Last update 26 Dec 2024

Telaprevir

Last update 26 Dec 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

(1S,3aR,6aS)-(2S)-2-cyclohexyl-N-(pyrazinylcarbonyl)glycyl-3-methyl-L-valyl-N-((1S)-1-((cyclopropylamino)oxoacetyl)butyl)octahydrocyclopenta(c)pyrrole-1-carboxamide, Telaprevir (JAN/USAN/INN), Telavic

+ [8]

Target

NS3/NS4A x cysteine protease

Mechanism

NS3/NS4A inhibitors(Hepatitis C virus serine protease, NS3/NS4A inhibitors), cysteine protease inhibitors(Cysteine protease inhibitors)

Therapeutic Areas

Infectious DiseasesDigestive System DisordersNeoplasms+ [7]

Active Indication-

Inactive Indication

Chronic hepatitis C genotype 1Chronic hepatitis C genotype 1bChronic hepatitis C genotype 2+ [12]

Originator Organization

Eli Lilly & Co.

Vertex Pharmaceuticals, Inc.

Active Organization-

Inactive Organization

Vertex Pharmaceuticals, Inc.Tibotec Virco Virology BV

Mitsubishi Tanabe Pharma Corp.

+ [5]

Drug Highest PhaseWithdrawn

First Approval Date

US (23 May 2011),

Hepatitis C, Chronic

Regulation-

Structure

Molecular FormulaC36H53N7O6

InChIKeyBBAWEDCPNXPBQM-GDEBMMAJSA-N

CAS Registry402957-28-2

108

Clinical Trials associated with Telaprevir

NCT02333292 / CompletedNot ApplicableIIT

Efficacy and Safety of Treatment Against Hepatitis C Virus Infection Based on Direct-acting Antivirals in Real-life Conditions: The GEHEP Cohort

Objectives: 1) To evaluate la proportion of hepatitic C virus (HCV)-monoinfected patients who show sustained virologic response (SVR) to treatment including direct-acting antivirals (DAAs) in the clinical practice in clinical units that treat infectious diseases and 2) to determine the frequency of adverse events, including those that are severe and/or cause treatment interruption, in DAA-based therapy in this setting.
Design: Multicentric, prospective post-authorised cohort study. Setting: Hospitals of the Hepatitis Study Group (GEHEP) of the Spanish Society of Infectious Diseases and Microbiology (SEIMC).
Study population: HCV-monoinfected patients that initiate DAA-based treatment outside clinical trials.
Variables: The primary efficacy outcome variable is the proportion of patients who reach undetectable HCV-RNA 12 weeks after the scheduled end of therapy (SVR12). The primary safety outcome variable is the percentage of subjects who discontinue therapy due to adverse events.
Statistical analysis: A descriptive study will be performed, as well as a double sensibility analysis of the frequency of SVR12 using both an intention-to-treat and an on-treatment approach. Those variables that are associated with SVR12 with a p-value <0.2 will be included in a logistic regression analysis in which SVR12 will be the dependent variable.

Start Date01 Dec 2014

Sponsor / Collaborator

Hospital Universitario de Canarias

[+6]

NCT02087111 / CompletedPhase 4

Telaprevir in Patients With Genotype 3 HCV: Pilot Clinical Study to Evaluate Efficacy and Predictability of Therapy in Patients Who Have Failed to Respond to Pegylated Interferon and Ribavirin

Patients with genotype 3 hepatitis C who have advanced liver disease (cirrhosis) have a very high chance of developing fatal complications of their disease unless they receive effective treatment. Unfortunately the best drugs that are currently available to treat genotype 3 hepatitis C (pegylated interferon and ribavirin) only work in about 50% of patients with advanced liver disease and therefore a large number of patients who have failed treatment are waiting for new, better drugs. Currently there are no treatments available for these patients. Telaprevir is a new drug that is licensed to treat genotype 1 hepatitis C and which works very well in these patients. In patients with genotype 3 hepatitis C small scale trials and laboratory studies show that some patients do respond quite well and others respond a little bit when given telaprevir. In patients who have exhausted all other treatment options the investigators speculate that telaprevir treatment may help some patients by clearing their infection. The purpose of this study is to see if telaprevir can help these patients and to determine if the investigators can predict in advance which people can be helped.

Start Date01 Apr 2014

Sponsor / Collaborator

Queen Mary University of London

[+4]

NCT02006745 / CompletedPhase 3

Open Label, Randomised, Pilot Trial of Pegylated Interferon, Ribavirin & Telaprevir vs Pegylated Interferon & Ribavirin Alone in Response Guided Treatment of Acute Hepatitis C Genotype 1 Virus Infection in Patients With HIV-1 Co-infection

The purpose of the study is to explore the treatment of patients with acute hepatitis C infection (infection acquired within the last 6 months) who are also infected with human immunodeficiency virus (HIV).

