PRVB Provention Bio Inc.

6.53
-0.01  -0%
Previous Close 6.53
Open 6.54
52 Week Low 5.59
52 Week High 20.05
Market Cap $413,520,165
Shares 63,374,738
Float 58,084,618
Enterprise Value $231,142,817
Volume 120,443
Av. Daily Volume 681,392
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Upcoming Catalysts

Drug Stage Catalyst Date
PRV-101 - PROVENT
Coxsackievirus B (CVB) vaccine
Phase 1
Phase 1
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AMG 714 / PRV-015
Celiac disease
Phase 2b
Phase 2b
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Drug Pipeline

Drug Stage Notes
PRV-6527
Crohn's disease
Phase 2a
Phase 2a
Phase 2a data did not meet primary endpoint - October 22, 2019.
Teplizumab (PRV-031)
Type 1 diabetes
CRL
CRL
CRL issued on July 2, 2021. FDA Type A meeting on PK Model in 4Q 2021.
PRV-031 (teplizumab) - (PROTECT)
Recent Onset Type 1 Diabetes
Phase 3
Phase 3
Phase 3 enrollment to be completed 3Q 2021.
PRV-3279
Systemic Lupus Erythematosus (SLE) and Lupus nephritis (LN)
Phase 2a
Phase 2a
Phase 2a portion to commence 2H 2021.
PRV-300
Ulcerative Colitis
Phase 1b
Phase 1b
Phase 1b top-line data May 8, 2019 noted primary safety and tolerability endpoint met but efficacy and other secondary endpoints were not met.

Latest News

  1. RED BANK, N.J., Sept. 16, 2021 /PRNewswire/ -- Provention Bio, Inc. (NASDAQ:PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today announced that management will participate in a fireside chat presentation at the Oppenheimer Fall Healthcare Life Sciences and MedTech Summit on Wednesday, September 22, 2021 at 9:05 am E.T.

    The presentation will be webcast live and can be accessed by visiting the Events and Webcasts section of the Company's website: http://investors.proventionbio.com/events. The webcast will be archived on the Company's website for 30 days following the presentation.

    About Provention Bio, Inc.:

    Provention Bio, Inc. (NASDAQ:PRVB) is a biopharmaceutical company focused on advancing the development of investigational therapies that may intercept and prevent debilitating and life-threatening immune-mediated disease. The Company's pipeline includes clinical-stage product candidates that have demonstrated in pre-clinical or clinical studies proof-of-mechanism and/or proof-of-concept in autoimmune diseases, including type 1 diabetes, celiac disease and lupus. Visit www.ProventionBio.com for more information and follow us on Twitter: @ProventionBio.

    Internet Posting of Information:

    Provention Bio, Inc. uses its website, www.proventionbio.com, as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation F.D. Such disclosures will be included on the Company's website in the "News" section. Accordingly, investors should monitor this portion of the Company's website, in addition to following its press releases, SEC filings and public conference calls and webcasts.

    Investor Contacts:

    Robert Doody, VP of Investor Relations

    rdoody@proventionbio.com

    484-639-7235

    Sam Martin, Argot Partners

    proventionbio@argotpartners.com   

    212-600-1902

    Media Contact:

    Lori Rosen, LDR Communications

    lori@ldrcommunications.com

    917-553-6808

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/provention-bio-to-present-at-the-oppenheimer-fall-healthcare-life-sciences-and-medtech-summit-301377988.html

    SOURCE Provention Bio, Inc.

    View Full Article Hide Full Article
  2. RED BANK, N.J., Sept. 13, 2021 /PRNewswire/ -- Provention Bio, Inc. (NASDAQ:PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today provided an update on the status and timing of its ongoing efforts to address FDA considerations cited in the Complete Response Letter (CRL) issued to the Company by the FDA on July 2, 2021.

