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1. Guidance on mucositis assessment from the MASCC Mucositis Study Group and ISOO: an international Delphi studyResearch in context

Author

Ragda Abdalla-Aslan, Pierluigi Bonomo, Dorothy Keefe, Nicole Blijlevens, Katrina Cao, Yin Ting Cheung, Eduardo Rodrigues Fregnani, Robert Miller, Judith Raber-Durlacher, Joel Epstein, Ysabella Van Sebille, Elisa Kauark-Fontes, Abhishek Kandwal, Emma McCurdy-Franks, Joel Finkelstein, Victoria McCarvell, Yehuda Zadik, Giulia Ottaviani, Rui Amaral Mendes, Caroline Margina Speksnijder, Hannah Rose Wardill, Paolo Bossi, Alexa Laheij, Arghavan Tonkaboni, Jacqui Scott, Rania Abasaeed, Adel Kauzman, Adriana Do Socorro Lima Flato, Adwaita Gore, Anne-Marie Hardman, Agnes Horvath, Allan Hovan, Aisha Al-Jamaei, Aya koizumi, Alan Santos-Silva, Alessandra Majorana, Alexandre Giannini, Aléxia Teixeira, Muhammad Ali Shazib, Alison Melvin, Aluísio Miranda Filho, Amanda Gruza, Amber Brown-Dahl, Amit Harilall, Amr El Maghrabi, Ana Andabak Rogulj, Ana Raphaela Curvo, Ana Laura Soares, Andrea Stringer, Andréa Moreira, Andy Kurtzweil, Angelyn Salaberry, Anne Blazy, Anne Margrete Gussgard, Anne Marie Lynge Pedersen, Annette Freidank, Anura Ariyawardana, Adrian Ramseier, Jann Arends, Ariel Blanchard, Adriana Sesti Paz, Angela Thermann, Augusto Poropat, Azael Freites-Martinez, Abdul Rahman Al-Azri, Bente Brokstad Herlofson, Sitaraman BalajiSubramanian, Barbara Ballantyne, Kivanc Bektas-Kayhan, Bengt Hasséus, Benjamin Kaffenberger, Bernar Benites, Bernice Kwong, Beth Test, Fernando Chiantia, Bo Pettersson, Bomi Framroze, Božana Lončar Brzak, Brittany Dulmage, Sorin Buga, Caroline Spekssnijder, Carlton Brown, Antonio Carlos Moura de Melo, Ana Carolina Ribeiro, Caroline Silva, Caroline Fulop, Carryn Anderson, Catherine Flaitz, Cathy Massoud, Cesar Migliorati, Callie Gross, Chiara Gandini, Charles Loprinzi, Charlotte de Mooij, Catherine Hong, Ying Chu Choi, Maria Choy, Christine Boers-Doets, Leonard Schmeel, Cibele Nagano, Maria Coeli Franco, Courtney Subramaniam, Carolyn Patrick, Catherine Poh, Cristina Neuenschwander, Cesar Virgen, Dorothea Riesenbeck, Dale Weaver, Daniel Cohen Goldemberg, Daniel Sundaresan, Daniela Nunes, Danyel Perez, Daphine Travassos, David Yang, Daniela Ribeiro, Dean Kolbinson, Deborah Buick, Deborah Saunders, Juliane De Bortolli, Deepika Chugh, Denise Markstrom, Denise Travassos, Dianna Weikel, Dimitra Galiti, Dinusha Peiris, Fedja Djordjevic, Pankaj Singhai, Douglas Peterson, Douglas Fonseca, Doreen Pon, Iuliia Kovalenko, Aleksandra Polonskaia, Rogério Caldas, Kevin Saganski, Julia Néri, Dennis Abbott, Abhijna Vithal Yergolkar, Cristina Del Conte, Januaria Passos, Katia Uezu, Paula Silva, Steven Gilbert, Keng Yeoh, Kunal Jain, Madhup Rastogi, Satheeshkumar Poolakkad Sankaran, Deborah Manne, Evgeniya Shatokhina, Esther Adebayo-Olojo, Eszter Somogyi-Ganss, Eli Ehrenpreis, Wilber Bernaola-Paredes, Eduardo Fregnani, Elaci Cardoso, Elena Bardellini, Eleni Arvanitou, Elisa Kauark Fontes, Elise Bruning, Eloise Neumann, Elsa Madureira, Marcia Ramires, Erofili Papadopoulou, Etiene Munhoz, Fred Spijkervet, Fabiana Granzotto, Fabiana Martins, Fabio Alves, Farah Mougeot, Federica Aielli, Fernanda Pigatti, Fernanda Fonseca, Firoozeh Samim, Flavia Carvalho, Florence Cuadra Zelaya, Cesar Freytes, Gabriela da Silveira, Gabriela Torino, Gabriela Martins, Geisa Silva, Gemma Caro, Gemma Bryan, Georgette Radford, Ghanyah Al-Qadami, Giorgia Albini, Gisele Mainville, Georgios Gkardiakos, Gleidston Potter, Gulbin Hoeberechts, Gordon Howarth, Grace Bradley, Gunjan Verma, Gustavo dos Santos, Margaret Randles-Guzzardi, Hanlie Engelbrecht, Hannah Wardill, Heidi Hansen, Iquebal Hasan, Hironobu Hata, Helena Ullgren, Heliton Spindola Antunes, Heloísa Laís dos Santos, Howard Weld, Helen McInnes, Hans Peter Jungbluth, Hsiaofen Weng, Ian Hewson, Ingrid Santos, Jorge Illarramendi, Ines Semendric, Rol Menge, Inger Von Bultzingslowen, Maria da Gloria de Melo, Iona Leong, Isabella