A Phase 1b Trial of Adaptive Stereotactic Body Radiotherapy in Combination With Durvalumab (MEDI4736), Platinum, and Etoposide in Extensive Stage Small Cell Lung Cancer

This is trial studying the safety of adaptive stereotactic body radiotherapy (SBRT) combined with durvalumab immunotherapy, platinum chemotherapy, and etoposide chemotherapy in platinum refractory extensive stage small cell lung cancer (SCLC).

Start Date31 Dec 2025

Sponsor / Collaborator

University of Maryland Baltimore

[+1]

NCT07001995

/ Not yet recruitingPhase 2IIT

A Single-center, Single-arm Phase II Study of Limertinib Plus Carboplatin and Etoposide in EGFR-mutant NSCLC Patients With SCLC Transformation After EGFR-TKI Progression

This single-center, prospective study and aims to evaluate the efficacy and safety of limertinib combined with etoposide and carboplatin in EGFR-mutant NSCLC patients who develop small-cell lung cancer transformation following progression on EGFR-TKI therapy.

Start Date01 Oct 2025

Sponsor / Collaborator

Hunan Cancer Hospital

NCT06820957

/ Not yet recruitingPhase 2/3IIT

Randomized Phase 2/3 Trial of Vincristine-Irinotecan-Regorafenib in Combination With Vincristine-Doxorubicin-Cyclophosphamide (VDC) and Ifosfamide-Etoposide (IE) in Patients With Newly Diagnosed Metastatic Ewing Sarcoma

This phase II/III trial compares the effect of vincristine, irinotecan, and regorafenib (VIrR) in combination with vincristine, doxorubicin, cyclophosphamide (VDC), ifosfamide and etoposide (IE) to usual treatment with VDC/IE for the treatment of newly diagnosed Ewing sarcoma or other round cell sarcomas that have spread from where they first started (primary site) to other places in the body (metastatic). Vincristine is in a class of medications called vinca alkaloids. It works by stopping tumor cells from growing and dividing and may kill them. Irinotecan is in a class of antineoplastic medications called topoisomerase I inhibitors. It blocks a certain enzyme needed for cell division and deoxyribonucleic acid (DNA) repair and may kill tumor cells. Regorafenib, a type of kinase inhibitor and a type of antiangiogenesis agent, blocks certain proteins, which may help keep tumor cells from growing. It may also prevent the growth of new blood vessels that tumors need to grow. Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's DNA and may kill tumor cells. It also blocks a certain enzyme needed for cell division and DNA repair. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill tumor cells. It may also lower the body's immune response. Ifosfamide, a type of alkylating agent and a type of antimetabolite, attaches to DNA in cells and may kill tumor cells. 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 tumor cells. Giving VIrR/VDC/IE may be more effective than usual treatment with VDC/IE in treating patients with newly diagnosed metastatic Ewing sarcoma or other round cell sarcomas.

Start Date13 Sep 2025

Sponsor / Collaborator

The Children's Oncology Group Foundation, Inc.

100 Clinical Results associated with Etoposide

100 Translational Medicine associated with Etoposide

100 Patents (Medical) associated with Etoposide

35,738

Literatures (Medical) associated with Etoposide

31 Dec 2025·NMC case report journal

A Primary Spinal Intramedullary Mixed Germ Cell Tumor: A Case Report and Literature Review

Article

Author: SHIMAUCHI-OHTAKI, Hiroya ; HORIGUCHI, Keishi ; HIRATO, Junko ; NAKATA, Satoshi ; HONDA, Fumiaki ; YOKOO, Hideaki ; GOTO, Yuta ; OYA, Soichi ; TOMOMASA, Ran ; NAKAMURA, Shunsuke

Central nervous system germ cell tumors are rare and account for 2% to 3% of all central nervous system tumors in Japan. Here, we report an extremely rare case of a primary spinal intramedullary mixed germ cell tumor. A 33-year-old man presented with a chief report of dysuria and numbness in the right lower extremity. Magnetic resonance imaging revealed a mass lesion on the left side of the intramedullary spinal cord at the Th10-11 vertebral body level with hyperintensity on T2-weighted images, isointensity on T1-weighted images, and uniform contrast in gadolinium. Cerebrospinal fluid examination revealed a few atypical cells. Although tumor removal using the posterior median sulcus approach was attempted, only a biopsy was performed because intraoperative rapid pathology suggested a possible diagnosis of germinoma. Permanent pathology revealed a mixed germ cell tumor (mainly comprising a germinoma with a yolk sac tumor). Postoperatively, cerebrospinal irradiation and 8 courses of the carboplatin and etoposide regimen were administered. No recurrence or new lesions were observed on magnetic resonance imaging at 94 months postoperatively. Our extensive literature search found only 4 cases of a mixed germ cell tumor of primary intramedullary origin in the spinal cord. Most spinal germ cell tumors described in the literature are either germinomas or mature teratomas; however, mixed germ cell tumors can also occur, albeit infrequently. Although additional cases need to be accumulated, our case suggests that yolk sac elements in spinal mixed germ cell tumors might not be directly associated with poor life expectancy.

31 Dec 2025·JOURNAL OF ENZYME INHIBITION AND MEDICINAL CHEMISTRY

Synthesis, in vitro and in silico studies of a novel chrysin-ferrocene Schiff base with potent anticancer activity via G1 arrest, caspase-dependent apoptosis and inhibition of topoisomerase II

Article

Author: Break, Mohammed Khaled Bin ; Alkahtani, Hamad M. ; Ansari, Siddique Akber ; Alshammari, Maali D. ; Katamesh, Ahmed A. ; Albadari, Najah

A novel chrysin-ferrocene Schiff base (CFSB) was synthesised as a potential anticancer agent. CFSB demonstrated high cytotoxicity against cancer cells with HepG2 (liver) being the most susceptible (IC₅₀ = 3.11 µM). The compound was less toxic towards normal MRC5 cells and exhibited ∼5-fold selectivity towards most cancer cells. CFSB caused G1-phase arrest, induced caspase-dependent apoptosis by increasing Bax/Bcl2 ratio and reduced metastasis by decreasing MMP9 in HepG2. Furthermore, CFSB was inactive against CDK2, EGFR, TrkA and VEGFR, but it strongly inhibited topoisomerase II (IC₅₀ = 20 µM) with potency comparable to etoposide (IC₅₀ = 15 µM), while weak inhibition was observed against tubulin (IC₅₀ = 76 µM). DFT calculations revealed that CFSB had desirable reactivity, while docking indicated high binding affinity with topoisomerase II. Molecular dynamics and MM-GBSA analyses showed that CFSB-topoisomerase II complex was stable with favourable binding energies, while in silico ADMET studies showed drug-like properties for CFSB.