    The Company has completed the collection of data from a PK/PD substudy in the ongoing PROTECT Phase 3 trial in newly diagnosed T1D patients (AGC Biologics N~30 patients, Eli Lilly N~130 patients) to determine comparability between the Company's planned commercial drug product and drug product originating from drug substance manufactured for historical trials of teplizumab.  During ongoing informal discussions with the FDA to finalize and agree upon the design of the population PK model that will generate the PK parameters comparing drug products, the FDA has recommended that the Company request a formal Type A meeting and submit briefing documents related to the population PK model. The objective of this meeting with the FDA is to agree on the PK model's design prior to the Company populating the model with relevant PK data collected from the PROTECT substudy.  The Company is working towards a request and submission to allow this Type A meeting to occur in the fourth quarter of this year.

    Additionally, the Company disclosed preliminary PD marker information upon therapeutic dosing of teplizumab from the substudy data that the Company believes are supportive, although not determinative, of comparability between the two drug products. The FDA has not yet opined on these data or their significance, and the Company looks forward to discussing with the FDA.  These PD markers include lymphocyte counts, CD3 receptor occupancy and T-cell activation.

    The Company also recently completed a Type A meeting with the FDA to discuss several additional considerations related to product quality that were cited in the CRL.  The Company continues to believe that the product quality CRL considerations have either already been addressed by prior amendments to the BLA or are addressable in the short term.  As it relates to the deficiencies noted during the recent general inspection at a fill/finish facility used by the Company mentioned in the CRL, this facility's inspection has since been closed out by the FDA in August of 2021.

    The Company has posted an update to its corporate slide presentation containing additional details pertaining to the information commented on within this press release.  The presentation can be found at www.proventionbio.com in the Investor's section.

    "We believe we are making significant progress in our work to address the observations cited by the FDA in the CRL for teplizumab we received in July and we will continue to work with the sense of urgency that the patient community and our investors expect of us," said Ashleigh Palmer, co-founder and CEO of Provention Bio. "We are encouraged by our interactions with the FDA and look forward to finalizing, to the FDA's satisfaction, the design of the population PK model that will be used to further determine comparability, as well as evaluate the clinical relevance of the outputs.  Additionally we are encouraged by the consistent incremental PD marker data that we are sharing today."

    The Unmet Need in Type 1 Diabetes (T1D):

    Over 1.6 million Americans have T1D, an autoimmune disease caused by the destruction of beta cells. Diagnosis of T1D usually occurs in children and young adults, but it can happen at any age after symptoms appear when a person cannot make enough insulin. However, T1D starts in the body long before any symptoms and can be detected through a blood test. The psychological impact of T1D is hard to quantify, but a diagnosis is life-altering, and regular monitoring and maintenance can be extremely stressful. T1D typically takes more than a decade off a person's life, and life expectancy is reduced by 16 years on average for people diagnosed before the age of 10. Insulin therapy and glucose monitoring are currently the standard of care for treating clinical-stage T1D, and are necessary to keep T1D patients alive. The constant monitoring and administration of insulin represents a significant life-long burden for patients. No disease-modifying treatments for T1D are currently available.

    About Teplizumab (PRV-031):

    Teplizumab is an investigational anti-CD3 monoclonal antibody (mAb) being developed for the delay of clinical type 1 diabetes (T1D) in at-risk individuals. In the pivotal TN-10 Study, a single 14-day course of teplizumab delayed insulin-dependent, clinical-stage disease by a median of at least two years in presymptomatic patients with Stage 2 T1D compared to placebo. The observed adverse events were mechanism-based, transient, and predictable, including lymphopenia, transaminase elevations, rash, and cytokine release events.  These results were published in the New England Journal of Medicine and simultaneously presented at the American Diabetes Association meeting in 2019.  More than 800 patients have received teplizumab in multiple clinical studies involving more than 1,000 subjects. In previous studies of newly diagnosed patients, teplizumab consistently demonstrated the ability to preserve beta-cell function as shown by C-peptide, a measure of endogenous insulin production. It correspondingly reduced the need for insulin use. Teplizumab has been granted Breakthrough Therapy Designation by the FDA and PRIME designation by the European Medicines Administration. Provention is currently also evaluating teplizumab in patients with newly diagnosed insulin-dependent T1D (the Phase 3 PROTECT study).

