作者: Athale, Shruti ; Mason, Clifford ; Ribble, Wendy ; Ochsner, Urs A ; Jarvis, Thale ; Hoang, Teresa ; Howe, David ; Patel, Swati ; Gingrich, Matthew ; Chapagain, Moti ; Sun, Xicheng ; Day, Joshua ; Gumbo, Tawanda

AbstractBackgroundListeriosis is an orphan disease, which is nevertheless fatal in immunocompromised people. CRS0540 is a novel PolC DNA polymerase inhibitor that has demonstrated good in vitro and in vivo activity against Listeria monocytogenes.MethodsRodent-to-human allometry projection-based human population pharmacokinetics of CRS0540 were used for all studies. CRS0540 pharmacokinetics/pharmacodynamics studies in an intracellular hollow-fibre system model of disseminated listeriosis (HFS-Lister) examined the effect of eight treatment doses, administered daily over 7 days, in duplicate units. Total bacterial burden versus AUC/MIC exposures on each day were modelled using the inhibitory sigmoid Emax model, while CRS0540-resistant bacterial burden was modelled using a quadratic function. Ten thousand-subject Monte Carlo simulations were used to predict an optimal clinical dose for treatment.ResultsThe mean CRS0540 intracellular/extracellular AUC0–24 ratio was 34.07 (standard error: 15.70) as measured in the HFS-Lister. CRS0540 demonstrated exposure-dependent bactericidal activity in the HFS-Lister, with the highest exposure killing approximately 5.0 log10 cfu/mL. The free drug AUC0–24/MIC associated with 80% of maximal kill (EC80) was 36.4. Resistance emergence versus AUC/MIC was described by a quadratic function, with resistance amplification at an AUC/MIC of 54.8 and resistance suppression at an AUC/MIC of 119. Monte Carlo simulations demonstrated that for the EC80 target, IV CRS0540 doses of 100 mg/kg achieved PTAs of >90% at MICs up to 1.0 mg/L.ConclusionsCRS0540 is a promising orphan drug candidate for listeriosis. Future PK/PD studies comparing it with penicillin, the standard of care, could lead to this drug as a new treatment in immunocompromised patients.

2021-08-12·Journal of Antimicrobial Chemotherapy2区 · 医学

Improving outcomes and antibiotic stewardship (IOAS) for patients with Gram-positive bloodstream infections through use of rapid testing: a quasi-experimental multicentre study of the Accelerate PhenoTest™ BC Kit

2区 · 医学

Article

作者: Rosenbaum, Eric R. ; Ince, Dilek ; MacVane, Shawn H. ; Dare, Ryan K. ; Humphries, Romney M. ; Ford, Bradley ; Kinn, Patrick ; Wolfe, Kaleb ; Bhalodi, Amira A. ; Percival, Kelly M.

AbstractBackgroundData from the Improving Outcomes and Antibiotic Stewardship for Patients with Bloodstream Infections: Accelerate PhenoTest™ BC Kit (AXDX) Registry Study were analysed to determine the impact of rapid organism identification and antimicrobial susceptibility testing (AST) for Gram-positive bacteraemia.Patients and methodsThis multicentre, quasi-experimental study evaluated clinical and antimicrobial stewardship metrics following the implementation of AXDX. Data from hospitalized patients with bacteraemia were compared between groups, one that underwent testing on AXDX (post-AXDX) and one that underwent traditional identification and AST (pre-AXDX). An analysis of patients with Gram-positive bacteraemia was performed. The primary outcome was time to optimal therapy (TTOT). Secondary outcomes included time to first antibiotic modification (overall and Gram-positive), duration of unnecessary MRSA coverage, incidence of adverse events, length of stay and mortality.ResultsA total of 219 (109 pre-AXDX, 110 post-AXDX) patients with Gram-positive bacteraemia were included. Median TTOT was 36.3 h (IQR, 16.9–56.7) in the pre-AXDX group and 20.4 h (IQR, 7.5–36.7) in the post-AXDX group (P = 0.01). Compared with pre-AXDX, median time to first antibiotic modification (29.1 versus 15.9 h; P = 0.002), time to first Gram-positive antibiotic modification (33.2 versus 17.2 h; P = 0.003) and median duration of unnecessary MRSA coverage (58.4 versus 29.7 h; P = 0.04) were reduced post-AXDX. A trend towards decreased acute kidney injury (24% versus 13%; P = 0.06) was observed in the post-AXDX group. Groups did not differ in other secondary outcomes.ConclusionsImplementation of AXDX testing for patients with Gram-positive bacteraemia shortened the TTOT and reduced unnecessary antibiotic exposure due to faster antibiotic modifications.

