A Randomized Clinical Trial for the Addition of Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer Without Deep PSA Response

This study is being done to answer the following question: can the chance of prostate cancer growing or spreading be lowered by adding a drug to the usual combination of drugs?
This study would like to find out if this approach is better or worse than the usual approach for prostate cancer.
The usual approach for patients who are not in a study is hormone treatment with Androgen Deprivation Therapy (ADT) and Androgen-Receptor Pathway Inhibitor (ARPI).

Start Date15 Jan 2025

Sponsor / Collaborator

Canadian Cancer Trials Group

[+4]

NCT06576037 / Not yet recruitingPhase 1IIT

Phase Ib Study of CBP-1019 in Combination With FOLFOX +/- Bevacizumab, Pembrolizumab, or Enzalutamide for Metastatic TRPV6-overexpressing Solid Tumors of Epithelial Origin

An open-label, Phase Ib dose escalation and dose expansion clinical trial evaluating the safety and efficacy of CBP-1019 combinations in patients with solid tumors of epithelial origin.

Start Date31 Dec 2024

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

NCT06236139 / RecruitingPhase 1/2IIT

Phase 1/2 Dose-Escalation and Cohort Study of STEAP1 CART With Enzalutamide in Participants With mCRPC

This phase I/II trial tests the safety and effectiveness of cell therapy (STEAP1 CART) with enzalutamide in treating patients with prostate cancer that continues to grow despite surgical or medical treatments to block androgen production (castration-resistant) and that has spread from where it first started (the prostate) to other places in the body (metastatic). Prostate cancer is the second leading cause of cancer deaths in men. Localized prostate cancer is often curable and even metastatic disease may respond to treatment for a few years. Despite multiple therapies, including hormone therapy and chemotherapy, metastatic castration-resistant prostate cancer (mCRPC) still remains an incurable disease. Recently, adoptive cellular immunotherapies have been developed to transfer immunogenic cells to the patient to produce an anti-tumor response. Chimeric antigen receptor T (CART)-cell therapy is a type of treatment in which a patient's T-cells (a type of immune cell) are changed in the laboratory so they will attack tumor cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's tumor cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Prostate stem cell antigen and prostate specific membrane antigen CAR T cell therapies have been shown to be safe and effective, but objective tumor responses remain rare. STEAP1 is an antigen that promotes cancer growth and spread and is found to be broadly expressed in mCRPC tissues. STEAP1 CART is CAR T cells that have been engineered with a STEAP1 antigen to better target prostate tumor cells. Enzalutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of cancer cells. Giving STEAP1 CART with enzalutamide may kill more tumor cells in patients with mCRPC.

Start Date01 Dec 2024

Sponsor / Collaborator

Fred Hutchinson Cancer Research Center

[+1]

100 Clinical Results associated with Enzalutamide

100 Translational Medicine associated with Enzalutamide

100 Patents (Medical) associated with Enzalutamide

3,029

Literatures (Medical) associated with Enzalutamide

31 Dec 2024·Journal of medical economics

Adverse events and costs among non-metastatic castration-resistant prostate cancer patients

Article

Author: Appukkuttan, Sreevalsa ; Yao, Jianying ; Freedland, Stephen J ; Parkin, Jacqueline ; Partridge, Jamie ; Kong, Sheldon X

BACKGROUND:

Limited real-world evidence exists on the economic burden of adverse events (AEs) to the healthcare system among patients with non-metastatic castration-resistant prostate cancer (nmCRPC) treated with second-generation androgen receptor antagonists (ARAs). Current data is needed to understand real-world clinical event rates among ARAs and the cost of these events.

OBJECTIVES:

Describe the incidence of non-central nervous system (CNS)-related AEs and CNS-related AEs among nmCRPC patients treated in the United States with second-generation ARAs (apalutamide and enzalutamide) and evaluate healthcare resource utilization (HCRU) and costs for these patients.

METHODS AND STUDY DESIGN:

This was a retrospective observational cohort study using claims data from Optum Clinformatics Data Mart to identify adult males with prostate cancer, castration, no metastases, and >1 claim for apalutamide or enzalutamide. The study was conducted from January 2017 to March 2020, with a patient index identification period from January 2018 to December 2019. AEs were classified as CNS-related or non-CNS-related.

