4CAST: A Phase 1b Dose Exploration and Dose Expansion, Open-label, Single-centre Study Evaluating the Safety and Efficacy of INO-464 in Combination With Chemotherapy in Patients With metASTatic Breast Cancer

To facilitate the clinical testing of seviteronel and dexamethasone (SEVI-D) in combination with docetaxel in androgen receptor (AR) positive triple-negative breast cancer.

Start Date01 Nov 2022

Sponsor / Collaborator

St. Vincent's Hospital Sydney Pty Ltd.

ACTRN12618001074280

/ RecruitingPhase 2IIT

A Single arm, open label, signal seeking, Phase II a trial of the activity of seviteronel in patients with androgen receptor (AR) positive solid tumours.

Start Date13 Aug 2018

Sponsor / Collaborator-

NCT03600467

/ TerminatedPhase 2IIT

A Single-arm, Open-label, Signal-seeking, Phase IIa Trial of the Activity of Seviteronel in Patients With Androgen Receptor (AR)-Positive GBM

This study's purpose is to facilitate and expedite the clinical testing of SEVI-D in a population with advanced GBM that are androgen receptor (AR) positive.
Who is it for? You may be eligible for this study if you have a GBM with clinical/radiological progression on or following last anticancer therapy.
Study details:
All participants will be screened to confirm if their GBM is AR positive by the study team. If eligible, participants will receive the medications of Serivteronel and Dexamethasone (also known as SEVI-D) by oral tablets continuously per cycle (4 weeks). Participants will be asked to have blood tests, scans, complete questionnaire and regularly meet with the study doctor and team.
It is hoped this research will demonstrate this treatment could be beneficial for the treatment of GBM that are known to be human androgen receptor positive.

Start Date13 Aug 2018

Sponsor / Collaborator

St. Vincent's Hospital Sydney Pty Ltd.

100 Clinical Results associated with Seviteronel

100 Translational Medicine associated with Seviteronel

100 Patents (Medical) associated with Seviteronel

Literatures (Medical) associated with Seviteronel

01 Nov 2023·Critical reviews in oncology/hematology

Targeting androgen receptor in glioblastoma

Review

Author: Wang, Xueni ; Gan, Xia ; Liu, Yonghong

Glioblastomas are primary brain tumors that originate from glial stem cells or progenitor cells. There is a large difference in the incidence of glioblastoma between males and females. Studies revealed that the gender differences in the tumor may be attributable to the androgen receptor signaling axis. The incidence rate of glioblastoma in men is higher than that in women. Aberrant activation of the androgen receptor signaling pathway, or interactions between the androgen receptor signaling axis and other signaling axes promote the development of glioblastoma. Therefore, targeting the androgen receptor holds promise as a therapeutic approach for glioblastoma. This review investigates the dynamics of drug research into the treatment of glioblastoma by targeting the androgen receptor. The first finding in line with expectations is that androgen receptor antagonists, represented by enzalutamide, have been studied and shown to have anti-glioblastoma effects. In addition, it was found that the combination of 5-alpha reductase inhibitors and androgen receptor antagonists resulted in better therapeutic outcomes than each of them alone. Similar results were obtained with the combination of an epidermal growth factor receptor inhibitor and an androgen receptor antagonist. In addition, four small molecule compounds have been shown to exert significant anti-glioblastoma effects by directly or indirectly targeting the androgen receptor. Expectantly, one of these small molecules, seviteronel, progressed to the phase II clinical trial stage. These findings suggest that targeting the androgen receptor for glioblastoma may be a promising therapeutic option.

01 Sep 2022·British journal of cancer

Androgen and oestrogen receptor co-expression determines the efficacy of hormone receptor-mediated radiosensitisation in breast cancer

Article

Author: Ward, Connor ; Eisner, Joel R ; Speers, Corey W ; Zhang, Amanda ; Rae, James M ; Pesch, Andrea M ; Wilder-Romans, Kari ; Schwartz, Rachel ; Pierce, Lori J ; Michmerhuizen, Anna R ; Lerner, Lynn M

Abstract:

Purpose:

Radiation therapy (RT) and hormone receptor (HR) inhibition are used for the treatment of HR-positive breast cancers; however, little is known about the interaction of the androgen receptor (AR) and estrogen receptor (ER) in response to RT in AR-positive, ER-positive (AR+/ER+) breast cancers. Here we assessed radiosensitisation of AR+/ER+ cell lines using pharmacologic or genetic inhibition/degradation of AR and/or ER.

