[Translation] A multicenter, randomized, developmental, single-dose, two-period, double-crossover bioequivalence study of ixazomib citrate capsules (4 mg) in patients in the fasting state

按有关生物等效性试验的规定，选择Takeda Pharma A/S为持证商的枸橼酸伊沙佐米胶囊（商品名：Ninlaro(恩莱瑞)®，规格：4mg）为参比制剂，对东曜药业有限公司生产，合肥亿帆生物制药有限公司提供的受试制剂枸橼酸伊沙佐米胶囊（规格：4mg）进行空腹给药人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，评估两种制剂在空腹给药条件下的生物等效性。

[Translation]

In accordance with relevant bioequivalence testing regulations, ixazomib citrate capsules (trade name: Ninlaro®, strength: 4 mg) manufactured by Takeda Pharma A/S were selected as the reference preparation. Fasting-administered human bioequivalence studies were conducted against the test preparation, ixazomib citrate capsules (strength: 4 mg), manufactured by Dongyao Pharmaceutical Co., Ltd. and provided by Hefei Yifan Biopharmaceutical Co., Ltd. The absorption rate and extent of the test preparation were compared with those of the reference preparation to determine whether they were within an acceptable range, and the bioequivalence of the two preparations under fasting-administered conditions was evaluated.

Start Date01 Nov 2025

Sponsor / Collaborator

Hefei Yifan Biological Pharmaceutical Co., Ltd.

CTR20253002

/ RecruitingNot Applicable

枸橼酸伊沙佐米胶囊在肿瘤患者空腹状态下随机、开放、两周期、两交叉生物等效性研究

[Translation] A randomized, open-label, two-period, two-crossover bioequivalence study of ixazomib citrate capsules in cancer patients under fasting conditions

评价正大天晴药业集团股份有限公司提供的枸橼酸伊沙佐米胶囊（4mg）和Takeda Pharma A/S持证的枸橼酸伊沙佐米胶囊（恩莱瑞®）（4mg）在空腹状态下给药的人体生物等效性；观察受试制剂枸橼酸伊沙佐米胶囊（4mg，正大天晴药业集团股份有限公司）和参比制剂枸橼酸伊沙佐米胶囊（恩莱瑞®）（4mg，Takeda Pharma A/S持证）在肿瘤患者中的安全性

[Translation]

To evaluate the bioequivalence of ixazomib citrate capsules (4 mg) provided by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. and ixazomib citrate capsules (Enlairui®) (4 mg) licensed by Takeda Pharma A/S when administered in the fasting state in humans; to observe the safety of the test formulation ixazomib citrate capsules (4 mg, Chia Tai Tianqing Pharmaceutical Group Co., Ltd.) and the reference formulation ixazomib citrate capsules (Enlairui®) (4 mg, licensed by Takeda Pharma A/S) in cancer patients.

Start Date13 Aug 2025

Sponsor / Collaborator

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

CTR20252862

/ RecruitingNot Applicable

评估受试制剂枸橼酸伊沙佐米胶囊（规格：4 mg）与参比制剂（恩莱瑞®，规格：4 mg）在患者空腹状态下的多中心、开放、随机、单剂量、两周期、两序列、交叉生物等效性试验

[Translation] A multicenter, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study evaluating the bioequivalence of the test preparation, ixazomib citrate capsules (strength: 4 mg), and the reference preparation (Enlari®, strength: 4 mg) in patients under fasting conditions.

主要试验目的：研究空腹状态下单次口服受试制剂枸橼酸伊沙佐米胶囊（规格：4 mg，成都苑东生物制药股份有限公司生产）与参比制剂枸橼酸伊沙佐米胶囊（恩莱瑞®，规格：4 mg；Haupt Pharma Amareg GmbH生产）在多发性骨髓瘤患者体内的药代动力学特征，评价空腹状态口服两种制剂的生物等效性。次要试验目的：研究受试制剂枸橼酸伊沙佐米胶囊（规格：4 mg）和参比制剂枸橼酸伊沙佐米胶囊（恩莱瑞®，规格：4 mg）在患者中的安全性。

[Translation]

The primary objective of the study was to investigate the pharmacokinetic characteristics of a single oral dose of the test formulation, ixazomib citrate capsules (4 mg, manufactured by Chengdu Yuandong Biopharmaceutical Co., Ltd.), compared with the reference formulation, ixazomib citrate capsules (Enlairui®, 4 mg, manufactured by Haupt Pharma Amareg GmbH), in patients with multiple myeloma after fasting, and to evaluate the oral bioequivalence of the two formulations in the fasting state. The secondary objective was to investigate the safety of the test formulation, ixazomib citrate capsules (4 mg), compared with the reference formulation, ixazomib citrate capsules (Enlairui®, 4 mg).

