A Pilot Study of Epcoritamab With Dose Adjusted Etoposide, Cyclophosphamide, Vincristine, Doxorubicin, Prednisone and Rituximab (EPOCH-R) for Upfront Treatment of Aggressive B-Cell Non-Hodgkin Lymphomas

This phase II trial tests the safety, best dose, and effectiveness of epcoritamab when given with etoposide, cyclophosphamide, vincristine, doxorubicin, prednisone and rituximab (EPOCH-R) for the treatment of patients with aggressive B-cell non-Hodgkin lymphoma. Epcoritamab is a bispecific antibody that can bind to two different antigens at the same time. Epcoritamab binds to CD3, a T-cell surface antigen, and CD20 (a tumor-associated antigen that is expressed on B-cells during most stages of B-cell development and is often overexpressed in B-cell cancers) and may interfere with the ability of cancer cells to grow and spread. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill cancer cells. It may also lower the body's immune response. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's DNA and may kill cancer cells. It also blocks a certain enzyme needed for cell division and DNA repair. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. The EPOCH-R is administrated as the standard of care treatment. This may help the immune system kill cancer cells. Giving epcoritamab with EPOCH-R may be safe, tolerable, and effective in treating patients with aggressive B-cell non-Hodgkin lymphoma.

Start Date01 Jan 2026

Sponsor / Collaborator

University of Washington

[+1]

NCT07076186

/ Not yet recruitingPhase 2IIT

Phase II Decentralized Pragmatic Trial of Adjuvant Doxorubicin - Trabectedin Chemotherapy in Uterine Leiomyosarcoma

The goal of this clinical research study is to learn about the safety and effects of M032 given directly into the tumor in children and adults with DMG and who have received standard-of-care radiation therapy.

Start Date01 Dec 2025

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

NCT07078604

/ Not yet recruitingPhase 2IIT

A Phase II Trial of the Immunogenicity of a DNA Plasmid-Based Vaccine (STEMVAC) Encoding Th1 Selective Epitopes From Five Antigens Associated With Breast Cancer Stem Cells (MDM2, YB1, SOX2, CDH3, CD105) in Patients With Metastatic Triple-Negative Breast Cancer

This phase II trial studies how well a cancer vaccine called STEMVAC works in combination with chemotherapy in treating patients with PD-L1 negative, triple-negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic). STEMVAC is designed to target proteins that are expressed on breast cancer stem cells, and it is believed to work by boosting the immune system to recognize and destroy the invader tumor cells that are causing the disease. The allowable combination chemotherapy includes: (1) Paclitaxel is in a class of chemotherapy medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. (2) Docetaxel is in a class of chemotherapy medications called taxanes. It stops tumor cells from growing and dividing and may kill them. (3) Cisplatin is in a class of chemotherapy medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. (4) Carboplatin is in a class of chemotherapy medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. (5) Doxorubicin is in a class of chemotherapy medications called anthracyclines. Doxorubicin damages the cell's deoxyribonucleic acid (DNA) and may kill tumor cells. It also blocks a certain enzyme needed for cell division and DNA repair. (6) Liposomal doxorubicin is a form of the anticancer drug doxorubicin that is contained inside very tiny, fat-like particles. Liposomal doxorubicin may have fewer side effects and work better than other forms of the drug. (7) Eribulin is in a class of chemotherapy medications called microtubule dynamics inhibitors. It works by stopping the growth and spread of tumor cells. Giving STEMVAC in combination with chemotherapy may be an effective treatment for PD-L1 negative metastatic triple-negative breast cancer.

Start Date01 Dec 2025

Sponsor / Collaborator

University of Washington

100 Clinical Results associated with Doxorubicin Hydrochloride

100 Translational Medicine associated with Doxorubicin Hydrochloride

100 Patents (Medical) associated with Doxorubicin Hydrochloride

98,149

Literatures (Medical) associated with Doxorubicin Hydrochloride

01 Mar 2026·BIOMATERIALS

Targeted degradation of hexokinase 2 by a novel engineered bispecific chimeric liposome-based Nano-PROTACs for enhancing tumor chemotherapy

