The purpose of this study is to find out what treatment works best for participants with metastatic prostate cancer that are not responding to hormone treatment and docetaxel and are also Prostate-specific membrane antigen(PSMA) positive.

Start Date14 Jul 2025

Sponsor / Collaborator

The Case Comprehensive Cancer Center

NCT06890832

/ Not yet recruitingPhase 2

A Phase-2, Open-label, Randomized, Parallel-Group, Three-Arm Study to Assess Efficacy and Safety of Cabazitaxel Lipid Tablet in Combination with Prednisone for the Treatment of Adult Men with Metastatic Castration-Resistant Prostate Cancer Previously Treated with a Docetaxel-containing Treatment Regimen

A total of 75 participants will be enrolled in the study, with 25 participants allocated per intervention group. In Group 1, participant will take 50 mg cabazitaxel every week for 6 cycles (3 doses per cycle), 10 mg prednisone daily till the end of cycle 6. In Group 2, participant will take 100 mg cabazitaxel every week for 6 cycles (3 doses per cycle), 10 mg prednisone daily till the end of cycle 6. In Group 3, participant will take 200 mg cabazitaxel every 3 weeks for 6 cycles (1 doses per cycle), 10 mg prednisone daily till the end of cycle 6.
The study comprises three phases: a 21-day screening phase, an 18-week intervention phase starting on Day 1 (baseline), and a post-intervention follow-up phase lasting up to 12 months from Day 1. The total duration of participation for each individual will be approximately one year.
Key efficacy assessments include CT scans/MRI, bone scans, PSA, ALP, LDH, symptomatic skeletal events, and pain evaluations. Key safety assessments encompass the monitoring of adverse events (AEs), ECOG performance status, physical examinations, vital sign measurements, clinical laboratory tests, peripheral neuropathy evaluation, 12-lead ECG, and echocardiogram (ECHO) assessments.
Pharmacokinetic parameters will also be evaluated.

Start Date01 May 2025

Sponsor / Collaborator

Jina Pharmaceuticals, Inc.

NCT06632977

/ RecruitingPhase 2IIT

PREcision DIagnostics in Prostate Cancer Treatment (PREDICT)

This phase II trial evaluates whether genetic testing in prostate cancer is helpful in deciding which study treatment patients are assigned. Patient cancer tissue samples are obtained from a previous surgery or biopsy procedure and tested for deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) abnormalities or mutations in their cancer. Valemetostat tosylate is in a class of medications called EZH1/EZH2 inhibitors. It blocks proteins called EZH1 and EZH2, which may help slow or stop the spread of tumor cells. Carboplatin is in a class of 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. Cabazitaxel injection is in a class of medications called microtubule inhibitors. It works by slowing or stopping the growth of tumor cells. Abiraterone acetate blocks tissues from making androgens (male hormones), such as testosterone. This may cause the death of tumor cells that need androgens to grow. It is a type of anti-androgen. Enzalutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of tumor cells. Lutetium Lu 177 vipivotide tetraxetan is in a class of medications called radiopharmaceuticals. It works by targeting and delivering radiation directly to tumor cells which damages and kills these cells. Assigning patients to targeted treatment based on genetic testing may help shrink or slow the cancer from growing

Start Date06 Feb 2025

Sponsor / Collaborator

Alliance for Clinical Trials in Oncology

[+1]

100 Clinical Results associated with Cabazitaxel Acetone

100 Translational Medicine associated with Cabazitaxel Acetone

100 Patents (Medical) associated with Cabazitaxel Acetone

1,678

Literatures (Medical) associated with Cabazitaxel Acetone

01 Dec 2025·Translational Oncology

USP11 is involved in the sensitivity of liver cancer cells to ferroptosis and taxanes through the regulation of NRF2 ubiquitin-mediated degradation

Article

Author: Li, Jiaxun ; Li, Yanwen ; Pan, Xin ; Kong, Shujia ; Zhao, Chen

BACKGROUND:

Ubiquitin-specific protease 11 (USP11) plays a significant role in tumor progression through various mechanisms. However, in hepatocellular carcinoma (HCC) research, the mechanism by which USP11 impacts ferroptosis and sensitivity to taxanes in HCC remains ambiguous. The aim of this study was to investigate the effects of USP11 on ferroptosis and sensitivity to taxanes in HCC.

METHODS:

Research was conducted on clinical HCC specimens, cell lines (THLE2, HepG2, SNU449, Huh7, and Hep3B), and subcutaneous tumorigenesis models. Gene and protein expression was detected using real-time quantitative polymerase chain reaction (RT‒qPCR), western blotting, and immunohistochemistry. Cell proliferation and migration were detected using cell counting kit-8 (CCK-8), colony, scratch, and Transwell assays. Ferroptosis was evaluated by Fe²⁺, glutathione (GSH), malondialdehyde (MDA) and reactive oxygen species (ROS)-related indices.