Start Date12 Aug 2025

Sponsor / Collaborator

Chengdu Easton Biopharmaceuticals Co., Ltd.

100 Clinical Results associated with Ixazomib citrate

100 Translational Medicine associated with Ixazomib citrate

100 Patents (Medical) associated with Ixazomib citrate

922

Literatures (Medical) associated with Ixazomib citrate

01 Sep 2026·BIOCHEMICAL PHARMACOLOGY

Nanoparticle-Based delivery of proteasome inhibitors for glioblastoma Therapy: Strategies to overcome Blood-Brain barrier and therapeutic resistance

Review

Author: Ali, Meser M ; Apu, Ehsanul Hoque ; Yadab, Mahesh Kumar ; Rahman, Md Ataur

Glioblastoma (GBM), the most malignant primary brain tumor, has a poor prognosis despite surgical resection, radiation, and temozolomide-based chemotherapy. GBM's strong infiltrativeness, intratumoral heterogeneity, activation of compensatory survival mechanisms, and the tight blood-brain barrier (BBB) prevent medication delivery to tumor regions, causing therapeutic failure. Dysregulation of the ubiquitin-proteasome system (UPS), which regulates proteostasis, apoptosis, cell cycle progression, and stress responses, contributes to glioblastoma progression and therapeutic resistance. Thus, proteasome inhibitors (PIs) such bortezomib (BTZ), carfilzomib, ixazomib, and marizomib are promising treatments. However, low BBB penetration, systemic toxicity, and drug resistance mechanisms have hampered its GBM clinical usefulness. Nanoparticle-based therapeutic delivery technologies improve drug solubility, pharmacokinetics, and brain tumor targeting to address these issues. Liposomes, polymeric nanoparticles, dendrimers, inorganic nanoparticles, and exosome-derived vesicles can improve PI bioavailability and treatment efficacy in preclinical GBM models. Surface functionalization with targeted ligands, peptides, and antibodies improves BBB transport and tumor uptake. Stimuli-responsive nanocarriers and multi-modal nanoparticle systems allow regulated drug release and combinatorial delivery of chemotherapeutics, genetic materials, and radiosensitizers. To improve glioblastoma clinical outcomes with nanomedicine and proteasome inhibition, we also explore translational difficulties and prospects. This review provides the UPS's biological role in GBM, proteasome inhibitors and their limitations, and nanoparticle-enabled delivery techniques to bypass BBB barriers and treatment resistance.

01 Jul 2026·EUROPEAN JOURNAL OF HAEMATOLOGY

Treatment‐Specific Prediction Models in Multiple Myeloma: A Critical Review of Current Evidence and Future Directions

Review

Author: Jarrah, Mays M. ; McKinnon, Ross A. ; Sorich, Michael J. ; Abuhelwa, Ahmad Y. ; Abuhelwa, Ziad ; Hopkins, Ashley M. ; Semreen, Mohammad H. ; Al‐Shamsi, Humaid O. ; Bustanji, Yasser

ABSTRACT:

Background and Objectives:

Multiple myeloma (MM) is characterized by substantial clinical heterogeneity, leading to wide variability in treatment response and toxicity. Although numerous prognostic tools exist, relatively few models estimate outcomes conditional on a specific therapeutic regimen. Treatment‐specific prediction models are an important step toward individualized therapy selection. This review synthesizes the current landscape of treatment‐specific clinical prediction models in MM.

Methods:

A structured search of PubMed and Embase/Scopus identified multivariable clinical prediction models developed within a static treatment framework, evaluating treatment‐specific therapeutic or toxicity‐related outcomes in MM. Information was extracted on treatment regimens, predictors, modeling methods, validation strategies, and reporting of clinical utility.

Results:

Thirteen models were identified, evaluating therapeutic ( n = 10) or toxicity‐related ( n = 3) outcomes across regimens including bortezomib‐based induction, daratumumab‐containing combinations, ixazomib‐based triplets, and CAR‐T therapy. Predictors were mainly routine clinical and laboratory variables, with limited integration of cytogenetics or patient‐reported outcomes. Most models used traditional regression methods; calibration was inconsistently reported, and external validation was performed in seven studies. Decision curve analysis was included in only two models.

Conclusions:

Methodological and translational gaps remain, including limited transparency, scarce external validation, and lack of patient‐reported or longitudinal predictors. None of the models have been implemented as online calculators or integrated into electronic decision‐support systems, limiting real‐world uptake. Addressing these gaps is essential for developing clinically meaningful prediction tools to support personalized treatment in MM.