Article

Author: Gong, Linlin ; Hou, Peng ; Liu, Runjie ; Yang, Dan ; Yan, Li ; Li, Shasha ; Liu, Dechun ; Zhao, Yuelei ; Wang, Simeng ; Wang, Jianling ; Ji, Meiju ; Sun, Jiahui

Aerobic glycolysis is critical for tumor development and metastasis. Regulating the activity of vital metabolic enzymes in the tumor glycolysis process, such as hexokinase 2 (HK-2), is expected for tumor treatment. However, conventional small molecule inhibitors only block the activity of proteases with consistently high doses via occupation-driven pattern, leading to off-target effects which limit their clinical application. Herein, we reported a novel engineered bispecific chimeric liposome-based Nano-proteolysis targeting chimeras (LIPOTAC) for HK-2 degradation. LIPOTAC consisted of three parts containing HK-2 binding moiety, E3 ubiquitin ligase binder and liposome vehicle. It was worth noting that in this system, on the one hand, liposomes played a role similar to linker in proteolysis targeting chimeras (PROTACs), achieving flexible regulation of targeting probes ratio, and on the other hand, liposomes could enhance tumor accumulation and cellular uptake compared to traditional small molecule PROTACs. Then, LIPOTAC could bind to HK-2, hijack cereblon (CRBN) to induce HK-2 ubiquitination, and efficiently degrade HK-2 with proteasomes in the cytoplasm of tumor cell. More than 91 % or 82 % of HK-2 in B16F10 or 4T1 tumor cells could be degraded by LIPOTAC, respectively. Moreover, doxorubicin (DOX) was remote-loaded into LIPOTAC vesicle via an ammonium sulfate gradient method for enhancing the anti-tumor effect of LIPOTAC, named DOX@LIPOTAC. DOX@LIPOTAC effectively induced tumor cell apoptosis in vitro, triggered targeted proteolysis of HK-2 and inhibited the growth of B16F10 and 4T1 cell-derived xenograft tumors and prevented lung metastasis in the orthotopic 4T1-luciferase tumor-bearing mouse model, while minimized systemic side effects. The persistent HK-2 degradation strategy boosted tumor aerobic glycolysis inhibition for synergistic enhancement of tumor chemotherapy. Therefore, our study offers new insights into how to regulate tumor glucose metabolism through an innovative protein degradation strategy for cancer treatment.

01 Feb 2026·COMPUTATIONAL BIOLOGY AND CHEMISTRY

Esculetin attenuates doxorubicin-induced cardiac toxicity: Evidence from gene expression, enzyme activity, and molecular docking analyses

Article

Author: Demir, Yeliz ; Yeşilkent, Esra Nur ; Ceylan, Hamid ; Kizir, Duygu ; Türkeş, Cüneyt ; Beydemir, Şükrü ; Karaman, Melike

Doxorubicin (DOX) is a potent chemotherapeutic agent whose dose-dependent cardiotoxicity is associated with oxidative stress, inflammation, and enzymatic dysfunction. This study evaluates the cardioprotective potential of esculetin, a natural coumarin derivative, against DOX-induced cardiac injury in rats. Forty-eight male Sprague-Dawley rats were divided into six groups, including control, DOX, esculetin (50 and 100 mg/kg), and combination treatments. DOX markedly altered the expression of oxidative stress-related genes (Ache, Ar, Sord upregulated; Pon1, Gst downregulated) and impaired enzyme activities, accompanied by increased malondialdehyde and depleted glutathione levels. Esculetin administration, particularly at 100 mg/kg, reversed these molecular and biochemical disturbances, restoring antioxidant defense and normalizing gene expression. Molecular docking revealed strong binding interactions of esculetin with the active sites of key enzymes including AR, SORD, AChE, GST, and PON1, supporting its regulatory role. These findings suggest that esculetin exerts multi-targeted protective effects and may serve as a promising candidate for mitigating chemotherapy-induced cardiotoxicity. Further research is warranted to explore its integration into clinical cardioprotective strategies.

