A Phase Ib/II Open-Label, Dose-Escalation, Safety, Pharmacokinetic, Pharmacodynamic and Efficacy Study of Bemcentinib Plus Pacritinib In Patients With Advanced Lung Adenocarcinoma

This is a Phase Ib/II, open-label, single institution dose-escalation, safety, pharmacokinetics, pharmacodynamic and efficacy study.

Start Date01 Sep 2024

Sponsor / Collaborator

University of Texas Health Science Center At San Antonio

[+1]

NCT05469178 / RecruitingPhase 1/2

Phase 1b/2a Safety and Tolerability Study of Bemcentinib With Pembrolizumab/Carboplatin/Pemetrexed in Subjects With Untreated Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) Without/With a STK11 Mutation

The primary purpose of this study is to determine the safety and tolerability of the combination of bemcentinib with chemo-immunotherapy (CIT) to identify the recommended phase 2 dose (RP2D) when administered as first line (1L) treatment in participants with locally advanced (Stage IIIb/IIIC) or metastatic (Stage IV) non-squamous NSCLC with no actionable mutations and to determine the anti-tumor activity of the combination of bemcentinib with CIT when administered as 1L treatment in participants with locally advanced (Stage IIIb/IIIc) or metastatic (Stage IV) non-squamous NSCLC with serine/threonine kinase 11 (STK11) mutation and no actionable mutations.

Start Date14 Dec 2022

Sponsor / Collaborator

BerGenBio ASA

CTIS2022-500363-12-00 / Not yet recruitingIIT

Efficacy and Safety of AXL-Inhibitor bemcentinib for the Treatment of Moderate COVID-19 (AXL-SolidAct) - AXL-SolidAct

Start Date27 Sep 2022

Sponsor / Collaborator-

100 Clinical Results associated with Bemcentinib

100 Translational Medicine associated with Bemcentinib

100 Patents (Medical) associated with Bemcentinib

139

Literatures (Medical) associated with Bemcentinib

01 Dec 2024·Experimental Neurology

Gas6/Axl signaling promotes hematoma resolution and motivates protective microglial responses after intracerebral hemorrhage in mice

Article

Author: Ye, Xiang-Hua ; Shen, Dan ; Tong, Lu-Sha ; Gao, Feng ; Jin, Yu-Jia ; Li, Jia-Wen ; Xu, Xu-Hua ; Xu, Zhi-Ming

BACKGROUNDIntracerebral hemorrhage (ICH) stands out as the most fatal subtype of stroke, currently devoid of effective therapy. Recent research underscores the significance of Axl and its ligand growth arrest-specific 6 (Gas6) in normal brain function and a spectrum of neurological disorders, including ICH. This study is designed to delve into the role of Gas6/Axl signaling in facilitating hematoma clearance and neuroinflammation resolution following ICH.METHODSAdult male C57BL/6 mice were randomly assigned to sham and ICH groups. ICH was induced by intrastriatal injection of autologous arterial blood. Recombinant mouse Gas6 (rmGas6) was administered intracerebroventricularly 30 min after ICH. Virus-induced knockdown of Axl or R428 (a selective inhibitor of Axl) treatment was administrated before ICH induction to investigate the protective mechanisms. Molecular changes were assessed using western blot, enzyme-linked immunosorbent assay and immunohistochemistry. Coronal brain slices, brain water content and neurobehavioral tests were employed to evaluate histological and neurofunctional outcomes, respectively. Primary glia cultures and erythrophagocytosis assays were applied for mechanistic studies.RESULTSThe expression of Axl increased at 12 h after ICH, peaking on day 3. Gas6 expression did not remarkably changed until day 3 post-ICH. Early administration of rmGas6 following ICH significantly reduced hematoma volume, mitigated brain edema, and restored neurological function. Both Axl-knockdown and Axl inhibitor treatment abolished the neuroprotection of exogenous Gas6 in ICH. In vitro studies demonstrated that microglia exhibited higher capacity for phagocytosing eryptotic erythrocytes compared to normal erythrocytes, a process reversed by blocking the externalized phosphatidylserine on eryptotic erythrocytes. The erythrophagocytosis by microglia was Axl-mediated and Gas6-dependent. Augmentation of Gas6/Axl signaling attenuated neuroinflammation and drove microglia towards pro-resolving phenotype.CONCLUSIONSThis study demonstrated the beneficial effects of recombinant Gas6 on hematoma resolution, alleviation of neuroinflammation, and neurofunctional recovery in an animal model of ICH. These effects were primarily mediated by the phagocytotic role of Axl expressed on microglia.