    About Provention Bio, Inc.:

    Provention Bio, Inc. (NASDAQ:PRVB) is a biopharmaceutical company focused on advancing the development of investigational therapies that may intercept and prevent debilitating and life-threatening immune-mediated disease. The Company's pipeline includes clinical-stage product candidates that have demonstrated in pre-clinical or clinical studies proof-of-mechanism and/or proof-of-concept in autoimmune diseases, including type 1 diabetes, celiac disease and lupus. Visit www.ProventionBio.com for more information and follow us on Twitter: @ProventionBio.

    Internet Posting of Information:

    Provention Bio, Inc. uses its website, www.proventionbio.com, as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation F.D. Such disclosures will be included on the Company's website in the "News" section. Accordingly, investors should monitor this portion of the Company's website, in addition to following its press releases, SEC filings and public conference calls and webcasts.

    Forward-Looking Statements:

    Certain statements in this press release are forward-looking, including but not limited to, statements relating to the medical need in T1D at-risk patients, the potential therapeutic effects and safety of teplizumab in at-risk T1D patients, the potential for PK/PD substudy data and analyses to address the FDA's PK comparability considerations, the Company's belief that the remaining product quality issues cited in the CRL are addressed or may be adressable in the short-term, the timing of the FDA's review of such data and analyses if submitted by the Company and the Company's plans to address the other matters raised in the CRL. These statements may be identified by the use of forward-looking words such as "will," "believe," and "may," among others. These forward-looking statements are based on the Company's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to FDA disagreeing with the Company's interpretation of data and analysis, including the preliminiary PD data referenced in this release which could change as these data are finalized; delays in or failure to obtain FDA approvals for teplizumab or other Company product candidates and the potential for noncompliance with FDA regulations; any inability to successfully work with FDA to find a satisfactory solution to address its concerns in a timely manner or at all, including any inability to provide the FDA with PK/PD data from our ongoing Phase 3 PROTECT study or other data sufficient to support an approval of the BLA for teplizumab; an inability to satisfactorily address other matters cited in the CRL including relating to product quality, the safety update required by FDA or any other FDA requirements for an approval of teplizumab; the potential impacts of COVID-19 on our business and financial results; changes in law, regulations, or interpretations and enforcement of regulatory guidance;  uncertainties of patent protection and litigation; the Company's dependence upon third parties; substantial competition; the Company's need for additional financing and the risks listed under "Risk Factors" in the Company's quarterly report on Form 10-Q for the quarter ended June 30, 2021 and any subsequent filings with the Securities and Exchange Commission. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Provention does not undertake an obligation to update or revise any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by applicable law. The information set forth herein speaks only as of the date hereof.

    Investor Contacts:

    Robert Doody, VP of Investor Relations

    rdoody@proventionbio.com

    484-639-7235

    Sam Martin, Argot Partners

    sam@argotpartners.com   

    212-600-1902

    Media Contact:

    Lori Rosen, LDR Communications

    lori@ldrcommunications.com

    917-553-6808

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/provention-bio-provides-update-on-the-potential-timing-of-teplizumab-at-risk-type-1-diabetes-t1d-biologics-license-application-bla-resubmission-301374834.html

    SOURCE Provention Bio, Inc.

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  3. RED BANK, N.J., July 29, 2021 /PRNewswire/ -- Provention Bio, Inc. (NASDAQ:PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today announced that it will report its second quarter 2021 financial results on Thursday, August 5, 2021, before the opening of the U.S. financial markets. Subsequently, at 8:00 am E.T., the company will host a conference call to discuss its financial results and provide a corporate update.

