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Archives: Press Releases

Cybrexa Therapeutics Selects Lead Clinical Candidate CBX-11, Combining its alphalex™ Technology with an Approved PARP Inhibitor to Treat Various Solid Tumors in Combination with Chemotherapy

CBX-11 selected based on robust efficacy and safety in combination with chemotherapy demonstrated in preclinical models

Positive pre-IND Meeting with FDA supports on track plan to file IND in Q4 2019

New Haven, Conn., January 2, 2019 – Cybrexa Therapeutics, a biotechnology company developing a new class of cancer therapeutics through its alphalex™ tumor-targeting platform, today announced that it has selected CBX-11 as its lead clinical development candidate for the treatment of patients with various solid tumors.

In addition, the company announced positive feedback from its pre-Investigational New Drug (IND) meeting with the U.S. Food and Drug Administration (FDA), concluding that the FDA agrees with the company’s proposed IND as well as the Phase 1 clinical development plans for CBX-11.

Cybrexa plans to submit the IND application for CBX-11 by the fourth quarter of 2019, with a Phase 1 clinical trial evaluating CBX-11 anticipated to begin in the first quarter of 2020.

CBX-11 combines Cybrexa’s proprietary alphalex™ technology with an already-approved oral small molecule poly ADP-ribose polymerase (PARP) inhibitor. CBX-11 will be evaluated as a monotherapy and in combination with chemotherapy.

Vishwas Paralkar, PhD, Cybrexa Chief Scientific Officer said, “The combination of PARP inhibitors with DNA damaging chemotherapy is believed to have significant anti-cancer potential. However, these combinations are often associated with potentially life-threatening toxicity, including bone marrow suppression. Our alphalex™ technology platform enables direct intracellular delivery of small molecule cancer therapeutics into tumor cells, while limiting off-target toxicity. We believe by leveraging alphalex™ with an approved PARP inhibitor taken in combination with chemotherapy, we will be able to mitigate toxic effects and provide potent, effective therapy for patients with various solid tumors.”

Multiple preclinical studies have demonstrated that the alphalex technology enhances the therapeutic index of the PARP inhibitor, improves tumor control and overall survival while limiting toxicity.

Per Hellsund, President and CEO of Cybrexa, commented, “Selection of our lead clinical candidate is the first step in establishing the human proof-of-concept data for our alphalex™ technology and marks a major milestone for Cybrexa. The positive feedback from our pre-IND meeting with the FDA is extremely encouraging and will be valuable as we prepare our IND application to launch our first-in-human Phase 1 trial of CBX-11.”

About the alphalex™ Technology Platform

The Cybrexa alphalex™ technology platform enables the delivery of small molecules across the cell membrane under low pH conditions, which is a universal feature of cancer cells. As a result, alphalex™ technology – which consists of a novel peptide, linker and small molecule anti-cancer agent – allows for antigen-independent, intracellular delivery of small molecule anti-cancer agents directly into the tumor cell. View a video of the mechanism of action of the technology at www.cybrexa.com.

About Cybrexa

Cybrexa is a privately-held biotechnology company dedicated to developing an entirely new class of cancer therapies using its alphalex™ platform to deliver anti-cancer agents directly into tumor cells. The Company’s lead candidate, CBX-11, an alphalex™-PARP inhibitor combination, is in preclinical development with advancing plans to initiate clinical development. Cybrexa was founded by physician-scientists, and has an experienced management team that has built numerous successful life sciences companies and raised hundreds of millions of dollars in venture capital. For more information about Cybrexa, please visit www.cybrexa.com.

Contacts

Media Relations

[email protected]

Cybrexa Therapeutics Presents Preclinical Data Demonstrating its alphalex™ Tumor Targeting Platform Delivers a High Dose of PARP Inhibitor in Combination with Chemotherapy

Synergistic combination selectively kills tumors and prevents bone marrow toxicities

Poster presentation today during 30th EORTC-NCI-AACR Molecular Targets and Cancer Therapeutics Symposium

Marks initial introduction to company’s alphalex™ tumor-selective technology platform

NEW HAVEN, Conn., Nov. 13, 2018 (GLOBE NEWSWIRE) — Cybrexa Therapeutics, a biotechnology company developing a new class of cancer therapeutics through its alphalex™ tumor targeting platform, today announced that the company presented preclinical data regarding the alphalex™ platform’s application to a poly (ADP- ribose) polymerase (PARP) inhibitor. These data were presented today during the 30th EORTC-NCI-AACR Molecular Targets and Cancer Therapeutics Symposium, being held November 13-16 in Dublin, Ireland. This work was presented by Dr. Ranjit Bindra, Cybrexa scientific Co-founder and Associate Professor at the Yale School of Medicine.