RESULTS:

USP11 was upregulated in HCC clinical tissues, and overexpression or knockdown of USP11 promoted or inhibited the proliferation, migration and invasion of HCC cells in vitro, respectively. Furthermore, when triggered by erastin, overexpression of USP11 led to a reduction in Fe²⁺, MDA, and ROS levels in HepG2 and SNU449 cells but an increase in GSH, solute carrier family 7 member 11 (SLC7A11), and glutathione peroxidase 4 (GPX4), thus inhibiting ferroptosis in HCC cells. USP11 also inhibited the sensitivity of HCC cells to taxanes (paclitaxel, docetaxel, and cabazitaxel). From a mechanistic standpoint, USP11 enhanced nuclear factor erythroid-2-related factor 2 (NRF2) expression via deubiquitination, thus reducing ferroptosis and taxane sensitivity in HCC cells.

CONCLUSION:

This research highlights the crucial role of USP11 in ferroptosis and drug resistance in HCC, identifying a new potential target for the treatment of HCC.

01 Nov 2025·CURRENT OPINION IN UROLOGY

Intravesical chemotherapy combination treatments for BCG-unresponsive nonmuscle invasive bladder cancer

Review

Author: Zaurito, Paolo ; Briganti, Alberto ; Moschini, Marco ; Scilipoti, Pietro ; Montorsi, Francesco

Purpose of review:

There is an increasing interest in developing bladder sparing therapies (BSTs) for patients with Bacillus Calmette-Guérin unresponsive (U-BCG) nonmuscle invasive bladder cancer (NMIBC) as an alternative to radical cystectomy (RC). We aimed to perform a review of efficacy and safety of intravesical chemotherapy combination treatments for U-BCG NMIBC patients according to the most recent evidence.

Recent findings:

The use of intravesical chemotherapy combination treatments for U-BCG patients has shown promising efficacy and tolerability especially in retrospective series. For U-BCG patients, the most used option in this context is intravesical gemcitabine plus docetaxel, with a 2-year recurrence free-survival ranging between 37–62%, and a 2-year progression free-survival rate of 70–95%, with grade 3–5 adverse events (AEs) varying between 3–8% according to the most recent reports. Other studies are investigating the combination of more than two chemotherapy agents, with a recent prospective trial showing encouraging results for the combination of three intravesical drugs (gemcitabine, cabazitaxel, cisplatin) with a cystectomy-free survival rate of 97% at 1-year and no evidence of grade 3–5 AEs at a median follow-up of 20 months.

Summary:

Recent evidence on intravesical chemotherapy combination treatment for U-BCG NMIBC is mostly based on retrospective studies, especially those investigating gemcitabine/docetaxel. However, some studies are currently investigating the combination of more than two chemotherapy agents. Overall, studies show good short-term efficacy, acceptable rates of disease progression, and tolerability in patients with U-BCG NMIBC. Nevertheless, prospective studies will be needed to support the widespread use of new BSTs as valid alternatives to RC in patients who failed BCG.

01 Nov 2025·CANCER LETTERS

Chimeric antigen receptor-engineered (CAR)-T cell therapy for metastatic prostate cancer

Review

Author: Verma, Shiv ; Gupta, Sanjay ; Feinberg, Daniel ; Tharian, Leah ; Parameswaran, Reshmi

Metastatic prostate cancer is associated with a significantly reduced survival rate, often indicating a more aggressive disease phenotype with diminished responsiveness to conventional therapies. Several FDA-approved treatments have demonstrated improved overall survival in men with metastatic disease. These include androgen receptor signaling inhibitors such as enzalutamide and abiraterone acetate, taxane-based chemotherapies including docetaxel and cabazitaxel, and bone-targeting radiopharmaceuticals like radium-223. Immunotherapeutic agents have also contributed to expanding treatment options with Sipuleucel-T, a dendritic cell-based vaccine, and pembrolizumab, a PD-1 immune checkpoint inhibitor approved for select patient populations. Furthermore, the introduction of poly (ADP-ribose) polymerase inhibitors like olaparib and rucaparib, has transformed the therapeutic landscape, particularly for patients with DNA repair deficiencies in metastatic prostate cancer. More recently, prostate-specific membrane antigen (PSMA)-targeted immunotherapies have shown promise for the treatment of advanced-stage malignancy. Ongoing developments in immunotherapy, particularly those targeting the tumor microenvironment, are expected to significantly reshape the management of metastatic prostate cancer. Among these, chimeric antigen receptor T-cells (CAR-Ts) have revolutionized the treatment of hematologic malignancies, are now being extensively evaluated in solid tumors. In this review, we highlight adoptive cellular therapies utilizing CAR-T cells engineered to recognize prostate cancer-specific antigens, aiming to overcome immune evasion mechanisms. We summarize current CAR-T modalities with their limitations and prospects being evaluated in both preclinical and clinical settings of metastatic prostate cancer.