Methods:

Radiosensitisation was assessed with AR antagonists (enzalutamide, apalutamide, darolutamide, seviteronel, ARD-61), ER antagonists (tamoxifen, fulvestrant) or using knockout of AR.

Results:

Treatment with AR antagonists or ER antagonists in combination with RT did not result in radiosensitisation changes (radiation enhancement ratios [rER]: 0.76–1.21). Fulvestrant treatment provided significant radiosensitisation of CAMA-1 and BT-474 cells (rER: 1.06–2.0) but not ZR-75-1 cells (rER: 0.9–1.11). Combining tamoxifen with enzalutamide did not alter radiosensitivity using a 1 h or 1-week pretreatment (rER: 0.95–1.14). Radiosensitivity was unchanged in AR knockout compared to Cas9 cells (rER: 1.07 ± 0.11), and no additional radiosensitisation was achieved with tamoxifen or fulvestrant compared to Cas9 cells (rER: 0.84–1.19).

Conclusion:

While radiosensitising in AR + TNBC, AR inhibition does not modulate radiation sensitivity in AR+/ER+ breast cancer. The efficacy of ER antagonists in combination with RT may also be dependent on AR expression.

01 Aug 2021·The Journal of biological chemistryQ2 · BIOLOGY

Stepwise binding of inhibitors to human cytochrome P450 17A1 and rapid kinetics of inhibition of androgen biosynthesis

Q2 · BIOLOGY

Article

Author: McCarty, Kevin D ; Chapman, Jesse G ; Tateishi, Yasuhiro ; Guengerich, F Peter

Cytochrome P450 (P450) 17A1 catalyzes the 17α-hydroxylation of progesterone and pregnenolone as well as the subsequent lyase cleavage of both products to generate androgens. However, the selective inhibition of the lyase reactions, particularly with 17α-hydroxy pregnenolone, remains a challenge for the treatment of prostate cancer. Here, we considered the mechanisms of inhibition of drugs that have been developed to inhibit P450 17A1, including ketoconazole, seviteronel, orteronel, and abiraterone, the only approved inhibitor used for prostate cancer therapy, as well as clotrimazole, known to inhibit P450 17A1. All five compounds bound to P450 17A1 in a multistep process, as observed spectrally, over a period of 10 to 30 s. However, no lags were observed for the onset of inhibition in rapid-quench experiments with any of these five compounds. Furthermore, the addition of substrate to inhibitor-P450 17A1 complexes led to an immediate formation of product, without a lag that could be attributed to conformational changes. Although abiraterone has been previously described as showing slow-onset inhibition (t_1/2 = 30 min), we observed rapid and strong inhibition. These results are in contrast to inhibitors of P450 3A4, an enzyme with a larger active site in which complete inhibition is not observed with ketoconazole and clotrimazole until the changes are completed. Overall, our results indicate that both P450 17A1 reactions-17α-hydroxylation and lyase activity-are inhibited by the initial binding of any of these inhibitors, even though subsequent conformational changes occur.

News (Medical) associated with Seviteronel

16 Feb 2023

·www.prnewswire.com

DelveInsight Evaluates a Robust Prostate Cancer Pipeline as 170+ Influential Pharma Players to Set Foot in the Domain

