A Phase 1/1b Study of AOH1996 Alone or in Combination With the BCL-2 Inhibitor Venetoclax +/- Azacitidine in Patients With Relapsed/Refractory Acute Myeloid Leukemia

This phase I trial tests safety, side effects, and best dose of AOH1996 alone or in combination with venetoclax with or without azacitidine for the treatment of patients with acute myeloid leukemia (AML) that has come back after a period of improvement (relapsed) or AML that has not responded to previous treatment (refractory). AOH1996 is in a class of medications called PCNA inhibitors. It inhibits cancer growth and induces deoxyribonucleic acid (DNA) damage. This may help keep cancer cells from growing and damage cancer cell DNA. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking BCL-2, a protein needed for cancer cell survival. Azacitidine is in a class of medications called demethylation agents. It works by helping the bone marrow to produce normal blood cells and by killing abnormal cells in the bone marrow. Giving AOH1996 alone or in combination with venetoclax with or without azacitidine may be safe, tolerable and/or effective in treating patients with AML.

开始日期2025-08-16

申办/合作机构

City of Hope National Medical Center

[+1]

ACTRN12624000738527

/ Not yet recruiting临床2期IIT

AMLM22/D4: The International AML Platform Consortium (IAPC) trial – is a randomised, 2-arm trial that will investigate the efficacy of oral Azacitidine combined with an allogeneic dendritic cell vaccine vididencel, compared with oral Azacitidine alone, in maintaining or inducing negativity for measurable residual disease (MRD) in AML patients in first complete remission (CR1) following intensive chemotherapy.

开始日期2025-06-30

申办/合作机构

The Australian Leukaemia & Lymphoma Group

[+1]

NCT06782542

/ Not yet recruiting临床2期IIT

Single-Arm Phase 2 Study of Olutasidenib, Venetoclax, and Azacitidine in IDH1 Mutated Newly Diagnosed Acute Myeloid Leukemia Patients Who Are Eligible for Intensive Induction Chemotherapy

The purpose of this study is as follows:
1. Determine whether people receiving the combination treatment of olutasidenib, venetoclax, and azacitidine have the same, more, or fewer side effects compared to the usual chemotherapy treatment that people with this condition receive.
2. Determine how well the combination treatment of olutasidenib, venetoclax, and azacitidine works compared to the usual chemotherapy treatment that people with this condition receive.

开始日期2025-06-01

申办/合作机构

University of Miami

[+1]

100 项与阿扎胞苷相关的临床结果

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100 项与阿扎胞苷相关的转化医学

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100 项与阿扎胞苷相关的专利（医药）

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9,176

项与阿扎胞苷相关的文献（医药）

2025-12-01·MOLECULAR BIOLOGY REPORTS

Effects of 5-azacytidine and N6-methyladenosine combination on apoptosis and stemness in human breast cancer stem cells

Article

作者: Mukhtarova, Gunel ; Angin, Mesude ; Caner, Ayse ; Gunduz, Cumhur

BACKGROUND:

This study investigates the combined effects of the epigenetic anticancer drug 5-azacytidine (5-Aza) and N6-methyladenosine (m6A) on breast cancer stem cells (CSCs) and normal breast epithelial cells. CSCs are characterized by their ability to self-renew, their resistance to conventional therapies, and their role in metastasis, presenting a significant challenge in breast cancer treatment.

METHODS AND RESULTS:

The study utilized flow cytometry to isolate CD44 + /CD24low CSCs from MCF-7 breast cancer cells and evaluated these cells through spheroid formation assays. The results demonstrated that both 5-Aza and m6A, both individually and in combination, exert cytotoxic effects on CSCs, induce apoptosis, and reduce their migratory capacity. Importantly, these treatments did not produce similar effects on normal breast epithelial cells (MCF-10A), indicating selective action on CSCs. Gene expression analysis revealed that treatment with 5-Aza, m6A, and their combination altered the expression of key stem cell-related genes, including OCT4, NANOG, SOX2, and c-MYC, which are associated with CSC self-renewal and malignancy.

CONCLUSIONS:

These findings suggest that epigenetic modulation through 5-Aza and m6A could effectively target CSCs, disrupting their ability to drive tumor progression and metastasis, particularly in aggressive breast cancer subtypes. This study highlights the potential of 5-Aza and m6A as a combinatorial therapeutic approach, offering a promising avenue for improving treatment outcomes in breast cancer patients, especially those with therapy-resistant disease. Further clinical investigation is needed to validate these findings and explore their therapeutic implications.

2025-12-01·MOLECULAR BIOLOGY REPORTS

DNMT1 inhibition improves the activity of memory-like natural killer cells by enhancing the level of autophagy

Article

作者: Guo, Chong ; Li, Yixun ; Cheng, Shenju ; Zeng, Yun ; Zhang, Fujia ; Luo, Shan ; Wu, Kun ; Zhao, Yaling ; Li, Yanhong

BACKGROUND:

Acute myeloid leukemia (AML) is a common hematological tumor, but it is difficult to treat. DNMT1 is a DNA methyltransferase whose main function is to maintain stable DNA methylation during the DNA replication process. DNMT1 also plays an important role in AML, but its function in cytokine-induced memory-like natural killer (CIML NK) cell activity remains unclear.