News (Medical) associated with Cabazitaxel Acetone

22 Jul 2025

·www.globenewswire.com

Dr Oliver Sartor Appointed to Radiopharm Scientific Advisory Board

SYDNEY, July 22, 2025 (GLOBE NEWSWIRE) -- Radiopharm Theranostics (ASX:RAD, “Radiopharm” or the “Company”), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, is pleased to announce the appointment of Dr Oliver Sartor, MD to the Company’s Scientific Advisory Board (SAB). Dr Sartor is an internationally recognised medical oncologist and scientist specialising in prostate cancer and radiopharmaceutical therapies. He currently serves as Director of Radiopharmaceutical Clinical Trials and Chair of the Genitourinary Cancer Disease Group at the world-renowned Mayo Clinic, in Rochester, Minnesota. He was previously Laborde Professor of Medicine and Urology and Medical Director of Tulane Cancer Center in New Orleans under Tulane University School of Medicine. Dr Sartor has also held senior roles at LSU Health Sciences Center, Dana‑Farber/Harvard Medical School, and as Medical Oncology Co‑Chair of the GU Committee of NRG Oncology. Dr Sartor received his MD with honours from Tulane University School of Medicine in 1982, completed internal medicine residency at Tulane, and a medical oncology fellowship at the National Cancer Institute (NCI). Since 1990 he has focused on prostate cancer clinical research, authoring more than 500 peer‑reviewed publications and leading multiple pivotal Phase 3 trials that resulted in FDA approvals for therapies including samarium‑153 EDTMP, cabazitaxel, radium‑223, and PSMA‑targeted radioligand therapy. “Dr Sartor brings an unparalleled depth of expertise in both clinical translation and radiopharmaceutical therapies,” said Riccardo Canevari, Managing Director and CEO of Radiopharm Theranostics. “We’re very honoured to welcome him to our SAB. His insight and leadership will be invaluable as we advance our radiopharmaceutical pipeline.” About Radiopharm Theranostics Radiopharm Theranostics is a clinical stage radiotherapeutics company developing a world-class platform of innovative radiopharmaceutical products for diagnostic and therapeutic applications in areas of high unmet medical need. Radiopharm is listed on ASX (RAD) and on NASDAQ (RADX). The company has a pipeline of distinct and highly differentiated platform technologies spanning peptides, small molecules and monoclonal antibodies for use in cancer. The clinical program includes one Phase 2 and three Phase 1 trials in a variety of solid tumor cancers including lung, breast, and brain metastases. Learn more at radiopharmtheranostics.com. Authorized on behalf of the Radiopharm Theranostics Board of Directors by Executive Chairman Paul Hopper. For more information: Investors:Riccardo CanevariCEO & Managing DirectorP: +1 862 309 0293E: rc@radiopharmtheranostics.com Anne Marie Fields Precision AQ (Formerly Stern IR) E: annemarie.fields@precisionaq.com Media:Matt WrightNWR CommunicationsP: +61 451 896 420E: matt@nwrcommunications.com.au Follow Radiopharm Theranostics: Website – https://radiopharmtheranostics.com/ Twitter – https://twitter.com/TeamRadiopharm Linked In – https://www.linkedin.com/company/radiopharm-theranostics/InvestorHub – https://investorhub.radiopharmtheranostics.com/

Executive ChangePhase 1Phase 3

10 Oct 2024

·www.prnewswire.com

Metastatic Castration-Resistant Prostate Cancer Clinical Trial Pipeline Appears Robust With 90+ Key Pharma Companies Actively Working in the Therapeutics Segment | DelveInsight

