This is an open-label, single-arm phase II study of bipolar androgen therapy (BAT) given in addition with standard of care Sipuleucel-T to determine the interferon (IFN) gamma Enzyme-linked Immunospot (ELISPOT) response rate to PA2024 (an engineered fusion protein of prostatic acid phosphatase and granulocyte-macrophage colony-stimulating factor which the activated autologous dendritic cells in the Sipuleucel-T vaccine are loaded with) in patients with metastatic castration resistant prostate cancer (mCRPC).

Start Date20 Dec 2023

Sponsor / Collaborator

Yale University

[+1]

NCT06134232 / Not yet recruitingPhase 3

An Open -Label, Multicenter Study of Subjects With Metastatic Castrate-Resistant Prostate Cancer Treated With PROVENGE ® and Boosted With A Single Infusion of Sipuleucel-T to Measure Immune Response

A multicenter, open-label, prospective study to investigate immune boost response changes in patients with metastatic castrate-resistant prostate cancer (mCRPC).

Start Date27 Nov 2023

Sponsor / Collaborator

Dendreon Corp.

NCT05806814 / RecruitingPhase 1IIT

Pilot Trial to Investigate Immune Response to an Extended Course of Sipuleucel-T Immunotherapy in Patients With Metastatic Castration-resistant Prostate Cancer (OU-SCC-EXCITE)

Proposed immunotherapy with an extended course of Sipuleucel-T treatment may induce a more robust immune response and improve the anti-cancer efficacy of Sipuleucel-T in patients with metastatic Castration-Resistant Prostate Cancer (mCRPC).

Start Date12 Nov 2023

Sponsor / Collaborator

University of Oklahoma

[+1]

100 Clinical Results associated with Sipuleucel-T (Dendreon Corporation)

100 Translational Medicine associated with Sipuleucel-T (Dendreon Corporation)

100 Patents (Medical) associated with Sipuleucel-T (Dendreon Corporation)

665

Literatures (Medical) associated with Sipuleucel-T (Dendreon Corporation)

01 Nov 2024·Urology Case Reports

Utility of pembrolizumab for metastatic castrate resistant prostate cancer with MMR deficiency

Article

Author: Skomra, Andrew ; Dovirak, Iryna ; Rutkowski, John ; Dinerman, Brian F. ; Dinerman, Brian F

Molecular tumor profiling has become an important diagnostic for prostate cancer, allowing for personalized treatment regimens based on somatic and germline genetic information. We report a 67-year-old patient with metastatic castrate-resistant prostate cancer which was intermittently responsive to androgen-deprivation therapy, docetaxel, abiraterone, radium-223, Sipuleucel-T, and radiotherapy who ultimately demonstrated a remarkable and durable response to pembrolizumab. Our case report underlines the significance of early tumor molecular profiling in aggressive or atypical prostate cancer patients and exhibits the potential for a remarkable clinical response with immunotherapy in candidates with the appropriate tumor profiles.

01 Oct 2024·JOURNAL OF ONCOLOGY PHARMACY PRACTICE

Review of drug-drug interactions in patients with prostate cancer

Review

Author: Ruplin, Andrew ; Segal, Eve ; McFarlane, Tom

Objective:

The objective of this review is to provide an overview of common drug-drug interactions (DDIs) associated with prostate cancer treatments and outline recommendations for managing polypharmacy.

Data sources:

A literature search of PubMed, Embase, and CINAHL was carried out to identify pharmacokinetic and pharmacodynamic changes caused by DDIs that are relevant for prostate cancer patients, DDIs between prostate cancer therapies and co-administered medications (both prescription and over-the-counter), and measures to prevent DDIs. Medication package inserts were used to identify the impact of DDI on the prostate cancer therapy and suggested interventions.

