ALVR AlloVir Inc.

18.25
-0.58  -3%
Previous Close 18.83
Open 18.28
52 Week Low 16.66
52 Week High 48.96
Market Cap $1,143,716,057
Shares 62,669,373
Float 22,080,564
Enterprise Value $982,110,847
Volume 198,849
Av. Daily Volume 173,864
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Upcoming Catalysts

Drug Stage Catalyst Date
Posoleucel (Viralym-M, ALVR105)
Multi-virus prevention trial (following allo-HSCT)
Phase 2
Phase 2
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Viralym-M (ALVR105)
BK viremia
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
ALVR107
Hepatitis B virus (HBV)
Phase 1
Phase 1
IND to be submitted by year end 2021.
Viralym-M (ALVR105)
Virus-associated hemorrhagic cystitis
Phase 3
Phase 3
Phase 3 trial ongoing, November 5, 2021.
ALVR109
COVID-19
Phase 1b
Phase 1b
Phase 1b data displayed that the treatment was well tolerated and was associated with clinical improvement in the four enrolled transplant and non-transplant patients, with cells that expanded and persisted post-infusion, noted September 29, 2021.
ALVR106
RSV, influenza
Phase 1
Phase 1
Phase 1 trial to commence 2H 2021.

Latest News

  1. AlloVir, Inc. (NASDAQ:ALVR), a late clinical-stage cell therapy company, announced today that the company will participate in the upcoming Piper Sandler 33rd Annual Virtual Healthcare Conference.

    A pre-recorded fireside chat will be available from Monday, November 22 to Thursday, December 2, 2021, on the conference website and on the Investors & Press section of the AlloVir website at https://ir.allovir.com.

    About AlloVir

    AlloVir is a leading late clinical-stage cell therapy company with a focus on restoring natural immunity against life-threatening viral diseases in pediatric and adult patients with weakened immune systems. The company's innovative and proprietary technology platforms leverage off-the-shelf, allogeneic, single- and multi-virus-specific…

    AlloVir, Inc. (NASDAQ:ALVR), a late clinical-stage cell therapy company, announced today that the company will participate in the upcoming Piper Sandler 33rd Annual Virtual Healthcare Conference.

    A pre-recorded fireside chat will be available from Monday, November 22 to Thursday, December 2, 2021, on the conference website and on the Investors & Press section of the AlloVir website at https://ir.allovir.com.

    About AlloVir

    AlloVir is a leading late clinical-stage cell therapy company with a focus on restoring natural immunity against life-threatening viral diseases in pediatric and adult patients with weakened immune systems. The company's innovative and proprietary technology platforms leverage off-the-shelf, allogeneic, single- and multi-virus-specific T cells for patients with T cell deficiencies who are at risk from the life-threatening consequences of viral diseases. AlloVir's technology and manufacturing process enable the potential for the treatment and prevention of a spectrum of devastating viruses with each single allogeneic cell therapy. The company is advancing multiple mid- and late-stage clinical trials across its product portfolio. For more information, visit www.allovir.com or follow us on Twitter or LinkedIn.

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  2. Company is prioritizing prevention and treatment programs with the potential to transform transplant patient care and outcomes

    Positive interim data from posoleucel multi-virus prevention Phase 2 study will be presented at ASH

    Posoleucel Phase 3 study for the treatment of adenovirus and ALVR106 proof-of-concept clinical trial for the treatment of multiple respiratory viruses are on track to initiate this year

    AlloVir (NASDAQ:ALVR), a late clinical-stage cell therapy company, today reported financial results for the third quarter ended September 30, 2021. The company also shared progress on the advancement of its prioritized virus-specific T cell (VST) programs to prevent or treat life-threatening viral diseases.

    "AlloVir's allogeneic, off-the-shelf…

    Company is prioritizing prevention and treatment programs with the potential to transform transplant patient care and outcomes

    Positive interim data from posoleucel multi-virus prevention Phase 2 study will be presented at ASH

    Posoleucel Phase 3 study for the treatment of adenovirus and ALVR106 proof-of-concept clinical trial for the treatment of multiple respiratory viruses are on track to initiate this year

    AlloVir (NASDAQ:ALVR), a late clinical-stage cell therapy company, today reported financial results for the third quarter ended September 30, 2021. The company also shared progress on the advancement of its prioritized virus-specific T cell (VST) programs to prevent or treat life-threatening viral diseases.