Metastatic Castration-Resistant Prostate Cancer (mCRPC) refers to prostate cancer that has spread (metastasized) to other parts of the body and continues to progress despite treatments that lower testosterone levels (androgen deprivation therapy or ADT) major pharmaceutical companies are heavily investing in research and development of new treatments, including immunotherapy (e.g., sipuleucel-T) and targeted therapies, which are seen as the next frontier in treating mCRPC. The use of precision medicine to identify genetic profiles in patients has further expanded the potential for targeted treatment. LAS VEGAS , Oct. 10, 2024 /PRNewswire/ -- DelveInsight's ' Metastatic Castration-Resistant Prostate Cancer Pipeline Insight 2024 ' report provides comprehensive global coverage of pipeline mCRPC therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the mCRPC pipeline domain. Key Takeaways from the Metastatic Castration-Resistant Prostate Cancer Pipeline Report DelveInsight's mCRPC pipeline report depicts a robust space with 90+ active players working to develop 100+ pipeline therapies for mCRPC treatment. Key mCRPC companies such as Regeneron Pharmaceuticals, AstraZeneca, Hinova Pharmaceuticals, Zenith Epigenetic, Eli Lilly and Company, Astellas Pharma, Seagen, Pfizer, Progenics Pharmaceutical, Molecular Insight Pharmaceuticals, Bayer, Accutar Biotechnology Inc, Hinova Pharmaceuticals, Forma Therapeutics, Inc., HALDA THERAPEUTICS INC., Tavanta Therapeutics, Lantheus, Pfizer, AB Science, Syntrix Pharmaceuticals, Exelixis, Laekna Therapeutics Shanghai Co. Ltd., Cardiff Oncology, Ipsen, Norroy Bioscience, Astellas Pharma, Novartis, Johnson & Johnson, Tempest Therapeutics, and others are evaluating new mCRPC drugs to improve the treatment landscape. Promising mCRPC pipeline therapies such as REGN 4336, Capivasertib, Deutenzalutamide, ZEN003694, Abemaciclib, Enfortumab vedotin, Talazoparib, I-131-1095, Pelgifatamab corixetan, AC176, HP518, FT-7051, HLD-0915, TAVT-45, PNT2002, Mevrometostat, Masitinib, SX-682, XL092, LAE001, Onvansertib, Tazemetostat, 177Lu-NYM032, PRL-02, 225 Actinium PSMA 617, ARX51, TPST-1120, and others are under different phases of mCRPC clinical trials. In October 2024, Curium announced that it had entered into a strategic partnership with PDRadiopharma Inc, a wholly-owned subsidiary of PeptiDream, for the clinical development, regulatory filing, and commercialization in Japan of 177Lu-PSMA-I&T and 64Cu-PSMA-I&T. The two agents 177Lu-PSMA-I&T and 64Cu-PSMA-I&T target prostate-specific membrane antigen (PSMA) expressed on prostate cancer cells and are being investigated for prostate cancer treatment and diagnostics. In July 2024, the US FDA granted fast-track designation to the prostate-specific membrane antigen (PSMA)–targeted radiopharmaceutical 225Ac-FL-020 for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). In July 2024, Merck and Orion Corporation announced the mutual exercise of option providing Merck global exclusive rights to Opevesostat, an investigational CYP11A1 inhibitor, for the treatment of Metastatic Castration-Resistant Prostate Cancer. In July 2024, the US FDA granted fast-track designation to the antibody-drug conjugate (ADC) BNT324/DB-1311 to potentially treat patients with unresectable advanced or metastatic castration-resistant prostate cancer (mCRPC) whose disease had progressed on or after standard systemic regimens. In July 2024, FutureChem announced that the FC-705 has received orphan drug designation from the Ministry of Food and Drug Safety (MFDS) for the treatment of prostate cancer. In June 2024, CAR T-Cell Therapy demonstrated promising results for mCRPC according to Phase I trial results. In January 2024, Lava Therapeutics announced that it has signed a clinical trial collaboration and supply agreement with Merck to evaluate its prostate cancer therapy LAVA-1207 as a combination treatment with MSD's Keytruda (pembrolizumab). In July 2024, Blue Earth Therapeutics announced the signing of a clinical research collaboration with University College London (UCL). The collaboration is centered on a Phase I/II trial designed to evaluate the safety, tolerability, radiation dosimetry, and antitumor activity of the 225Ac-rhPSMA-10.1 in men with metastatic castrate-resistant prostate cancer who have previously responded to lutetium 177 (177Lu)-PSMA therapy. Request a sample and discover the recent advances in mCRPC treatment drugs @ Metastatic Castration-Resistant Prostate Cancer Pipeline Report The mCRPC pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage mCRPC drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the mCRPC clinical trial landscape. Metastatic Castration-Resistant Prostate Cancer Overview Metastatic castration-resistant prostate cancer (mCRPC) is an advanced stage of prostate cancer that continues to grow and spread despite hormone therapy aimed at lowering testosterone levels. The term "metastatic" refers to cancer spreading to other parts of the body, such as the bones, lymph nodes, or distant organs, while "castration-resistant" indicates that the cancer no longer responds to treatments that reduce testosterone, a key driver of prostate cancer growth. mCRPC is typically more aggressive and challenging to treat than earlier stages of prostate cancer. The causes of mCRPC stem from genetic and environmental factors. Genetic mutations in the androgen receptor pathway can make cancer cells less dependent