ALVR AlloVir Inc.
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
ALVR109
COVID-19
|
Phase 1
Phase 1
|
Proof of concept trial to be initiated 4Q 2020.
|
|
Viralym-M (ALVR105)
Virus-associated hemorrhagic cystitis
|
Phase 3
Phase 3
|
Phase 3 trial planned for 4Q 2020.
|
|
Viralym-M (ALVR105)
Cytomegalovirus (CMV)
|
Phase 3
Phase 3
|
Phase 3 trial planned.
|
|
Viralym-M (ALVR105)
Aleution disease virus (ADV)
|
Phase 3
Phase 3
|
Phase 3 trial planned.
|
|
Viralym-M (ALVR105)
Prevention of Multi-Virus Infections (BKV, CMV, AdV, EBV, HHV-6, and JCV)
|
Phase 2
Phase 2
|
Phase 2 trial planned.
|
|
Viralym-M (ALVR105)
Cytomegalovirus (CMV)
|
Phase 2
Phase 2
|
Phase 2 trial planned.
|
|
Viralym-M (ALVR105)
BK virus
|
Phase 2
Phase 2
|
Phase 2 trial planned.
|
|
ALVR106
Hematopoietic stem cell transplantation
|
Phase 1/2
Phase 1/2
|
Phase 1/2 trial to be initiated 4Q 2020.
|
Latest News
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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]
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CAMBRIDGE, Mass., Sept. 08, 2020 (GLOBE NEWSWIRE) -- AlloVir (NASDAQ:ALVR), a late clinical-stage cell therapy company, announced the appointment of Ercem Atillasoy, M.D., as the company's Chief Regulatory and Safety Officer, a newly created position. Dr. Atillasoy brings nearly 25 years of experience leading drug, biologic, and infectious disease product development. Most recently, Dr. Atillasoy was at Merck Research Laboratories serving as Vice President and Therapeutic Area Head of Vaccines and Infectious Disease in Global Regulatory Affairs and Clinical Safety. He had responsibility and oversight for Merck's extensive portfolio of infectious disease products, many of which have transformed human health. In addition, he oversaw engagement and strategy with regulatory agencies across the world, including those in the United States, Europe, Japan, and China.
"We are delighted that Ercem is joining AlloVir as we prepare to enter multiple late-stage clinical trials across our pipeline of highly innovative therapeutics for patients suffering from, or at risk of, life-threatening viral diseases," said David Hallal, Chairman and Chief Executive Officer of AlloVir. "Ercem's extensive global regulatory expertise and successes within the infectious disease therapeutic area represent a very important addition to our executive team as we expand our development programs in the U.S., Europe, and Asia."
During his nearly 20 years at Merck, Dr. Atillasoy had an instrumental role in expediting development and approval of novel medicines and vaccines that have changed the world, including vaccines against viruses, such as Ebola (Ervebo®), human papillomaviruses that cause cancers, (Gardasil® and Gardasil®9), rotaviruses (RotaTeq®), and those that cause pediatric illnesses (ProQuad® and Vaxelis™). Most recently, he had regulatory oversight for Merck's publicly announced investigational COVID-19-related vaccine and small molecule programs. Dr. Atillasoy has led regulatory filings and approvals for many antiviral agents, such as those against HIV (Isentress®, Delstrigo™, and Pifeltro™), cytomegalovirus (Prevymis™), and hepatitis C (Zepatier®). In addition, Dr. Atillasoy oversaw the first investigational new drug (IND) filing for Keytruda® for melanoma, and he has supported approval of other oncology products including Zolinza® for cutaneous T cell lymphoma and Emend® for the prevention of chemotherapy-associated nausea.*
"AlloVir has built a proprietary, highly efficient technology platform that has yielded an investigational pipeline of allogeneic, off-the-shelf T cell therapies. The platform offers novel solutions with potential to address significant unmet global health needs among patients suffering from viral diseases who lack effective treatments today," said Dr. Atillasoy. "I am excited to join the AlloVir team and guide our products through development and anticipated regulatory filings and approvals."
