MBP-134

SAN ANTONIO, Dec. 19, 2022 /PRNewswire/ -- A Sudan ebolavirus vaccine and antibody therapeutic tested at Texas Biomedical Research Institute have been sent to Uganda as part of efforts to control the outbreak there. Sudan ebolavirus is one of six known Ebola species, with a fatality rate ranging between 41% and 100%. The approved Ebola vaccine is effective against the Zaire species, not the closely related Sudan species currently affecting Uganda. Since the Sudan virus outbreak began in September, at least 142 people have been infected and 55 people have died, including many children. Continue Reading A vaccine and therapeutic tested at Texas Biomed have been sent to Uganda to help control the Sudan ebolavirus outbreak. Tweet this The World Health Organization and other global entities announced in November they are working with Ugandan officials to distribute Sudan ebolavirus vaccine candidates in clinical trials. One of those candidates, currently being developed by Sabin Vaccine Institute, has been undergoing preclinical testing at Texas Biomed to evaluate safety and efficacy, and an initial shipment of the vaccine is now in Uganda. The Institute has also been subcontracted by Mapp Biopharmaceutical Inc. to support the development of its antibody therapeutic, MBP134, which has been deployed to the region to treat infected patients. Development of the vaccine and antibody candidates is currently being funded in whole or in part by the U.S. Department of Health and Human Services, Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA)*. Texas Biomed will continue to help advance vaccines and therapies for Sudan ebolavirus. Notably, the Institute has been awarded more than $35 million in subcontracts to run detailed studies required by the FDA to determine if Sudan ebolavirus vaccines and therapies are effective. "These new multi-year contracts underscore how Texas Biomed is a trusted and valued partner across industry, government and nonprofit sectors all focused on tackling some of the greatest health challenges we face as a global community," says Cory Hallam, PhD, Texas Biomed's Vice President for Business Development and Strategic Alliances. Texas Biomed's contract research enterprise has tripled in the last three years due in large part to its specialized expertise and facilities. "There are only a few labs that can perform the regulated and specialized studies required by FDA to support approval of a vaccine or treatment for these types of pathogens," explains Ricardo Carrion, Jr., PhD, who directs Texas Biomed's Maximum Containment Contract Research unit. Work on these deadly viruses must be carried out in a biosafety level 4 (BSL-4) laboratory, which is the highest, most secure level. Texas Biomed opened the nation's first independently operated BSL-4 in 1999. The Institute also hosts the Southwest National Primate Research Center, one of seven supported by the U.S. government. Over the past decade, Texas Biomed has worked to establish animal models required to conduct the studies that provide foundational information for a vaccine or therapy that may go to FDA for review. "Our work helps pharmaceutical companies move their vaccines and therapies forward faster, because we've done the first part for them, providing the baseline information about the virus in animal models," says Texas Biomed Staff Scientist Kendra Alfson, PhD, the first author of the paper describing the Sudan ebolavirus animal model. Dr. Carrion adds: "We are proud to help contribute this knowledge so our partners can develop effective tools that will protect people from these deadly viruses, especially as outbreaks become more common." *BARDA contracts 75A50122C00061 and 75A50119C00055 Texas Biomed is a nonprofit research institute focused on infectious diseases. Through basic research, preclinical testing and innovative partnerships, Texas Biomed accelerates diagnostics, therapies and vaccines for the world's deadliest pathogens. SOURCE Texas Biomedical Research Institute

The Sudan Ebola and Marburg mAb programs were awarded approximately $190 million of BARDA funding covering manufacturing, efficacy and safety evaluations, and regulatory approval Los Gatos, Calif., Dec. 05, 2022 (GLOBE NEWSWIRE) -- Aridis Pharmaceuticals, Inc. (NASDAQ: ARDS), a biopharmaceutical company focused on the discovery and development of novel anti-infective therapies for treating life-threatening infections, signed an exclusive term sheet to secure international development and global commercial rights upon licensure for the pan-Ebola and pan-Marburg monoclonal antibody (mAbs) programs from Mapp Biopharmaceutical, Inc. (MappBio), a privately-owned leading developer of novel pharmaceuticals for the prevention and treatment of infectious diseases with a focus on unmet needs in global health and biodefense. Aridis and MappBio have committed to work exclusively with each other to expeditiously complete