01 Jan 2026·BIOMATERIALS

Modulating tumor acidity with hydroxyethyl starch-based nanoparticles by targeting CA9 to eliminate cancer stem cells and overcome immunosuppression

Article

Author: Yang, Xiangliang ; Hua, Ao ; Zhang, Zhijie ; Li, Zifu ; Deng, Qingyuan ; Yang, Tian ; Zhao, Qingfu ; Wang, Qiang

The acidic microenvironment in solid tumors, primarily driven by Warburg effect, promotes tumor progression, immune evasion, and resistance to therapy. Cancer stem cells (CSCs), a critical subset within tumor tissues, exacerbate this acidity through overexpression of pH-regulating proteins such as carbonic anhydrase IX (CA9), which plays a pivotal role in maintaining pH homeostasis, contributes to immune suppression, and sustains CSC stemness and proliferation. In this study, we designed CA9 inhibitor (CAi) coupled hydroxyethyl starch-based nanoparticles (CHHD-Cu NPs) that integrate doxorubicin (DOX) mediated chemotherapy with copper ions (Cu²⁺) mediated chemodynamic therapy to target and eliminate CA9-expressing CSCs. Upon administration, CHHD-Cu NPs bind to CA9 and disrupt pH regulation, thereby lowering intracellular pH and raising extracellular pH. This pH modulation enhances intracellular releases of DOX and Cu²⁺ and alleviates extracellular acidity to boost effector T cells infiltration and activity. Our rationally designed CHHD-Cu NPs eliminate CSCs in two ways: firstly, by robust intracellular DOX- and copper-induced cytotoxicity, and secondly, via pH modulation-mediated activation of anti-tumor immunity. Our strategy offers novel approaches for treatment of immunosuppressive solid tumors.

452

News (Medical) associated with Doxorubicin Hydrochloride

05 Sep 2025

·www.prnewswire.com

Huadong Medicine Announces Positive Preliminary Results from a Phase Ⅰ study of HDM2005, a ROR1-Targeting ADC

HANGZHOU, China, Sept. 5, 2025 /PRNewswire/ -- Huadong Medicine Co., Ltd. (hereinafter referred to as "Huadong Medicine") today announced positive preliminary results from a Phase I study of HDM2005, an independently developed Class 1 innovative antibody–drug conjugate (ADC) targeting receptor tyrosine kinase-like orphan receptor 1 (ROR1), in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL) or classical Hodgkin lymphoma (cHL). The results showed that HDM2005 demonstrated promising efficacy with a favorable safety and tolerability profile in B-NHL and cHL, which will support the clinical development moving forward. ROR1 is a transmembrane protein overexpressed in various cancers, including lymphomas. HDM2005 is composed of a humanized IgG1 monoclonal antibody, a proteolytically cleavable linker, and the cytotoxic payload monomethyl auristatin E (MMAE). In preclinical studies, HDM2005 demonstrated potent anti-tumor activity across multiple lymphoma and solid tumor models. This first-in-human Phase I study (NCT06615193) enrolled patients with relapsed or refractory B-NHL or cHL. The primary objectives were to evaluate safety and tolerability, determine the maximum tolerated dose (MTD) and the recommended Phase Ⅱ doses (RP2Ds) and perform a preliminary evaluation of antitumor efficacy in lymphoma. As of July 4, 2025, a total of 29 patients were enrolled (n=1, 4, 10, 11 and 3 in the 0.3, 1.0, 1.8. 2.5 and 2.75 mg/kg dose cohorts), including 17 patients with mantle cell lymphoma (MCL), 8 patients with diffuse large B-cell lymphoma (DLBCL), and 4 patients with cHL. Most patients (21, 72.4%) had received ≥3 prior lines of anti-tumor therapy. No patient permanently discontinued treatment due to treatment related adverse events (TRAEs). In the 1.8 mg/kg and 2.5 mg/kg cohorts, 38.1% of patients (8/21) experienced Grade ≥3 TRAEs, the most common (≥5%) being neutrophil count decrease (4 patients, 19.0%). No Grade ≥3 gastrointestinal adverse reactions or peripheral neuropathy were reported. Peripheral neuropathy occurred in 4 patients (13.8%), all of which were Grade 1 or 2. In the 1.8 mg/kg and 2.5 mg/kg cohorts, the objective response rate (ORR) was 50% (6/12) in MCL patients, including 1 complete response (CR) and 5 partial responses (PR). The ORR was 100% (2/2) in cHL patients with CRs. The preliminary results of this Phase I clinical trial show that HDM2005 was well-tolerated and demonstrated promising anti-tumor activity in patients with relapsed/refractory B-NHL or cHL. Huadong Medicine will commit to its "science-driven, patient-centered" mission, advance HDM2005 through clinical development and registration, and strive to bring more treatment options to patients. About HDM2005 HDM2005 Injection is a Class 1 innovative biologic drug targeting ROR1. It is an ADC independently developed by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Huadong Medicine, which holds global intellectual property rights. The clinical trials for HDM2005 were approved in June 2024 by the National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA) respectively, for the treatment of advanced malignant tumors. In February 2025, HDM2005 received Orphan Drug Designation from the U.S. FDA for the treatment of mantle cell lymphoma (MCL). In April 2025, its Investigational New Drug (IND) application for use in combination with rituximab, cyclophosphamide, doxorubicin (or epirubicin), and prednisone (R-CHP) for previously untreated diffuse large B-cell lymphoma (DLBCL) was approved by the NMPA. The project is currently advancing at the first tier of the global clinical R&D landscape for ROR1 ADC. The following 3 clinical trials are currently ongoing in China: A Phase I trial of HDM2005 monotherapy for advanced hematologic malignancies (MCL, DLBCL, cHL): four dose-escalation cohorts have been completed, the fifth cohorts is ongoing, with expansion phases initiated at two dose levels. A Phase I trial of HDM2005 monotherapy for advanced solid tumors: the first patient was dosed in May 2025, and the trial is currently in dose-escalation. A Phase I b/Ⅱ trial of HDM2005 combination therapy for DLBCL patients: the leading site has been activated. SOURCE HUADONG MEDICINE WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 1Clinical ResultOrphan DrugADCDrug Approval