Earlier in his career, Dr. Atillasoy worked with the Medical Affairs Departments at Sandoz and Novartis Pharmaceuticals, where he supported licensure of anti-infective, dermatology, tissue engineered products (including Apligraf®)*, and cell therapies. In addition to his professional accomplishments, Dr. Atillasoy was selected and currently serves as the industry representative to the U.S. Food and Drug Administration (FDA) Dermatologic and Ophthalmologic Drugs Advisory Committee and served as Merck's senior representative to the PhRMA Regulatory Steering Group and the BIO Vaccine Regulatory Advisory Committee. Dr. Atillasoy has published papers on a range of topics, including infectious disease, gene therapy, melanoma, dermatology, and tissue engineering.
Dr. Atillasoy is a graduate of the Yale University School of Medicine and completed his medical internship at Yale New Haven Hospital and his dermatology residency at the University of Pennsylvania. He conducted research in carcinogenesis and gene therapy at the Wistar Institute. He graduated summa cum laude with a Bachelor of Arts degree in English from the City University of New York.
*Ervebo®, Gardasil® and Gardasil®9, RotaTeq®, ProQuad® Isentress®, Zepatier®, Zolinza®, Keytruda® and Emend® are registered trademarks of Merck and Co., Inc. Vaxelis™, Delstrigo™, Pifeltro™, and Prevymis™ are trademarks of Merck and Co., Inc. Apligraf® is a registered trademark of Organogenesis Inc.
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] -
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CAMBRIDGE, Mass., Sept. 02, 2020 (GLOBE NEWSWIRE) -- AlloVir (NASDAQ:ALVR), a late clinical-stage cell therapy company, today reported financial results for the second quarter ended June 30, 2020.
"AlloVir has achieved important scientific and operational milestones that have us well positioned for growth," said David Hallal, Chairman and Chief Executive Officer of AlloVir. "As we have advanced our portfolio of allogeneic, off -the-shelf, virus specific T cell therapies and are bolstered by a strong cash position stemming from our recent IPO, we look forward to executing our robust plans to progress the important pivotal and proof-of-concept studies across our pipeline."
Second Quarter 2020 Financial Highlights
- Research and development expenses were $8.9 million for the quarter ended June 30, 2020 compared to $2.8 million for the quarter ended June 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 $3.3 million for the quarter ended June 30, 2020 compared to $3.2 million for the quarter ended June 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 $0.5 million and $1.4 million for the three months ended June 30, 2020 and 2019, respectively.
- As of June 30, 2020, AlloVir had cash, cash equivalents, and marketable securities of $104.5 million, which compares to cash, cash equivalents, and marketable securities of $126.1 million as of December 31, 2019.
- For the quarter ended June 30, 2020, net loss was $11.6 million or $4.43 per share compared to a net loss of $5.3 million or $5.05 per share for the quarter ended June 30, 2019. The total number of common shares and preferred shares outstanding as of June 30, 2020 was 2,801,059 and 59,398,350, respectively. For purposes of calculating the earnings per share, only the common shares were used in the denominator.
Subsequent Events
- In August, the Company closed on an initial public offering raising $317.7mm in gross proceeds prior to deducting underwriting discounts, commissions and offering expenses. We believe that the net proceeds from our IPO, together with our existing cash, cash equivalents and short-term investments, will enable us to fund our operating expenses and capital expenditure requirements into 2023.
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.