Start Date01 Jan 2014

Sponsor / Collaborator-

100 Clinical Results associated with Telaprevir

100 Translational Medicine associated with Telaprevir

100 Patents (Medical) associated with Telaprevir

1,214

Literatures (Medical) associated with Telaprevir

01 Feb 2025·EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

Pyrrolidine SS13 induces oxidative stress and autophagy-mediated cell death in colorectal cancer cells

Article

Author: Majirska, Monika ; Keselakova, Alexandra ; Pilatova, Martina Bago ; Kello, Martin ; Martinkova, Miroslava ; Mirossay, Andrej ; Nosalova, Natalia ; Fabianova, Dominika

INTRODUCTION:

Pyrrolidines, nitrogenous organic compounds, are among the most intensively studied agents because of their antibacterial, antiviral, neurological, and promising antitumor effects. Moreover, many medicinal drugs contain pyrrolidine moiety such as sunitinib (anticancer drug), telaprevir and ombitasvir (antiviral drugs) or ramipril (antihypertensive drug).

RATIONALE OF THE STUDY:

Based on the pro-apoptotic effect of pyrrolidine SS13, this study focuses on the pro-oxidative properties of the tested pyrrolidine SS13 on colorectal cancer cells to deepen the understanding of its mechanisms of action.

RESEARCH HYPOTHESIS:

We hypothesize that SS13 induces oxidative stress and autophagy activation in HCT116 and Caco-2 cell lines, thus contributing to antiproliferative effects.

METHODS:

Flow cytometry, western blot, fluorescence microscopy and qRT-PCR were used to evaluate the effect of pyrrolidine SS13.

CONCLUSION AND FUTURE DIRECTIONS:

Pyrrolidine SS13 induced oxidative stress through the accumulation of reactive oxygen and nitrogen species in both cell lines and the modulation of both superoxide dismutase isoenzymes (SOD1, SOD2). Oxidative stress was also associated with the activation of DNA damage response system and modulation of stress/survival pathways. We demonstrated for the first time that pyrrolidine SS13 is involved in the induction of autophagy accompanied by increased levels of autophagic markers (p-AMPK, p-ULK, LC3I/II and ATG7) and a significant decrease in p62 protein levels in both cell lines. Finally, chloroquine, an inhibitor of autophagy, enhanced cell survival and suppressed the cytotoxic effect of SS13 in HCT116 and Caco-2 cells, indicating that SS13 contributes to autophagy-mediated cell death. Taken together, our results suggest that oxidative stress and autophagy participate in the antiproliferative effect of pyrrolidine SS13 on colorectal cancer cells. Further research using primary cell cultures obtained from different animal tissues as well as performing in vivo experiments is needed to understand these processes in detail and to investigate the potential therapeutic application of new pyrrolidine derivatives.

01 Nov 2024·INTERNATIONAL IMMUNOPHARMACOLOGY

Focusing on non-responders to infliximab with ulcerative colitis, what can we do first and next?

Article

Author: Ma, Xueni ; Wang, Pengfei ; Pu, Dan ; Gong, Hang ; Li, Muyang ; Tian, Yonggang ; Wang, Xiang ; Zhang, Dekui

BACKGROUND:

Ulcerative colitis (UC) is a chronic immune-mediated inflammation of the colorectum, for which infliximab (IFX) is currently the mainstay of treatment. However, one-third of patients with UC still fail to benefit from the IFX therapy, and early exposure to IFX impairs the efficacy of other subsequent biologics. Therefore, personalized therapeutic system is urgently needed to assist in clinical decision-making and precision treatment.

METHODS:

Four microarray datasets of colonic biopsies from UC patients treated with IFX were obtained from the GEO database to form the Training Cohort and Validation Cohort. Differentially expressed genes (DEGs) in Training Cohort were identified and enriched for GO, KEGG and immune cell infiltration analysis. A prediction model for IFX efficacy was developed based on the LASSO and Logistic regression. The predictive accuracy of the model was verified by the Validation Cohort, and the model-genes/proteins were validated by immunohistochemistry. Gene-drug, gene-ncRNA interaction analysis were performed to identify drugs or non-coding RNAs (ncRNAs) that potentially interacted with the model-genes. Homology Modeling and Molecular Docking were conducted to filter the optimal candidate as the subsequent adjuvant or alternative for IFX in predicted non-responders. At last, the down-regulation of the key model-gene/protein CYP24A1 by the drug candidate Deferasirox was verified by Western Blot and qRT-PCR Assay based on cellular experiments.