METHODS AND RESULTS:

In this study, we isolated primary NK cells from the peripheral blood of healthy volunteers and AML patients and treated them with 10 ng/mL IL-12, 50 ng/mL IL-15 and 50 ng/mL IL-18 to promote their differentiation into CIML NK cells. The activity of CIML NK cells was evaluated by RT‒qPCR, western blotting, ELISAs, and flow cytometry. DNMT1 was highly expressed in NK cells from AML patients. Knocking down DNMT1 significantly increased the expression of CD25, CD137, CD107a, IFN-γ, and TNF-α and increased the activity of CIML NK cells. Mechanistically, knocking down DNMT1 promoted autophagy by activating the AMPK/mTOR signaling pathway, thereby enhancing the activity of CIML NK cells and alleviating the progression of AML.

CONCLUSIONS:

Our study revealed that the downregulation of DNMT expression may be a new target for the treatment of AML.

2025-08-01·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Simultaneous analysis of various anticancer drugs by supercritical fluid chromatography-mass spectrometry. Part I: Optimization of chromatographic separation

Article

作者: Guillarme, Davy ; Rudaz, Serge ; Fleury-Souverain, Sandrine ; Bonnabry, Pascal ; Nguyen, Nathalie

This work presents a generic SFC-MS method for the simultaneous analysis of 22 anticancer drugs (fluorouracil, busulfan, cyclophosphamide, cytarabine, dacarbazine, daunorubicin, docetaxel, doxorubicin, epirubicin, etoposide, gemcitabine, idarubicin, ifosfamide, irinotecan, methotrexate, paclitaxel, pemetrexed, raltitrexed, topotecan, treosulfan, vinblastine, vincristine). The separation conditions were optimized by screening nine stationary phases (2-picolylamine, bare hybrid silica, 2-ethylpyridine, fluoro-phenyl, octadecyl, diethylamine, diol, 1-aminoanthracene, zwitterionic modification), evaluating additives effects (2-5 % water, 20-50 mM ammonium formate, 0-1 mM ammonium fluoride), and adjusting the organic modifier composition (methanol, ethanol, isopropanol, acetonitrile). The optimized SFC-MS method successfully analyzed 22 anticancer drugs, along with 5 additional challenging compounds (azacitidine, mitomycin, cisplatin, oxaliplatin, carboplatin), in 12 min, using a diol column (100 × 3 mm, 1.7 µm) and a gradient of 2-100 % methanol containing 2 % water and 50 mM ammonium formate. To overcome overpressure generated by high organic solvent content, a backpressure gradient (110-150 bar) and a flow rate gradient (0.6-1.5 mL/min) were applied. The diol column was selected as the most promising based on five predefined chromatographic criteria. Additives with 5 % water or ammonium fluoride were excluded due to overpressure and signal loss, respectively. Increasing ammonium formate concentration improved peak symmetry by 29 %. For the organic modifier, pure methanol was chosen since ternary mixtures led to system overpressure without improving separation. Comparison with the LC-MS method using real samples confirmed the potential applicability of the SFC method, as the same trace compounds were detected with comparable concentrations. Sensitivity optimization and method validation will be discussed separately in a later paper.

1,132

项与阿扎胞苷相关的新闻（医药）

2025-04-08

·PRNewswire

TIBSOVO's Continued Success Solidifies Its Position as a Leader in IDH1 Mutant Space | DelveInsight

