Phase II Trial of pTVG-HP DNA Vaccine With or Without pTVG-AR DNA Vaccine and Pembrolizumab in Patients With Castration-Resistant, Metastatic Prostate Cancer

This trial will evaluate the use of one versus two DNA vaccines, delivered concurrently with PD-1 blockade using pembrolizumab followed by treatment with pembrolizumab alone, and delivered over a prolonged period of time (for a maximum of 2 years (32 cycles) or until radiographic progression) on the treatment of castrate-resistant, metastatic prostate cancer. The hypothesis to be tested is that delivering two vaccines with PD-1 blockade will elicit a greater frequency and magnitude of tumor-directed CD8+ T cells, and thereby increase the percentage of patients experiencing objective anti-tumor effect as measured by PSA declines and/or objective radiographic responses. Participants must be 18 years of age or older and can expect to be on treatment for 2 years (32 cycles) and on study for up to 4 years (including 2 years of follow up via phone).

Start Date21 Oct 2019

Sponsor / Collaborator

University of Wisconsin-Madison

[+3]

NCT03600350 / Active, not recruitingPhase 2IIT

Phase II Trial of a DNA Vaccine Encoding Prostatic Acid Phosphatase (pTVG-HP) and Nivolumab in Patients With Non-Metastatic, PSA-Recurrent Prostate Cancer

The purpose of this study is to evaluate the safety of an investigational DNA vaccine, pTVG-HP, a plasmid DNA encoding human prostatic acid phosphatase (PAP), in combination with nivolumab, and the efficacy of this combination in decreasing serum Prostate-Specific Antigen (PSA) in patients with non-metastatic, non-castrate prostate cancer (clinical stage D0/M0).

Start Date10 Sep 2018

Sponsor / Collaborator

University of Wisconsin-Madison

[+3]

NCT01706458 / CompletedPhase 2IIT

Pilot Trial of Sipuleucel-T, With or Without pTVG-HP DNA Booster Vaccine, in Patients With Castrate-Resistant, Metastatic Prostate Cancer

This randomized pilot clinical trial studies sipuleucel-T with or without deoxyribonucleic acid (DNA) vaccine therapy in treating patients with prostate cancer that has not responded to previous treatment with hormones and has spread to other places in the body. Vaccines may help the body build an effective immune response to kill tumor cells. It is not yet known whether giving sipuleucel-T vaccine works better with or without DNA vaccine therapy in treating prostate cancer.

Start Date20 May 2013

Sponsor / Collaborator

University of Wisconsin-Madison

[+1]

100 Clinical Results associated with PAP Vaccine(Madison Vaccines, Inc.)

100 Translational Medicine associated with PAP Vaccine(Madison Vaccines, Inc.)

100 Patents (Medical) associated with PAP Vaccine(Madison Vaccines, Inc.)

585

Literatures (Medical) associated with PAP Vaccine(Madison Vaccines, Inc.)

01 Feb 2024·Sleep medicine

A real-world observational study assessing relationships between excessive daytime sleepiness and patient satisfaction in obstructive sleep apnea

Article

Author: Hyman, Danielle ; Morris, Susan ; Doherty, James ; Ying Vang, Mai Ka ; Saad, Ragy ; Zhang, Jerry ; Parthasarathy, Sairam ; Schroeder, Jessica ; Marshall, Nell J ; Parks, Gregory S ; Fox, Benjamin ; Eldemir, Lev

OBJECTIVES/BACKGROUND:

To estimate prevalence and severity of excessive daytime sleepiness among patients with obstructive sleep apnea (OSA) who were prescribed treatment; assess perception and satisfaction of OSA-related care; describe relationships between excessive daytime sleepiness, treatment adherence, and patient satisfaction.

PATIENTS/METHODS:

A national population-based cross-sectional sample of US adults with clinician-diagnosed OSA was surveyed in January 2021 via Evidation Health's Achievement App. Patients completed the Epworth Sleepiness Scale, rated satisfaction with healthcare provider and overall OSA care, and reported treatment adherence. Covariates affecting excessive daytime sleepiness (average weekly sleep duration, treatment adherence, sleepiness-inducing medications, age, sex, body mass index, nasal congestion, smoking status, and comorbidities) were adjusted in multivariate regression models.