    To access the call, please dial 1-877-870-4263 (domestic) or 1-412-317-0790 (international) ten minutes prior to the start time and ask to be connected to the "Provention Bio Call." An audio webcast will also be available on the "Events and Webcasts" page of the Investors section of the Company's website, www.proventionbio.com. An archived webcast will be available on the Company's website approximately two hours after the conference call.

    About Provention Bio, Inc.:

    Provention Bio, Inc. (NASDAQ:PRVB) is a biopharmaceutical company focused on advancing the development of investigational therapies that may intercept and prevent debilitating and life-threatening immune-mediated disease. The Company's pipeline includes clinical-stage product candidates that have demonstrated in pre-clinical or clinical studies proof-of-mechanism and/or proof-of-concept in autoimmune diseases, including type 1 diabetes, celiac disease and lupus. Visit www.ProventionBio.com for more information and follow us on Twitter: @ProventionBio.

    Internet Posting of Information:

    Provention Bio, Inc. uses its website, www.proventionbio.com, as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD. Such disclosures will be included on the Company's website in the "News" section. Accordingly, investors should monitor this portion of the Company's website, in addition to following its press releases, SEC filings and public conference calls and webcasts.

    Investor Contacts:

    Robert Doody, VP of Investor Relations

    rdoody@proventionbio.com

    484-639-7235

    Sam Martin, Argot Partners

    sam@argotpartners.com  

    212-600-1902

    Media Contact:

    Lori Rosen, LDR Communications

    lori@ldrcommunications.com

    917-553-6808

     

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/provention-bio-to-report-second-quarter-2021-financial-results-on-august-5-2021-301342457.html

    SOURCE Provention Bio, Inc.

    View Full Article Hide Full Article
  4. RED BANK, N.J., July 12, 2021 /PRNewswire/ -- Provention Bio, Inc. (NASDAQ:PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today announced that teplizumab, an anti-CD3 monoclonal antibody (mAb), was awarded an Innovation Passport for the delay of clinical type 1 diabetes (T1D) in at-risk individuals. Teplizumab is one of the first investigational medicines to receive this designation under the United Kingdom's (UK) Innovative Licensing and Access Pathway (ILAP) launched by The Medicines and Healthcare products Regulatory Agency (MHRA) in January 2021.

    In the UK, approximately 400,000 people have T1D, including about 39,000 children 19 years and younger1. The UK has one of the highest rates of T1D globally, and new diagnoses are increasing by about 4% each year. T1D is managed through insulin therapy and glucose monitoring to keep patients alive but still can reduce life expectancy for patients by up to a decade. Currently, there is no approved disease-modifying treatment that targets the underlying cause of T1D.

    Teplizumab is being developed for the delay of clinical T1D in at-risk individuals. In the pivotal TN-10 Study, a single 14-day course of teplizumab delayed insulin-dependent, clinical-stage disease by a median of at least two years in presymptomatic patients with Stage 2 T1D compared to placebo. The observed adverse events were mechanism-based, transient, and predictable, including lymphopenia, transaminase elevations, rash, and cytokine release events.  These results were published in the New England Journal of Medicine and simultaneously presented at the American Diabetes Association meeting in 2019.

    "My patients sometimes ask me if they can ever have a day without insulin. Teplizumab is the first treatment to potentially offer this, delaying the need for insulin by a median of 2-3 years following a single course in the TN-10 study," stated Colin Dayan, MA, MBBS, FRCP, PhD, Professor of Clinical Diabetes and Metabolism, Cardiff University School of Medicine. "For newly diagnosed children and adults, these are years when they can eat and enjoy playing sports just like their peers, free from the fear of hypoglycemia, while at the same time accruing the long-term benefits of excellent blood glucose control. We are very excited at the potential of having this drug available for treatment of patients before onset of T1D in the UK."