18 Aug 2025

·www.globenewswire.com

LIXTE Biotech Advances Precision Oncology Pipeline with First Phase 1B/2 Trial Readout Expected in 2H 2025

Breakthrough Protein Phosphatase 2A inhibitor LB-100 Targets Ovarian Clear Cell Carcinoma, Advanced Soft Tissue Sarcoma, and MSS Metastatic Colon Cancer 24/7 Market News Issues Corrected Information on Previously issued Press Release with same title Aug. 14, 2025 -- 247marketnews.com, a pioneer in digital media dedicated to the swift distribution of financial market news and corporate information, spotlights LIXTE Biotechnology Holdings, Inc. (Nasdaq: LIXT), a clinical-stage pharmaceutical company focused on developing novel cancer therapies by targeting the modulation of key cellular pathways. 2H 2025 is shaping up to be a defining year for LIXTE. With a focus on its lead compound LB-100, a first-in-class small molecule inhibitor of protein phosphatase 2A (PP2A), a master regulator of cell signaling and DNA damage response. By inhibiting PP2A, LB-100 sensitizes tumors to DNA-damaging agents, including chemotherapy, radiation, and immunotherapy, LIXTE is targeting high-unmet needs in the $200 billion global oncology market (Grand View Research, 2025 projection). Potential upcoming catalysts in 2025, including a first trial result, position LIXTE as a potential disruptor in resistant cancers, where traditional treatments fail due to limited efficacy and toxicity. 1B/2 Trial – Ovarian Clear Cell Carcinoma (OCCC) Ovarian clear cell carcinoma is an aggressive and chemoresistant subtype of epithelial ovarian cancer, accounting for ~5–10% of all ovarian malignancies but disproportionately contributing to ovarian cancer mortality. The Phase 1B/2 study of LB-100 plus the checkpoint inhibitor dostarlimab (GSK) is designed leverage LB-100’s synergistic enhancement of immune checkpoint blockade. Status: Enrolled, with interim safety completed Upcoming Milestone: Preliminary safety and efficacy data expected Q4 2025 Potential Market Impact: Global OCCC treatment market is projected to exceed $750 million by 2028 due to rising incidence and limited targeted therapies 1B/2 Trial – Advanced Soft Tissue Sarcoma (STS) Soft tissue sarcomas are a diverse and difficult-to-treat group of cancers arising from connective tissues. For patients with advanced or metastatic disease, prognosis remains poor. LIXTE’s Phase 1B/2 study evaluates LB-100 in combination with doxorubicin, the current standard of care, in patients with advanced STS. Status: Dose escalation completed. Upcoming Milestone: Safety report Q4 2025 Potential Market Impact: The global STS drug market is estimated to reach $2.1 billion by 2030, driven by the emergence of combination therapies and unmet medical need 1B Trial – Metastatic Microsatellite Stable (MSS) Colon Cancer MSS colon cancer, representing roughly 85% of metastatic colorectal cancer (mCRC), remains unresponsive to checkpoint inhibitors. LIXTE is conducting a Phase 1B trial assessing the safety and activity of LB-100 in combination with+ atezolizumab (Roche) (an ICI), seeking to overcome immune resistance in this cold tumor type. Status: Trial open, first patients recruited Potential Market Impact: The global colorectal cancer therapeutics market is expected to surpass $18 billion by 2030, with MSS disease representing the majority of treatment-resistant cases LIXTE’s strategy of targeting PP2A to potentiate multiple treatment modalities positions LB-100 as a versatile combination agent with broad applicability across solid tumors. The platform’s potential spans oncology subtypes with high unmet need, limited innovation, and growing incidence. Strong IP Position: Multiple issued and pending patents covering composition, methods of use, and combinations Pipeline Expansion: Additional tumor types and investigator-sponsored studies are under review, including glioblastoma. Partnership Potential: Ongoing discussions with academic institutions and biopharma partners for co-development opportunities LIXTE is a clinical-stage pharmaceutical company focused on discovering and developing innovative cancer therapies targeting the protein phosphatase 2A (PP2A) pathway, a previously underexplored avenue in cancer treatment. The company’s lead compound, LB-100, is a first-in-class PP2A inhibitor that has demonstrated strong preclinical results and early-stage clinical tolerability. LIXTE is currently advancing proof-of-concept trials in Ovarian Clear Cell Carcinoma, Metastatic Colon Cancer, and Advanced Soft Tissue Sarcoma. The content above comes from the network. if any infringement, please contact us to modify.