Fonseca, Isadora Kalif, James Carroll, Janet Coller, Johann Beck-Mannagetta, Joanne Bowen, Jose Meurer, Ricky McCullough, Jennifer Powers, Jesus Gomez, Jimma Lenjisa, jaya Vangara, Jasna Leko, Jane Fall-Dickson, Jean-Luc Mougeot, Joan Fox, Jolien Robijns, Jonn Wu, Patricio Palma, Jaya Amaram-Davila, Jim Siderov, Juliana Dantas, Juliana Jasper, Juliana Monteiro, Julia Bruno, julie pfeffer, Julija Jovanovic Ristivojevic, Juliana Brito, Jyothsna Kuriakose, Yuji Kabasawa, Kanan Dave, Karin Barczyszyn, Karol Sartori Lima, Kate Secombe, Kate White, Kate Cooper, Kouji Katsura, Karen Biggs, Katharine Ciarrocca, Kristopher Dennis, Ken Tomizuka, Kevin Hendler, Ikuko Komo, Kristina Skallsjö, Kristy Hodgins, Katia Rupel, Keiko Tanaka, Seema Kurup, Luiz Gueiros, Larissa Agatti, Laura Garzona-Navas, Letícia Guerra, Leila Portela, Leilani Iossi, Linda Elting, Lene Baad-Hansen, Leslie Reeder, Leticia Lang, Liciane Menezes, Liliana Braun, Liliane Grando, Mathew Lim, Lina Fernandez, Lucy McKeage, Luana Campos, Luciana Simonato, Luciana Muniz, Leah van Draanen, Mieko Mizutani, Tsai-Wei Huang, Mahfujul Riad, Mahnoor Nazar, Maíra Souza, Mariana Minamisako, Manoela Pereira, Carlos Mantelato, Márcio Diniz-Freitas, Marco Montezuma, Marco Andrade, Marcos Santos, Margherita Gobbo, Maria Caterina Fortuna, Mariana Vitor, Joana Marinho, Alina Markova, Marlyse Knuchel, Marta Carlesimo, Marta Neves, Andrew Mazar, Maria Cristina Gomez Amarilla, Mark Chambers, Melissa de Araujo, Alexandre Melo, Melody Cole, Mohamed Elsayed, Monica Fliedner, Martin Hauer-Jensen, Micaela Bouchacourt, Michael Brennan, Michael Thirlwell, Michio Nakamura, Midori Nakagaki, Camila Rossi, Mireille Kaprilian, Michael Kase, Michael Dougan, Monique Stokman, Ragnhild Monsen, Alisha Morgan, Jocelyn Harding, Maryam Taleghani, Marie-Therese Genot, Mukund Seshadri, Brian Muzyka, Nancy Batista, Nancy Gadd, Naoko Tanda, Narmin Nasr, Natália Garcia, Nathan Lee, Natalia Palmier, Norman Brito-Dellan, Nancy Corbitt, Neli Pieralisi, Verônica Serrano, Nicola Alessandro Iacovelli, Norma Lúcia Sampaio, Nour Karra, Niveditha Venkatesh, Noam Yarom, Renata Cristina Borin, Olivia Lemenchick, Ondina Mendes, Ourania Nicolatou-Galitis, Vasiliy Shchitka, Paula Reis, Paulo Sérgio Santos, Paz Fernandez-Ortega, Ira Parker, Raquel García, Peter Fritz, Edmund Peters, Pamela Gardner, Pierre Saint Girons, Priya Tiwari, Pravin Chaturvedi, Tais de Moraes, Priscila Andrade, Raj Nair, Rachel Gibson, Rachita Gururaj, Raghu Thota, Rajesh Lalla, Raquel Almeida Prado, Ravikiran Ongole, George Taybos, Regina Mackey, Renata Rego, Renata Camilotti, Renata Ferrari, Renato Junior, Rene-Jean Bensadoun, Richard Logan, Roberta Sales, Roberta Zanicotti, Roberta Tunes, Rodolfo Mauceri, Rosiene Feitoza, Kathryn Ruddy, Cynthia Rybczyk, Stephanie Trager, Sachiyo Mitsunaga, Sahani Gunathilake, Rajan Saini, Viola Salvestrini, Sandip Mukhopadhyay, Sandrina Angeloz, Pramod Sankar S, Luciana S Barbosa Barbosa, Elena Volkova, Sharon Elad, Sergio Cantoreggi, Sharon Gordon, Shelly Brown, Shu Yie Janine Tam, Sibelle Faleiro, Silmara da Silva, Silvia de Oliveira, Siri Beier Jensen, Ivana Skrinjar, Sophie Beaumont, Felipe Sperandio, Sandra Reese, Steven Roser, Sachiko Seo, Stephanie van Leeuwen, Stephen Sonis, Stephen Bernard, Stephen Rajan Samuel, Stuart Taylor, Suranjan Maitra, Susanne Skulski, Suzanne Carlisle, Sylvie Louise Avon, Tomoya Yokota, Takashi Yurikusa, Tabata Santos Polvora, Tabitha Kelock, Tauana Fernandes, Taylor Wain, Timothy Brown, Tetsuhito konishi, Thalyta Amanda Ferreira, Tomoko Kataoka, Thomas Kelly, Takehiko Mori, Tomoko Higuchi, Toshiaki Saeki, Nikolaos Tsoukalas, Typhaine Maupoint De Vandeul, Masatoshi Usubuchi, Vanessa Lacerda, Vanessa Tilly, Emmanuelle Vigarios, Alessandro Villa, Vinicius Torregrossa, Vinodh Kumar Selvaraj, Viviane Sarmento, Vivien Heng, Wagner Gomes-Silva, Petter Wilberg, Wanessa Miranda e Silva, Wan Nor I'zzah Wan Mohamad Zain, Wonse Park, Wim Tissing, Yoshihiko Soga, Bella Van Sebille, and Yuhei Matsuda