RESULTS:

In 2289 participants (50.3 % women; 44.8 ± 11.1 years), EDS was highly prevalent (42 %), and was experienced by 36 % of patients with high positive airway pressure (PAP) therapy adherence. Each additional hour of nightly PAP use was associated with improved sleepiness (a 0.28-point lower Epworth score; p < 0.001). Excessive daytime sleepiness was associated with lower patient satisfaction with healthcare providers and overall care (OR [95 % CI] 0.62 [0.48-0.80] and 0.50 [0.39-0.64], respectively; p < 0.0001), whereas PAP adherence was associated with higher patient satisfaction (OR [95 % CI] 2.37 [1.64-3.43] and 2.91 [2.03-4.17]; p < 0.0001), after adjusting for confounders.

CONCLUSIONS:

In a real-world population-based study of patients with OSA, excessive daytime sleepiness was highly prevalent and associated with poor patient satisfaction ratings. Better patient-centered care among patients with OSA may require interventions aimed at addressing excessive daytime sleepiness and treatment adherence.

08 Jan 2024·Inorganic chemistry

Elucidating the Role of Atomically Dilute Copper Centers Impregnating a Phosphamide Polymer for the Preferential Hydrogen Evolution Reaction over CO₂ Reduction

Article

Author: Adak, Mrinal Kanti ; Kundu, Avinava ; Chaudhary, Monika ; Karmakar, Tarak ; Chakraborty, Biswarup ; Kumari, Nidhi ; Dhananjay ; Basak, Hirak Kumar

Organic polymers have attracted considerable interest in designing a multifunctional electrocatalyst. However, the inferior electro-conductivity of such metal-free polymers is often regarded as a shortcoming. Herein, a nitrogen- and phosphorus-rich polymer with phosphamide functionality (PAP) in the repeating unit has been synthesized from diaminopyridine (DAP) and phenylphosphonic dichloride (PPDC) precursors. The presence of phosphamide oxygen and pyridine nitrogen in the repeating unit of PAP leads to the coordination of the Cu^II ion and the incorporation of 3.29 wt % in the polymer matrix (Cu₃₀@PAP) when copper salt is used to impregnate the polymer. Combined with a spectroscopic, microscopic, and DFT study, the coordination and geometry of copper in the PAP matrix has been established to be a distorted square planar Cu^II in a N₂O₂ ligand environment where phosphamide oxygen and pyridine nitrogen of the PAP coordinate to the metal center. The copper incorporation in the PAP modulates its electrocatalytic activity. On the glassy carbon electrode, PAP shows inferior activity toward the hydrogen evolution reaction (HER) in 0.5 M H₂SO₄ while 3 wt % copper incorporation (Cu₃₀@PAP) significantly improves the HER performance with an overpotential of 114 mV at 10 mA cm^-2. The notable electrochemical activity with Cu₃₀@PAP occurs due to the impregnation of Cu(II) in PAP, improved electro-kinetics, and better charge transfer resistance (R_ct). When changing the electrolyte from H₂SO₄ to CO₂-saturated bicarbonate solution at nearly neutral pH, PAP shows HER as the dominant pathway along with the partial reduction of CO₂ to formate. Moreover, the use of Cu₃₀@PAP as an electrolcatalyst could not alter the predominant HER path, and only 20% Faradaic efficiency for the CO₂ reduced products has been achieved. Post-chronoamperometric characterization of the recovered catalyst suggests an unaltered valence state of the copper ion and the intact chemical structure of PAP. DFT studies unraveled that the copper sites of Cu₃₀@PAP promote water adsorption while phosphamide-NH of the PAP can weakly hold the CO₂ adduct via a hydrogen bonding interaction. A detailed calculation has pointed out that the tetra-coordinated copper centers present in the PAP frame are the reactive sites and that the formation of the [Cu^I-H] intermediate is the rate-limiting step for both HER and its competitive side reaction, i.e., CO₂ reduction to formate or CO formation. The high proton concentration in the electrolyte of pH < 7 leads to HER as the predominant pathway. This combined experimental and theoretical study has highlighted the crucial role of copper sites in electrocatalysis, emphasizing the plausible reason for electrocatalytic selectivity.

