ALVR AlloVir Inc.
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
|---|---|---|
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ALVR106
Hematopoietic stem cell transplantation
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Phase 2
Phase 2
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Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
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Viralym-M (ALVR105)
BK virus
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Phase 2
Phase 2
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Phase 2 trial to be initiated 4Q 2020.
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Viralym-M (ALVR105)
Cytomegalovirus (CMV)
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Phase 2
Phase 2
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Phase 2 trial to be initiated 4Q 2020.
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Viralym-M (ALVR105)
Aleution disease virus (ADV)
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Phase 2
Phase 2
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Phase 2 trial to be initiated 4Q 2020.
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Viralym-M (ALVR105)
Cytomegalovirus (CMV)
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Phase 2
Phase 2
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Phase 2 trial to be initiated 4Q 2020.
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Viralym-M (ALVR105)
Virus-associated hemorrhagic cystitis
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Phase 3
Phase 3
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Phase 3 trial planned for 4Q 2020.
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ALVR109
COVID-19
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Phase 1/2
Phase 1/2
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Phase 1/2 trial has been initiated.
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Latest News
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AlloVir, Inc. (NASDAQ:ALVR), a late clinical-stage cell therapy company, will present a corporate overview at the Piper Sandler 32nd Annual Virtual Healthcare Conference on December 1, 2020.
The presentations will be available for registered attendees via the Piper Sandler conference site from November 23 to December 3 and will also 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 patients with weakened immune systems. The company's innovative and proprietary technology platforms leverage off-the-shelf, allogeneic, 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 enables 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20201124005319/en/
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- Completed initial public offering raising $317.7M in gross proceeds
- Viralym-M (multi-virus-specific T cell therapy) registrational study in lead indication in virus-associated hemorrhagic cystitis and proof-of-concept study in prevention of multiple viral infections on track to initiate before year end
- ALVR109 (virus-specific T cell therapy designed to combat SARS-CoV-2) Phase 1/2 clinical trial initiated for the treatment of high risk COVID-19 patients
- Commenced tech transfer for AlloVir proprietary virus-specific T-cell manufacturing process to ElevateBio BaseCamp, as part of planned manufacturing capacity expansion and redundancy within supply chain
CAMBRIDGE, Mass., Nov. 10, 2020 (GLOBE NEWSWIRE) -- AlloVir (NASDAQ:ALVR), a late clinical-stage cell therapy company, today reported financial results for the third quarter ended September 30, 2020.
"In the third quarter, we completed our $317.7 million initial public offering creating a solid financial foundation for the next stage of AlloVir's growth," said David Hallal, Chairman and Chief Executive Officer of AlloVir. "We are now focused on leveraging our robust capabilities to execute our objectives across our pipeline, including commencing up to nine pivotal and proof-of-concept studies across three cell therapies this year and throughout 2021."
David Hallal continued, "the Phase 1/2 clinical trial with ALVR109, our virus-specific T cell therapy designed to combat SARS-CoV-2 – the virus that causes COVID-19 – has been initiated in high-risk patients and we are on track to initiate two additional studies with our lead product, Viralym-M, including a registrational, Phase 3 clinical trial for the treatment of virus-associated hemorrhagic cystitis and a proof-of-concept study for the prevention of multiple viral infections, both in allogeneic stem cell transplant patients before year end."
Third Quarter Business Highlights
- In August, the company closed its initial public offering (IPO) raising $317.7 million in gross proceeds prior to deducting underwriting discounts, commissions and offering expenses. The company expects its current cash and cash equivalents, inclusive of IPO net proceeds, will be sufficient to fund its current operating plan into 2023.
- AlloVir expanded its regulatory expertise and management team by hiring Ercem Atillasoy, M.D., to the newly created position of Chief Regulatory and Safety Officer. Dr. Atillasoy has over 25 years of experience in clinical development, regulatory affairs, and safety. Most recently, he was the regulatory head at Merck and Co., responsible for all regulatory activities globally for the Infectious Disease and Vaccines franchises.
- In September, Dana Alexander, M.B.A., joined the team as Senior Vice President, Technical Operations. Mr. Alexander brings more than 20 years of experience in biopharmaceutical operations, most recently as Head of Viral Vector Business Operations and Site General Manager at Brammer Bio, now part of Thermo Fisher Scientific. Prior to Brammer Bio, he held senior operational and manufacturing leadership positions at Anika Therapeutics and Genzyme, a Sanofi Company.