RESULTS:

Of 605 patients (156 apalutamide and 449 enzalutamide), most were ≥65 years (94%) and had ≥1 non-CNS-related AE (55%). Many had ≥1 CNS-related AE (32%). Pain (12%) and arthralgia (11%) were the most frequently reported non-CNS-related AEs. Fatigue/asthenia (14%) and dizziness (7%) were the most frequently reported CNS-related AEs. Among patients with versus without non-CNS-related AEs, 34% versus 8% had emergency room (ER) events, and 25% versus 2% had inpatient events. Among patients with versus without CNS-related AEs, 41% versus 14% had ER events, and 38% versus 4% had inpatient events. Adjusted per-patient per-year cost (in 2020 USD) differences were significant between patients with and without non-CNS-related AEs ($30,765, p = 0.0018) and between patients with and without CNS-related AEs ($40,689, p = 0.0017).

CONCLUSION:

There is significant HCRU and cost burden among nmCRPC patients treated with ARAs developing AEs, highlighting the need for treatments with improved tolerability. Additional studies are warranted to include recently approved agents.

01 Dec 2024·Clinical Proteomics

Proteomic profiling of prostate cancer reveals molecular signatures under antiandrogen treatment

Article

Author: Yang, Guanglin ; Zhou, Menghan ; Lin, Qiliang ; Zhang, Qingyun ; Huang, Yurun ; Wang, Shan ; Yang, Yiping ; Yao, Xinpeng ; Fang, Yue ; Meng, Qinggui

Abstract:

Background:

Tumorigenesis and progression of prostate cancer (PCa) are indispensably dependent on androgen receptor (AR). Antiandrogen treatment is the principal preference for patients with advanced PCa. However, the molecular characteristics of PCa with antiandrogen intervention have not yet been fully uncovered.

Methods:

We first performed proteome analysis with 32 PCa tumor samples and 10 adjacent tissues using data-independent acquisition (DIA)- parallel accumulation serial fragmentation (PASEF) proteomics. Then label-free quantification (LFQ) mass spectrometry was employed to analyze protein profiles in LNCaP and PC3 cells.

Results:

M-type creatine kinase CKM and cartilage oligomeric matrix protein COMP were demonstrated to have the potential to be diagnostic biomarkers for PCa at both mRNA and protein levels. Several E3 ubiquitin ligases and deubiquitinating enzymes (DUBs) were significantly altered in PCa and PCa cells under enzalutamide treatment, and these proteins might reprogram proteostasis at protein levels in PCa. Finally, we discovered 127 significantly varied proteins in PCa samples with antiandrogen therapy and further uncovered 4 proteins in LNCaP cells upon enzalutamide treatment.

Conclusions:

Our research reveals new potential diagnostic biomarkers for prostate cancer and might help resensitize resistance to antiandrogen therapy.

01 Dec 2024·Clinical Genitourinary Cancer

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

Article

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

INTRODUCTION AND OBJECTIVES:

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

MATERIALS AND METHODS:

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

RESULTS:

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

CONCLUSION:

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

438

News (Medical) associated with Enzalutamide

14 Nov 2024

·www.globenewswire.com

PDS Biotech Provides Clinical Programs Update and Reports Third Quarter 2024 Financial Results

