美国称中国南海岛礁年底竣工 导弹已瞄准(1)-海外视角
Vivek Subbiah, Chief of Early-Phase Drug Development at the Sarah Cannon Research Institute (USA), shared a post on X:
“By popular demand, I’m pleased to share the top Phase 1 clinical trial publications of 2024!
These papers highlight the incredible bench to bedside progress and innovation in early-phase drug development.
I invite you to join the conversation by adding your favorite early phase papers to this X.
Together, let’s celebrate these significant advances in our field and look forward to groundbreaking developments in drug discovery in 2025!
1. Inhibition of lysine acetyltransferase KAT6 in ER+HER2? metastatic breast cancer: a phase 1 trial.
Epigenetic targeting in solid tumors finally successful!
HDAC inhibitors have shown limited success before in the treatment of solid tumors owing to a lack of cancer specificity or satisfactory therapeutic window. KAT6 works!!!
Inhibition of lysine acetyltransferase KAT6 in ER+HER2? metastatic breast cancer: a phase 1 trial.
Authors: Toru Mukohara, Yeon Hee Park, David Sommerhalder, Kan Yonemori, Erika Hamilton, Sung-Bae Kim, Jee Hyun Kim, Hiroji Iwata, Toshinari Yamashita, Rachel M. Layman, Monica Mita, Timothy Clay, Yee Soo Chae, Catherine Oakman, Fengting Yan, Gun Min Kim, Seock-Ah Im, Geoffrey J. Lindeman, Hope S. Rugo, Marlon Liyanage, Michelle Saul, Christophe Le Corre, Athanasia Skoura, Li Liu, Meng Li and Patricia M. LoRusso.
2. Results From First-in-Human Phase I Dose-Escalation Study of a Novel Bicycle Toxin Conjugate Targeting EphA2 (BT5528) in Patients With Advanced Solid Tumors.
BT5528 is a Bicycle Toxin Conjugate, a novel class of chemically synthesized molecules, comprising a bicyclic peptide targeting EphA2 tumor antigen, linked to a cytotoxin (monomethyl auristatin E [MMAE]).
EphA2 is overexpressed in many solid tumors and contributes to oncogenesis, tumor-associated angiogenesis, and metastasis.
Authors: Babar Bashir, Judy S. Wang, Gerald Falchook, Elisa Fontana, Hendrik-Tobias Arkenau, Louise Carter, Rachel Galot, Bristi Basu, Alastair Greystoke, Vivek Subbiah, Debra L. Richardson, Hanna Orr, Gavin Bennett, Rajiv Sharma, Hongmei Xu, Paola Paganoni, Cong Xu, Carly Campbell, Meredith McKean.
3. Intrathecal bivalent CAR T cells targeting EGFR and IL13Rα2 in recurrent glioblastoma: phase 1 trial interim results.
Car-T cells shows early signals in glioblastoma.
Authors: Stephen J. Bagley, Meghan Logun, Joseph A. Fraietta, Xin Wang, Arati S. Desai, Linda J. Bagley, Ali Nabavizadeh, Danuta Jarocha, Rene Martins, Eileen Maloney, Lester Lledo, Carly Stein, Amy Marshall, Rachel Leskowitz, Julie K. Jadlowsky, Shannon Christensen, Bike Su Oner, Gabriela Plesa, Andrea Brennan, Vanessa Gonzalez, Fang Chen, Yusha Sun, Whitney Gladney, David Barrett, MacLean P. Nasrallah, Wei-Ting Hwang, Guo-Li Ming, Hongjun Song, Donald L. Siegel, Carl H. June, Elizabeth O. Hexner, Zev A. Binder Donald M. O’Rourke.
4. MYC targeting by OMO-103 in solid tumors: a phase 1 trial.
MYC remained an elusive target in cancer biology for decades.
First successful phase?1 clinical trial validating the safety and tolerability of a first-in-modality direct MYC inhibitor.
MYC targeting by OMO-103 in solid tumors: a phase 1 trial.
Authors: Elena Garralda, Marie-Eve Beaulieu, Víctor Moreno, Sílvia Casacuberta-Serra, Sandra Martínez-Martín, Laia Foradada, Guzman Alonso, Daniel Massó-Vallés, Sergio López-Estévez, Toni Jauset, Elena Corral de la Fuente, Bernard Doger, Tatiana Hernández, Raquel Perez-Lopez, Oriol Arqués, Virginia Castillo Cano, Josefa Morales, Jonathan R. Whitfield, Manuela Niewel, Laura Soucek, Emiliano Calvo
5. Menin Inhibition With Revumenib for KMT2A-Rearranged Relapsed or Refractory Acute Leukemia (AUGMENT-101).
Revumenib Revises the Treatment Landscape for KMT2A-r Leukemia.”
Authors: Ghayas C. Issa, Ibrahim Aldoss, Michael J. Thirman, John DiPersio, Martha Arellano, James S. Blachly, Gabriel N. Mannis, Alexander Perl, David S. Dickens, Christine M. McMahon, Elie Traer, C. Michel Zwaan, Carolyn S. Grove, Richard Stone, Paul J. Shami, Ioannis Mantzaris, Matthew Greenwood, Neerav Shukla, Branko Cuglievan, Tibor Kovacsovics, Yu Gu, Rebecca G. Bagley, Kate Madigan, Yakov Chudnovsky, Huy Van Nguyen, Nicole McNeer, Eytan M. Stein
Vivek Subbiah is the Chief of Early-Phase Drug Development at the Sarah Cannon Research Institute (USA). He is the former Executive Director of Oncology Research and former Associate Professor in the Department of Investigational Cancer Therapeutics at the MD Anderson Cancer. He focuses on translational cancer research and the design and implementation of early-phase biomarker-driven clinical trials. His work specifically targets antibody-drug conjugates, radiopharmaceuticals, immunoconjugates, and basket trials. He has also received the Yvonne Award 2024 by OncoDaily in the “Voice of Oncology” category.
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