Immunotherapy

06 Aug 2025

·www.globenewswire.com

Moleculin Biotech, Inc. Unveils Promising Preclinical Data of Annamycin in Liver Cancer Treatment

Presented data highlights the potential of Annamycin for treating broad range of human cancers, including high-need oncology indications Annamycin currently in late-stage clinical development in combination with cytarabine for the treatment of AML; Anticipated preliminary data readout in 2H 2025 HOUSTON, Aug. 06, 2025 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced the presentation of encouraging preclinical data for its lead drug candidate, Annamycin, also known by its non-proprietary name of naxtarubicin, which demonstrated significant efficacy against various primary and metastatic liver cancers, including hepatocellular carcinoma (HCC), colorectal liver metastases, and pancreatic ductal adenocarcinoma (PDAC) liver metastases. This is believed to be the result of targeted accumulation in the liver and other organs. These findings were highlighted in a poster titled "Liposomal Annamycin (L-ANN) Efficacy Against Primary and Metastatic Liver Cancers," presented by Dr. Waldemar Priebe, Lead Author and Chairman of the Scientific Advisory Board at Moleculin at the recently held Shelby-Lavine Pancreatic Cancer Symposium at MD Anderson Cancer Center. Key Highlights Targeted Accumulation in Organs: The preclinical studies confirmed that Annamycin exhibits distinct organotropic properties, leading to significantly higher concentrations in the liver, spleen, lungs, and pancreas when compared to doxorubicin (DOX). This targeted accumulation is critical for effectively treating liver-localized tumors.Efficacy in Orthotopic Hepatocellular Carcinoma (HCC) Models: Annamycin demonstrated excellent anti-tumor activity in orthotopic HCC models (Hepa 1-6 Luc), showing a marked reduction in tumor progression and improved survival rates in treated animals compared to vehicle controls.Potent Impact on Colorectal Liver Metastasis: In an experimental liver metastatic model of colorectal carcinoma (CT26 Luc), Annamycin significantly inhibited metastatic growth and extended survival, highlighting its potential for addressing liver metastases in colon cancer that affects close to 50% of patients.Promising Results in Pancreatic Cancer Liver Metastasis: Annamycin also showed compelling efficacy in liver-implanted human pancreatic ductal adenocarcinoma (MIA PaCa-2), leading to inhibition of tumor growth, suggesting its potential role in managing advanced pancreatic cancer with liver involvement.Favorable Safety Profile: Consistent with previous preclinical and clinical findings, Annamycin continued to show low or no cardiotoxicity, a significant advantage over traditional anthracyclines like doxorubicin, which are often limited by dose-dependent cardiac side effects. This safety profile was previously observed in clinical trials, where 32 out of 42 subjects reviewed received more than the FDA-established lifetime maximum allowable level of anthracycline without evidence of cardiotoxicity. “We are incredibly encouraged by these preclinical results, which further validate Annamycin’s potential as a powerful and differentiated therapeutic agent for liver cancers,” said Dr. Priebe. “The ability of Annamycin to concentrate effectively in the liver, combined with its demonstrated efficacy across multiple aggressive liver cancer models and its favorable cardiotoxicity profile, positions it as a highly promising candidate for patients facing these devastating diseases. We believe these data provide a strong foundation for advancing Annamycin in clinical development for these indications, offering new hope where treatment options are often limited.” Walter Klemp, Chairman and CEO of Moleculin, added, “We continue