A Phase III Study of Cabazitaxel With or Without Carboplatin in Patients With Metastatic Castrate-Resistant Prostate Cancer (mCRPC), Stratified by Aggressive Variant Signature

This phase III trial compares the effect of adding carboplatin to the standard of care chemotherapy drug cabazitaxel versus cabazitaxel alone in treating prostate cancer that keeps growing even when the amount of testosterone in the body is reduced to very low levels (castrate-resistant) and that has spread from where it first started (primary site) to other places in the body (metastatic). Carboplatin is in a class of medications known as platinum-containing compounds. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Chemotherapy drugs, such as cabazitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Prednisone is often given together with chemotherapy drugs. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs and to help the chemotherapy work. Giving carboplatin with the standard of care chemotherapy drug cabazitaxel may be better at treating metastatic castrate-resistant prostate cancer.

Start Date12 Dec 2024

Sponsor / Collaborator

SWOG

[+1]

NCT06632977 / Not yet 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 Date13 Oct 2024

Sponsor / Collaborator

Alliance for Clinical Trials in Oncology

[+1]

NCT06353386 / RecruitingPhase 1/2

MK-5684-01A Substudy: A Phase 1/2 Umbrella Substudy of MK-5684-U01 Master Protocol to Evaluate the Safety and Efficacy of MK-5684-based Treatment Combinations or MK-5684 Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC)

Substudy 01A is part of a larger research study that is testing experimental treatments for metastatic castration-resistant prostate cancer (mCRPC). The larger study is the umbrella study (U01).
The goal of substudy 01A is to evaluate the safety and efficacy of opevesostat-based treatment combinations, or as a single agent, in participants with mCRPC.
This substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety lead-in phase will be used to evaluate the safety and tolerability, and to establish a recommended Phase 2 dose (RP2D) for the opevesostat-based treatment combinations. There will be no hypothesis testing in this study.

Start Date20 May 2024

Sponsor / Collaborator

Merck Sharp & Dohme LLC

[+1]

100 Clinical Results associated with Cabazitaxel Acetone

100 Translational Medicine associated with Cabazitaxel Acetone

100 Patents (Medical) associated with Cabazitaxel Acetone

1,206

Literatures (Medical) associated with Cabazitaxel Acetone

01 Feb 2025·Clinical Genitourinary Cancer

The role of Cabazitaxel in Patients With Castration-Resistant and Osseous Metastases Prostate Cancer. A Hellenic Cooperative Oncology Group Phase II Study

Article

Author: Samantas, Epaminontas ; Fountzilas, George ; Petrakis, Georgios ; Efstathiou, Eleni ; Visvikis, Anastasios ; Tsiatas, Marinos ; Fountzilas, Elena ; Kanellis, Georgios ; Goussia, Anna ; Liontos, Michalis ; Papadopoulou, Kyriaki ; Korfiatis, Nikolaos

BACKGROUND:

Cabazitaxel is an effective treatment in metastatic castration-resistant prostate cancer (mCRPC) patients previously exposed to docetaxel and novel hormonal treatments. Understanding the molecular biology of mCRPC disease and taking into account the several approved treatment options, biomarkers are needed to guide decision making including cabazitaxel treatment.

METHODS:

Cababone was a phase II translational study that attempted to identify predictors of cabazitaxel efficacy. mCRPC with documented bone metastases were enrolled prospectively and treated with cabazitaxel 25mg/m² every 3 weeks. Prostate cancer biopsies, bone marrow aspirates and blood samples were collected for translational research.

RESULTS:

Sixty patients were enrolled and 59 received treatment according to protocol. Six-month progression free survival (PFS) rate was 47% (95% CI: 33% - 59%) and 12-month Overall Survival (OS) rate was 70% (95% CI: 56% - 80%). Patients with reactive hematopoiesis had improved PFS and OS with cabazitaxel treatment. Mutations in HRR genes were detected in 7 patients.

CONCLUSIONS:

No differences in cabazitaxel efficacy were noted according to mutational status of HRR genes analyzed. No new safety issues were detected. In conclusion, CabaBone confirmed efficacy of cabazitaxel in mCRPC patients including the subgroup of patients with HRR mutations. Reactive hematopoiesis in bone marrow biopsies was related to improved survival warranting further investigation of bone biomarkers as predictors of cabazitaxel efficacy.