2019-02-01·JBJS Reviews

Antibiotic Prophylaxis in the Management of Open Fractures

Review

作者: Wang, Mei ; Bhatnagar, Neera ; Mirza, Reza Donald ; Naji, Faysal N. ; Milovanovic, Lazar ; Cho, Sung Min ; Lopes, Luciane Cruz ; Kennedy, Sean Alexander ; Negm, Ahmed ; Wang, Li ; Jin, Lin ; Schandelmaier, Stefan ; Guyatt, Gordon H. ; Hu, Shiyun ; Chang, Yaping ; Zhao, Yanping ; Bhandari, Mohit ; Agarwal, Arnav ; Zhu, Kan Lun ; Ristevski, Bill ; Siemieniuk, Reed A.C. ; Petrisor, Brad ; Ren, Melody ; Kamran, Rakhshan ; Fei, Yutong

Background:Evidence with regard to antibiotic prophylaxis for patients with open fractures of the extremities is limited. We therefore conducted a systematic survey addressing current practice and recommendations.Methods:We included publications from January 2007 to June 2017. We searched Embase, MEDLINE, CINAHL, the Cochrane Central Registry of Controlled Trials (CENTRAL), and the Cochrane Database of Systematic Reviews for clinical studies and surveys of surgeons; WorldCat for textbooks; and web sites for guidelines and institutional protocols.Results:We identified 223 eligible publications that reported 100 clinical practice patterns and 276 recommendations with regard to systemic antibiotic administration, and 3 recommendations regarding local antibiotic administration alone. Most publications of clinical practice patterns used regimens with both gram-positive and gram-negative coverage and continued the administration for 2 to 3 days. Most publications recommended prophylactic systemic antibiotics. Most recommendations suggested gram-positive coverage for less severe injuries and administration duration of 3 days or less. For more severe injuries, most recommendations suggested broad antimicrobial coverage continued for 2 to 3 days. Most publications reported intravenous administration of antibiotics immediately.Conclusions:Current practice and recommendations strongly support early systemic antibiotic prophylaxis for patients with open fractures of the extremities. Differences in antibiotic regimens, doses, and durations of administration remain in both practice and recommendations. Consensus with regard to optimal practice will likely require well-designed randomized controlled trials.Clinical Relevance:The current survey of literature systematically provides surgeons’ practice and the available expert recommendations from 2007 to 2017 on the use of prophylactic antibiotics in the management of open fractures of extremities.

项与 CRS-0540 相关的新闻（医药）

2024-09-05

·PipelineReview

Crestone Announces Positive Data From Phase 2 Clinical Trial of CRS3123 for C. Difficile Infections (CDI)