Conference call and webcast today at 8:30 a.m. Eastern TimePRINCETON, N.J., Nov. 14, 2024 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines, today provided a business update and reported financial results for the third quarter of 2024. “Since our last update in August, we have been actively engaged with investors and clinicians to discuss our strategy and funding requirements for our VERSATILE-003 Phase 3 trial of Versamune® HPV + pembrolizumab compared to pembrolizumab as a potential treatment for first-line recurrent/metastatic HPV16-positive head and neck squamous cell cancer (HNSCC),” said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. Dr. Bedu-Addo further noted that “based on investor feedback, discussions with key opinion leaders involved with the study and other experts, we have made minor modifications to the VERSATILE-003 trial design to reduce the overall cost and time required to achieve an interim data readout and trial completion.” With submission of the updated Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) this week, the Company expects the FDA clearance decision by mid-December, allowing the Company to initiate site activation in the first quarter of 2025. “Elsewhere in our pipeline, we were pleased with the data from the IMMUNOCERV Phase 2 clinical trial evaluating Versamune® HPV with chemoradiation to treat locally advanced cervical cancer presented at the American Society for Radiation Oncology (ASTRO) annual meeting. The presented data demonstrated promising clinical activity and a compelling safety profile. Based on continued research in various HPV-positive cancers conducted by PDS Biotech and independent researchers who recognize its potential, Versamune® HPV appears to work in combination with a variety of therapeutic agents to generate clinical responses and promote improved survival in patients with favorable toxicity. We are exploring the next steps in the development of Versamune® HPV for cervical cancer,” concluded Dr. Bedu-Addo. Recent Developments Update to Phase 3 VERSATILE-003 Trial Design in HPV16-positive first-line recurrent and/or metastatic HNSCC Updated trial design to include approximately 350 patientsVERSATILE-002 results have shown broadly improving clinical responses across multiple parameters with increases in patient size and duration of patient follow up over the last year, demonstrating durability of the anti-tumor responsesThe design, which is informed by the observed durability of the clinical responses, retains statistical power and remains within the confines of our agreement with the FDA on registrational designDesign maintains 2:1 randomization and median overall survival as primary endpointDesign imparts potential for earlier interim readouts and study completionDesign presents potential for reduced execution costsAmended IND (updated design) submitted November 2024 In September 2024, we provided updated results from our VERSATILE-002 Phase 2 clinical trial in recurrent and/or metastatic HPV16-positive HNSCC patients treated with the combination of Versamune® HPV and pembrolizumab presented at European Society for Medical Oncology (ESMO) Congress 2024 by Jared Weiss, M.D., Section Chief of Thoracic and Head/Neck Oncology, Professor of Medicine at the University of North Carolina, and principal investigator of the VERSATILE-002 clinical trial. Press release here. In October 2024, we provided updated results from our IMMUNOCERV Phase 2 clinical trial in locally advanced cervical cancer patients treated with Versamune® HPV and chemoradiotherapy presented at the ASTRO Annual Meeting by Adam Grippin, M.D., Ph.D., The University of Texas MD Anderson Cancer Center. Press release here. Ravi A. Madan, M.D., Head, Prostate Cancer Clinical Research Section, Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, part of the U.S. National Institutes of Health presented the rationale and design of recurrent prostate cancer trial combining Xtandi® + PDS01ADC vs Xtandi® alone during an oral presentation at the 12th Annual Meeting of the International Cytokine and Interferon Society, October 2024. Press release here. Third Quarter 2024 Financial ResultsReported net loss was approximately $10.7 million, or $0.29 per basic share and diluted share, for the three months ended September 30, 2024, compared to a net loss of $10.8 million, or $0.35 per basic share and diluted share, for the three months ended September 30, 2023. The decrease was