Data summary:

No DDIs are expected for the LHRH agonists leuprolide acetate, histrelin, goserelin, or leuprolide mesylate. However, DDIs have been reported for GnRH antagonists, anti-androgens, PARP inhibitors, and taxanes. Although there are no confirmed DDIs for sipuleucel-T to date, it is not generally recommended to use sipuleucel-T concurrently with immunosuppressive medications. Interventions to prevent DDIs include the use of software that can detect clinically significant DDIs, up-to-date medication reconciliation, the inclusion of dedicated clinical pharmacists in cancer treatment teams, and patient/caregiver education.

Conclusions:

Prostate cancer patients have a high risk of potential DDIs due to numerous new anti-cancer therapies, the increased use of treatment combinations, and the likelihood of comorbid conditions also requiring drug therapy. Drug-drug interaction screening software, up-to-date medication reconciliation, inclusion of oncology pharmacists on healthcare teams, and patient/caregiver education will aid the development of treatment plans that focus on achieving an optimal risk-benefit profile whilst reducing the risk of DDIs.

01 Jul 2024·Cancer research communications

Race-Related Differences in Sipuleucel-T Response among Men with Metastatic Castrate–Resistant Prostate Cancer

Article

Author: Smith, Melanie P. ; Schienschang, Amy ; Lum, Lawrence G. ; Heilbrun, Lance ; Boerner, Julie L. ; Heath, Elisabeth I. ; Smith, Daryn ; Thakur, Archana ; Schalk, Dana L. ; Hwang, Clara ; Chen, Wei ; Paller, Channing J. ; Polend, Amanda ; Cackowski, Frank C. ; Dickow, Brenda ; Vaishampayan, Ulka N. ; Whitaker, Sarah A.

Abstract:

Sipuleucel-T is an autologous cellular immunotherapy that targets prostatic acid phosphatase (PAP) and is available for treatment of men with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC). In this single-arm, two-cohort, multicenter clinical study, potential racial differences in immune responses to sipuleucel-T in men with mCRPC were explored. Patients’ blood samples were obtained to assess serum cytokines, humoral responses, and cellular immunity markers before and after treatment. Baseline cumulative product parameters (total nucleated and CD54+ cell counts and CD54 upregulation) were evaluated. IgM titers against the immunogen PA2024, the target antigen PAP, prostate-specific membrane antigen (PSMA) and prostate-specific antigen (PSA) were quantified by ELISA. Cytotoxic T-lymphocyte activity was determined by ELISpots, and cytokine and chemokine concentrations were determined by Luminex.Twenty-nine African American (AA) men and 28 non-African American (non-AA) men with mCRPC received sipuleucel-T. Baseline total nucleated cell count, CD54+ cell count, CD54 expression, and cumulative product parameters were higher in non-AA men. Although PSA baseline levels were higher in AA men, there were no racial differences in IgM antibody and IFNγ ELISpots responses against PA2024, PAP, PSA, and PSMA before and after treatment. Expression of co-stimulatory receptor ICOS on CD4+ and CD8+ T cells, and the levels of Th1 cytokine granulocyte-macrophage colony-stimulating factor and chemokines CCL4 and CCL5, were significantly higher in AA men before and/or after treatment. Despite no difference in the overall survival, PSA changes from baseline were significantly different between the two races. The data suggest that immune correlates in blood differ in AA and non-AA men with mCRPC pre- and post-sipuleucel-T.

Significance::

Our novel findings of higher expression of co-stimulatory receptor ICOS on CD4+ and CD8+ T cells in African American patients with metastatic castrate-resistant prostate cancer (mCRPC) prior and post-sipuleucel-T suggest activation of CD4+ and CD8+ T cells. The data indicate that racial differences observed in these and other immune correlates before and after sipuleucel-T warrant additional investigation to further our understanding of the immune system in African American men and other men with mCRPC.