01 Nov 2024·Transplantation

Gas6/AXL Alleviates Hepatic Ischemia/Reperfusion Injury by Inhibiting Ferroptosis via the PI3K/AKT Pathway

Article

Author: Du, Jian ; Wang, Zhen ; Liu, Deng ; Chen, Lijian ; Wang, Weizhi ; Fang, Qi ; Zhang, Ruixin ; Zhan, Mengting ; Yao, Lei ; Xu, Yaru ; Yan, Qi

Background.Hepatic ischemia/reperfusion (I/R) injury is a major cause of complications in clinical liver surgery. AXL receptor tyrosine kinase (AXL) is a member of the TAM receptor tyrosine kinase family (TYRO3, AXL, and MERTK). Our previous study has shown that AXL expression was markedly upregulated in liver transplantation patients. However, the underlying mechanism of AXL in hepatic I/R injury remains unclear.Methods.A mouse liver warm I/R model and a primary hepatocyte hypoxia/reoxygenation model were established to investigate the role of AXL activation and ferroptosis in hepatic I/R injury by pretreating with recombinant mouse growth arrest-specific protein 6 (AXL activator) or R428 (AXL inhibitor). Moreover, we used LY294002 (phosphatidylinositol 3-kinase [PI3K] inhibitor) to evaluate the relationship between the PI3K/AKT (the Ser and Thr kinase AKT) pathway and ferroptosis in hepatic I/R injury.Results.Hepatic I/R injury decreased phosphorylation AXL expression and enhanced ferroptosis in liver transplantation patients and hepatic I/R-subjected mice. AXL activation attenuated lipid peroxidation and ferroptosis in hepatic I/R injury in vivo and in vitro. Inhibition of AXL activation exacerbated liver pathological damage and liver dysfunction, as well as iron accumulation and lipid peroxidation in hepatic I/R injury. Mechanistically, activated growth arrest-specific protein 6/AXL and its downstream PI3K/AKT signaling pathway inhibited ferroptosis during hepatic I/R injury.Conclusions.AXL activation protects against hepatic I/R injury by preventing ferroptosis through the PI3K/AKT pathway. This study is the first investigation on the AXL receptor and ferroptosis, and activating AXL to mitigate ferroptosis may be an innovative therapeutic strategy to combat hepatic I/R injury.

07 Oct 2024·Oncogene

Targeting MERTK on tumour cells and macrophages: a potential intervention for sporadic and NF2-related meningioma and schwannoma tumours

Article

Author: Hanemann, C. Oliver ; Ercolano, Emanuela ; Adams, Claire L ; Dave, Foram ; Hilton, David A. ; van de Weijer, Laurien L ; Kurian, Kathreena M ; Henderson, Summer ; van de Weijer, Laurien L. ; Herrera, Kevin ; Sofela, Agbolahan A. ; Sofela, Agbolahan A ; Maze, Emmanuel A ; Lockley, Alex ; Kurian, Kathreena M. ; Adams, Claire L. ; Ammoun, Sylwia ; Maze, Emmanuel A. ; Hilton, David A ; Hook, Laura ; Hanemann, C Oliver

