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FLORHAM PARK, N.J.--( BUSINESS WIRE )--Shionogi Inc., the United States subsidiary of Shionogi & Co., Ltd., (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.) will have 22 scientific presentations across the company’s infectious disease portfolio at IDWeek 2024 (October 16-19, 2024) in Los Angeles, California. Key among Shionogi’s 13 data presentations for Fetroja® (cefiderocol) will be a new real-world evidence study including approximately 1,000 patients treated with cefiderocol from across the U.S. and Europe. This trial, known as PROVE, is the largest study to evaluate cefiderocol use in hospitalized patients with serious Gram-negative infections, the majority of whom were resistant to carbapenem antibiotics. Notably, Shionogi will have two oral presentations featuring nonclinical data evaluating cefiderocol activity against some of the most difficult-to-treat bacterial strains that were resistant to antibiotics, alone and in combination with xeruborbactam, an investigational beta-lactamase inhibitor that became part of the Shionogi pipeline with the acquisition of Qpex Biopharma, Inc. (hereafter “Qpex”) by Shionogi Inc. in 2023. “Here in the U.S., a core focus of our work includes continuing to evaluate real-world outcomes associated with the use of our antibiotic for the treatment of certain Gram-negative infections and ensuring we’re meeting the educational and practical needs of our customers and their patients,” said Nate McCutcheon, President and Chief Executive Officer, Shionogi Inc. “We’re proud to make this important medication available and we also recognize that ongoing innovation is critical in infectious disease. That’s why we recently announced plans to expand our global infectious disease and antimicrobial research operations in the U.S. through Qpex with the establishment of our first U.S.-based discovery laboratory in San Diego.” Shionogi is honored to announce that Michael N. Dudley, PharmD, President and CEO of Qpex will deliver the keynote address at the Society of Infectious Diseases Pharmacists (SIDP) Annual Meeting, taking place in conjunction with IDWeek. In addition to numerous scientific presentations at IDWeek, Shionogi will once again enable the infectious disease community to join the fight and take a stand against the global public health threat of antimicrobial resistance (AMR) with a new version of its award-winning AMR Warrior experience. All visitors to Shionogi’s Booth #322 will have the opportunity to create their own AMR Warrior and use the image to spread awareness amongst their own networks and communities. Shionogi’s presence at IDWeek will also include a sponsored Learning Lounge on Friday, October 18, at 10:15 AM PT, featuring Thomas Lodise, PharmD, PhD, Professor at the Albany College of Pharmacy and Health Sciences, entitled “Fetroja® (cefiderocol): An Overview of In Vitro, Clinical, and Real-world Data.” Summary of Presentations Cefiderocol data presentations at IDWeek will include: Oral #513: Cefiderocol Retains in vitro Activity Against Enterobacterales Non-Susceptible to beta-lactam-beta-lactamase Inhibitor Combinations Poster #650: In vitro Activity of Cefiderocol and Comparator Agents Against Global Enterobacterales Isolates from Hospitalized Patients with Pneumonia Collected as Part of the SENTRY Surveillance Program (2020-2022) Poster #1099: Correlation Analysis of Cefiderocol in vitro Activity and in vivo Efficacy Against Acinetobacter baumannii Strains with Difficult-to-Read MIC Endpoints Poster #1100: Activity of Cefiderocol and Comparator Agents Against Global Isolates of Stenotrophomonas maltophilia from the SENTRY Antimicrobial Surveillance Program (2020–2023) Poster #1360: Activity of Cefiderocol Against Carbapenem Non-susceptible Enterobacterales, Including Molecularly Characterized Multidrug-resistant Clinical Isolates, Causing Infections in United States Hospitals (2020–2023) Poster #1361: Cefiderocol Activity Against Pseudomonas aeruginosa , Including Resistant Subsets and Isolates Carrying Carbapenemase beta-lactamase Genes, from United States Hospitals (2020–2023) Poster #1362: Cefiderocol Activity Against Carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex, Including Molecularly Characterized Clinical Isolates, Causing Infections in United States Hospitals (2020–2023) Poster #1363: Cefiderocol