- AlloVir has commenced tech transfer of its proprietary T cell manufacturing platform to ElevateBio BaseCamp, creating redundancy and ensuring manufacturing supply for full clinical pipeline with dedicated good manufacturing practice (GMP) capacity.
Viralym-M (ALVR105) Program Highlights
- The planned Phase 3, multicenter, double-blind, placebo-controlled study to assess the efficacy and safety of Viralym-M for the treatment of patients with virus-associated hemorrhagic cystitis (HC) following allogeneic hematopoietic stem cell transplantation (allo-HSCT) is on track to initiate in before year end.
- Additionally, a proof-of-concept (POC) clinical trial targeting the prevention of BK virus (BKV), cytomegalovirus (CMV), adenovirus (AdV), Epstein Barr virus (EBV), human herpesvirus 6 (HHV-6), and JC virus (JCV) in patients following allo-HSCT is also expected to initiate before year end
- Real-world data demonstrating the burden of multi-virus infections following allo-HSCT, was presented in a poster session at IDWeek 2020.
- Results from the Phase 2, POC, CHARMS study with Viralym-M as well as data demonstrating the economic and clinical burden of virus-associated HC in patients following allo-HSCT will be showcased in two oral presentations at the 62nd American Society of Hematology Annual Meeting & Exposition (ASH) in December 2020.
ALVR109 Program Highlights
- Initial clinical trial manufacturing runs of ALVR109 have been released and the proof-of-concept clinical trial with ALVR109 has been initiated.
- In September, the U.S. Food and Drug Administration (FDA) cleared the Investigational New Drug application (IND) for ALVR109, AlloVir's allogeneic, off-the-shelf, virus-specific T cell therapy candidate designed to target SARS-CoV-2, the virus that causes the severe and life-threatening viral disease, COVID-19.
- Pre-clinical data on this program will be presented in an oral session at ASH and will be featured in the conference press program.
ALVR106 Program Highlights
- AlloVir anticipates filing the IND before year end for ALVR106, an allogeneic, off-the-shelf, multi-respiratory, virus-specific T cell therapy designed to target respiratory syncytial virus (RSV), influenza, parainfluenza virus (PIV), and human metapneumovirus (hMPV).
- The POC clinical trial will now initiate in 2021 as the company is assessing the impact of the COVID-19 pandemic on the incidence, diagnosis and treatment of the respiratory viral infections which ALVR106 targets.
- Real-world data demonstrating the burden of respiratory tract infections following allo-HSCT was presented in an oral session at IDWeek 2020.
Third Quarter 2020 Financial Highlights
- Research and development expenses were $17.2 million for the quarter ended September 30, 2020 compared to $5.7 million for the quarter ended September 30, 2019. 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.
- General and administrative expense was $6.7 million for the quarter ended September 30, 2020 compared to $2.8 million for the quarter ended September 30, 2019. The increase year-over-year was primarily attributable to legal, accounting and professional fees related to costs associated with operating activities and the preparations for becoming a public company.
- Stock-based compensation expense was $3.9 million and $0.6 million for the three months ended September 30, 2020 and 2019, respectively.
- As of September 30, 2020, AlloVir had cash, cash equivalents, and marketable securities of $378.5 million, which compares to cash, cash equivalents, and marketable securities of $104.5 million as of June 30, 2020.
- For the quarter ended September 30, 2020, net loss was $23.6 million or $0.58 per share compared to a net loss of $7.3 million or $4.97 per share for the quarter ended September 30, 2019. The total number of common shares outstanding as of September 30, 2020 was 65,106,873.