With its ability to specifically inhibit the mutant IDH1 enzyme, TIBSOVO addresses an unmet need in personalized cancer treatment, offering new hope for patients with limited options. As clinical evidence continues to support its efficacy and safety, TIBSOVO is positioned for strong growth in the oncology market, especially with expanding indications and global market penetration. LAS VEGAS, April 8, 2025 /PRNewswire/ -- DelveInsight's " TIBSOVO Market Size, Forecast, and Market Insight Report" highlights the details around TIBSOVO, the first and only targeted therapy approved for patients with previously treated IDH1-mutated cholangiocarcinoma. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of TIBSOVO. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Servier's TIBSOVO (ivosidenib) Overview TIBSOVO (ivosidenib) is a small molecule developed by Servier, acts as an isocitrate dehydrogenase-1 (IDH1) inhibitor. It is indicated for patients with a susceptible IDH1 mutation, which is identified through an FDA-approved test. Currently, TIBSOVO is approved for the treatment of newly diagnosed acute myeloid leukemia (AML), relapsed or refractory AML, relapsed or refractory myelodysplastic syndromes (MDS), and locally advanced or metastatic cholangiocarcinoma. According to Servier's pipeline, TIBSOVO is also being actively investigated for a range of additional indications, with key areas of exploration including solid tumors and hematological malignancies. Learn more about TIBSOVO projected market size for AML, cholangiocarcinoma, and MDS @ TIBSOVO Market Potential The oncology market has experienced significant growth in recent years, driven by advances in cancer research, the development of targeted therapies, and the increasing global prevalence of cancer. As the second-leading cause of death worldwide, cancer continues to pose a major public health challenge, creating a substantial demand for innovative treatments. The market is marked by a shift toward personalized medicine, where therapies are tailored to an individual's genetic profile, allowing for more effective and less toxic treatments. Immunotherapies, such as checkpoint inhibitors, CAR-T cell therapies, and oncolytic virus therapies, are at the forefront of these advancements, offering new hope to patients with previously untreatable cancers. Moreover, the oncology market is expanding due to the growing adoption of precision oncology and molecular diagnostics, which enable earlier and more accurate detection of cancer. This has led to increased investments in research and development, especially in areas like liquid biopsies, companion diagnostics, and next-generation sequencing. The demand for more effective and accessible cancer treatments is fueling innovation in both the pharmaceutical and biotechnology sectors, with numerous new drugs and therapies entering clinical trials and moving toward commercialization. As a result, the oncology market is poised to continue growing, with significant opportunities for breakthrough therapies in immuno-oncology, targeted treatments, and gene therapies. DelveInsight has expertise in the oncology market with an experienced team handling the oncology domain proficiently. DelveInsight has released a series of epidemiology-based market reports on Acute Myeloid Leukemia, Cholangiocarcinoma, and Myelodysplastic Syndrome. These reports include a comprehensive understanding of current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Gain deeper insights into these diseases with a customized report tailored to your needs. Connect with us today—our experts are ready to assist you! Emerging Competitors of TIBSOVO TIBSOVO faces significant competition in the newly diagnosed AML market from several alternative treatments. Oral therapies like VENCLEXTA (venetoclax), which inhibits BCL-2, and DAURISMO (glasdegib), which targets the hedgehog pathway, present strong contenders. Additionally, emerging therapies such as Lisaftoclax (Ascentage Pharma), another BCL-2 inhibitor, and gilteritinib (Astellas), a kinase inhibitor, are expected to further challenge TIBSOVO in the newly diagnosed AML space. In the R/R AML market, TIBSOVO competes with several therapies, including XOSPATA (gilteritinib), IDHIFA (enasidenib), and others. Emerging therapies such as Ziftomenib (Kura Oncology) and RVU-120 (Ryvu Therapeutics) are also expected to compete with TIBSOVO upon their approval. Ziftomenib, a small molecule developed by Kura Oncology, is currently in Phase I/II trials. In the relapsed/refractory (R/R) MDS market, TIBSOVO faces competition from therapies such as RYTELO (Imetelstat), an IV injection that inhibits oligonucleotide telomerase, and REBLOZYL (Luspatercept), a subcutaneous injection, among other treatment options. In the metastatic cholangiocarcinoma market, TIBSOVO faces relatively less competition, as there are few approved therapies. One such competitor is PEMAZYRE (pemigatinib), a kinase inhibitor that was approved in the US in 2020 and in Europe in 2021. Whereas, Tyra Biosciences' TYRA-200, an FGFR1/2/3 inhibitor, is in phase I stage of development that might be a threat to TIBSOVO one approved. To know more about the number of competing drugs in development, visit @ TIBSOVO Market Positioning Compared to Other Drugs Key Developmental Activities of TIBSOVO In October 2023, Servier announced that the FDA has approved TIBSOVO (ivosidenib tablets) for the treatment of IDH1-mutated R/R MDS. In May 2023, Servier announced that the European Commission has approved TIBSOVO as a targeted therapy in two indications: in combination with azacitidine for the treatment of adult patients with newly diagnosed AML with an isocitrate dehydrogenase-1 R132 mutation who are not eligible to receive standard induction chemotherapy; as well as in monotherapy for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an IDH1 R132 mutation who were previously treated by at least one prior line of systemic therapy. In May 2022, Servier announced FDA approval of TIBSOVO (ivosidenib tablets) in combination with azacitidine for patients with newly diagnosed IDH1-mutated acute myeloid leukemia. In August 2021, Servier announced FDA approval for TIBSOVO (ivosidenib tablets) for the treatment of adult patients with previously treated, locally advanced, or metastatic cholangiocarcinoma with an IDH1 mutation