Activity Against Clinical Enterobacterales Isolates Carrying Metallo-beta-lactamase Genes in United States and European Hospitals (2020–2023) Poster #1364: Cefiderocol Activity Against Pseudomonas aeruginosa Clinical Isolates Carrying Metallo-beta-lactamase Genes in United States and European Hospitals (2020–2023) Poster #1472: Cefiderocol Remains Highly Active Against Carbapenemase-Producing Enterobacterales Poster #1475: Real-World Effectiveness and Safety of Cefiderocol in the Treatment of Patients with Serious Gram-negative Bacterial Infections: Results of the PROVE Chart Review Study Poster #1484: In vitro Activity of Cefiderocol and Comparator Agents Against Non-fermentative Gram-negative Bacilli Isolated from Patients Hospitalized with Pneumonia as part of the SENTRY Global Surveillance Program (2020-2022) Poster #1530: Evaluation of Phenotypic Cross-Resistance Between Cefiderocol and beta-lactam/beta-lactamase Inhibitor Combinations Against Pseudomonas aeruginosa Isolates from US Medical Centers Xeruborbactam data presentations at IDWeek will include: Oral #514: The Impact of Xeruborbactam on in vitro Activity of Cefiderocol Against a Panel of Acinetobacter baumannii Enriched in Isolates with Reduced Cefiderocol Susceptibility Poster #1110: The Impact of Xeruborbactam on in vitro Activity of Cefiderocol Against a Panel of Enterobacterales Enriched with Isolates with Reduced Cefiderocol Susceptibility For Full Prescribing Information for Fetroja® (cefiderocol), including approved Indications and Safety Information, please visit https://www.shionogi.com/content/dam/shionogi/si/products/pdf/fetroja.pdf . Shionogi’s scientific contributions at IDWeek will also include seven poster presentations featuring clinical, nonclinical and real-world evidence from its COVID-19 franchise. For more information, including a complete list of abstracts, please visit https://idweek.org/program/ . IDWeek attendees can learn more about Shionogi at Booth #322. About Shionogi in Infectious Disease Since 1953, Shionogi has been a leader in infectious disease discovery and commercialization. Our R&D story extends beyond antibiotics to include novel medications for HIV and influenza. Today, our global pipeline includes investigational agents developed to address global health challenges including antimicrobial resistance, COVID-19, influenza, rare fungal diseases and respiratory syncytial virus. As part of our commitment to addressing unmet medical needs, Shionogi is partnering with several non-governmental organizations to increase equitable access to our medications worldwide. Shionogi has a landmark license and technology transfer agreement for cefiderocol with Global Antibiotic Research and Development Partnership (GARDP) and a collaboration agreement with the Clinton Health Access Initiative (CHAI) to transform the landscape of access to antibiotics in many low-income countries, most lower middle- and upper middle-income countries, and select high-income countries. About Shionogi Inc. Shionogi Inc. is a U.S. subsidiary of Shionogi & Co., Ltd., a Japanese research-driven pharmaceutical company committed to developing innovative medicines that address unmet medical needs for people worldwide. Since 1878, we have been harnessing the full potential of science to address global health challenges. Over the past six decades, we have discovered several novel antibiotics and medications for HIV and influenza. Today, we’ve focused on developing antibiotics for infections due to serious Gram-negative bacteria and antivirals for COVID-19. In addition to infectious disease, we are also advancing rare disease clinical programs in Fragile X syndrome and Pompe disease. Learn more at Shionogi.com . About Qpex Biopharma Inc., a Shionogi Group Company Qpex Biopharma, Inc. is a resistance-focused infectious disease company on a mission to make both a dramatic and sustainable improvement in patient care across both inpatient and outpatient settings. Advancing a robust portfolio of best-in-class, clinical-stage products, the company’s lead program is based on xeruborbactam, an investigational beta-lactamase inhibitor discovered by Qpex scientists. For more information, please visit www.qpexbio.com . Forward-Looking Statements This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, lack of availability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.

