Review
Immunology
Anna K. Blakney, Shell Ip, Andrew J. Geall
Summary: This review explores the four major pillars required for design and development of an saRNA vaccine, discussing antigen design, vector design, non-viral delivery systems, and manufacturing. It reports on major innovations, preclinical and clinical data from the last five years, and provides insights into future prospects.
Review
Immunology
Chaoying Hu, Jianyang Liu, Feiran Cheng, Yu Bai, Qunying Mao, Miao Xu, Zhenglun Liang
Summary: This review summarizes the research progress of amplifying mRNA vaccines and provides an outlook on their prospects and future directions in cancer treatment.
FRONTIERS IN IMMUNOLOGY
(2023)
Article
Pharmacology & Pharmacy
Sebastian Guelman, Ying Zhou, Ann Brady, Kun Peng
Summary: Autogene cevumeran is a personalized therapy for solid tumors that stimulates and expands neoantigen-specific T cells. In order to evaluate the therapy's performance in patients, lipid and mRNA content in circulation need to be measured, and a method to measure mRNA levels in plasma needs to be established. Special precautions are required to preserve mRNA integrity during sample collection and storage.
Article
Immunology
Shen Wang, Mian Qin, Long Xu, Ting Mu, Ping Zhao, Bing Sun, Yue Wu, Lingli Song, Han Wu, Weicheng Wang, Xingwen Liu, Yanyan Li, Fengmei Yang, Ke Xu, Zhanlong He, Michel Klein, Ke Wu
Summary: This study demonstrates that administering BV-AdCoV-1 or C68-COA04 via aerosol inhalation is a promising approach to prevent SARS-CoV-2 infection and transmission. Aerosol inhalation elicits immune responses comparable to intramuscular injection, and heterologous boosting can provide cross-neutralizing immunity against different variants.
Article
Microbiology
Tamara Elliott, Hannah M. Cheeseman, Abbey B. Evans, Suzanne Day, Leon R. McFarlane, Jessica O'Hara, Mohini Kalyan, Fahimah Amini, Tom Cole, Alan Winston, Sarah Fidler, Katrina M. Pollock, James A. Harker, Robin J. Shattock
Summary: This study investigated the immune responses of COVID-19 patients and non-infected individuals who received saRNA and mRNA vaccinations and compared them to those who received only vaccinations. The results showed that individuals with previous COVID-19 infection had stronger immune responses in terms of antibody production, neutralizing antibody breadth, and T-cell responses.
Article
Toxicology
Xuedong Dai, Weijun Zhao, Xin Tong, Wei Liu, Xianhuan Zeng, Xiaohui Duan, Hua Wu, Lili Wang, Zhen Huang, Xinying Tang, Yong Yang
Summary: This study evaluated the immunogenicity and safety of the candidate vaccine AdC68-19S in rats and rhesus macaques. The results showed that AdC68-19S can induce effective and long-lasting immune responses without any toxic reactions.
ARCHIVES OF TOXICOLOGY
(2022)
Article
Pharmacology & Pharmacy
Alexis A. Ellis, Sean M. Geary, Aliasger K. Salem
Summary: Heterologous prime-boost vaccines consisting of a microparticle formulation and an adenoviral vaccine were used in this study to investigate their effect on antigen-specific immune responses. The results showed that this prime-boost vaccine significantly enhanced cellular immune responses and conferred a significant survival advantage in a prophylactic animal tumor model.
INTERNATIONAL JOURNAL OF PHARMACEUTICS
(2023)
Article
Infectious Diseases
Robert H. Shaw, Melanie Greenland, Arabella S. V. Stuart, Parvinder K. Aley, Nick J. Andrews, J. Claire Cameron, Sue Charlton, Elizabeth A. Clutterbuck, Andrea M. Collins, Tom Darton, Tanya Dinesh, Christopher J. A. Duncan, Saul N. Faust, Daniela M. Ferreira, Adam Finn, Anna L. Goodman, Christopher A. Green, Bassam Hallis, Paul T. Heath, Helen Hill, Teresa Lambe, Vincenzo Libri, Patrick J. Lillie, Ella Morey, Yama F. Mujadidi, Ruth Payne, Emma L. Plested, Samuel Provstgaard-Morys, Maheshi N. Ramasamy, Mary Ramsay, Robert C. Read, Hannah Robinson, Gavin R. Screaton, Nisha Singh, David P. J. Turner, Paul J. Turner, Rachel White, Jonathan S. Nguyen-Van-Tam, Xinxue Liu, Matthew D. Snape
Summary: This report aims to understand the persistence of immune response to different COVID-19 vaccine platforms used in homologous and heterologous priming combinations, which will inform future vaccine development.