RESULTS:

A total of 113 DEGs were identified in the Training Cohort, mainly enriched in inflammatory cell chemotaxis, migration, and response to molecules derived from intestinal microbiota. Activated pro-inflammatory innate immune cells, including neutrophils, M1 macrophages, activated dendritic cells and mast cells, were significantly enriched in colons of non-responders. The prediction model based on three model-genes (IFI44L, CYP24A1, and RGS1) exhibited strong predictive efficacy, with AUC values of 0.901 and 0.80 in the Training and Validation Cohorts, respectively. Higher expression of the three model-genes/proteins in colons of non-responders to IFX was confirmed by clinical colonic mucosal biopsies. 4 Drugs (Calcitriol, Lunacalcipol, Deferasirox, Telaprevir), 15 miRNAs and 66 corresponding lnRNAs interacting with model-genes were identified. The protein 3D structure of the key model-gene/protein (human-derived CYP24A1) was developed. Through the Molecular Docking and cellular experimental validation, Deferasirox, which significantly down-regulated both the RNA and protein expression of CYP24A1, was identified as the optimal adjuvant or alternative for IFX in predicted non-responders with UC.

CONCLUSION:

This study developed a novel prediction model for pre-assessing the efficacy of IFX in patients with UC, as the first step towards personalized therapy. Meanwhile, drugs and non-coding RNAs were provided as potential candidates to develop the next-step precise treatment for the predicted non-responders. In particular, Defeasirox appears to hold promise as an adjuvant or alternative to IFX for the optimization of UC therapy.

01 Nov 2024·Journal of biomolecular structure & dynamics

Structure-based virtual screening of natural compounds against wild and mutant (R1155K, A1156T and D1168A) NS3-4A protease of Hepatitis C virus

Article

Author: Murahari, Manikanta ; Pattabiraman, Ramya ; Krishna, Swati ; Murthy, T. P. Krishna ; Kumar, S. Birendra ; Ramaswamy, Amutha ; Samantaray, Mahesh

NS3-4A, a serine protease, is a primary target for drug development against Hepatitis C Virus (HCV). However, the effectiveness of potent next-generation protease inhibitors is limited by the emergence of mutations and resulting drug resistance. To address this, in this study a structure-based drug design approach is employed to screen a large library of 7320 natural compounds against both wild-type and mutant variants of NS3-4A protease. Telaprevir, a widely used protease inhibitor, was recruited as the control drug. The top 10 compounds with favorable binding affinities underwent drug-likeness evaluation. Based on ADMET studies, complexes of NP_024762 and NP_006776 were selected for molecular dynamic simulations. Principal component analysis (PCA) was employed to explore the conformational space and protein dynamics of the protein-ligand complex using a Free Energy Landscape (FEL) approach. The cosine values obtained from FEL analysis ranged from 0 to 1, and eigenvectors with cosine values below 0.2 were chosen for further analysis. To forecast binding free energies and evaluate energy contributions per residue, the MM-PBSA method was employed. The results highlighted the crucial role of amino acids in the catalytic domain for the binding of the protease with phytochemicals. Stable associations between the top compounds and the target protease were confirmed by the formation of hydrogen bonds in the binding pocket involving residues: His1057, Gly1137, Ser1139, and Ala1157. These findings suggest the potential of these compounds for further validation through biological evaluation.Communicated by Ramaswamy H. Sarma.

News (Medical) associated with Telaprevir

26 Feb 2024

·www.biospace.com

Disc Medicine Expands Leadership Team with Appointment of Industry Veteran Pamela Stephenson, MPH as Chief Commercial Officer

