Michael Kaleko

Center for Biologics Evaluation and Research — United States

Biochemistry, Genetics and Molecular Biology · Life Sciences

40h-index4.7kcitations87works1.52yr avg
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Research Topics

Virus-based gene therapy research(39), Hemophilia Treatment and Research(14), Clostridium difficile and Clostridium perfringens research(14), CRISPR and Genetic Engineering(12), Gut microbiota and health(11)

Publications87 total

2216MO VIRAGE trial: Randomized phase IIb, open-label, study of nab-paclitaxel and gemcitabine with/without intravenous VCN-01 in patients with metastatic pancreatic cancer (mPDAC)
Annals of Oncology·2025· 1 cited
VIRAGE: A phase IIb, open-label, randomized study of nab-paclitaxel and gemcitabine plus/minus VCN-01 in patients with metastatic pancreatic cancer.
Journal of Clinical Oncology·2024· 2 cited
Maternal treatment with oral intestinal alkaline phosphatase mitigates high fat diet-induced cognitive disorders in offspring mice
Behavioural Brain Research·2020· 11 citedOpen Access
Neutralization of pertussis toxin by a single antibody prevents clinical pertussis in neonatal baboons
Science Advances·2020· 48 citedOpen Access
SYN-007, an Orally Administered Beta-Lactamase Enzyme, Protects the Gut Microbiome from Oral Amoxicillin/Clavulanate without Adversely Affecting Antibiotic Systemic Absorption in Dogs
Microorganisms·2020· 14 citedOpen Access
Oral intestinal alkaline phosphatase improves efficacy of 5-FU in a colorectal cancer mouse model
Annals of Oncology·2019Open Access
673. Novel Delayed-Release Formulation of an Oral β-Lactamase Prevents Gut Microbiome Damage and Attenuates Antibiotic Resistance Caused by Oral Amoxicillin/Clavulanate without Interfering with Amoxicillin Systemic Absorption in Dogs
Open Forum Infectious Diseases·2019· 1 citedOpen Access
Oral Beta-Lactamase Protects the Canine Gut Microbiome from Oral Amoxicillin-Mediated Damage
Microorganisms·2019· 13 citedOpen Access
1140 – Syn-007, an Oral Beta-Lactamase Prevents Gut Microbime Dysbiosis Caused by Oral Amoxicillin and Oral Amoxicillin/Clavulanate Without Affecting Amoxicillin Systemic Absorption in Dogs
Gastroenterology·2019
Oral Metallo-Beta-Lactamase Protects the Gut Microbiome From Carbapenem-Mediated Damage and Reduces Propagation of Antibiotic Resistance in Pigs
Frontiers in Microbiology·2019· 42 citedOpen Access
Identification, Characterization, and Formulation of a Novel Carbapenemase Intended to Prevent Antibiotic-Mediated Gut Dysbiosis
Microorganisms·2019· 5 citedOpen Access
Low dose oral beta-lactamase protects the gut microbiome from oral beta-lactam-mediated damage in dogs
AIMS Public Health·2019· 13 citedOpen Access
620. Oral β-Lactamase Therapies Prevent Microbiome Damage and Attenuate Antibiotic Resistance From IV and Oral Antibiotics in Large Animal Models of Antibiotic-Mediated Gut Dysbiosis
Open Forum Infectious Diseases·2018· 2 citedOpen Access
Sa1839 - Orally Delivered Beta-Lactamase Prevents Gut Microbiome Dysbiosis Caused by IV and Oral Antibiotics and Mitigates Propagation of Antibiotic Resistance in Porcine and Canine Models
Gastroenterology·2018· 2 cited
Distinct consequences of amoxicillin and ertapenem exposure in the porcine gut microbiome
Anaerobe·2018· 35 cited
An Orally Delivered Beta-Lactamase Protects the Gut Microbiome from Antibiotic-Mediated Damage and Mitigates the Propagation of Antibiotic-Resistance Genes in a Porcine Dysbiosis Model
Gastroenterology·2017
SYN-004 (ribaxamase), an oral beta-lactamase, mitigates antibiotic-mediated dysbiosis in a porcine gut microbiome model
Journal of Applied Microbiology·2017· 38 citedOpen Access
Gut Antibiotic Inactivation by Β-Lactamases Is Intended to Prevent Microbiome Damage and Attenuate Antibiotic Resistance in Large Animal Models
Open Forum Infectious Diseases·2017· 1 citedOpen Access
SYN-006, a Novel Carbapenemase, Intended to Protect the Gut Microbiome from Antibiotic-Mediated Damage May Also Reduce Propagation of Carbapenem-Resistant Pathogens
Open Forum Infectious Diseases·2017· 2 citedOpen Access
Passive Immunization with Anti-Pertussis Toxin Humanized Monoclonal Antibody Mitigates Clinical Signs of Pertussis Infection in Newborn Baboons
Open Forum Infectious Diseases·2017Open Access
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Frequent Co-authors

Sheila Connelly(26), Theodore A Smith(8), Alan McClelland(8), A. Dusty Miller(7), Neeraja Idamakanti(7), J. Andrews(7), Dawn B. Kayda(6), Michele Kaloss(6), Pamela S. Shirley(6), Susan C. Stevenson(4), Michael J. Kadan(4), Peter A. Campochiaro(4), P. Seshidhar Reddy(4), A M Gallo-Penn(4), J. Andrew Bristol(4), Nur A. Hasan(4), Michele G. Mehaffey(3), Michele L. Rollence(3), Laura A. King(3), Russette M. Lyons(3)