JOURNAL OF INFECTION
(2023)
Review
Pharmacology & Pharmacy
Mohammad M. Pourseif, Yosef Masoudi-Sobhanzadeh, Erfan Azari, Sepideh Parvizpour, Jaleh Barar, Rais Ansari, Yadollah Omidi
Summary: mRNA-based vaccines offer safe, tunable, scalable, streamlined, and effective treatment possibilities, with self-amplifying mRNA vaccines providing advantages including self-replication and adjuvant properties. Essential optimizations improve the stability, safety, and immunogenicity of vaccine constructs.
DRUG DISCOVERY TODAY
(2022)
Article
Gastroenterology & Hepatology
Tamsin Cargill, Paola Cicconi, Anthony Brown, Louise Holland, Benaka Karanth, Kathryn Rutkowski, Emily Ashwin, Reena Mehta, Senthil Chinnakannan, Sarah Sebastian, Louise Bussey, Henrik Sorensen, Paul Klenerman, Thomas Evans, Eleanor Barnes
Summary: This study assesses the safety and immunogenicity of the therapeutic vaccine ChAdOx1-HBV in healthy volunteers and patients with chronic hepatitis B infection (CHB). Vaccination with ChAdOx1-HBV was shown to be safe and induced high magnitude T cell responses in healthy volunteers and lower levels of responses in patients with CHB. The findings support the development of ChAdOx1-HBV as part of a wider therapeutic strategy to achieve functional cure for hepatitis B.
Article
Biochemistry & Molecular Biology
Swarda Deo, Kaushik Desai, Aishwarya Patare, Rucha Wadapurkar, Saniya Rade, Siddhi Mahudkar, Madhura Sathe, Shalini Srivastava, Pragya Prasanna, Ajay Singh
Summary: This study examines the longevity, safety, and genomic integration of mRNA vaccines and finds that mRNA vaccines based on the SAM platform have the potential to become a modality in the future.
BIOCHEMICAL AND BIOPHYSICAL RESEARCH COMMUNICATIONS
(2023)
Review
Cell Biology
Steve Pascolo
Summary: By September 2021, twenty-one anti-COVID-19 vaccines have been approved worldwide, with utilization expected to help bring an end to the pandemic. In addition to traditional vaccine formats such as inactivated viruses and protein-based vaccines, new formats like recombinant adenovirus, DNA, and mRNA have been validated. Western countries primarily reserve or use protein vaccines, adenovirus vaccines, and mRNA vaccines, with mRNA vaccines being seen as the superior option in terms of speed and effectiveness.
Article
Virology
Gerardo Casucci, Domenico Acanfora
Summary: Recent reports of adverse reactions, particularly thrombus formation, following administration of the Oxford-AstraZeneca vaccine have led some European countries to halt its use. However, a case study demonstrated that these side effects can be easily managed with prompt diagnosis and common medication, showcasing the safety of the vaccine.
Article
Medicine, Research & Experimental
Yoann Aldon, Paul F. McKay, Jorge Moreno Herrero, Annette B. Vogel, Reka Levai, Pauline Maisonnasse, Nathalie Dereuddre-Bosquet, Heinrich Haas, Katalin Fabian, Roger Le Grand, Ugur Sahin, Robin J. Shattock
Summary: saRNA platform, particularly VEEV saRNA, shows potential for high protein expression and strong immune responses in delivering stabilized HIV-1 Env. Membrane-bound Env design leads to faster immune kinetics and better IgG responses, with promise for diverse vaccine regimens.
MOLECULAR THERAPY-NUCLEIC ACIDS
(2021)
Article
Multidisciplinary Sciences
Ivan T. Lee, Raffael Nachbagauer, David Ensz, Howard Schwartz, Lizbeth Carmona, Kristi Schaefers, Andrei Avanesov, Daniel Stadlbauer, Carole Henry, Ren Chen, Wenmei Huang, Daniela Ramirez Schrempp, Jintanat Ananworanich, Robert Paris
Summary: Despite vaccine availability, influenza remains a significant global public health concern. Preliminary results from a phase 1/2 clinical trial show that mRNA-1010, a quadrivalent mRNA vaccine against seasonal influenza, is safe and elicits a strong immune response in adults. The vaccine produces higher or comparable levels of hemagglutination inhibition (HAI) antibodies compared to the licensed comparator vaccine.