    "AlloVir's allogeneic, off-the-shelf, virus-specific T cell platform has the potential to transform the care of and outcomes for patients – from stem cell and solid organ transplant recipients to broader patient groups with immunodeficiency. The interim data we will be presenting at ASH provide the first look at the potential for posoleucel, a multi-virus specific T cell therapy, to change the treatment paradigm for stem cell transplant recipients, moving upstream to prevent the most common life-threatening viral diseases for these patients before they occur," said Diana Brainard, M.D., Chief Executive Officer, AlloVir. "Across our portfolio, we are prioritizing programs with the largest potential benefit for patients, including the prevention of life-threatening viral diseases caused by six devastating viruses with a single therapy. We are focusing on key areas where there are limited or no treatment options, such as hemorrhagic cystitis, BK viremia and adenovirus."

    Upcoming Q4 2021 Highlights/Activities:

    • Initial data from the open-label cohort of a Phase 2 clinical trial to assess the safety and efficacy of posoleucel for the prevention of multiple viruses following allogeneic hematopoietic stem cell transplantation (allo-HSCT) will be presented at the 63rd American Society of Hematology Annual Meeting in December (Abstract #1760). The study is evaluating the potential for posoleucel to prevent clinically significant viral infections (adenovirus, BK virus, cytomegalovirus, Epstein-Barr virus, human herpesvirus-6, JC virus) in high-risk, adult and pediatric allo-HSCT patients. The study is ongoing and continues to enroll patients.
    • In December, AlloVir plans to submit initial data from its Phase 2 proof-of-concept (POC) clinical trial with posoleucel for the preemptive treatment of BK viremia in adult kidney transplant recipients, for presentation at a scientific congress in the first half of 2022. BK viremia is detected in up to 20% of kidney transplant patients and can lead to nephropathy causing decreased kidney survival and a return to end-stage renal disease and dialysis.
    • AlloVir remains on track to initiate a Phase 3 study this year evaluating posoleucel for the treatment of adenovirus (AdV) in adult and pediatric allo-HSCT recipients. AdV-associated viral disease is among the leading causes of life-threatening complications following allo-HSCT, occurring in 32% of pediatric and 6% of adult allo-HSCT patients. AdV-associated viral disease often results in multi-organ involvement with the virus invading the brain, lungs, liver and other vital organs. There is no approved treatment for adenovirus infection.
    • A POC clinical trial of ALVR106, an investigational multi-respiratory VST therapy designed to target infections and diseases caused by human metapneumovirus, influenza, parainfluenza virus and respiratory syncytial virus in allogeneic and autologous HSCT recipients, is on track to initiate before year-end, coinciding with the respiratory virus season.
    • Preclinical and Investigational New Drug (IND)-enabling studies for ALVR107 to treat hepatitis B virus (HBV) are on track for completion by the end of this year. Chronic HBV infection is associated with significant morbidity and mortality. Current treatment options for chronic HBV consist of life-long antiviral therapy to suppress virus replication, which can slow the progression of liver cirrhosis and reduce the incidence of liver cancer. However, there are no curative therapies available.

    Recent Clinical and Scientific Highlights:

    • Positive preclinical and early clinical data presented in an oral presentation at IDWeek™ 2021 demonstrated that ALVR109, an investigational VST therapy targeting SARS-CoV-2, provides antiviral activity and coverage against multiple variant strains, including Delta. Beyond SARS-CoV-2, these data reinforce the potential for AlloVir's VST therapies to address the major public health issue posed by ubiquitous respiratory viruses.
    • In October, the U.S. Food and Drug Administration granted Orphan Drug Designation to posoleucel for the treatment of virus-associated hemorrhagic cystitis. Posoleucel previously received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA, and Orphan Medicinal Product and PRIority MEdicines (PRIME) designations from the European Medicines Agency.