Meningioma and schwannoma are common tumours of the nervous system. They occur sporadically or as part of the hereditary NF2-related schwannomatosis syndrome. There is an unmet need for new effective drug treatments for both tumour types. In this paper, we demonstrate overexpression/activation of TAM (TYRO3/AXL/MERTK) receptors (TAMs) and overexpression/release of ligand GAS6 in patient-derived meningioma tumour cells and tissue. For the first time, we reveal the formation of MERTK/TYRO3 heterocomplexes in meningioma and schwannoma tissue. We demonstrate the dependence of AXL and TYRO3 expression on MERTK in both tumour types, as well as interdependency of MERTK and AXL expression in meningioma. We show that MERTK and AXL contribute to increased proliferation and survival of meningioma and schwannoma cells, which we inhibited in vitro using the MERTK/FLT3 inhibitor UNC2025 and the AXL inhibitor BGB324. UNC2025 was effective in both tumour types with superior efficacy over BGB324. Finally, we found that TAMs are expressed by tumour-associated macrophages in meningioma and schwannoma tumours and that UNC2025 strongly depleted macrophages in both tumour types.

News (Medical) associated with Bemcentinib

07 Oct 2024

·www.prnewswire.com

BerGenBio Announces Safety Data from Dose Escalation Phase 1b in First Line NSCLC Patients

Ph1b data support safety, predictable PK and adequate plasma exposure BERGEN, Norway, Oct. 7, 2024 /PRNewswire/ -- BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical needs, announced today preliminary safety data from the Phase 1b portion of the BGBC016 study in first-line (1L) Non-Small Cell Lung Cancer (NSCLC) patients. The Phase 1b part of the study evaluated three escalating doses of BerGenBio's selective AXL inhibitor bemcentinib in combination with standard chemo-immunotherapy (CIT), doublet chemotherapy and pembrolizumab, Keytruda®, for the 1L treatment of advanced/metastatic NSCLC patients. The primary endpoint was the assessment of the safety profile of the combination in NSCLC patients regardless of their STK11 mutational status. Key conclusions include: All three selected doses demonstrated that the triplet combination is well tolerated with no new safety signals identified, supporting the further clinical development of bemcentinib and CIT in 1L NSCLC patients. No dose-related impact on electrocardiographic changes (QTc), a known class effect of tyrosine kinase inhibitors, was reported for bemcentinib during the observation period. Pharmacokinetic analyses confirmed adequate plasma exposure of bemcentinib, achieving levels consistent with that previously observed in responders in BerGenBio's BGBC008 study of bemcentinib and pembrolizumab in second-line NSCLC patients. Martin Olin, Chief Executive Officer of BerGenBio, commented: "The data show that bemcentinib has a manageable safety profile and gives us increased confidence in continuing the BGBC016 clinical trial. The global trial is currently enrolling patients in Phase 2a targeting patients with a mutation in the STK11 gene, and we look forward to sharing the first preliminary data as they mature." Contacts Martin Olin CEO, BerGenBio ASA [email protected] Rune Skeie, CFO, BerGenBio ASA [email protected] Investor Relations / Media Relations Jan Lilleby [email protected] About STK11m NSCLC Patients with STK11m NSCLC have a significantly poorer response to current therapies, including immune checkpoint inhibitors, when compared with patients with wild-type (non-mutated) STK11. AXL plays a significant role in the survival and spread of cancer and STK11m NSCLC patients have a high expression of AXL suggesting that AXL is an important target to prevent disease progression and resistance to existing therapies. Bemcentinib's selective inhibition of AXL has been shown to improve the response to immune checkpoint inhibition in STK11m patient-derived preclinical models and in early clinical studies. There are currently no targeted therapies available for the STK11m NSCLC patient population, which represents up to 20% of 1L NSCLC patients. About BerGenBio ASA BerGenBio is a clinical-stage biopharmaceutical company focused on developing transformative drugs targeting AXL as a potential cornerstone of therapy for aggressive diseases, including cancer and severe respiratory infections. The Company is focused on its proprietary lead candidate, bemcentinib, a potentially first-in-class selective AXL inhibitor in development for STK11 mutated NSCLC and severe respiratory infections. BerGenBio is based in Bergen, Norway with a subsidiary in Oxford, UK. The company is listed on the Oslo Stock Exchange (ticker: BGBIO). For more information, visit This information is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act. This information was brought to you by Cision SOURCE BerGenBio ASA WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ImmunotherapyPhase 1Phase 2Clinical Result