31 Dec 2025·ANNALS OF MEDICINE

Construction of a novel prognostic model based on lncRNAs-related to DNA damage repair for predicting the prognosis of clear cell renal cell carcinoma

Article

Author: Chen, Peng ; Li, Jian ; Tian, Renli

BACKGROUND:

CcRCC has the characteristics of high aggression, high metastasis, high mortality, wide tumour heterogeneity and variable clinical course. The purpose of this study was to explore the potential value of lncRNAs-related to DNA damage repair (DDR) in predicting the prognosis of ccRCC by construction and verification a novel prognostic model.

METHODS:

RNA-seq data and clinical data of ccRCC were downloaded from public databases. Subsequently, Pearson correlation analysis and differential expression analysis were performed to identify DElncRNAs-related to DDR. Then, through univariate Cox analysis and LASSO analysis, the DElncRNAs-related to DDR associated with prognosis were screened for the construction of novel risk score prognostic model. In addition, functional annotation, tumour mutation burden, immune correlation and drug sensitivity analyses were performed based on risk score to assess the characteristics of patients in different risk score groups.

RESULTS:

Based on univariate Cox analysis and LASSO analysis, four best DElncRNAs-related to DDR were selected. Subsequently, a novel risk score prognostic model based on these four DElncRNAs was constructed through LASSO. Multivariate Cox analysis showed that risk score and age were independent prognostic factors for ccRCC (p < 0.05). Functional enrichment analysis showed that DDR-related biological processes were mainly enriched in the high risk group. The highly mutated genes in the high and low risk groups were the same (VHL, PBRM1 and TTN), but they also had their own unique mutated genes. Pearson correlation analysis showed that the risk score was significantly (p < 0.05) positively correlated with the infiltration degree of CD8 T cells evaluated by six algorithms. In addition, it was found that the high and low risk groups had different sensitivities to the drugs Etoposide, Imatinib, Sorafenib, Bosutinib and Sunitinib.

CONCLUSION:

A novel prognostic model was constructed based on four DElncRNAs-related to DDR. The model has satisfactory accuracy in predicting survival of ccRCC patients.

295

News (Medical) associated with Etoposide

25 Jul 2025

·www.prnewswire.com

Leads Biolabs Lists on HKEX, Raising USD 189 Million Through Initial Public Offering