Per Hellsund, President and Chief Executive Officer of Cybrexa Therapeutics, commented, “PARP inhibitors have emerged as an effective treatment option for some solid tumors, especially following DNA damaging chemotherapy. PARP inhibitors have enormous potential in combination with chemotherapy, but these combinations are often associated with life-threatening limitations of toxicity and bone marrow suppression. This preclinical study demonstrates that our alphalex™ technology is able to successfully combine a potent PARP inhibitor with chemotherapy in doses that effectively kill cancer cells, while at the same time preventing bone marrow suppression through intracellular, antigen-independent targeting of anti-cancer agents.”

Researchers attached talazoparib (BMN673, marketed as Talzenna™), a PARP inhibitor recently approved by the FDA for the treatment of breast cancer patients with BRCA1/2 mutations, to its novel alphalex™ peptide, which forms an alpha helix in the low-pH tumor microenvironment that is able to cross the cell membrane and release the combination therapy directly into tumor cells.

In the study, the conjugation of talazoparib to the alphalex™ peptide demonstrated:

  • pH-dependent delivery of functional talazoparib into tumor cells in vitro;
  • Sustained and selective in vivo tumor localization of talazoparib;
  • Target engagement and penetration by talazoparib specifically in tumor tissue;
  • Prevention of bone marrow toxicity when combined with chemotherapy; and
  • Selective tumor cell killing in both non-HRD and HRD xenografts, including patient-derived xenografts (PDXs).

About alphalex™ Platform

The Cybrexa alphalex™ platform consists of a novel peptide-based technology developed from research at Yale University. This technology enables the delivery of small molecules across the cell membrane under low pH conditions, which is a universal feature of cancer cells. As a result of its low-pH dependent peptide, alphalex™ allows for antigen independent, intracellular delivery of small molecule anti-cancer agents. View a video of the mechanism of action of the technology at www.cybrexa.com.

About Cybrexa

Cybrexa is a privately-held biotechnology company dedicated to developing an entirely new class of cancer therapies using the alphalex™ platform to attach existing anti-cancer agents to the alphalex™ peptide that directly target the tumor microenvironment. The Company’s lead candidate, an alphalex™-PARP inhibitor combination, is in preclinical development with advancing plans for initiating clinical development. Cybrexa was founded by physician-scientists and an experienced management team that has built numerous successful life sciences ventures and raised hundreds of millions of dollars in venture capital. For more information about Cybrexa, please visit www.cybrexa.com.

Contacts

Media Relations

[email protected]

Cybrexa Therapeutics to Present Preclinical Data for its Tumor-Selective Technology Platform at the 30th EORTC-NCI-AACR Molecular Targets and Cancer Therapeutics Symposium

New Haven, Conn., November 5, 2018– Cybrexa Therapeutics, a biotechnology company developing a new class of cancer therapeutics through its tumor-selective technology platform, today announced that the company will present preclinical data at the 30thEORTC-NCI-AACR Molecular Targets and Cancer Therapeutics Symposium to be held November 13 – 16, 2018 in Dublin, Ireland. The preclinical data that will be presented includes the successful conjugation of BMN673 (Talazoparib, a PARP inhibitor commonly used for the treatment of breast cancer patients with BRCA1/2 mutations) to a low pH-sensing peptide, using the company’s proprietary tumor-selective technology platform. Cybrexa’s platform leverages a novel, peptide-based technology capable of efficiently and selectively delivering small molecules across the membrane of tumor cells, specifically under low pH conditions.