    ILAP was launched at the start of 2021 to accelerate the development and access to promising medicines in the UK, thereby facilitating and improving patient access to new medicines. The pathway, part of the UK's plan to attract life sciences development in the post-Brexit era, features enhanced input and interactions with the MHRA and other stakeholders, including the National Institute for Health and Care Excellence (NICE) and the Scottish Medicines Consortium (SMC). The decision to award the Innovation Passport to the teplizumab program was made by the ILAP Steering Group, which is comprised of representatives from MHRA, NICE, and SMC. The process is also supported by such bodies as the National Health Service (NHS) England, the NHS Improvement, Health Research Authority and the National Institute for Health Research.

    To receive an Innovation Passport, an experimental drug needs to meet the following public health and/or patient-centric criteria: (1) the condition is life-threatening or seriously debilitating; (2) the program fulfills at least one of the following: innovative medicine, clinically significant new indication or, it is intended for a special population; and (3) the medicine has the potential to offer benefits to patients. The Innovation Passport designation is the first step in the ILAP process. It triggers the MHRA and its partner agencies to create a target development profile to chart out a roadmap for regulatory and development milestones with the goal of early patient access in the UK. Other benefits of ILAP include a 150-day accelerated assessment, rolling review, and a continuous benefit-risk assessment.

    "There have been no new therapeutic innovations in T1D since the development of insulin 100 years ago, despite the significant life-long burden of the disease and steady increase of new diagnoses," said Ashleigh Palmer, co-founder and CEO of Provention Bio. "We are pleased to be developing one of the first medicines granted an Innovation Passport. We look forward to working closely with the MHRA and the other partner agencies involved in the ILAP process to advance teplizumab towards being a therapeutic option for patients at risk of developing clinical-stage T1D in the UK."

    The Unmet Need in Type 1 Diabetes in the United Kingdom: 

    Approximately 400,000 people in the United Kingdom have type 1 diabetes (T1D), an autoimmune disease caused by the destruction of beta cells. Diagnosis of T1D usually occurs in children and young adults, but it can happen at any age after symptoms appear when a person cannot make enough insulin. However, T1D starts in the body long before any symptoms and can be detected through a blood test. The psychological impact of T1D is hard to quantify, but a diagnosis is life-altering, and regular monitoring and maintenance can be extremely stressful. T1D typically takes more than a decade off a person's life, and life expectancy is reduced by 16 years on average for people diagnosed before the age of 10. Insulin therapy and glucose monitoring are currently the standard of care for treating clinical-stage T1D and are necessary to keep T1D patients alive. The constant monitoring and administration of insulin represents a significant life-long burden for patients. No disease-modifying treatments for T1D are currently available.

    About Teplizumab (PRV-031):



    Teplizumab is an investigational anti-CD3 monoclonal antibody (mAb) being developed for the delay of clinical type 1 diabetes (T1D) in at-risk individuals. In the pivotal TN-10 Study, a single 14-day course of teplizumab delayed insulin-dependent, clinical-stage disease by a median of at least two years in presymptomatic patients with Stage 2 T1D compared to placebo. The observed adverse events were mechanism-based, transient, and predictable, including lymphopenia, transaminase elevations, rash, and cytokine release events.  These results were published in the New England Journal of Medicine and simultaneously presented at the American Diabetes Association meeting in 2019.  More than 800 patients have received teplizumab in multiple clinical studies involving more than 1,000 subjects. In previous studies of newly diagnosed patients, teplizumab consistently demonstrated the ability to preserve beta-cell function as shown by C-peptide, a measure of endogenous insulin production. It correspondingly reduced the need for insulin use. Teplizumab has been granted Breakthrough Therapy Designation by the FDA and PRIME designation by the European Medicines Administration. Provention is currently also evaluating teplizumab in patients with newly diagnosed insulin-dependent T1D (the Phase 3 PROTECT study).