    Third Quarter Financial Highlights:

    • Research and development expenses were $33.1 million for the quarter ended September 30, 2021, compared with $17.2 million for the quarter ended September 30, 2020. The increase year-over-year is attributable to costs related to the development of the company's product candidates, increased activity in outsourcing of manufacturing, and an increase in headcount and external consultants in support of research activities.
    • The general and administrative expense was $12.4 million for the quarter ended September 30, 2021, compared with $6.7 million for the quarter ended September 30, 2020. The increase year-over-year was primarily attributable to increased headcount and professional fees for legal and accounting associated with operating as a public company.
    • Stock-based compensation expense was $10.3 million and $3.9 million for the quarter ended September 30, 2021, and 2020, respectively.
    • As of September 30, 2021, AlloVir had cash, cash equivalents, and marketable securities of $275.8 million, compared with $356.3 million as of December 31, 2020.
    • For the quarter ended September 30, 2021, net loss was $45.5 million or $0.72 per share, compared with a net loss of $23.6 million or $0.58 per share for the quarter ended September 30, 2020.

    About AlloVir

    AlloVir is a leading late clinical-stage cell therapy company with a focus on restoring natural immunity against life-threatening viral diseases in pediatric and adult patients with weakened immune systems. The company's innovative and proprietary technology platforms leverage off-the-shelf, allogeneic, single- and multi-virus-specific T cells for patients with T cell deficiencies who are at risk from the life-threatening consequences of viral diseases. AlloVir's technology and manufacturing process enable the potential for the treatment and prevention of a spectrum of devastating viruses with each single allogeneic cell therapy . The company is advancing multiple mid- and late-stage clinical trials across its product portfolio. For more information, visit www.allovir.com or follow us on Twitter or LinkedIn.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding AlloVir's development and regulatory status of our product candidates, the planned conduct of its preclinical studies, and clinical trials and its prospects for success in those studies and trials, and its strategy, business plans and focus. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties, and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those related to AlloVir's financial results, the timing for the initiation and successful completion of AlloVir's clinical trials of its product candidates, whether and when, if at all, AlloVir's product candidates will receive approval from the U.S. Food and Drug Administration, or FDA, or other foreign regulatory authorities, competition from other biopharmaceutical companies, the impact of the COVID-19 pandemic on AlloVir's product development plans, supply chain, and business operations and other risks identified in AlloVir's SEC filings. AlloVir cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. AlloVir disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent AlloVir's views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.

     

    ALLOVIR, INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (unaudited, in thousands)

     
           
    September 30,     December 31,  

    2021

       

    2020

     
    Assets      
    Current assets:      

    Cash, cash equivalents and short-term investments

    $

    275,841

        $

    356,324

     

    Other current assets

    6,031

       

    4,993

     

    Total current assets

    281,872

       

    361,317

     
           
    Other assets

    34,658

       

    9,504

     

    Total assets

    $

    316,530

        $

    370,821

     
    Liabilities and stockholders' equity      
    Current liabilities $

    24,173

        $

    12,294

     
    Long-term liabilities

    25,053

       

    5,463

     

    Total liabilities

    49,226

       

    17,757

     
           
    Total stockholders' equity

    267,304

       

    353,064

     
    Total liabilities and stockholders' equity $

    316,530

        $

    370,821

     
           
             

    ALLOVIR, INC.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

    (unaudited, in thousands, except share and per share data)

     
             
    Three Months Ended

    September 30,
        Nine Months Ended

    September 30,
     

    2021

     

    2020

       

    2021

     

    2020

     
    Operating expenses:          

    Research and development

    33,062

     

     

    17,182

     

       

    79,132

     

     

    32,906

     

     

    General and administrative

    12,442

     

     

    6,718

     

       

    34,890

     

     

    12,987

     

     

    Total operating expenses

    45,504

     

     

    23,900

     

       

    114,022

     

     

    45,893

     

     
    Loss from operations

    (45,504

    )

     

    (23,900

    )

       

    (114,022

    )

     

    (45,893

    )

     
    Total other income (loss), net:          

    Interest income

    253

     

     

    112

     

       

    1,233

     

     

    735

     

     

    Other (loss) income, net

    (259

    )

     

    174

     

       

    (1,232

    )

     

    573

     

     
    Net loss $

    (45,510

    )

      $

    (23,614

    )

        $

    (114,021

    )

      $

    (44,585

    )