WATERTOWN, Mass., Feb. 26, 2024 (GLOBE NEWSWIRE) -- Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, today announced the appointment of Pamela Stephenson, MPH as the company’s Chief Commercial Officer. Ms. Stephenson is an experienced biotech executive with significant expertise in commercial and strategic leadership, particularly in therapies for rare diseases, and will be responsible for all aspects of Disc’s global commercialization strategy and execution. “We are delighted to welcome an accomplished leader such as Pamela to Disc, where her breadth of commercial experience and acumen will be instrumental as the company continues to grow,” said John Quisel, J.D., Ph.D., President and Chief Executive Officer of Disc. “Pamela’s track record of building and executing successful global commercial launches, particularly for rare disease markets, comes at an opportune time for Disc as we enter late-stage development and begin commercial planning and engaging key stakeholders.” “I am excited to be joining Disc at this pivotal time in the company’s trajectory towards building a leading hematology company. Disc’s assets have the potential to make a significant impact on the lives of patients, with compelling value propositions and meaningful market opportunities,” said Ms. Stephenson. “With significant milestones this year for all three pipeline programs, I look forward to leading the commercialization efforts to support Disc’s mission of delivering novel treatments to patients with high unmet need.” Ms. Stephenson has more than 25 years of biopharma commercial leadership experience across multiple functions and disease areas. Most recently, she served as the Chief Commercial Officer of Albireo, which was acquired by Ipsen, spearheading the successful launch of Bylvay for a rare cholestatic liver disease. Before joining Albireo, Ms. Stephenson served as Vice President, Global Market Access and Value, at Vertex Pharmaceuticals, where she led the global market access and pricing strategy for current and future products. Earlier in her tenure at Vertex, she led marketing and sales activities for the company’s hepatitis C and cystic fibrosis lines of business, and oversaw the U.S. launches of Incivek® (telaprevir) and Orkambi® (lumacaftor/ivacaftor). Prior to Vertex, Ms. Stephenson spent 10 years at Pfizer in marketing roles of increasing responsibility for brands such as Viagra® (sildenafil citrate), Lyrica® (pregabalin), and Aromasin® (exemestane). Ms. Stephenson served as board member of Zynerba Pharmaceuticals, a public biotech company focused on developing therapeutics for patients with rare neuropsychiatric conditions, which was acquired by Harmony Biosciences in October 2023. Ms. Stephenson holds a bachelor’s degree from Brown University and received her master’s degree in public health from Boston University School of Public Health. In connection with Ms. Stephenson’s appointment, Disc granted to Ms. Stephenson an inducement equity award outside of Disc’s Amended and Restated 2021 Stock Option and Incentive Plan in accordance with NASDAQ Listing Rule 5635(c)(4), comprised of (i) an option to purchase 55,000 shares (the “Option Award”) of Disc’s common stock (“Common Stock”), at an exercise price equal to the closing price of the Common Stock on the date of grant, and (ii) a restricted stock unit award for 36,666 shares of Common Stock (the “RSU Award” and, together with the Option Award, the “Inducement Award”). The Option Award shall vest 25% on the first anniversary of Ms. Stephenson’s start date, with the remainder vesting in 36 equal monthly installments thereafter. The RSU Award shall vest in equal installments on each of the first, second, third, and fourth anniversaries of the vesting date set by Disc’s company vesting policy. The Inducement Award was approved by Disc’s Board of Directors (the “Board”), including a majority of the independent directors serving on the Board. About Disc Medicine Disc Medicine (NASDAQ:IRON) is a clinical-stage biopharmaceutical company committed to discovering, developing, and commercializing novel treatments for patients who suffer from serious hematologic diseases. We are building a portfolio of innovative, potentially first-in-class therapeutic candidates that aim to address a wide spectrum of hematologic diseases by targeting fundamental biological pathways of red blood cell biology, specifically heme biosynthesis and iron homeostasis. For more information, please visit Disc Cautionary Statement Regarding Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, express or implied statements regarding Disc’s expectations with respect to the chief commercial officer position, data read-outs, and Disc’s development and commercialization. The use of words such as, but not limited to, “believe,” “expect,” “estimate,” “project,” “intend,” “future,” “potential,” “look forward,” “continue,” “may,” “might,” “plan,” “will,” “should,” “seek,” “anticipate,” or “could” or the negative of these terms and other similar words or expressions that are intended to identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on Disc’s current beliefs, expectations and assumptions regarding the future of Disc’s business, future plans and strategies, clinical results and other future conditions. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Disc may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and investors should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements as a result of a number of material risks and uncertainties including but not limited to: Disc’s expectations regarding the chief commercial officer position; Disc’s expectations regarding leadership, future growth and innovation; Disc’s expectations regarding the milestones for its research and development programs in 2024; Disc’s expectations of entering late-stage development and planning for commercialization; and the other risks and uncertainties described in the “Risk Factors” section of our Annual Report on Form 10-K for the year ended December 31, 2022, Quarterly Reports on Form 10-Q for the quarters ended March 31, 2023, June 30, 2023, and September 30, 2023 and other documents filed by Disc from time to time with the Securities and Exchange Commission (SEC), as well as discussions of potential risks, uncertainties, and other important factors in Disc’s subsequent filings with the SEC. Any forward-looking statement speaks only as of the date on which it was made. None of Disc, nor its affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as result of new information, future events or otherwise, except as required by law. Media Contact Peg Rusconi Verge Scientific Communications prusconi@vergescientific.com Investor Relations Contact Christina Tartaglia Stern Investor Relations christina.tartaglia@sternir.com

Executive ChangeAcquisition

08 Dec 2022

·www.biospace.com

Wren Taps Vertex Veteran Executives and Other Leaders to Advance First-in-Class Small-Molecule Drugs into Clinical Testing for Neurodegenerative Diseases