FPI-2059 induces tumor growth inhibition in colorectal tumor model TEM-1 and EGFRvIII demonstrate potential as TAT targets HAMILTON, Canada and BOSTON, MA, USA I April 19, 2023 I Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced the presentation of preclinical data that provide further support of its clinical stage FPI-2059, a neurotensin receptor 1 (NTSR1) targeted alpha therapy (TAT), and additional preclinical development programs. The Company presented these data in three poster presentations at the American Association for Cancer Research (AACR) Annual Meeting. "These data highlight the strong scientific rationale supporting clinical development of FPI-2059, demonstrating that targeting NTSR1 with the tumor killing power of actinium-225 has the potential to induce suppression in solid tumors. We are pleased to be progressing FPI-2059 in our ongoing Phase 1 study," said Fusion Chief Scientific Officer Christopher Leamon, Ph.D. "With our discovery platform, the Fusion team has quickly and efficiently developed TATs for various targets and progressed to multiple clinical programs. The data presented on exploratory targets, such as EGFRvIII and TEM-1, show the ability of our TATs to impact hard to treat cancers." Data from preclinical studies of FPI-2059, a small molecule TAT designed to deliver actinium-225 to tumor sites expressing NTSR1, a protein expressed in gastrointestinal, prostate, pancreatic ductal adenocarcinoma (PDAC) and multiple other cancers, were presented in a poster presentation titled, "NTSR1-targeted alpha therapeutic [Ac-225]-FPI-2059 induces growth inhibition in a preclinical colorectal tumor model". Outcomes of the study demonstrate robust FPI-2059 tumor uptake and dose-dependent tumor growth inhibition and therapeutic efficacy in a preclinical colorectal tumor model. These data provide further evidence supporting the clinical development of FPI-2059, which is currently being evaluated in a Phase 1 study for the treatment of solid tumors expressing NTSR1. Data from additional preclinical studies highlight the potential of tumor endothelial marker 1 (TEM-1) and epidermal growth factor receptor variant 3 (EGFRvIII) as targets for actinium-225 labelled TATs. In sarcoma xenograft models, TEM-1-targeted alpha therapy demonstrates strong dose-dependent and target level-dependent efficacy with no apparent toxicity. In glioblastoma multiforme (GBM) models, EGFRvIII-targeted alpha therapy demonstrates therapeutic efficacy as a single agent and in combination with standard of care. Further, EGFRvIII-targeted alpha therapy demonstrates efficacy in models with both leaky and intact blood-brain tumor barriers, suggesting that even low tumor uptake has potential anti-tumor effect. Copies of the poster presentations can be found at: https://fusionpharma.com/fusion-scientific-presentations/ following the conclusion of the AACR Annual Meeting. About FPI-2059 FPI-2059 is a small molecule radiopharmaceutical targeting neurotensin receptor 1 (NTSR1) which is overexpressed in multiple solid tumors, including pancreatic ductal adenocarcinoma, colorectal, squamous cell carcinoma head & neck, gastric, Ewings sarcoma, and neuroendocrine differentiated prostate. FPI-2059 is based upon a compound previously referred to as IPN-1087 and 3BP-227 that had previously been studied in investigator sponsored studies and a Phase 1 clinical trial as a beta-emitting radiopharmaceutical. Fusion acquired the asset in 2021 and converted it to an alpha emitting radiopharmaceutical using actinium-225. The diagnostic analogue which uses indium-111 in place of actinium-225 is referred to as FPI-2058. About Fusion Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitting payloads to tumors. Fusion's clinical portfolio includes: FPI-2265 targeting prostate specific membrane antigen (PSMA) for metastatic castration resistant prostate cancer currently in a Phase 2 trial; FPI-1434 targeting insulin-like growth factor 1 receptor currently in a Phase 1 trial; FPI-1966, targeting the fibroblast growth factor receptor 3 (FGFR3), currently in a Phase 1 trial; and FPI-2059, a small molecule targeting