Primary endpoint met with high rates of clinical cure at day 12 Very low rates of recurrence observed with CRS3123 CRS3123 was generally safe and well tolerated NIAID exercises $4.5 million option to fund phase 2 supporting studies BOULDER, CO, USA I September 05, 2024 I Crestone, Inc. (“Crestone”) today announced positive topline results from the Phase 2 clinical trial evaluating CRS3123 in patients with Clostridioides difficile infection (CDI). CRS3123 is a novel drug candidate that has demonstrated narrow spectrum and minimal disruption of normal gut microbiota in preclinical and Phase 1 studies. Among the 43 patients in the primary intent-to-treat (ITT) analysis population, clinical cure rates at the day 12 test-of-cure visit were comparable in all three treatment groups, including 28/29 (97%) in patients receiving one of two dosages of CRS3123 versus 13/14 (93%) in those receiving vancomycin. There were no clinical failures at the day 12 time point; the results in two patients were indeterminate. Importantly, rates of CDI recurrence were considerably lower in those patients who received CRS3123. For example, at day 40 recurrence rates were 4% for CRS3123 versus 23% for vancomycin. CRS3123 was well tolerated, with no serious treatment-emergent adverse events. Crestone plans to present the results from the Phase 2 trial at an upcoming medical conference. CDI is the most common hospital-acquired infection in the U.S. and is now even more prevalent in the community, including in younger patients. In the U.S. there are almost half a million infections each year and approximately 30,000 deaths. Dr. Thomas Louie of University of Calgary, Canada, principal investigator for this study, stated: “Treatment of C. difficile infection remains in urgent need of agents that spare normal gut microbes, so they can reconstitute the microbiome and prevent further recurrences of CDI. The findings of this study support CRS3123 as such a candidate for further development.” Epidemiology analysis and toxin testing for this study were performed at the University of Leeds. Dr. Mark Wilcox, Professor at Leeds Teaching Hospitals and University of Leeds and Lead on CDI for UK Health Security Agency, stated: “It is now abundantly clear that curbing C. difficile while preserving healthy intestinal flora is what we want in a CDI therapeutic. The outcome of this phase 2 study further reinforces that goal.” “We are very pleased with these results,” said Dr. Jon Bruss, Acting Chief Medical Officer to Crestone. “This was a challenging study to execute given pandemic disruptions to healthcare. We want to sincerely thank all the patients, families, clinicians and collaborators who contributed to the generation of these important data.” The company also announced that, based upon the results of this study, the National Institute of Allergy and Infectious Diseases (NIAID) has exercised its option under an existing agreement with Crestone to provide $4.5 million in new funding for microbiome analyses, manufacturing process optimization and other phase 2 supporting studies. This project has been funded with federal funds from NIAID, National Institutes of Health, Department of Health and Human Services, under Contract No. 75N93019C00056. “We very much appreciate NIAID’s scientific input and the more than $28 million in funding for phase 2 development of CRS3123,” said Urs Ochsner, PhD, co-Founder, Vice President of R&D and CEO at Crestone. “With these topline data and further data to come in the next few months, we look forward to discussions with the FDA and prospective development partners and investors about accelerating into pivotal CDI studies with CRS3123,” said Dr. Ochsner. About the Phase 2 Clinical Trial of CRS3123 The Phase 2, randomized, double-blind, comparator-controlled, multicenter study evaluated safety and efficacy of two dosages of CRS3123 (200 mg and 400 mg) administered twice-daily compared with vancomycin 125 mg administered four times daily in 43 adults diagnosed with a primary episode or first recurrence of CDI. The duration of treatment for all study treatment arms was 10 days. Patients with clinically documented, toxin-positive CDI were enrolled at sites in the U.S. and Canada. The primary endpoint was defined as the rate of clinical cure at day 12 in the ITT population. Secondary and exploratory endpoints included rates of recurrence and global cure, time to resolution of diarrhea and the effect of CRS3123 on commensal bacteria in the gut. About C. difficile Infection CDI has been identified by the Centers for Disease Control and Prevention (CDC) as an “urgent” threat. CDI is an infection of the gut with symptoms of painful diarrhea, associated mental anguish and sometimes toxic megacolon or death. Currently, most patients are treated with suboptimal, broad-spectrum antibiotics that prevent healthy gut microbiota from recovering, contributing to CDI recurrence rates of 20-40%. Once CDI recurs, it is more likely to recur again and again even after further treatment with existing therapeutics, leading to substantially increased morbidity and mortality. 30-day CDI mortality rates ranging from 6% to 11% have been reported by CDC and multiple other sources. Among Medicare beneficiaries over 65 with a first CDI episode, mortality from all causes within 12 months was between 35% and 45%. An effective therapy that treats CDI while preventing recurrent CDI continues to be urgently needed. About CRS3123 CRS3123 is a small molecule that selectively inhibits one form of the bacterial methionyl-tRNA synthetase, which is the mechanistic basis of its narrow spectrum. This target is not present in human cells, nor in other important bacterial species that are part of the normal microbiota of the gut. As a protein synthesis inhibitor, CRS3123 blocks not only C. difficile growth, but also toxin production and spore formation. In Phase 1 trials in healthy subjects and in this Phase 2 trial in CDI patients, CRS3123 achieved high intestinal concentrations, low systemic exposure and was generally safe and well tolerated. The FDA has granted QIDP and Fast Track designations to CRS3123 for the treatment of CDI. About Crestone, Inc. Boulder, Colorado-based Crestone, Inc. is a clinical stage biopharmaceutical company focused on inventing and developing novel mechanism of action, small molecule antimicrobial drugs. Its pipeline includes CRS3123 in clinical development to treat CDI and under investigation to treat symptoms of autism spectrum disorder, symptoms of Pitt Hopkins Syndrome (a rare genetic disease), prevention of graft versus host disease (GvHD) and other indications. The pipeline also includes CRS0540 to treat resistant Gram-positive infections such as methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant Enterococcus (VRE), and other programs directed at nontuberculous mycobacterial (NTM) disease and other bacterial and viral diseases. The company has been funded primarily through multiple research and development grants and contracts worth more than $50 million, including two ongoing NIAID contracts for CRS3123 and CRS0540, respectively. The company is owned by its scientific founders and staff and currently retains worldwide, royalty-free rights to both programs. SOURCE: Crestone