Prostate cancer is the most common cancer in men and accounts for the second most cancer deaths among men globally. The rise in the number of cases of prostate cancer has led to growing government funding and rising initiatives by public and private organizations to spread awareness about prostate cancer. The emergence of strong pipeline drugs and the presence of novel prostate cancer treatments are the prominent factors that will escalate the growth rate of the prostate cancer therapeutics market. LAS VEGAS, Feb. 16, 2023 /PRNewswire/ -- DelveInsight's ' Prostate Cancer Pipeline Insight – 2023 ' report provides comprehensive global coverage of available, marketed, and pipeline prostate cancer therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the prostate cancer pipeline domain. Key Takeaways from the Prostate Cancer Pipeline Report DelveInsight's prostate cancer pipeline report depicts a robust space with 170+ active players working to develop 200+ pipeline therapies for prostate cancer treatment. Key prostate cancer companies such as Merck & Co, Pfizer, Orion, Zenith Epigenetics, ESSA Pharma, RhoVac, AstraZeneca, Advaxis, Inc., Tracon Pharmaceuticals Inc., Bristol-Myers Squibb, Laekna Limited, Bracco Diagnostics, Inc, Arvinas Inc, Epizyme, Regeneron Pharmaceuticals, Veru Inc., Eli Lilly and Company, Exelixis, Luye Pharma Group, Amgen, Innocrin Pharmaceutical, Bayer, Nymox Pharmaceutical, Matrix Biomed, Tavanta Therapeutics, Fortis Therapeutics, Inc., Janssen Research & Development, LLC, Clarity Pharmaceuticals, Leap Therapeutics, Hinova pharmaceuticals, Vaccitech, Cardiff Oncology, Suzhou Kintor Pharmaceuticals, Teneobio, Inc., Janux Therapeutics, Fusion Pharmaceuticals, Corbus Pharmaceuticals, BioXcel Therapeutics, Onxeo S.A, Ayala Pharmaceuticals, HOOKIPA Pharma, Nuvation Bio, Ambrx, enGene, Jemincare, CellVax Therapeutics, POINT Biopharma, Oncternal Therapeutics, Immunic AG, BioNTech SE, and others are evaluating new prostate cancer drugs to improve the treatment landscape. Promising prostate cancer pipeline therapies in various stages of development include Pembrolizumab, Talazoparib, ODM-208, ZEN 3694, EPI-7386, RV 001, Adavosertib, Capivasertib, ADXS31-142, TRC253, Nivolumab, LAE001, BR55, ARV-110, Tazemetostat, REGN5678, VERU-111, Abemaciclib, Cabozantinib, LY01005, Tarlatamab, VT-464, BAY2315497, NX-1207, MBM-02, TAVT-45, FOR46, JNJ-78278343, 64Cu-SAR-bisPSMA, DKN-01, HC-1119, ChAdOx1-MVA 5T4, Onvansertib, GT0918, TNB-585, JANX007, 225Ac-PSMA I&T, CRB-701, BXCL701, AsiDNA, ADXS-504, HB-300, NUV-868, ARX517, JMKX002992, Zilovertamab, IMU-935, BNT112, and others. In February 2023, Fusion Pharmaceuticals announced the acquisition from RadioMedix, Inc. of the investigational new drug application for an ongoing Phase II clinical trial (the "TATCIST" trial) evaluating 225Ac-PSMA I&T, a small molecule targeting prostate-specific membrane antigen ("PSMA") expressed on prostate cancers. Following the closing, the alpha-emitting radiopharmaceutical being evaluated in the TATCIST trial will be known as FPI-2265. In February 2023, Corbus Pharmaceuticals entered into an exclusive licensing agreement with CSPC Megalith Biopharmaceutical Co., Ltd, a subsidiary of CSPC Pharmaceutical Group Limited for development and commercialization of CRB-701 (SYS6002): a novel clinical-stage antibody drug conjugate (ADC) targeting Nectin-4. The agreement covers exclusive commercialization rights to CRB-701 in the United States, Canada, the European Union (including the European Free Trade Area), the United Kingdom, and Australia. CSPC will retain all rights to SYS6002 in the remaining global markets. Clinical development is underway and will focus on urothelial cancer and other Nectin-4-positive solid tumors, potentially including lung, breast and prostate cancer. In February 2023, BioXcel Therapeutics, Inc.reported full data from its Phase IIa trial of BXCL701, the Company's investigational, oral innate immune activator, in combination with KEYTRUDA (pembrolizumab) in small cell neuroendocrine (SCNC) variant metastatic castration-resistant prostate cancer (mCRPC) patients after at least one prior line of chemotherapy for locally advanced or metastatic prostate cancer. Results will be presented in a rapid abstract presentation and a poster presentation at the 2023 American Society of Clinical Oncology Genitourinary Cancers (ASCO GU) Symposium on February 16, 2023. In January 2023, Onxeo S.A. gave an update on the clinical development program of its first-in-class drug candidate AsiDNA. Onxeo has activated its first US clinical study site, Next Oncology San Antonio. This phase