— Executive leaders in R&D management, medicinal chemistry, technical operations and translational biology to lead build-out of discovery platform and pipeline — BOSTON, Dec. 8, 2022 /PRNewswire/ -- Wren Therapeutics announced today a number of senior leadership appointments as the company advances its first investigational therapies toward the clinic, based on the company's breakthrough approach to discovering small molecules that precisely target and shut down the sources of oligomer and aggregate generation in neurodegenerative diseases. The company recently welcomed Vertex Pharmaceuticals veterans John Thomson, PhD and Patrick Connelly, PhD as its Chief Scientific Officer and first Chief Innovation Officer, respectively. Dr. Thomson and Dr. Connelly are Vertex founding scientists who worked together on leadership teams that discovered and developed Vertex's seven FDA-approved drugs. In addition to Drs. Thomson and Connelly, new appointments to Wren's leadership team include: Mike Dey, PhD: Head of Manufacturing and Technical Operations Janeta Popovici-Muller, PhD: Head Drug Design and Advancement Rajeev Sivasankaran, PhD: Head Translational Development "It is often said that drug discovery and development is the ultimate team sport—it takes a great many people with immense talent, dedication, and focus working together on breakthrough science," said Bart Henderson, CEO of Wren. "We couldn't be more pleased to welcome John, Pat, Mike, Janeta, and Rajeev to Wren's team—all proven executives in their fields. With this lineup of experienced talent, Wren has the leadership team to break open the field of neurodegenerative diseases targeting the molecular mechanisms at the source of toxic oligomer generation." John Thomson, PhD | Chief Scientific Officer Dr. Thomson was formerly Head of Research for Vertex Pharmaceuticals' USA-based research operations, a company he helped to build from the ground up. During his 25-year tenure, he was involved with all Vertex research programs spanning antivirals and anti-infectives, immunoregulation, inflammation, neurological dysfunction, cystic fibrosis, and oncology research. He headed the Hepatitis C project that yielded INCIVEK® (telaprevir) and contributed to the discovery and selection of more than 40 development candidates—many first-in-class, and of which six were eventually approved as drugs. Patrick Connelly, PhD | Chief Innovation Officer Dr. Connelly is a biophysics expert who created and led a number of specialized R&D business units at Vertex Pharmaceuticals, where he was a founding scientist and former employee. He established the unique Materials Discovery & Characterization development function at Vertex, where he, his staff, and colleagues co-invented three first-in-class medicines—INCIVEK® for hepatitis C, and KALYDECO® and ORKAMBI® for cystic fibrosis. Dr. Connelly also co-founded and led Vertex's Corporate Innovation unit that catalyzed the company's entry into sickle cell disease and was a member of the Vertex-CRISPR Therapeutics Joint Research Committee that brought forth Exa-cel, one of the first gene-editing medicines to be tested in humans, currently in Phase 3 clinical trials. Mike Dey, PhD | Head of Manufacturing and Technical Operations Dr. Day's extensive experience in drug development, industrialization, and manufacturing encompasses more than 40 NDA/BLA approvals. Previous to joining Wren, Dr. Dey was Vice President, Pharmaceutical Development and Vice President, Endocrinology Strategy team at Ipsen, where he supported Somatuline in becoming a $1 billion product as well as out-licensing partnerships on early products that are now approved life-changing therapies. He held senior manufacturing and R&D positions at Aventis (now Sanofi) in various mergers for which he led integration of industrialization and R&D teams to accelerate new products. He has developed novel equipment and built facilities in the U.S., EU, and Asia to secure supply from earliest clinical trials to global launches. He is an inventor of multiple formulation and drug delivery patents supporting several approved products. Janeta Popovici-Muller, PhD | Head of Drug Design & Advancement Dr. Popovici-Muller has more than 20 years of experience in early and late-stage drug discovery. She was a founding employee and Senior Vice President, Head of Drug Discovery at Rectify Pharmaceuticals and served as Vice President, Head of Chemistry at Decibel Therapeutics. Dr. Popovici-Muller co-led drug discovery programs at Agios Pharmaceuticals that delivered clinical-stage molecules in the areas of cancer metabolism (co-inventor of Tibsovo®) and rare genetic metabolic disorders (Pyrukynd®). Preceding her tenure at Agios, Dr. Popovici-Muller spent 10 years at Merck Research Labs in Cambridge, MA (through merger with Schering-Plough) focused on small-molecule drug discovery in oncology, inflammation, and anti-viral therapeutic areas. Rajeev Sivasankaran | [Head of Translational Development Dr. Sivasankaran joined Wren as Head of Translational Development after an 18-year tenure at the Novartis Institutes of Biomedical Research (NIBR) leading drug discovery programs ranging from small molecules to gene therapy—from early ideation to human clinical trials—most recently as Executive Director and Head of Rare Diseases in the Neuroscience Division. His group initiated and advanced drug discovery programs focused on a broad range of monogenic neurodegenerative and neurodevelopmental diseases including spinal muscular atrophy, Huntington's disease, Friedreich's ataxia, and autism spectrum disorders. About Wren Therapeutics Wren is a biopharmaceutical company transforming drug discovery for neurodegenerative diseases, targeting the fleeting protein intermediates central to many disease pathways that are beyond the reach of conventional drug discovery approaches. We have built a unique drug discovery platform to assay and target the transient protein intermediates—the oligomers—in these disease pathways, to interrupt the molecular mechanisms that are the source of oligomer generation with small-molecule therapeutics. We are focusing this platform first on some of the greatest unmet medical needs of our time: Parkinson's disease, Alzheimer's disease, and ALS. For more information, please visit: . Contact: Mary Moynihan M2Friend Biocommunications +1 (802) 951-9600 mary@m2friend.com