临床结果临床2期快速通道临床1期微生物疗法

2023-05-15

·BioSpace

Elevation Oncology Reports First Quarter 2023 Financial Results and Highlights Recent Business Achievements

Partner CSPC Pharmaceutical Group Limited's ongoing Phase 1 SYSA1801 (EO-3021) clinical trial data selected for poster presentation and poster discussion at ASCO 2023 Presented EO-3021 preclinical proof-of-concept data at AACR 2023 which demonstrated anti-tumor activity in models expressing varying levels of Claudin 18.2; clinical case study highlighted SYSA1801 (EO-3021) induced a confirmed partial response in a patient with metastatic gastric cancer NEW YORK, May 15, 2023 /PRNewswire/ -- Elevation Oncology, Inc. (Nasdaq: ELEV), an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs, today announced financial results for the quarter ended March 31, 2023, and highlighted recent business achievements. "Throughout the first quarter of 2023, we made significant progress as a company. Most recently, we presented preclinical data for our lead candidate, EO-3021, demonstrating anti-tumor activity in preclinical models expressing varying levels of Claudin 18.2, and highlighted a clinical case study showing EO-3021 induced a confirmed partial response in a patient with metastatic gastric cancer," said Joseph Ferra, Interim Chief Executive Officer of Elevation Oncology. "This is an exciting time for us as we and our partner, CSPC Pharmaceutical Group Limited, embark on sharing initial clinical data from the ongoing Phase 1 study of EO-3021 at ASCO 2023. In addition, we remain on track to initiate our Phase 1 trial evaluating EO-3021 in the US in the second half of 2023." Recent Business Achievements EO-3021 Presented preclinical proof-of-concept data at AACR 2023. Key preclinical findings included demonstrating anti-tumor activity in preclinical xenograft models of pancreatic and gastric cancers expressing varying levels of Claudin 18.2. A single-dose of EO-3021 demonstrated tumor regression across low, medium, and high Claudin 18.2-expressing models, with a lower minimal efficacious dose in models with medium and high levels of Claudin 18.2 relative to models with low levels of Claudin 18.2. EO-3021 also outperformed standard of care chemotherapy in gastric and pancreatic cancer preclinical xenograft models. Highlighted clinical case study of EO-3021 at AACR 2023. A clinical case study of a patient with metastatic gastric cancer in an ongoing Phase 1 clinical trial of SYSA1801 (EO-3021) in China (NCT05009966) conducted by CSPC Pharmaceutical Group Limited (HKEX: 01093) was also highlighted. The patient was treated with dose level 2, or 1.0mg/kg EO-3021, intravenously, every three weeks (treatment ongoing). The best overall response, as evaluated per RECIST v1.1, was a confirmed partial response (66.7% maximal tumor reduction), while the duration of response was approximately 11 months and ongoing. SYSA1801 (EO-3021) Phase 1 data selected for presentation at ASCO 2023. An abstract featuring SYSA1801 (EO-3021) Phase 1 clinical data has been selected for a poster presentation and poster discussion at the upcoming American Society of Clinical Oncology (ASCO) 2023 Annual Meeting, being held June 2-6, 2023, in Chicago, IL. The ongoing Phase 1 dose escalation and dose expansion study is evaluating SYSA1801 in patients with Claudin 18.2-positive advanced solid tumors and is being conducted in China by Elevation Oncology's partner, CSPC Pharmaceutical Group Limited (CSPC; HKEX: 01093). Other Pipeline Programs Continue research and development efforts to advance novel therapeutic drug candidates and targets. Additional pipeline programs include those through its existing partnership with Caris Life Sciences. Expected Upcoming Milestones and Operational Objectives Initiate Phase 1 clinical trial of EO-3021 in the US in the second half of 2023 Ongoing target evaluation for future pipeline expansion First Quarter 2023 Financial Results As of March 31, 2022, the Company had cash, cash equivalents and marketable securities totaling $73.9 million, compared to $90.3 million as of December 31, 2022. Research and development expenses for the first quarter 2023 were $7.3 million, compared to $13.6 million for the first quarter 2022. The decrease in R&D expense in the first quarter of 2023 was primarily related to the decrease in costs related to manufacturing clinical supply of seribantumab for use in the CRESTONE clinical trial. The Company prioritized its pipeline and realigned resources to advance its EO-3021 product candidate. General and administrative expenses for the first quarter 2023 were $4.3 million, compared