01 Jan 2024·Chest

Performance of Claims-Based Algorithms for Adherence to Positive Airway Pressure Therapy in Commercially Insured Patients With OSA

Article

Author: Cole, Kate V ; Sterling, Kimberly L ; Wickwire, Emerson M ; Dexter, R Benjamin ; Alpert, Naomi

BACKGROUND:

Positive airway pressure (PAP) therapy is first-line therapy for OSA, but consistent use is required for it to be effective. Previous studies have used Medicare fee-for-service claims data (eg, device, equipment charges) as a proxy for PAP adherence to assess its effects. However, this approach has not been validated in a US commercially insured population, where coverage rules are not standardized.

RESEARCH QUESTION:

In a commercially insured population in the United States, how well do claims-based algorithms for defining PAP adherence correspond with objective PAP device usage?

STUDY DESIGN AND METHODS:

Deidentified administrative claims data of commercially insured patients (aged 18-64 years) with OSA were linked to objective PAP therapy usage data from cloud-connected devices. Adherence was defined based on device use (using an extension of Centers for Medicare & Medicaid Services 90-day compliance criteria) and from claims-based algorithms to compare usage metrics and identify potential misclassifications.

RESULTS:

The final sample included 213,341 patients. Based on device usage, 48% were adherent in the first year. Based on claims, between 10% and 84% of patients were identified as adherent (accuracy, sensitivity, and specificity ranges: 53%-68%, 12%-95%, and 26%-92%, respectively). Relative to patients who were claims-adherent, patients who were device-adherent had consistently higher usage across all metrics (mean, 339.9 vs 260.0-290.0 days of use; 6.6 vs 5.1-5.6 d/wk; 6.4 vs 4.6-5.2 h/d). Consistent PAP users were frequently identified by claims-based algorithms as nonadherent, whereas many inconsistent users were classified by claims-based algorithms as adherent.

INTERPRETATION:

In aggregate US commercial data with nonstandardized PAP coverage rules, concordance between existing claims-based definitions and objective PAP use was low. Caution is warranted when applying existing claims-based algorithms to commercial populations.

News (Medical) associated with PAP Vaccine(Madison Vaccines, Inc.)

01 Feb 2024

·www.biospace.com

Hologic Announces First and Only FDA-Cleared Digital Cytology System – Genius™ Digital Diagnostics System

