Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial, With Cross-Over, of Posoleucel (ALVR105) for the Treatment of Adenovirus Infection in Pediatric and Adult Participants Receiving Standard of Care Following Allogeneic Hematopoietic Cell Transplantation
This study will assess the safety and efficacy of Posoleucel for the treatment of adenovirus (AdV) infection in pediatric and adult allo-HCT recipients receiving standard of care (SoC).
Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of ALVR105 Posoleucel (ALVR105,Viralym-M) Compared to Placebo for the Prevention of AdV, BKV, CMV, EBV, HHV-6, and JCV Infection and/or Disease, in High-Risk Patients After Allogeneic Hematopoietic Cell Transplant
This is a Phase 3 study to evaluate posoleucel (ALVR105, Viralym-M); an allogeneic, off-the-shelf multi-virus specific T cell therapy that targets six viral pathogens: BK virus, cytomegalovirus, adenovirus, Epstein-Barr virus, human herpesvirus 6 and JC virus.
Phase 1/2, Double-Blind, Placebo-Controlled, Dose Escalation and Expansion Study of ALVR106 in Addition to Standard of Care for the Treatment of High-Risk Patients With Respiratory Viral Infections After Hematopoietic Cell Transplant
A study to evaluate ALVR106; an allogeneic, off-the-shelf multi-virus specific T cell therapy that targets four community acquired respiratory viruses: respiratory syncytial virus (RSV), influenza, human metapneumovirus (hMPV), and/or parainfluenza virus (PIV) following hematopoietic cell transplant (HCT)
Pictured: Graphic of stock data overlaid over stacks of coins/iStock, ipopba
On June 27, Gilead Sciences purchased nearly 3 million shares of AlloVir stock, costing more than $10 million. The very next day, Gilead purchased just over 1 million shares of Arcus Biosciences for nearly $20 million.
This practice of biopharma companies buying stock from one another used to be rather typical, Ira Leiderman, a managing director of healthcare at Cassel Salpeter & Co., told BioSpace, but times have changed. So, Gilead’s move “is a good example [of the phenomenon], but I don’t think you’ll find many deals like this,” he said.
Commonly referred to as equity investments or cross-holdings, these transactions are made for various reasons. For example, they enable businesses to form strategic alliances, drawing on one another’s knowledge and resources to address challenging problems in drug development.
“Cross-ownership can allow companies to expand their product portfolios, gain access to new technologies and enter different markets more effectively,” Adam Garcia, CEO of the Stock Dork, told BioSpace. Stock purchases can also reinforce relationships that have already been forged.
Indeed, Gilead has been a longtime financial supporter of AlloVir, which went public in 2020, and AlloVir’s CEO, Diana Brainard, was head of the virology therapeutic area at Gilead for a decade. Similarly, Gilead was already working with Arcus on discovering and developing cancer immunotherapies and combination therapies. By purchasing stocks in these companies, Gilead is effectively funneling money into its existing partnerships.
Equity investments can also help diversify and mitigate risks. “By holding shares in multiple biopharma companies, a company can spread its investments across different therapeutic areas and business models,” Garcia added. “This diversification can help cushion the impact of failures in specific drug development programs and maintain a more stable financial position.”
In addition, stock purchases can lead to silent takeovers, where a company gradually accumulates a significant stake in another, often without publicly acknowledging that it has acquired a majority share. By doing so, a company can avoid a traditional public takeover bid, which often involves negotiations and regulatory approvals. Silent takeovers cut through the red tape of the public takeover bid but still effectively shift leadership, strategic direction and overall control of the acquired company, impacting the overall market.
Leiderman and his colleague Margery Fischbein, another managing director of healthcare at Cassel Salpeter, told BioSpace that silent takeovers aren’t happening in biopharma today, however, and that Gilead’s actions of buying stock in a partner are actually not at all common in the current economic environment. And there are several reasons for that, they said.
For one, many companies in the biopharma industry are still trying to return to business as usual following the disruptions caused by the COVID-19 pandemic, making them less appealing to investors, including other biopharma firms, Fischbein said.
At the same time, companies that may have at one time considered buying biopharma stock are themselves short on funding. “The most precious resource to a biotech is cash, and it’s tough times out there,” Leiderman said. Rather than buying up stock in other companies, then, some biopharmas are looking to sell stocks to come up with much-needed capital.