neurotensin receptor 1 (NTSR1), currently in a Phase 1 trial. In addition to a robust proprietary pipeline, Fusion has a collaboration with AstraZeneca to jointly develop novel targeted alpha therapies (TATs) and combination programs between Fusion's TATs and AstraZeneca's DNA Damage Response Inhibitors (DDRis) and immuno-oncology agents. The Company recently received IND clearance for the first novel TAT under the collaboration, which targets EGFT-cMET. Fusion has also entered into a collaboration with Merck to evaluate FPI-1434 in combination with Merck's KEYTRUDA® (pembrolizumab) in patients with solid tumors expressing IGF-1R. To support Fusion's growing pipeline of TATs, the Company has signed strategic actinium supply agreements with TRIUMF, Niowave, Inc. and BWXT Medical. SOURCE: Fusion Pharmaceuticals

FPI-2059 induces tumor growth inhibition in colorectal tumor model TEM-1 and EGFRvIII demonstrate potential as TAT targets HAMILTON, ON and BOSTON, April 19, 2023 /PRNewswire/ -- Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced the presentation of preclinical data that provide further support of its clinical stage FPI-2059, a neurotensin receptor 1 (NTSR1) targeted alpha therapy (TAT), and additional preclinical development programs. The Company presented these data in three poster presentations at the American Association for Cancer Research (AACR) Annual Meeting. "These data highlight the strong scientific rationale supporting clinical development of FPI-2059, demonstrating that targeting NTSR1 with the tumor killing power of actinium-225 has the potential to induce suppression in solid tumors. We are pleased to be progressing FPI-2059 in our ongoing Phase 1 study," said Fusion Chief Scientific Officer Christopher Leamon, Ph.D. "With our discovery platform, the Fusion team has quickly and efficiently developed TATs for various targets and progressed to multiple clinical programs. The data presented on exploratory targets, such as EGFRvIII and TEM-1, show the ability of our TATs to impact hard to treat cancers." Data from preclinical studies of FPI-2059, a small molecule TAT designed to deliver actinium-225 to tumor sites expressing NTSR1, a protein expressed in gastrointestinal, prostate, pancreatic ductal adenocarcinoma (PDAC) and multiple other cancers, were presented in a poster presentation titled, "NTSR1-targeted alpha therapeutic [Ac-225]-FPI-2059 induces growth inhibition in a preclinical colorectal tumor model". Outcomes of the study demonstrate robust FPI-2059 tumor uptake and dose-dependent tumor growth inhibition and therapeutic efficacy in a preclinical colorectal tumor model. These data provide further evidence supporting the clinical development of FPI-2059, which is currently being evaluated in a Phase 1 study for the treatment of solid tumors expressing NTSR1. Data from additional preclinical studies highlight the potential of tumor endothelial marker 1 (TEM-1) and epidermal growth factor receptor variant 3 (EGFRvIII) as targets for actinium-225 labelled TATs. In sarcoma xenograft models, TEM-1-targeted alpha therapy demonstrates strong dose-dependent and target level-dependent efficacy with no apparent toxicity. In glioblastoma multiforme (GBM) models, EGFRvIII-targeted alpha therapy demonstrates therapeutic efficacy as a single agent and in combination with standard of care. Further, EGFRvIII-targeted alpha therapy demonstrates efficacy in models with both leaky and intact blood-brain tumor barriers, suggesting that even low tumor uptake has potential anti-tumor effect. Copies of the poster presentations can be found at: following the conclusion of the AACR Annual Meeting. About FPI-2059 FPI-2059 is a small molecule radiopharmaceutical targeting neurotensin receptor 1 (NTSR1) which is overexpressed in multiple solid tumors, including pancreatic ductal adenocarcinoma, colorectal, squamous cell carcinoma head & neck, gastric, Ewings sarcoma, and neuroendocrine differentiated prostate. FPI-2059 is based upon a compound previously referred to as IPN-1087 and 3BP-227 that had previously been studied in investigator sponsored studies and a Phase 