildkraut, J.M., Brown, R., Berchuck, A., Chenevix-Trench, G., deFazio, A., Beeghly-Fadiel, A., Fasching, P.A., Orsulic, S.

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Apitegromab in Spinal Muscular Atrophy (SMA): An Analysis of Multiple Efficacy Endpoints in the TOPAZ Trial (P15-5.005) von Crawford, Thomas, Darras, Basil, Day, John, Song, Guochen, Nomikos, George, Place, Amy, Barrett, Doreen, Bilic, Sanela, O‘Neil, Janet, Kertesz, Nathalie, Cote, Shaun, Patel, Jagdish, Chyung, Yung

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Nonclinical Development of SRK-181: An Anti-Latent TGF beta 1 Monoclonal Antibody for the Treatment of Locally Advanced or Metastatic Solid Tumors von Welsh, Brian T., Faucette, Ryan, Bilic, Sanela, Martin, Constance J., Schurpf, Thomas, Chen, David, Nicholls, Samantha, Lansita, Janice, Kalra, Ashish

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Initial results of dose finding in a first-in-human phase 1 study of a novel Claudin 6 (CLDN6) targeted antibody drug conjugate (ADC) TORL-1-23 in patients with advanced solid tumo... von Konecny, Gottfried E., Wahner Hendrickson, Andrea Elisabeth, Winterhoff, Boris, Chander, Cinthiya, Bilic, Sanela, Davenport, Simon, Chung, Adrine, Miller, Lei-Lani, Press, Michael F., Letrent, Stephen P., Slamon, Dennis J.

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Safety and Efficacy of Apitegromab in Patients With Spinal Muscular Atrophy Types 2 and 3: The Phase 2 TOPAZ Study von Crawford, Thomas O, Darras, Basil T, Day, John W, Dunaway Young, Sally, Duong, Tina, Nelson, Leslie L, Barrett, Doreen, Song, Guochen, Bilic, Sanela, Cote, Shaun, Sadanowicz, Mara, Iarrobino, Ryan, Xu, Tiina J, O'Neil, Janet, Rossello, José, Place, Amy, Kertesz, Nathalie, Nomikos, George, Chyung, Yung

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A phase 1 trial of the bifunctional EGFR/TGFβ fusion protein BCA101 alone and in combination with pembrolizumab in patients with advanced solid tumors von Bedard, Philippe L., Hernando-Calvo, Alberto, Carvajal, Richard D., Morris, Van K., Paik, Paul K., Zandberg, Dan Paul, Kaczmar, John M., Niculescu, Liviu, Bohr, David, Reiners, Ralf, Gharakhani, Elham, Salazar, Rachel, Bilic, Sanela, Hanna, Glenn J.

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Conference Report: Hot Topics in Antibody–Drug Conjugate Development von Thudium, Karen, Bilic, Sanela

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First-in-human phase I study of the bifunctional EGFR/TGF β fusion protein BCA101 in patients with EGFR-driven advanced solid cancers von Janku, Filip, Hanna, Glenn J., Carvajal, Richard D., Paik, Paul K., Hernando-Calvo, Alberto, Gillison, Maura L., Fu, Siqing, Wheler, Jennifer J., Bohr, David, Reiners, Ralf, Tan, Seng-Lai, Bilic, Sanela, Bedard, Philippe L.

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Drug-regulated CD33-targeted CAR T cells control AML using clinically optimized rapamycin dosing von Appelbaum, Jacob, Price, April E, Oda, Kaori, Zhang, Joy, Leung, Wai-Hang, Tampella, Giacomo, Xia, Dong, So, Pauline Pl, Hilton, Sarah K, Evandy, Claudya, Sarkar, Semanti, Martin, Unja, Krostag, Anne-Rachel, Leonardi, Marissa, Zak, Daniel E, Logan, Rachael, Lewis, Paula, Franke-Welch, Secil, Ngwenyama, Njabulo, Fitzgerald, Michael, Tulberg, Niklas, Rawlings-Rhea, Stephanie, Gardner, Rebecca A, Jones, Kyle, Sanabria, Angelica, Crago, William, Timmer, John, Hollands, Andrew, Eckelman, Brendan, Bilic, Sanela, Woodworth, Jim, Lamble, Adam, Gregory, Philip D, Jarjour, Jordan, Pogson, Mark, Gustafson, Joshua A, Astrakhan, Alexander, Jensen, Michael C

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Clinical Translation of SC-DARIC33: A Pharmacologically Controlled CD33-Targeted Anti-AML CAR T Cell Product Regulated By Low Nanomolar Concentrations of Rapamycin von Appelbaum, Jacob S., Price, April, Zhang, Joy, Oda, Kaori, Sundaram, Sumati, Lewis, Paula, Bilic, Sanela, Tampella, Giacomo, Xia, Dong, Krostag, Anne-Rachel, So, Pauline, Martin, Unja, Leung, Wai-Hang, Astrakhan, Alexander, Pogson, Mark, Jarjour, Jordan, Gustafson, Josh, Jensen, Michael CV

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A Phase 1 Study of CFT7455, a Novel Degrader of IKZF1/3, in Multiple Myeloma and Non-Hodgkin Lymphoma von Berdeja, Jesus, Ailawadhi, Sikander, Horwitz, Steven M., Matous, Jeffrey V., Mehta-Shah, Neha, Martin, Thomas, Muchtar, Eli, Richardson, Paul G., Richard, Shambavi, Bhutani, Manisha, Yee, Andrew J., Palmer, Michael R., Gorman, Cathleen, Schoenborn-Kellenberger, Oliver, Bilic, Sanela, Crystal, Adam, Mahler, Michelle, Lonial, Sagar

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