“That’s why a lot of companies [biotechs] want to go public because they believe it would be easier for them to raise additional capital,” he said.
At this point, only financially secure firms such as Gilead are in a position to purchase stock in other companies, Leiderman added. “Gilead has a larger bank account than God.”
Fischbein said that the situation comes down to “haves and have-nots,” and in today’s environment, there are more “have-nots,” including in terms of balance sheets, cash and stock prices.
But for those biotechs able to secure financial backing from a pharma firm like Gilead, it could potentially give the company the leg up that it needs, Fischbein said. “It really adds credibility. If somebody like Gilead, GSK, or Novartis is backing the company by taking a significant stake, it’s a real mark of quality and possible likelihood of success.”
Ana Mulero is a freelance writer based in Puerto Rico. She can be reached at firstname.lastname@example.org and @anitamulero on Twitter.
WALTHAM, Mass.--(BUSINESS WIRE)-- AlloVir, Inc. (Nasdaq: ALVR), a late-clinical stage allogeneic T cell immunotherapy company, today announced that Diana Brainard, M.D., Chief Executive Officer, will participate in the following upcoming investor conferences:
Morgan Stanley 21st Annual Global Healthcare Conference
Fireside Chat: Monday, September 11, 2023 at 4:55 pm ET
H.C. Wainwright 25th Annual Global Investment Conference
Presentation: Tuesday, September 12, 2023 at 12:00 pm ET
A live webcast and archived replay of these presentations will be available on the Investors & Press section of the AlloVir website at .
AlloVir is a leading late-clinical stage cell therapy company focused 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 platform leverages 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 or follow us on Twitter/X or LinkedIn.
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Company's three Phase 3 global registrational trials for its allogeneic, off-the-shelf, virus-specific T cell therapy, posoleucel, in three distinct, first-to-market indications in allo-HCT patients continue to enroll, with data anticipated in second half of 2024
Positive data from the Phase 2 trial of posoleucel for treatment of BK viremia in kidney transplant recipients presented orally at late-breaking session at the American Transplant Congress (ATC 2023)
ALVR106, a multi-respiratory virus-specific T cell therapy targeting human metapneumovirus, influenza, parainfluenza, and respiratory syncytial virus, completed enrollment in the dose-escalation (Part A) portion of the Phase 1b/2a clinical trial in HCT and solid organ transplant patients
Recent stock offering extends cash runway through Phase 3 data readouts and into 2025
WALTHAM, Mass.--(BUSINESS WIRE)-- AlloVir, Inc. (Nasdaq: ALVR), a late-clinical stage allogeneic T cell immunotherapy company, today reported financial results from the second quarter ended June 30, 2023. The company shared progress across its allogeneic, off-the-shelf virus-specific T cell (VST) programs, including its lead investigational therapy, posoleucel, for prevention and treatment of life-threatening infections and diseases from up to six viruses that commonly impact patients following allogeneic hematopoietic cell transplant (allo-HCT), and for the treatment of BK viremia (BKV) in adult kidney transplant recipients.
“We are excited to be advancing our company’s three Phase 3 global registrational trials of posoleucel for three indications that threaten allo-HCT recipients. Treating and preventing life-threatening viral infections using T cells that focus on restoring natural immunity addresses a significant unmet need for allo-HCT patients, which could have a significant impact on patient outcomes, morbidity, and survival,” said Diana Brainard, M.D., Chief Executive Officer, AlloVir. “We are very pleased with our progress to date and are on track to report data from all three studies in the second half of 2024.”
In May 2023, the company announced the appointment of Cintia Piccina, PharmD, MBA, as Chief Commercial Officer. Ms. Piccina is an industry veteran with cell therapy expertise and more than 25 years of global commercial leadership experience. She is driving AlloVir’s global commercialization strategy, with a focus on its lead product, posoleucel. She is also responsible for building a commercial team in anticipation of a potential 2025 launch.
AlloVir delivered an oral presentation at the 49th annual meeting of the European Society for Blood and Marrow Transplantation (EBMT 2023) detailing positive results from the Phase 2 study of posoleucel for the prevention of clinically significant infections from six common and devastating viruses in allo-HCT recipients, including 0% non-relapse mortality at the 52-week follow-up visit.