primarily due to lower operating expenses. Research and development expenses increased to approximately $6.8 million for the three months ended September 30, 2024, from $6.4 million for the three months ended September 30, 2023. The increase of $0.4 million was primarily attributable to higher manufacturing expenses, partially offset by lower clinical costs and personnel expenses. General and administrative expenses decreased to approximately $3.4 million for the three months ended September 30, 2024, from approximately $4.1 million for the three months ended September 30, 2023. The decrease of $0.7 million was primarily attributable to lower personnel costs and professional fees. Total operating expenses decreased to approximately $10.2 million for the three months ended September 30, 2024, from $10.5 million for the three months ended September 30, 2023. Net interest expenses increased to approximately $0.5 million for the three months ended September 30, 2024, from $0.3 million for the three months ended September 30, 2023. Cash and cash equivalents as of September 30, 2024 totaled approximately $49.8 million. Conference Details Date: November 14, 2024Time: 8:30 a.m. ETDial-in 1-877-704-4453 or 1-201-389-0920Webcast Registration: Click HereCall Me™ Registration: Click Here (Available 15 minutes prior to call) About PDS Biotechnology PDS Biotechnology is a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines. The Company plans to initiate a pivotal clinical trial to advance its lead program in advanced HPV16-positive head and neck squamous cell cancers. PDS Biotech’s lead investigational targeted immunotherapy Versamune® HPV is being developed in combination with a standard-of-care immune checkpoint inhibitor, and also in a triple combination including PDS01ADC, an IL-12 fused antibody drug conjugate (ADC), and a standard-of-care immune checkpoint inhibitor. For more information, please visit www.pdsbiotech.com Forward Looking Statements This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for Versamune® HPV, PDS01ADC and other Versamune® and Infectimune® based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning Versamune® HPV, PDS01ADC and other Versamune® and Infectimune® based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company’s currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the Company’s ability to continue as a going concern; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company 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.   Versamune® and Infectimune® are registered trademarks of PDS Biotechnology Corporation. Keytruda® is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, N.J., USA. Xtandi® is a registered trademark of Astellas Pharma Inc. Investor Contact:Mike MoyerLifeSci AdvisorsPhone +1 (617) 308-4306 Email: mmoyer@lifesciadvisors.com Media Contact:Janine McCargo6 DegreesPhone +1 (646) 528-4034Email: jmccargo@6degreespr.com PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARY Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) Three Months Ended Sep 30, Nine Months Ended Sep 30, 2024 2023 2024 2023 Operating expenses: Research and development expenses $6,803,900 $6,448,528 $18,035,762 $20,297,066 General and administrative expenses $3,374,794 $4,071,158 $10,924,863 $12,341,207 Total operating expenses $10,178,694 $10,519,686 $28,960,625 $32,638,273 Loss from operations $(10,178,694) $(10,519,686) $(28,960,625) $(32,638,273) Interest income (expense), net Interest income $666,770 $739,404 $2,010,874 $2,219,399 Interest expense $(1,214,734) $(1,068,887) $(3,577,450) $(3,031,129) Interest income (expense), net $(547,964) $(329,483) $(1,566,576) $(811,730) Loss before income taxes $(10,726,658) $(10,849,169) $(30,527,201) $(33,450,003) Benefit for income taxes $869,169 $1,406,021 Net loss and comprehensive loss $(10,726,658) $(10,849,169) $(29,658,032) $(32,043,982) Per share information: Net loss per share, basic and diluted $(0.29) $(0.35) $(0.82) $(1.04) Weighted average common shares outstanding basic and diluted 36,806,592 30,910,520 36,107,900 30,715,458 PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARY Unaudited Selected Balance Sheet Data Sep 30,December 31, 2024 2023 Cash and cash equivalents$49,751,252 $56,560,517 Working capital$33,791,108 $45,425,098 Total assets$52,450,653 $59,390,080 Long term debt$12,031,986 $19,506,183 Accumulated deficit$(174,158,647)$(144,500,615)Total stockholders’ equity$22,000,805 $26,130,947