as detected by an FDA-approved test. TIBSOVO is the first and only targeted therapy approved for patients with previously treated IDH1-mutated cholangiocarcinoma. In May 2019, Agios announced FDA approval of TIBSOVO (ivosidenib tablets) as monotherapy for newly diagnosed adult patients with IDH1 mutant acute myeloid leukemia not eligible for intensive chemotherapy. In July 2018, the FDA approved TIBSOVO (ivosidenib) for relapsed or refractory acute myeloid leukemia with an idh1 mutation. In February 2018, the FDA accepted a new drug application and granted priority review for ivosidenib in relapsed or refractory AML with an IDH1 mutation. In December 2017, Agios submitted an NDA to the FDA for ivosidenib for the treatment of patients with relapsed/refractory aml and an IDH1 mutation. TIBSOVO Patent Details TIBSOVO is a drug owned by Servier Pharmaceuticals. Currently, it is protected by 10 Orange book-listed patents filed from 2018 to 2023, out of which none have expired yet. It is also protected by ODE exclusivity for various indications. Discover how TIBSOVO is shaping the blood cancer treatment landscape @ TIBSOVO Side Effects TIBSOVO Market Dynamics In recent years, the therapeutic landscape has undergone significant changes, with promising approaches including immunotherapy, chemotherapy combined with targeted treatments, and the regulation of immune checkpoint-mediated signaling pathways. One such treatment, Ivosidenib, works by inducing the bone marrow to develop normal blood cells, helping to reduce the frequency of blood transfusions. Investment in the research and development of drugs has surged, contributing to a rich pipeline and forecasting promising opportunities in the treatment markets for AML and cholangiocarcinomas. Therapies like TIBSOVO have the potential to capture market attention due to their efficacy and innovation. As healthcare spending continues to rise globally, the pharmaceutical market is expected to expand, providing greater opportunities for market penetration by manufacturers and facilitating the development and distribution of new treatments. Despite progress in cancer treatment, significant gaps remain in understanding the full process that governs carcinogenesis and resistance to treatments, particularly in cancers like acute myeloid leukemia (AML). This highlights the need for more advanced research to address these challenges. Additionally, the limited biomarker testing for patients with the IDH1 mutation restricts the targeted patient pool, posing a challenge for therapies like TIBSOVO to achieve their expected market share. The increasing competition from emerging therapies, such as KEYTRUDA (pembrolizumab), IMFINZI (durvalumab), and the combination of Azacitidine + Venetoclax, further intensifies the pressure on TIBSOVO. Moreover, the difficulty in obtaining sufficient patient pools and diagnostic samples during disease recurrence presents significant hurdles to the effective development of translational research, potentially slowing progress in optimizing treatments. Dive deeper to get more insight into TIBSOVO's strengths & weaknesses relative to competitors @ TIBSOVO Market Drug Report Table of Contents Related Reports Acute Myeloid Leukemia Market Acute Myeloid Leukemia Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key AML companies including Agios Pharmaceuticals, Abbvie, Jazz Pharmaceuticals, Astellas Pharma, Pfizer, Novartis Oncology, Daiichi Sankyo, AstraZeneca, Astex Pharmaceuticals, Inc., Chimerix, Takeda, Rafael Pharmaceuticals Inc., Delta-Fly Pharma, GlycoMimetics Incorporated, BerGenBio ASA, MacroGenics, Syndax Pharmaceuticals, Arog Pharmaceuticals, Forma Therapeutics, Sellas Life Sciences Group, Actinium Pharmaceuticals, Clear Creek Bio Inc., CellCentric Ltd., Biosight Ltd., Astex Pharmaceuticals, Inc., Curis, Inc., NexImmune Inc., Immunomedics, Inc., Sumitomo Dainippon Pharma Co., Ltd., Incyte Corporation, Aprea Therapeutics, Immunicum, DCPrime BV, GT Biopharma, Inc., Hanmi Pharmaceutical Company Limited, Cardiff Oncology, Bio-Path Holdings, Actinium Pharmaceuticals, Aptevo Therapeutics, Synimmune GmbH, GEMoaB Monoclonals, ImmunoGen, Inc., AGC Biologics S.p.A., Precigen, Inc., Novartis Pharmaceuticals, Xencor, Inc., Novartis, Celgene, Bristol Myers Squibb, among others. Relapsed/Refractory Acute Myeloid Leukemia Market Relapsed/Refractory Acute Myeloid Leukemia Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key R/R AML companies including Agios Pharmaceuticals, Abbvie, Jazz Pharmaceuticals, Astellas Pharma, Pfizer, Novartis Oncology, Daiichi Sankyo, AstraZeneca, Astex Pharmaceuticals, Inc., Chimerix, Takeda, Rafael Pharmaceuticals Inc., Delta-Fly Pharma, GlycoMimetics Incorporated, BerGenBio ASA, MacroGenics, Syndax Pharmaceuticals, Arog Pharmaceuticals, Forma Therapeutics, Sellas Life Sciences Group, Actinium Pharmaceuticals, Clear Creek Bio Inc., CellCentric Ltd., Biosight Ltd., Astex Pharmaceuticals, Inc., Curis, Inc., NexImmune Inc., Immunomedics, Inc., Sumitomo Dainippon Pharma Co., Ltd., Incyte Corporation, Aprea Therapeutics, Immunicum, DCPrime BV, GT Biopharma, Inc., Hanmi Pharmaceutical Company Limited, Cardiff Oncology, Bio-Path Holdings, Actinium Pharmaceuticals, Aptevo Therapeutics, Synimmune GmbH, GEMoaB Monoclonals, ImmunoGen, Inc., AGC Biologics S.p.A., Precigen, Inc., Novartis Pharmaceuticals, Xencor, Inc., Novartis, Celgene, Bristol Myers Squibb, among others. Myelodysplastic Syndrome Market Myelodysplastic Syndrome Market Insight, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of market trends, market drivers, market barriers, and key MDS companies such as Bristol-Myers Squibb, Astex Pharmaceutical, Taiho Oncology, Fibrogen, AbbVie, Gilead Sciences, Novartis, Syros Pharmaceuticals, Takeda, Pfizer, Geron Corporation, Karyopharm Therapeutics, Antengene Corporation, BerGenBio ASA, Jazz Pharmaceuticals, Aprea Therapeutics, Sanofi, Medac, among others. Cholangiocarcinoma Market Cholangiocarcinoma Market Insight, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of market trends, market drivers, market barriers, and key cholangiocarcinoma companies such as AstraZeneca, Decalth Systems, Basilea Pharmaceutica, Taiho Oncology, Eisai Pharmaceuticals, TransThera Sciences, Incyte Corporation, Roche, Agios Pharmaceuticals, Servier Pharma, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