to be strongly encouraged by the potential of Annamycin. Beyond our preliminary programs in AML and soft tissue sarcoma lung metastases (STS lung mets), we continue to advance and develop Annamycin through multiple investigator-initiated studies to further unlock its potential as a treatment option for many other types of cancers. We believe this preclinical data highlights that potential and provides additional validation of its unique pharmacological profile and importantly showcases the opportunity for its use across a wide range of cancers.” Moleculin’s novel drug candidate is being positioned to become the first ever non-cardiotoxic anthracycline to be approved and is currently being developed for the treatment of AML and STS lung mets. For more information, please visit moleculin.com. About Moleculin Biotech, Inc. Moleculin Biotech, Inc. is a Phase 3 clinical stage pharmaceutical company advancing a pipeline of therapeutic candidates addressing hard-to-treat tumors and viruses. The Company’s lead program, Annamycin, is a next-generation highly efficacious and well tolerated anthracycline designed to avoid multidrug resistance mechanisms and to lack the cardiotoxicity common with currently prescribed anthracyclines. Annamycin is currently in development for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases.The Company has begun the MIRACLE (Moleculin R/R AML AnnAraC Clinical Evaluation) Trial (MB-108), a pivotal, adaptive design Phase 3 trial evaluating Annamycin in combination with cytarabine, together referred to as AnnAraC, for the treatment of relapsed or refractory acute myeloid leukemia. Following a successful Phase 1B/2 study (MB-106), with input from the FDA, the Company believes it has substantially de-risked the development pathway towards a potential approval for Annamycin for the treatment of AML. This study remains subject to appropriate future filings with potential additional feedback from the FDA and their foreign equivalents.Additionally, the Company is developing WP1066, an Immune/Transcription Modulator capable of inhibiting p-STAT3 and other oncogenic transcription factors while also stimulating a natural immune response, targeting brain tumors, pancreatic and other cancers. Moleculin is also engaged in the development of a portfolio of antimetabolites, including WP1122 for the potential treatment of pathogenic viruses, as well as certain cancer indications. For more information about the Company, please visit www.moleculin.com and connect on X, LinkedIn and Facebook. Forward-Looking StatementsSome of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the whether the preclinical results described above are able to be reproduced in clinical trials. Moleculin will require significant additional financing, for which the Company has no commitments, in order to conduct its clinical trials as described in this press release, and the milestones described in this press release assume the Company’s ability to secure such financing on a timely basis. Although Moleculin believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin has attempted to identify forward-looking statements by terminology including ‘believes,’ ‘estimates,’ ‘anticipates,’ ‘expects,’ ‘plans,’ ‘projects,’ ‘intends,’ ‘potential,’ ‘may,’ ‘could,’ ‘might,’ ‘will,’ ‘should,’ ‘approximately’ or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. “Risk Factors” in our most recently filed Form 10-K filed with the Securities and Exchange Commission (SEC) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events. Investor Contact:JTC Team, LLCJenene Thomas(908) 824-0775MBRX@jtcir.com

Phase 3Clinical Result

100 Deals associated with Doxorubicin Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D01275	Doxorubicin Hydrochloride	L01DB01	DB00997

