Androgen receptor (AR), a steroid receptor, plays a pivotal role in the pathogenesis of prostate cancer (PCa). AR controls the transcription of genes that help cells avoid apoptosis and proliferate, thereby contributing to the development of PCa. Understanding AR molecular mechanisms has led to the development of newer drugs that inhibit androgen production enzymes or block ARs. The FDA has approved a small number of AR-inhibiting drugs for use in PCa thus far, as the identification of novel AR inhibitors is difficult, expensive, time-consuming, and labor-intensive. To accelerate the process, artificial intelligence (AI) algorithms were employed to predict AR inhibitors using a dataset of 2242 compounds. Four machine learning (ML) and deep learning (DL) algorithms were used to train different prediction models based on molecular descriptors (1D, 2D, and molecular fingerprints). The DL-based prediction model outperformed the other trained models with accuracies of 92.18% and 93.05% on the training and test datasets, respectively. Our findings highlight the potential of DL, particularly the DNN model, as an effective approach for predicting AR inhibitors, which could significantly streamline the process of identifying novel AR inhibitors in PCa drug discovery. Further validation of these models using experimental assays and prospective testing of newly designed compounds would be valuable to confirm their predictive power and applicability in practical drug discovery settings.Communicated by Ramaswamy H. Sarma.

01 Aug 2024·Zhongguo Zhong yao za zhi = Zhongguo zhongyao zazhi = China journal of Chinese materia medica

[Ultrafiltration of Angelicae Sinensis Radix and Astragali Radix inhibits ferroptosis and improves pulmonary fibrosis in rats by regulating Nrf2/xCT/GPX4 signaling pathway].

Article

Author: Lyu, Xin-Fang ; Zhao, Xin-Ke ; Li, Ying-Dong ; Jiang, Hu-Gang ; Ren, Chun-Zhen ; Chen, Qi-Lin ; Zhi, Xiao-Dong ; Wang, Chun-Ling ; Wu, Xue ; Wang, Xu-Yong

This study aims to investigate the mechanism of ferroptosis mediated by the nuclear factor-E2-related factor 2(Nrf2)/solute carrier family 7 member 11(SLC7A11, also known as xCT)/glutathione peroxidase 4(GPX4) signaling pathway in radiationinduced pulmonary fibrosis and the intervention effect of Angelicae Sinensis Radix(ASR) and Astragali Radix(AR) ultrafiltration extract. Fifty Wistar rats were randomly divided into five groups, with 10 rats in each group. Except for the blank group without radiation, the rats in each group were anesthetized and subjected to a single local chest irradiation of 40 Gy X-rays once to establish a rat model of radiation-induced pulmonary fibrosis. After radiation, the rats in the intervention groups were orally administered with ASR-AR ultrafiltration extract at doses of 0. 12, 0. 24, and 0. 48 g·kg~(-1), respectively, once a day for 30 days. After 30 days of continuous administration, the levels of oxidative stress indicators superoxide dismutase(SOD) activity, reduced glutathione(GSH),malondialdehyde(MDA), and ferrous ion(Fe~(2+)) in lung tissues of each group were detected by colorimetry. Immunofluorescence was used to detect reactive oxygen species(ROS) fluorescence expression in lung tissues. Hematoxylin-eosin(HE) and Masson staining were performed to observe pathological changes in lung tissues. Immunohistochemistry and Western blot were used to detect the expression levels of Nrf2/xCT/GPX4 signaling pathway and fibrotic proteins in lung tissues. The results showed that compared with the results in the blank group, the levels of Fe~(2+) and MDA in the model group increased, while SOD activity and GSH levels decreased,and ROS levels increased. HE and Masson staining results showed that the structure of lung tissue was seriously damaged, the pulmonary interstitium was significantly proliferated, the alveoli collapsed and consolidated severely, and there were more inflammatory cell aggregates and collagen fiber deposits. Transmission electron microscopy showed that the degree of lung tissue damage in the model group was relatively high, with increased, smaller, and disorganized damaged mitochondria, irregular morphology, shallow matrix,most mitochondria ruptured and shortened, mildly expanded, some mitochondria with increased electron density of the matrix, partial mitochondrial outer membrane rupture, and characteristic changes of ferroptosis-specific mitochondria. Immunohistochemistry showed that the expression of transferrin receptor protein 1(TFR1) in lung tissues was significantly increased, while the expression of GPX4,ferritin heavy chain 1(FTH1), Nrf2, and xCT was significantly decreased. Western blot showed that the expression of α-smooth muscle actin(α-SMA) and collagen Ⅰ protein increased. Compared with the model group, the intervention group with ASR-AR ultrafiltration extract significantly improved lipid peroxidation and antioxidant-related indicators, decreased Fe~(2+) levels, alleviated fibrosis, and decreased the expression of TFR1, α-SMA, and collagen Ⅰ proteins in lung tissues, while increased the expression of GPX4, FTH1, Nrf2, and xCT proteins. In summary, ASR-AR ultrafiltration extract has an ameliorative effect on radiation-induced pulmonary fibrosis, and its mechanism may involve the inhibition of ferroptosis by regulating the Nrf2/xCT/GPX4 signaling pathway.