on testosterone, allowing them to thrive even under hormone-suppressing treatments. Environmental factors like diet, lifestyle, and exposure to certain chemicals may also contribute to the development and progression of prostate cancer. Symptoms of mCRPC often include pain in bones, fatigue, difficulty urinating, weight loss, and general weakness. As the cancer spreads, it can impair the function of other organs, depending on the site of metastasis. Diagnosis of mCRPC usually involves a combination of tests, including prostate-specific antigen (PSA) blood tests, imaging studies like CT scans, MRIs, or bone scans, and sometimes biopsies to confirm the spread and resistance to treatment. Treatment options for mCRPC are more complex and may include newer hormonal therapies (e.g., abiraterone, enzalutamide), chemotherapy (docetaxel or cabazitaxel), immunotherapy (e.g., sipuleucel-T), or targeted therapies such as PARP inhibitors. Bone-targeting therapies, radiation, and palliative care can also be used to manage symptoms and improve the quality of life. Treatment is typically tailored to the individual based on the extent of the disease and the patient health. Find out more about mCRPC treatment drugs @ Drugs for Metastatic Castration-Resistant Prostate Cancer Treatment A snapshot of the mCRPC Pipeline Drugs mentioned in the report: Learn more about the emerging mCRPC pipeline therapies @ Metastatic Castration-Resistant Prostate Cancer Clinical Trials Metastatic Castration-Resistant Prostate Cancer Therapeutics Assessment The mCRPC pipeline report proffers an integral view of the mCRPC emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Metastatic Castration-Resistant Prostate Cancer Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Intravenous, Subcutaneous Therapeutics Assessment By Molecule Type: Small molecule, Cell therapy, Peptides, Polymer, Small molecule, Gene therapy Therapeutics Assessment By Mechanism of Action: Androgen receptor degradation enhancers, Antibody-dependent cell cytotoxicity, Proto-oncogene protein c-akt inhibitors, Androgen receptor antagonists, Bromodomain and extraterminal domain protein inhibitors, Cyclin-dependent kinase 4 inhibitors, Cyclin-dependent kinase 6 inhibitors, Ionizing radiation emitters, PPAR alpha antagonists. Key Metastatic Castration-Resistant Prostate Cancer Companies: Regeneron Pharmaceuticals, AstraZeneca, Hinova Pharmaceuticals, Zenith Epigenetic, Eli Lilly and Company, Astellas Pharma, Seagen, Pfizer, Progenics Pharmaceutical, Molecular Insight Pharmaceuticals, Bayer, Accutar Biotechnology Inc, Hinova Pharmaceuticals, Forma Therapeutics, Inc., HALDA THERAPEUTICS INC., Tavanta Therapeutics, Lantheus, Pfizer, AB Science, Syntrix Pharmaceuticals, Exelixis, Laekna Therapeutics Shanghai Co. Ltd., Cardiff Oncology, Ipsen, Norroy Bioscience, Astellas Pharma, Novartis, Johnson & Johnson, Tempest Therapeutics, and others. Key Metastatic Castration-Resistant Prostate Cancer Pipeline Therapies: REGN 4336, Capivasertib, Deutenzalutamide, ZEN003694, Abemaciclib, Enfortumab vedotin, Talazoparib, I-131-1095, Pelgifatamab corixetan, AC176, HP518, FT-7051, HLD-0915, TAVT-45, PNT2002, Mevrometostat, Masitinib, SX-682, XL092, LAE001, Onvansertib, Tazemetostat, 177Lu-NYM032, PRL-02, 225 Actinium PSMA 617, ARX51, TPST-1120, and others. Dive deep into rich insights for new drugs for mCRPC treatment, visit @ Metastatic Castration-Resistant Prostate Cancer Drugs Table of Contents For further information on the mCRPC Cancer pipeline therapeutics, reach out @ Metastatic Castration-Resistant Prostate Cancer Treatment Drugs Related Reports Metastatic Castration-Resistant Prostate Cancer Market Metastatic Castration-Resistant Prostate Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key mCRPC companies including AstraZeneca, Merck Sharp & Dohme, Hinova Pharmaceuticals, Pfizer, Astellas Pharma, Modra Pharmaceuticals, AB Science, Eli Lilly and Company, Zr Pharma & GmbH, Bristol-Myers Squibb, Ipsen, Exelixis, Takeda, Janssen Research & Development, Tesaro, Lantheus Holdings, Kintor Pharmaceutical, MacroGenics, Daiichi Sankyo, Madison Vaccines, Novartis, Point Biopharma, Xencor, Essa Pharma, Telix International, Bayer, Arvinas, among others. Metastatic Prostate Cancer Market Metastatic Prostate Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key metastatic prostate cancer companies including AstraZeneca, Arvinas, Madison Vaccines, Phosplatin Therapeutics, Hinova Pharmaceuticals, Bristol Myers Squibb, Merck, MacroGenics, Daiichi Sankyo, Seagen, Taiho Pharmaceutical, Modra Pharmaceuticals, Xencor, Point Biopharma, Lantheus Holdings, Zenith Epigenetics, Essa Pharma, Telix Pharmaceuticals, Kintor Pharmaceutical, AB Science, Eli Lilly and Company, Exelixis among others. Metastatic Castration-Sensitive Prostate Cancer Market Metastatic Castration-Sensitive Prostate Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key mCSPC companies including Myovant Sciences, Pfizer, Bayer, Orion, Novartis, AstraZeneca, Pfizer, Janssen, Merck, Eli Lilly, among others. Metastatic Castration-Sensitive Prostate Cancer Pipeline Metastatic Castration-Sensitive Prostate Cancer Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, including clinical and non-clinical stage products, and the key mCSPC companies, including Myovant Sciences, Pfizer, Bayer, Orion, Novartis, AstraZeneca, Pfizer, Janssen, Merck, Eli Lilly, 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