Through a Combination of Advanced Imaging and Novel Artificial Intelligence, Latest Diagnostic System for Cervical Cancer Screening Can Help More Accurately Detect Disease, Improve Workflow and Enhance Patient Care MARLBOROUGH, Mass.--(BUSINESS WIRE)-- Hologic, Inc., (Nasdaq: HOLX) announced today that its new Genius™ Digital Diagnostics System with the Genius™ Cervical AI algorithm has received clearance from the U.S. Food and Drug Administration (FDA), making it the first and only FDA-cleared digital cytology system that combines deep-learning-based artificial intelligence (AI) with advanced volumetric imaging technology to help identify pre-cancerous lesions and cervical cancer cells. This press release features multimedia. View the full release here: Genius™ Digital Diagnostics System Station (Graphic: Business Wire) “Hologic is a leading innovator in women’s health with a commitment to advancing cervical and breast cancer screening technologies, from the first liquid-based cytology test to the first 3D mammography system and now the first FDA-cleared digital cytology platform,” said Jennifer Schneiders, Ph.D., President, Diagnostic Solutions at Hologic. “Our technologies have had a tremendous impact on decreasing cancer rates in women, and we are incredibly excited by the promise of Genius Digital Diagnostics. The system delivers more actionable and accurate insights for laboratories and healthcare professionals to enhance patient care.” In its most recent update, the American Cancer Society estimated that 13,820 cases of invasive cervical cancer will be diagnosed in the United States in 2024, and approximately 4,360 women will die from the disease. Detecting and identifying cervical cancer in the earliest stages is critical to effective prevention and treatment. Screenings for cervical cancer include a Pap test, where a sample is generally collected at an OB-GYN office, and the cervical cells are sent to a lab where they are transferred to a glass slide. To date, this glass slide has been reviewed under a microscope. With the Genius Digital Diagnostics System, the glass slides are digitally imaged and an artificial intelligence algorithm is applied to pinpoint the cells that cytologists and pathologists should review. The new process and technology demonstrated an overall improvement in sensitivity without a corresponding decrease in specificity. Notably, there was a 28% reduction in false negatives of high-grade squamous intraepithelial and more severe lesions compared to microscopic review.1 The Genius Digital Diagnostics System will help laboratories arm healthcare professionals with the information they need to guide more timely and effective treatment decisions for patients. The Genius Digital Diagnostics System also offers the opportunity for greater collaboration across lab and other healthcare settings. The system allows cytologists and pathologists to securely review cases remotely, so patients can benefit from the collective knowledge of geographically dispersed experts. The Genius Digital Diagnostics System consists of the Genius™ Digital Imager for image acquisition, the Genius™ Cervical AI algorithm for image analysis, the Genius™ Image Management Server for image storage and the Genius™ Review Station for local or remote case review. The complete system is scalable and designed to fit the present and future needs of laboratories. The Genius Digital Diagnostics System is already commercially available in Europe, Australia and New Zealand. Commercial availability in the U.S. is expected in early 2024. About Cervical Cancer Screening Cervical cancer is preventable and, if caught early, can be highly treatable. Co-testing — combining a Pap test with an HPV test — has been shown to be the most sensitive testing option for cervical cancer screening compared to either test used alone.2,3,4,5 Hologic pioneered the first FDA-approved liquid-based cytology test, the ThinPrep® Pap test, and the first FDA-approved mRNA-based HPV test, the Aptima® HPV Assay. Healthcare professionals have the choice to perform a co-test with ThinPrep and Aptima. About Hologic, Inc. Hologic, Inc. is a global medical technology innovator focused on improving the health and well-being of women, their families and communities through early detection and treatment. Its advancements include invention of the world’s first commercial 3D mammography system to find breast cancer earlier; leadership in testing for cervical cancer, sexually transmitted infections and respiratory illnesses; minimally invasive surgical technologies for uterine fibroids and abnormal uterine bleeding; and advanced vessel sealing and dissection devices. The company also champions women through the Hologic Global Women’s Health Index, which provides a science-backed data framework for improving women’s well-being. Forward-Looking Statements This press release may contain forward-looking information that involves risks and uncertainties, including statements about the use of Hologic products. There can be no assurance these products will achieve the benefits described herein or that such benefits will be replicated in any particular manner with respect to an individual patient, as the actual effect of the use of the products can only be determined on a case-by-case basis. In addition, there can be no assurance that these products will be commercially successful or achieve any expected level of sales. Hologic expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any such statements presented herein to reflect any change in expectations or any change in events, conditions or circumstances on which any such statements are based. Hologic, The Science of Sure, Aptima, Genius and ThinPrep and associated logos are trademarks and/or registered trademarks of Hologic, Inc. and/or its subsidiaries in the United States and/or other countries. Source: Hologic, Inc. ____________________ 1 Genius Digital Diagnostics System with the Genius Cervical AI Algorithm Instructions for Use AW-23890-001. Hologic, Inc.; 2024 2 Austin RM, et al. Enhanced detection of cervical cancer and precancer through use of imaged liquid-based cytology in routine cytology and HPV co-testing. Am J Clin Pathol.2018;150(5):385-392. doi: 10.1093/ajcp/aqy114 (Study included the ThinPrep® Pap test, ThinPrep imaging, digene HPV, Cervista HPV and Aptima HPV). 3 Blatt AJ, et al. Comparison of cervical cancer screening results among 256,648 women in multiple clinical practices. Cancer Cytopathol. 2015;123(5):282-288. doi:10.1002/ cncy.21544 (Study included ThinPrep, SurePath and Hybrid Capture 2 assay). 4 Kaufman H, et al. Contributions of Liquid-Based (Papanicolaou) Cytology and Human Papillomavirus Testing in Cotesting for Detection of Cervical Cancer and Precancer in the United States. Am J Clin Pathol. 2020:XX:0-0 DOI: 10.1093/AJCP/AQAA074 (Study included ThinPrep Pap test, ThinPrep imaging, SurePath Pap test, SurePath imaging, Aptima HPV assay and Hybrid Capture 2 HPV assay). 5 Zhou H, et al. Clinical performance of the Food and Drug Administration-Approved high-risk HPV test for the detection of high-grade cervicovaginal lesions. Cancer Cytopathol. 2016 May;124(5):317-23. doi: 10.1002/cncy.21687. (Study included Cobas HPV, SurePath and ThinPrep).