NATURE COMMUNICATIONS
(2023)
Article
Medicine, General & Internal
Lipika Goyal, Funda Meric-Bernstam, Antoine Hollebecque, Juan W. Valle, Chigusa Morizane, Thomas B. Karasic, Thomas A. Abrams, Junji Furuse, Robin K. Kelley, Philippe A. Cassier, Heinz-Josef Kluempen, Heung-Moon Chang, Li-Tzong Chen, Josep Tabernero, Do-Youn Oh, Amit Mahipal, Markus Moehler, Edith P. Mitchell, Yoshito Komatsu, Kunihiro Masuda, Daniel Ahn, Robert S. Epstein, Abdel-Baset Halim, Yao Fu, Tehseen Salimi, Volker Wacheck, Yaohua He, Mei Liu, Karim A. Benhadji, John A. Bridgewater
Summary: In this study, 103 patients with FGFR2-altered intrahepatic cholangiocarcinoma were treated with futibatinib for a median duration of 17.1 months. The results showed that futibatinib treatment could effectively inhibit tumor growth, improve survival, and maintain quality of life for patients.
NEW ENGLAND JOURNAL OF MEDICINE
(2023)
Editorial Material
Pharmacology & Pharmacy
Sakti Chakrabarti, Amit Mahipal
Review
Oncology
Amr Mohamed, Sulin Wu, Mohamed Hamid, Amit Mahipal, Sakti Cjakrabarti, David Bajor, J. Eva Selfridge, Sylvia L. L. Asa
Summary: Appendiceal neuroendocrine neoplasms (ANENs) are usually found incidentally during appendectomy. They are rare, accounting for a small percentage of intestinal neoplasms. The management of ANENs varies based on histological differentiation and tumor grade.
Article
Oncology
Sri Harsha Tella, Nathan Foster, Shi Qian, Tran Nguyen, Mitesh J. Borad, Robert R. McWilliams, Steven R. Alberts, Wen Wee Ma, Sakti Chakrabarti, Briant Fruth, Jaclynn Wessling, Mindy Hartgers, Leslie Washburn, Martin E. Fernandez-Zapico, Tara L. Hogenson, Henry Pitot, Zhaohui Jin, Amit Mahipal
Summary: This study investigated the safety and efficacy of trifluridine/tipiracil in combination with irinotecan for refractory, advanced unresectable biliary tract carcinoma. The combination treatment showed promising results in terms of progression-free and overall survival. Adverse events were observed, but the genetic mutation status did not affect treatment response. Larger randomized trials are needed to confirm these findings.
Article
Oncology
Nirosha D. Perera, Tiffany R. Bellomo, Walker M. Schmidt, Henry K. Litt, Margaret Shyu, MaKenna A. Stavins, Max M. Wang, Alexander Bell, Massoud Saleki, Katherine Wolf, Ruxandra Ionescu, Jacqueline J. Tao, Sunjong Ji, Ryan M. O'Keefe, Matthew Pun, Jordan M. Takasugi, Jecca R. Steinberg, Ronald S. Go, Brandon E. Turner, Amit Mahipal
Summary: This study evaluates the representation of female participants in oncology clinical trials in the US, finding that women are underrepresented in surgical and invasive trials, but overrepresented in hematologic and pancreatic trials. Additionally, industry-funded trials have higher female representation compared to government and academic-funded trials.
Article
Multidisciplinary Sciences
Christine D. Palmer, Ciaran D. Scallan, Lauren D. Kraemer Tardif, Melissa A. Kachura, Amy R. Rappaport, Daniel O. Koralek, Alison Uriel, Leonid Gitlin, Joshua Klein, Matthew J. Davis, Harshni Venkatraman, Meghan G. Hart, Jason R. Jaroslavsky, Sonia Kounlavouth, Martina Marrali, Charmaine N. Nganje, Kyounghwa Bae, Tiffany Yan, Katharyn Leodones, Milana Egorova, Sue-Jean Hong, Jenchun Kuan, Silvia Grappi, Pedro Garbes, Karin Jooss, Andrew Ustianowski
Summary: This study reports interim findings of a phase I trial evaluating the GRT-R910 vaccine in previously vaccinated healthy older adults. The vaccine showed good safety and tolerability profile and induced neutralizing antibodies and T cell responses, providing long-lasting immune protection.
NATURE COMMUNICATIONS
(2023)
Article
Oncology
Stephanie Pitts, Amit Mahipal, David Bajor, Amr Mohamed
Summary: Parathyroid hormone-related protein (PTHrP) secretion is often found in solid tumors, but it is rare in neuroendocrine tumors. We presented a case report of a patient with metastatic pancreatic neuroendocrine tumor (PNET) who developed hypercalcemia due to elevated PTHrP. The patient's hypercalcemia and PTHrP levels improved with the use of a long-acting somatostatin analogue. The optimal management of malignant hypercalcemia caused by PTHrP-producing PNETs was also discussed based on current literature.