上市批准免疫疗法临床1期优先审批

2025-04-04

·aptevotherapeutics.gcs-web.com

Aptevo Therapeutics Announces the Closing of $2.1 Million Registered Direct Offering and Concurrent Private Placement Priced At-The-Market Under Nasdaq Rules

SEATTLE, WASHINGTON / ACCESS Newswire / April 4, 2025 / Aptevo Therapeutics Inc. (Nasdaq:APVO) ("Aptevo" or the "Company"), a clinical-stage biotechnology company focused on developing novel immune-oncology therapeutics based on its proprietary ADAPTIR™ and ADAPTIR-FLEX™ platform technologies, announced the closing of its previously announced offering of 1,764,710 shares of the Company's common stock in a registered direct offering and warrants to purchase up to 3,529,420 shares of common stock in a concurrent private placement (together with the registered direct offering, the "offering") at a combined purchase price of $1.19 per share and accompanying warrant. The warrants issued pursuant to the concurrent private placement have an exercise price of $1.19 per share, will be exercisable upon the receipt of stockholder approval and will expire 5 years from the date of stockholder approval. Roth Capital Partners acted as the exclusive placement agent for the offering. Gross proceeds from the offering were approximately $2.1 million, before deducting the placement agent's fees and other estimated offering expenses payable by the Company. Aptevo intends to use the net proceeds from the proposed offering for the continued clinical development of its product candidates, working capital, and other general corporate purposes. A shelf registration statement on Form S-3 (File No. 333-284969) relating to the shares of common stock issued in the registered direct offering was previously filed with the Securities and Exchange Commission (the "SEC") and is currently effective. The registered direct offering was made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement, relating to the registered direct offering that will be filed with the SEC. The warrants were issued in a concurrent private placement. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained on the SEC's website at http://www.sec.gov or by contacting Roth Capital Partners, LLC at 888 San Clemente Drive, Newport Beach CA 92660, by phone at (800) 678-9147 or by email at rothecm@roth.com. The private placement of the warrants and the underlying shares will be made in reliance on an exemption from registration under Section 4(a)(2) of the Securities Act and/or Regulation D thereunder. Accordingly, the securities issued in the concurrent private placement cannot be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. This press release does not constitute an offer to sell, or the solicitation of an offer to buy, the shares of common stock or warrants, nor will there be any sale of the shares of common stock or warrants in any state or other jurisdiction in which such offer, solicitation or sale is not permitted. The Company also amended certain existing warrants that were previously issued on December 12, 2024 to purchase up to 1,647,088 shares of the Company's common stock and have an exercise price of $9.53 per share, effective upon the closing of the offering, such existing warrants have a reduced exercise price of $1.19 per share, shall become exercisable upon stockholder approval and will expire 5 years from the date of stockholder approval. About Aptevo Therapeutics Aptevo Therapeutics Inc. is a clinical-stage biotechnology company focused on developing novel bispecific immunotherapies for the treatment of cancer. The company has two clinical candidates. Mipletamig is currently being evaluated in RAINIER, a Phase 1b/2 trial for the treatment of frontline acute myeloid leukemia in combination with standard-of-care venetoclax + azacitidine. Mipletamig has received orphan drug designation ("orphan status") for AML according to the Orphan Drug Act. ALG.APV-527, a bispecific conditional 4-1BB agonist, only active upon simultaneous binding to 4-1BB and 5T4, is being co-developed with Alligator Bioscience and is being evaluated in a Phase 1 clinical trial for the treatment of multiple solid tumor types likely to express 5T4. The Company has three pre-clinical candidates with different mechanisms of action designed to target a range of solid tumors. All pipeline candidates were created from two proprietary platforms, ADAPTIR® and ADAPTIR-FLEX® The Aptevo mission is to improve treatment outcomes and transform the lives of cancer patients. For more information, please visit www.aptevotherapeutics.com. Safe Harbor Statement This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including, without limitation, statements regarding the use of proceeds of the offering and any other statements containing the words "may," "continue to," "believes," "expects," "optimism," "potential," "designed," "promising," "plans," "will" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based on Aptevo's current intentions, beliefs, and expectations regarding future events. Aptevo cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from Aptevo's expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. There are several important factors that could cause Aptevo's actual results to differ materially from those indicated by such forward-looking statements, including a deterioration in Aptevo's business or prospects; uncertainties related to market conditions, the satisfaction of customary closing conditions related to the offering, compliance with Nasdaq listing requirements, and changes in regulatory, social, macroeconomic, and political conditions. For instance, actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the uncertainties inherent in the results of preliminary data and preclinical studies being predictive of the results of later-stage clinical trials, initiation, enrollment and maintenance of patients, and the completion of clinical trials, the availability and timing of data from ongoing clinical trials, the trial design includes combination therapies that may make it difficult to accurately ascertain the benefits of mipletamig, expectations for the timing and steps required in the regulatory review process, expectations for regulatory approvals, the impact of competitive products, our ability to enter into agreements with strategic partners or raise funds on acceptable terms or at all and other matters that could affect the availability or commercial potential of Aptevo's product candidates, business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises such as the coronavirus (referred to as COVID-19), geopolitical risks, including the current war between Russia and Ukraine, war between Israel and Hamas, and macroeconomic conditions such as economic uncertainty, rising inflation and interest rates, increased market volatility and decreased consumer confidence. These risks are not exhaustive, Aptevo faces known and unknown risks. Additional risks and factors that may affect results are set forth in Aptevo's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and its subsequent current reports on Form 8-K. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Aptevo's expectations in any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, Aptevo does not assume any obligation to update any forward-looking statement to reflect new information, events, or circumstances. CONTACT: Miriam Weber Miller Aptevo Therapeutics Email: IR@apvo.com or Millerm@apvo.com Phone: 206-859-6628 SOURCE: Aptevo Therapeutics