01 Jul 2026·LEUKEMIA RESEARCH

Comparison of adverse event profiles of carfilzomib-, elotuzumab-, and ixazomib-based therapies combined with lenalidomide and dexamethasone in patients with multiple myeloma using VigiBase

Article

Author: Matsumoto, Jun ; Takeda, Tatsuaki ; Ariyoshi, Noritaka ; See, Gerard Lee Lo ; Zamami, Yoshito ; Sugimoto, Shiho ; Higashionna, Tsukasa ; Hamano, Hirofumi ; Sakai, Tomonori ; Loyao, Beatrix Bermudo

No head-to-head studies have directly compared differences in adverse events (AEs) associated with carfilzomib, elotuzumab, and ixazomib plus lenalidomide and dexamethasone therapies (KRd, EloRd, and IxaRd, respectively) in patients with multiple myeloma. Here, we comprehensively compare the AE profiles of KRd, EloRd, and IxaRd using data from the World Health Organization global pharmacovigilance database, VigiBase. AE reports related to KRd, EloRd, and IxaRd up to December 2024 were extracted from VigiBase. Disproportionality analyses were performed using reporting odds ratios (RORs) with 95% confidence intervals (CIs) for both the system organ class (SOC) and preferred term (PT) levels. Overall, 3950, 1210, and 3948 reports were extracted for KRd, EloRd, and IxaRd, respectively. KRd showed significant disproportionality signals in four SOCs, including Blood and lymphatic system (ROR [95% CI]: 1.74 [1.44-2.10] vs EloRd and 1.60 [1.42-1.81] vs IxaRd) and Cardiac (1.71 [1.32-2.22] and 2.14 [1.79-2.56]) disorders. Representative PTs included neutropenia and cardiac failure. IxaRd exhibited the broadest AE profile, with significant signals in seven SOCs, notably Gastrointestinal (2.47 [2.18-2.80] vs KRd and 3.05 [2.46-3.77] vs EloRd) and Nervous system (1.52 [1.33-1.74] and 2.82 [2.19-3.62]) disorders. Representative PTs encompassed nausea and peripheral neuropathy. In contrast, EloRd exhibited no SOC with significant signals in comparison with both the other therapies. Distinct AEs were identified with KRd and IxaRd, while EloRd exhibited a relatively narrower AE profile. These findings highlight the importance of considering therapy-specific toxicities when selecting appropriate treatments for patients with multiple myeloma.