to $3.8 million for the first quarter 2022. The increase in G&A expense in the first quarter of 2023 was primarily related to increases in personnel costs, professional services and other administrative costs. Restructuring charges were $5.1 million for the first quarter 2023, and consisted primarily of one-time charges related to the pipeline prioritization and realignment of resources to advance our EO-3021 product candidate, including $1.6 million of termination and contractual termination benefits for severance, healthcare and related benefits. Net loss for the first quarter 2023 was $17.1 million, compared to $17.3 million for the first quarter 2022. About EO-3021 EO-3021 (also known as SYSA1801) is a differentiated, clinical-stage antibody drug conjugate (ADC) comprised of an immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that targets Claudin 18.2 and is site-specifically conjugated to the monomethyl auristatin E (MMAE) payload via a cleavable linker with a drug-to-antibody ratio (DAR) of 2. Claudin 18.2 is a specific isoform of Claudin 18 that is only expressed in gastric epithelial cells. During malignant transformation of gastric cancer, the tight junctions may become disrupted, exposing Claudin 18.2 and allowing them to be accessible by Claudin 18.2 targeting agents. Claudin 18.2 can also be expressed in other solids tumors. An Investigational New Drug application for EO-3021 has been cleared by the U.S. Food and Drug Administration. About Elevation Oncology, Inc. Elevation Oncology is an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs. We are rethinking drug development by seeking out innovative, selective cancer therapies that can be matched to a patient's unique tumor characteristics. Our lead candidate, EO-3021, is a potential best-in-class antibody drug conjugate (ADC) designed to target Claudin 18.2, a clinically validated molecular target. EO-3021 selectively delivers a cytotoxic payload directly to cancer cells expressing Claudin 18.2. We are working to rapidly advance EO-3021 into the clinic in the US across a range of solid tumor indications, as well as exploring other opportunities through new or existing partnerships and business development opportunities to expand our novel oncology pipeline. For more information, visit . Forward Looking Statements This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, anticipated preclinical and clinical development activities, expected timing of announcements of clinical results, potential benefits of Elevation Oncology's product candidates, potential market opportunities for Elevation Oncology's product candidates, the ability of Elevation Oncology's product candidates to treat their targeted indications and Elevation Oncology's expectations about its cash runway. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These forward-looking statements may be accompanied by such words as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "goal," "intend," "may," "might," "plan," "potential," "possible," "will," "would," and other words and terms of similar meaning. Although Elevation Oncology believes that the expectations reflected in such forward-looking statements are reasonable, Elevation Oncology cannot guarantee future events, results, actions, levels of activity, performance or achievements, and the timing and results of biotechnology development and potential regulatory approval are inherently uncertain. Forward-looking statements are subject to risks and uncertainties that may cause Elevation Oncology's actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to Elevation Oncology's ability to advance its product candidates, the timing and results of preclinical studies and clinical trials, approvals and commercialization of product candidates, the receipt and timing of potential regulatory designations, the impact of the continued presence of COVID-19 on Elevation Oncology's business, Elevation Oncology's ability to fund development activities and achieve development goals, Elevation Oncology's ability to protect intellectual property, Elevation Oncology's ability to establish and maintain collaborations with third parties, and other risks and uncertainties described under the heading "Risk Factors" in documents Elevation Oncology files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and Elevation Oncology undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof. Elevation Oncology Investor and Media Contact Candice Masse, 978-879-7273 Senior Director, Corporate Communications & Investor Relations Cmasse@elevationoncology.com Company Codes: NASDAQ-NMS:ELEV