    About Provention Bio, Inc.:

    Provention Bio, Inc. (NASDAQ:PRVB) is a biopharmaceutical company focused on advancing the development of investigational therapies that may intercept and prevent debilitating and life-threatening immune-mediated disease. The Company's pipeline includes clinical-stage product candidates that have demonstrated in pre-clinical or clinical studies proof-of-mechanism and/or proof-of-concept in autoimmune diseases, including type 1 diabetes, celiac disease and lupus. Visit www.ProventionBio.com for more information and follow us on Twitter: @ProventionBio.

    Internet Posting of Information:

    Provention Bio, Inc. uses its website, www.proventionbio.com, as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation F.D. Such disclosures will be included on the Company's website in the "News" section. Accordingly, investors should monitor this portion of the Company's website, in addition to following its press releases, SEC filings and public conference calls and webcasts.

    Forward-Looking Statements:  

    Certain statements in this press release are forward-looking, including but not limited to, statements relating to the medical need in T1D at-risk patients, the potential therapeutic effects and safety of teplizumab in at-risk T1D patients, and the advancement of teplizumab towards being a therapeutic option for patients at risk of developing clinical-stage T1D in the UK. These statements may be identified by the use of forward-looking words such as "will," "potentially" and "may," among others. These forward-looking statements are based on the Company's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to delays in or failure to obtain FDA, MHRA or other applicable approvals for teplizumab or other Company product candidates and the potential for noncompliance with FDA, MHRA or other applicable regulations; any inability to successfully work with FDA to find a satisfactory solution to address its concerns in a timely manner or at all, including any inability to provide the FDA with PK/PD data from our ongoing Phase 3 PROTECT study or other data sufficient to support an approval of the BLA for teplizumab; an inability to satisfactorily address other matters cited in the complete response letter received from the FDA, including those relating to product quality, fill/finish manufacturer deficiencies identified in a general inspection, the safety update required by FDA or any other FDA requirements for an approval of teplizumab; the potential impacts of COVID-19 on our business and financial results; changes in law, regulations, or interpretations and enforcement of regulatory guidance;  uncertainties of patent protection and litigation; the Company's dependence upon third parties; substantial competition; the Company's need for additional financing and the risks listed under "Risk Factors" in the Company's quarterly report on Form 10-Q for the quarter ended March 31, 2021 and any subsequent filings with the Securities and Exchange Commission. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Provention does not undertake an obligation to update or revise any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by applicable law. The information set forth herein speaks only as of the date hereof.

    Investor Contacts:

    Robert Doody, VP of Investor Relations

    rdoody@proventionbio.com

    484-639-7235

    Sam Martin, Argot Partners

    sam@argotpartners.com   

    212-600-1902

    Media Contact:



    Lori Rosen, LDR Communications

    lori@ldrcommunications.com

    917-553-6808

    1 International Diabetes Foundation (IDF) Atlas 9th Edition 2019, https://www.diabetesatlas.org/en

     

     

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/teplizumab-awarded-innovation-passport-in-the-united-kingdom-uk-for-the-delay-of-onset-of-clinical-type-1-diabetes-in-at-risk-individuals-301328920.html

    SOURCE Provention Bio, Inc.

    View Full Article Hide Full Article
  5. RED BANK, N.J., July 6, 2021 /PRNewswire/ -- Provention Bio, Inc. (NASDAQ:PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Company's Biologics License Application (BLA) for teplizumab for the delay of clinical type 1 diabetes (T1D) in at-risk individuals.

    In the CRL, received late evening on July 2nd, 2021, the FDA stated that a single, low-dose pharmacokinetic/pharmacodynamic (PK/PD) bridging study in healthy volunteers to compare planned commercial product with drug product originating from drug substance manufactured for historic clinical trials had failed to show PK comparability. "As PK remains the primary endpoint for demonstration of comparability between the two products, you will need to establish PK comparability appropriately between the intended commercial product and the clinical trial product or provide other data that adequately justify why PK comparability is not necessary."