31 Dec 2024·Cancer biology & therapy

Association between the apoptotic effect of Cabazitaxel and its pro-oxidant efficacy on the redox adaptation mechanisms in prostate cancer cells with different resistance phenotypes

Article

Author: Cecener, Gulsah ; Eryilmaz, Isil Ezgi ; Egeli, Unal

Redox adaptation causes poor prognosis by adapting cancer cells to excessive oxidative stress. Previously, we introduced an oxidative stress-resistant metastatic prostate cancer (mPC) model (LNCaP-HPR) that redox adaptation reduced the effect of Cabazitaxel (Cab), the last taxane-derivative for metastatic castration-resistant PC (mCRPC). Whereas, we investigated for the first time whether there is an association between the altered apoptotic effect and pro-oxidant efficacy of Cab on the redox adaptation in PC cells with different phenotypes, including LNCaP mPC, LNCaP-HPR, C4-2 mCRPC, and RWPE-1 cells. Cab was shown pro-oxidant efficacy proportionally with the apoptotic effect, more prominent in the less aggressive LNCaP cells, by increasing the endogenous ROS, mitochondrial damage, and inhibiting nuclear ROS scavengers, p-Nrf2 and HIF-1α. However, the pro-oxidant and apoptotic effect was lower in the LNCaP-HPR and C4-2 cells, indicating that the drug sensitivity of the cells adapted to survive with more ROS was reduced via altered regulation of redox adaptation. Additionally, unlike LNCaP, Cab caused an increase in the p-NF-κB activation, suggesting that the p-NF-κB might accompany maintaining survival with the increased ROS in the aggressive PC cells. Moreover, the cytotoxic and apoptotic effects of Cab were less on RWPE-1 cells compared to LNCaP but were closer to those on the more aggressive LNCaP-HPR and C4-2 cells, except for the changing pro-oxidant effect of Cab. Consequently, this study indicates the variable pro-oxidant effects of Cab on redox-sensitive proteins, which could be a target for improving Cab's apoptotic effect more in aggressive PC cells.

01 Dec 2024·Clinical Genitourinary Cancer

Real-life Data on First- and Second-Line Treatment of Metastatic Castration-Resistant Prostate Cancer With Abiraterone, Enzalutamide and Cabazitaxel – A multicentric Study From Portugal

Article

Author: Augusto, Isabel ; Custódio, Sandra ; Febra, Joana ; Rodrigues, Filipe ; Silva, Carlos ; Portela, Catarina ; Braga, Isaac ; Miranda, André ; Pacheco-Figueiredo, Luís ; Teves, Frederico ; Leão, Ricardo ; Gago, Patrícia ; Liu, Patrícia ; Oliveira, Jorge ; Dias, Jorge ; Botelho, Francisco

INTRODUCTION AND OBJECTIVES:

New drugs for metastatic castrate resistant prostate cancer (mCRPC) were approved, first in the pos-docetaxel and then in the pre-docetaxel setting. We aim to assess the real daily practice benefit of abiraterone (Abi), enzalutamide (Enz) and cabazitaxel (Cab) in patients with mCRPC, compare it with RCT results and compare Abi vs Enz.

MATERIALS AND METHODS:

We retrospectively collected the data of all consecutive mCRPC patients treated with Abi, Enz or Cab in the six major oncological hospitals in the north of Portugal until December 2020.

RESULTS:

A total of 470 treatments pre-docetaxel (163 Abi and 307 Enz) and 373 pos-docetaxel (160 Abi, 148 Enz and 59 Cab) were included, with median follow-up time of 35 months. Mean age was 73.1, 84.4% had ECOG status < 2, ISUP grade was ≥ 4 in 59% and 28.0% had oligometastatic disease. In first line, for Abi and for Enz respectively, the proportion of patients with PSA reduction > 50% was 64.4% and 80.4% (P < .001), the mean duration of treatment (DT) was 10 and 14 months (P = .037) and the median overall survival (OS) was 25 months and 30 months (P = .17). In second line the results for Abi, Enz and Cab were respectively: proportion of patients with PSA reduction > 50% was 40.4%, 57.4% and 24.6% (p for Abi vs Enz=0.004); DT was 7, 8, and 3 months (p for Abi vs Enz = 0.27); OS was 17, 22 and 10 months (p for Abi vs. Enz = 0,07).

