Delving into the Latest Updates on MEDI-8852 with Synapse

The purposes of this study are to determine if MEDI8852 administered with standard of care (oseltamivir) will reduce the time to normalization of respiratory function for adults who are hospitalized with influenza caused by Type A strains and to determine if MEDI8852 has an acceptable safety profile in adults who are hospitalized with influenza caused by Type A strains.

Start Date24 Jul 2017

Sponsor / Collaborator

MedImmune LLC

EUCTR2015-004276-29-BE

/ Not yet recruitingPhase 2

A Phase 2b, Randomized, Double-blind, Single-dose, Active-controlled,Dose Ranging Study to Evaluate the Efficacy and Safety of MEDI8852 inAdults who are Hospitalized with Influenza Caused by Type A Strains

Start Date02 Feb 2017

Sponsor / Collaborator

MedImmune LLC

100 Clinical Results associated with MEDI-8852

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100 Translational Medicine associated with MEDI-8852

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100 Patents (Medical) associated with MEDI-8852

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8

Literatures (Medical) associated with MEDI-8852

15 Apr 2025·PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA

A monoclonal anti-hemagglutinin stem antibody modified with zanamivir protects against both influenza A and B viruses

Article

Author: Ploegh, Hidde L. ; Balligand, Thomas ; Liu, Xin ; Le Gall, Camille

Influenza remains a significant public health threat. Both monoclonal antibodies and small-molecule inhibitors can target the influenza surface glycoproteins hemagglutinin (HA) or neuraminidase (NA) for prevention and treatment of influenza. Here, we combine the strengths of anti-influenza antibodies and small molecules by site-specific conjugation of the NA inhibitor zanamivir to MEDI8852, an HA-specific fully human monoclonal antibody. MEDI8852 targets the conserved stem region of HA and inhibits HA-mediated fusion of the viral and host cell membranes. Elimination of virus-infected cells involves Fcγ receptor–mediated effector functions. The efficacy of MEDI8852 is limited to influenza A viruses. Zanamivir, on the other hand, binds to the active site of NA in both influenza A and B viruses to inhibit NA activity and virus release. However, because of its small size, zanamivir has a short half-life and requires repeated dosing at high concentrations. We produced a MEDI8852–zanamivir antibody–drug conjugate (ADC) that engages Fc-mediated effector functions and benefits from neonatal Fc receptor (FcRn)-mediated recycling. The MEDI8852–zanamivir conjugate extends the circulatory half-life of zanamivir, targets both influenza HA and NA, and shows enhanced antibody-dependent cellular cytotoxicity (ADCC) compared to MEDI8852 alone. The MEDI8852–zanamivir conjugate protected mice from a lethal (10 × LD 50 ) challenge with influenza A and B viruses at a dose similar to that required for broadly neutralizing anti-NA antibodies, with the added advantage of simultaneously targeting NA (influenza A and B) and HA (influenza A).

01 Mar 2025·STRUCTURE

Computational design and improvement of a broad influenza virus HA stem targeting antibody

Article

Author: Yang, Xuehua ; Dong, Xuemeng ; Zhang, Xinhui ; Gao, Peixiang ; Liao, Yi ; Liu, Xiuying ; Zhang, Fangyuan ; Yang, Wei ; Pan, Shengnan ; Chi, Xiaojing ; Duan, Huarui

Broadly neutralizing antibodies (nAbs) are vital therapeutic tools to counteract both pandemic and seasonal influenza threats. Traditional strategies for optimizing nAbs generally rely on labor-intensive, high-throughput mutagenesis screens. Here, we present an innovative structure-based design framework for the optimization of nAbs, which integrates epitope-paratope analysis, computational modeling, and rational design approaches, complemented by comprehensive experimental assessment. This approach was applied to optimize MEDI8852, a nAb targeting the stalk region of influenza A virus hemagglutinin (HA). The resulting variant, M18.1.2.2, shows a marked enhancement in both affinity and neutralizing efficacy, as demonstrated both in vitro and in vivo. Computational modeling reveals that this improvement can be attributed to the fine-tuning of interactions between the antibody's side-chains and the epitope residues that are highly conserved across the influenza A virus HA stalk. Our dry-wet iterative protocol for nAb optimization presented here yielded a promising candidate for influenza intervention.

31 Jan 2025·SCIENCE

Pre-exposure antibody prophylaxis protects macaques from severe influenza

Article

Author: Lundy, Jeneveve ; Kanekiyo, Masaru ; Batsche, Lucia Ortiz ; Ritter, Isabella ; Gillespie, Rebecca A. ; O’Malley, Katherine ; Martí, Michelle M. ; Chavva, Hasitha ; Mascola, John R. ; Walker, Reagan ; Williams, Connor ; Midgett, Morgan ; Treat, Benjamin R. ; Yun, Gabin ; Perez, Daniel R. ; Cooper, Kristine ; Castanha, Priscila M. S. ; Reed, Douglas S. ; Canedo, Vanessa Guerra ; Graham, Barney S. ; Loo, Yueh-Ming ; Corry, Jacqueline ; Olsen, Emily ; Creanga, Adrian ; Lipinski, Abby ; Kettenburg, Gwenddolen ; Yang, Eun Sung ; Esser, Mark ; Barratt-Boyes, Simon M. ; Wallace, Megan ; Blair, Wade ; Boritz, Eli A. ; Treaster, Luke ; Pegu, Amarendra ; Laughlin, Amanda ; Barrick, Stacey