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 patients with weakened immune systems. The company's innovative and proprietary technology platforms leverage off-the-shelf, allogeneic, 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 enables 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.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 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 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, 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 STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS UNAUDITED Three Months Ended Nine Months Ended (in thousands, except share and per share data) September 30, September 30, 2020 2019 2020 2019 Revenue $ – $ – $ – $ 165 Operating expenses: Research and development 17,182 5,655 32,906 9,561 General and administrative 6,718 2,823 12,987 7,800 Total operating expenses 23,900 8,478 45,893 17,361 Loss from operations (23,900 ) (8,478 ) (45,893 ) (17,196 ) Total other income, net: Interest income 112 781 735 1,400 Other income, net 174 427 573 700 Net loss $ (23,614 ) $ (7,270 ) $ (44,585 ) $ (15,096 ) Net loss per share --- basic and diluted $ (0.58 ) $ (4.97 ) $ (2.93 ) $ (13.67 ) Weighted-average common shares outstanding---basic and diluted 40,465,705 1,463,421 15,195,000 1,104,454 ALLOVIR, INC. CONDENSED CONSOLIDATED BALANCE SHEETS UNAUDITED (in thousands) September 30, December 31, 2020 2019 Assets Current assets: Cash, cash equivalents and short-term investments $ 378,488 $ 126,077 Other current assets 5,453 1,236 Total current assets 383,941 127,313 Other assets 9,769 12,109 Total assets $ 393,710 $ 139,422 Liabilities and stockholders' deficit Current liabilities $ 13,521 $ 9,106 Long-term liabilities 6,286 8,692 Total liabilities 19,807 17,798 Preferred stock – 173,127 Total stockholders' equity (deficit) 373,903 (51,503 ) Total liabilities, preferred stock, and stockholders' deficit $ 393,710 $ 139,422 Media contact:
Courtney Heath
ScientPR
[email protected]
617-872-2462Investor contact:
Medha Chadha
AlloVir
[email protected]
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CAMBRIDGE, Mass., Nov. 04, 2020 (GLOBE NEWSWIRE) -- AlloVir (NASDAQ:ALVR), a late clinical-stage cell therapy company, announced that it will present three abstracts as oral presentations that support its pipeline of allogeneic, off-the-shelf virus-specific T cell therapies during the 62nd American Society of Hematology (ASH) Annual Meeting & Exposition taking place virtually December 5 – 8, 2020.
Details of the presentations at ASH are as follows:
Presentation Title: Using Allogeneic, Off-the-Shelf, SARS-CoV-2-specific T Cells to Treat High Risk Patients with COVID-19*
Session Name: Adoptive Immunotherapy: Mechanisms and New Approaches: Adoptive Cell Therapy beyond CAR T cells
Session Date & Time: Monday, December 7, 2020, 9 – 10:30 a.m.
Presentation Time: 10:00 a.m. PT (1:00 p.m. ET)
Presenter: Spyridoula Vasileiou, Center for Cell and Gene Therapy, Baylor College of Medicine, Texas Children's Hospital and The Methodist Hospital
Abstract Number: 612*This abstract will be highlighted in an ASH press briefing on Saturday, December 5, 8:00 a.m. PT (11:00 – 11:30 a.m. ET.)
Presentation Title: Treatment of severe, drug-refractory viral infections with allogeneic, off-the-shelf multi-virus specific T cell therapy in patients following HSCT: Results from a phase 2 Study
Session Name: Adoptive Immunotherapy: Mechanisms and New Approaches: Adoptive Cell Therapy beyond CAR T cells
Session Date & Time: Monday, December 7, 2020, 9 – 10:30 a.m.
Presentation Time: 9:15 a.m. PT (12:15 p.m. ET)
Presenter: Ifigeneia Tzannou, Center for Cell and Gene Therapy, Baylor College of Medicine, Texas Children's Hospital and The Methodist Hospital
Abstract Number: 609Presentation Title: Economic and Clinical Burden of Virus Associated Hemorrhagic Cystitis in Patients Following Allogeneic Hematopoietic Stem Cell Transplantation
Session Name: Health Services Research—Malignant Conditions (Lymphoid Disease) I
Session Date and Time: Monday, December 7, 2020, 1:30 – 3:00 p.m.
Presentation Time: 2:45 p.m. PT (5:45 p.m. ET)
Presenter: Joseph P. McGuirk, DO, The University of Kansas Cancer Center
Abstract Number: 747About AlloVir
AlloVir is a leading late clinical-stage cell therapy company with a focus on restoring natural immunity against life-threatening viral diseases in patients with severely weakened immune systems. The company's innovative and proprietary technology platforms leverage off-the-shelf, allogeneic, 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 enables 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.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 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 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, 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.Media contact:
Courtney Heath
ScientPR
[email protected]
617-872-2462Investor contact:
Medha Chadha
AlloVir
[email protected] -
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CAMBRIDGE, Mass., Oct. 21, 2020 (GLOBE NEWSWIRE) -- AlloVir (NASDAQ:ALVR), a late clinical-stage cell therapy company, today announced that health outcomes analyses to be presented at IDWeek™ 2020 demonstrate the economic and clinical burden associated with respiratory tract infections and multi-virus infections following allogeneic hematopoietic cell transplantation (allo-HCT). The presentations include an oral presentation evaluating the economic and clinical burden of respiratory virus infections (RVI) in allo-HCT recipients and a poster presentation on health resource utilization and costs associated with multi-virus infections after allo-HCT. The studies report on U.S. claims data analyses of 13,363 allo-HCT patients between Jan. 1, 2012 and Dec. 31, 2017 to assess total healthcare reimbursement, health resource utilization (HRU), and clinical outcomes in the year following allo-HCT.