News (Medical) associated with Sipuleucel-T (Dendreon Corporation)

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

10 May 2024

·www.pharmaceutical-technology.com

WestGene wins FDA approval for mRNA vaccine to treat certain cancers

Chinese biotech WestGene announced an FDA approval for its mRNA therapeutic cancer vaccine. Credit: aslysun via Shutterstock. The US Food and Drug Administration (FDA) has approved an mRNA therapeutic cancer vaccine developed by China-based biotech WestGene. This decision makes the vaccine the world’s first approved mRNA therapeutic vaccine to treat Epstein Barr (EB)-virus-related cancers. The approval was based on results from investigator-initiated trials that evaluated the vaccine in patients with nasopharyngeal carcinoma (NPC) and natural killer T cell lymphoma. EB virus is a part of the herpesvirus family and spreads primarily through bodily fluids. The illness infects more than 90% of the global adult population but does not always lead to cancer, as detailed by Cancer Research UK. The virus has been linked with NPC, gastric cancer, lung cancer and other diseases. In a 10 May press release, WestGene highlighted liver cancer, oesophageal cancer, breast cancer and the aforementioned diseases as potential future indications for the vaccine. The Chinese company has a pipeline that includes four infectious disease vaccines, seven anti-tumour immunotherapies, and three gene editing treatments amongst other therapies. See Also: Formosa and Tabuk sign deal for FDA-approved ophthalmic suspension Four ways the vaccine rush will define infectious disease trends for CROs in 2024 In 2010, the FDA approved Dendreon Pharmaceutical’s prostate cancer prophylactic Provenge (sipuleucel-T) as the first marketed therapeutic cancer vaccine. Since its approval, other therapeutic cancer vaccines have entered the US market, with eight being available in the US, according to GlobalData. GlobalData is the parent company of Pharmaceutical Technology. In 2021, Pfizer and BioNTech gained the first-ever FDA approval for an mRNA vaccine with Comirnaty (BNT162b2) as a preventative measure against Covid-19. Since this milestone, several preventive and therapeutic mRNA vaccines have been in development for a wide range of conditions. Some pharmaceutical companies are using the mRNA approach to develop vaccines for other infectious diseases such as respiratory syncytial virus (RSV), Influenza A, Influenza B and cytomegalovirus while companies, including Moderna , Curevac , and Cartesian Therapeutics, are developing therapeutic mRNA vaccines for treating different cancers.

VaccineDrug ApprovalImmunotherapymRNA

18 Apr 2024

·firstwordpharma.com

Biotech secures $54M to ‘Corner’ the market on dendritic cell-amplifying vaccines