News (Medical) associated with Ixazomib citrate

27 Apr 2026

·www.einpresswire.com

Study finds myeloma care still lacking practical tools to personalize treatment

A recent study published in the European Journal of Haematology reports that patients with the same cancer diagnosis can respond very differently to treatment. SHARJAH, EMIRATE OF SHARJAH, UNITED ARAB EMIRATES, April 27, 2026 / EINPresswire.com / -- Although patients with the same cancer diagnosis may respond very differently to treatment, clinicians still have limited tools at their disposal to predict who is most likely to benefit or suffer from a particular myeloma therapy. These findings are reported in a recent study published in the European Journal of Haematology, in which the authors present a comprehensive review of the field. The study maps the current approaches to prediction in multiple myeloma, highlighting what is missing and outlining the path forward for truly personalized care of cancer patients. “This paper does not claim to have solved the problem,” said Dr. Ahmad Abuhelwa, Associate Professor of Clinical Pharmacology and Pharmacometrics at the University of Sharjah and a co-author. “Instead, it clearly identifies the problem, explains why it matters, and defines what is needed next.” Dr. Abuhelwa explained that while existing prediction models in multiple myeloma are promising, they remain insufficient for routine care. “We highlight major gaps in tools needed to personalize treatment,” he said. “Patients with multiple myeloma … still lack reliable ways to predict treatment response before therapy begins.” The researchers argue that practical, clinically usable tools are essential to guide personalized treatment in multiple myeloma, a disease with promising and expanding treatment options. By identifying what precision care is currently, the authors aim to set the agenda for next-generation precision tools in multiple myeloma that are meaningful for both doctors and patients. The researchers examine the growing interest in artificial intelligence and clinical integration. They caution that AI tools, though very useful, cannot yet provide precise prediction. The work clarifies what must be developed before clinicians can safely and effectively deploy existing prediction tools in everyday practice. “Multiple myeloma treatment is becoming more complex,” Dr. Abuhelwa emphasized. “But decision-based tools are lagging behind. Better treatment decisions need better prediction.” Current state of clinical prediction models The authors, affiliated with universities in the US, Australia, Jordan, and the United Arab Emirates (UAE), conducted a structured search of PubMed and Embase/Scopus to identify multivariable clinical prediction models developed within a static treatment framework for multiple myeloma. The authors focused on models evaluating treatment-specific therapeutic or toxicity-related outcomes. Data was extracted on treatment regimes, predictors, modeling methods, validation strategies, and reporting of clinical utility. Analyzing the data, the researchers identified 13 eligible models, 10 of which measured therapeutic outcomes and the remaining three assessed toxicity-related outcomes. Developed across a range of treatment settings, these models included bortezomib-based induction therapy, daratumumab-containing combinations, ixazomib-based triplets, and CAR T therapy. “Most models used traditional regression methods; calibration was inconsistently reported, and external validation was performed in seven studies. Decision curve analysis was included in only two models,” the authors write. Precision oncology is not only about discovering biomarkers, said Mays M. Jarrah, the study’s lead author and a doctoral candidate at the University of Sharjah’s College of Pharmacy. “It is also about translating data into decisions that improve patient care. This review highlights why that translation step remains a major unmet need in multiple myeloma.” Asked about the study’s significance, Jarrah said the findings underscore several critical messages. While promising models already exist, “very few of them have undergone the level of validation and implementation needed for real-world use. That is the gap between academic development and clinical impact and closing that gap should be the next priority.” According to Jarrah, the study’s importance lies in its efforts to clarify where the field currently stands and chart a path forward. “Once we [authors] identified the methodological and translational gaps,” she said, “we moved to provide a roadmap for building more clinically meaningful, patient-centered tools that could eventually help clinicians and patients make more informed treatment decisions.” Gaps between prediction models and clinical practice The research is of immediate practical relevance because it clearly outlines what must be in place before prediction tools can meaningfully support clinical practice. In real-world myeloma care, treatment decisions often require careful trade-offs between the risk of serious side effects and potential treatment benefits. According to the authors, effective treatment-specific prediction models could eventually help clinicians estimate survival outcomes, predict treatment response, or assess the likelihood of severe toxicities for individual patients before treatment begins. A key practical contribution of the study is its articulation of design standards that future tools should meet. These include stronger and more consistent validation, improved calibration, broader integration of biologically relevant variables, inclusion of patient-reported outcomes, and translation into usable platforms such as web-based calculators or decision-support systems. “Methodological and translational gaps remain, including limited transparency, scarce external validation, and lack of patient-reported or longitudinal predictors,” the authors note. “None of the models have been implemented as online calculators or integrated into electronic decision-support systems, limiting real-world uptake. Addressing these gaps is essential for developing clinically meaningful prediction tools to support personalized treatment in multiple myeloma.” The topic is of clear interest to healthcare providers and cancer centers, as it sits at the intersection of precision medicine, digital health, and patient-centered cancer care. It is also highly relevant for developers of clinical decision-support tools, as the review identifies the practical and methodological barriers that currently hinder useful implementation. “Multiple myeloma is not one uniform disease,” emphasized Dr. Abuhelwa. “Patients can respond very differently to the same treatment, and that creates real uncertainty in clinical practice. Our review shows that while prediction models are emerging, the tools currently available are still not ready to fully support routine personalized treatment decisions.” Prediction models have limits While the authors acknowledge that the field is moving in the right direction, they find that many models still suffer from important limitations. Most rely mainly on routine clinical and laboratory variables, with only a few incorporating more advanced disease characteristics such as cytogenetics. Notably, none of the reviewed models included patient-reported outcomes. The authors also found that external validation was limited, calibration was inconsistently reported, and decision curve analysis was rarely performed. None of the identified models had been translated into online calculators or integrated electronic decision-support tools. “In simple terms, promising ideas exist, but they are not yet mature enough for widespread use in everyday care,” said Dr. Abuhelwa. Multiple myeloma is the second most common blood cancer worldwide. In 2022 alone, an estimated 188,000 new cases and 121,000 deaths were reported globally. It is a highly heterogeneous disease, with patients experiencing widely different disease trajectories, treatment responses, and side effects. Although treatment options have expanded significantly in recent years, selecting the optimal treatment for the right patient remains a significant clinical challenge. “This study is important because it shows that science is moving toward precision care in myeloma, but the practical tools clinicians need are still missing,” said Prof. Humaid Al-Shamsi of the Department of Oncology at the UAE Burjeel Cancer Institute and a co-author of the study. “We hope this work helps accelerate the development of reliable, user-friendly models that can better support patients and doctors.” Original Source URL: https://doi-org.sutd.idm.oclc.org/10.1111/ejh.70177 Leon Barkho University Of Sharjah +971 50 165 4376 email us here Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Clinical Result

07 Aug 2025

·www.prnewswire.com

Nuvalent Highlights Pipeline and Business Achievements, Reiterates Key Anticipated Milestones, and Reports Second Quarter 2025 Financial Results