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
AIDS-related Kaposi Sarcoma	Japan	Baxter Holdings Ltd. (Japan)	04 Jan 2007
Kaposi Sarcoma	Japan	Mochida Pharmaceutical Co., Ltd.	04 Jan 2007
acute leukemia	Brazil	Libbs Farmacêutica Ltda.	20 Nov 2006
Hepatocellular Carcinoma	Brazil	Libbs Farmacêutica Ltda.	20 Nov 2006
Non-Hodgkin Lymphoma	Brazil	Libbs Farmacêutica Ltda.	20 Nov 2006
Soft Tissue Sarcoma	Brazil	Libbs Farmacêutica Ltda.	20 Nov 2006
Bone Cancer	Japan	Sandoz AG	14 Feb 2005
Bone Tissue Neoplasms	Japan	Sandoz AG	14 Feb 2005
Childhood Malignant Solid Neoplasm	Japan	Sandoz AG	14 Feb 2005
Endometrial Carcinoma	Japan	Sandoz AG	14 Feb 2005
Ewing Sarcoma	Japan	Sandoz AG	14 Feb 2005
Hepatoblastoma	Japan	Sandoz AG	14 Feb 2005
Multiple Myeloma	Japan	Sandoz AG	14 Feb 2005
Retinoblastoma	Japan	Sandoz AG	14 Feb 2005
Rhabdomyosarcoma	Japan	Sandoz AG	14 Feb 2005
Soft Tissue Neoplasms	Japan	Sandoz AG	14 Feb 2005
Transitional Cell Carcinoma	Japan	Sandoz AG	03 Jan 2004
Lung Cancer	China	Pfizer Pharmaceutical (Wuxi) Co. Ltd.	01 Jan 2001
Stomach Cancer	United States	Pfizer Inc.	23 Dec 1987
Ovarian Cancer	United States	Pfizer Inc.	23 Dec 1987

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Neoplasms	NDA/BLA	China	NATCO Pharma Ltd.	30 Jan 2022
Neoplasms	NDA/BLA	China	Dr. Reddy's Laboratories Ltd.	30 Jan 2022
Relapse multiple myeloma	Phase 3	United States	Janssen Research & Development LLC	01 Dec 2004
Relapse multiple myeloma	Phase 3	Argentina	Janssen Research & Development LLC	01 Dec 2004
Relapse multiple myeloma	Phase 3	Australia	Janssen Research & Development LLC	01 Dec 2004
Relapse multiple myeloma	Phase 3	Austria	Janssen Research & Development LLC	01 Dec 2004
Relapse multiple myeloma	Phase 3	Belgium	Janssen Research & Development LLC	01 Dec 2004
Relapse multiple myeloma	Phase 3	Canada	Janssen Research & Development LLC	01 Dec 2004
Relapse multiple myeloma	Phase 3	Czechia	Janssen Research & Development LLC	01 Dec 2004
Relapse multiple myeloma	Phase 3	France	Janssen Research & Development LLC	01 Dec 2004