I/II multicenter, basket trial intends to assess the safety and preliminary activity of AsiDNA in combination with olaparib in patients with recurrent ovarian, breast, and metastatic castration-resistant prostate cancer (mCRPC) who have progressed on previous PARP inhibitor therapy. In October 2022, Ayala Pharmaceuticals, Inc. and Advaxis, Inc. entered into a definitive merger agreement. The merger would result in a combined company that will focus predominantly on the development and commercialization of Ayala's lead program AL102 for the treatment of desmoid tumors and Advaxis's candidate ADXS-504 in development for prostate cancer. In October 2022, Janux Therapeutics announced that the first patient had been dosed in Phase I clinical trial of JANX007 in subjects with metastatic castration-resistant prostate cancer (mCRPC). JANX007 is a prostate-specific membrane antigen (PSMA) directed T cell engager (TCE) and is the first product candidate utilizing Janux's TRACTr platform to be administered in humans. Request a sample and discover the recent advances in prostate cancer drug treatment @ Prostate Cancer Pipeline Report The prostate cancer pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage prostate cancer drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the prostate cancer clinical trial landscape. Prostate Cancer Overview Prostate cancer is a type of cancer that arises from the prostate gland. It is the second leading cause of cancer death in men in the United States. 1 in every 9 men will be diagnosed with prostate cancer during their lifetime. Prostate cancer will be diagnosed in nearly 250,000 men this year. Breaking away from a prostate tumor allows prostate cancer cells to spread. They can spread to other body parts by passing through blood vessels or lymph nodes. Cancer cells that have spread may attach to other tissues and grow to form new tumors, causing damage wherever they land. Prostate cancer symptoms vary from person to person. Some men have no symptoms at all. Common prostate cancer symptoms include blood in the urine or semen, painful ejaculation, pain or burning during urination, and others. A biopsy is a primary tool for prostate cancer diagnosis, but a doctor can use other tools to ensure that the biopsy is performed in the correct location. Doctors may, for example, use transrectal ultrasound or magnetic resonance imaging (MRI) to guide the biopsy. Find out more about drugs for prostate cancer @ New Prostate Cancer Drugs A snapshot of the Prostate Cancer Pipeline Drugs mentioned in the report: Learn more about the emerging prostate cancer pipeline therapies @ Prostate Cancer Clinical Trials Prostate Cancer Therapeutics Assessment The prostate cancer pipeline report proffers an integral view of prostate cancer emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the 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, Parenteral, Intravenous, Subcutaneous, Topical Therapeutics Assessment By Molecule Type: Monoclonal Antibody, Peptides, Polymer, Small molecule, Gene therapy Therapeutics Assessment By Mechanism of Action: Programmed cell death-1 receptor antagonists, Poly(ADP-ribose) polymerase inhibitors, Proto oncogene protein c-akt inhibitors, Tubulin inhibitors; Tubulin polymerisation inhibitors, Antioxidants; Blood coagulation factor inhibitors; Inflammation mediator inhibitors; RNA replicase inhibitors, Bromodomain and extraterminal domain protein inhibitors, Immunostimulants, DNA topoisomerase I inhibitors, Androgen receptor antagonists, Polycomb repressive complex 2 inhibitors Key Companies: Merck & Co, Pfizer, Orion, Zenith Epigenetics, ESSA Pharma, RhoVac, AstraZeneca, Advaxis, Inc., Tracon Pharmaceuticals Inc., Bristol-Myers Squibb, Laekna Limited, Bracco Diagnostics, Inc, Arvinas Inc, Epizyme, Regeneron Pharmaceuticals, Veru Inc., Eli Lilly and Company, Exelixis, Luye Pharma Group, Amgen, Innocrin Pharmaceutical, Bayer, Nymox Pharmaceutical, Matrix Biomed, Tavanta Therapeutics, Fortis Therapeutics, Inc., Janssen Research & Development, LLC, Clarity Pharmaceuticals, Leap Therapeutics, Hinova pharmaceuticals, Vaccitech, Cardiff Oncology, Suzhou Kintor Pharmaceuticals, Teneobio, Inc., Janux Therapeutics, Fusion Pharmaceuticals, Corbus Pharmaceuticals, BioXcel Therapeutics, Onxeo S.A, Ayala Pharmaceuticals, HOOKIPA Pharma, Nuvation Bio, Ambrx, enGene, Jemincare, CellVax Therapeutics, POINT Biopharma, Oncternal Therapeutics, Immunic AG, BioNTech SE, and others. Key Prostate Cancer Pipeline Therapies: Pembrolizumab, Talazoparib, ODM-208, ZEN 3694, EPI-7386, RV 