Diagnostic Reagents

13 Dec 2023

·www.prnewswire.com

Metastatic Prostate Cancer Market to Exhibit Positive Growth at a CAGR of 22% and 7.5% for mHSPC and mCRPC, respectively During the Study Period (2019-2032), Assesses DelveInsight

The dynamics of the metastatic prostate cancer market are anticipated to change in the coming years owing to the rise in the number of companies taking interest in the development of specific drugs for mCRPC and nmCRPC along with increasing awareness and penetration of already approved prostate cancer drugs. LAS VEGAS, Dec. 13, 2023 /PRNewswire/ -- DelveInsight's Metastatic Prostate Cancer Market Insights report includes a comprehensive understanding of current treatment practices, metastatic prostate cancer emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan]. Key Takeaways from the Metastatic Prostate Cancer Market Report As per DelveInsight analysis, the total market size in the 7MM for metastatic castration-resistant prostate cancer (mCRPC) was estimated to be nearly USD 6.4 billion in 2022, which is expected to show positive growth by 2032. In 2022, the United States held the highest market share for mCRPC and mCSPC in the 7MM, at 63% and 61%, respectively, followed by the EU4 countries and the UK. As per DelveInsight estimates, the total prevalent population of prostate cancer in the 7MM was nearly 8 million cases in 2022. These cases will increase during the study period, i.e., 2019–2032. Leading metastatic prostate cancer companies such as 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, and others are developing novel metastatic prostate cancer drugs that can be available in the metastatic prostate cancer market in the coming years. The promising metastatic prostate cancer therapies in the pipeline include HC-1119, Talazoparib, Enzalutamide, Niraparib, Boosted Oral Docetaxel, Masitinib, EPI-7386, Verzenio, 177Lu-PSMA-617, Capivasertib, I-131-1095, Proxalutamide (GT0918), MGC018, DS-7300, MVI-816, ARV-110, 177Lu-PNT2002 (PNT2002), Vudalimab (XmAb20717), 177Lu-DOTA-rosopatamab (TLX591), and others. Established therapies in the metastatic prostate cancer market include Astella/Pfizer's and Jansenn's blockbuster products XTANDI and ZYTIGA, respectively, approved for metastatic patients for over a decade now. Even though ZYTIGA's generics have entered the US market since 2019, and the EU since late 2022, leading to a drastic decline in the revenue mainly in the US, the product is extensively being evaluated in combination with novel emerging therapies, leading to an increase in patient share on the compound abiraterone acetate. Whereas, Jansenn's XTANDI, the biggest revenue generator in the prostate cancer market, has witnessed stable growth since 2021 owing to increased competition. Quantitatively mCRPC pipeline seems to be quite strong, however with recent failures/terminations of several trials of certain therapies in the past year, we have mentioned the most promising ones, which include ESSA Pharma's EPI-7386, Macrogenics, and Daiichi's anti-B7-H3 Antibody Drug Conjugates, MGC-018 and DS-7300 respectively, Arvinas, AR-targeted PROTAC protein degrader, and Point Biopharma's Radioligand therapy. Except for Point Biopharma's therapy, none of these potential players have initiated a Phase III trial, even though Arvinas is planning to opt for an accelerated approval based on its Phase II data readout. The landscape of mHSPC has evolved tremendously in the past decades. The treatment paradigm has shifted from androgen deprivation therapy (ADT) alone to doublet combinations comprising ADT with docetaxel or an androgen receptor inhibitor, and now triplet therapy involving all three classes of agents. Apart from XTANDI, ZYTIGA, and ERLEADA in the mCSPC market, Bayer's NUBEQA is another rising contender with a strong uptake in a short period. Bayer is further strategizing to increase the prescription by volume for NUBEQA by label expansion in patients who are not eligible for chemotherapy in the ARANOTE Phase III trial. PARP inhibitors such as AKEEGA and TALZENNA are also currently being evaluated in the mHSPC space alone and with ARIs. Novartis' radioligand therapy, PLUVICTO approved in 2022, has generated an unexpected revenue from the third-line mCRPC setting, further plans to expand in an earlier line in mCRPC by 2024 in the United States. The approval of PLUVICTO has also marked a crucial advancement in treating progressive mCRPC, offering improved survival rates for those with limited treatment options. The drug had an exceptionally robust initial market performance, garnering a stronger-than-expected uptake in the US. The drug is currently being studied in the Phase III PSMAddition study to see if that triplet combination is better than ADT and an androgen receptor signaling inhibitor alone in patients with mHSPC. Discover which therapies are expected to grab the major