临床1期免疫疗法孤儿药

2025-04-03

·aptevotherapeutics.gcs-web.com

Aptevo Therapeutics $2.1 Million Registered Direct Offering and Concurrent Private Placement Priced At-The-Market Under Nasdaq Rules

SEATTLE, WA / ACCESS Newswire / April 3, 2025 / Aptevo Therapeutics Inc. (Nasdaq:APVO) ("Aptevo" or the "Company"), a clinical-stage biotechnology company focused on developing novel immune-oncology therapeutics based on its proprietary ADAPTIR™ and ADAPTIR-FLEX™ platform technologies, announced today that it has entered into definitive securities purchase agreements for the purchase and sale of 1,764,710 shares of the Company's common stock in a registered direct offering and warrants to purchase up to 3,529,420 shares of common stock in a concurrent private placement (together with the registered direct offering, the "offering") at a combined purchase price of $1.19 per share and accompanying warrant. The warrants issued pursuant to the concurrent private placement will have an exercise price of $1.19 per share, will be exercisable upon the receipt of shareholder approval following the date of issuance and will expire 5 years from the initial exercise date. The offering is expected to close on or about April 4, 2025 subject to the satisfaction of customary closing conditions. Roth Capital Partners is acting as the exclusive placement agent for the offering. Aptevo expects the gross proceeds from the offering to be approximately $2.1 million, before deducting the placement agent's fees and other estimated offering expenses payable by the Company. Aptevo intends to use the net proceeds from the proposed offering for the continued clinical development of its product candidates, working capital, and other general corporate purposes. A shelf registration statement on Form S-3 (File No. 333-284969) relating to the shares of common stock (and common stock equivalents) to be issued in the registered direct offering was previously filed with the Securities and Exchange Commission (the "SEC") and is currently effective. The registered direct offering is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement, relating to the registered direct offering that will be filed with the SEC. The warrants will be issued in a concurrent private placement. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC's website at http://www.sec.gov or by contacting Roth Capital Partners, LLC at 888 San Clemente Drive, Newport Beach CA 92660, by phone at (800) 678-9147 or by email at rothecm@roth.com. The private placement of the warrants and the underlying shares will be made in reliance on an exemption from registration under Section 4(a)(2) of the Securities Act and/or Regulation D thereunder. Accordingly, the securities issued in the concurrent private placement may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. This press release does not constitute an offer to sell, or the solicitation of an offer to buy, the shares of common stock, nor will there be any sale of the shares of common stock in any state or other jurisdiction in which such offer, solicitation or sale is not permitted. The Company also has agreed to amend certain existing warrants that were previously issued December 12, 2024 to purchase up to 1,647,088 shares of the Company's common stock and have an exercise price of $9.53 per share, effective upon the closing of the offering, such existing warrants will have a reduced exercise price of $1.19 per share, shall become exercisable upon stockholder approval and will expire 5 years from the date of stockholder approval. About Aptevo Therapeutics Aptevo Therapeutics Inc. is a clinical-stage biotechnology company focused on developing novel bispecific immunotherapies for the treatment of cancer. The company has two clinical candidates. Mipletamig is currently being evaluated in RAINIER, a Phase 1b/2 trial for the treatment of frontline acute myeloid leukemia in combination with standard-of-care venetoclax + azacitidine. Mipletamig has received orphan drug designation ("orphan status") for AML according to the Orphan Drug Act. ALG.APV-527, a bispecific conditional 4-1BB agonist, only active upon simultaneous binding to 4-1BB and 5T4, is being co-developed with Alligator Bioscience and is being evaluated in a Phase 1 clinical trial for the treatment of multiple solid tumor types likely to express 5T4. The Company has three pre-clinical candidates with different mechanisms of action designed to target a range of solid tumors. All pipeline candidates were created from two proprietary platforms, ADAPTIR® and ADAPTIR-FLEX® The Aptevo mission is to improve treatment outcomes and transform the lives of cancer patients. For more information, please visit www.aptevotherapeutics.com. Safe Harbor Statement This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including, without limitation, statements regarding the completion, timing, size and use of proceeds of the offering, the satisfaction of customary closing conditions related to the offering and any other statements containing the words "may," "continue to," "believes," "expects," "optimism," "potential," "designed," "promising," "plans," "will" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based on Aptevo's current intentions, beliefs, and expectations regarding future events. Aptevo cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from Aptevo's expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. There are several important factors that could cause Aptevo's actual results to differ materially from those indicated by such forward-looking statements, including a deterioration in Aptevo's business or prospects; uncertainties related to market conditions, the satisfaction of customary closing conditions related to the offering, compliance with Nasdaq listing requirements, and changes in regulatory, social, macroeconomic, and political conditions. For instance, actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the uncertainties inherent in the results of preliminary data and preclinical studies being predictive of the results of later-stage clinical trials, initiation, enrollment and maintenance of patients, and the completion of clinical trials, the availability and timing of data from ongoing clinical trials, the trial design includes combination therapies that may make it difficult to accurately ascertain the benefits of APVO436, expectations for the timing and steps required in the regulatory review process, expectations for regulatory approvals, the impact of competitive products, our ability to enter into agreements with strategic partners or raise funds on acceptable terms or at all and other matters that could affect the availability or commercial potential of Aptevo's product candidates, business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises such as the coronavirus (referred to as COVID-19), geopolitical risks, including the current war between Russia and Ukraine, war between Israel and Hamas, and macroeconomic conditions such as economic uncertainty, rising inflation and interest rates, increased market volatility and decreased consumer confidence. These risks are not exhaustive, Aptevo faces known and unknown risks. Additional risks and factors that may affect results are set forth in Aptevo's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and its subsequent current reports on Form 8-K. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Aptevo's expectations in any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, Aptevo does not assume any obligation to update any forward-looking statement to reflect new information, events, or circumstances. CONTACT: Miriam Weber Miller Aptevo Therapeutics Email: IR@apvo.com or Millerm@apvo.com Phone: 206-859-6628 SOURCE: Aptevo Therapeutics