NANJING, China, July 24, 2025 /PRNewswire/ -- On 25 July, 2025 (China Time), Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs" or the "Company") listed on the Main Board of The Stock Exchange of Hong Kong Limited (HKEX) under the stock code "09887". The clinical-stage biotech company priced its IPO at HKD 35 per share, offering 36.86 million shares (excluding green shoe option). The deal included a Hong Kong public tranche of 16.03 million shares (43% of the total) and an international placement of 20.84 million shares (57%). Morgan Stanley and CITIC Securities acted as joint sponsors of the transaction. Gross proceeds totaled approximately USD 189 million (including green shoe option). According to Leads Biolabs, the proceeds will be allocated as follows: ~65% for ongoing and planned clinical trials and regulatory affairs; ~15% for advancing preclinical assets, expanding existing pipelines, and optimizing technology platforms ~10% for upgrading manufacturing capacity and commercialization preparedness post-approval; ~10% for working capital and general corporate purposes. Dr. Xiaoqiang Kang, Founder, Chairman, and CEO of Leads Biolabs, commented: "Our HKEX debut represents a major leap from laboratory innovation to global capital markets, accelerating our innovation-driven international expansion. For more than a decade, we've pursued one goal: becoming a global leader in immuno-oncology therapeutics. At this inflection point, we reaffirm our founding commitment to eradicating disease while maintaining the entrepreneurial vigor that defines us. Through strengthened global execution and accelerated translation of breakthrough therapies from bench to bedside, we will deliver paradigm-shifting treatments to patients across the globe." Founded in 2012, Leads Biolabs is a clinical-stage biotechnology company dedicated to the discovery, development, and commercialization of innovative therapies to address unmet medical needs in oncology, autoimmune, and other severe diseases both in China and globally. The Company has built a differentiated pipeline of 14 innovative drug candidates, including six clinical-stage drug candidates, of which four lead products are among the top-tier clinically advanced candidates globally. Leads Biolabs operates an integrated business model encompassing in-house discovery, development and commercialization of innovative tumor immunotherapies. The Company has strategically developed assets in three areas: Immuno-oncology 2.0 (IO 2.0), T-cell engagers (TCEs), and antibody-drug conjugates (ADCs). Its oncology pipeline includes 12 investigational products, including 3 monoclonal antibodies, 5 bispecific antibodies, 3 ADCs and 1 bispecific fusion protein. The Company is also progressing two promising candidates for autoimmune diseases—a bispecific fusion protein and a trispecific antibody. Leads Biolabs' R&D is powered by multiple proprietary technology platforms that feature integrated, AI-powered and diversified antibody engineering capabilities, including LeadsBody™ (a CD3 T-cell engager platform), X-body™ (a 4-1BB engager platform) and its linker-payload platform for ADC development. These platforms have demonstrated clinical proof-of-concept, particularly with bispecific antibody combinations. The LeadsBody™ platform delivers strong technological capabilities for developing CD3-targeted bispecific antibodies. Its innovative molecular design enables precise affinity modulation between TCEs and both CD3 and tumor-associated antigens (TAAs). With spatially optimized steric hindrance architecture, the platform enables conditional T-cell activation exclusively within the tumor microenvironment (TME), significantly lowering the risk of cytokine release syndrome (CRS) and systemic toxicity. This molecular engineering approach is designed to optimize the therapeutic index through customized spatial configurations that reduce treatment interruptions due to toxicity. By minimizing adverse systemic effects, the platform enables extended treatment durations and, ultimately, aims to improve patient quality of life (QoL). Building on this platform, Leads Biolabs has established a position of leadership in the promising field of solid tumor immunotherapies. The company has developed six differentiated TCE therapeutic candidates, forming a portfolio spanning three major therapeutic areas: hematologic malignancies, solid tumors, and autoimmune diseases. Hematologic Malignancies: LBL-034: A GPRC5D/CD3 bispecific antibody for the treatment of multiple myeloma (MM) LBL-043: A LILRB4/CD3 bispecific antibody targeting acute myeloid leukemia (AML) and multiple myeloma (MM) Solid Tumors: LBL-033: A MUC16/CD3 bispecific antibody targeting solid tumors overexpressing MUC16, with a focus on gynecologic cancers including ovarian cancer, cervical cancer, and endometrial carcinoma LBL-054: A CDH17/CD3 T-cell engager under development for colorectal cancer (CRC), gastric cancer, pancreatic ductal adenocarcinoma (PDAC), and neuroendocrine neoplasms (NENs) LBL-058: A first-in-class TCE-ADC (antibody-drug conjugate) targeting DLL3, demonstrating encouraging efficacy in DLL3-positive small cell lung cancer (SCLC) and NENs Autoimmune Diseases: LBL-051: A first-in- class CD19/BCMA/CD3 trispecific antibody designed to block autoantibody production by B cells and plasma cells while regulating B-cell hyperactivation, differentiation, and plasmacytic transformation. The candidate's unique mechanism of action enables broad-based B-cell modulation, potentially delivering superior clinical outcomes. The program is being advanced through a strategic collaboration with NewCo, a portfolio company of leading biotech investor Aditum Bio. The company's X-body™ platform utilizes advanced antibody engineering to develop 2:2 bispecific antibody structures. Its lead candidate, LBL-024 (PD-L1/4-1BB), represents a key advance in 4-1BB agonist therapies, becoming the first agent in this class to enter global registrational trials. The platform's 2:2 configuration is designed to restrict 4-1BB activation to the tumor microenvironment (TME), addressing systemic toxicity issues, particularly hepatotoxicity, that have undermined earlier efforts in this category. This platform-driven approach enables precise control of immune activation within the TME, minimizing off-target adverse effects while reactivating exhausted T cells and driving clonal expansion. The mechanism has shown particular promise in tumors resistant to PD-1/PD-L1 inhibitors, as well as in so-called immunologically "cold" tumors. The successful execution of this strategy with LBL-024 underscores its potential as a best-in-class immunotherapy candidate. At the 2025 ASCO Annual Meeting, Leads Biolabs presented data from a multicenter Phase Ib/II trial evaluating LBL-024 in combination with etoposide and platinum-based chemotherapy in first-line advanced extra-pulmonary neuroendocrine carcinoma (EP-NEC). The study reported a 75.0% objective response rate (ORR) and a 92.3% disease control rate (DCR) among the efficacy-evaluable population (n=52). In the 15 mg/kg cohort, ORR reached 83.3%, with a DCR of 100%. Overall, 57.7% of patients (30/52) achieved tumor reduction exceeding 50%. These results substantially outperformed historical benchmarks for chemotherapy alone, which typically show ORR in the 30–55% range. While progression-free survival (PFS) data were not yet mature at the April 15, 2025 cutoff (median follow-up: 8.2 months), all dose cohorts showed favorable trends compared with historical controls. EP-NEC is a rare and aggressive cancer with poor advanced-stage outcomes and no approved second-line or later therapies. Recognizing this unmet medical need, China's National Medical Products Administration (NMPA) granted approval on April 30, 2024 for a pivotal single-arm registrational trial of LBL-024 in EP-NEC, potentially establishing it as the first approved therapy for this indication. As the world's first 4-1BB-targeted molecule to have reached registrational stage, LBL-024 could establish 4-1BB as the fourth approved immuno-oncology target following PD-1/L1, CTLA-4 and LAG-3. The candidate has earned Breakthrough Therapy Designation from China's NMPA for relapsed/refractory EP-NEC and Orphan Drug Designation from U.S. FDA for neuroendocrine neoplasms (NENs). LBL-024 has also secured regulatory approvals to investigate indications including small cell lung cancer (SCLC), biliary tract cancer (BTC), ovarian cancer (OC), non-small cell lung cancer (NSCLC), esophageal squamous cell carcinoma (ESCC), hepatocellular carcinoma (HCC), and gastric cancer (GC). Early clinical data have shown promising antitumor activity in SCLC, BTC and OC, supporting its potential as a broad-spectrum oncology therapeutic. Leads Biolabs has enhanced end-to-end capabilities across the entire drug development lifecycle—from early-stage target screening and discovery to preclinical research, clinical development, CMC (Chemistry, Manufacturing, and Controls), and pilot manufacturing. Demonstrating exceptional efficiency, the Company has achieved IND submission within just three years of target selection, significantly outpacing the industry average of 5 to 6 years (based on Frost & Sullivan data). In addition to its proprietary R&D initiatives, Leads Biolabs is exploring strategic collaborations to accelerate clinical development and commercialization of promising drug candidates. The Company is well-positioned to capitalize on market opportunities through out-licensing agreements, co-marketing partnerships, and other strategic alliances. As its clinical-stage assets progress toward commercialization, Leads Biolabs may expand its infrastructure to include commercial-scale manufacturing facilities while bolstering commercialization capabilities—both through collaborative ventures and the development of an in-house sales force. SOURCE Leads Biolabs WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ImmunotherapyOrphan Drug