1 clinical trial as a beta-emitting radiopharmaceutical. Fusion acquired the asset in 2021 and converted it to an alpha emitting radiopharmaceutical using actinium-225. The diagnostic analogue which uses indium-111 in place of actinium-225 is referred to as FPI-2058. About Fusion Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitting payloads to tumors. Fusion's clinical portfolio includes: FPI-2265 targeting prostate specific membrane antigen (PSMA) for metastatic castration resistant prostate cancer currently in a Phase 2 trial; FPI-1434 targeting insulin-like growth factor 1 receptor currently in a Phase 1 trial; FPI-1966, targeting the fibroblast growth factor receptor 3 (FGFR3), currently in a Phase 1 trial; and FPI-2059, a small molecule targeting neurotensin receptor 1 (NTSR1), currently in a Phase 1 trial. In addition to a robust proprietary pipeline, Fusion has a collaboration with AstraZeneca to jointly develop novel targeted alpha therapies (TATs) and combination programs between Fusion's TATs and AstraZeneca's DNA Damage Response Inhibitors (DDRis) and immuno-oncology agents. The Company recently received IND clearance for the first novel TAT under the collaboration, which targets EGFT-cMET. Fusion has also entered into a collaboration with Merck to evaluate FPI-1434 in combination with Merck's KEYTRUDA® (pembrolizumab) in patients with solid tumors expressing IGF-1R. To support Fusion's growing pipeline of TATs, the Company has signed strategic actinium supply agreements with TRIUMF, Niowave, Inc. and BWXT Medical. Forward-Looking Statements This press release contains "forward-looking statements" for purposes of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995, including but not limited to the statements regarding Fusion's future business and financial performance. For this purpose, any statements contained herein that are not statements of historical fact may be deemed forward-looking statements. Without limiting the foregoing, the words "expect," "plans," "anticipates," "intends," "will," and similar expressions are also intended to identify forward-looking statements, as are expressed or implied statements with respect to Fusion's potential drug candidates, including any expressed or implied statements regarding the successful development of its product candidates. Actual results may differ materially from those indicated by such forward-looking statements as a result of risks and uncertainties, including but not limited to the following: the ability to close the Offering; the timing and advancement of current and planned clinical trials; Fusion's ability to maintain its intellectual property portfolio; and the timing and success of our development and commercialization of its product candidates; risks relating to the regulatory process; unexpected patient recruitment delays or regulatory actions or delays; Fusion's ability to obtain additional funding required to conduct its research, development and commercialization activities; changes in Fusion's business plan or objectives; and Fusion's ability to obtain, maintain and enforce patent and other intellectual property protection for its product candidates and its discoveries. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. These and other risks which may impact management's expectations are described in greater detail under the heading "Risk Factors" in Fusion's quarterly report on Form 10-K for the year ended December 31, 2022, as filed with the U.S. Securities and Exchange Commission (the "SEC") and in any subsequent periodic or current report that Fusion files with the SEC. All forward-looking statements reflect Fusion's estimates only as of the date of this release (unless another date is indicated) and should not be relied upon as reflecting Fusion's views, expectations or beliefs at any date subsequent to the date of this release. While Fusion may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, even if Fusion's estimates change. Contact: Amanda Cray Senior Director of Investor Relations & Corporate Communications (617) 967-0207 cray@fusionpharma.com Company Codes: NASDAQ-NMS:FUSN