Funding
The study was funded by Merrimack Pharmaceuticals, Inc. The manuscript was supported by Elevation Oncology, Inc.
Conflicts of interest/Competing interests
CSD has received institutional research funding from Advaxis, Agios Pharmaceuticals, Amgen, Array BioPharma, AstraZeneca, Bayer, BeiGene, Bristol Myers Squibb, Eli Lilly & Co, Exelixis, Genentech, Genmab, ImClone, InCyte, Lycera, Macrogenics, MedImmune, Merrimack Pharmaceuticals, OncoMed, Pfizer, Sanofi Aventis and Zymeworks. She has served on advisory boards for Astellas, Bayer, BeiGene, Bristol Myers Squibb, Carevive, Eli Lilly & Co, EMD Serono, Exelixis, Merck, Merrimack Pharmaceuticals, and Taiho, and on a data safety monitoring board for Zymeworks. She has received writing support from Pfizer.
VLK has received institutional research funding from Adaptimmune, Advenchen, AstraZeneca, Bayer, Bristol Myers Squibb, CytRx, Daiichi Sankyo, Deciphera, Eli Lilly & Co, Genentech, ImClone, Immune Design, MedPacto, Merrimack Pharmaceuticals, Pfizer, Plexxikon, Roche, Sanofi Aventis, Springworks, Tracon, and Threshold. She has served on advisory boards for Daiichi Sankyo, Janssen and Karyopharm.
VM was previously an employee of Merrimack Pharmaceuticals during the period of study conduct and is a co-inventor on some patents relating to seribantumab and other Merrimack Products, but currently does not own any stock/stock options at Merrimack Pharmaceuticals. He is currently an employee and equity holder at L.E.A.F. Pharmaceuticals and LEAF4Life Inc.
GM was a founder, employee and shareholder of Merrimack Pharmaceuticals and is an inventor on patents relating to seribantumab. He is currently the Chief Scientific Officer of TScan Therapeutics.
GIS has received research funding from Eli Lilly, Merck KGaA/EMD-Serono, Merck and Sierra Oncology. He has served on advisory boards for Almac, Angiex, Artios, Asana, Astex, Atrin, Bayer, Bicycle Therapeutics, Boehringer Ingelheim, Concarlo Holdings, Cybrexa Therapeutics, CytomX Therapeutics, Daiichi Sankyo, Eli Lilly, Fusion Pharmaceuticals, G1 Therapeutics, ImmunoMet, Ipsen, Merck KGaA/EMD-Serono, Pfizer, Roche, Seattle Genetics, Sierra Oncology, Syros, and Zentalis. In addition, he holds a patent entitled, “Dosage regimen for sapacitabine and seliciclib,” also issued to Cyclacel Pharmaceuticals, and a pending patent entitled, “Compositions and Methods for Predicting Response and Resistance to CDK4/6 Inhibition,” together with Liam Cornell.
Availability of data and material
The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request. Further details are also available via [email protected] or at https://elevationoncology.com.
Code availability
Not applicable.
Authors' contributions
CSD: Design of the work, acquisition of data for the work, interpretation of data for the work, drafting and critical revision of the work
VLK: Acquisition of data for the work, interpretation of data for the work, drafting and critical revision of the work
VM: Design of the work, study conduct, critical revision of the work
GM: Design and acquisition of pre-clinical data supporting the study, retrospective translational work, critical revision of the work
GIS: Design of the work, acquisition of data for the work, interpretation of data for the work, drafting and critical revision of the work
Ethics approval
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee, and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.
Consent to participate
Informed consent was obtained from all patients in the study.
Consent for publication
All authors and the sponsor of the study gave consent to publication of this study.
Acknowledgments
The authors would like to thank the patients and their families for their participation in this clinical study, coinvestigators and clinical research coordinators for processing this study, James Murray (at Merrimack Pharmaceuticals at the time of the study) for the study oversight and development of the clinical study protocol and Mace Rothenberg (at Vanderbilt University Medical Center as Professor of Medicine and Ingram Professor of Cancer Research at the time of the study) and Kwok Kin Wong (at Dana-Farber Cancer Institute at the time of the study) for their contributions to the initial discussions of the trial. Medical writing support, including assisting authors with the development of the outline and initial draft, and incorporation of comments, was provided by Miriam Cohen, PhD, and Natasha Tracey, PhD, and editorial support was provided by Michelle Seddon, Dip Psych, all of Paragon, Knutsford, UK, supported by Elevation Oncology, Inc. follows all current policies established by the International Committee of Medical Journal Editors and Good Publication Practice guidelines (link). The sponsor and prior owner of seribantumab, Merrimack Pharmaceuticals was involved in the analysis and interpretation of data, as well as data checking of information provided in the manuscript. However, ultimate responsibility for opinions, conclusions and data interpretation lies with the authors.