001, Adavosertib, Capivasertib, ADXS31-142, TRC253, Nivolumab, LAE001, BR55, ARV-110, Tazemetostat, REGN5678, VERU-111, Abemaciclib, Cabozantinib, LY01005, Tarlatamab, VT-464, BAY2315497, NX-1207, MBM-02, TAVT-45, FOR46, JNJ-78278343, 64Cu-SAR-bisPSMA, DKN-01, HC-1119, ChAdOx1-MVA 5T4, Onvansertib, GT0918, TNB-585, JANX007, 225Ac-PSMA I&T, CRB-701, BXCL701, AsiDNA, ADXS-504, HB-300, NUV-868, ARX517, JMKX002992, Zilovertamab, IMU-935, BNT112, and others. Dive deep into rich insights for new drugs for prostate cancer treatment; visit @ Prostate Cancer Medications Table of Contents For further information on the prostate cancer pipeline therapeutics, reach out @ Prostate Cancer Drug Treatment Related Reports Metastatic Prostate Cancer Pipeline Metastatic Prostate Cancer Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, including clinical and non-clinical stage products and the key metastatic prostate cancer companies, including Veru, Tracon, Sotio, among others. Metastatic Castration-Sensitive Prostate Cancer Pipeline Metastatic Castration-Sensitive Prostate Cancer Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, including clinical and non-clinical stage products, and the key metastatic castration-sensitive prostate cancer companies, including Merck, Pfizer, Veru, Tracon, Sotio, 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 Merck, Pfizer, Veru, Tracon, Sotio, among others. Metastatic Castration-Resistant Prostate Cancer Epidemiology Forecast Metastatic Castration-Resistant Prostate Cancer Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology as well as the metastatic castration-resistant prostate cancer epidemiology trends. Metastatic Castration-Resistant Prostate Cancer Market Metastatic Castration-Resistant Prostate Cancer Market Insights, Epidemiology, and Market Forecast – 2032 report deliver 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 Zenith Epigenetics, Surface Oncology, Opna-IO LLC, Regeneron Pharmaceuticals, Veru Inc, among others. Other Trending Reports Tay-sachs Disease Or Gm2 Gangliosidosis Market | Onycholysis Market | Diagnostic Imaging Equipment Market | Chemotherapy-induced Peripheral Neuropathy Market | Global Electrophysiology Devices Market | Anaphylaxis Market | Atherectomy Devices Market | Helicobacter Pylori Infections Market | Ophthalmic Imaging Equipment Market | Androgenetic Alopecia Market | Allergic Rhinitis Market | Chronic Inflammatory Demyelinating Polyneuropathy Market | Chronic Inflammtory Demyelinating Polyneuropathy Market | Colorectal Cancer Crc Market | Opioid Induced Constipation Market | Vertigo Market | Bone Anchored Hearing Systems Market | Wound Closure Devices Market | Hip Replacement Devices Market | Hemodynamic Monitoring Systems Market | Egfr Non-small Cell Lung Cancer Market | Helicobacter Pylori Infection Market | Hyperkalemia Market | Polycythemia Market Neurostimulation Devices Market | Carpal Tunnel Syndrome Market | Ventilator Market | Cerebral Aneurysm Market | Alpha Antitrypsin Market | Binge Eating Disorder Market | Bunion Market | Concussions Market Size | Exocrine Pancreatic Insufficiency Market | Healthcare Due Diligence Services | Minimal Residual Disease Market | Hypertrophic Scar Market | Lung Fibrosis Market | Anterior Uveitis Market | 22q11.2 deletion syndrome Market | X-Linked Retinitis Pigmentosa (XLRP) Market | Acute Radiation Syndrome Market | Alpha-1 Protease Inhibitor Deficiency Market | Androgenetic Alopecia Market | Hyperlipidemia Market | Cardiotoxicity Market | Hypertrophic Cardiomyopathy Market | Fatty Acid Oxidation Disorders (FAODs) Market | Androgen Insensitivity Syndrome Market | Emphysema Market | Canaloplasty Market | Dravet Syndrome Market | Celiac Disease Market | Chlamydia Infections Market | Syphilis Market | Renal Tubular Acidosis Market | Palmoplantar Pustulosis (PPP) Market | Aplastic Anemia Market | Bacterial Pneumonia Market | B cell Chronic Lymphocytic Leukemia Market | B cell Lymphomas Market | Behcets Disease Market Neoantigen-based Personalized Cancer therapeutic Vaccines Competitive Landscape and Market Forecast—by 2035 | Glioblastoma Market Related Healthcare Blogs Metastatic Castration-Sensitive Prostate Cancer Market PARP Inhibitors for Metastatic Castration-Resistant Prostate Cancer Prostate Cancer Market Outlook Related Healthcare Services Healthcare Consulting Healthcare Competitive Intelligence Services Healthcare Asset Prioritization Services 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 . Connect with us on LinkedIn |Facebook|Twitter Additionally, get in touch with our business executive to explore @ Healthcare Due Diligence Services Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