CONCLUSION:

These drugs have good efficacy in real-world evidence, similar to those reported in randomized clinical trials, with the expected exception of lower OS due to the inclusion of a broader sample of patients. Our results add to the evidence that Enz might have better efficacy in this setting compared with Abi.

News (Medical) associated with Cabazitaxel Acetone

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

09 Jan 2024

·www.prnewswire.com

Castration-Resistant Prostate Cancer (CRPC) Treatment Market size to grow by USD 5.98 billion from 2023 to 2028, North America to account for 47% of market growth- Technavio

NEW YORK, Jan. 8, 2024 /PRNewswire/ -- The castration-resistant prostate cancer (CRPC) treatment market is expected to grow by USD 5.98 billion from 2023 to 2028. In addition, the momentum of the market will progress at a CAGR of 8.83% during the forecast period, according to Technavio Research. The market has been segmented by distribution channels (hospital pharmacies, retail pharmacies, and online pharmacies), therapy (hormonal therapy, chemotherapy, and others), and geography (North America, Europe, Asia, and the Rest of the World (ROW)). North America is estimated to contribute 47% to the growth of the global market during the forecast period. Moreover, this region's market growth is driven by high-quality healthcare infrastructure. Continue Reading Technavio has announced its latest market research report titled Global Castration-Resistant Prostate Cancer (CRPC) Treatment Market 2024-2028 This report offers an up-to-date analysis of the current market scenario, the latest trends and drivers, and the overall market environment. Read a Free PDF Sample Report Company Profile: Active Biotech AB, Allarity Therapeutics Inc., Amgen Inc., Amneal Pharmaceuticals Inc., Astellas Pharma Inc., Bayer AG, BeiGene Ltd., Daiichi Sankyo Co. Ltd., Dr Reddys Laboratories Ltd., Everest Pharmaceuticals Ltd., F. Hoffmann La Roche Ltd., Johnson and Johnson, Medias Klinikum GmbH and Co. KG, Merck KGaA, Novartis AG, Pfizer Inc., Robotic Prostate Centre Cambridge, Sanofi SA, The Focal Therapy Clinic, and Ono Pharmaceutical Co. Ltd. Allarity Therapeutics Inc. - The company offers Castration-Resistant Prostate Cancer CRPC treatments such as LiPlaCis and Irofulven, in Phase II trials. To gain access to more company profiles available with Technavio, buy the report! Castration-Resistant Prostate Cancer (CRPC) Treatment Market: Segmentation Analysis The hospital pharmacies segment is estimated to witness significant growth during the forecast period. A specific category of pharmacies operating within the premises of a healthcare facility is included in this hospital pharmacy segment. Learn about the contribution of each segment summarized in concise infographics and thorough descriptions. View a Free PDF Sample Report Castration-Resistant Prostate Cancer (CRPC) Treatment Market: Market Dynamics Key Driver The increasing Early detection of prostate cancer is a key factor driving market growth. This growth has intensified the use of Androgen Deprivation Therapy (ADT), Chemotherapy (including Docetaxel and cabazitaxel), and novel medications like Abiraterone Acetate, Enzalutamide, Radium-223 Dichloride. Additionally, the emergence of immunotherapy, PARP Inhibitors such as Olaparib, and advancements in targeted therapies focusing on Prostate-Specific Membrane Antigen (PSMA) are further catalyzing innovative treatment approaches for CRPC. Leading Trend The evolution of CRPC treatment options stands as a significant trend driving the growth of the Castration-Resistant Prostate Cancer (CRPC) Treatment Market. This evolution includes Clinical Trials, addressing Hormone Refractory Prostate Cancer and Metastatic CRPC (mCRPC), with a focus on Novel Therapeutics developed by Biopharmaceutical Companies. FDA Approvals of these treatments, alongside an emphasis on Personalized Medicine to combat Treatment Resistance Mechanisms, are shaping the landscape. Additionally, attention to Health Economics and Reimbursement aligns with improving Patient's Quality of Life. Significant Challenge The prevalence of health complications linked to CRPC drugs emerges as a significant challenge impeding the Castration-Resistant Prostate Cancer (CRPC) Treatment Market growth. Challenges persist regarding Biomarkers in CRPC and Genetic Testing, impacting the efficacy of treatments like Radiopharmaceuticals and Bone-targeted Therapy. Market Trends and Forecasts, influenced by Healthcare Policies and Regulations, affect the Drug Development Pipeline and Oncology Research and Development, complicating Global Market Analysis within the CRPC treatment landscape. Identify key trends, drivers, and challenges in the market. Download a sample to gain access to this information. Related Reports The fallopian tube cancer treatment market is estimated to generate a value of USD 998.75 million in 2018, anticipated to reach USD 2.14 billion by 2028. The head and neck cancer treatment market size is estimated to grow by USD 5,077.38 million at a CAGR of 11.27% between 2022 and 2027. What are the key data covered in this castration-resistant prostate cancer (CRPC) treatment market report? CAGR of the market during the forecast period Detailed information on factors that will drive the growth of the castration-resistant prostate cancer (CRPC) treatment market between 2023 and 2028. Precise estimation of the castration-resistant prostate cancer (CRPC) treatment market size and its contribution to the market in focus on the parent market Accurate predictions about upcoming trends and changes in consumer behavior Growth of the castration-resistant prostate cancer (CRPC) treatment market across North America, Europe, Asia, and ROW A thorough analysis of the market's competitive landscape and detailed information about companies Comprehensive analysis of factors that will challenge the growth of castration-resistant prostate cancer (CRPC) treatment market companies. ToC: Executive Summary Market Landscape Market Sizing Historic Market Sizes Five Forces Analysis Market Segmentation by Distribution Channel Market Segmentation by Therapy Market Segmentation by Geography Customer Landscape Geographic Landscape Drivers, Challenges, & Trends Company Landscape Company Analysis Appendix About Technavio Technavio is a leading global technology research and advisory company. Their research and analysis focus on emerging market trends and provide actionable insights to help businesses identify market opportunities and develop effective strategies to optimize their market positions. With over 500 specialized analysts, Technavio's report library consists of more than 17,000 reports and counting, covering 800 technologies, spanning across 50 countries. Their client base consists of enterprises of all sizes, including more than 100 Fortune 500 companies. This growing client base relies on Technavio's comprehensive coverage, extensive research, and actionable market insights to identify opportunities in existing and potential markets and assess their competitive positions within changing market scenarios. Contacts Technavio Research Jesse Maida Media & Marketing Executive US: +1 844 364 1100 UK: +44 203 893 3200 Email: [email protected] Website: SOURCE Technavio