Oral Presentation: Economic and Clinical Burden of Respiratory Virus Infections in Allogeneic Hematopoietic Cell Transplantation Recipients
Date: On Demand, Starting Wednesday, October 21
Presenter: Michael G. Ison, MD, MS, Northwestern University Feinberg School of Medicine, Chicago, ILU.S. claims data from the Decision Resources Group Real World Evidence Data Repository was analyzed to identify allo-HCT recipients from 2012 – 2017 to assess health care reimbursements, HRU, and clinical outcomes in the one-year following allo-HCT in patients with and without RVI. The analysis studied patients who had been coded with one of four RVIs, including respiratory syncytial virus (RSV), influenza, parainfluenza virus (PIV), and human metapneumovirus (hMPV). A generalized linear model was used to determine adjusted total reimbursement stratified by the presence or absence of any acute or chronic graft-versus-host diseases (GVHD) after adjusting for age, health plan, underlying disease, stem cell source, number of comorbidities, baseline costs, and follow-up time.
Unadjusted median reimbursements were $132,395 higher for any RVI ($139,439 RSV, $101,963 influenza, $185,041 PIV, and $248,029 hMPV) compared to those without RVIs. Adjusted reimbursements were significantly higher for patients with any RVI compared to patients without that infection (p<.0001) with or without GVHD. Patients with any RVI had significantly longer length of stay (LOS) for the HCT hospitalization, higher readmission rate, and longer LOS after allo-HCT hospitalization compared to patients without RVI (p<.0001). The mean overall hospital LOS was significantly longer for patients with an RVI as compared to those without (13 days; p<.0001): 11 days longer for patients with RSV (p<.0001), 10 days longer for patients with influenza (p=.0002), 28 days longer for patients with PIV (p=.0001), and 19 days longer for patients with hMPV (p<.0001). A significantly higher proportion of patients with any RVI had pneumonia as compared to patients without that infection, irrespective of presence of GVHD (p< .0001). In the adjusted analysis, the presence of any RVI was significantly associated with all-cause mortality, regardless of the presence of GVHD (p<.0001).
"Patients with T cell deficiencies, like those undergoing HCT, are at higher risk for respiratory viral infections," said Michael G. Ison, MD, MS, Professor, Northwestern University Feinberg School of Medicine and presenting author. "These data show that respiratory viral infections have a significant impact on patient outcomes, as exemplified by a higher proportion of patients developing pneumonia and a greater risk of mortality. Additionally, the burden to our healthcare system is great in terms of higher total cost, prolonged patient hospitalization, and more frequent patient readmissions. It's clear we need better treatment options to help patients prevent and fight off these commonly occurring respiratory viruses."
Poster Presentation: Healthcare Resource Utilization and Costs Associated with Multi-virus Infection After Allogeneic Hematopoietic Cell Transplantation
Date: On Demand, Starting Wednesday, October 21
Poster #1089
Presenter: Joshua A. Hill, MD, Assistant Professor, Fred Hutchinson Cancer Research Center, University of Washington, SeattleU.S. claims data was analyzed to compare health care reimbursements, HRU, and clinical outcomes between allo-HCT patients with no versus multiple dsDNA infections due to cytomegalovirus (CMV), BK virus (BKV), Epstein-Barr virus (EBV), JC virus (JCV), adenovirus (AdV), and human herpesvirus-6 (HHV-6). The unadjusted mean reimbursements per patient group were $266,345 for individuals who did not have a dsDNA viral infection compared to $431,614 for patients with one virus; $639,097 for those with two viruses; and $964,378 for those with three or more viruses. Adjusted reimbursements were significantly higher for each additional viral infection among patients with and without GVHD compared to patients with no viral infections (p<.0001). HRU also increased as the number of viral infections increased: the mean overall hospital LOS increased significantly with each additional viral infection (p<.0001): 41.3 days for patients with no viruses compared to 61.4 days for one virus, 77.0 days for two viruses, and 103.3 days for three or more viruses. The LOS and the number of days in the ICU during the index hospitalization as well as in readmissions after index also increased significantly with each additional viral infection (p<.0001 for both outcomes).