Phase 1Phase 2ASCO

22 Oct 2014

·www.biospace.com

Viamet Pharmaceuticals Withdraws $75 Million IPO, Spins Off Cancer Program To Form Innocrin Pharmaceuticals

October 22, 2014 By Krystle Vermes , BioSpace.com Breaking News Staff North Carolina-based Viamet Pharmaceuticals, Inc. announced today that it will withdraw its planned $75 million initial public offering and instead has the formed a privately held pharmaceutical company as a spin-out of its prostate cancer program, dubbed Innocrin Pharmaceuticals, Inc . Innocrin will be focused on the development of small molecule CYP17 lyase inhibitors. CYP17 lyase is an enzyme target for the treatment of castration-resistant prostate cancer. VT-464, which is Innocrin ’s lead asset, is an oral drug candidate that is in numerous Phase II studies for the treatment of castration-resistant prostate cancer. “The Board of Directors and our investors are pleased to announce the formation of Innocrin , which is focused on developing what we hope to be the best-in-class drug candidate for CRPC,” said Doug Reed , chairman of the board at Innocrin , in a statement. “VT-464 selectively inhibits a highly validated biochemical pathway required for prostate cancer growth. The molecule is the only member of the CYP17 inhibitor class clinically proven to reduce androgens without altering the synthesis of the mineralocorticoids or glucocorticoids.” CYP17 may also have commercial potential for the treatment of breast cancer in patients, as well as non-oncologic syndromes that spawn as a result of excess hormones. Novartis Venture Fund , Lilly Ventures , Hatteras Venture Partners , Intersouth Partners , Lurie Holdings , and Astellas Venture Management are some of the many investors who are funding Innocrin and its work. “I am delighted to lead the team that is devoted to discovering and developing novel, selective, oral inhibitors of CYP17 lyase that do not clinically block CYP17 hydroxylase, thereby avoiding the side effects and improving upon the efficacy observed with other CYP17 inhibitors,” said William Moore , president and chief executive officer of Innocrin . “Innocrin’s lead molecule, VT-464, is both a potent and selective CYP17 lyase inhibitor and AR antagonist that has outperformed the leading CYP17 inhibitor and AR antagonist CRPC drugs in advanced preclinical models.” Innocrin wholly owns CYP17 and VT-464. In an ongoing Phase I/II open-label study, VT-464 is being evaluated for safety, tolerability, pharmacokinetics and efficacy in CRPC patients. A Phase II open-label study being funded by the National Cancer Institute is looking at the efficacy and safety of the drug in patients with CRPC who have been previously treated with another drug called Xtandi. var switchTo5x=true; stLight.options({publisher: "0341611e-38a4-415d-9e18-75e093ff27e0", doNotHash: false, doNotCopy: false, hashAddressBar: false});

Phase 2Phase 1IPO

100 Deals associated with Seviteronel

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KEGG	Wiki	ATC	Drug Bank
-	Seviteronel	-	DB12275