21 Aug 2024

·www.prnewswire.com

BerGenBio Second Quarter Results 2024: Solid clinical and financial progress

BERGEN, Norway, Aug. 21, 2024 /PRNewswire/ -- BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical needs, today announced financial results for the quarter and half year ended June 30, 2024, and provided a business update. Highlights, including post period: BGBC016 1L NSCLC STK11m study continues to progress as planned. Enrollment in the Ph1b part completed. Data Safety Monitoring Board review of data from the final Ph1b dose cohort supports safety and tolerability of the combination of bemcentinib with standard of care chemo/immunotherapy allowing initiation of the 2 nd dose in the Ph2a part. All Ph2a sites have now been activated. Innovative approach established with leading genomic AI provider to accelerate development of bemcentinib. Established data and regulatory collaboration with technology company Tempus AI (Nasdaq: TEM) to provide prospective comparative clinical data from 1L STK11m NSCLC patients to aid in the evaluation of BGBC016 results. Strengthened financial position. Secured gross funding of NOK 138.9 million from warrant exercise in June 2024 securing funding into H2 2025. Financial position of NOK 200.1 million end of Q2 2024. Stable cash use. Continued decreased and stabilized operating expenses at NOK 90.5 million for first half 2024 compared to NOK 120.2 million in first half 2023. Operating expenses NOK 50.8 million in Q2 2024 compared to NOK 47.8 million in Q2 2023. Martin Olin, Chief Executive Officer of BerGenBio stated: "The BGBC016 clinical trial continued to progress well during the quarter. An independent review of the final cohort in the Ph1b part showed acceptable safety allowing initiation of the 2nd dose in the Ph2a part, and we completed the activation of the Ph2a sites. We now look forward to sharing preliminary efficacy data from the Ph2a portion of the study as they mature. During the quarter we strengthened our financial position which will, combined with our continuing cost discipline, fund our planned activities into the second half of 2025. The BGBC016 clinical trial is our highest priority, and we remain dedicated to unlocking the significant value potential in bemcentinib." Presentation and Financial Report The Q2 2024 Financial report is attached to this stock exchange announcement and the report and the Q2 2024 presentation are available at the Company's website . Webcast details BerGenBio's senior management team will provide a business update today at 9:45 am CET. The presentation will webcast live. To participate in the webcast, please use the following link: A recording of the webcast will be available at in the Investors/Financial Reports section () shortly afterwards. Contacts Martin Olin CEO, BerGenBio ASA [email protected] Rune Skeie, CFO, BerGenBio ASA [email protected] Media Relations Jan Lilleby [email protected] About BerGenBio ASA BerGenBio is a clinical-stage biopharmaceutical company focused on developing transformative drugs targeting AXL as a potential cornerstone of therapy for aggressive diseases, including cancer and severe respiratory infections. The Company is focused on its proprietary lead candidate, bemcentinib, a potentially first-in-class selective AXL inhibitor in clinical development for STK11 mutated NSCLC and preclinical development for severe respiratory infections. BerGenBio is based in Bergen, Norway, with a subsidiary in Oxford, UK. The company is listed on the Oslo Stock Exchange (ticker: BGBIO). For more information, visit Forward looking statements This announcement may contain forward-looking statements, which as such are not historical facts, but are based upon various assumptions, many of which are based, in turn, upon further assumptions. These assumptions are inherently subject to significant known and unknown risks, uncertainties, and other important factors. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied in this announcement by such forward-looking statements. This information is considered to be inside information pursuant to the EU Market Abuse Regulation and subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act. This information was brought to you by Cision The following files are available for download:

Financial StatementClinical Study

20 Aug 2024

·www.prnewswire.com

BerGenBio Collaborates with Tempus to Potentially Accelerate Development in STK11m Non-Small Cell Lung Cancer