Fast TrackImmunotherapyPhase 1Clinical Result

25 Jan 2024

·www.globenewswire.com

Bionano Announces Publication of a Study that Applied OGM to Discovery of Structural Variants Driving Drug Resistance and Sensitivity in Cancer

SAN DIEGO, Jan. 25, 2024 (GLOBE NEWSWIRE) -- Bionano Genomics, Inc. (Nasdaq: BNGO) today announced a peer-reviewed publication in Cancers from a team of cancer researchers primarily at the NCI-Designated Cancer Center, Sanford Burnham Prebys Medical Discovery Institute and Scripps MD Anderson in La Jolla, California. The publication describes what could be the first study to use optical genome mapping (OGM) for the discovery of structural variants (SVs) that drive drug resistance and sensitivity in cancer. Study Design Patient Samples. The study analyzed 26 leukemia samples from 23 subjects, including 3 samples from subjects after relapse. Genome Variation Signatures. The study compared genome variation signatures obtained from the leukemia samples by OGM and by classical cytogenetic methods including karyotyping (KT) and fluorescence in situ hybridization (FISH). Drug Library. The study used a broad collection of 120 cancer drugs based on the Oncology Drug Library (ODL, ODL2 and ODL3) and the FDA-approved oncology collection drugs from the NCI’s Developmental Therapeutics Program, including some experimental agents and those in phase II/III trials. Drug Resistance & Sensitivity Assay. The study used a cell viability and drug screening assay based on growing leukemia-enriched cell collections in the presence of different concentrations of drug agents to measure cell viability. Cells that grew well in the presence of drugs were determined to be resistant and those that didn’t were determined to be sensitive. Key Findings Overall, the study shows that OGM for SV detection combined with drug sensitivity data for the same samples is a useful approach to identifying potentially pathogenic SVs that may be drivers of drug sensitivity or resistance. Key findings are as follows: OGM detected all SVs that had been observed using classical cytogenetic methods as well as multiple additional variants that were not previously reportedBCR-ABL1 translocated leukemia samples are sensitive to the tyrosine kinase inhibitor Nilotinib, as expected, but exhibit resistance to proteasome inhibitorsDrug sensitivities associated with previously unreported genomic rearrangements were revealed Leukemia samples with KMT2A translocations are associated with drug sensitivities to the microtubule disruptors Paclitaxel and Cabazitaxel and resistance to Bcl-2 family inhibitorsChemosensitivity associations with SVs detected by OGM are able to reveal several potential new treatment strategies for leukemia “This paper represents incredibly well-done research that demonstrates the potential biological and clinical significance of structural variants and the ability of OGM to detect SVs in a reliable and efficient sample to answer workflow. SVs are historically underrepresented in genomics studies due to limitations associated with classical cytogenetic methods and sequencing. We are pleased to see this type of biomarker discovery research and hope it will lead others to conduct more studies, which we believe will help pharmaceutical companies develop better drugs and clinicians provide the right drugs to the right patients,” commented Erik Holmlin, PhD, president and chief executive officer of Bionano. The paper is available at: https://www.mdpi.com/2072-6694/16/2/418. About Bionano Bionano is a provider of genome analysis solutions that can enable researchers and clinicians to reveal answers to challenging questions in biology and medicine. The Company’s mission is to transform the way the world sees the genome through OGM solutions, diagnostic services and software. The Company offers OGM solutions for applications across basic, translational and clinical research. Through its Lineagen, Inc. d/b/a Bionano Laboratories business, the Company also provides diagnostic testing for patients with clinical presentations consistent with autism spectrum disorder and other neurodevelopmental disabilities. The Company also offers an industry-leading, platform-agnostic software solution, which integrates next-generation sequencing and microarray data designed to provide analysis, visualization, interpretation and reporting of copy number variants, single-nucleotide variants and absence of heterozygosity across the genome in one consolidated view. The Company additionally offers nucleic acid extraction and purification solutions using proprietary isotachophoresis (ITP) technology. For more information, visit www.bionano.com, www.bionanolaboratories.com or www.purigenbio.com. Bionano’s OGM products are for research use only and not for use in diagnostic procedures. Forward-Looking Statements of Bionano This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “believe,” “could,” “potential,” “will” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) convey uncertainty of future events or outcomes and are intended to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the ability and utility of OGM to detect SVs in leukemia samples; the ability and utility of OGM to detect SVs that drive drug resistance and sensitivity in cancer; the ability and utility of OGM to detect SVs compared to classical cytogenetic methods, including FISH and KT; the ability and utility of OGM to detect SVs in a reliable and efficient sample to answer workflow; the ability and utility of OGM to detect novel causative or pathogenic SVs associated with drug efficacy and resistance; and execution of our stated strategies and plans. Each of these forward-looking statements involves risks and uncertainties. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include the risks and uncertainties associated with: the impact of geopolitical and macroeconomic developments, such as recent and potential future bank failures, supply chain disruptions, global pandemics, inflation and the ongoing conflicts between Ukraine and Russian and Israel and Hamas, on our business and the global economy; general market conditions; the failure of OGM to detect SVs in leukemia samples; the failure of OGM to detect SVs that drive drug resistance and sensitivity in cancer; the failure of OGM to detect SVs compared to classical cytogenetic methods, including FISH and KT; the failure of OGM to detect SVs in a reliable and efficient sample to answer workflow; the failure of OGM to detect novel causative or pathogenic SVs associated with drug efficacy and resistance; study results that differ or contradict the results reported in the study referenced in this press release; changes in the competitive landscape and the introduction of competitive technologies or improvements to existing technologies; changes in our strategic and commercial plans; our need and ability to obtain sufficient financing to fund our strategic plans and commercialization efforts, our ability to effectively manage our uses of cash, and our ability to continue as a “going concern”; the ability of medical and research institutions to obtain funding to support adoption or continued use of our technologies; and the risks and uncertainties associated with our business and financial condition in general, including the risks and uncertainties described in our filings with the Securities and Exchange Commission, including, without limitation, our Annual Report on Form 10-K for the year ended December 31, 2022 and in other filings subsequently made by us with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. We do not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise. CONTACTSCompany Contact:Erik Holmlin, CEOBionano Genomics, Inc.+1 (858) 888-7610eholmlin@bionano.com Investor Relations:David HolmesGilmartin Group+1 (858) 888-7625IR@bionano.com