Executive ChangePhase 3

19 Apr 2021

·www.biospace.com

Translate Bio Announces Key Leadership Additions and Promotions

-- Seasoned healthcare executive, Brendan Smith, appointed as Chief Financial Officer, bringing strategic operations and financial leadership -- -- Appointments enhance capabilities across pulmonary programs, manufacturing and financial operations with a goal of advancing platform, preclinical and clinical milestones -- LEXINGTON, Mass., April 19, 2021 (GLOBE NEWSWIRE) -- Translate Bio (Nasdaq: TBIO), a clinical-stage messenger RNA (mRNA) therapeutics company developing a new class of potentially transformative medicines to treat or prevent debilitating or life-threatening diseases, today announced several key leadership appointments, including Brendan Smith as Chief Financial Officer, Greg Troiano as Chief Manufacturing Officer, and Jim Sullivan as Senior Vice President, Pulmonary Discovery. These leadership appointments support the Company’s long-term strategic plan, TBIO 2025, that emphasizes several areas for value creation across the Company including adding key in-house quality and manufacturing capabilities, deepening pulmonary expertise and increasing research and development (R&D) investments with a goal of advancing platform innovation and driving multiple programs into the clinic. “Now is an exciting time for Translate Bio—and there is considerable momentum in the mRNA field. From vaccines to therapeutics, we have seen the substantial role that mRNA can play, and we have outlined key steps as part of TBIO 2025, our 5-year strategic plan, that we believe will enable the advancement of multiple investigational new drug applications (INDs), new pipeline programs and platform innovation,” said Ronald Renaud, chief executive officer of Translate Bio. “Adding key talent across the company to the Translate Bio team is a critical aspect of our plan and I am thrilled to share these important leadership appointments today that we believe will position us well to capture the significant potential of mRNA.” Brendan Smith, Chief Financial Officer & Corporate Strategy Mr. Smith was appointed Chief Financial Officer & Corporate Strategy effective April 19, 2021, his first day of employment with Translate Bio. Mr. Smith is an accomplished executive with more than two decades of experience within high-growth biopharma environments where he made significant contributions in various operations and strategy positions. A key area of strength in these roles was providing strategic financial leadership relating to long-term growth planning focused on operational efficiencies, building manufacturing and supply capabilities, and evaluation of business development opportunities and commercial planning assessments. In the role of Chief Financial Officer & Corporate Strategy, Mr. Smith will be responsible for Translate Bio’s finance and accounting, information technology, investor relations, and corporate strategy functions while working with the Company’s leadership team to ensure measured growth while executing on its strategic plan. Previously, as a Partner at Boston Consulting Group, Mr. Smith led integrated biopharma client engagements that included planning and executing on R&D strategy, operations, business development and deal diligence. Prior to that, Mr. Smith was VP, Head of Business Operations for Worldwide R&D at Pfizer where he led financial and headcount planning across discovery and development operations. In addition, as Executive Director, Head of Business Strategy and Operations for Biologics Pharmaceutical Sciences at Pfizer, Mr. Smith led manufacturing and financial operations for the company’s global biologics process development organization. Mr. Smith received a B.S. in Biochemistry from Worcester Polytechnic Institute and an M.B.A. from Harvard Business School. Greg Troiano, Chief Manufacturing Officer Mr. Troiano joined Translate Bio as SVP of Technical Operations in May of 2020, and was appointed Chief Manufacturing Officer in March 2021. Mr. Troiano is a seasoned manufacturing operations executive who has led the development of pharmaceutical products from feasibility through commercial production. In the role of CMO, Mr. Troiano will be responsible for strategic oversight of all aspects of cGMP CMC operations, including clinical supply, analytical testing, quality and engineering. Previously, he was VP of Technology and Chief Engineer at Seer, a life sciences and health data company using nanotechnology for proteomics and biomarker discovery. He was also VP of Nanomedicine Development and Manufacturing within Pfizer’s Pharmaceutical Sciences group where he led the development and manufacturing of novel nanoparticle drug products. Over his 20+ year biopharma career, Mr. Troiano supported the technical operations behind the commercialization of Gliadel® Wafer, Nutropin Depot®, Risperdal Consta®, Vivitrol® and Bydureon®. Mr. Troiano received his M.S.E. and B.S. in Biomedical Engineering from The Johns Hopkins University. He is an inventor on more than 20 process and equipment patents/applications and an author on over a dozen scientific publications in drug delivery. He was elected and inducted into the American Institute for Medical and Biological Engineering (AIMBE) College of Fellows in 2020 for recognition of his accomplishments in drug delivery. Jim Sullivan, PhD, Senior Vice President, Pulmonary Discovery Dr. Sullivan joined Translate Bio in January 2021 as Senior Vice President, Pulmonary Discovery. In this role, Dr. Sullivan leads preclinical discovery efforts for all pulmonary programs. Dr. Sullivan’s drug development experience in both basic research and clinical development (early and late stage) will strengthen Translate Bio’s translational research efforts, with a goal of bringing novel mRNA therapeutics to patients. Prior to joining Translate Bio, Dr. Sullivan was most recently at Sana Biotechnology, where he was an Executive Director focused on cell and gene therapy. In this role, Dr. Sullivan was Head of Translational Sciences and a Program Lead for novel treatment modalities for certain inherited diseases. Before Sana, Dr. Sullivan was Director at Vertex where he was an s/NDA team member for several products, including, for cystic fibrosis, Kalydeco®, Orkambi® and Symdeko®, as well as Incivek® for Hepatitis C. Dr. Sullivan was also an IND team member for multiple assets currently in clinical development to treat alpha-1-antitrypsin (AAT) deficiency and the first-ever CRISPR-based gene editing therapeutic product for the treatment of certain hemoglobinopathies. Dr. Sullivan received a B.S. in Biology from Boston College, an M.S. in Environmental Chemistry from University College Dublin, and a Ph.D. in Genome Sciences/Genetics from Boston University. He has authored more than 30 publications in peer-reviewed journals. About Translate Bio Translate Bio is a clinical-stage mRNA therapeutics company developing a new class of potentially transformative medicines to treat diseases caused by protein or gene dysfunction, or to prevent infectious diseases by generating protective immunity. Translate Bio is primarily focused on applying its technology to treat pulmonary diseases with a lead pulmonary candidate being evaluated as an inhaled treatment for cystic fibrosis (CF) in a Phase 1/2 clinical trial. Additional pulmonary diseases are being evaluated in discovery-stage research programs that utilize a proprietary lung delivery platform. Translate Bio also believes its technology may apply broadly to a wide range of diseases, including diseases that affect the liver. Additionally, the platform may be applied to various classes of treatments, such as therapeutic antibodies or protein degradation. Translate Bio is also pursuing the development of mRNA vaccines for infectious diseases under a collaboration with Sanofi Pasteur. For more information about the Company, please visit or on Twitter at @TranslateBio. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, those regarding: Translate Bio’s expectations regarding the anticipated contributions of Mr. Smith, Mr. Troiano and Dr. Sullivan to the leadership team, its strategic plan, TBIO 2025, and the Company’s platform; Translate Bio’s plan to continue to grow the Company; Translate Bio’s belief that its strategic plan, TBIO 2025, will enable the advancement of multiple INDs, broaden its pipeline opportunities and advance platform innovation; and Translate Bio’s plans strategies and prospects for its business, including its lead development programs. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “forward,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from current expectations and beliefs, including but not limited to: the current and potential future impacts of the COVID-19 pandemic on Translate Bio’s business, financial condition, operations and liquidity; Translate Bio’s ability to advance the development of its platform and programs, including without limitation, under the timelines it projects, demonstrate the requisite safety and efficacy of its product candidates and replicate in clinical trials any positive findings from preclinical studies or early-stage clinical trials; the content and timing of decisions made by the U.S. Food and Drug Administration, other regulatory authorities and investigational review boards at clinical trial sites, including decisions as it relates to ongoing and planned clinical trials; Translate Bio’s ability to obtain, maintain and enforce necessary patent and other intellectual property protection; the availability of significant cash required to fund operations; competitive factors; general economic and market conditions and other important risk factors set forth under the caption “Risk Factors” in Translate Bio’s Annual Report on Form 10-K for the year ended December 31, 2020 filed with the Securities and Exchange Commission (“SEC”) on March 1, 2021 and in any other subsequent filings made with the SEC by Translate Bio. Any forward-looking statements contained in this press release speak only as of the date hereof, and Translate Bio specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Investor Relations Media Relations Teri Dahlman Maura Gavaghan Tel.: +1 (617) 817-8655 Tel: +1 (617) 233-1154 tdahlman@translate.bio mgavaghan@translate.bio