Details for the poster presentation are as follows:

PB-014 –Development of tumor-targeted PARP inhibitors for the treatment of solid cancers

Session:                  DNA Repair Modulation

Date and Time:       November 13; 12:00 – 6:30 p.m. CET

Location:                Exhibition Hall

Presenting Author: Ranjit S. Bindra, MD, PhD – Cybrexa Scientific Co-founder, and

Associate Professor at the Yale School of Medicine

About Cybrexa

 Cybrexa is a privately-held biotechnology company dedicated to developing an entirely new class of small molecule DNA repair inhibitors and DNA damaging agents (TSDs) that directly target the tumor microenvironment. This approach will both improve the efficacy while at the same time reduce toxicity of existing cancer drugs. The Company has made significant progress since its inception and now has several drug candidates that are being run through its in vitroand in vivoscreening platform. The objective is to have at least one of its TSDs ready for a phase I clinical trial within two years. Cybrexa was founded by successful entrepreneurs Per Hellsund, Kevin Didden and Kevin Rakin, who most recently built and successfully exited Cyvek, Inc. For more information about Cybrexa, please visit www.cybrexa.com.

Contacts

Media Relations

[email protected]

Cybrexa Therapeutics Expands Scientific Advisory Board Ahead of IND Filing

Dr. Geoffrey Shapiro and Dr. Timothy Yap bring extensive expertise in targeting cell-cycle and DNA repair mechanisms in oncology drug development

NEW HAVEN, Conn., Oct. 22, 2018 (GLOBE NEWSWIRE) — Cybrexa Therapeutics, a biotechnology company developing a new class of cancer therapeutics through its tumor selective technology platform that enables expedited development of potentially superior therapeutics and novel combinations of anticancer agents through safe, targeted drug delivery, today announced that it has expanded its Scientific Advisory Board with the appointments of Geoffrey Shapiro, M.D., Ph.D. Director, the Dana-Farber Cancer Institute and Timothy Yap MBBS, Ph.D., MRCP(UK), BSc (Hons), PgDip of The University of Texas MD Anderson Cancer Center.

Per Hellsund, President & CEO of Cybrexa, commented, “Cybrexa is currently at a major inflection point as we rapidly move toward entering the clinic with the first candidate generated from our paradigm-changing tumor-selective technology platform. Dr. Shapiro and Dr. Yap both bring a wealth of knowledge and experience that is critical as we transform into a clinical-stage company. In particular, Dr. Shapiro’s expertise in the preclinical and clinical development of molecules exploiting cell cycle and DNA repair-related proteins and Dr. Yap’s expertise in first-in-human and combinatorial development of molecularly targeted agents, especially those targeting of the DNA damage response, will be instrumental in our clinical development. These important additions further expand Cybrexa’s collective depth of knowledge and we look forward to their contributions.”

Dr. Shapiro currently serves as Director, Early Drug Development Center and Clinical Director, Center for DNA Damage and Repair, and an Institute Physician at the Dana-Farber Cancer Institute. His research focuses on the investigation of the role of cell cycle and DNA repair-related proteins in a variety of solid tumors, including breast, ovarian, pancreatic and lung, with clinical interests in developmental therapeutics and Phase I clinical trials. He is also a Professor of Medicine at Harvard Medical School and serves as the Principal Investigator on the National Cancer Institute/Clinical Trials Evaluation Program (NCI/CTEP) Early Therapeutics UM1 Grant for Dana-Farber/Harvard Cancer Center.  He is a member of the NCI Investigational Drug Steering Committee and has served on scientific committees of both the American Association for Cancer Research (AACR) and the American Society of Clinical Oncology (ASCO), as well as the European Society of Medical Oncology (ESMO) International Congress on Targeted Anticancer Therapies. Dr. Shapiro holds Ph.D. and M.D. degrees from Cornell University, and completed his postgraduate training in internal medicine at Beth Israel Hospital, Boston, where he served as chief medical resident, followed by a fellowship in medical oncology at the Dana-Farber Cancer Institute.

Dr. Yap is a Medical Oncologist and Physician-Scientist at The University of Texas MD Anderson Cancer Center. He is also an Associate Professor in the Department for Investigational Cancer Therapeutics (Phase I Program), and the Department of Thoracic/Head and Neck Medical Oncology. Dr. Yap also is the Medical Director of the Institute for Applied Cancer Science, part of MD Anderson’s Therapeutics Discovery division, and the Associate Director of Translational Research in the Institute for Personalized Cancer Therapy. Prior to his current positions at MD Anderson, Dr. Yap was a Consultant Medical Oncologist at The Royal Marsden Hospital in London, UK and National Institute for Health (NIH) Research BRC Clinician Scientist at The Institute of Cancer Research, London. Dr. Yap holds a BSc degree with First Class Honors in Immunology and Infectious Diseases from the Imperial College London and was awarded the Huggett Memorial Prize. He holds a M.D. from Imperial College London and completed his medical training at Oxford.