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00278408 (UNFOLDER, CTgov)	Phase 3	CD20 positive B-Cell Lymphoma	700	R-CHOP-21 (Interventional: 6 R-CHOP-21 for Patients With Radiotherapy Indication)	zjiwtyheyz = elouvbjixs crkektzvoz (pukfoiwyuy, gulnaojnuz - gnnwzpcwnz) View more	-	26 Aug 2025
				R-CHOP-14 (Interventional: 6 R-CHOP-14 for Patients With Radiotherapy Indication)	zjiwtyheyz = jxtqhpobrk crkektzvoz (pukfoiwyuy, aeksyjhmsp - uxfvlqlrii) View more
NCT03517137 (COBRA \| EORTC-1537-COBRA, CTgov)	Phase 2	Hodgkin's Lymphoma \| Relapsing classical Hodgkin lymphoma	150	Radiation Therapy+Dacarbazine+Etoposide+Cyclophosphamide+Adriamycin+Vinblastine+Brentuximab Vedotin	nzneevcnxx(kibtoemrfl) = qtbqgjqhqi cputiahzyq (bcuummlytx, wjxusfegxk - xldjihipvm) View more	-	11 Aug 2025
NCT00878254 (CTgov)	Phase 2	Mantle-Cell Lymphoma	25	Mesna+Etoposide+Cyclophosphamide+Leucovorin+G-CSF+Doxorubicin+ifosfamide+Methotrexate+Rituximab+Vincristine+Cytarabine	xgntbaqjdm(yitsgjqjnm) = uahujkslgv kunkzyirrn (vnvinzwbiy, endwcxehye - dlbmjvymlg) View more	-	23 Jul 2025
["HD21"] (Pubmed \| J Clin Oncol)	Phase 2	Classical Hodgkin's Lymphoma First line	83	Brentuximab vedotin + Etoposide + Cyclophosphamide + Doxorubicin + Dacarbazine + Dexamethasone (BrECADD) (PET2-negative)	eqspkwdbut(qnfflbitwl) = idgvubdwwj narlneiucc (dkdtdijrfd, 84 - 98) View more	Positive	17 Jul 2025
NCT03930680 (PHOENIX1, CTgov)	Phase 1	Heart Failure \| Breast Cancer	25	Dexrazoxane (Dexrazoxane 100mg/m2)	mjdutakrrj = zoyoxfrvyb acnwqotsnf (haejwqgnai, laucfrywdv - ucuqubgrhj) View more	-	12 Jun 2025
				Dexrazoxane (Dexrazoxane 200mg/m2)	mjdutakrrj = zfstivttxm acnwqotsnf (haejwqgnai, iqizvixlpi - sjxhxnmhjm) View more
NCT00476190 (CTgov)	Phase 2	Adult Acute Lymphocytic Leukemia	112	Radiation Therapy+PEG-Asparaginase+Etoposide+doxorubicin+Hydrocortisone Sodium Succinate+6-MP+Methotrexate+Cytarabine+Methylprednisone+Cyclophosphamide+Imatinib+Dexamethasone+E. coli Asparaginase+Vincristine (Pre-amendment Cohort, 2500 IU/m2 q2 Weeks)	ksffchjmcu = gakfbnugqq xymbtiqeei (maxdfjmegz, rmttgeixva - jsqmrwuanb) View more	-	12 Jun 2025
				Radiation Therapy+PEG-Asparaginase+Etoposide+Doxorubicin+Hydrocortisone Sodium Succinate+6-MP+Methotrexate+Cytarabine+Methylprednisone+Cyclophosphamide+Imatinib+Dexamethasone+E. coli Asparaginase+Vincristine (Post-amendment Cohort, 2000 IU/m2 q3 Weeks)	ksffchjmcu = ovpnjbvraw xymbtiqeei (maxdfjmegz, odqqweojwu - grszxipxbr) View more
ASCO2025	Not Applicable	Breast Cancer Adjuvant Her2 neu negative	-	Doxorubicin/cyclophosphamide combined with paclitaxel (ACT)	rscbrygnmg(hzbosnypcw) = zfgnbvdqzz ytvuiuecft (mbvbxwaeau ) View more	Negative	30 May 2025
				Docetaxel/cyclophosphamide (TC)	rscbrygnmg(hzbosnypcw) = qmcloikiky ytvuiuecft (mbvbxwaeau ) View more
ASCO2025	Not Applicable	Toxicity	125	Pegylated liposomal doxorubicin (PLD) 20 mg/m2	icpyefuncn(hmuyxcyuki) = Cardiac toxicity occurred in 3 patients ccnptjrfrj (hmukyntxkg ) View more	-	30 May 2025
				Pegylated liposomal doxorubicin (PLD) 40 mg/m2
NCT04224337 (KCSG LU-19-24, ASCO2025)	Phase 2	Pulmonary sarcomatoid carcinoma PD-L1 positive	20	Durvalumab + Doxorubicin + Ifosfamide	ptcvzltirn(xdustkrokh) = gdrscbcxhd uissftzjfz (tbbsysktvj, 17.7 - 55.8) View more	Positive	30 May 2025
ASCO2025	Not Applicable	Leiomyosarcoma Maintenance	20	Doxorubicin plus dacarbazine	cwxlwqgsem(hktehsfaxc) = ztjffuloxs unkqwzmbwi (liclxfxbfo )	Positive	30 May 2025

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