Phase 2Immunotherapy

100 Deals associated with Cabazitaxel Acetone

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KEGG	Wiki	ATC	Drug Bank
D09755 D10452	Cabazitaxel Acetone	L01CD04	DB06772

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Approved

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

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Adenocarcinoma of prostate	Phase 3	FR	Sanofi	01 Dec 2013
Localized Prostate Carcinoma	Phase 3	FR	Sanofi	01 Dec 2013
Transitional Cell Carcinoma	Phase 3	GB	Sanofi	01 Jan 2013
Castration-Resistant Prostatic Cancer	Phase 3	US	Aventis Pharma	05 May 2011
Castration-Resistant Prostatic Cancer	Phase 3	US	Sanofi (China) Investment Co. Ltd.	05 May 2011
Castration-Resistant Prostatic Cancer	Phase 3	US	Sanofi-Aventis Recherche et Développement SA	05 May 2011
Castration-Resistant Prostatic Cancer	Phase 3	JP	Sanofi (China) Investment Co. Ltd.	05 May 2011
Castration-Resistant Prostatic Cancer	Phase 3	JP	Sanofi-Aventis Recherche et Développement SA	05 May 2011
Castration-Resistant Prostatic Cancer	Phase 3	JP	Aventis Pharma	05 May 2011
Castration-Resistant Prostatic Cancer	Phase 3	DK	Sanofi (China) Investment Co. Ltd.	05 May 2011