Clinical Study

100 Deals associated with Cabazitaxel Acetone

External Link

KEGG	Wiki	ATC	Drug Bank
D09755 D10452	Cabazitaxel Acetone	L01CD04	DB06772

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Prostatic Cancer	Japan	Sanofi KK	04 Jul 2014
Metastatic castration-resistant prostate cancer	United States	Sanofi-Aventis U.S. LLC	17 Jun 2010

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Adenocarcinoma of prostate	Phase 3	France	Sanofi	01 Dec 2013
Localized Prostate Carcinoma	Phase 3	France	Sanofi	01 Dec 2013
Transitional Cell Carcinoma	Phase 3	United Kingdom	Sanofi	01 Jan 2013
Castration-Resistant Prostatic Cancer	Phase 3	United States	Aventis Pharma	05 May 2011
Castration-Resistant Prostatic Cancer	Phase 3	Japan	Aventis Pharma	05 May 2011
Castration-Resistant Prostatic Cancer	Phase 3	Denmark	Aventis Pharma	05 May 2011
Castration-Resistant Prostatic Cancer	Phase 3	Finland	Aventis Pharma	05 May 2011
Castration-Resistant Prostatic Cancer	Phase 3	Peru	Aventis Pharma	05 May 2011
Castration-Resistant Prostatic Cancer	Phase 3	Sweden	Aventis Pharma	05 May 2011
Ovarian Cancer	Phase 2	United Kingdom	Starpharma Holdings Ltd.	30 Jan 2018