BERGEN, Norway, Aug. 20, 2024 /PRNewswire/ -- BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical needs, announced today a collaboration with Tempus, a technology company leading the adoption of AI to advance precision medicine and patient care, to advance the clinical development of BerGenBio's selective AXL inhibitor bemcentinib in first line (1L) Non-Small Cell Lung Cancer (NSCLC) patients with STK11 mutations (STK11m). BerGenBio's on-going BGBC016 Phase 1b/2a trial is designed to assess the benefit of adding bemcentinib to the current standard of care treatment (immunotherapy + doublet chemotherapy) in 1L STK11m patients, a population with poor outcomes and no specific therapies today. The collaboration will provide BerGenBio with access to a tailored cohort of Tempus' real-world clinical and molecular data that is intended to establish a synthetic control to provide a contextual benchmark for BerGenBio's innovative study, which aims to address the urgent medical need for effective treatments in STK11m NSCLC patients. Tempus' comprehensive, AI-enabled platform will enable BerGenBio to receive customized analyses of Tempus data and gain deeper insights into the genomic landscape and therapeutic responses of NSCLC patients with STK11m. Upon conclusion of the BGBC016 study, the parties intend to present insights derived from the resulting data to appropriate regulatory agencies as a next step in the further development of bemcentinib. Martin Olin, CEO of BerGenBio, expressed enthusiasm about the collaboration, stating, "We are excited to partner with Tempus to harness the power of their advanced technology in our mission to improve outcomes for NSCLC patients with STK11 mutations. By integrating Tempus' platform into our study, we aim to enhance our understanding of the disease biology and treatment outcomes, ultimately driving our ability to accelerate further development of bemcentinib". "We are excited to collaborate with BerGenBio to accelerate the development of precision therapies for STK11m NSCLC patients," said Kate Sasser, Chief Scientific Officer at Tempus. "Together, we aim to unlock new insights that will ultimately improve patient outcomes and redefine the standard of care in this challenging disease setting." For further information, please contact: Martin Olin CEO, BerGenBio ASA [email protected] Rune Skeie, CFO, BerGenBio ASA [email protected] Investor Relations / Media Relations Jan Lilleby [email protected] About BerGenBio ASA BerGenBio is a clinical-stage biopharmaceutical company focused on developing transformative drugs targeting AXL as a potential cornerstone of therapy for aggressive diseases, including cancer and severe respiratory infections. The Company is focused on its proprietary lead candidate, bemcentinib, a potentially first-in-class selective AXL inhibitor in development for STK11 mutated NSCLC and severe respiratory infections. BerGenBio is based in Bergen, Norway with a subsidiary in Oxford, UK. The company is listed on the Oslo Stock Exchange (ticker: BGBIO). For more information, visit This information is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act. This information was brought to you by Cision

ImmunotherapyClinical Study

100 Deals associated with Bemcentinib

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KEGG	Wiki	ATC	Drug Bank
D11438	Bemcentinib	-	DB12411

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Triple Negative Breast Cancer	Phase 2	NO	BerGenBio ASA	26 Jul 2017
Triple Negative Breast Cancer	Phase 2	GB	BerGenBio ASA	26 Jul 2017
Triple Negative Breast Cancer	Phase 2	US	BerGenBio ASA	26 Jul 2017
Metastatic melanoma	Phase 2	NO	BerGenBio ASA	13 Feb 2017
Acute Myeloid Leukemia	Phase 2	IT	BerGenBio ASA	01 Sep 2014
Acute Myeloid Leukemia	Phase 2	US	BerGenBio ASA	01 Sep 2014
Myelodysplastic Syndromes	Phase 2	IT	BerGenBio ASA	01 Sep 2014
Myelodysplastic Syndromes	Phase 2	US	BerGenBio ASA	01 Sep 2014
Non-Small Cell Lung Cancer	Phase 2	US	Rigel Pharmaceuticals, Inc.	-
Myelodysplastic Syndromes	Phase 1	NO	BerGenBio ASA	01 Sep 2014

