
Bruker Launches New timsUltra AIP System with Further Enhanced, Extreme Sensitivity for Single-Cell Proteomics, FNA Biopsy Immunopeptidomics and Metaproteomics
New timsUltra AIP is Delivering Breakthrough Sensitivity
The timsUltra AIP further enhances sensitivity by featuring the new AIP technology for further significant advances in high-sensitivity, high-throughput applications on complex biological samples, such as fine-needle aspiration (FNA) tumor biopsies, immunopeptidomics, single-cell proteomics, and metaproteomics. The sensitivity boost is delivered through the novel AIP technology allowing enhanced product ion transfer and optimal orthogonal TOF sampling of MS/MS fragment ions.
With up to 20% gains in protein identifications and up to 35% gains in peptide identifications—depending on the application—the timsUltra AIP system delivers enhanced sensitivity and sequence coverage for sample-limited applications such as single-cell studies. It also enables more comprehensive ion coverage for de novo peptide sequencing and immunopeptidomics neoantigen discovery. Jennifer Van Eyk, Director of Basic Science Research in the Barbra Streisand Women's Heart Center and Professor of Cardiology at Cedars-Sinai in Los Angeles, stated: "With the new timsUltra AIP, we are able to gain much deeper proteomics insights into particularly challenging-to-study single cardiomyocytes. The sensitivity, throughput, and robustness of the timsUltra AIP enables us to gain novel insights into cardiovascular diseases."
Nikolai Slavov, Professor of Bioengineering, Director of the Single-Cell Proteomics Center at Northeastern University, and Founding Director of the Parallel Square Technology Institute, commented: 'The new timsUltra AIP delivers a 3-fold sensitivity gain for peptide fragment ions in single-cell proteomics, which bolsters peptide sequence identifications and enables proteomic analysis at a new level of sensitivity, e.g., even for small red blood cell precursors.'
Metaproteomics presents unique challenges as it must contend with highly diverse and dynamic proteome mixtures derived from numerous, often genetically uncharacterized microbial species. The vast search space and sequence homology among microbes increases false discovery rates and hinders accurate taxonomic and functional assignment. These challenges are being addressed by TIMS-enhanced ultra-high sensitivity of the timsUltra AIP.
David Gómez-Varela, Director of the Center of Excellence of Metaproteomics at the University of Vienna in Austria, said: 'We live in a microbial world, where trillions of microorganisms shape the health of every ecosystem. Yet the protein-level signatures that reflect bacterial activity remain largely elusive due to sensitivity limitations. With the new timsUltra AIP, we can now detect bacterial peptides in the sub-picogram range, reflecting the level of a single bacterium's proteome — a major leap in sensitivity. This enables exploration of microbial life in unprecedented detail, unlocking new insights into the functional diversity of microorganisms.'
Breaking News: Preliminary data shows that in combination with the new Evosep Eno nLC system (Evosep Biosystems, Odense, Denmark), the timsUltra AIP can deliver over 5000 protein identifications at 250 pg (sample amount of a single HeLa cell) with a throughput of 100 samples per day (SPD). Even at 500 SPD, with less than 2.5 minutes per sample injection, more than 2000 proteins can be identified. This high-throughput capability, combined with ultra-high sensitivity, is a game-changer for applications requiring both depth and scale—such as rapid immunopeptidomics neoantigen profiling from FNA biopsies, single-cell proteomics, deep visual proteomics, and the complex challenges of metaproteomics.
About Bruker Corporation – Leader of the Post-Genomic Era (Nasdaq: BRKR)
Bruker is enabling scientists and engineers to make breakthrough post-genomic discoveries and develop new applications that improve the quality of human life. Bruker's high performance scientific instruments and high value analytical and diagnostic solutions enable scientists to explore life and materials at molecular, cellular, and microscopic levels. In close cooperation with our customers, Bruker is enabling innovation, improved productivity, and customer success in post-genomic life science molecular and cell biology research, in applied and biopharma applications, in microscopy and nanoanalysis, as well as in industrial and cleantech research, and next-gen semiconductor metrology in support of AI. Bruker offers differentiated, high-value life science and diagnostics systems and solutions in preclinical imaging, clinical phenomics research, proteomics and multiomics, spatial and single-cell biology, functional structural and condensate biology, as well as in clinical microbiology and molecular diagnostics. For more information, please visit www.bruker.com.