Initiated rolling NDA submission for zidesamtinib for TKI pre-treated patients with advanced ROS1-positive NSCLC, with target completion in the third quarter of 2025 Initiated ALKAZAR Phase 3 randomized, controlled trial of neladalkib for front-line ALK-positive NSCLC Topline pivotal data for neladalkib for TKI pre-treated patients with advanced ALK-positive NSCLC expected by year-end 2025 Preliminary data for neladalkib in patients with ALK-positive solid tumors beyond NSCLC to be presented at the ESMO Congress 2025 Jason Waters, MBA, promoted to Senior Vice President, Commercial CAMBRIDGE, Mass., Aug. 7, 2025 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today outlined pipeline and business achievements, reiterated key anticipated milestones, and reported second quarter 2025 financial results. "With the initiation of our rolling NDA submission for zidesamtinib in TKI pre-treated advanced ROS1-positive NSCLC and the dosing of the first patient in our ALKAZAR Phase 3 trial of neladalkib in TKI-naïve advanced ALK-positive NSCLC, 2025 has been marked by transformative milestones towards our mission to discover, develop, and deliver precisely targeted therapies for patients with cancer," said Alexandra Balcom, Chief Financial Officer of Nuvalent. "We remain focused on continuing to deliver value that is grounded in prioritizing patient impact with topline pivotal data from our ALKOVE-1 trial of neladalkib in TKI pre-treated advanced ALK-positive NSCLC expected by year-end and the first report of preliminary data for other ALK-positive solid tumors at ESMO, continued momentum in our HEROEX-1 trial of NVL-330 for HER2-altered NSCLC, and a robust discovery pipeline." "In parallel to our continued execution against development and regulatory milestones, we are actively building the strong commercial infrastructure needed to achieve our vision of becoming a fully integrated, commercial-stage biopharmaceutical company," said James Porter, Ph.D., Chief Executive Officer of Nuvalent. "Today we are proud to announce the promotion of Jason Waters to Senior Vice President, Commercial, in recognition of his leadership in establishing our commercial strategy and shaping a launch-ready organization that extends from our founding values of Patient Impact, Empowerment, and Collaboration. Supported by a growing team and strong cash runway into 2028, we believe we are well-positioned to achieve our goals." Recent Pipeline Achievements and Anticipated Milestones ROS1 Program The company has initiated its rolling NDA submission for zidesamtinib, a novel ROS1-selective inhibitor, in tyrosine kinase inhibitor (TKI) pre-treated patients with advanced ROS1-positive non-small cell lung cancer (NSCLC). The FDA agreed to accept the NDA for participation in the Real-Time Oncology Review (RTOR) pilot program, which facilitates earlier submission of topline efficacy and safety results prior to the submission of the complete application, to support an earlier start to the FDA's evaluation of the application. Completion of the NDA submission is targeted for the third quarter of 2025. The NDA submission is based on positive pivotal data for TKI pre-treated patients with advanced ROS1-positive NSCLC enrolled in the global ARROS-1 Phase 1/2 clinical trial. These data were recently reported along with preliminary data from the ongoing Phase 2 TKI-naïve cohort of ARROS-1, in which a total of 104 patients had been enrolled as of June 16, 2025. The company continues to engage with the FDA on potential opportunities for line-agnostic expansion. ALK Program Nuvalent recently announced the dosing of the first patient in ALKAZAR, the company's global Phase 3 randomized, controlled trial designed to evaluate neladalkib for the treatment of patients with TKI-naïve ALK-positive NSCLC. Patients will be randomized 1:1 to receive neladalkib monotherapy or alectinib monotherapy, a front-line standard of care, reflecting input from collaborating physician-scientists and alignment with global regulatory agencies. Evaluation of neladalkib is ongoing in the ALKOVE-1 Phase 1/2 trial for patients with advanced ALK-positive NSCLC and other solid tumors: The company expects to report pivotal data for TKI pre-treated patients with advanced ALK-positive NSCLC by year-end 2025. The company will present preliminary data from the Phase 2 exploratory cohort for patients with ALK-positive solid tumors beyond NSCLC during a poster presentation at the European Society for Medical Oncology (ESMO) Congress 2025, taking place October 17-21, 2025, in Berlin, Germany. Details of the presentation are as follows: Title: Neladalkib (NVL-655) efficacy and safety in patients with ALK-positive solid tumors in the ALKOVE-1 study Presentation Number: 972P Session Category: Poster Session Session Title: Developmental Therapeutics Presentation Date and Time: Sunday, October 19, 2025, 12:00 – 12:45 CEST Location: Hall 25 Presenter: Benjamin J. Solomon, MBBS, Ph.D. (Peter MacCallum Cancer Centre, Melbourne, Australia) HER2 Program Enrollment is ongoing in the HEROEX-1 Phase 1a/1b clinical trial evaluating the overall safety and tolerability of NVL-330 for pre-treated patients with HER2-altered NSCLC. Additional objectives include determination of the recommended Phase 2 dose, characterization of NVL-330's pharmacokinetic profile, and preliminary evaluation of anti-tumor activity. The company expects to continue to progress the HEROEX-1 trial throughout 2025. Business Updates Jason Waters, MBA, Promoted to Senior Vice President, Commercial: Jason joined Nuvalent in 2024, bringing more than 20 years of experience in biopharma, and 15 years in commercial oncology focused on product launches and commercialization. Most recently, Jason served as the Head of Commercial at Mersana Therapeutics, where he led launch preparedness efforts and companion diagnostic strategy for the market entry of a novel antibody-drug conjugate. Prior