    The Company expects relevant additional PK/PD data being, or to be, collected from a PK/PD substudy in patients receiving 12-days of therapy in the ongoing Phase 3 PROTECT trial in newly diagnosed T1D patients later this quarter. These data will be analyzed by independent, unblinded third-parties to maintain the integrity of this placebo-controlled trial. Upon review of the results from this substudy, the Company will determine whether to submit these data to the FDA for its review, along with any other relevant data and analyses based on our ongoing discussions with FDA, to support PK comparability or otherwise justify why PK comparability is not necessary.

    In the CRL, the FDA cited several additional considerations related to product quality,  which the Company believes have either been addressed in amendments already submitted to the BLA or can be addressed in the short-term. The CRL acknowledged that the FDA had not reviewed several amendments already submitted by the Company in response to certain Chemistry, Manufacturing and Controls (CMC) information requests.

    The FDA also stated that certain deficiencies conveyed during a recent general inspection, not specific to teplizumab, at a fill/finish manufacturing facility used by the Company will need to be resolved before approval.

    The CRL did not cite any clinical deficiencies related to the efficacy and safety data packages submitted to the BLA and confirmed the acceptability of the proposed proprietary name for teplizumab. The FDA requested that the Company provide a safety update as part of its BLA resubmission. The CRL contained other comments and recommendations that do not impact approvability, as well as general guidance regarding the resubmission process.

    "We want to recognize the patients, their families, study investigators, clinicians and T1D champions that have played such a crucial role in the development of teplizumab and thank our partners and our team of dedicated employees and consultants for their outstanding contributions. We also want to acknowledge the efforts of Drs. Yanoff and Unger and the review team at the FDA, who have worked so closely and transparently with us throughout the priority review of our BLA for this Breakthrough Therapy drug," said Ashleigh Palmer, co-founder and CEO of Provention Bio. "We know the T1D community is urgently awaiting therapeutic advancements to address their medical needs and believe our collective passion and committment will continue to drive us forward to meet this goal. We will continue to work collaboratively with the FDA to hopefully secure approval of teplizumab and bring the first disease-modifying therapy for T1D to at-risk patients as soon as possible."

    The Unmet Need in Type 1 Diabetes (T1D):

    Over 1.6 million Americans have T1D, an autoimmune disease caused by the destruction of beta cells. Diagnosis of T1D usually occurs in children and young adults, but it can happen at any age after symptoms appear when a person cannot make enough insulin. However, T1D starts in the body long before any symptoms and can be detected through a blood test. The psychological impact of T1D is hard to quantify, but a diagnosis is life-altering, and regular monitoring and maintenance can be extremely stressful. T1D typically takes more than a decade off a person's life, and life expectancy is reduced by 16 years on average for people diagnosed before the age of 10. Insulin therapy and glucose monitoring are currently the standard of care for treating clinical-stage T1D, and are necessary to keep T1D patients alive. The constant monitoring and administration of insulin represents a significant life-long burden for patients. No disease-modifying treatments for T1D are currently available.

    About Teplizumab (PRV-031):



    Teplizumab is an investigational anti-CD3 monoclonal antibody (mAb) being developed for the delay of clinical type 1 diabetes (T1D) in at-risk individuals. In the pivotal TN-10 Study, a single 14-day course of teplizumab delayed insulin-dependent, clinical-stage disease by a median of at least two years in presymptomatic patients with Stage 2 T1D compared to placebo. The observed adverse events were mechanism-based, transient, and predictable, including lymphopenia, transaminase elevations, rash, and cytokine release events.  These results were published in the New England Journal of Medicine and simultaneously presented at the American Diabetes Association meeting in 2019.  More than 800 patients have received teplizumab in multiple clinical studies involving more than 1,000 subjects. In previous studies of newly diagnosed patients, teplizumab consistently demonstrated the ability to preserve beta-cell function as shown by C-peptide, a measure of endogenous insulin production. It correspondingly reduced the need for insulin use. Teplizumab has been granted Breakthrough Therapy Designation by the FDA and PRIME designation by the European Medicines Administration. Provention is currently also evaluating teplizumab in patients with newly diagnosed insulin-dependent T1D (the Phase 3 PROTECT study).