On the heels of early, but promising, cancer vaccine data released at this year’s American Association for Cancer Research (AACR) annual meeting, Corner Therapeutics on Thursday detailed how its two technology platforms can supercharge the modality. The biotech also announced a $54-million series A that will help put its first vaccine to the clinical test next year. In addition to the financing, which was led by Ziff Capital Partners and saw participation from Cockrell Interests, Tanis Ventures, and Sandia Holdings, Corner also has grant funding from the Bill & Melinda Gates Foundation to apply its technology to infectious diseases, including HIV, influenza and COVID-19.The company’s tech is designed to elicit a strong, long-lasting immune response by activating dendritic cells – the so-called “apex regulators” of the immune system because they are the only cell type that can stimulate new T cell responses. While the idea of dendritic cell-associated cancer vaccines is not new, Corner has come a long way from the earliest iteration at Dendreon Therapeutics and the long and messy history of its Provenge (sipuleucel-T). The FDA approved the immunotherapy in 2010 to treat prostate cancer, but at the time it was seen as an expensive and difficult-to-use treatment – with questionable efficacy – and failed to be a commercial success, leading to a bankruptcy declaration from Dendreon in 2014. The company has since managed to turn its business around and began earning a profit in 2018. For more, see ViewPoints: Now officially walking, Dendreon sets its sights on running. Powering up dendritic cellsThere are two major differences between Dendreon and Corner’s vaccine work, CEO Steven Altschuler told FirstWord. He previously was CEO of the Children’s Hospital of Philadelphia from 2000 to 2015 and also co-founded Spark Therapeutics, serving as chair until Roche acquired the gene therapy company for $4.3 billion in 2019.First, the biotech’s products will be in vivo, while Provenge is an ex vivo therapy that sources dendritic cells from a patient and exposes them to antigens before readministration. And second, Corner’s first platform is intended to promote a heightened state in dendritic cells – not just activated, but “hyper”activated. Dendritic hyperactivation was first discovered more than eight years ago by scientific co-founder Jonathan Kagan, a professor of paediatrics at Harvard Medical School. He found that when dendritic cells are in this state – triggered when the body sends both “infection” and “tissue damage” signals – stronger CD8+ T cell responses are generated, thanks to a pair of cellular processes that don’t occur during normal activation.Within dendritic cells, inflammasomes form and secrete IL-1β, a cytokine known to generate new, and reactivate existing, memory T cells. Additionally, a mass migration of dendritic cells to the lymph nodes – the primary T cell meet-up zone – is triggered. “These extra stimuli that we can apply makes a world of difference in terms of generating cellular immunity,” Altschuler said.A protein antigen-based vaccine developed with Corner’s hyperactivation platform will comprise three components: a proprietary oxidised lipid to send the “damage” signal, a TLR7/8 agonist to activate the “infection” signal, and the disease antigens. According to Altschuler, the modality is antigen-agnostic and can use neoantigens sourced from a cancer patient to create a personalised treatment, or incorporate a viral antigen for an off-the-shelf infectious disease vaccine. A STINGing immune boostIn tandem, Corner is developing a catalytic adjuvant technology intended to boost the power of mRNA-based vaccines by activating a well-known immune pathway: STING.While STING agonists have struggled to show efficacy in clinical cancer trials, Altschuler said Corner’s tactic causes continuous pathway activation.The company has developed an mRNA-encoded enzyme that reacts with naturally occurring cellular DNA to catalyse the formation of cGAMP, which is a precursor of the STING pathway.“What we have found is that this mechanism induces very profound antigen-specific T cell responses,” Altschuler said, adding that the platform is “very flexible and in effect, antigen-agnostic.”As an example of the platform’s potential power, Altschuler pointed to mRNA-based cancer vaccines already in development, such as Moderna’s mRNA-4157 (V940). At AACR, the biotech shared new data showing that the individualised neoantigen therapy, in combination with partner Merck & Co.’s anti-PD-1 antibody Keytruda (pembrolizumab), led to a response rate of 27.3% in 22 patients with unresectable, metastatic HPV-negative head and neck squamous cell cancer (HNSCC).If Corner’s catalytic adjuvant technology was incorporated into an mRNA-based vaccine, “we would expect our platform to enhance the efficacy of those vaccines because of this much better T cell response,” Altschuler said, which could in turn confer longer immunity.

VaccineAcquisitionImmunotherapyAACRDrug Approval

100 Deals associated with Sipuleucel-T (Dendreon Corporation)

External Link

KEGG	Wiki	ATC	Drug Bank
-	Sipuleucel-T (Dendreon Corporation)	L03AX17	DB06688

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Prostatic Cancer	US	Bausch Health Americas, Inc.	02 May 2010
Metastatic castration-resistant prostate cancer	US	Dendreon Pharmaceuticals, Inc.	29 Apr 2010

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Adenocarcinoma of prostate	Phase 3	US	Dendreon Corp.	18 Oct 2018
Castration-Resistant Prostatic Cancer	Phase 3	US	Dendreon Corp.	01 Jul 2003
Castration-Resistant Prostatic Cancer	Phase 3	CA	Dendreon Corp.	01 Jul 2003
Metastatic Prostate Carcinoma	Phase 3	US	Dendreon Corp.	01 Jul 2003
Metastatic Prostate Carcinoma	Phase 3	CA	Dendreon Corp.	01 Jul 2003
Non-metastatic prostate cancer	Phase 3	US	Dendreon Corp.	01 Oct 2001
Localized Prostate Carcinoma	Phase 2	US	Dendreon Corp.	01 Jul 2008
Advanced Prostate Carcinoma	Phase 1	US	Dendreon Corp.	12 Nov 2023