01 Mar 2024·Advanced Science

Identification of PRDX5 as A Target for The Treatment of Castration‐Resistant Prostate Cancer

Article

Author: Wang, Yang ; Sun, Qiaoyang ; Ni, Jiang ; Tan, Soo Yong ; Ding, Lingwen ; Chen, Yong Q ; Ran, Xuebin ; Mi, Yuanyuan ; Koeffler, H Phillip ; Feng, Ninghan ; Wang, Rong

AbstractTreatment of castration‐resistant prostate cancer (CRPC) is a long‐standing clinical challenge. Traditionally, CRPC drugs work by either reducing dihydrotestosterone biosynthesis or blocking androgen receptor (AR) signaling. Here it is demonstrated that AR inhibitor treatment gives rise to a drug‐tolerant persister (DTP) state. The thioredoxin/peroxiredoxin pathway is up‐regulated in DTP cells. Peroxiredoxin 5 (PRDX5) promotes AR inhibitor resistance and CRPC development. Inhibition of PRDX5 suppresses DTP cell proliferation in culture, dampens CRPC development in animal models, and stabilizes PSA progression and metastatic lesions in patients. Therefore, the study provides a novel mechanism and potential target for the management of castration‐resistant prostate cancer.

News (Medical) associated with AR Degrader (Proteovant Therapeutics)