AlloVir, Inc. Statement of Operations (Unaudited)
Three and Six Months Ended June 30, 2020 and 2019Three Months Ended Six Months Ended (in thousands, except share and per share data) June 30, June 30, 2020 2019 2020 2019 Revenue $ — $ — $ — $ 165 Operating expenses: Research and development 8,885 2,755 15,724 3,906 General and administrative 3,268 3,190 6,269 4,977 Total operating expenses ** 12,153 5,945 21,993 8,883 Loss from operations (12,153 ) (5,945 ) (21,993 ) (8,718 ) Total other income, net: Interest income 166 503 623 619 Other income, net 355 140 399 273 Net loss $ (11,632 ) $ (5,302 ) $ (20,971 ) $ (7,826 ) Net loss per share --- basic and diluted $ (4.43 ) $ (5.05 ) $ (8.66 ) $ (8.49 ) Weighted-average common shares outstanding---basic and diluted 2,625,648 1,050,190 2,420,797 921,995 AlloVir, Inc. Balance Sheet
As of June 30, 2020 (Unaudited) and December 31, 2019(in thousands) June 30, December 31, 2020 2019 Assets Current assets: Cash, cash equivalents and short-term investments $ 104,451 $ 126,077 Other current assets 2,837 1,236 Total current assets 107,288 127,313 Other assets 10,558 12,109 Total assets $ 117,846 $ 139,422 Liabilities and stockholders' deficit Current liabilities $ 8,915 $ 9,106 Long-term liabilities 7,098 8,692 Total liabilities 16,013 17,798 Preferred Stock 173,127 173,127 Total stockholders' deficit (71,294 ) (51,503 ) Total liabilities, preferred stock, and stockholders' deficit $ 117,846 $ 139,422 Media contact:
Courtney Heath
ScientPR
[email protected]
617-872-2462Investor contact:
Medha Chadha
AlloVir
[email protected] -
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CAMBRIDGE, Mass., Aug. 25, 2020 (GLOBE NEWSWIRE) -- AlloVir, Inc. (NASDAQ:ALVR), a late clinical-stage cell therapy company, will present a corporate overview at the virtual Morgan Stanley 18th Annual Global Healthcare Conference on September 17, 2020 at 5:00 p.m. ET.
A live webcast of the presentation will be available on the Investors & Press section of the AlloVir website at https://ir.allovir.com. An archived replay of the webcast 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 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.Media contact:
Courtney Heath
ScientPR
[email protected]
617-872-2462Investor contact:
Medha Chadha
AlloVir
[email protected] -
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CAMBRIDGE, Mass., Aug. 03, 2020 (GLOBE NEWSWIRE) -- AlloVir, Inc. (NASDAQ:ALVR), a late clinical-stage cell therapy company, today announced the closing of its upsized initial public offering of 18,687,500 shares of common stock, which includes the exercise in full of the underwriters' option to purchase up to 2,437,500 additional shares of common stock, at a public offering price of $17.00 per share, before underwriting discounts and commissions. All of the common stock was offered by AlloVir. The gross proceeds of the offering, before deducting underwriting discounts and commissions and other offering expenses payable by AlloVir, were approximately $317.7 million. AlloVir's common stock is listed on The Nasdaq Global Market under the ticker symbol "ALVR."
Morgan Stanley, J.P. Morgan, SVB Leerink and Piper Sandler & Co. acted as joint book-running managers for the offering.
A registration statement relating to the shares being sold in this offering has been filed with the Securities and Exchange Commission and was declared effective on July 29, 2020. The offering was made only by means of a prospectus. Copies of the final prospectus relating to this offering may be obtained from Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014, or by email at [email protected]; from J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, telephone: 1-866-803-9204 or email at [email protected]; from SVB Leerink LLC, by mail at One Federal Street, 37th Floor, Boston, MA 02110, Attention: Syndicate Department, by telephone at (800) 808-7525, ext. 6218, or by email at [email protected]; or from Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, by telephone at (800) 747-3924, or by email at [email protected].
This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities law of any such state or jurisdiction.
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.Media contact:
Courtney Heath
ScientPR
[email protected]
617-872-2462Investor contact:
Medha Chadha
AlloVir
[email protected]