Phase 2ImmunotherapyASCOFinancial Statement

12 Nov 2024

·www.globenewswire.com

FibroGen Reports Third Quarter 2024 Financial Results

Topline results from Phase 2 portion of the investigator-sponsored study of FG-3246, a first-in-class antibody-drug conjugate (ADC) targeting CD46, in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC) are expected in 1H 2025Initiation of Phase 2 monotherapy dose optimization study of FG-3246 in mCRPC anticipated in 1Q 2025Third quarter net revenue growth of 15% year over year, driven by strong performance of roxadustat in China, with year over year volume growth of 34% Reiterate full year net product revenue guidance of $135 million to $150 million, representing full year total roxadustat net sales in China1 between $330 million to $350 million Meaningful progress on U.S. cost reduction plan Expected to be substantially complete by year-end 2024 Cash, cash equivalents and accounts receivable balance of $160.0 million SAN FRANCISCO, Nov. 12, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today reported financial results for the third quarter 2024 and provided an update on the company’s recent developments. “This past quarter we transformed into a lean and more focused organization, resulting in significant cost savings that will extend into the future. Moreover, roxadustat continued its impressive performance, generating $96.6 million in net sales in China during the quarter,” said Thane Wettig, Chief Executive Officer, FibroGen. “Having implemented our cost reduction plan, we are well positioned to advance FG-3246, with topline results from the Phase 2 portion of the investigator-sponsored study of FG-3246 in combination with enzalutamide at the University of California San Francisco (UCSF) on track for the first half of 2025, and the anticipated start of our Phase 2 monotherapy trial in the first quarter of 2025. We continue to be optimistic about our future prospects.” Recent Developments and Key Events of Third Quarter 2024: Meaningful progress on U.S. cost reduction plan. Expected to be substantially complete by year-end 2024 Reported topline results from the pamrevlumab arm of PanCAN Precision Promise Phase 2/3 adaptive platform trial for the treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC), in which the trial did not meet the primary endpoint.Reported topline results from the LAPIS Phase 3 study of pamrevlumab in patients with locally advanced, unresectable pancreatic cancer (LAPC), in which the trial did not meet the primary endpoint. Upcoming Milestones: Roxadustat Expect approval decision for roxadustat in chemotherapy-induced anemia (CIA) in China in early 2025. If approved, FibroGen will receive a $10 million milestone payment from AstraZeneca. FG-3246 and FG-3180 (PET Imaging Agent) Topline results from the Phase 2 portion of the investigator-sponsored Phase 1b/2 study conducted by UCSF of FG-3246 in combination with enzalutamide in patients with mCRPC expected in 1H 2025.Anticipate initiation of Phase 2 monotherapy dose optimization study of FG-3246 in mCRPC in 1Q 2025. This trial will include a sub-study of FG-3180 to enable assessment of CD46 expression and response to FG-3246. China: Third quarter FibroGen net product revenue under U.S. GAAP from the sale of roxadustat in China was $46.2 million compared to $29.4 million in the third quarter of 2023, an increase of 57% year over year.Third quarter total roxadustat net sales in China1 by FibroGen and the distribution entity jointly owned by FibroGen and AstraZeneca (JDE) was $96.6 million, compared to $77.1 million in the third quarter of 2023, an increase of 25% year over year, driven by a 34% increase in volume.Roxadustat continues to be the number one brand based on value share in the anemia of CKD market in China.For 2024, FibroGen’s expected full year net product revenue under U.S. GAAP reiterated to a range between $135 million to $150 million, representing expected full year roxadustat net sales in China1 by FibroGen and the JDE of $330 million to $350 million. Financial: Total revenue for the third quarter of 2024 was $46.3 million, as compared to $40.1 million for the third quarter of 2023, an increase of 15% year over year.Net loss for the third quarter of 2024 was $17.1 million, or $0.17 net loss per basic and diluted share, compared to a net loss of $63.6 million, or $0.65 net loss per basic and diluted share one year ago.At September 30, 2024, FibroGen reported $160.0 million in cash, cash equivalents and accounts receivable.Assuming additional repatriation of cash from our China operations, we expect our cash, cash equivalents and accounts receivable to be sufficient to fund our operating plans into 2026. Conference Call and Webcast Details FibroGen management will host a conference call and webcast today, Tuesday, November 12, 2024, at 5:00 PM Eastern Time to discuss financial results and provide a business update. Interested parties may access the conference call by dialing 1-877-300-8521 (in the U.S.) or 1-412-317-6026 (outside the U.S.). The call will be available via webcast by clicking here or on the “Events and Presentation” page on the FibroGen website. About RoxadustatRoxadustat, an oral medication, is the first in a new class of medicines comprising HIF-PH inhibitors that promote erythropoiesis, or red blood cell production, through increased endogenous production of erythropoietin, improved iron absorption and mobilization, and downregulation of hepcidin. Roxadustat is in clinical development for chemotherapy-induced anemia (CIA) and a Supplemental New Drug Application (sNDA) has been accepted by the China Health Authority. Roxadustat is approved in China, Europe, Japan, and numerous other countries for the treatment of anemia of CKD in adult patients on dialysis (DD) and not on dialysis (NDD). Astellas and FibroGen are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia in territories including Japan, Europe, Turkey, Russia, and the Commonwealth of Independent States, the Middle East, and South Africa. AstraZeneca and FibroGen continue to collaborate on the development