Allo-HCT patients with multiple dsDNA viral infections have worse clinical outcomes such as new diagnosis of renal impairment, irrespective of the presence of GVHD, and higher mortality rate for patients with GVHD. Among patients with GVHD, all-cause mortality (21.0%-21.4%) and new diagnosis of renal impairment (27.5%-35.7%) were significantly higher for patients with one or more viral infections as compared to patients with no viral infections (all-cause mortality: 16.8%; new diagnosis of renal impairment: 22.3%). Among patients without GVHD, new diagnosis of renal impairment (20.9%-30.2%) was significantly higher for patients with one or more viral infections as compared to patients with no viral infections (14.6%). In addition, patients with an increasing number of viral infections had a higher risk of all-cause mortality, after adjusting for GVHD and baseline characteristics.
"Allogeneic hematopoietic cell transplantation has revolutionized the way we treat some cancers," said Joshua A. Hill, MD, Assistant Professor, Fred Hutchinson Cancer Research Center and presenting author. "However, because of the conditioning regimen required to prepare patients for the transplant, it puts them in an immunocompromised state and at greater risk for viral infections. These data show that these viral infections have both significant impact on patient outcomes and on the health care systems working to treat them. For many of the viruses affecting these patients, there are limited or no treatment options."
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 patients with severely weakened immune systems. The company's innovative and proprietary technology platforms leverage off-the-shelf, allogeneic, 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 enables 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.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 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 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, 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.Media contact:
Courtney Heath
ScientPR
[email protected]
617-872-2462Investor contact:
Medha Chadha
AlloVir
[email protected] -
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- ALVR109 is an allogeneic, off-the-shelf virus-specific T cell therapy candidate designed to target SARS-CoV-2 for high-risk COVID-19 patients
- Proof-of-concept clinical trial with ALVR109 to begin in Q42020
CAMBRIDGE, Mass., Sept. 17, 2020 (GLOBE NEWSWIRE) -- AlloVir (NASDAQ:ALVR), a late clinical-stage cell therapy company, announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug application (IND) for ALVR109, an allogeneic, off-the-shelf virus-specific T cell therapy candidate designed to target SARS-CoV-2, the virus that causes the severe and life-threatening viral disease, COVID-19. ALVR109 is being developed to arrest the progression of COVID-19 by eradicating SARS-CoV-2 virus-infected cells.
"SARS-CoV-2 continues to have a devastating impact on patients and families around the world," said David Hallal, Chairman and Chief Executive Officer of AlloVir. "There is an increasing body of evidence about the important role of T cells in the body's fight against COVID-19. At AlloVir, together with our colleagues at Baylor College of Medicine, we are working with a great sense of urgency to leverage our highly innovative virus-specific T-cell platform to advance ALVR109 into a proof-of-concept study in high-risk COVID-19 patients."
Early research suggests that T cells play an important role in the body's fight against COVID-19. Over 80% of hospitalized patients with COVID-19 are lymphopenic, with reduced CD8+ and CD4+ T cell counts. These reductions in T cell counts correlate negatively with survival. Reduced T cell counts have been observed to be prevalent in older COVID-19 patients and those with severe illness, regardless of age.
On March 23, 2020, AlloVir announced it expanded its research collaboration with Baylor College of Medicine (BCM) to discover and develop allogeneic, off-the-shelf, virus-specific T-cell therapies for COVID-19. Following the submission of the IND for ALVR109 by BCM, the FDA notified BCM of a clinical hold due to questions related to raw materials used in the manufacturing process for ALVR109. BCM submitted a complete response to the questions identified in the clinical hold and the FDA has removed the hold allowing the clinical study to start.
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 patients with severely weakened immune systems. The company's innovative and proprietary technology platforms leverage off-the-shelf, allogeneic, 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 enables 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.
AlloVir uses its website as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD. Such disclosures will be included on the Company's website in the ‘Investors & Media' section. Accordingly, investors should monitor such portions of the AlloVir website, in addition to following press releases, SEC filings and public conference calls and webcasts.
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 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 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, 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.Media contact:
Courtney Heath
ScientPR
[email protected]
617-872-2462Investor contact:
Medha Chadha
AlloVir
[email protected]