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


STAMP and STRIDE Trials (Pubmed)	Not Applicable	Metastatic castration-resistant prostate cancer	-	Sipuleucel-T + Abiraterone Acetate	amoibpicyb(issbwhyfcf) = significantly elevated vs baseline mygqhoihys (vcklilwemj )	-	14 Apr 2023
				Sipuleucel-T + Enzalutamide
SITC2022	Not Applicable	Metastatic castration-resistant prostate cancer	10	Sipuleucel-T	lsinabjrhk(pxlnlmkvuo) = pgyryveqrl fqaqlcthaw (hluphfocyh, 1 - 82) View more	Positive	07 Nov 2022
AACR2022	Not Applicable	Metastatic castration-resistant prostate cancer	14	Sipuleucel T	nuyapzqugp(tinknezhcp) = ogyocphzcn iuxgwfxsko (dmvbzzdpit ) View more	-	15 Jun 2022
NCT01818986 (CTgov)	Phase 2	Metastatic castration-resistant prostate cancer	20	Stereotactic Ablative Body Radiation+Sipuleucel-T	evohjyjdmq(thqknnchpi) = xsygtomuvc mqahwsvcwt (eevoawvbgz, scfojyswem - tinddtjxjh) View more	-	06 May 2022
NCT01306890 (PROCEED, Pubmed \| Prostate Cancer Prostatic Dis)	Not Applicable	Metastatic castration-resistant prostate cancer	1,902	Sipuleucel-T	rsvhzajfzn(pwcyjzaqjn) = wnabnxnsrw qrapfvfdup (sjswuyyemj ) View more	Positive	10 Feb 2022
NCT03024216 (Pubmed \| J Immunother Cancer) Manual	Phase 1	Castration-Resistant Prostatic Cancer	37	atezolizumab+sipuleucel-T (Arm 2)	jlbzrkxspw(pozxvxtbxa) = uckmbzyxfz iuejvseprj (lrhmxavewj ) View more	Positive	01 Aug 2021
				atezolizumab+sipuleucel-T	sxchmmbvvg(fhdioabgsy) = oualmmzbio zidghrrphw (kcgfjhzwxk ) View more
NCT01807065 (CTgov)	Phase 2	Recurrent Prostate Carcinoma \| Metastatic castration-resistant prostate cancer \| Bone metastases ... View more	51	laboratory biomarker analysis+sipuleucel-T (Arm A (Sipuleucel-T))	yeblnrrarz(hnaopwuldi) = kwjjcovnii bpjyujieyi (llknxkipsj, scvhlujlbi - trigpxbgjm) View more	-	25 Aug 2020
				laboratory biomarker analysis+sipuleucel-T (Arm B (Radiation Therapy, Sipuleucel-T))	yeblnrrarz(hnaopwuldi) = qsozgnqfzj bpjyujieyi (llknxkipsj, keqrivegaz - ulzllgonoc) View more
NCT02463799 (ASCO2020)	Phase 2	Metastatic castration-resistant prostate cancer	32	Sipuleucel-T	bpvctrlxem(enjtqwkrwx) = mrpnqljixq gsuwcihlzn (zfphdxhshk ) View more	Positive	25 May 2020
				Sipuleucel-T + Radium-223	bpvctrlxem(enjtqwkrwx) = kkntgghwms gsuwcihlzn (zfphdxhshk ) View more
ASCO2020	Not Applicable	Castration-Resistant Prostatic Cancer	-	sipuleucel-T (White patients)	cinbcectmq(kcpacyaren): HR = 0.69 (95% CI, 0.4 - 1.4), P-Value = 0.277	-	25 May 2020
				sipuleucel-T (Asian patients)
NCT01306890 (PROCEED, Pubmed \| Prostate Cancer Prostatic Dis)	Not Applicable	Prostatic Cancer \| Advanced Prostate Carcinoma	1,900	sipuleucel-T (African American men)	qktipohtaa(yxhahlcymr) = mpxlllwnko lzzsmxctcs (xfccpcauch )	-	28 Feb 2020
				sipuleucel-T (Caucasian men)	qktipohtaa(yxhahlcymr) = nkggoklwez lzzsmxctcs (xfccpcauch )

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