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02485691 (CARD, Pubmed \| JCI Insight)	Phase 3	Metastatic castration-resistant prostate cancer chromosomal instability in circulating tumor cells	600	cabazitaxel	daxblrtbcx(gdkrcyjctb) = rdeiukdzzw cidjbcyrag (qwjeiqbela )	Positive	04 Nov 2025
				alternative ARPI	daxblrtbcx(gdkrcyjctb) = auqjekexay cidjbcyrag (qwjeiqbela )
ESMO2025	Not Applicable	Metastatic castration-resistant prostate cancer	38,315	Docetaxel	bhkmmdesgi(hvekyxudsw) = baxusyngib wgjeiaowlp (oflbkhiocb )	Positive	17 Oct 2025
				Docetaxel	bhkmmdesgi(hvekyxudsw) = qtwpjyzhyb wgjeiaowlp (oflbkhiocb )
NCT04592237 (C3NIRA, ASCO2025)	Phase 2	Prostatic Cancer Maintenance	120	Cabazitaxel	ofpoglvfwe(iihwqgphyk) = nmuusztzgo qljsnyhxpb (nhutbzahpu, 2.0 - 4.4)	Positive	30 May 2025
				Niraparib	qzyvyqwdpn(ymhuiuhfcc) = qgxsgcdnhr xahgzgtvvu (gayngilqls, 6.4 - 19.6)
ASCO2025	Not Applicable	Metastatic castration-resistant prostate cancer	-	Cabazitaxel	xdpcniyroz(hepknclplp) = ikqqkkwznz dseijpjssj (xdvtnudqpz, 6.6 - 10.8) View more	Positive	30 May 2025
				Lutetium Lu-177 vipivotide tetraxetan	xdpcniyroz(hepknclplp) = kkjqmwjrpy dseijpjssj (xdvtnudqpz, 8.9 - 12.8) View more
NCT03392428 (TheraP, Pubmed \| Nat Med)	Phase 2	Metastatic Prostate Carcinoma circulating tumor DNA (ctDNA) fraction \| PTEN alterations \| ATM defects	180	Lutetium-177-PSMA-617	cbxfwrxgph(qduqycwwue) = loheabxiyi rpxmgqmtvr (ferwxemhei ) View more	Positive	27 May 2025
				Cabazitaxel	cbxfwrxgph(qduqycwwue) = wyngmnnbts rpxmgqmtvr (ferwxemhei ) View more
ASCO_GU2025	Not Applicable	Metastatic castration-resistant prostate cancer Third line	-	First line of therapy	uorczzckkq(ewvmpuxxsv) = ttnlswbogb rocssfhyuq (pnbqajxlos, 9.5 - 14) View more	-	13 Feb 2025
				Second line of therapy	uorczzckkq(ewvmpuxxsv) = upfmrztgfq rocssfhyuq (pnbqajxlos, 6.6 - 8.4) View more
NCT02218606 (CTgov)	Phase 2	Metastatic castration-resistant prostate cancer	81	prednisone 5 mg po BID+Abiraterone acetate 1000 mg po daily (Abiraterone Acetate 1000 mg po Daily + Prednisone 5 mg po BID)	nimfopzzcn(nlrelaqfju) = exhevjlhnk umtvalcnug (xeqnioaafs, bfmvwqoxho - aznhcnkogf) View more	-	10 Dec 2024
				Cabazitaxel 25 mg/m2 IV+prednisone 5 mg po BID+Abiraterone acetate 1000 mg po daily (Cabazitaxel 25 mg/m2 IV + Abiraterone Acetate 1000 mg po Daily)	nimfopzzcn(nlrelaqfju) = nkgilghrai umtvalcnug (xeqnioaafs, qildjrktpm - qnhmlcgbhb) View more
NCT02512458 (CabaBone, Pubmed)	Phase 2	Castration-Resistant Prostatic Cancer Third line	59	卡巴他赛	dhfgifutgz(xjfrwsuoxn) = zsdvgfmfsb dqsvxdzodl (aayirvzhkb ) View more	Positive	26 Oct 2024
NCT02202772 (ESMO2024) Manual	Phase 2	Non-Muscle Invasive Bladder Urothelial Carcinoma	33	cabazitaxell cabazitaxelcisplatinbine, and cisplatin (CGC)	mxsopstfuu(maxetpluxt) = iakrgrlrhu lmtdciuxya (tlpthbyyxw ) View more	Positive	15 Sep 2024
EUCTR2016-001179-60-DE \| NCT02961257 (CABASTY, ESMO2024)	Phase 3	Metastatic castration-resistant prostate cancer	194	Triweekly 25mg/m2 cabazitaxel	rwjxflcoco(byrwasqfpf) = rfvnhdoqme rukamgntjs (mkppzpprag, 17.4 - 29.8)	Positive	15 Sep 2024
				Biweekly 16mg/m2 cabazitaxel	rwjxflcoco(byrwasqfpf) = zkopimigmd rukamgntjs (mkppzpprag )

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