Influenza virus pandemics and seasonal epidemics have claimed countless lives. Recurrent zoonotic spillovers of influenza viruses with pandemic potential underscore the need for effective countermeasures. In this study, we show that pre-exposure prophylaxis with broadly neutralizing antibody (bnAb) MEDI8852 is highly effective in protecting cynomolgus macaques from severe disease caused by aerosolized highly pathogenic avian influenza H5N1 virus infection. Protection was antibody dose–dependent yet independent of Fc-mediated effector functions at the dose tested. Macaques receiving MEDI8852 at 10 milligrams per kilogram or higher had negligible impairment of respiratory function after infection, whereas control animals were not protected from severe disease and fatality. Given the breadth of MEDI8852 and other bnAbs, we anticipate that protection from unforeseen pandemic influenza A viruses is achievable.

1

News (Medical) associated with MEDI-8852

05 Oct 2023

·www.labiotech.eu

Humabs and MedImmune partnership to develop an Influenza A treatment

"*" indicates required fields Medimmune starts phase I clinical trial to investigate an antibody developed under a collaboration with Humabs BioMed for the treatment of influenza A. The novel antibody developed through Humabs’ Cellclone technology will be investigated a trial being conducted by MedImmune, the global biologics research and development arm of AstraZeneca. The investigational antibody, which has broad influenza-neutralizing properties, was isolated by Humabs from human memory B cells and further optimized for higher potency by MedImmune. The resulting antibody, MEDI8852, is exclusively licensed to MedImmune. The Phase I trial is designed to evaluate the safety and pharmacokinetics of MEDI8852 in healthy adults. “Our strong, ongoing partnership and collaborations with Humabs reflect our commitment to seeking out innovative new science and technologies, both within and outside our organization, that can help expedite and advance the development of new medicines for the prevention and treatment of challenging infectious diseases,” said Dr. JoAnn Suzich, vice president of infectious disease research and development at MedImmune. MEDI8852 binds to a novel site in the hemagglutinin stem region that is shared in viruses from all 18 Influenza A subtypes. This region is highly conserved and is considered to be the “Achilles’ heel” of the virus. Alcide Barberis, Humabs BioMed´s CEO, added, “The influenza A antibody currently under development by our partner MedImmune is just one example of our broad pipeline of therapeutic antibodies. Our antibodies against infectious diseases, cancer and inflammatory diseases are at various clinical and preclinical stages, with four of them already partnered to global pharma companies.” Influenza A is a quickly evolving virus with 18 subtypes. The human antibody response is ineffective against most strains belonging to the H1 and H3 subtypes and therefore new vaccines are developed each year to match these strains. Humans are also susceptible to avian flu viruses such as H5N1, H7N9 and H9N2, and to H2, which caused the pandemic of the years 1957-58. It is estimated that millions of people are infected with influenza A viruses every year. Although the majority of infections are mild, those in high-risk groups, such as the elderly, immunocompromised patients or infants, may be at risk for serious complications or even death. Are you interested in antibody therapy R&D?

Phase 1VaccineImmunotherapyADC

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Indication	Highest Phase	Country/Location	Organization	Date
Influenza A virus infection	Phase 2	South Africa	MedImmune LLC	07 Dec 2015
Influenza, Human	Phase 2	United States	MedImmune LLC	07 Dec 2015
Influenza, Human	Phase 2	South Africa	MedImmune LLC	07 Dec 2015

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02603952 (Pubmed \| Antimicrob Agents Chemother) Manual	Phase 1/2	Influenza A virus infection	126	oseltamivir+MEDI8852	jmofuacpxq(mujzwmtnus) = eauyawfbmo lbysdnyllu (polvqsmljp ) View more	Positive	24 Oct 2018
				Placebo+oseltamivir	jmofuacpxq(mujzwmtnus) = nsirjanmpq lbysdnyllu (polvqsmljp ) View more
NCT02603952 (MEDI8852, CTgov)	Phase 1/2	Influenza A virus infection \| Influenza, Human	126	Placebo+Oseltamivir (Placebo + Oseltamivir 75 mg)	rsdatibspm = howicmqmvs rkcpjyaope (znabgucair, grxxuxlauy - duoimiidaa) View more	-	08 Jun 2018
				MEDI8852+Oseltamivir (MEDI8852 750 mg + Oseltamivir 75 mg)	rsdatibspm = xxztvcpodf rkcpjyaope (znabgucair, jtwqdhvpzy - hcebevepdl) View more
NCT02350751 (Pubmed \| Biologicals) Manual	Phase 1	Influenza A virus infection	40	MEDI8852	ebremonjdu(aimfvaaonv) = No subjects discontinued the study due to a TEAE. fxqgntllbt (dcvmfjwiwh )	Positive	01 Nov 2017
				Placebo

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