Subjects
Oral mucositis, Gastrointestinal mucositis, Mucositis assessment tools, Patient-reported outcome measures, Medicine (General), R5-920
Abstract

Summary: Background: Mucositis is a common and highly impactful side effect of conventional and emerging cancer therapy and thus the subject of intense investigation. Although common practice, mucositis assessment is heterogeneously adopted and poorly guided, impacting evidence synthesis and translation. The Multinational Association of Supportive Care in Cancer (MASCC) Mucositis Study Group (MSG) therefore aimed to establish expert recommendations for how existing mucositis assessment tools should be used, in clinical care and trials contexts, to improve the consistency of mucositis assessment. Methods: This study was conducted over two stages (January 2022–July 2023). The first phase involved a survey to MASCC-MSG members (January 2022–May 2022), capturing current practices, challenges and preferences. These then informed the second phase, in which a set of initial recommendations were prepared and refined using the Delphi method (February 2023–May 2023). Consensus was defined as agreement on a parameter by >80% of respondents. Findings: Seventy-two MASCC-MSG members completed the first phase of the study (37 females, 34 males, mainly oral care specialists). High variability was noted in the use of mucositis assessment tools, with a high reliance on clinician assessment compared to patient reported outcome measures (PROMs, 47% vs 3%, 37% used a combination). The World Health Organization (WHO) and Common Terminology Criteria for Adverse Events (CTCAE) scales were most commonly used to assess mucositis across multiple settings. Initial recommendations were reviewed by experienced MSG members and following two rounds of Delphi survey consensus was achieved in 91 of 100 recommendations. For example, in patients receiving chemotherapy, the recommended tool for clinician assessment in clinical practice is WHO for oral mucositis (89.5% consensus), and WHO or CTCAE for gastrointestinal mucositis (85.7% consensus). The recommended PROM in clinical trials is OMD/WQ for oral mucositis (93.3% consensus), and PRO-CTCAE for gastrointestinal mucositis (83.3% consensus). Interpretation: These new recommendations provide much needed guidance on mucositis assessment and may be applied in both clinical practice and research to streamline comparison and synthesis of global data sets, thus accelerating translation of new knowledge into clinical practice. Funding: No funding was received.