    About Provention Bio, Inc.:

    Provention Bio, Inc. (NASDAQ:PRVB) is a biopharmaceutical company focused on advancing the development of investigational therapies that may intercept and prevent debilitating and life-threatening immune-mediated disease. The Company's pipeline includes clinical-stage product candidates that have demonstrated in pre-clinical or clinical studies proof-of-mechanism and/or proof-of-concept in autoimmune diseases, including type 1 diabetes, celiac disease and lupus.

    Visit www.ProventionBio.com for more information and follow us on Twitter: @ProventionBio.

    Internet Posting of Information:

    Provention Bio, Inc. uses its website, www.proventionbio.com, as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation F.D. Such disclosures will be included on the Company's website in the "News" section. Accordingly, investors should monitor this portion of the Company's website, in addition to following its press releases, SEC filings and public conference calls and webcasts.

    Forward-Looking Statements:

    Certain statements in this press release are forward-looking, including but not limited to, statements relating to the medical need in T1D at-risk patients, the potential therapeutic effects and safety of teplizumab in at-risk T1D patients, the timing and ability of the Company to obtain additional PK/PD data from a PK/PD substudy in the ongoing Phase 3 PROTECT trial and other data and analysis relevant to PK comparability, the potential for these data to address the FDA's PK comparability considerations, the Company's belief that the remaining product quality issues cited in the CRL are addressed or can be addressed in the short-term, the FDA review of such data if submitted by the Company, the need for resolution of deficiencies identified at a fill/finish manufacturer used by the Company,and the Company's plans to address the other matters raised in the CRL including plans to continue working collaboratively with FDA to hopefully secure teplizumab approval . These statements may be identified by the use of forward-looking words such as "likely," and "may," among others. These forward-looking statements are based on the Company's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to delays in or failure to obtain FDA approvals for teplizumab or other Company product candidates and the potential for noncompliance with FDA regulations; any inability to successfully work with FDA to find a satisfactory solution to address its concerns in a timely manner or at all, including any inability to provide the FDA with PK/PD data from our ongoing Phase 3 PROTECT study or other data sufficient to support an approval of the BLA for teplizumab; an inability to satisfactorily address other matters cited in the CRL including relating to product quality, fill/finish manufacturer deficiencies identified in a general inspection, safety update required by FDA or any other FDA requirements for an approval of teplizumabthe potential impacts of COVID-19 on our business and financial results; changes in law, regulations, or interpretations and enforcement of regulatory guidance; uncertainties of patent protection and litigation; the Company's dependence upon third parties; substantial competition; the Company's need for additional financing and the risks listed under "Risk Factors" in the Company's quarterly report on Form 10-Q for the quarter ended March 31, 2021 and any subsequent filings with the Securities and Exchange Commission. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Provention does not undertake an obligation to update or revise any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by applicable law. The information set forth herein speaks only as of the date hereof.

    Investor Contacts:

    Robert Doody, VP of Investor Relations

    rdoody@proventionbio.com

    484-639-7235

    Sam Martin, Argot Partners

    sam@argotpartners.com   

    212-600-1902

    Media Contact:

    Lori Rosen, LDR Communications

    lori@ldrcommunications.com

    917-553-6808

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/provention-bio-receives-complete-response-letter-crl-to-biologics-license-application-bla-for-teplizumab-for-the-delay-of-clinical-type-1-diabetes-t1d-in-at-risk-individuals-301325697.html

    SOURCE Provention Bio, Inc.

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