临床1期免疫疗法孤儿药

100 项与阿扎胞苷相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D03021	阿扎胞苷	L01BC07	DB00928

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
幼年型骨髓单核细胞白血病	美国	Bristol Myers Squibb Co.	2022-05-20
骨髓增生性疾病	欧盟	betapharm Arzneimittel GmbH	2020-03-24
骨髓增生性疾病	冰岛	betapharm Arzneimittel GmbH	2020-03-24
骨髓增生性疾病	列支敦士登	betapharm Arzneimittel GmbH	2020-03-24
骨髓增生性疾病	挪威	betapharm Arzneimittel GmbH	2020-03-24
费城染色体阳性慢性粒细胞白血病	中国	Bristol-Myers Squibb Pharma EEIG	2017-04-24
高危骨髓增生异常综合征	澳大利亚	Celgene Pty Ltd.	2009-11-30
急性髓性白血病	欧盟	Bristol-Myers Squibb Pharma EEIG	2008-12-17
急性髓性白血病	冰岛	Bristol-Myers Squibb Pharma EEIG	2008-12-17
急性髓性白血病	列支敦士登	Bristol-Myers Squibb Pharma EEIG	2008-12-17
急性髓性白血病	挪威	Bristol-Myers Squibb Pharma EEIG	2008-12-17
慢性粒单核细胞白血病	欧盟	Bristol-Myers Squibb Pharma EEIG	2008-12-17
慢性粒单核细胞白血病	冰岛	Bristol-Myers Squibb Pharma EEIG	2008-12-17
慢性粒单核细胞白血病	列支敦士登	Bristol-Myers Squibb Pharma EEIG	2008-12-17
慢性粒单核细胞白血病	挪威	Bristol-Myers Squibb Pharma EEIG	2008-12-17
骨髓增生异常综合征	美国	Bristol Myers Squibb Co.	2004-05-19

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
免疫母细胞性淋巴结病	临床3期	日本	Celgene Corp.	2018-11-06
血小板减少症	临床3期	美国	Celgene Corp.	2013-04-26
血小板减少症	临床3期	澳大利亚	Celgene Corp.	2013-04-26
血小板减少症	临床3期	比利时	Celgene Corp.	2013-04-26
血小板减少症	临床3期	巴西	Celgene Corp.	2013-04-26
血小板减少症	临床3期	加拿大	Celgene Corp.	2013-04-26
血小板减少症	临床3期	捷克	Celgene Corp.	2013-04-26
血小板减少症	临床3期	丹麦	Celgene Corp.	2013-04-26
血小板减少症	临床3期	芬兰	Celgene Corp.	2013-04-26
血小板减少症	临床3期	法国	Celgene Corp.	2013-04-26