Previously appointed members of Cybrexa’s SAB include:

Dr. Ranjit Bindra is a physician-scientist and biotech entrepreneur at the Yale School of Medicine and a co-founder of Cybrexa. Clinically, Dr. Bindra treats adult and pediatric primary CNS tumors, and he is a member of the Yale radiosurgery team, with expertise in treating brain metastases and benign tumors such as arteriovenous malformations. Dr. Bindra also runs Phase I and II clinical trials at Yale, which are largely based on discoveries from his own laboratory. Dr. Bindra’s group led four major laboratories at Yale discovering IDH1/2-mutant tumors harbor a profound DNA repair defect that renders them exquisitely sensitive to PARP inhibitors. This work was published in Science Translational Medicine and has received international attention with major clinical implications. As a biotech entrepreneur, Dr. Bindra has started two life sciences ventures over the last decade and is incubating a third company via a Program in Innovative Therapeutics for Connecticut’s Health (PITCH) award at Yale. Dr. Bindra received his undergraduate degree in Molecular Biophysics and Biochemistry from Yale University, and both his M.D. and Ph.D. from the Yale School of Medicine. He completed his medical internship, radiation oncology residency, and post-doctoral research studies at the Memorial Sloan-Kettering Cancer Center.

Dr. Peter Glazer is currently the Hunter Professor and Chairman of the Department of Therapeutic Radiology and Professor of Genetics at Yale. Dr. Glazer lab’s main focus has been on elucidating the regulation of DNA repair in cancer and developing novel agents to exploit DNA repair for cancer therapy. He is credited with making the seminal observation that tumor hypoxia promotes genetic instability, and he has systematically dissected the mechanism for this effect, revealing that DNA repair is dysregulated in hypoxic cancer cells. Dr. Glazer has also pioneered the use of triplex-forming oligonucleotides for targeted gene editing, with recent work demonstrating successful gene editing in a living animal by simple intravenous administration of oligonucleotide-containing nanoparticles, providing a potentially safer and simpler alternative to CRISPR. Dr. Glaser Glazer served as Chairperson of the Radiation Therapeutics and Biology Study Section for NIH, as well as on councils and program committees for several national societies. He has also led the Yale Cancer Center’s Radiobiology & Radiotherapy research program for more than 20 years. Dr. Glazer has received awards from the Radiation Research Society, the American Society for Photobiology, and the Leukemia and Lymphoma Society, and was elected to the Association of American Physicians in 2014. In 2017, Dr. Glazer received the John Yuhas Award from the University of Pennsylvania in recognition of his work in cancer research and received an Outstanding Investigator Award from the National Cancer Institute. Dr. Glazer received a BA in Chemistry from Harvard, an MS in Biochemistry from the University of Oxford, and an M.D. and Ph.D. (in Genetics) from Yale.

Dr. Patricia LoRusso brings more than 25 years of expertise in medical oncology, drug development, and early phase clinical trials. Currently Dr. LoRusso is the Associate Director for experimental therapeutics at Yale University and the Principal Investigator of the National Cancer Institute/Clinical Trials Evaluation Program (NCI/CTEP) Early Therapeutics UM1 Grant for Yale University. Prior to this, Dr. LoRusso served in numerous leadership roles at Wayne State University’s Barbara Karmanos Cancer Institute, most recently as director of the Phase I Clinical Trials Program and of the Eisenberg Center for Experimental Therapeutics. She also serves on the Board of Directors for the American Association of Cancer Research (AACR) and on the Board of Scientific Council for the National Cancer Institute (NCI) Intramural Program. Previously Dr. LoRusso was co-chair of the NCI Cancer Therapy Evaluation Program (CTEP) Investigational Drug Steering Committee. She has also served on the education and scientific committees of the American Society of Clinical Oncology (ASCO), the scientific committee of the AACR, and as a parent member of the NCI’s Quick Trials Clinical Subcommittee.