metastatic prostate cancer market share @ Metastatic Prostate Cancer Market Report Metastatic Prostate Cancer Overview Prostate cancer, a form of malignancy specific to the prostate gland within the male reproductive system, can advance to a metastatic stage, spreading from the prostate to other areas of the body. This advanced stage is often referred to as metastatic or advanced prostate cancer, commonly extending to lymph nodes or bones. Prostate cancer symptoms can differ widely among individuals. Although some men might not experience any symptoms, typical signs may include the presence of blood in the urine or semen, painful ejaculation, discomfort or a burning sensation during urination, and various other related symptoms. The primary diagnostic method involves prostate-specific antigen (PSA) testing, which detects elevated PSA levels in individuals affected by prostate cancer or other prostate-related conditions. Screening processes may also include a digital rectal exam to identify any notable prostate tumors, alongside additional methods such as prostate ultrasound and MRI scans. However, a conclusive diagnosis typically necessitates a transrectal ultrasound-guided (TRUS) prostate tissue biopsy. Metastatic Prostate Cancer Epidemiology Segmentation As per DelveInsight analysis, the United States had the highest number of diagnosed prostate cancer cases in 2022, with approximately 2.9 million reported cases. In 2022, total cases of metastatic CSPC/HSPC and metastatic CRPC were around 100K and 120K, respectively, in the 7MM. These cases are expected to increase by 2032. The metastatic prostate cancer market report proffers epidemiological analysis for the study period 2019–2032 in the 7MM segmented into: Total Prevalent Cases of Prostate Cancer Total Diagnosed Cases of Prostate Cancer Age-Specific Cases of Prostate Cancer Total Diagnosed Cases of Prostate Cancer by Clinical Stages Total Metastatic Cases of Prostate Cancer Total Treated Cases of mCRPC Total Treated Cases of mCSPC Metastatic Prostate Cancer Treatment Market Metastatic Castration-Resistant Prostate Cancer (mCRPC) is a stage of prostate cancer that has spread to other parts of the body, such as lymph nodes or bones, and no longer responds to treatment that lowers testosterone. Despite currently approved therapeutics, mCRPC remains a terminal diagnosis with an aggressive disease course. ADT is a stalwart therapy for the initial treatment of metastatic disease. Unfortunately, most men in this situation will go on to develop mCRPC and require secondary systemic therapy. This disease state can be very challenging to treat. Docetaxel was the only agent available for the treatment of mCRPC until 2010, which showed an increase in overall survival compared with the standard of care. It was approved in 2004 for mCRPC with prednisone. Patients failed to first-line docetaxel for many years, and no standard treatment option was approved. However, in the last few years, several drugs such as JEVTANA, ZYTIGA, XTANDI, LYNPARZA, TALZENNA, AKEEGA, and others have received regulatory approval for mCRPC in the United States. Most recently, PARP inhibitors have shown tremendous development in this area with AKEEGA (Janssen), followed by TALZENNA (Pfizer/Astellas Pharma) and LYNPARZA in combination (AstraZeneca/Merck) getting approved in mCRPC in 2023. The approval of PLUVICTO has also marked a crucial advancement in treating progressive mCRPC, offering improved survival rates for those with limited treatment options. The drug had an exceptionally robust initial market performance, garnering a stronger-than-expected uptake in the US. Quantitatively, the mCRPC pipeline seems to be quite strong. ADCs such as MGC018 and DS-7300 have both displayed encouraging results in clinical trials involving patients with mCRPC. However, except for Point Biopharma's therapy, none of these potential players have initiated a Phase III trial, even though Arvinas plans to opt for an accelerated approval based on its Phase II data readout. Metastatic Castrate-Sensitive Prostate Cancer (mCSPC) is an advanced form of cancer in which cancer cells have spread from the prostate to other body areas. However, the patient is still sensitive to androgen deprivation therapy (ADT) (some mCSPC patients have never had ADT, while others may have had ADT but have recovered testicular function). The backbone of all treatments in mCSPC is androgen deprivation therapy (ADT) with medications that suppress the level of testosterone in the body because testosterone is the fuel for prostate cancer and gives the signals to grow and spread. Studies over the last decade have demonstrated that intensification of androgen deprivation with different treatment modalities correlates with prolongation of survival. The options for intensification include docetaxel chemotherapy, different androgen receptor-targeted agents, including