FRONTIERS IN ONCOLOGY
(2023)
Article
Oncology
Sri Harsha Tella, Kristin Mara, Sakti Chakrabarti, Zhaohui Jin, Amit Mahipal
Summary: This study utilized SEER 14 registries to predict the future burden of esophageal carcinoma. The incidence rate of esophageal adenocarcinoma in the age group of 40-65 years is expected to increase, while the incidence rate of esophageal squamous cell carcinoma in the age groups of 40-65 years and >65 years will significantly decrease. Preventive efforts should primarily target males under the age of 65 and females aged 40-65, who will be in the older age group (>65 years) in 2040.
JOURNAL OF GASTROINTESTINAL ONCOLOGY
(2023)
Review
Oncology
Amr Mohamed, Sylvia L. Asa, Zhenghong Lee, Sree H. Tirumani, Qiubai Li, Norbert Avril, David Bajor, Amit Mahipal, Sakti Chakrabarti, J. Eva Selfridge, Arash Kardan
Summary: Treatment with radiolabelled somatostatin analogs has changed the management of patients with advanced GEP-NETs. Prognostic and predictive markers are urgently needed for patients who do not benefit from this treatment. This study reviewed the literature and reported a case series to summarize the predictive value of dual SSTR/FDG PET imaging in metastatic GEP-NETs.
JOURNAL OF GASTROINTESTINAL ONCOLOGY
(2023)
Letter
Oncology
Sakti Chakrabarti, Amit Mahipal
JOURNAL OF CLINICAL ONCOLOGY
(2023)
Article
Surgery
Mohamedraed Elshami, Lauryn Bailey, Richard S. Hoehn, John B. Ammori, Jeffrey M. Hardacre, J. Eva Selfridge, David Bajor, Amr Mohamed, Sakti Chakrabarti, Amit Mahipal, Jordan M. Winter, Lee M. Ocuin
Summary: This study examined differences in surgical intervention for early-stage hepatocellular carcinoma patients at minority-serving hospitals compared to non-minority-serving hospitals. The findings revealed that patients treated at minority-serving hospitals were less likely to undergo surgical intervention. Furthermore, minority patients treated at non-minority-serving hospitals also had a decreased likelihood of surgery, though to a lesser extent. Surgery was associated with improved overall survival, regardless of minority status or hospital type.
Article
Oncology
Mathias E. Palmer, Jennifer J. Gile, Michael H. Storandt, Zhaohui Jin, Tyler J. Zemla, Nguyen H. Tran, Amit Mahipal
Summary: The use of lenvatinib following immunotherapy has shown favorable clinical outcomes in patients with advanced hepatocellular carcinoma, serving as a viable second-line therapy.
Article
Oncology
Michael H. Storandt, Kara R. Rogen, Anushka Iyyangar, Rylie R. Schnell, Jessica L. Mitchell, Joleen M. Hubbard, Frank A. Sinicrope, Aminah Jatoi, Amit Mahipal, Qian Shi, Zhaohui Jin
Summary: Rates of early-onset colorectal cancer have increased, with about one-quarter of cases being associated with a hereditary cancer syndrome. This study found that approximately one in four patients with early-onset colorectal cancer had a pathogenic germline variant, including 8.3% with Lynch syndrome. Similar rates of detection of pathogenic germline variants were seen in patients with average-onset colorectal cancer. This study underscores the importance of genetic testing for all patients with colorectal cancer, especially those with early-onset.
Meeting Abstract
Clinical Neurology
Iben Spanggaard, Marc Matrana, Caio Rocha-Lima, Amit Mahipal, Maria Vieito, Alice Hervieu, Myung-Ju Ahn, Lipika Goyal, Jordi Rodon Ahnert, Luisa Veronese, Natalia Oliveira, Xin Li, Michael Schaffer, Santosh Kesari
Article
Oncology
Nirosha D. Perera, Tiffany R. Bellomo, Walker M. Schmidt, Henry K. Litt, Margaret Shyu, MaKenna A. Stavins, Max M. Wang, Alexander Bell, Massoud Saleki, Katherine I. Wolf, Ruxandra Ionescu, Jacqueline J. Tao, Sunjong Ji, Ryan M. O'Keefe, Matthew Pun, Jordan M. Takasugi, Jecca R. Steinberg, Ronald S. Go, Brandon E. Turner, Amit Mahipal
Summary: This study evaluated the representation of female participants in US oncology clinical trials and found that females were underrepresented in surgical and invasive trials. The representation of females varied among different cancer sites, with some types of trials and industry-funded trials showing better female representation. It is important to consider female representation when interpreting trial results.