Dr. Ruth Plummer is Professor of Experimental Cancer Medicine at the Northern Institute for Cancer Research, Newcastle University and an honorary consultant medical oncologist in Newcastle Hospitals NHS Foundation Trust.  She is Director of the Sir Bobby Robson Cancer Trials Research Centre within the Northern Centre for Cancer Care, which is a dedicated clinical trials unit based within the regional cancer center. Dr. Plummer leads the Newcastle Experimental Cancer Medicine Centre and the CRUK Newcastle Cancer Centre.  Her research interests are in the field of DNA repair and early phase clinical trials of novel agents, and is responsible for taking the first-ever PARP inhibitor into the clinic in 2003, ATR inhibitor in 2012 and MCT1 inhibitor in 2014. Nationally she chairs the Cancer Research UK New Agents Committee and sits as a member of Cancer Research UK’s Clinical Research Committee and until recently Science Committee.  She is a member of the MRC Stratified Medicine Group. Dr. Plummer trained at Cambridge and Oxford Universities and obtained both a M.D. and scientific Ph.D.

Dr. Leonard Post has over 30 years of experience with all stages of drug development, from early discovery through FDA approval, with a particular focus on oncology and genetic diseases. Dr. Post was a founder and Chief Scientific Officer (CSO) of LEAD Therapeutics, which led to the discovery of Talazoparib (BMN-673) and was later acquired by BioMarin Pharmaceuticals where he then served as CSO. Previously, he served as Senior Vice President of Research and Development for Onyx Pharmaceuticals where he was responsible for the co-development through to FDA approval of Nexavar for renal cancer, and led Onyx’s oncolytic virus clinical program. Dr. Post is currently the CSO of Vivace Therapeutics, an oncology-focused portfolio-based drug discovery and development company adopting a capital-efficient and modality-indifferent approach to bring novel therapies to patients in need. Dr. Post holds a BS in Chemistry from the University of Michigan and a Ph.D. in Biochemistry from the University of Wisconsin, Madison.

About Cybrexa

Cybrexa is a privately-held biotechnology company dedicated to developing an entirely new class of small molecule DNA repair inhibitors and DNA damaging agents (TSDs) that directly target the tumor microenvironment. This approach will both improve the efficacy while at the same time reduce toxicity of existing cancer drugs. The Company has made significant progress since its inception and now has several drug candidates that are being run through its in vitro and in vivoscreening platform. The objective is to have at least one of its TSDs ready for a phase I clinical trial within two years. Cybrexa was founded by successful entrepreneurs Per Hellsund, Kevin Didden and Kevin Rakin, who most recently built and successfully exited Cyvek, Inc. For more information about Cybrexa, please visit www.cybrexa.com.

Contacts

Media Relations

[email protected]

Cybrexa Therapeutics Appoints Keely Zipp as Vice President of Marketing

Adds oncology marketing and strategy experience from Incyte Corporation and GlaxoSmithKline

Press Release:

NEW HAVEN, Conn., Oct. 08, 2018 (GLOBE NEWSWIRE) — Cybrexa Therapeutics, an early-stage biotechnology company developing a new class of cancer therapeutics through its tumor-selective technology platform, today announced that it further strengthened its leadership team with the appointment of Keely Zipp as Vice President of Marketing. Ms. Zipp adds nearly 15 years of strategic planning and marketing experience to the Cybrexa team and will lead the company’s marketing, communications, and branding efforts.

Ms. Zipp brings with her a breadth of knowledge in business development, corporate operations, and strategic marketing. Prior to joining Cybrexa, she served as Senior Director of Global Strategic Planning and Corporate Operations at Incyte Corporation where she led corporate and product strategy and financial planning initiatives for the publicly-traded, commercial-stage, biotechnology company. Previously, Ms. Zipp served as Commercial Director at GlaxoSmithKline, where she developed, implemented, and embedded business strategies, processes, and change initiatives across the Global Oncology Franchise.  She was also a Manager of Global Business Development, Mergers & Acquisitions at Wyeth, a Pfizer company. Ms. Zipp holds an MBA from The Wharton School at the University of Pennsylvania and graduated magna cum laude with a BA in Biochemistry and Molecular Biology from Dartmouth College.