definitive licensing agreements MappBio’s pan-Ebola and pan-Marburg mAb programs are currently in Phase 1 clinical studies and both products have shown best-in-class protection against live virus challenges in non-human primates “We are very pleased to continue our history of collaborations with MappBio, particularly on the acquisition of clinical-stage assets that have supportive funding in place through licensure,” said Vu Truong, Ph.D., Chief Executive Officer of Aridis Pharmaceuticals. “This latest partnership will significantly expand our antiviral mAb portfolio with product candidates that are critical to U.S. public health preparedness and enhance the US government’s Strategic National Stockpile to protect against the next Ebola or Marburg outbreak.” The Strategic National Stockpile is a federally funded program that acquires, stores, and distributes medical countermeasures in the event of a public health emergency. “We are delighted at the idea of working with Aridis on these programs given their team’s strong experience with antibody development and commercialization,” commented Larry Zeitlin, Co-Founder and President of MappBio. “The current outbreak of Sudan Ebola underway in Uganda highlights the importance of advancing these programs as rapidly as possible.” “These are important MappBio projects with strong commercial potential with both government and private market buyers globally,” added Kevin Whaley, Co-Founder and CEO of MappBio. “Vu and the Aridis team are tremendous potential commercial partners for these mAb programs, and we look forward to completing our full licensing agreement to officially move forward.” About pan-Ebola and pan-Marburg mAb programs The pan-Ebola program, MBP134, is a two mAb cocktail that has demonstrated effectiveness against Sudan virus (SUDV), Zaire Ebola virus (EBOV), Bundibugyo virus (BDBV), Taï Forest virus (TAFV), Reston virus (RESTV), and Bombali ebolavirus (BOMV) in laboratory studies to date, suggesting it has potential to serve as a broad-spectrum Ebolavirus countermeasure. MBP134 fully protected non-human primates from lethal Sudan Ebola virus challenge and is currently in Phase 1 studies in healthy adults. MappBio was recently awarded $110 million by BARDA to further advance the program, including the development of a lyophilized (freeze-dried) formulation of MBP134 in order to reduce the need for cold-chain storage and improve its transportability. The funding under this new award (up to $837 million, if options are exercised) covers activities necessary to request regulatory approval of MBP134, including support for manufacturing, efficacy and safety evaluations, and regulatory submissions. MBP134 is the first SUDV therapeutic in BARDA’s portfolio. MBP134 is eligible for a Priority Review Voucher (PRV). MBP091 is a single human mAb that is being developed as an anti-Marburg virus therapeutic for the treatment of hemorrhagic fevers caused by Marburg virus disease and it has also been shown to be active against the closely related Ravn virus. MBP091 has been evaluated in numerous preclinical experiments and has demonstrated the ability to neutralize Marburg virus in vitro and fully protect from lethal challenge of Marburg in vivo. A Phase 1 clinical study evaluating the safety and pharmacokinetics of MBP091 in healthy adults is underway. MappBio was recently awarded $80 million in funding from BARDA to continue to advance the development of MBP091 towards licensure. The funding under this new award (up to $267 million, if options are exercised) covers activities necessary to request regulatory approval of MBP091. MBP091 is the first Marburg virus therapeutic in BARDA’s portfolio. MBP091 is eligible for a Priority Review Voucher (PRV). Ebola and Marburg viruses are members of the filovirus family that cause severe hemorrhagic fevers. Ebola, a deadly virus that most commonly affects people and non-human primates, is believed to be animal-borne and can spread through contact with blood, body fluids and tissues. Marburg virus was first identified in 1967 and has caused numerous outbreaks (for example, 2022 in Ghana, 2021 in Guinea, and 2017 in Uganda), with relatively high mortality rates. About Mapp Biopharmaceutical, Inc. Mapp Biopharmaceutical was founded in 2003 by Drs. Kevin Whaley and Larry Zeitlin to develop novel pharmaceuticals for the prevention and treatment of infectious diseases, focusing on unmet needs in global health and biodefense. About Aridis Pharmaceuticals, Inc. Aridis Pharmaceuticals, Inc. discovers and develops novel anti-infective therapies to treat life-threatening infections, including anti-infectives to be used as add-on treatments to standard-of-care antibiotics. The Company is utilizing its proprietary ʎPEXTM and MabIgX® technology platforms to rapidly identify rare, potent antibody-producing B-cells from patients who have successfully overcome an infection, and to rapidly manufacture