abiraterone acetate, apalutamide, and enzalutamide, and radiation to the prostate. Most recently, the treatment paradigm for mHSPC shifted to triplet therapy, NUBEQA combined with ADT and chemotherapy. According to the findings presented at the ASCO GU 2023, the regimen should be considered the new standard of care for this patient population. To know more about metastatic prostate cancer treatment guidelines, visit @ Metastatic Prostate Cancer Management Metastatic Prostate Cancer Pipeline Therapies and Key Companies Capivasertib (AZD 5363): AstraZeneca Bavdegalutamide (ARV-110): Arvinas MVI-816 (pTVG-HP): Madison Vaccines PT-112: Phosplatin Therapeutics HC-1119: Hinova Pharmaceuticals OPDIVO (nivolumab): Bristol Myers Squibb KEYTRUDA (Pembrolizumab/MK-3475): Merck MGC018 (vobramitamab duocarmazine): MacroGenics DS-7300: Daiichi Sankyo Ceralasertib: AstraZeneca Ladiratuzumab vedotin: Seagen/Merck BMS-986218: Bristol-Myers Squibb TAS-115: Taiho Pharmaceutical ModraDoc006/r: Modra Pharmaceuticals Vudalimab: Xencor (Lu-177) - PNT2002: Point Biopharma LNTH-1095 (MIP-1095): Lantheus Holdings ZEN-3694: Zenith Epigenetics EPI-7386: Essa Pharma 177Lu-DOTA-rosopatamab: Telix Pharmaceuticals Proxalutamide: Kintor Pharmaceutical Masitinib: AB Science VERZENIO (Abemaciclib/LY2835219): Eli Lilly and Company CABOMETYX (cabozantinib): Exelixis Learn more about the FDA-approved drugs for metastatic prostate cancer @ Drugs for Metastatic Prostate Cancer Treatment Metastatic Prostate Cancer Market Dynamics The dynamics of the metastatic prostate cancer are expected to change in the coming years. Before 2010, docetaxel was the primary therapeutic option for metastatic castration-resistant prostate cancer (mCRPC), demonstrating improved overall survival compared to the established standard of care. Its approval in 2004, alongside prednisone, marked a milestone in mCRPC treatment. Following initial docetaxel therapy failure, patients faced a dearth of approved second-line treatments for numerous years. However, recent years have witnessed regulatory approvals of multiple drugs in the United States for mCRPC, transforming the treatment landscape. Notably, medications such as JEVTANA, ZYTIGA, XTANDI, LYNPARZA, TALZENNA, AKEEGA, and several others have gained approval. Of late, significant advancements have emerged in the realm of mCRPC, particularly with PARP inhibitors. AKEEGA from Janssen, TALZENNA jointly developed by Pfizer and Astellas Pharma, and the combination of LYNPARZA by AstraZeneca and Merck garnered approval in 2023, showcasing remarkable progress in this domain. PLUVICTO's approval is a significant leap forward in the management of progressive metastatic castration-resistant prostate cancer, bringing improved survival rates to patients with limited treatment alternatives. The drug witnessed an exceptional and robust initial performance in the US market, exceeding expectations. In numerical terms, the pipeline for metastatic castration-resistant prostate cancer appears robust. Antibody-drug conjugates like MGC018 and DS-7300 have demonstrated promising outcomes in clinical trials among mCRPC patients. Nevertheless, except for Point Biopharma's treatment, the majority of these prospective treatments have yet to commence a Phase III trial. Despite this, Arvinas intends to pursue an expedited approval pathway leveraging its Phase II data for regulatory approval. Scope of the Metastatic Prostate Cancer Market Report Therapeutic Assessment: Metastatic Prostate Cancer current marketed and emerging therapies Metastatic Prostate Cancer Market Dynamics: Key Market Forecast Assumptions of Emerging Metastatic Prostate Cancer Drugs and Market Outlook Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Metastatic Prostate Cancer Market Access and Reimbursement Discover more about metastatic prostate cancer drugs in development @ Metastatic Prostate Cancer Clinical Trials Table of Contents Related Reports Prostate Cancer Epidemiology Forecast Prostate Cancer Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, and prostate cancer epidemiology trends. Metastatic Prostate Cancer Pipeline Metastatic Prostate Cancer Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the 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-Resistant Prostate Cancer Market Metastatic Castration-Resistant Prostate Cancer Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key metastatic castration-resistant 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 Hormone-Refractory Prostate Cancer Pipeline Metastatic Hormone-Refractory Prostate Cancer Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, including clinical and non-clinical stage products, and the key metastatic hormone-refractory 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. 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] +91-9650213330 Logo: SOURCE DelveInsight Business Research, LLP