21 Jul 2025

·www.globenewswire.com

Expanding Analyst Interest in ORYZON

New U.S. investment bank joins, bringing total coverage to ten analystsMADRID and CAMBRIDGE, Mass., July 21, 2025 (GLOBE NEWSWIRE) -- Oryzon Genomics, S.A. (ISIN Code: ES0167733015, Ticker: ORY), a clinical-stage biopharmaceutical company and a European leader in epigenetics, today announced that Maxim LLC, a U.S.-based investment bank, has initiated research coverage of the company, effective July 18, 2025. This milestone reflects Oryzon’s ongoing commitment to transparency and proactive communication with the investment community. Over the years, the company has consistently worked to communicate the clinical value of its programs, the unmet medical needs they aim to address, and their commercial potential, engaging with a broad network of biotech analysts. Oryzon firmly believes that independent, high-quality research is essential for helping biotech investors make informed portfolio decisions. With the addition of Maxim LLC, Oryzon is now covered by ten financial analysts, further enhancing the company's visibility in global capital markets. The current analyst coverage includes: United States: ROTH Capital Partners, Maxim LLCUnited Kingdom: Jefferies, Rx Securities, Edison GroupContinental Europe: Van Lanschot Kempen, Invest Securities, JBCapital, Estrategias de Inversión, Luis Navia This level of coverage places Oryzon among the most broadly followed European biotech companies, underscoring the company’s leadership and growing relevance in the sector. Please note: Any opinions, estimates, or forecasts regarding Oryzon Genomics, S.A.’s performance made by these analysts are theirs alone and do not represent the views or guidance of Oryzon Genomics, S.A. or its management. Reference to or distribution of such coverage does not imply endorsement or concurrence by the company. About OryzonFounded in 2000 in Barcelona, Spain, Oryzon (ISIN Code: ES0167733015) is a clinical stage biopharmaceutical company and the European leader in epigenetics, with a strong focus on personalized medicine in CNS disorders and oncology. Oryzon’s team is composed of highly qualified professionals from the pharma industry located in Barcelona, Boston, and San Diego. Oryzon has an advanced clinical portfolio with two LSD1 inhibitors, vafidemstat in CNS (Phase III-ready) and iadademstat in oncology (Phase II). The company has other pipeline assets directed against other epigenetic targets like HDAC-6 where a clinical candidate, ORY-4001, has been nominated for its possible development in CMT and ALS. In addition, Oryzon has a strong platform for biomarker identification and target validation for a variety of malignant and neurological diseases. For more information, visit www.oryzon.com About IadademstatIadademstat (ORY-1001) is a small oral molecule, which acts as a highly selective inhibitor of the epigenetic enzyme LSD1 and has a powerful differentiating effect in hematologic cancers (see Maes et al., Cancer Cell 2018 Mar 12; 33 (3): 495-511.e12.doi: 10.1016 / j.ccell.2018.02.002.). A FiM Phase I/IIa clinical trial with iadademstat in R/R AML patients demonstrated the safety and good tolerability of the drug and preliminary signs of antileukemic activity, including a CRi (see Salamero et al, J Clin Oncol, 2020, 38(36): 4260-4273. doi: 10.1200/JCO.19.03250). Iadademstat has shown encouraging safety and strong clinical activity in combination with azacitidine in a Phase IIa trial in elder 1L AML patients (ALICE trial) (see Salamero et al., ASH 2022 oral presentation & The Lancet Haematology, 2024, 11(7):e487-e498). Iadademstat is currently being evaluated in combination with gilteritinib in the ongoing Phase Ib FRIDA trial in patients with relapsed/refractory AML with FLT3 mutations, and in combination with azacitidine and venetoclax in 1L AML in an investigator-initiated study led by OHSU and in a trial sponsored by the U.S. National Cancer Institute (NCI) under the Cooperative Research and Development Agreement (CRADA) signed between Oryzon and the NCI to collaborate on further clinical development of iadademstat in different types of hematologic and solid cancers. Beyond hematological cancers, the inhibition of LSD1 has been proposed as a valid therapeutic approach in some solid tumors such as small cell lung cancer (SCLC), neuroendocrine tumors (NET), medulloblastoma and others. In a Phase IIa trial in combination with platinum/etoposide in second line ED-SCLC patients (CLEPSIDRA trial), preliminary activity and safety results have been reported (see Navarro et al., ESMO 2018 poster). Iadademstat is in a Phase I/II randomized trial in 1L ED-SCLC in combination with ICI sponsored by NCI and led by the Memorial Sloan Kettering Cancer Center. Oryzon is further expanding the clinical development of iadademstat through additional investigator-initiated studies in oncology, and it has announced plans to expand its clinical development in non-oncological hematology indications like sickle cell disease (protocol submitted) and essential thrombocythemia (trial in preparation). Iadademstat has orphan drug designation for SCLC in the US and for AML in the US and EU. About Vafidemstat Vafidemstat (ORY-2001) is an oral, CNS-optimized LSD1 inhibitor. The molecule acts on several levels: it reduces cognitive impairment, including memory loss and