and commercialization of roxadustat in China. About FibroGen FibroGen, Inc. is a biopharmaceutical company focused on accelerating the development of novel therapies at the frontiers of cancer biology. Roxadustat (爱瑞卓®, EVRENZOTM) is currently approved in China, Europe, Japan, and numerous other countries for the treatment of anemia in chronic kidney disease (CKD) patients on dialysis and not on dialysis. Roxadustat is in clinical development for chemotherapy-induced anemia (CIA) and a Supplemental New Drug Application (sNDA) has been accepted for review by the China Health Authority. FG-3246 (also known as FOR46), a first-in-class antibody-drug conjugate (ADC) targeting CD46 is in development for the treatment of metastatic castration-resistant prostate cancer. This program also includes the development of an associated CD46-targeted PET imaging agent, FG-3180. In addition, FibroGen’s research and development portfolio includes two immuno-oncology product candidates for the treatment of solid tumors. For more information, please visit www.fibrogen.com. Forward-Looking Statements This release contains forward-looking statements regarding FibroGen’s strategy, future plans and prospects, including statements regarding its commercial products and clinical programs and those of its collaboration partners Fortis and UCSF. These forward-looking statements include, but are not limited to, statements regarding the efficacy, safety, and potential clinical or commercial success of FibroGen products and product candidates, statements under the caption “Upcoming Milestones”, statements regarding the potential for cash, cash equivalents and accounts receivable to fund FibroGen’s operating plans into 2026, and statements about FibroGen’s plans and objectives. These forward-looking statements are typically identified by use of terms such as “may,” “will”, “should,” “on track,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. FibroGen’s actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties related to the continued progress and timing of its various programs, including the enrollment and results from ongoing and potential future clinical trials, and other matters that are described in FibroGen’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, and our Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, each as filed with the Securities and Exchange Commission (SEC), including the risk factors set forth therein. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and FibroGen undertakes no obligation to update any forward-looking statement in this press release, except as required by law. 1 Total roxadustat net sales in China includes sales made by the distribution entity as well as FibroGen China’s direct sales, each to its own distributors. The distribution entity jointly owned by AstraZeneca and FibroGen is not consolidated into FibroGen’s financial statements. Condensed Consolidated Balance Sheets(In thousands) September 30, 2024 December 31, 2023 (Unaudited) (1) Assets Current assets: Cash and cash equivalents$131,003 $113,688 Short-term investments — 121,898 Accounts receivable, net 29,030 12,553 Inventory 23,937 41,565 Prepaid expenses and other current assets 60,559 41,855 Total current assets 244,529 331,559 Restricted time deposits 1,658 1,658 Property and equipment, net 7,603 13,126 Equity method investment in unconsolidated variable interest entity 5,806 5,290 Operating lease right-of-use assets 2,093 68,093 Other assets 2,732 3,803 Total assets$264,421 $423,529 Liabilities, stockholders’ equity and non-controlling interests Current liabilities: Accounts payable$9,238 $17,960 Accrued and other liabilities 151,141 172,891 Deferred revenue 28,858 12,740 Operating lease liabilities, current 1,293 14,077 Total current liabilities 190,530 217,668 Product development obligations 18,199 17,763 Deferred revenue, net of current 126,219 157,555 Operating lease liabilities, non-current 707 66,537 Senior secured term loan facilities, non-current 72,779 71,934 Liability related to sale of future revenues, non-current 56,850 51,413 Other long-term liabilities 837 2,858 Total liabilities 466,121 585,728 Redeemable non-controlling interests 21,480 21,480 Total stockholders’ deficit attributable to FibroGen (243,667) (204,166) Nonredeemable non-controlling interests 20,487 20,487 Total deficit (223,180) (183,679) Total liabilities, redeemable non-controlling interests and deficit$264,421 $423,529 (1) The condensed consolidated balance sheet amounts at December 31, 2023 are derived from audited financial statements. Condensed Consolidated Statements of Operations(In thousands, except per share data) Three Months Ended September 30, Nine Months Ended September 30, 2024 2023 2024 2023 (Unaudited) Revenue: License revenue$— $2,649 $— $9,649 Development and other revenue 385 6,775 1,532 15,825 Product revenue, net 46,210 29,390 126,391 77,439 Drug product revenue, net (262) 1,320 24,954 17,701 Total revenue 46,333 40,134 152,877 120,614 Operating costs and expenses: Cost of goods sold 5,295 4,243 36,227 13,441 Research and development 21,708 61,194 94,206 231,158 Selling, general and administrative 17,554 25,573 62,650 91,029 Restructuring charge 18,554 12,606 18,554 12,606 Total operating costs and expenses 63,111 103,616 211,637 348,234 Loss from operations (16,778) (63,482) (58,760) (227,620) Interest and other, net: Interest expense (4,994) (5,022) (14,774) (10,464)Interest income and other income (expenses), net 3,802 4,296 5,092 7,984 Total interest and other, net (1,192) (726) (9,682) (2,480) Loss before income taxes (17,970) (64,208) (68,442) (230,100)Benefit from income taxes 12 84 (217) (77)Investment income in unconsolidated variable interest entity 898 677 2,664 2,023 Net loss$(17,084) $(63,615) $(65,561) $(228,000) Net loss per share - basic and diluted$(0.17) $(0.65) $(0.66) $(2.35) Weighted average number of common shares used to calculate net loss per share - basic and diluted 100,515 98,245 99,780 96,901 For Investor Inquiries:David DeLucia, CFAVice President of Corporate FP&A / Investor Relationsir@fibrogen.com