临床1期财报ASCO会议AACR会议临床结果

2022-11-03

·BioSpace

Elevation Oncology Reports Third Quarter 2022 Financial Results and Highlights Recent Company Progress

On track to report additional interim seribantumab data from the Phase 2 CRESTONE study in the first half of 2023 Preparations are underway to initiate a Phase 1 clinical trial of EO-3021 in the US in 2023 NEW YORK, Nov. 3, 2022 /PRNewswire/ -- Elevation Oncology, Inc. (Nasdaq: ELEV), a clinical stage biopharmaceutical company focused on the development of precision oncology products for patients with genomically defined cancers, today announced financial results for the quarter ended September 30, 2022, and highlighted recent progress. "Our newly expanded pipeline provides an opportunity to continue building an industry leading precision oncology company for patients with genomically defined cancers and significant unmet medical needs. We remain focused on execution, as we continue enrolling and treating patients in the ongoing Phase 2 CRESTONE study evaluating seribantumab," said Shawn M. Leland, PharmD, RPh, Founder and Chief Executive Officer of Elevation Oncology. "We are also committed to bringing EO-3021, our differentiated ADC targeting Claudin18.2 into the clinic and plan to initiate a Phase 1 clinical trial in the US in patients with solid tumors in 2023." Recent Progress and Highlights Seribantumab On track to report additional interim data from Cohort 1 of the CRESTONE study in the first half of 2023. CRESTONE is a Phase 2 potential registration-enabling study evaluating seribantumab in patients with solid tumors harboring NRG1 gene fusions. Initial data presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting showed positive clinical proof-of-concept data supporting the potential of seribantumab to induce deep and durable benefit for patients. EO-3021 Phase 1 clinical trial in the US to evaluate EO-3021 in solid tumors expected to initiate in 2023. In July 2022, Elevation Oncology expanded its pipeline through the licensing of EO-3021, a differentiated, clinical-stage antibody-drug conjugate (ADC) that binds to Claudin18.2 and delivers a cytotoxic payload to eliminate tumor cells. Claudin18.2 is a clinically validated oncology target expressed in several solid tumor types including many gastrointestinal cancers such as gastric, gastroesophageal junction, and pancreatic cancer. Our collaboration partner, CSPC Pharmaceutical Group (HKEX: 01093) is currently conducting a Phase 1, dose escalation clinical trial in China in patients with solid tumors. Expected Upcoming Milestones and Operational Objectives Additional interim seribantumab data from the Phase 2 CRESTONE study are expected in the first half of 2023 Phase 1 clinical trial in the US to evaluate EO-3021 expected to initiate in 2023 Topline data for seribantumab from the Phase 2 CRESTONE study results are expected in 2024 Ongoing target evaluation and continued execution of the Company's strategy for future pipeline expansion Third Quarter 2022 Financial Results As of September 30, 2022, the Company had cash, cash equivalents and marketable securities totaling $107.9 million, compared to $122.5 million as of June 30, 2022. Research and development expenses for the third quarter 2022 were $34.3 million, compared to $9.3 million for the third quarter 2021. The increase in R&D expense was primarily related to a one-time upfront license fee of $27.0 million paid to CSPC Megalith Biopharmaceutical Co., Ltd., a subsidiary of CSPC Pharmaceutical Group Limited, for the exclusive rights to develop and commercialize EO-3021 outside of Greater China. General and administrative expenses for the third quarter 2022 were $4.2 million, compared to $3.0 million for the third quarter 2021. The increase in G&A expense was primarily related to personnel costs, professional services and other administrative costs. Net loss for the third quarter 2022 was $38.8 million, compared to $12.3 million