neuroinflammation, and at the same time has neuroprotective effects. In animal studies vafidemstat not only restores memory but reduces the exacerbated aggressiveness of SAMP8 mice, a model for accelerated aging and Alzheimer’s disease (AD), to normal levels and also reduces social avoidance and enhances sociability in murine models. In addition, vafidemstat exhibits fast, strong, and durable efficacy in several preclinical models of multiple sclerosis (MS). Oryzon has performed two Phase IIa clinical trials in aggressiveness in patients with different psychiatric disorders (REIMAGINE, see Ferrer et al, Psychiatry & Clin Neurosci, 2025, doi.org/10.1111/pcn.13800) and in aggressive/agitated patients with moderate or severe AD (REIMAGINE-AD), with positive clinical results reported in both. Additional finalized Phase IIa clinical trials with vafidemstat include the ETHERAL trial in patients with Mild to Moderate AD, where a significant reduction of the inflammatory biomarker YKL40 was observed after 6 and 12 months of treatment, and the pilot, small-scale SATEEN trial in Relapse-Remitting and Secondary Progressive MS, where anti-inflammatory activity was also observed. Vafidemstat has also been tested in a Phase II in severe Covid-19 patients (ESCAPE) assessing the capability of the drug to prevent ARDS, one of the most severe complications of the viral infection, where it showed significant anti-inflammatory effects in severe Covid-19 patients. Vafidemstat is currently advancing as a Phase III-ready asset in Borderline Personality disorder (BPD) following completion of the global, randomized, double blind Phase IIb PORTICO trial (final data presented at ECNP-2024). Following receipt of the minutes from the End-of-Phase II meeting with the FDA to discuss PORTICO’s results, the company announced plans to move forward with a Phase III PORTICO-2 trial in agitation/aggression in BPD (PhIII protocol submitted to FDA). Vafidemstat is also being investigated in a double-blind, randomized, placebo-controlled Phase IIb trial in negative symptoms of schizophrenia (EVOLUTION trial, recruitment ongoing). The company is also deploying a CNS precision medicine approach with vafidemstat in genetically defined patient subpopulations of certain CNS disorders, as well as in neurodevelopmental syndromes, and is evaluating the feasibility of conducting clinical trials in autistic conditions like Fragile X syndrome and Phelan-McDermid syndrome. FORWARD-LOOKING STATEMENTS This communication contains, or may contain, forward-looking information and statements about Oryzon, including financial projections and estimates and their underlying assumptions, statements regarding plans, objectives, and expectations with respect to future operations, capital expenditures, synergies, products and services, and statements regarding future performance. Forward-looking statements are statements that are not historical facts and are generally identified by the words “expects,” “anticipates,” “believes,” “intends,” “estimates” and similar expressions. Although Oryzon believes that the expectations reflected in such forward-looking statements are reasonable, investors and holders of Oryzon shares are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Oryzon that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include those discussed or identified in the documents sent by Oryzon to the Spanish Comisión Nacional del Mercado de Valores (CNMV), which are accessible to the public. Forward-looking statements are not guarantees of future performance and have not been reviewed by the auditors of Oryzon. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date they were made. All subsequent oral or written forward-looking statements attributable to Oryzon or any of its members, directors, officers, employees, or any persons acting on its behalf are expressly qualified in their entirety by the cautionary statement above. All forward-looking statements included herein are based on information available to Oryzon on the date hereof. Except as required by applicable law, Oryzon does not undertake any obligation to publicly update or revise any forward‐looking statements, whether as a result of new information, future events, or otherwise. This document does not constitute an offer or invitation to purchase or subscribe shares in accordance with the provisions of Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017, and/or the restated text of the Securities Market Law, approved by Law 6/2023 of 17 March, and its implementing regulations. Nothing in this document constitutes investment advice. In addition, this document does not constitute an offer of purchase, sale or exchange, nor a request for an offer of purchase, sale or exchange of securities, nor a request for any vote or approval in any jurisdiction. The shares of Oryzon Genomics, S.A. may not be offered or sold in the United States of America except pursuant to an effective registration statement under the Securities Act of 1933 or pursuant to a valid exemption from registration.. Spain Oryzon IR & Media, Europe & USPatricia Cobo/Mario Cordera Emili Torrell Sandya von der Weid Atrevia Chief BD Officer LifeSci Advisors, LLC +34 91 564 07 25 +34 673 33 97 65 +34 93 515 1313 +41 78 680 05 38 pcobo@atrevia.com mcordera@atrevia.com etorrell@oryzon.com svonderweid@lifesciadvisors.com