22 Apr 2024

·www.prnewswire.com

GT20029 China Phase II Trial For AGA Reached Primary Endpoint

SUZHOU, China, April 21, 2024 /PRNewswire/ -- Kintor Pharmaceutical Limited ("Kintor Pharma", HKEX: 9939), a clinical-stage biotechnology company developing innovative small molecules and biological therapeutics, announced that the China phase II clinical trial (the "Phase II Clinical Trial") of its in-house developed first-in-class androgen receptor ("AR") proteolysis targeting chimera ("PROTAC") compound GT20029 tincture for the treatment of male androgenetic alopecia ("AGA") has reached the primary endpoint, with statistically significant and clinically meaningful results, as well as good safety and tolerability. Based on the results of the Phase II Clinical Trial, the company will actively deploy subsequent clinical strategies for GT20029, such as initiating a phase III clinical trial in China and a phase II clinical trial in the U.S. for male AGA. In addition, the company is also preparing to conduct a phase II clinical trial of GT20029 for the treatment of acne. The Phase II Clinical Trial is a multi-center, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of GT20029 for treating male AGA, and to determine the recommended dosage for phase III clinical trial. This trial involves a total of 12 clinical research centers in China, and Professor Yang Qinping from Fudan University Huashan Hospital is the leading principal investigator (leading PI). The primary endpoint of this trial is the average change from baseline in non-vellus target area hair counts ("TAHC") after 12 weeks of treatment in comparison to placebo. Safety assessments included adverse events, laboratory tests, subjective evaluations of the topical medication and dermatological assessments. The trial enrolled 180 male AGA patients, divided into once daily ("QD") and twice weekly ("BIW") dosing cohorts, each with control groups (dosing placebo) and experiment groups (dosing GT20029 tincture), receiving either 0.5% or 1% doses. The results showed: In terms of efficacy, GT20029 tincture demonstrated statistically significant therapeutic efficacy and clinical significance compared to placebo in both the QD and BIW dosing cohorts. After 12 weeks of treatment, the 0.5% QD GT20029 group showed an increase of 16.80 hairs/cm² from baseline, which was 6.69 hairs/cm² more than the placebo group, with statistically significant results (P<0.05). The TAHC of GT20029 1.0% BIW group showed an increase of 11.94 hairs/cm² from baseline, which was 7.36 hairs/cm² more than the placebo, also yielding statistically significant results (P<0.05). For the BIW cohort, the study indicated a dose-response relationship among different doses of GT20029. Regarding safety, GT20029 tincture demonstrated good safety and tolerability, with the incidence of adverse events during treatment comparable to that of placebo. In addition, no adverse sexual events were observed during the trial. The 1% BIW dosage of GT20029 was identified as the optimal dosing level in the Phase II Clinical Trial and has been recommended for the phase III clinical trial for male AGA in China. As the world's first dermatological topical novel AR degrader developed using the company's in-house developed PROTAC platform, GT20029 is the first topical PROTAC compound that has completed phase I clinical trials both in China and the U.S.. It works by targeting AR proteins for degradation via recruitment to E3 ubiquitin ligase. GT20029 acts locally on peripheral skin tissues, avoiding systemic exposure and reducing the sensitivity of AR to androgens in local hair follicle sebaceous gland. Hence, it is developed by the Group for treating both AGA and acne. Dr. Youzhi Tong, the founder, chairman and CEO of Kintor Pharma, said, "As the pioneering topical PROTAC drug, GT20029's phase II clinical trial has attracted significant attention. The conclusion of phase I clinical trials in China and the U.S. has provided crucial safety and pharmacokinetics data at both local and systemic levels. Our phase II clinical trial has further affirmed the safety profile of this innovative PROTAC technology for sustained local applications. More importantly, our trial is the first one to demonstrate the initial therapeutic benefits of topical PROTAC compound. A better AGA treatment for calls for fast efficacy, superior results, and reduced administration frequency. We are poised to demonstrate these objectives in our upcoming GT20029 clinical trials." SOURCE Kintor Pharmaceutical Limited

Clinical ResultPhase 2Phase 1

09 Nov 2023

·www.globenewswire.com

Oncternal Therapeutics Provides Business Update and Announces Third Quarter 2023 Financial Results