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ROCKVILLE, Md. and SUZHOU, China, Aug. 17, 2025 (GLOBE NEWSWIRE) -- Ascentage Pharma (NASDAQ: AAPG; HKEX: 6855), a global, commercial stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel, differentiated therapies to address unmet medical needs in cancer, announced that it has received clearance by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to conduct GLORA-4 study (NCT06641414), a global registrational Phase III study of lisaftoclax (APG-2575), a proprietary Bcl-2 inhibitor, in combination with azacitidine (AZA), for the treatment of patients with newly diagnosed higher-risk myelodysplastic syndrome (HR-MDS). This marks the second registrational Phase III study of lisaftoclax to receive clearance from both the FDA and EMA. 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The clearances of the GLORA-4 study by the U.S. FDA and EMA, coinciding with the approval by the China CDE, pave the way for lisaftoclax to potentially become the first Bcl-2 inhibitor approved globally for first-line treatment of higher-risk MDS and the first targeted therapy approved for this indication since the introduction of HMA, which fundamentally reshapes the treatment landscape.' The GLORA-4 trial is being conducted simultaneously in China, the U.S., and Europe. This will significantly accelerate the clinical development of lisaftoclax in MDS and accelerate the drug's path to potential market authorization. Moving forward, we will remain steadfastly committed to our mission of addressing unmet clinical needs in China and around the world, actively advancing our clinical programs for the benefit of more patients.' GLORA-4 is a multi-region, multi-center, randomized, double-blind Phase III trial designed to evaluate the efficacy and safety of lisaftoclax in combination with AZA compared to placebo plus AZA in newly diagnosed adult patients with higher-risk MDS. The study was originally approved by the China CDE in 2024. Currently, the study is enrolling patients globally, with the first patients already enrolled in China and Europe. Guillermo Garcia-Manero, MD, Chair of the Department of Leukemia, The University of Texas MD Anderson Cancer Center (MDACC), and Prof. Xiaojun Huang, MD, an academician of the Chinese Academy of Engineering, director of the Institute of Hematology at Peking University, and director of the Department of Hematology at Peking University People's Hospital, are global co-leading principal investigators of the study. MDS is a myeloid clonal disease originating from hematopoietic stem cells with strongly age-correlated characteristics. Global epidemiological data of MDS show an exponential increase in incidence with age (22/100,000 in the population aged over 65 years), with a median age of diagnosis of 70 years1. More than 75% of patients with MDS present a complex disease profile that includes at least two comorbidities2. The primary risk of MDS is clonal evolution leading to progression to acute myeloid leukemia (AML), with 40-60% of higher-risk patients (high/very high risk, as classified by IPSS-R) progressing to AML within five years3. These patients have a dismal prognosis and a median survival of less than six months4. As the standard first-line therapy for higher-risk MDS, HMAs offer inadequate responses to treatment, with an overall response rate (ORR) of just 30-40%5, a complete response (CR) rate of 10-17%, and a median duration of response of 9-12 months6, 8. While allo-HSCT can offer a potential cure, it is limited by the median age of patients, complex disease profiles, common depletion of the hematopoietic stem cell reserve, and a transplantation-related mortality (TRM) rate of 25-35%. As a result, only 5-10% of eligible patients can receive transplantation7. The five-year survival rate of patients who are classified by the IPSS-R as high-risk remains at 16-24%8, highlighting an urgent unmet medical need for innovative therapies that can change the treatment paradigm. Lisaftoclax is a proprietary, novel, orally administered Bcl-2 selective inhibitor being developed by Ascentage Pharma to treat patients with malignancies by selectively blocking the anti-apoptotic protein Bcl-2 and restoring the normal apoptosis process in cancer cells. Lisaftoclax is already approved in China for adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have previously received at least one systemic therapy, including Bruton's tyrosine kinase (BTK) inhibitors. Previously, the Company released the clinical data of lisaftoclax in combination with AZA in treatment-naïve (TN) MDS during the 2024 American Society of Hematology (ASH) Annual Meeting and the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. These data showed an ORR of 75%, much higher than HMAs alone, which demonstrated the clinical benefit of the combination regimen. The combination also showed a favorable safety profile, with a low incidence of severe hematologic toxicities and neutropenia-related infections. In addition, the proportion of patients requiring dose adjustments was low and there were no treatment-related mortalities within 60 days9, 10. Professor Huang commented, 'Despite the significant advancement in the treatment of hematologic malignancies, higher-risk MDS remains a major clinical challenge because of a range of factors. First, the current standard of care treatment with HMAs only offers limited efficacy, with