Phase 2Clinical ResultOrphan Drug

07 Jul 2025

·www.prnewswire.com

Precision Genetic Medicine Platform Could Disrupt Standard of Care in Metastatic Cancer, Other Indications of Unmet Needs

NetworkNewsWire Editorial Coverage NEW YORK, July 7, 2025 /PRNewswire/ -- An estimated 20 million people are diagnosed annually with cancer, while cancer kills almost 10 million people a year worldwide () with these numbers expected to grow. The American Cancer Society projects that by 2050, 35 million people will be diagnosed with cancer every year. Despite significant progress made in treating the disease, there is still a desperate need — and an enormous market potential — for new and more effective cancer drugs. Calidi Biotherapeutics Inc. (NYSE American: CLDI) (Profile) is committed to developing a novel approach to treating cancer through the precise delivery of genetic medicines to both primary tumors and metastatic sites of disease. This cutting-edge platform, which harnesses engineered viruses that can target sites of cancer in the body and deliver potent genetic medicines to attack tumors, has the potential to revolutionize the way cancer is treated. And while cancer is the initial focus for Calidi, the company has also begun to assess the potential of this technology in other areas of large unmet need such as autoimmune disease. Calidi is joining an elite group of high-quality companies focused on making a difference in the world of cancer and genetic medicines, including Regeneron Pharmaceuticals Inc. (NASDAQ: REGN), CG Oncology Inc. (NASDAQ: CGON), Roche (OTCQX: RHHBY) and Merck & Co. Inc. (NYSE: MRK). Cancer remains one of the most devastating health challenges facing the globe today, responsible for about one in six deaths worldwide. Calidi's decade-long development journey has culminated in novel precision genetic medicine delivery platforms with real therapeutic promise. The company has taken a decisive step in the fight against advanced and hard-to-treat cancers with CLD-401, its first compound designed for systemic administration that delivers IL-15 superagonist directly to tumor sites, including metastatic cancers . Calidi Biotherapeutics has unveiled compelling preclinical data this year at two of the most influential oncology conferences. Click here to view the custom infographic of the Calidi Biotherapeutics Inc. editorial. Sustained Investment in Research, Development Cancer remains one of the most devastating health challenges facing the globe today, responsible for about one in six deaths worldwide (). The most common cancer types worldwide include lung cancer (accounting for around 2.2 million new cases and 1.8 million deaths in 2020), breast cancer (2.26 million new cases), colorectal cancer (1.93 million) and prostate cancer (1.41 million). In the United States, cancer claims more than 600,000 lives each year, with more than two million new cases expected in 2025 alone. These figures highlight both the scale of human suffering and the enormous burden cancer places on health systems around the world. These statistics underscore the importance of sustained investment in research and development. The global oncology drugs market was valued at approximately $190.1 billion in 2023 and is projected to grow to more than $564.5 billion by 2033, reflecting a compound annual growth rate (CAGR) of 11.5% over the forecast period (). This rapid expansion highlights the critical role of sustained investment in research and development, which drives advancements in early detection, targeted therapies, immunotherapies and personalized medicine — key tools in reducing the overwhelming global cancer burden Advancing Precision Delivery of Genetic Medicines Calidi Biotherapeutics Inc (NYSE American: CLDI) has spent more than a decade developing a breakthrough technology platform that enables the systemic delivery of genetic medicines to targeted tumor sites, including metastatic sites in cancer patients. At the core of this innovation is the company's proprietary engineered viral system, which cloaks therapeutic payloads in a protective human cell membrane (the "envelope") designed to evade the immune system and reach distant metastases with precision where genetic medicines that can drive tumor clearance are expressed. Calidi's decade-long development journey, from stem cell-based delivery systems to the enveloped systemic virotherapies, has culminated in novel precision genetic delivery platforms with real therapeutic promise. The company's preclinical breakthroughs have been detailed in peer-reviewed conferences and investor communications, leading to upcoming IND filing goals and potential partnerships on the horizon. Calidi appears to be well positioned to pioneer a new era of targeted cancer treatment, where genetic payloads reach disease sites directly, immune activation is localized, and patients benefit from safer, more effective therapies. Understanding the Platform Calidi Biotherapeutics is clinical stage biotechnology company that is developing genetic medicines and proprietary genetically engineered oncolytic viruses. Calidi's RedTail systemic antitumor virotherapy platform is a novel tumor-selective vaccinia virus strain designed to target all tumor sites (). The platform is capable of producing a high amount of enveloped vaccinia viruses resistant to humoral immunity. The technology allows the therapy to reach tumor sites and kill tumors by expressing genetic medicines in the tumor microenvironment. According to the company, the lead candidate from the RedTail platform, CLD-401, targets lung cancer and other tumor types with high unmet medical need. Pioneering Systemic Cancer Targeting Calidi Biotherapeutics has taken a decisive step in the fight against advanced and hard-to-treat cancers with CLD-401, its first compound designed for systemic administration. This lead candidate harnesses the company's decade-long innovation in enveloped viral delivery to simultaneously destroy cancer cells and deliver genetic medicine aimed at preventing disease recurrence at metastatic sites. By enabling intravenous administration, CLD–401 ushers in a new era of precision oncology where genetic payloads reach tumors throughout the body, rather than relying on localized injections. Central to CLD–401's mechanism is the company's proprietary RedTail platform. CLD–401 is an enveloped oncolytic vaccinia virus engineered to express a chimeric CD55 receptor, significantly enhancing its resistance to immune clearance and enabling systemic circulation to metastatic tumors. Loaded with an IL–15 superagonist payload, the virus not only lyses tumor cells but also delivers powerful genetic material directly into the tumor. This cytokine-based genetic medicine activates CD8+ T cells and natural killer cells, effectively transforming "cold" tumors into immunologically "hot" targets. Preclinical data has confirmed the platform's potential. "Of particular excitement is the rapid progress we have made with RedTail, the company's approach to systemically delivering genetic medicines to metastatic sites in patients with advanced cancer using our proprietarily engineered enveloped virus," reported Calidi CEO Dr. Eric Poma in a recent shareholder letter (). "RedTail represents the culmination of over a decade of meticulous research and innovation at Calidi to create what we believe is the most advanced systemic virotherapy platform. Advancing this novel platform is the company's main focus and priority." Sharing Compelling Preclinical Data Calidi Biotherapeutics has unveiled compelling preclinical data at two of the most influential oncology conferences — the American Association of Cancer Research (AACR) and the American Association of Clinical Oncology (ASCO) — highlighting the tumor-clearing and recurrence-blocking potential of CLD–401. At the AACR Annual Meeting, held in April 2025, Calidi presented key findings under the title "Development of a Systemic Enveloped Virotherapy for Targeting All Metastatic Sites" (). The data revealed that RedTail's enveloped vaccinia virus, coated with a human-like extracellular envelope, can survive immune