Published
2024
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2. Discovery of N,4-Di(1H-pyrazol-4-yl)pyrimidin-2-amine-Derived CDK2 Inhibitors as Potential Anticancer Agents: Design, Synthesis, and Evaluation

Author

Biruk Sintayehu Fanta, Jimma Lenjisa, Theodosia Teo, Lianmeng Kou, Laychiluh Mekonnen, Yuchao Yang, Sunita K. C. Basnet, Ramin Hassankhani, Matthew J. Sykes, Mingfeng Yu, and Shudong Wang

Subjects
CDK2, CDK2 inhibitor, pyrazole, N,4-di(1H-pyrazol-4-yl)pyrimidin-2-amine, antiproliferative activity, bioisosteric replacement, Organic chemistry, QD241-441
Abstract

Cyclin-dependent kinase 2 (CDK2) has been garnering considerable interest as a target to develop new cancer treatments and to ameliorate resistance to CDK4/6 inhibitors. However, a selective CDK2 inhibitor has yet to be clinically approved. With the desire to discover novel, potent, and selective CDK2 inhibitors, the phenylsulfonamide moiety of our previous lead compound 1 was bioisosterically replaced with pyrazole derivatives, affording a novel series of N,4-di(1H-pyrazol-4-yl)pyrimidin-2-amines that exhibited potent CDK2 inhibitory activity. Among them, 15 was the most potent CDK2 inhibitor (Ki = 0.005 µM) with a degree of selectivity over other CDKs tested. Meanwhile, this compound displayed sub-micromolar antiproliferative activity against a panel of 13 cancer cell lines (GI50 = 0.127–0.560 μM). Mechanistic studies in ovarian cancer cells revealed that 15 reduced the phosphorylation of retinoblastoma at Thr821, arrested cells at the S and G2/M phases, and induced apoptosis. These results accentuate the potential of the N,4-di(1H-pyrazol-4-yl)pyrimidin-2-amine scaffold to be developed into potent and selective CDK2 inhibitors for the treatment of cancer.

Published
2023
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3. Kinase inhibitors: Opportunities for small molecule anticancer immunotherapies

Author

Ava Safaroghli-Azar, Fatemeh Emadi, Jimma Lenjisa, Laychiluh Mekonnen, Shudong Wang, Safaroghli-Azar, Ava, Emadi, Fatemeh, Lenjisa, Jimma, Mekonnen, Laychiluh, and Wang, Shudong

Subjects
Pharmacology, Drug Discovery, kinase inhibitors, immunotherapy, anti-tumor immunity, checkpoint inhibitors, small molecule inhibitors
Abstract

Refereed/Peer-reviewed As the fifth pillar of cancer treatment, immunotherapy has dramatically changed the paradigm of therapeutic strategies by focusing on the host’s immune system. In the long road of immunotherapy development, the identification of immune-modulatory effects for kinase inhibitors opened a new chapter in this therapeutic approach. These small molecule inhibitors not only directly eradicate tumors by targeting essential proteins of cell survival and proliferation but can also drive immune responses against malignant cells. This review summarizes the current standings and challenges of kinase inhibitors in immunotherapy, either as a single agent or in a combined modality.