     
    Net loss per share --- basic and diluted $

    (0.72

    )

      $

    (0.58

    )

        $

    (1.82

    )

      $

    (2.93

    )

     
    Weighted-average common shares outstanding---basic and diluted

    62,962,434

     

     

    40,465,705

     

       

    62,588,898

     

     

    15,195,000

     

     
             

     

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  3. ODD for posoleucel adds to RMAT designation by FDA and OMP and PRIME designations by EMA

    Phase 3 registrational study of posoleucel in virus-associated hemorrhagic cystitis is ongoing

    AlloVir, Inc. (NASDAQ:ALVR), a late clinical-stage cell therapy company, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to posoleucel (Viralym-M, ALVR105) for the treatment of virus-associated hemorrhagic cystitis (HC). Posoleucel is an investigational, allogeneic, off-the-shelf, multi-virus specific T cell therapy under development for the treatment and prevention of serious diseases caused by six devastating viral pathogens: BK virus (BKV) and the related polyomavirus JC virus (JCV), cytomegalovirus…

    ODD for posoleucel adds to RMAT designation by FDA and OMP and PRIME designations by EMA

    Phase 3 registrational study of posoleucel in virus-associated hemorrhagic cystitis is ongoing

    AlloVir, Inc. (NASDAQ:ALVR), a late clinical-stage cell therapy company, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to posoleucel (Viralym-M, ALVR105) for the treatment of virus-associated hemorrhagic cystitis (HC). Posoleucel is an investigational, allogeneic, off-the-shelf, multi-virus specific T cell therapy under development for the treatment and prevention of serious diseases caused by six devastating viral pathogens: BK virus (BKV) and the related polyomavirus JC virus (JCV), cytomegalovirus (CMV), human herpes virus-6 (HHV-6), Epstein Barr virus (EBV) and adenovirus (AdV).

    An inflammatory disease of the bladder, virus-associated HC is a serious complication of hematopoietic stem cell transplantation (HSCT) that can significantly prolong hospitalization and increase mortality and for which there are currently no approved or effective antiviral treatment options. The company's Phase 3 study of posoleucel for the treatment of virus-associated HC is ongoing and enrolling adult and pediatric patients following allogeneic HSCT (allo-HSCT).

    "This Orphan Drug Designation acknowledges the urgent need for new treatment options for patients who have undergone hematopoietic stem cell transplantation and are at risk for developing viral infections and hemorrhagic cystitis," said Ercem Atillasoy, M.D., Chief Regulatory and Safety Officer, AlloVir. "We look forward to working with the FDA and regulators around the globe as we advance this therapy for patients in need."

    In addition to this ODD, posoleucel has been granted Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA, and Orphan Medicinal Product (OMP) and PRIority MEdicines (PRIME) designations from the European Medicines Agency (EMA). Posoleucel is one of the first seven investigational therapies to receive both PRIME and RMAT designations.

    ODD is granted by the FDA to drugs or biological products intended for the treatment of diseases or conditions that impact fewer than 200,000 people in the U.S. The designation acts as a stimulus for the development of drugs for rare diseases through several incentives, including research and development tax credits, waiver of filing fees and the potential for a seven-year marketing exclusivity period after FDA approval. Drugs with this designation undergo the same rigorous scientific evaluation as other investigational medicines seeking FDA approval.

    About Virus-Associated Hemorrhagic Cystitis (HC)

    Virus-associated HC is a well-described complication after HSCT in which a viral infection causes the bladder lining to become inflamed, resulting in hematuria, or blood in the urine. More than half of patients with HC experience clot formation and/or severe bladder hemorrhage with renal impairment. Bleeding may be life-threatening, requiring urologic interventions including cystectomy, or the removal of the urinary bladder.

    Clinical manifestations of HC include kidney dysfunction or failure, blood in the urine and severe abdominal pain frequently requiring narcotics. With no approved or effective antiviral treatments, virus-associated HC is primarily managed with supportive care, including forced diuresis, continuous bladder irrigation, platelet transfusion and anti-spasmodics, in addition to urinary and opioid analgesics.

    Newly published data1 demonstrate that patients with virus-associated HC had a 70% higher risk of mortality, and the viral disease was associated with significantly prolonged hospitalization, including increased intensive care unit stay and hospital readmission rates.