The company presented final results from a Phase 2 randomized, placebo-controlled trial evaluating posoleucel for the treatment of BKV in adult kidney transplant recipients at the American Transplant Congress (ATC 2023) in June 2023. Findings demonstrated that treatment with posoleucel was safe, well tolerated and produced clinically meaningful reductions in BK viral load as compared to placebo with the greatest antiviral activity seen among patients with higher viral loads and those who received more frequent posoleucel dosing. The company is preparing to meet with the FDA to gain alignment on a Phase 3 clinical study design to evaluate posoleucel’s treatment of BKV infection in kidney transplant patients.
In June 2023, the company closed a public offering of common stock with gross proceeds of approximately $75.0 million before deducting underwriting discounts and commissions and other estimated offering expenses. The company anticipates that its cash position will fund operations into 2025, through anticipated data readouts from the posoleucel Phase 3 trials.
The company completed enrollment in Part A of the Phase 1b/2a clinical trial of ALVR106, a multi-respiratory virus-specific T cell therapy targeting human metapneumovirus, influenza, parainfluenza, and respiratory syncytial virus (RSV) in allo-HCT and solid organ transplant patients. Data from this dose-escalation portion of the clinical trial will be submitted for presentation at a future scientific congress.
Data from three Phase 3 registrational trials of posoleucel in three indications for allo-HCT patients is anticipated in the second half of 2024:
The prevention of clinically significant infection or disease from adenovirus (AdV), BKV, cytomegalovirus (CMV), Epstein-Barr virus (EBV), human herpesvirus-6 (HHV-6) and JC virus (JCV)
The treatment of virus-associated hemorrhagic cystitis (vHC)
The treatment of AdV infection
Second Quarter Financial Results
Research and development expenses were $34.8 million for the quarter ended June 30, 2023, compared with $31.4 million for the quarter ended June 30, 2022. The increase year-over-year was primarily attributable to an increase in costs related to the development of the company’s lead product candidate, posoleucel.
General and administrative expenses were $12.5 million for the quarter ended June 30, 2023, compared with $13.2 million for the quarter ended June 30, 2022. The decrease year-over-year was primarily attributable to a decrease in consulting and personnel related costs.
Stock-based compensation expense was $10.3 million and $11.0 million for the quarter ended June 30, 2023, and 2022, respectively.
As of June 30, 2023, AlloVir had cash, cash equivalents, and short-term investments of $246.5 million, compared with cash, cash equivalents, and short-term investments of $233.8 million as of December 31, 2022.
For the quarter ended June 30, 2023, net loss was $45.3 million or $0.48 per share compared with a net loss of $44.6 million or $0.69 per share for the quarter ended June 30, 2022.
2023 Financial Guidance
For fiscal year 2023, AlloVir expects operating expenses to be in the range of $150 million to $170 million, excluding non-cash expenses.
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: adenovirus (AdV), BK viremia (BKV), cytomegalovirus (CMV), Epstein-Barr virus (EBV), human herpesvirus-6 (HHV-6) and JC virus (JCV). In a Phase 2 open-label study of posoleucel for the prevention of clinically significant infections due to the six viruses posoleucel targets, 88% of allo-HCT patients who received posoleucel remained free of clinically significant infections through week 14, the primary endpoint. Moreover, the non-relapse mortality rate in patients who received posoleucel was 0% through the 52-week follow-up visit. Additionally, in the positive Phase 2 proof-of-concept CHARMS treatment study, which enrolled allo-HCT recipients infected by one or more of the six viruses posoleucel targets, more than 90% of patients who failed conventional treatment and received posoleucel demonstrated a complete or partial clinical response based on predefined criteria.
AlloVir is a leading late-clinical stage cell therapy company focused 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 platform leverages 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 or follow us on Twitter or LinkedIn.
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 of posoleucel as a treatment for three distinct indications, the potential of posoleucel to prevent infection or disease, the potential of posoleucel to treat vHC or AdV, the timing of data readouts for our three Phase 3 studies, the projection that our cash will fund operations through data readouts for our three Phase 3 trials and into 2025, that preventing viral infections in allo-HCT patients could be transformational, our anticipated commercial launch in 2025, AlloVir's development and regulatory status of its 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 the safety and efficacy of posoleucel, 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 (FDA), or other foreign regulatory authorities, competition from other biopharmaceutical companies, supply chain, and business operations and other risks identified in AlloVir's SEC filings, including AlloVir’s form 10-Q for the period ended March 31, 2023. 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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