to this, he held various commercial leadership roles at GSK, including Field Vice President and US Brand Lead for ZEJULA®, where he led the integration and multiple launches of the brand following the acquisition of TESARO in acquisition in 2019. At TESARO, Jason served as the Global Brand Lead for ZEJULA®, coordinating its EU launch. Earlier in his career, Jason was Senior Director, Sales Strategy at Takeda Oncology, where he contributed to the launches of subcutaneous VELCADE® and NINLARO®. He also held various sales, operational, and leadership roles at Sanofi, Aventis, and Abbott Laboratories. Christy Oliger Appointed to Board of Directors: Nuvalent announced the appointment of Christy Oliger to its board of directors. Ms. Oliger brings more than 30 years of commercial and business experience in the pharmaceutical and biotechnology industry to the Nuvalent board. Most recently, Ms. Oliger served as Senior Vice President of the Oncology Business Unit at Genentech, where she was responsible for all commercial activities in the U.S. During her 20-year tenure at Genentech, Ms. Oliger held a number of senior leadership roles in both commercial and research and development across a variety of therapeutic areas, including oncology, neurology, rare disease, respiratory, dermatology and immunology. Prior to Genentech, she held management positions at Schering-Plough. Second Quarter 2025 Financial Results Cash Position: Cash, cash equivalents and marketable securities were $1.0 billion as of June 30, 2025. Nuvalent continues to believe its existing cash, cash equivalents and marketable securities will be sufficient to fund its current operating plan into 2028. R&D Expenses: Research and development (R&D) expenses were $80.9 million for the second quarter of 2025. G&A Expenses: General and administrative (G&A) expenses were $23.7 million for the second quarter of 2025. Net Loss: Net loss was $99.7 million for the second quarter of 2025. About Nuvalent Nuvalent, Inc. (Nasdaq: NUVL) is a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for patients with cancer, designed to overcome the limitations of existing therapies for clinically proven kinase targets. Leveraging deep expertise in chemistry and structure-based drug design, we develop innovative small molecules that have the potential to overcome resistance, minimize adverse events, address brain metastases, and drive more durable responses. Nuvalent is advancing a robust pipeline with investigational candidates for ROS1-positive, ALK-positive, and HER2-altered non-small cell lung cancer, and multiple discovery-stage research programs. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding Nuvalent's strategy, business plans, and focus; the period over which Nuvalent estimates its cash, cash equivalents and marketable securities will be sufficient to fund its future operating expenses and capital expenditure requirements; the expected timing of data announcements, NDA submissions and FDA product approvals; the preclinical and clinical development programs for zidesamtinib, neladalkib and NVL-330; the potential benefits and effects of Nuvalent's product development candidates; the design and enrollment of the ARROS-1, ALKAZAR, ALKOVE-1, and HEROEX-1 trials; the potential of Nuvalent's pipeline programs, including zidesamtinib, neladalkib and NVL-330; the implications of data readouts and presentations; Nuvalent's research and development programs for the treatment of cancer; and risks and uncertainties associated with drug development. The words "may," "might," "will," "could," "would," "should," "expect," "plan," "anticipate," "aim," "goal," "intend," "believe," "expect," "estimate," "seek," "predict," "future," "project," "potential," "continue," "target" or the negative of these terms and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. You should not place undue reliance on these statements or the scientific data presented. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties, and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation: risks that Nuvalent may not fully enroll its clinical trials or that enrollment will take longer than expected; unexpected concerns that may arise from additional data, analysis, or results obtained during preclinical studies or clinical trials; the risk that results of earlier clinical trials may not be predictive of the results of later-stage clinical trials; the risk that data from our clinical trials may not be sufficient to support registration and that Nuvalent may be required to conduct one or more additional studies or trials prior to seeking registration of our product candidates; the occurrence of adverse safety events; risks that the FDA may not approve our potential products on the timelines we expect, or at all; risks of unexpected costs, delays, or other unexpected hurdles; risks that Nuvalent may not be able to nominate drug candidates from its discovery programs; the direct or indirect impact of public health emergencies or global geopolitical circumstances on the timing and anticipated timing and results of Nuvalent's clinical trials, strategy, and future operations; the timing and outcome of Nuvalent's planned interactions with regulatory authorities; and risks related to obtaining, maintaining, and protecting Nuvalent's intellectual property. These and other risks and uncertainties are described in greater detail in the section entitled "Risk Factors" in Nuvalent's Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, as well as any prior and subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent Nuvalent's views only as of today and should not be relied upon as representing its views as of any subsequent date. Nuvalent explicitly disclaims any obligation to update any forward-looking statements. SOURCE Nuvalent, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Executive ChangePhase 3Phase 1Financial Statement