defenses, access multiple tumor sites following intravenous administration and induce strong tumor killing even in traditionally hard-to-treat metastatic lung models, by delivering genetic medicines such as IL-15 superagonist directly to the tumor. The abstract emphasized the platform's ability to evade complement activation, substantially improving systemic circulation time and therapeutic impact. The momentum continued into the ASCO Annual Meeting in June 2025, where Calidi presented results demonstrating that CLD–401, enhanced with a chimeric CD55 receptor, further resists immune clearance and delivers its IL-15 superagonist payload directly into tumors (). This immune payload triggered robust expansion of CD8+ T cells and natural killer cells in the tumor microenvironment, key players in sustained anti-tumor immunity. Collectively, these data sets presented at AACR and ASCO illustrate the dual potency of CLD–401: it both breaks down tumor tissue and educates the immune system to prevent relapse. The systemic reach of RedTail, along with its tumor-targeted immune stimulation, positions Calidi's platform as a significant advancement in the field of immuno-oncology, especially for metastatic cancers with high unmet needs. "Looking ahead, our roadmap for the next 18 months includes multiple critical milestones," said Poma. "We are working to complete IND-enabling studies ahead of an IND filing by the end of 2026 for our lead RedTail candidate that delivers IL-15 superagonist to tumor sites, CLD-401. Our clinical strategy includes an optimized dose-escalation study designed to swiftly demonstrate efficacy and validate the systemic administration of RedTail in patients with metastatic disease." With promising results in hand and strategic plans in place, Calidi is positioning itself to enter human trials that may redefine how genetic medicines reach and treat cancer throughout the body. Leading Biotech Firms Share Promising Advances The global effort to transform cancer care continues to accelerate as leading biopharmaceutical companies report groundbreaking clinical data across multiple tumor types. Industry leaders are showcasing the progress of novel immunotherapies and targeted treatments aimed at some of the most challenging cancers. Regeneron Pharmaceuticals Inc. (NASDAQ: REGN) shared new and updated data from its oncology and hematology portfolio at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting (). According to the company, its 18 presentations will share the latest insights from ongoing research of approved and investigational treatment regimens across a range of difficult-to-treat cancers including non-melanoma and melanoma skin cancer, lung cancer, lymphoma and multiple myeloma. CG Oncology Inc . (NASDAQ: CGON), a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients with bladder cancer, presented key data at the 2025 American Urological Association (AUA) Annual Meeting (). The data was from the phase 3 BOND-003 Cohort C study of patients with high-risk non-muscle invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette Guerin (BCG) treatment with carcinoma in situ (CIS) with or without Ta or T1 disease. Roche (OTCQX: RHHBY) is reporting positive results from its phase 3 IMforte study of Tecentriq(R) (atezolizumab) in combination with lurbinectedin (Zepzelca(R)) as a first-line maintenance treatment for people with extensive-stage small cell lung cancer (ES-SCLC), following induction therapy with carboplatin, etoposide and Tecentriq (). The company noted that the data showed that this combination reduced the risk of disease progression or death by 46% and the risk of death by 27%, compared to Tecentriq maintenance therapy alone. Merck & Co. Inc. (NYSE: MRK) announced that its phase 3 KEYNOTE-B96 trial, also known as ENGOT-ov65, met its primary endpoint of progression-free survival (PFS) for the treatment of patients with platinum-resistant recurrent ovarian cancer whose tumors expressed PD-L1 and in all comers (). The study also met a secondary endpoint of overall survival (OS) in patients whose tumors express PD-L1. The study is evaluating KEYTRUDA(R) (pembrolizumab), Merck's anti-PD-1 therapy, in combination with chemotherapy (paclitaxel) with or without bevacizumab for these patients. Together, these data presentations and reports underscore the power of innovation in oncology, where immunotherapy combinations, genetic medicine therapies and personalized treatment approaches are driving new standards of care. With each development, the cancer research community moves one step closer to achieving more durable responses, longer survival and, ultimately, potential cures. For more information, visit Calidi Biotherapeutics Inc. (NYSE American: CLDI). About NetworkNewsWire NetworkNewsWire ("NNW") is a specialized communications platform with a focus on financial news and content distribution for private and public companies and the investment community. It is one of 70+ brands within the Dynamic Brand Portfolio @ IBN that delivers : (1) access to a vast network of wire solutions via InvestorWire to efficiently and effectively reach a myriad of target markets, demographics and diverse industries ; (2) article and editorial syndication to 5,000+ outlets ; (3) enhanced press release enhancement to ensure maximum impact ; (4) social media distribution via IBN to millions of social media followers ; and (5) a full array of tailored corporate communications solutions. With broad reach and a seasoned team of contributing journalists and writers, NNW is uniquely positioned to best serve private and public companies that want to reach a wide audience of investors, influencers, consumers, journalists and the general public. By cutting through the overload of information in today's market, NNW brings its clients unparalleled recognition and brand awareness. NNW is where breaking news, insightful content and actionable information converge. For more information, please visit Please view full terms of use and disclaimers on the NNW website applicable to all content provided by NNW, wherever published or re-published: NetworkNewsWire is powered by IBN DISCLAIMER: NetworkNewsWire (NNW) is the source of the Article and content set forth above. References to any issuer other than the profiled issuer are intended solely to identify industry participants and do not constitute an endorsement of any issuer and do not constitute a comparison to the profiled issuer. The commentary, views and opinions expressed in this release by NNW are solely those of NNW. Readers of this Article and content agree that they cannot and will not seek to hold liable NNW for any investment decisions by their readers or subscribers. NNW is a news dissemination and financial marketing solutions provider and are NOT registered broker-dealers/analysts/investment advisers, hold no investment licenses and may NOT sell, offer to sell or offer to buy any security. The Article and content related to the profiled company represent the personal and subjective views of the Author, and are subject to change at any time without notice. The information provided in the Article and the content has been obtained from sources which the Author believes to be reliable. However, the Author has not independently verified or otherwise investigated all such information. None of the Author, NNW, or any of their respective affiliates, guarantee the accuracy or completeness of any such information. This Article and content are not, and should not be regarded as investment advice or as a recommendation regarding any particular security or course of action; readers are strongly urged to speak with their own investment advisor and review all of the profiled issuer's filings made with the Securities and Exchange Commission before making any investment decisions and should understand the risks associated with an investment in the profiled issuer's securities, including, but not limited to, the complete loss of your investment. NNW HOLDS NO SHARES OF ANY COMPANY NAMED IN THIS RELEASE. 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Clinical ResultImmunotherapyPhase 3ASCO