    HC can be caused by several viruses, including AdV and CMV; however, up to 90% of HC cases are caused by BKV. HC is the primary clinical manifestation associated with BKV following HSCT, occurring in up to 25% of pediatric patients and up to 54% of adult patients.

    About Posoleucel (Viralym-M, ALVR105)

    AlloVir's lead product, posoleucel, is in late-stage clinical development as an allogeneic, off-the-shelf, multi-virus specific T-cell therapy targeting six viral pathogens in immunocompromised individuals: BKV, CMV, AdV, EBV, HHV-6 and JCV. In the positive Phase 2, proof-of-concept CHARMS study, more than 90% of patients who failed conventional treatment and received posoleucel, demonstrated a complete or partial clinical response based on predefined criteria, most with complete elimination of detectable virus in the blood and resolution of major clinical symptoms.

    About AlloVir's Ongoing Clinical Studies with Posoleucel

    • A Phase 3 (NCT04390113), multicenter, double-blind, placebo-controlled study to assess the efficacy and safety of posoleucel for the treatment of patients with virus-associated HC following allo-HSCT is open and recruiting patients.
    • A proof-of-concept study (NCT04693637) targeting the prevention of clinically significant disease caused by BKV, CMV, AdV, EBV, HHV-6 and JCV in patients following allo-HSCT is open and recruiting patients. Approximately 90% of all allo-HSCT patients experience at least one infection associated with BKV, CMV, AdV, EBV or HHV-6, and more than 60% of these patients experience infections caused by two or more of these five viruses within 100 days post allo-HSCT. Data from the open-label phase of the study are anticipated before year-end.
    • A Phase 2 proof-of-concept study (NCT04605484) for the preemptive treatment of BK viremia in adult kidney transplant recipients is also ongoing and recruiting patients. BK viremia, which is detected in up to 20% of kidney transplant patients, can lead to decreased kidney survival and a return to end-stage renal disease and dialysis.

    For more information on clinical trials of posoleucel, visit www.clinicaltrials.gov.

    About AlloVir

    AlloVir is a leading late clinical-stage cell therapy company with a focus on restoring natural immunity against life-threatening viral diseases in pediatric and adult patients with weakened immune systems. The company's innovative and proprietary technology platforms leverage off-the-shelf, allogeneic, single and multi-virus-specific T cells for patients with T-cell deficiencies who are at risk from the life-threatening consequences of viral diseases. AlloVir's technology and manufacturing process enable the potential for the treatment and prevention of a spectrum of devastating viruses with each single allogeneic cell therapy. The company is advancing multiple mid- and late-stage clinical trials across its product portfolio. For more information, visit www.allovir.com or follow us on Twitter or LinkedIn.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding the development and regulatory status of our product candidates, the planned conduct of its clinical trials and its prospects for success in those studies and trials, and its strategy, business plans and focus. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties, and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those related to AlloVir's financial results, the timing for the initiation and successful completion of AlloVir's clinical trials of its product candidates, whether and when, if at all, AlloVir's product candidates will receive approval from the U.S. Food and Drug Administration, or FDA, or other foreign regulatory authorities, competition from other biopharmaceutical companies, the impact of the COVID-19 pandemic on AlloVir's product development plans, supply chain, and business operations and other risks identified in AlloVir's SEC filings, including but not limited to the risks discussed in AlloVir's Quarterly Report on Form 10-Q for the quarter ended June 30, 2021 and in our other filings with the SEC. AlloVir cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. AlloVir disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent AlloVir's views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.

    References

    1. Economic and Clinical Burden of Virus-Associated Hemorrhagic Cystitis in Patients Following Allogeneic Hematopoietic Stem Cell Transplantation in the United States; McGuirk, Joseph et al.; Transplantation and Cellular Therapy, Official Publication of the American Society for Transplantation and Cellular Therapy, Volume 27, Issue 6, 505.e1 - 505.e9; https://www.astctjournal.org/article/S2666-6367(21)00708-9/fulltext.