monoclonal antibodies (mAbs) for therapeutic treatment of critical infections. These mAbs are already of human origin and functionally optimized for high potency by the donor’s immune system; hence, they typically do not require genetic engineering or further optimization to achieve full functionality. The Company is advancing multiple clinical stage mAbs targeting bacteria that cause life-threatening infections such as ventilator associated pneumonia (VAP) and hospital acquired pneumonia (HAP), in addition to preclinical stage antiviral mAbs. The use of mAbs as anti-infective treatments represents an innovative therapeutic approach that harnesses the human immune system to fight infections and is designed to overcome the deficiencies associated with the current standard of care which is broad spectrum antibiotics. Such deficiencies include, but are not limited to, increasing drug resistance, short duration of efficacy, disruption of the normal flora of the human microbiome and lack of differentiation among current treatments. The mAb portfolio is complemented by a non-antibiotic novel mechanism small molecule anti-infective candidate being developed to treat lung infections in cystic fibrosis patients. The Company’s pipeline is highlighted below: Aridis' Pipeline AR-301 (VAP). AR-301 is a fully human IgG1 mAb targeting gram-positive Staphylococcus aureus (S. aureus) alpha-toxin and is being evaluated in a global Phase 3 superiority clinical study as an adjunctive treatment of S. aureus ventilator associated pneumonia (VAP). AR-320 (VAP). AR-320 is a fully human IgG1 mAb targeting S. aureus alpha-toxin that is being evaluated in a Phase 3 clinical study as a preventative treatment of S. aureus colonized mechanically ventilated patients who do not yet have VAP. AR-501 (cystic fibrosis). AR-501 is an inhaled formulation of gallium citrate with broad-spectrum anti-infective activity being developed to treat chronic lung infections in cystic fibrosis (CF) patients. This program is currently in Phase 2a clinical development in CF patients. AR-701 (COVID-19). AR-701 is a cocktail of fully human mAbs discovered from convalescent COVID-19 patients that are directed at multiple protein epitopes on the SARS-CoV-2 virus. It is formulated for delivery via intramuscular injection or inhalation using a nebulizer. AR-401 (blood stream infections). AR-401 is a fully human mAb preclinical program aimed at treating infections caused by gram-negative Acinetobacter baumannii. AR-101 (HAP). AR-101 is a fully human immunoglobulin M, or IgM, mAb in Phase 2 clinical development targeting Pseudomonas aeruginosa (P. aeruginosa) liposaccharides serotype O11, which accounts for approximately 22% of all P. aeruginosa hospital acquired pneumonia cases worldwide. AR-201 (RSV infection). AR-201 is a fully human IgG1 mAb out-licensed preclinical program aimed at neutralizing diverse clinical isolates of respiratory syncytial virus (RSV). For additional information on Aridis Pharmaceuticals, please visit . Forward-Looking Statements Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. These statements may be identified by the use of words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern Aridis' expectations, strategy, plans or intentions. These forward-looking statements are based on Aridis' current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, the need for additional financing, the timing of regulatory submissions, Aridis' ability to obtain and maintain regulatory approval of its existing product candidates and any other product candidates it may develop, approvals for clinical trials may be delayed or withheld by regulatory agencies, risks relating to the timing and costs of clinical trials, risks associated with obtaining funding from third parties, management and employee operations and execution risks, loss of key personnel, competition, risks related to market acceptance of products, intellectual property risks, risks related to business interruptions, including the outbreak of COVID-19 coronavirus, which could seriously harm our financial condition and increase our costs and expenses, risks associated with the uncertainty of future financial results, Aridis' ability to attract collaborators and partners and risks associated with Aridis' reliance on third party organizations. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, market conditions and the factors described under the caption "Risk Factors" in Aridis' 10-K for the year ended December 31, 2021 and Aridis' other filings made with the Securities and Exchange Commission. Forward-looking statements included herein are made as of the date hereof, and Aridis does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances. Contact: Media Communications: Matt Sheldon RedChip Companies Inc. Matt@redchip.com 1-917-280-7329 Investor Relations Dave Gentry Redchip Dave@redchip.com 1-800-733-2447 SOURCE Aridis Pharmaceuticals, Inc.