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


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)	ouehdeazim(qvjsmowudk) = ysffncnqhl reqqmjguie (cqrlknjkvx, npcuxpexkc - liogryitoi) 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)	ouehdeazim(qvjsmowudk) = iqdmdjqoee reqqmjguie (cqrlknjkvx, rpipupejhq - pfcqzyktwv) View more
NCT02202772 (ESMO2024) Manual	Phase 2	Non-Muscle Invasive Bladder Urothelial Carcinoma	33	cabazitaxell cabazitaxelcisplatinbine, and cisplatin (CGC)	pqguzmddfi(hcoywgjfye) = cobmoelukv rchprohqbw (phmprxjgyw ) View more	Positive	15 Sep 2024
CABASTY (ESMO2024)	Not Applicable	Metastatic castration-resistant prostate cancer	194	Triweekly 25mg/m2 cabazitaxel	rkzjoylkjc(xfzsygsmzg) = oxcfdgdqnv cszvdrlkoy (uqivlpdyjb, 17.4 - 29.8)	Positive	15 Sep 2024
				Biweekly 16mg/m2 cabazitaxel	rkzjoylkjc(xfzsygsmzg) = sbitqjstce cszvdrlkoy (uqivlpdyjb )
NCT02903160 (PRINT, CTgov)	Phase 2	Castration-Resistant Prostatic Cancer	40	Radium-223 dichloride+Enzalutamide+Cabazitaxel+Carboplatin+Prednisone+Abiraterone acetate	ceyczhmwel(gqdvdgdsjn) = nvuzeubgkq offjwldizd (dlofaoiqpv, djbtqhptsw - ambzgjmbwk) View more	-	07 Feb 2024
EUCTR2017-003424-76-GB (ASCO_GI2024) Manual	Phase 1/2	Esophageal Carcinoma	15	DEP cabazitaxel 20 mg/m2	aqdohvonvk(xoiqvamezp) = elsrkxqxvk xcrchyxrlh (frzfylmwqv ) View more	Positive	18 Jan 2024
				DEP cabazitaxel 20 mg/m2 (EG ADENOCA pts)	aqdohvonvk(xoiqvamezp) = rymktyepzg xcrchyxrlh (frzfylmwqv ) View more
NCT03295565 (OSTRICH, ESMO2023) Manual	Phase 2	Castration-Resistant Prostatic Cancer	106	Cabazitaxel	xorperombq(vcyfzaelxk) = kcadfbvxzf kjkmsjdbyc (vfrgnftetl, 46.1 - 74.2) View more	Non-superior	22 Oct 2023
				Abiraterone or Enzalutamide	xorperombq(vcyfzaelxk) = pqemurteee kjkmsjdbyc (vfrgnftetl, 52.9 - 79.7) View more
NCT03903835 (ProBio, ESMO2023) Manual	Phase 3	Castration-Resistant Prostatic Cancer First line	219	abiraterone or enzalutamide (Androgen receptor pathway inhibitors (ARPi))	oqhmfqluoj(ivadhomliy) = zixzsqdmvf oehiorwleg (ddsdeectcd, 9.8 ～ 13.1) View more	Positive	22 Oct 2023
				docetaxel or cabazitaxel (Taxanes)	ykuistkfjb(syaemhfnqs) = ntbzurlcgu pbsexjztvg (nslvfpdpoo, 18.4 ～ 23.0)
NCT04495179 (AARDVARC, CTgov)	Phase 2	Metastatic castration-resistant prostate cancer	30	AZD4635+Durvalumab (Arm A: AZD4635 + Durvalumab)	prgtuzopfj(kjscbnzvgr) = snxdajolpy xzkhfablij (xqfkzsirbx, paqptctcgn - adjoppkpgm) View more	-	09 Aug 2023
				Cabazitaxel+AZD4635+Durvalumab (Arm B: AZD4635 + Durvalumab + Cabazitaxel)	nqseyirfns(uveaqvtunp) = kvrrwjbdlq gnyneimghl (xjjrihztei, pwbfygrlln - rjhfdrifew) View more
NCT01616875 (ASCO_GU2023) Manual	Phase 2	Urothelial Carcinoma of the Urinary Bladder	26	Cabazitaxel + Cisplatin	dhbloomiuq(rkgjeqcvdy) = qymciduaku zfbysxmwbk (cafgqjacoy ) View more	Positive	21 Feb 2023
				Cabazitaxel + Cisplatin (achieved ORR)	uyvrharqop(meeefowbdv) = xuupdyhknr yxkdvpklat (fkjtawrwds )
Pubmed Manual	Phase 2/3	HER2-negative breast cancer First line HER2 Negative	158	cabazitaxel	vxhatnhntc(jaimwawxok) = klqpqgcldx ybglmpwlny (febsjeriff ) View more	Negative	24 Sep 2022
				paclitaxel	vxhatnhntc(jaimwawxok) = fsupypxouv ybglmpwlny (febsjeriff ) View more

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