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  4. Early clinical data show expansion and persistence of cells and support the efficacy and safety profile of ALVR109 in transplant and non-transplant patients with COVID-19

    AlloVir, Inc. (NASDAQ:ALVR), a late clinical-stage cell therapy company, today announced preclinical and early clinical data demonstrating that ALVR109, an investigational, allogeneic, off-the-shelf, virus-specific T cell (VST) therapy targeting SARS-CoV-2, provides antiviral activity and coverage against multiple variant strains, including Delta. The data were featured today in an oral presentation at IDWeek™ 2021.

    Preclinical research from Baylor College of Medicine demonstrated the ability to rapidly characterize the cellular immune response to SARS-CoV-2 in convalescent…

    Early clinical data show expansion and persistence of cells and support the efficacy and safety profile of ALVR109 in transplant and non-transplant patients with COVID-19

    AlloVir, Inc. (NASDAQ:ALVR), a late clinical-stage cell therapy company, today announced preclinical and early clinical data demonstrating that ALVR109, an investigational, allogeneic, off-the-shelf, virus-specific T cell (VST) therapy targeting SARS-CoV-2, provides antiviral activity and coverage against multiple variant strains, including Delta. The data were featured today in an oral presentation at IDWeek™ 2021.

    Preclinical research from Baylor College of Medicine demonstrated the ability to rapidly characterize the cellular immune response to SARS-CoV-2 in convalescent individuals and to develop VSTs targeting immunodominant T cell target antigens within the virus. This research enabled the study of ALVR109 in four patients who were hospitalized with COVID-19 with at least two risk factors for poor outcomes. Two of these patients were not prior recipients of a stem cell transplant.

    "The preclinical data presented today underscore the power of AlloVir's virus-specific T cell therapy platform, demonstrating the speed at which we can identify target antigens, advance these to our manufacturing process and generate highly potent VSTs that are effective against a broad range of SARS-CoV-2 variant strains, including the Delta variant," said Ann Leen, Ph.D., Chief Scientific Officer of AlloVir, and an author on the presentation. "These cells are capable of targeting not only spike, including the majority of spike-mutated T cell epitopes present in clinically important variant strains, but also four additional structural and non-structural proteins. This broad immune reactivity minimizes the potential risk of immune escape from our therapy."

    When advanced into clinical study, ALVR109 was well tolerated and was associated with clinical improvement in the four enrolled transplant and non-transplant patients, with cells that expanded and persisted post-infusion. Given the profile of ALVR109 from these clinical and preclinical data and the unmet medical need in immunocompromised patients with COVID-19, AlloVir continues to make ALVR109 available to physicians in response to compassionate use requests.

    Beyond SARS-CoV-2, the early clinical data presented at IDWeek reinforce the potential for AlloVir's VST therapies to address the major public health issue posed by ubiquitous respiratory viruses. The company plans to initiate a proof-of-concept study for its multi-respiratory virus-specific T cell therapy, ALVR106, targeting respiratory syncytial virus, influenza, parainfluenza and human metapneumovirus later this year.

    About the Preclinical Data

    Researchers screened peripheral blood mononuclear cells (PBMCs) from convalescent donors who had naturally controlled and cleared the SARS-CoV-2 virus to identify immunogenic and protective SARS-CoV-2 antigens. Of the proteins screened, a subset was identified as immunodominant and was advanced for VST manufacturing using AlloVir's proprietary, clinically validated and commercially scalable manufacturing and cell culture process.

    Though initially generated against the reference strain (Wuhan), AlloVir's ALVR109 recognized other clinically important variants in in vitro testing, including Alpha, Beta, Gamma, Epsilon, Kappa and, most notably, Delta. These data demonstrate that polyclonal, diverse VSTs targeting multiple antigens and epitopes can minimize the risk of immune escape due to viral mutation.

    About the Clinical Data

    A Phase 1b clinical trial enrolled adult, high-risk, hospitalized patients with at least two risk factors for poor outcomes, including age, history of malignancy, diabetes, hypertension and prior stem cell transplant. All four patients received standard of care and a single infusion of ALVR109, which was given at one of two dose levels. ALVR109 was well-tolerated, with only one serious adverse event of cytokine release syndrome 13 days after ALVR109 infusion; this event was transient and most likely attributable to COVID-19 disease progression. All four patients experienced clinical improvement after administration of ALVR109. One patient experienced clinical improvement after administration but subsequently experienced a late COVID-19 recurrence and died nearly four weeks following treatment with ALVR109. Three of the four patients experienced clinical improvement and remain well and virus-free.