09 Jun 2025

·www.activebiotech.com

Results from tasquinimod study in heavily pretreated patients with relapsed refractory multiple myeloma presented at ASCO 2025 available on Active Biotech’s website

Lund, June 9, 2025 – Active Biotech (NASDAQ Stockholm; ACTI) announced today that study results of its clinical drug candidate tasquinimod in heavily pretreated patients with relapsed refractory multiple myeloma (RRMM) are now available on Active Biotech’s website. The results were presented in a poster at the American Society of Clinical Oncology (ASCO) annual meeting May 30 – June 1, 2025. A total of 17 patients received tasquinimod in combination with ixazomib (proteasome inhibitor, PI), lenalidomide (Imid), and dexamethasone (IRd). Patients were heavily pretreated with a median of 7 prior lines of therapy (range 4-19) and all were triple-class refractory with 71% (12 patients) refractory to their most recent Imid/PI combination. In the total combination cohort, there was one partial response and 7 minimal responses which resulted in a 47% Clinical Benefit Rate (CBR). Among the 12 patients refractory to their latest Imid/PI combination there was one durable partial response (lasting 19.8 months) and three minimal responses (lasting 1.2, 1.5 and 6.7 months) resulting in a CBR of 33%. These patients were unlikely to respond to IRd alone and the result suggests synergistic efficacy of tasquinimod with the IRd combination. The results highlight the potential for targeting the tumor microenvironment with tasquinimod to augment the efficacy of other myeloma therapies. Tasquinimod was well tolerated in combination with IRd and the safety profile was in line with previous experience. The most common treatment emergent adverse events included fatigue, gastrointestinal events, pain and respiratory infections. Mostly of mild to moderate grade. The study (NCT04405167), was conducted at Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA with Dr. Dan Vogl as Principal Investigator. Full study results are being analyzed and will be published in a Scientific Journal. Information on the presentation: Abstract 7555, Clinical Activity of Novel Targeting of S100A9 with Tasquinimod for Relapsed and Refractory Multiple Myeloma (RRMM), Dan T. Vogl et al. was presented as a poster at the poster session Hematologic malignancies – Plasma cell dyscrasia on June 1, 2025. The poster is now available on Active Biotech’s website.

Clinical ResultASCOClinical Study

100 Deals associated with Ixazomib citrate

External Link

KEGG	Wiki	ATC	Drug Bank
D10131	Ixazomib citrate	L01XX50	DB09570

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Multiple Myeloma	United States	Takeda Pharmaceuticals U.S.A., Inc.	20 Nov 2015

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Plasmacytoma	Phase 3	United States	Millennium Pharmaceuticals, Inc.	29 Nov 2016
Spondylocarpotarsal Synostosis	Phase 3	United States	Millennium Pharmaceuticals, Inc.	17 Mar 2015
Spondylocarpotarsal Synostosis	Phase 3	United States	Takeda Pharmaceutical (China) Co. Ltd.	17 Mar 2015
Spondylocarpotarsal Synostosis	Phase 3	United States	Haupt Pharma Amareg GmbH	17 Mar 2015
Spondylocarpotarsal Synostosis	Phase 3	Japan	Takeda Pharmaceutical (China) Co. Ltd.	17 Mar 2015
Spondylocarpotarsal Synostosis	Phase 3	Japan	Millennium Pharmaceuticals, Inc.	17 Mar 2015
Spondylocarpotarsal Synostosis	Phase 3	Japan	Haupt Pharma Amareg GmbH	17 Mar 2015
Spondylocarpotarsal Synostosis	Phase 3	Argentina	Millennium Pharmaceuticals, Inc.	17 Mar 2015
Spondylocarpotarsal Synostosis	Phase 3	Argentina	Haupt Pharma Amareg GmbH	17 Mar 2015
Spondylocarpotarsal Synostosis	Phase 3	Argentina	Takeda Pharmaceutical (China) Co. Ltd.	17 Mar 2015