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced breast cancer	Phase 2	United States	Innocrin Pharmaceuticals Holdings LLC	01 Aug 2015
Male Breast Neoplasms	Phase 2	United States	Innocrin Pharmaceuticals Holdings LLC	01 Aug 2015
Metastatic breast cancer	Phase 2	United States	Innocrin Pharmaceuticals Holdings LLC	01 Aug 2015
Estrogen receptor positive breast cancer	Phase 2	United States	Innocrin Pharmaceuticals Holdings LLC	01 Apr 2014
Triple Negative Breast Cancer	Phase 2	United States	Innocrin Pharmaceuticals Holdings LLC	01 Apr 2014
Metastatic castration-resistant prostate cancer	Phase 2	United States	Innocrin Pharmaceuticals Holdings LLC	01 Dec 2011
Metastatic castration-resistant prostate cancer	Phase 2	Greece	Innocrin Pharmaceuticals Holdings LLC	01 Dec 2011
Metastatic castration-resistant prostate cancer	Phase 2	Switzerland	Innocrin Pharmaceuticals Holdings LLC	01 Dec 2011
Metastatic castration-resistant prostate cancer	Phase 2	United Kingdom	Innocrin Pharmaceuticals Holdings LLC	01 Dec 2011

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04947189 (4CAST, ASCO2024) Manual	Phase 1	Metastatic breast cancer androgen receptor (AR)	8	INO-464 450mg/d + docetaxel (IV 75mg/m2 q3wkly)	dfytouvgxc(xhhbrgxecw) = mostly low grade and chemotherapy related although G2 pneumonitis occurred beyond the DLT period in two patients, one of whom had prior sacituzimab govotecan-related pneumonitis. INO-464-related AEs were G1 fatigue/headache in 4/6 patients. jvlneyepbx (uwfyqombcq ) View more	Positive	24 May 2024
NCT02130700 (Pubmed \| Clin Genitourin Cancer) Manual	Phase 2	Metastatic castration-resistant prostate cancer	17	Seviteronel	wwjobpgcep(vzgkgqlzby) = reklrrplqh ctvuibwjqq (wprmqkifoe )	Negative	01 Aug 2020
NCT02361086 (Pubmed \| Clin Cancer Res) Manual	Phase 1	Castration-Resistant Prostatic Cancer	21	Seviteronel	qfgpwfpbde(tvtwwfytjy) = ttcrkateko npkpfnudqb (gcofpkjnle ) View more	Positive	01 Nov 2018
NCT02580448 (Pubmed \| Breast Cancer Res) Manual	Phase 1	Breast Cancer	19	seviteronel	pqhkuewkbf(hrwoftpjzc) = independent of relationship scpdwpebda (ataebwdejy ) View more	Positive	01 Aug 2018
NCT02580448 (CLARITY-01, ASCO2017)	Phase 2	Triple Negative Breast Cancer \| Estrogen receptor positive breast cancer	-	Seviteronel 450 mg oral daily	matsgsvjvk(zbliyidpoj) = 33% isysmrnbbz (ydhsnojteq ) View more	-	30 May 2017
NCT02580448 (ASCO2016)	Phase 1	Estrogen receptor positive breast cancer \| Advanced Triple-Negative Breast Carcinoma	13	Seviteronel 750 mg	delmuivqjr(ygumsbbnzh) = confusion at 750 mg and was a DLT ylbnvqosnt (yhpxomjzax ) View more	-	20 May 2016
NCT02580448 (ASCO2016)	Phase 1		13	Seviteronel 600 mg		-	20 May 2016
NCT02361086 (ASCO_GU2016)	Phase 1/2	Castration-Resistant Prostatic Cancer	57	VT-464	sdawwbmbfw(mwhfpszgns) = several pts receiving VT-464 in 28-day cycles were noted to have syncopal, pre-syncopal or vaso-vagal episodes with typical prodromes xelswpenpa (bzyceqbikj )	-	10 Jan 2016
NCT02012920 (INO-VT-464-CL-001, ASCO_GU2015)	Phase 1/2	Castration-Resistant Prostatic Cancer	-	VT-464	qgdwrrjfit(saduvpfyej) = Most Ph 1 adverse events (AEs) were grade 1 or 2 and not considered drug related. There were 18 grade 3 AEs and 1 grade 5 AE considered not related to study drug, plus 4 grade 3 AEs (vasovagal/syncope) considered at least possibly related. ctxhnkuogu (bgfylnjmgy ) View more	-	01 Mar 2015

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