Clinical ResultDrug ApprovalFinancial StatementPhase 3ADC

01 Nov 2024

·endpts.com

Essa’s shares tank as it looks for options after abandoning prostate cancer drug

Essa Pharma is exploring “strategic options” as it ends work on its prostate cancer drug that failed a mid-stage test. The company’s shares $EPIX nosedived by as much as 65% premarket Friday. In a planned Phase 2 interim analysis of 52 metastatic castration-resistant prostate cancer patients, Essa’s masofaniten plus Astellas and Pfizer’s Xtandi delivered a response rate of 64% in the primary endpoint of PSA90. But participants given Xtandi alone had a higher rate of 73%. The trial recruited patients who are naive to second-generation antiandrogens. A futility analysis suggested a low likelihood of the trial meeting its primary endpoint, the company said. Single-agent Xtandi showed a “much higher rate of PSA90 response … than were expected based upon historical data,” it added in a Thursday release . Astellas was supplying Xtandi for the Phase 2 under the terms of a 2021 clinical collaboration and supply agreement . Also, the South San Francisco-based biotech is ending a separate, early-stage test of masofaniten plus Johnson & Johnson’s Zytiga and Erleada in prostate cancer. Any investigator-sponsored trials will also be wrapped up, with Essa pulling all INDs and clinical trial applications for the drug. Essa said it is now focused on reviewing its “strategic options.” The company had $126.8 million in cash reserves and short-term investments as of the end of September. Prostate cancer is a notoriously challenging indication, with several drugmakers such as MacroGenics and Exelixis struggling to clear clinical hurdles this year.

Phase 2License out/inClinical ResultPhase 3

100 Deals associated with Enzalutamide

External Link

KEGG	Wiki	ATC	Drug Bank
D10218	Enzalutamide	L02BB04	DB08899

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Castration-sensitive prostate cancer	US	Astellas Pharma US, Inc.	16 Nov 2023
HRR Gene-mutated Castration-Resistant Prostate Cancer	US	Pfizer Inc.	20 Jun 2023
Castration-Resistant Prostatic Cancer	EU	Astellas Pharma Europe Ltd.	21 Jun 2013
Castration-Resistant Prostatic Cancer	IS	Astellas Pharma Europe Ltd.	21 Jun 2013
Castration-Resistant Prostatic Cancer	LI	Astellas Pharma Europe Ltd.	21 Jun 2013
Castration-Resistant Prostatic Cancer	NO	Astellas Pharma Europe Ltd.	21 Jun 2013
Hormone-dependent prostate cancer	EU	Astellas Pharma Europe Ltd.	21 Jun 2013
Hormone-dependent prostate cancer	IS	Astellas Pharma Europe Ltd.	21 Jun 2013
Hormone-dependent prostate cancer	LI	Astellas Pharma Europe Ltd.	21 Jun 2013
Hormone-dependent prostate cancer	NO	Astellas Pharma Europe Ltd.	21 Jun 2013
Metastatic castration-resistant prostate cancer	US	Astellas Pharma US, Inc.	31 Aug 2012

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Prostatic Cancer	Phase 3	CN	Astellas Pharma China, Inc.	11 Sep 2019
Alzheimer Disease	Phase 3	CN	Astellas Pharma China, Inc.	02 Sep 2019
Alzheimer Disease	Phase 3	CN	Astellas Pharma Global Development, Inc.	02 Sep 2019
Advanced Triple-Negative Breast Carcinoma	Phase 3	US	Astellas Pharma, Inc.	01 Sep 2016
Advanced Triple-Negative Breast Carcinoma	Phase 3	US	Pfizer Inc.	01 Sep 2016
Advanced Triple-Negative Breast Carcinoma	Phase 3	US	MediVation, Inc.	01 Sep 2016
Adenocarcinoma of prostate	Phase 3	US	MediVation, Inc.	22 Jan 2014
Adenocarcinoma of prostate	Phase 3	US	Astellas Pharma US, Inc.	22 Jan 2014
Adenocarcinoma of prostate	Phase 3	CA	Astellas Pharma US, Inc.	22 Jan 2014
Adenocarcinoma of prostate	Phase 3	CA	MediVation, Inc.	22 Jan 2014