The first patient was dosed in our Phase 1/2 study for ONCT-534, our dual-action androgen receptor inhibitor, for the treatment of patients with advanced prostate cancer who are resistant to approved androgen receptor pathway inhibitorsAdditional patients were treated in our ongoing Phase 1/2 study for ONCT-808, our ROR1-targeting autologous CAR T cell therapy, for the treatment of patients with relapsed or refractory aggressive B-cell lymphoma, including patients that have failed prior CD19 CAR T treatment; initial data readout expected in December 2023Cash, cash equivalents and short-term investments totaled $40.3 million as of September 30, 2023; cash runway projected into 2025Management to host webcast today at 5:00 pm ET SAN DIEGO, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, today provided a business update and reported third quarter 2023 financial results. “We continue to execute on our plan to advance both ONCT-534, our dual-action AR inhibitor for patients with advanced prostate cancer who have relapsed or are refractory to treatment with AR pathway inhibitors, and ONCT-808, our ROR1-targeting autologous CAR T for patients with aggressive B cell lymphoma, including those who relapse after CD19 CAR T treatment, towards potential significant clinical inflection points by mid-2024,” said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. “We believe ONCT-534 can address a significant unmet medical need for patients with advanced metastatic prostate cancer, especially those with splice variants of the androgen receptor, mutations in the ligand-binding domain of the AR, or AR amplification, common mechanisms of resistance to treatment with approved AR pathway inhibitors. With ONCT-808, we have seen encouraging expansion and persistence of CAR expressing T cells in our first advanced B-NHL patient, which we believe has been associated with positive responses for other CAR T therapies. We look forward to presenting an initial data update by the end of 2023.” Recent Highlights In October 2023, we announced that the first patient with metastatic castration-resistant prostate cancer (mCRPC) had been dosed in the Phase 1/2 dose escalation/dose expansion study of ONCT-534, our novel dual-action androgen receptor inhibitor (DAARI)In October 2023, the U.S. Food and Drug Administration granted fast track designation for the treatment of adult patients with relapsed or refractory mCRPC resistant to androgen receptor pathway inhibitors (ARPIs)In September and October 2023, we announced the establishment and expansion of our Prostate Cancer Scientific Advisory Board (SAB), which includes distinguished academic and industry leaders in the prostate cancer field, who will provide guidance for the clinical development of ONCT-534 Expected Upcoming Milestones ONCT-808, our autologous ROR1-targeted CAR T cell therapy Initial clinical data available by the end of 2023Additional clinical data readouts in 2024 ONCT-534, our dual-action androgen receptor inhibitor Initial clinical data available in the first half of 2024 Third Quarter 2023 Financial ResultsOur grant revenue was $0.2 million for the third quarter ended September 30, 2023. Our total operating expenses for the third quarter ended September 30, 2023 were $10.6 million, including $1.7 million in non-cash stock-based compensation expense. Research and development expenses for the quarter totaled $7.5 million, and general and administrative expenses for the quarter totaled $3.1 million. Interest income for the quarter totaled $0.5 million. Net loss for the quarter was $9.9 million, or a loss of $0.17 per share, basic and diluted. As of September 30, 2023, we had approximately 59.0 million shares of common stock outstanding, $40.3 million in cash, cash equivalents and short-term investments and no debt. We believe these funds will be sufficient to fund our operations into 2025. About Oncternal Therapeutics Oncternal Therapeutics is a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies for the treatment of patients with cancers that have critical unmet medical need. Oncternal pursues drug development targeting promising, yet untapped biological pathways implicated in cancer generation or progression, focusing on hematological malignancies and prostate cancer. ONCT-534 is an investigational dual-action androgen receptor inhibitor (DAARI) with preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR aberration. It is a potential treatment for