“I am confident that Keely’s depth of experience working at large, commercial stage companies will prove invaluable as Cybrexa advances its lead candidate into the clinic,” said Per Hellsund, President and Chief Executive Officer of Cybrexa Therapeutics. “In addition to Keely’s impressive experience within the life sciences arena, she also exemplifies our core values, and we are delighted to welcome her to the Cybrexa team.”

Keely Zipp, VP of Marketing at Cybrexa, added, “I am delighted to join Cybrexa as the team further positions the Company for clinical success and corporate growth, while working to provide such a meaningful platform that has the potential to impact so many lives. Cybrexa represents a unique opportunity as an early-stage oncology company with a truly innovative tumor-selective technology platform and I look forward to working diligently with the team to execute on its corporate objectives.”

About Cybrexa

Cybrexa is a privately-held biotechnology company dedicated to developing an entirely new class of small molecule DNA repair inhibitors and DNA damaging agents (TSDs) that directly target the tumor microenvironment. This approach will both improve the efficacy while at the same time reduce toxicity of existing cancer drugs. The Company has made significant progress since its inception and now has several drug candidates that are being run through its in vitro and in vivo screening platform. The objective is to have at least one of its TSDs ready for a phase I clinical trial within two years. Cybrexa was founded by successful entrepreneurs Per Hellsund, Kevin Didden and Kevin Rakin, who most recently built and successfully exited Cyvek, Inc. For more information about Cybrexa, please visit www.cybrexa.com.

Contacts

Media Relations

[email protected]

Cybrexa Therapeutics Appoints Vishwas Paralkar, Ph.D. as Chief Scientific Officer

We are very pleased to have Vishwas Paralkar join our team. We are confident that his leadership and breadth of drug development experience will enable us to move our technology from the research stage into the clinic.

Cybrexa Therapeutics, a start-up cancer therapeutics company, announced today that it has appointed Vishwas Paralkar to the role of chief scientific officer. In this role, Dr. Paralkar will lead the development of Cybrexa’s tumor targeting technology. He will report to Cybrexa’s president and CEO, Per Hellsund.

“I was impressed with Cybrexa’s revolutionary technology and excellent leadership team,” Dr. Paralkar said. “The team has had multiple past successes and I am excited to bring this technology to market.”

Dr. Paralkar will lead the drug development effort for Cybrexa’s tumor targeting technology.

Read the press release.

Cybrexa Therapeutics Secures $6 Million in Series B Financing

Jun 6, 2017 

Financing supports development of new class of cancer therapies.

Cybrexa Therapeutics, a start-up cancer therapeutics company, announced today that it has secured a Series B round of financing in the amount of $6 million. Connecticut Innovations, an investment vehicle affiliated with HighCape Partners, and a group of private investors participated in the round.

The Series B funding will enable Cybrexa to complete the build-out of its facilities and continue the development its tumor-localizing DNA repair inhibitors, which they refer to as Tumor Specific Drugs (TSDs).

Cybrexa was founded by successful entrepreneurs Per Hellsund, Kevin Didden and Kevin Rakin, who most recently built and successfully exited Cyvek, Inc.  Hellsund serves as the President and CEO, and Didden and Rakin serve as board members. Additional members of the founding team include Ranjit Bindra, M.D., Ph.D., and Peter Glazer, M.D., Ph.D., from the Yale School of Medicine. Bindra and Glazer are both physician-scientists and world-renowned experts in DNA repair. Their work has been published in numerous high-impact journals, including Science, Nature, and Science Translational Medicine.

Hellsund commented, “We are very pleased to have closed our Series B financing. Our approach has the potential to re-define the definition of “drug-like,” which will unlock a vast array of molecules for clinical development. Our collection of TSDs can be combined with numerous chemotherapies and also radiotherapy, allowing the safe delivery of higher drug doses, with enhanced efficacy.”

About Cybrexa:

Cybrexa is a privately funded biotechnology company dedicated to developing an entirely new class of small molecule DNA repair inhibitors (TSDs) that directly target the tumor microenvironment. This approach leverages a novel tumor-localizing peptide technology developed by an internationally recognized research laboratory at Yale. The Company is led by an experienced team of researchers and business executives who have developed and commercialized technologies, launched products, driven sales, negotiated partnerships, and led a number of companies from start up to liquidity events.

For more information about Cybrexa, please visit us on the web at www.cybrexa.com

Media Contact:

[email protected]

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