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03464201 (GETHI2016-01, Pubmed \| Gynecol Oncol)	Phase 2	Granulosa Cell Tumor of the Ovary hormone receptors	16	Enzalutamide 160 mg	crvshjevoy(rjrwdplkmm) = alyngvxqpb ylnshacbww (lmkqepiqyj, 46 - 91.5)	Positive	01 Dec 2024
NCT05075577 (PRNewswire) Manual	Phase 2	Metastatic castration-resistant prostate cancer	120	Enzalutamide 160mg QD	tkycnacyze(emulaemgct) = xtukoyrzaw qdjmcimejd (oafwgofmhf ) Not Met View more	Negative	31 Oct 2024
				Masofaniten 600mg BID + enzalutamide 160mg QD	tkycnacyze(emulaemgct) = peilzwopts qdjmcimejd (oafwgofmhf ) Not Met View more
NCT03395197 (TALAPRO-2, PipelineReview) Manual	Phase 3	Metastatic castration-resistant prostate cancer	-	talazoparib + enzalutamide	rxhcyktkob(tnuruzauvr) = Results showed a statistically significant and clinically meaningful improvement in the final OS in all-comers (cohort 1) as well as in those patients with homologous recombination repair (HRR) gene-mutated mCRPC (cohort 2), compared to XTANDI alone. hshnfgmszc (krbpmpwhxy )	Positive	10 Oct 2024
NCT04179864 (EZH-1101, ESMO2024) Manual	Phase 1/2	Metastatic castration-resistant prostate cancer	81	TAZ 1200 mg BID plus ENZ 160 mg QD	nmlmfjkuij(zzaduscrxv) = vpsxxjvkdl qcparqzuxe (zjtnllbvrd, 8.5 - NE) View more	Negative	15 Sep 2024
				ENZ 160 mg QD	nmlmfjkuij(zzaduscrxv) = hxmxemjxus qcparqzuxe (zjtnllbvrd, 6.6 - NE) View more
NCT03395197 (TALAPRO-2, ESMO2024) Manual	Phase 3	Metastatic castration-resistant prostate cancer First line	125	Talazoparib + Enzalutamide	wmtttsjavf(igclddzxie) = feraciuebd xjnlnmmshb (hvzymxssza ) View more	Positive	15 Sep 2024
				Placebo + Enzalutamide	wmtttsjavf(igclddzxie) = wfwfdcuosx xjnlnmmshb (hvzymxssza ) View more
NCT02319837 (EMBARK, ESMO2024)	Phase 3	Non-metastatic prostate cancer prostate-specific antigen (PSA) doubling time	-	Enzalutamide + Leuprolide	dxayurccvv(iiedvgqdbd) = Serious adverse events (AEs) were more common in older pts, but were low regardless of age. kfbojpnfkv (nmbzjisyng ) View more	Positive	15 Sep 2024
				Leuprolide alone
NCT02861573 (KEYNOTE-365, Pubmed \| Eur Urol Oncol) Manual	Phase 1/2	Metastatic castration-resistant prostate cancer First line prostate-specific antigen	102	pembrolizumab plus enzalutamide	osmtzdvcul(uvqvxopoih) = edvmbnhbsr bsydsnjdna (cjnrzpsdyq, 2.9 - 25) View more	Negative	01 Jun 2024
NCT02446405 (ENZAMET \| ANZUP 1304, ASCO2024) Manual	Phase 3	Castration-sensitive prostate cancer	1,125	TS+NSAA（±Doc） (PSA ≤0.2ng/mL)	dznhpaoupk(fzcpwgkprr) = hpbzoiodql ssiweyyatt (domkjpogyh ) View more	Positive	24 May 2024
				TS + ENZA (±Doc) (PSA ≤0.2ng/mL)	dznhpaoupk(fzcpwgkprr) = bgflukispz ssiweyyatt (domkjpogyh ) View more
NCT02935205 (ASCO2024)	Phase 1/2	Metastatic castration-resistant prostate cancer aldo-keto reductase 1C3 (AKR1C3)	26	Enzalutamide 160 mg	brkoxkbdbi(kshiyfrifl) = cxuulezjyb wufbqxvfna (mfbmstiaeu )	Positive	24 May 2024
				Indomethacin 50mg PO twice daily	vcfmujxoqs(cwohpvszdl) = kfbcbykcjl godnmbagpl (zpfklzdggv )

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