VaccineGene TherapyAntibodymRNA

100 Deals associated with Telaprevir

External Link

KEGG	Wiki	ATC	Drug Bank
D09012	Telaprevir	J05AP02	DB05521

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hepatitis C, Chronic	US	Vertex Pharmaceuticals, Inc.	23 May 2011

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hepatocellular Carcinoma	Phase 3	US	Vertex Pharmaceuticals, Inc.	01 Apr 2013
Pseudohyperkalemia Cardiff	Phase 3	JP	Mitsubishi Tanabe Pharma Corp.	01 Dec 2012
Coinfection	Phase 3	BE	Janssen-Cilag International NV	01 Jun 2012
Coinfection	Phase 3	DE	Janssen-Cilag International NV	01 Jun 2012
Coinfection	Phase 3	HU	Janssen-Cilag International NV	01 Jun 2012
Coinfection	Phase 3	IE	Janssen-Cilag International NV	01 Jun 2012
Coinfection	Phase 3	LU	Janssen-Cilag International NV	01 Jun 2012
Coinfection	Phase 3	PT	Janssen-Cilag International NV	01 Jun 2012
Coinfection	Phase 3	RU	Janssen-Cilag International NV	01 Jun 2012
Coinfection	Phase 3	GB	Janssen-Cilag International NV	01 Jun 2012