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05428969 (BEXMAB, ASH2024) 人工标引	临床1/2期	骨髓增生异常综合征 TP53 Mutation	14	Bexmarilimab+Azacitidine	繭鏇選衊鹹窪糧鏇構衊(積鏇顧簾構糧淵鏇夢網) = 蓋衊艱鏇選繭遞選鹹遞膚顧製糧獵願獵窪遞築 (艱選範網繭膚選選艱鹹 ) 更多	积极	2024-12-09
ASH2024	临床3期	急性髓性白血病	70	Azacitidine+HAG regime	鏇齋簾製簾襯憲糧衊醖(獵網鏇觸構憲構齋鑰鑰) = 鏇夢窪築遞壓鑰範製淵膚鹽憲襯齋觸廠築網鏇 (夢淵襯鏇鹹積獵蓋範鏇 ) 更多	积极	2024-12-09
ASH2024	N/A	复发性急性髓细胞白血病	-	Venetoclax	網襯鹽顧艱鑰廠淵願製(鹹鏇顧齋齋壓艱艱構繭) = 夢廠鬱蓋夢範構醖網遞憲選廠觸廠簾繭願製網 (壓憲顧繭築醖衊顧製網, 6.2 ~ 16.0)	-	2024-12-09
735 (ASH2024)	临床1/2期	急性髓性白血病 TP53mutation	110	Magrolimab (Magro) + Azacitidine (AZA) + Venetoclax (VEN)	築積願鑰願簾淵遞憲蓋(繭簾構艱壓夢窪襯獵糧) = 選廠膚淵鏇廠醖蓋獵膚餘選廠鬱衊獵網憲糧襯 (蓋觸廠願糧構糧醖夢蓋, 7 ~ 13) 更多	积极	2024-12-09
ASH2024	N/A	急性髓性白血病	-	Azacitidine + Venetoclax	艱鹽選製襯餘艱範積餘(鹹憲顧築鹹積鹹網廠衊) = 襯願顧積膚鏇積夢衊齋衊簾淵鹹選壓糧憲鹹遞 (憲憲鹹糧膚淵醖選衊艱 ) 更多	-	2024-12-09
NCT03013998 (BAMT, ASH2024)	临床1/2期	急性髓性白血病	1,096	Non-Intensive (Off-Protocol)	範夢選齋醖艱選糧衊憲(淵夢製憲鹹壓醖製鑰遞) = 鑰鬱積遞蓋鹽壓齋觸膚鏇獵鑰醖衊齋簾鹹遞繭 (膚鬱鬱淵衊遞簾膚鹽淵, 6.9 ~ 13.4) 更多	积极	2024-12-09
				Ven/HMA (Off-Protocol)	範夢選齋醖艱選糧衊憲(淵夢製憲鹹壓醖製鑰遞) = 鑰醖積構夢選願顧簾夢鏇獵鑰醖衊齋簾鹹遞繭 (膚鬱鬱淵衊遞簾膚鹽淵, 2.2 ~ 10.7) 更多
ASH2024	N/A	急性髓性白血病 \| 骨髓增生异常综合征	-	Azacitidine + Durvalumab	觸蓋憲選衊鑰壓遞醖衊(鹽衊築衊壓糧餘願簾選) = 醖蓋範觸夢網憲鏇鹽齋鑰遞構選構糧齋淵夢夢 (遞蓋顧鏇顧衊範憲餘繭 ) 更多	-	2024-12-09
				Azacitidine	觸蓋憲選衊鑰壓遞醖衊(鹽衊築衊壓糧餘願簾選) = 構鬱夢廠獵繭鹹積夢築鑰遞構選構糧齋淵夢夢 (遞蓋顧鏇顧衊範憲餘繭 ) 更多
NCT02719574 (ASH2024) 人工标引	临床1/2期	IDH1突变急性髓性白血病 IDH1 Mutation	67	Olutasidenib 150 mg + azacitidine	製艱獵築簾窪築蓋窪壓(製範願襯顧憲鏇鏇糧艱) = 遞繭網築鑰襯襯鏇齋蓋襯壓衊憲獵鑰齋餘鏇顧 (鹽夢繭顧齋願蓋艱糧夢, 21 ~ 44) 更多	积极	2024-12-08
				Olutasidenib 150 mg + azacitidine (prior OLU exposure)	製艱獵築簾窪築蓋窪壓(製範願襯顧憲鏇鏇糧艱) = 鏇糧遞願齋醖鑰選鬱構襯壓衊憲獵鑰齋餘鏇顧 (鹽夢繭顧齋願蓋艱糧夢, 24 ~ 52) 更多
NCT04501120 (APG2575AC101, ASH2024) 人工标引	临床1/2期	骨髓增生异常综合征	49	Lisaftoclax Azacitidineazacitidine (R/R MDS)	醖夢鑰鹽醖顧憲窪簾製(齋積窪網憲襯蓋製餘獵) = 齋願築鑰艱築鑰襯廠鹽醖蓋鹽淵簾醖範艱壓夢 (構廠顧遞遞鑰鹽醖構餘 ) 更多	积极	2024-12-08
				Lisaftoclax Azacitidineazacitidine (TN MDS)	衊範糧窪壓憲繭構淵淵 \| 醖夢鑰鹽醖顧憲窪簾製(窪憲餘獵選構襯鏇顧醖) = 築廠範鏇繭襯襯願獵齋窪鏇齋製鬱簾觸製繭艱 (願壓襯願窪願淵觸網廠, 61.5 ~ 89.2) 更多
NCT04550442 (ASH2024) 人工标引	临床1/2期	高危骨髓增生异常综合征 \| 慢性粒单核细胞白血病	33	AzacitidineVenetoclax	鹹憲醖鹽鬱願餘選願廠(憲構構艱鑰廠築鹽壓獵) = 憲範衊壓鹹膚願鹹衊範淵憲廠築艱襯蓋築鏇窪 (糧範糧選製窪遞製夢淵 ) 更多	积极	2024-12-08
				Azacitidine and Venetoclax (TP53 mutation)	觸襯網網齋願蓋齋鏇構(鏇鏇襯膚壓鏇糧廠鏇壓) = 膚蓋艱鑰廠範製糧憲觸範鹹齋壓醖網獵積齋鏇 (蓋鏇選襯淵窪範憲蓋齋, 0.9 ~ 5)