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04890509 (CTgov)	Phase 2	COVID-19	115	SoC	aeguneakhf(ixbiptfwtm) = mrusknxryc gltuuhzuxr (pnriuamleg, hcjfwcydqn - zchwshuhsz) View more	-	16 Oct 2024
NCT02488408 (BGBC003, ASH2023)	Phase 1/2	Acute Myeloid Leukemia \| Myelodysplastic Syndromes	86	Bemcentinib Monotherapy	(hwwzfbgsoe) = nfkboysxwg mhmrijstrb (xbjgmkwhoq ) View more	-	11 Dec 2023
				Bemcentinib + Cytarabine	(hwwzfbgsoe) = jjqfkfmmtn mhmrijstrb (xbjgmkwhoq ) View more
NCT02488408 (BGBC003, ASH2023)	Phase 1/2	Acute Myeloid Leukemia	32	Bemcentinib + Low-dose Cytarabine	(bdiawlrovy) = nfrjvjgsld dsgweqoxsm (jxrybadqiz ) View more	-	09 Dec 2023
NCT03649321 (CTgov)	Phase 1/2	Secondary malignant neoplasm of pancreas	9	Nab-paclitaxel+gemcitabine+cisplatin+Bemcentinib (Phase 1b)	(mcltuitscv) = vjagyryqnm rycpasjitz (wdvtsevmbt, jtziymsoxd - pympegatfe) View more	-	09 Nov 2023
				Nab-paclitaxel+gemcitabine+Bemcentinib (Phase 2)	(mcltuitscv) = ppqoqfoeax rycpasjitz (wdvtsevmbt, newbdvjkge - hegpsnetfn) View more
NCT03184571 (BGBC008, ESMO2023) Manual	Phase 2	Non-Small Cell Lung Cancer Second line	99	Bemcentinib + Pembrolizumab	(puhfvjzbhd) = mvkhjjmity urbnxqaobf (bhgnbvgzll ) View more	Positive	23 Oct 2023
				Bemcentinib + Pembrolizumab (AXL TPS > 5)	(puhfvjzbhd) = eyrswlchts urbnxqaobf (bhgnbvgzll ) View more
NCT02872259 (BGBIL006, ESMO2023) Manual	Phase 1/2	Metastatic melanoma	68	Bemcentinib+PembrolizumabPem or D/TDabrafenibTrametinib (Bemcentinib+Pembrolizumab or Dabrafenib/Trametinib)	(ndeqnxhzbs) = hqnintvlju tvkhcaphdt (eztkrzwtjn ) View more	Negative	21 Oct 2023
				PembrolizumabPem or D/TDabrafenibTrametinib (Pembrolizumab or Dabrafenib/Trametinib)	-
NCT03654833 (MiST3, ASCO2023) Manual	Phase 2	Mesothelioma	26	Pembrolizumab+Bemcentinib	(rxxuankjqk) = pqpndlobvm ybeuuxeqlo (fivuonnmub, 29.2 - 63.4) View more	Positive	26 May 2023
NCT02922777 (ASCO2022) Manual	Phase 1	Non-Small Cell Lung Cancer First line	21	Docetaxel+Bemcentinib	(iuqkmrblwt) = 60 mg/m2 docetaxel plus 200 mg bemcentinib daily csqjjolqhj (kgmdkdizlj ) View more	Positive	02 Jun 2022
NCT02488408 (BGBC003, EHA2022) Manual	Phase 2	Acute Myeloid Leukemia	22	Cytarabine+Bemcentinib	(gnxvshyuou) = vcsiqjquhi vhklcfucwp (rtgayfeunn ) View more	Positive	12 May 2022
				Cytarabine+Bemcentinib (in 1st relapse)	(gnxvshyuou) = pvltwsslqj vhklcfucwp (rtgayfeunn ) View more
NCT04890509 (BGBIL019 \| ACCORD2, PRNewswire) Manual	Phase 2	COVID-19	61	Standard of Care+bemcentinib	(eypugxnybw) = ggbnphivgw hilsjcixme (ddfyzygdgh ) View more	Positive	26 Apr 2022
				Standard of Care	(eypugxnybw) = hcvaxgthwq hilsjcixme (ddfyzygdgh ) View more

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