Phase 3Drug ApprovalClinical ResultPhase 2

100 Deals associated with PAP Vaccine(Madison Vaccines, Inc.)

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic castration-resistant prostate cancer	Phase 2	US	Madison Vaccines, Inc.	30 Jan 2022
Pancreatic Cancer	Phase 2	US	Madison Vaccines, Inc.	30 Jan 2022
Prostatic Cancer	Phase 2	-	University of Wisconsin-Madison	-

Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03600350 (CTgov)	Phase 2	Recurrent Prostate Carcinoma \| Non-metastatic prostate cancer	19	GM-CSF+Nivolumab+pTVG-HP	hxzdnkirmx(umwudafwux) = qyzlxprces hwjlunvnmc (kfgfuwlpoi, wizlqbweil - anqbbdjecu) View more	-	06 Dec 2023
NCT02499835 (Pubmed \| J Immunother Cancer) Manual	Phase 2	Metastatic castration-resistant prostate cancer	40	MVI 816+Pembrolizumab (arm 3)	qacyycdaof(ggmshimxkz) = coxatgvcsg yxqptihubi (nzrxejmmgy )	Positive	01 Mar 2022
				MVI 816+Pembrolizumab (arm 4)	qacyycdaof(ggmshimxkz) = lbltasgvyv yxqptihubi (nzrxejmmgy )
NCT01341652 (CTgov)	Phase 2	Non-metastatic prostate cancer	99	rhGM-CSF (GM-CSF Alone)	bhufgziock(npizqjlelp) = pumamcabde tcldytytid (kpclmzrrks, ymcgcrhkyb - rkbeelyeqx) View more	-	25 Nov 2020
				pTVG-HP (pTVG-HP Vaccine With GM-CSF)	bhufgziock(npizqjlelp) = ukcuiftoxo tcldytytid (kpclmzrrks, vjbizquvxw - jvtfiyjwja) View more
NCT01341652 (Pubmed \| J Urol) Manual	Phase 2	Castration-Resistant Prostatic Cancer	99	GM-CSF+pTVG-HP	pjfefjbvrb(muztknwsqj) = afkpywszps awguadhjdn (fxyfvbkikr ) View more	Negative	20 Dec 2019
				GM-CSF	pjfefjbvrb(muztknwsqj) = swsqdkyqgy awguadhjdn (fxyfvbkikr ) View more
NCT01706458 (P210, CTgov)	Phase 2	Castration-Resistant Prostatic Cancer	18	Sipuleucel-T (Sipuleucel-T)	gykkftznie(mltbhqkqrc) = hcezhzapfn oicqmjsadj (udcnnmcyce, bnpqmkmitt - xlquzsutwi) View more	-	17 Jul 2018
				DNA Vaccine+Sipuleucel-T (Sipuleucel-T With DNA Vaccine)	gykkftznie(mltbhqkqrc) = frqwkzplaw oicqmjsadj (udcnnmcyce, lksknvbimj - oiehclafvs) View more
NCT01706458 (Pubmed \| J Immunother Cancer) Manual	Phase 2	Metastatic castration-resistant prostate cancer	18	Sipuleucel-T+pTVG-HP	qmqcejcyhy(yfawtlhkus) = Th1-biased PAP-specific T-cell responses were detected in 11/18 individuals vgccapdhwz (egggecowib )	Positive	13 Mar 2018
NCT00849121 (CTgov)	Phase 2	Castration-Resistant Prostatic Cancer	17	rhGM-CSF+pTVG-HP (1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12)	fnvajumixh(jheiwfqvmm) = ctjgzaoerz sfvtmochil (yzyjzrhrde, jyolutsuov - ojsrxlyubj) View more	-	11 Sep 2014
				rhGM-CSF+pTVG-HP (2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12)	fnvajumixh(jheiwfqvmm) = nbljeofsik sfvtmochil (yzyjzrhrde, ixtarrdebr - utravjyzvr) View more

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