for the third quarter 2021. Financial Outlook Elevation Oncology expects its existing cash, cash equivalents and marketable securities as of September 30, 2022, will be sufficient to fund its current operations into 2024. About Elevation Oncology, Inc. Elevation Oncology is founded on the belief that every patient living with cancer deserves to know what is driving the growth of their disease and have access to therapeutics that can stop it. We aim to make genomic tests actionable by selectively developing drugs to inhibit the specific alterations that have been identified as drivers of tumor growth. Together with our peers, we work towards a future in which each tumor's unique genomic test result can be matched with a purpose-built precision medicine to enable an individualized treatment plan for each patient. Our most advanced candidate, seribantumab, is intended to inhibit tumor growth driven by NRG1 fusions and is currently being evaluated in the Phase 2 CRESTONE study for patients with solid tumors of any origin that have an NRG1 gene fusion. Details on the Phase 2 CRESTONE study are available at . Our other product candidate, EO-3021, is a differentiated, clinical stage antibody drug conjugate that targets Claudin18.2 and is currently being developed for the treatment of solid tumors. For more information, visit . Forward Looking Statements: This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, anticipated preclinical and clinical development activities, expected timing of announcements of clinical results, potential benefits of seribantumab, EO-3021 and Elevation Oncology's other future product candidates, potential opportunities to expand Elevation Oncology's product candidate pipeline, potential market opportunities for seribantumab, EO-3021 and Elevation Oncology's other future product candidates, the ability of seribantumab, EO-3021 and Elevation Oncology's other future product candidates to treat their targeted indications, and Elevation Oncology's expectations about its cash runway. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These forward-looking statements may be accompanied by such words as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "goal," "intend," "may," "might," "plan," "potential," "possible," "will," "would," and other words and terms of similar meaning. Although Elevation Oncology believes that the expectations reflected in such forward-looking statements are reasonable, Elevation Oncology cannot guarantee future events, results, actions, levels of activity, performance or achievements, and the timing and results of biotechnology development and potential regulatory approval is inherently uncertain. Forward-looking statements are subject to risks and uncertainties that may cause Elevation Oncology's actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to Elevation Oncology's ability to advance its product candidates, the timing and results of preclinical studies and clinical trials, approvals and commercialization of product candidates, the receipt and timing of potential regulatory designations, the impact of the COVID-19 pandemic on Elevation Oncology's business, Elevation Oncology's ability to fund development activities and achieve development goals, Elevation Oncology's ability to protect intellectual property, Elevation Oncology's ability to establish and maintain collaborations with third parties and other risks and uncertainties described under the heading "Risk Factors" in documents Elevation Oncology files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and Elevation Oncology undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof. Elevation Oncology Investor and Media Contact Candice Masse, 978-879-7273 Senior Director, Corporate Communications & Investor Relations cmasse@elevationoncology.com Company Codes: NASDAQ-NMS:ELEV

财报抗体抗体药物偶联物ASCO会议合作

100 项与 CRS-0540 相关的药物交易

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