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01753570 (CTgov)	Phase 3	Pseudohyperkalemia Cardiff	74	IFN beta(24 weeks)+RBV(24 weeks)+MP-424 (MP-424+RBV+IFN Beta, Genotype1)	mnklljbjaz(xoghkjeldq) = lwpzpzvibz fgjtyurhyn (vqtkuoojcn, dqecdzynwv - rmqmrnebpg) View more	-	26 Oct 2018
				IFN beta(48 weeks)+RBV(48 weeks) (RBV+IFN Beta, Genotype1)	mnklljbjaz(xoghkjeldq) = qxlnxanfwv fgjtyurhyn (vqtkuoojcn, mvyoyxudio - iercbrvslw) View more
NCT01355289 (CTgov)	Phase 2	Thrombocytopenia	65	Placebo (Placebo (Core Study))	wmsgbisvwm(rrjzxzdckh) = qwizeyppbi dkyfxtrlyb (aeaxqmxvks, wyuntwrevu - rlbteuymle) View more	-	22 Feb 2018
				Avatrombopag (Avatrombopag 10 mg (Core Study))	wmsgbisvwm(rrjzxzdckh) = hviueeiwpe dkyfxtrlyb (aeaxqmxvks, uhxjiazqvz - wmvpuyzlmp) View more
NCT01753570 (Pubmed \| Hepatol Res)	Phase 3	Depressive Disorder \| Hepatitis C, Chronic	74	TVR/IFN-β/RBV therapy	jepfemaxvg(eltuamrnum) = xnetbuufvb rxrmlfjtzs (czmpedpjqo )	-	01 Feb 2018
				IFN-β/RBV therapy	jepfemaxvg(eltuamrnum) = itefrudptu rxrmlfjtzs (czmpedpjqo )
NCT01753557 (Pubmed \| Hepatol Res) Manual	Phase 3	Hepatitis C	54	pegylated interferon α-2a+ribavirin+telaprevir (treatment-naïve)	mornqkblaa(yijswwwzpo) = vwvkijwgkg nuimryjlts (pnrfxhfgym )	Positive	01 May 2017
				pegylated interferon α-2a+ribavirin+telaprevir (relapsed)	mornqkblaa(yijswwwzpo) = qmwrnzzjwr nuimryjlts (pnrfxhfgym )
NCT01753557 (CTgov)	Phase 3	Chronic hepatitis C genotype 1 \| Hepatitis C, Chronic	54	PEG-IFN alfa-2a+RBV+MP-424 (Treatment-Naive)	udrmmmlhbp(pevljapzjk) = uxecvlkhdg cmbykytukl (qcdopiaekk, kmxxaberpd - riheykotms) View more	-	03 Oct 2016
				PEG-IFN alfa-2a+RBV+MP-424 (Treatment-Relapsed)	udrmmmlhbp(pevljapzjk) = ggzpuktvqi cmbykytukl (qcdopiaekk, gkjmntnyua - cioynjtohi) View more
NCT01701063 (CTgov)	Phase 1/2	Chronic hepatitis C genotype 1	42	Peg-IFN-alfa-2b+RBV+Telaprevir (Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV)	ldeqoyaaua(pzefccgete) = mdkfhigmaa lvthfegvlv (oulpxtcfzr, kaxklfwugt - ibieawfjqp) View more	-	20 Jul 2016
				Peg-IFN-alfa-2b+RBV+Telaprevir (Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV)	ldeqoyaaua(pzefccgete) = xaascwvxlu lvthfegvlv (oulpxtcfzr, ladkrqwxgr - scgzdhidfn) View more
NCT01571583 (REPLACE, Pubmed) Manual	Phase 3	Chronic hepatitis C genotype 1	74	Peginterferon alfa-2a+Ribavirin+telaprevir	pgxzgwaset(vsxvezkjqa) = lxyrnyosiv hbuepnbvxy (kmxjeafjvf, 59.9 - 81.5)	Positive	01 Jul 2016
NCT01513941 (INSIGHT, Pubmed \| J Antimicrob Chemother)	Phase 3	HIV Infections \| Hepatitis C, Chronic	162	Telaprevir-based therapy	sbukvzsvib(werbpcgjah) = oxiewhefdg vzjnstetur (gumklqznrt )	-	01 Jan 2016
NCT01500616 (Pubmed \| J Infect) Manual	Phase 3	HIV Infections \| Hepatitis C	118	PEG-IFN+ribavirin+Telaprevir	iuvqkvxadp(xkcucinuzh) = eguczrgmzy kmkjerdoln (lryepduzhh ) View more	Positive	01 Dec 2015
ANRS CO13-HEPAVIH (Pubmed \| J Clin Virol)	Not Applicable	HIV Infections \| Hepatitis C	89	BOC-based regimen	xufomsinas(vlqgblhihi) = njnobessnz tcsredhnot (ooibtbkvve )	-	01 Dec 2015
				TVR-based regimen	xufomsinas(vlqgblhihi) = idqjrpulmk tcsredhnot (ooibtbkvve )

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