patients with mCRPC with unmet medical need because of resistance to androgen receptor inhibitors, including those with AR amplification, mutations in the AR ligand binding domain (LBD), or splice variants with loss of the AR LBD. Oncternal has initiated Study ONCT-534-101 (NCT05917470), which is open and enrolling patients for treatment with mCRPC. ONCT-808 is an investigational autologous chimeric antigen receptor T (CAR T) cell therapy that targets Receptor Tyrosine Kinase-Like Orphan Receptor 1 (ROR1) using the binding domain from zilovertamab. ONCT-808 has demonstrated activity in preclinical models against multiple hematological malignancies and solid tumors and has been shown to be specific for cancer cells expressing ROR1. Oncternal has developed a robust and reproducible manufacturing process that has the potential to reduce the time patients must wait for their individual CAR T therapy to be produced, compared with currently approved CAR T products. Oncternal has dosed patients under Study ONCT-808-101 (NCT05588440) with relapsed or refractory aggressive B-cell lymphoma, including patients who have failed previous CD19 CAR T treatment. Zilovertamab is an investigational monoclonal antibody designed to inhibit the function of ROR1. Zilovertamab has been evaluated in a Phase 1/2 Study CIRM-0001 (NCT03088878) in combination with ibrutinib for the treatment of patients with mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL) and marginal zone lymphoma (MZL), which resulted in 100% progression free survival (PFS) at 42 months in CLL patients expressing a p53 mutation/del(17p), a population underserved by current treatment options. Zilovertamab is also being evaluated in an investigator-initiated Phase 1b study of zilovertamab in combination with docetaxel in patients with metastatic castration-resistant prostate cancer (NCT05156905). More information on our company and programs is available at https://oncternal.com/. Forward-Looking Information Oncternal cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negatives of these terms or other similar expressions. These statements are based on Oncternal’s current beliefs and expectations. Forward-looking statements include statements regarding Oncternal’s expected cash runway and statements regarding Oncternal’s development programs, including the anticipated timing for study enrollment and announcing clinical data. Forward-looking statements are subject to risks and uncertainties inherent in Oncternal’s business, including risks associated with the clinical development and process for obtaining regulatory approval of Oncternal’s product candidates, such as potential delays in the commencement, enrollment and completion of clinical trials; the risk that interim results of a clinical trial do not predict final results and that one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, as follow-up on the outcome of any particular patient continues, and as more patient data become available; and other risks described in Oncternal’s filings with the U.S. Securities and Exchange Commission. All forward-looking statements in this press release are current only as of the date hereof and, except as required by applicable law, Oncternal undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Contact Information: InvestorsRichard Vincent 858-434-1113rvincent@oncternal.com MediaCorey Davis, Ph.D.LifeSci Advisors212-915-2577cdavis@lifesciadvisors.com Oncternal Therapeutics, Inc.Condensed Consolidated Balance Sheets Data(in thousands) September 30,2023 December 31,2022 Cash, cash equivalents and short-term investments$40,305 $63,724 Total assets 43,195 68,651 Total liabilities 6,199 7,682 Accumulated deficit (188,615) (158,300)Total stockholders' equity 36,996 60,969 Oncternal Therapeutics, Inc.Condensed Consolidated Statements of Operations Data(in thousands, except per share data) Three Months EndedSeptember 30, Nine Months EndedSeptember 30, 2023 2022 2023 2022 Grant revenue$179 $382 $488 $1,319 Operating expenses: Research and development 7,475 8,442 23,083 24,182 General and administrative 3,094 3,265 9,483 10,169 Total operating expenses 10,569 11,707 32,566 34,351 Loss from operations (10,390) (11,325) (32,078) (33,032)Interest income 528 200 1,763 262 Net loss$(9,862) $(11,125) $(30,315) $(32,770)Net loss per share, basic and diluted$(0.17) $(0.21) $(0.52) $(0.64)Weighted-average shares outstanding, basic and diluted 58,964 54,212 58,738 51,252