100 Deals associated with Etoposide

External Link

KEGG	Wiki	ATC	Drug Bank
D00125	Etoposide	L01CB01	DB00773

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Bladder Cancer	Japan	Clinigen Ltd.	30 Apr 1987
Leukemia	Japan	Clinigen Ltd.	30 Apr 1987
Lymphoma	Japan	Nippon Kayaku Co., Ltd.	31 Mar 1987
Ovarian Cancer	Japan	Nippon Kayaku Co., Ltd.	31 Mar 1987
Uterine Cervical Cancer	Japan	Nippon Kayaku Co., Ltd.	31 Mar 1987
Small Cell Lung Cancer	United States	Corden Pharma Latina SpA	10 Nov 1983
Testicular Neoplasms	United States	Corden Pharma Latina SpA	10 Nov 1983

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Platinum-Resistant Ovarian Carcinoma	Phase 3	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	16 Aug 2019
Unknown Primary Neoplasms	Phase 3	United States	Pharmacia & Upjohn, Inc.	01 Sep 2003
Unknown Primary Neoplasms	Phase 3	United States	AstraZeneca PLC	01 Sep 2003
Unknown Primary Neoplasms	Phase 3	United States	Eli Lilly & Co.	01 Sep 2003
Extensive stage Small Cell Lung Cancer	Phase 3	United States	GSK Plc	01 Apr 2001
Extensive stage Small Cell Lung Cancer	Phase 3	China	GSK Plc	01 Apr 2001
Extensive stage Small Cell Lung Cancer	Phase 3	Austria	GSK Plc	01 Apr 2001
Extensive stage Small Cell Lung Cancer	Phase 3	Belgium	GSK Plc	01 Apr 2001
Extensive stage Small Cell Lung Cancer	Phase 3	Brazil	GSK Plc	01 Apr 2001
Extensive stage Small Cell Lung Cancer	Phase 3	Bulgaria	GSK Plc	01 Apr 2001

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00878254 (CTgov)	Phase 2	Mantle-Cell Lymphoma	25	G-CSF+Mesna+Etoposide+Cyclophosphamide+Leucovorin+Doxorubicin+ifosfamide+Methotrexate+Rituximab+Vincristine+Cytarabine	wrscyervxt(ueoedgzfdx) = oosozmzond utyrjuyjkp (gkltqruycs, wypxpblmyd - nnlevuwrjx) View more	-	23 Jul 2025
NCT04530487 (CTgov)	Phase 2	Refractory Malignant Solid Neoplasm \| Relapsed Solid Neoplasm \| Neuroblastoma recurrent ... View more	1	ATG+cyclosporine+etoposide+mephalan+tacrolimus+MMF+thiotepa	iykesktmmq(ixacqmoonu) = rrtzkcmbjx dbecsdnicl (jcezxhejqd, azlnoixnft - eejlwljwpn) View more	-	29 Jun 2025
NCT02262325 (CTgov)	Phase 2	Non-small cell lung cancer stage IIIA \| Non-small cell lung cancer stage IIIB \| Recurrent Non-Small Cell Lung Cancer ... View more	21	3-dimensional conformal radiation therapy+etoposide+cisplatin	jcvkrmzhoy = ghzuklqxap tjueftyfwg (kklrqnurrf, fdcucdgtdm - tfuvdmjsfa) View more	-	12 Jun 2025
NCT03811002 (NRG-LU005, CTgov)	Phase 3	Small cell lung cancer limited stage	544	Intensity-Modulated Radiation Therapy+Etoposide+Carboplatin+cisplatin (Arm I (Chemotherapy, Radiation Therapy))	vauaweshdh(epqwdyzuct) = sbgfkrnmji hiivuqcpss (irsbqjrokg, owyvjhrjld - zqdpovajrq) View more	-	12 Jun 2025
				Intensity-Modulated Radiation Therapy+Etoposide+Carboplatin+cisplatin+Atezolizumab (Arm II (Chemotherapy, Radiation Therapy, Atezolizumab))	vauaweshdh(epqwdyzuct) = fogtoppvcw hiivuqcpss (irsbqjrokg, pietncyfkn - rvttbdctba) 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)	mmcckbxhzi = logkzqystt hihgmimwsa (akhwwqxlsx, udjzuzbgwq - vyqktdiico) 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)	mmcckbxhzi = phlkmyhded hihgmimwsa (akhwwqxlsx, mkjvllalfp - aejqhnakwa) View more
ASCO2025	Not Applicable	Pediatric Intraocular Retinoblastoma	-	Vincristine + Topotecan	tlppporggl(aczbbsdeqq) = gccndlzpxa tvogkaftzl (irwnnyqkxp ) View more	Negative	30 May 2025
				High Dose Carboplatin + Etoposide + Vincristine	tlppporggl(aczbbsdeqq) = cmccmxxyrv tvogkaftzl (irwnnyqkxp ) View more
ASCO2025	Phase 2	High Risk Neuroblastoma	34	HITS (Irinotecan, Temozolomide, Naxitamab, GM-CSF)	txlmggotog(oabtewqncd) = ygemenzgqj elvspomksu (vxxwznokqu ) View more	Positive	30 May 2025
				NICE (Naxitamab, GM-CSF, Ifosfamide, Carboplatin, Etoposide)	txlmggotog(oabtewqncd) = tetmnwznqv elvspomksu (vxxwznokqu ) View more
NCT05784987 (EHA2025) Manual	Phase 2	Diffuse Large B-Cell Lymphoma TP53 Mutation \| BCL7A Rearrangement	47	R-MINE+X regimen	jzheftlmas(swcxlllojj) = kdkykltuss ranygvzacc (dywpdazsin ) View more	Positive	14 May 2025
				R-MINE+MCD/BN2	jzheftlmas(swcxlllojj) = rbtnbievdz ranygvzacc (dywpdazsin ) View more
PB3408 (EHA2025)	Not Applicable	Hematopoietic stem cell transplantation	57	Carboplatin, Etoposide, and Melphalan (CEM) regimen	fjlmhxthae(vmwmeavfsm) = kveimfhhxq xvlrjyzjby (tcdpyrtdjo ) View more	Positive	14 May 2025
NCT03980925 (GETNE T1913, CTgov)	Phase 2	Neuroendocrine neoplasm of gastrointestinal tract \| Gastro-Enteropancreatic Neuroendocrine Tumor	37	Nivolumab+Etoposide+Carboplatin	vifjnuohom = pwtdcvqizx rkrcpnafej (ximkugfrqc, tndmdhesvc - fbmsxfrkut) View more	-	13 Jan 2025

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