Published
2023
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4. 2-Anilino-4-(1-methyl-1H-pyrazol-4-yl)pyrimidine-derived CDK2 inhibitors as anticancer agents: Design, synthesis & evaluation

Author

Biruk Sintayehu Fanta, Laychiluh Mekonnen, Sunita K.C. Basnet, Theodosia Teo, Jimma Lenjisa, Nishat Z. Khair, Lianmeng Kou, Solomon Tadesse, Matthew J. Sykes, Mingfeng Yu, Shudong Wang, Fanta, Biruk Sintayehu, Mekonnen, Laychiluh, Basnet, Sunita KC, Teo, Theodosia, Lenjisa, Jimma, Khair, Nishat Z, Kou, Lianmeng, Tadesse, Solomon, Sykes, Matthew J, Yu, Mingfeng, and Wang, Shudong

Subjects
antiproliferative activity, CDK2, CDK2 inhibitor, Organic Chemistry, Clinical Biochemistry, Drug Discovery, Pharmaceutical Science, Molecular Medicine, 2-Anilino-4-(1-methyl-1H-pyrazol-4-yl)pyrimidine, bioisosteric replacement, Molecular Biology, Biochemistry, CDKI-73
Abstract

Refereed/Peer-reviewed Deregulation of cyclin-dependent kinase 2 (CDK2) and its activating partners, cyclins A and E, is associated with the pathogenesis of a myriad of human cancers and with resistance to anticancer drugs including CDK4/6 inhibitors. Thus, CDK2 has become an attractive target for the development of new anticancer therapies and for the amelioration of the resistance to CDK4/6 inhibitors. Bioisosteric replacement of the thiazole moiety of CDKI-73, a clinically trialled CDK inhibitor, by a pyrazole group afforded 9 and 19 that displayed potent CDK2-cyclin E inhibition (Ki = 0.023 and 0.001 μM, respectively) with submicromolar antiproliferative activity against a panel of cancer cell lines (GI50 = 0.025–0.780 μM). Mechanistic studies on 19 with HCT-116 colorectal cancer cells revealed that the compound reduced the phosphorylation of retinoblastoma at Ser807/811, arrested the cells at the G2/M phase, and induced apoptosis. These results highlight the potential of the 2-anilino-4-(1-methyl-1H-pyrazol-4-yl)pyrimidine series in developing potent and selective CDK2 inhibitors to combat cancer.

Published
2023
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5. An orally bioavailable and highly efficacious inhibitor of CDK9/FLT3 for the treatment of acute myeloid leukemia

Author

Abel Tesfaye Anshabo, Laychiluh Bantie, Sarah Diab, Jimma Lenjisa, Alemwork Kebede, Yi Long, Gary Heinemann, Jasmine Karanjia, Benjamin Noll, Sunita K. C. Basnet, Manjun Li, Robert Milne, Hugo Albrecht, Shudong Wang, Anshabo, Abel Tesfaye, Bantie, Laychiluh, Diab, Sarah, Lenjisa, Jimma, Kebede, Alemwork, Long, Yi, Heinemann, Gary, Karanjia, Jasmine, Noll, Benjamin, Basnet, Sunita KC, Li, Manjun, Milne, Robert, Albrecht, Hugo, and Wang, Shudong

Subjects
Cancer Research, Oncology, CDK9, FLT3, targeted therapy, cancer, leukemia, hemic and lymphatic diseases, rargeted therapy
Abstract

Mutations in FMS-like tyrosine kinase 3 (FLT3) occur in approximately one-third of AML patients and are associated with a particularly poor prognosis. The most common mutation, FLT3-ITD, is a self-activating internal tandem duplication (ITD) in the FLT3 juxtamembrane domain. Many FLT3 inhibitors have shown encouraging results in clinical trials, but the rapid emergence of resistance has severely limited sustainable efficacy. Co-targeting of CDK9 and FLT3 is a promising two-pronged strategy to overcome resistance as the former plays a role in the transcription of cancer cell-survival genes. Most prominently, MCL-1 is known to be associated with AML tumorigenesis and drug resistance and can be down-regulated by CDK9 inhibition. We have developed CDDD11-8 as a potent CDK9 inhibitor co-targeting FLT3-ITD with Ki values of 8 and 13 nM, respectively. The kinome selectivity has been confirmed when the compound was tested in a panel of 369 human kinases. CDDD11-8 displayed antiproliferative activity against leukemia cell lines, and particularly potent effects were observed against MV4-11 and MOLM-13 cells, which are known to harbor the FLT3-ITD mutation and mixed lineage leukemia (MLL) fusion proteins. The mode of action was consistent with inhibition of CDK9 and FLT3-ITD. Most importantly, CDDD11-8 caused a robust tumor growth inhibition by oral administration in animal xenografts. At 125 mg/kg, CDDD11-8 induced tumor regression, and this was translated to an improved survival of animals. The study demonstrates the potential of CDDD11-8 towards the future development of a novel AML treatment. Refereed/Peer-reviewed

Published
2022

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