Phase 1Cell TherapyFinancial StatementImmunotherapyFast Track

25 Oct 2023

·www.globenewswire.com

Oncternal Therapeutics Adds Matthew Smith, M.D., Ph.D. to its Prostate Cancer Scientific Advisory Board

SAN DIEGO, Oct. 25, 2023 (GLOBE NEWSWIRE) -- Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, today announced the addition of Matthew Smith, M.D., Ph.D. to its Prostate Cancer Scientific Advisory Board (SAB). Dr. Smith, along with the other Prostate Cancer SAB members, will help guide Oncternal’s next steps in the clinical development of its novel dual-acting androgen receptor inhibitor (DAARI), ONCT-534, which is currently under investigation in an ongoing Phase 1/2 clinical study, ONCT-534-101. “We wholeheartedly welcome Dr. Smith to Oncternal’s Prostate Cancer Scientific Advisory Board,” said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. “We believe Dr. Smith’s expertise and his experience leading global registrational studies for novel prostate cancer therapeutics will be instrumental in helping us shape the clinical and registrational strategy for ONCT-534.” “There is a significant unmet need for patients with metastatic prostate cancer and disease progression despite treatment with currently available AR pathway inhibitors, such as abiraterone acetate and enzalutamide,” said Matthew Smith, M.D., Ph.D. “I look forward to working with the Oncternal team to help bring their dual-acting AR inhibitor to patients. Preclinical studies suggest that ONCT-534 may address the most common escape mechanisms of metastatic castration-resistant prostate cancer, including activating mutations in the AR ligand-binding domain and constitutively active splice variants such as AR-V7.” Dr. Matthew R. Smith is Director of the Genitourinary Oncology Program at Massachusetts General Hospital Cancer Center and a Professor of Medicine at Harvard Medical School. He is an internationally recognized expert in prostate cancer. He has published extensively on the treatment and prevention of bone metastases, prostate cancer survivorship, and novel androgen receptor pathway inhibitors. He has authored more than 200 peer-reviewed articles including manuscripts in New England Journal of Medicine, The Lancet, Journal of Clinical Oncology, and Clinical Cancer Research. He graduated summa cum laude from Canisius College with a B.A. in biochemistry. He received his MD and PhD degrees from Duke University School of Medicine. He trained in Internal Medicine at Brigham and Women's Hospital. He completed a fellowship in Medical Oncology at Dana Farber Cancer Institute and a postdoctoral fellowship at Massachusetts Institute of Technology. About Oncternal TherapeuticsOncternal Therapeutics is a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies for the treatment of patients with cancers that have critical unmet medical need. Oncternal pursues drug development targeting promising, yet untapped biological pathways implicated in cancer generation or progression, focusing on hematological malignancies and prostate cancer. ONCT-534 is an investigational dual-action androgen receptor inhibitor (DAARI) with preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR aberration. It is a potential treatment for patients with mCRPC and unmet medical need because of resistance to androgen receptor inhibitors, including those with AR amplification, mutations in the AR ligand binding domain (LBD), or splice variants with loss of the AR LBD. Oncternal has initiated Study ONCT-534-101 (NCT05917470) for the treatment of patients with mCRPC. ONCT-808 is an investigational autologous chimeric antigen receptor T (CAR T) cell therapy that targets Receptor Tyrosine Kinase-Like Orphan Receptor 1 (ROR1) using the binding domain from zilovertamab. ONCT-808 has demonstrated activity in preclinical models against multiple hematological malignancies and solid tumors and has been shown to be specific for cancer cells expressing ROR1. Oncternal has developed a robust and reproducible manufacturing process that has the potential to reduce the time patients must wait for their individual CAR T product to be produced, compared with approved CAR T products. Oncternal has initiated Study ONCT-808-101 (NCT05588440) for the treatment of patients with relapsed or refractory aggressive B-cell lymphoma, including patients who have failed previous CD19 CAR T treatment. Zilovertamab is an investigational monoclonal antibody designed to inhibit the function of ROR1. Zilovertamab has been evaluated in a Phase 1/2 Study CIRM-0001 (NCT03088878) in combination with ibrutinib for the treatment of patients with MCL, chronic lymphocytic leukemia (CLL) and marginal zone lymphoma (MZL). Zilovertamab is also being evaluated in two investigator-initiated studies: a Phase 2 clinical trial of zilovertamab in combination with venetoclax, a Bcl-2 inhibitor, in patients with R/R CLL (NCT04501939), and a Phase 1b study of zilovertamab in combination with docetaxel in patients with metastatic castration-resistant prostate cancer (NCT05156905). More information on our company and programs is available at https://oncternal.com/. Contact Information: InvestorsRichard VincentChief Financial Officer858-434-1113rvincent@oncternal.com MediaCorey Davis, Ph.D.LifeSci Advisors212-915-2577 cdavis@lifesciadvisors.com

Phase 1Phase 2Executive ChangeCell Therapy

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Indication	Highest Phase	Country/Location	Organization	Date
Prostatic Cancer	Preclinical	-	Proteovant Therapeutics, Inc.Startup	02 Mar 2022

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