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02516423 (CTgov)	Phase 3	Plasmacytoma	11	Lenalidomide+ixazomib+zoledronic acid+dexamethasone (Ixazomib + Lenalidomide + Dexamethasone + Zoledronic Acid)	vcuqomhviv = vstjrttayt pdaprrrmpo (syxdtszuew, vxailrfhfr - regbpfygqu) View more	-	30 Jun 2026
				zoledronic acid (Zoledronic Acid)	vcuqomhviv = gzrvkvzqkz pdaprrrmpo (syxdtszuew, ckvlnjalto - sqpcsopbsr) View more
EHA2026	Not Applicable	Relapse multiple myeloma	24	Ixazomib, lenalidomide, and dexamethasone (IRd) (3 prior lines)	kvscelfmfp(dpvptqnqtt) = sjblsjfmwb enqvdxrnsh (hpgbbzwfjn )	Positive	12 May 2026
				Ixazomib, lenalidomide, and dexamethasone (IRd) (4-6 prior lines)	kvscelfmfp(dpvptqnqtt) = uywuinfbkt enqvdxrnsh (hpgbbzwfjn )
EHA2026	Not Applicable	Multiple Myeloma First line	12,905	IXAZOMIB-based triplet regimens	kfaojivejx(eugvuxyowa) = elyjuzicow qhbnidfxem (skksiofgja, 5.6 - 13.1) View more	Positive	12 May 2026
				BORTEZOMIB-based triplet regimens	kfaojivejx(eugvuxyowa) = adlshwzyyu qhbnidfxem (skksiofgja, 3.7 - 11.2) View more
EHA2026	Not Applicable	Multiple Myeloma	113	Ixazomib-based regimens	xjoogaaytm(xyyjiroozh) = Among those switching due to intolerance (n=17), 10/17 (58.8%) continued therapy, with no discontinuations attributed to adverse events dwjejrzowe (gjguezadbj )	Positive	12 May 2026
				Ixazomib-based regimens (High-risk)
EHA2026	Not Applicable	Multiple Myeloma Maintenance	47	Ixazomib-based maintenance	zuurvxohll(kqvjpygney) = The most common adverse events were hematologic toxicities (neutropenia: 11%, grade 3: 0%; thrombocytopenia: 4%, grade 3: 2%; anemia: 40%, grade 3: 0%), gastrointestinal events (diarrhea: 6.4%, grade 3: 2.1%; nausea: 2.1%, grade 3: 0%), rash (2.1%, grade 3), fatigue (2.1%, grade 2), upper respiratory tract infection (2.1%, grade 2), heart failure (2.1%, grade 2), and peripheral neuropathy (4.3%, grade 2). No treatment discontinuations due to adverse events were reported. nbgcldyqtj (qboztqftxs )	Positive	12 May 2026
NCT05722405 (MPACT, EHA2026)	Phase 2	Multiple Myeloma Maintenance	41	IXAZOMIB + REDUCED-DOSE LENALIDOMIDE	twvuoxesze(yjldybvrqr) = kugimuizyn vmczgtvvxh (ewmbpdvwio, 18.2 - 53.8)	Positive	12 May 2026
				IXAZOMIB	twvuoxesze(yjldybvrqr) = zbxiimwyvk vmczgtvvxh (ewmbpdvwio, 10.7 - 27.3)
EHA2026	Not Applicable	Refractory Multiple Myeloma	152	IXAZOMIB-LENALIDOMIDE-DEXAMETHASONE	acjebrfwcb(patzozfruy) = xnuoutmtsh ipitvvgyyq (orxqjwaipj ) View more	Positive	12 May 2026
				DARATUMUMAB-LENALIDOMIDE-DEXAMETHASONE	mcnzwujkkq(gnnqryuirn) = vxjlravhfd tjhqwtykti (oxdnqltsrr )
EHA2026	Phase 2	Multiple Myeloma	20	Dara-based induction	omtdjagcse(jbyghcsjtq) = fxcarkevur tvoyjsacmu (jvbrnbvwfd, 85.2 - 100) View more	Positive	12 May 2026
NCT03547700 (CTgov)	Phase 1/2	Peripheral T-Cell Lymphoma \| T-cell lymphoma recurrent	11	Romidepsin+Ixazomib (All Subjects Treated)	yrllrnjkqe = gfhoolicrn lwmnjbvumt (fylnhtdzbs, jgoqzkbipk - sawlpoxizl)	-	06 May 2026
				Romidepsin+Ixazomib (Phase I Dose Level 4:Romidepsin 10mg/m² IV on Days 1, 8, 15; Ixazomib 4 mg PO on Days 1, 8, 15)	kctuyidazy(yhnvdwhggw) = dlkziggvqo pjfdvmjnwg (vnrufhdlnj, bkxzugixbq - ppbrbfydra) View more
NCT02339922 (CTgov)	Phase 2	Lymphoplasmacytic Lymphoma \| Follicular Lymphoma \| Mantle-Cell Lymphoma ... View more	33	Laboratory Biomarker Analysis+Ixazomib Citrate+Rituximab	ntlfmvhsbl = ungmqmrzbr texzlzffdf (hhbofezzkt, xansrkfcjw - rritahtzad) View more	-	05 Mar 2026

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