    Researchers also performed exploratory studies to examine the in vivo expansion and persistence of the ALVR109 infused cells. In all four patients, substantial increases in SARS-CoV-2 specific T cells following administration were observed, and ALVR109 VSTs were detected out to at least three months post-infusion in two of the four patients.

    Spyridoula Vasileiou, Ph.D., from the Center for Cell and Gene Therapy, Baylor College of Medicine, Texas Children's Hospital, and presenting author said, "The data demonstrate that polyclonal SARS-CoV-2 VSTs can provide coverage against variant strains and, when administered to patients with COVID-19, these cells expand and persist in vivo."

    About AlloVir

    AlloVir is a leading late clinical-stage cell therapy company with a focus on restoring natural immunity against life-threatening viral diseases in pediatric and adult patients with weakened immune systems. The company's innovative and proprietary technology platforms leverage off-the-shelf, allogeneic, single and multi-virus-specific T-cells for patients with T-cell deficiencies who are at risk from the life-threatening consequences of viral diseases. AlloVir's technology and manufacturing process enable the potential for the treatment and prevention of a spectrum of devastating viruses with each single allogeneic cell therapy. The company is advancing multiple mid- and late-stage clinical trials across its product portfolio. For more information, visit www.allovir.com or follow us on Twitter or LinkedIn.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding the potential for AlloVir's VST therapies to address the major public health issue posed by ubiquitous respiratory viruses, the development and regulatory status of our product candidates, the planned conduct of its clinical trials and its prospects for success in those studies and trials, and its strategy, business plans and focus. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties, and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those related to AlloVir's financial results, the timing for the initiation and successful completion of AlloVir's clinical trials of its product candidates, whether and when, if at all, AlloVir's product candidates will receive approval from the U.S. Food and Drug Administration, or FDA, or other foreign regulatory authorities, competition from other biopharmaceutical companies, the impact of the COVID-19 pandemic on AlloVir's product development plans, supply chain, and business operations and other risks identified in AlloVir's SEC filings, including but not limited to the risks discussed in AlloVir's Quarterly Report on Form 10-Q for the quarter ended June 30, 2021 and in our other filings with the SEC. AlloVir cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. AlloVir disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent AlloVir's views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.

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  5. AlloVir, Inc. (NASDAQ:ALVR), a late clinical-stage cell therapy company, will present a corporate update at the Morgan Stanley 19th Annual Global Healthcare Conference on September 14th at 4:15 p.m. ET.

    The presentation will be available on the Investors & Press section of the AlloVir website at https://ir.allovir.com. An archived replay of the presentation will be available for approximately 30 days following the presentation.

    About AlloVir

    AlloVir is a leading late clinical-stage cell therapy company with a focus on restoring natural immunity against life-threatening viral diseases in pediatric and adult patients with weakened immune systems. The company's innovative and proprietary technology platforms leverage off-the-shelf, allogeneic…

    AlloVir, Inc. (NASDAQ:ALVR), a late clinical-stage cell therapy company, will present a corporate update at the Morgan Stanley 19th Annual Global Healthcare Conference on September 14th at 4:15 p.m. ET.

    The presentation will be available on the Investors & Press section of the AlloVir website at https://ir.allovir.com. An archived replay of the presentation will be available for approximately 30 days following the presentation.

    About AlloVir

    AlloVir is a leading late clinical-stage cell therapy company with a focus on restoring natural immunity against life-threatening viral diseases in pediatric and adult patients with weakened immune systems. The company's innovative and proprietary technology platforms leverage off-the-shelf, allogeneic, single, and multi-virus-specific T-cells targeting devastating viruses for patients with T-cell deficiencies who are at risk from the life-threatening consequences of viral diseases. AlloVir's technology and manufacturing process enable the potential for the treatment and prevention of a spectrum of devastating viruses with each single allogeneic cell therapy. The company is advancing multiple mid- and late-stage clinical trials across its product portfolio. For more information visit www.allovir.com or follow us on Twitter or LinkedIn.

    View Full Article Hide Full Article
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