just about one-third of patients achieving a response to treatment. Second, no breakthrough therapies have emerged globally in the two decades since the introduction of HMAs. As a result, there is an unmet clinical need for targeted therapies for higher-risk MDS. The compelling response rate and manageable safety profile observed in earlier studies of lisaftoclax are very encouraging. We hope this global Phase III study has the potential to provide new insights that could benefit how we treat and manage higher-risk MDS.' Dr. Garcia-Manero commented, 'Higher-risk MDS is more prevalent in older populations and thus presents unique clinical challenges. These patients often have multiple comorbidities and depleted hematopoietic reserves, making them less tolerant of treatment with particularly high requirement for safety. Preliminary clinical data of lisaftoclax demonstrated notable clinical benefit, with low rates of treatment-related dose adjustments and mortalities while maintaining significant response rates. We hope these characteristics of lisaftoclax will make it a potentially superior treatment option for patients.' References: About Ascentage Pharma Ascentage Pharma (NASDAQ: AAPG; HKEX: 6855) is a global, commercial stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel, differentiated therapies to address unmet medical needs in cancer. The company has built a rich pipeline of innovative drug candidates that includes inhibitors targeting key proteins in the apoptotic pathway, such as Bcl-2 and MDM2-p53 and next-generation kinase inhibitors. The lead asset, olverembatinib, is the first novel third-generation BCR-ABL1 inhibitor approved in China for the treatment of patients with CML in chronic phase (CML-CP) with T315I mutations, CML in accelerated phase (CML-AP) with T315I mutations, and CML-CP that is resistant or intolerant to first and second-generation TKIs. It is covered by the China National Reimbursement Drug List (NRDL). The Company is currently conducting an FDA-cleared, global registrational Phase III trial, or POLARIS-2, of olverembatinib for CML, as well as global registrational Phase III trials for patients with newly diagnosed Ph+ ALL and SDH-deficient GIST. The second lead asset, lisaftoclax, is the first China-approved third-generation Bcl-2 inhibitor indicated for the treatment of adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have previously received at least one systemic therapy, including Bruton's tyrosine kinase (BTK) inhibitors. The Company is currently conducting 4 global registrational Phase III trials: the GLORA study of lisaftoclax in combination with BTK inhibitors in patients with CLL/SLL who were previously treated with BTK inhibitors for more than 12 months with suboptimal response; the GLORA-2 study in patients with newly diagnosed CLL/SLL; the GLORA-3 study in newly diagnosed elderly and unfit patients with AML; and the GLORA-4 study in patients with newly diagnosed higher-risk MDS. Leveraging its robust R&D capabilities, Ascentage Pharma has built a portfolio of global intellectual property rights and entered into global partnerships and other relationships with numerous leading biotechnology and pharmaceutical companies, such as Takeda, AstraZeneca, Merck, Pfizer, and Innovent, in addition to research and development relationships with leading research institutions, such as Dana-Farber Cancer Institute, Mayo Clinic, National Cancer Institute and the University of Michigan. For more information, visit Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical facts, contained in this press release may be forward-looking statements, including statements that express Ascentage Pharma's opinions, expectations, beliefs, plans, objectives, assumptions or projections regarding future events or future results of operations or financial condition. These forward-looking statements are subject to a number of risks and uncertainties as discussed in Ascentage Pharma's filings with the SEC, including those set forth in the sections titled 'Risk factors' and 'Special note regarding forward-looking statements and industry data' in its Registration Statement on Form F-1, as amended, filed with the SEC on January 21, 2025, and the Form 20-F filed with the SEC on April 16, 2025, the sections headed 'Forward-looking Statements' and 'Risk Factors' in the prospectus of the Company for its Hong Kong initial public offering dated October 16, 2019, and other filings with the SEC and/or The Stock Exchange of Hong Kong Limited we made or make from time to time that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. The forward-looking statements contained in this presentation do not constitute profit forecast by the Company's management. As a result of these factors, you should not rely on these forward-looking statements as predictions of future events. The forward-looking statements contained in this press release are based on Ascentage Pharma's current expectations and beliefs concerning future developments and their potential effects and speak only as of the date of such statements. Ascentage Pharma does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Contact Information Investor Relations: Hogan Wan, Head of IR and Strategy Ascentage Pharma [email protected] +86 512 85557777 Stephanie Carrington ICR Healthcare [email protected] +1 (646) 277-1282 Media Relations: Jon Yu ICR Healthcare [email protected] +1 (646) 677-1855