Tillkännagivande • Jun 08

AlloVir, Inc. Reports Blinded, Preliminary, Phase 2 Data Supporting the Ongoing Study of Posoleucel, a Multi-Virus-Specific T Cell Therapy, for the Treatment of BK Viremia in Kidney Transplant Recipients

AlloVir, Inc. announced preliminary, blinded data from an ongoing Phase 2 study of posoleucel, an investigational, allogeneic, off-the-shelf, multi-virus-specific T cell (VST) therapy, for the treatment of BK viremia (BKV) in adult kidney transplant recipients. These data from the largest study of T cell therapy in solid organ transplant patients presented to date, provide an early indication of the safety and tolerability profile of posoleucel in kidney transplant recipients with BK viremia, which is associated with reduced graft survival and has no approved treatment. In addition to the oral presentation on the study of posoleucel for the treatment of BK viremia, a compassionate use report on the administration of posoleucel in a kidney transplant recipient with Epstein-Barr virus-associated leiomyosarcoma was featured in a poster at ATC (Abstract 1000). Compassionate use case reports of ALVR109 administered to four immunocompromised patients with protracted COVID-19 infection, including two lung transplant recipients, were featured in a late-breaking presentation at ATC (Abstract 9011). This ongoing, randomized, double-blind, placebo-controlled Phase 2 study is evaluating the safety and tolerability of posoleucel for the treatment of BK viremia in 61 adult kidney transplant recipients with BK viremia between 350-10,000,000 copies/mL. Enrollment in the study has completed. Patients were randomized 1:1:1 to receive one of two dosing regimens of posoleucel (weekly administration of posoleucel for three weeks then every two weeks, or weekly for three weeks then once a month) or placebo over a period of 12 weeks. Following this dosing period, patients are followed up through Week 24. At the time of the data cut-off for this preliminary blinded analysis, 61 patients had received at least one dose of posoleucel or placebo at a median of 458 days post-transplant, including 28 patients who had completed dosing, four patients who discontinued dosing due to resolution of BK viremia per protocol, and 12 patients who completed 26 weeks of the study. Of the 61 patients randomized, 56% (n=34) had a screening BK viral load under 10,000 copies/mL and 44% (n=27) had a screening BK viral load over 10,000 copies/mL. The primary study endpoint is safety and tolerability of posoleucel versus placebo. In this preliminary blinded analysis, headache, which was reported in six patients (10%), was the only adverse event judged by investigators to be related to study drug that occurred in more than 5% of patients. No grade 3-4 adverse events, treatment-related serious adverse events, treatment discontinuations due to adverse events, or deaths were reported. There were no cases of graft rejection and no episodes of graft versus host disease or cytokine release syndrome. One patient developed de novo donor-specific antibodies; these antibodies were not found to be directed against posoleucel antigens in the matching cell line. Overall kidney allograft function, as assessed by creatinine and estimated glomerular filtration rate, remained stable. Reduction in immunosuppression occurred in six patients (10%) at the discretion of study investigators who agreed to follow protocol-defined guidelines. The key secondary endpoint of the study is change in BK viremia in patients receiving posoleucel versus those receiving placebo. Declines in median BK viral load were observed in this blinded dataset irrespective of the baseline BK viral load. At baseline, 34 patients had a viral load below 10,000 copies/mL. The median viral load in these 34 patients was 2,042 copies/mL on Day 1. Among the 14 patients who had reached the Week 12 timepoint at the time of this analysis, the median viral load had declined to 245 copies/mL. At baseline, 27 patients had a viral load above 10,000 copies/mL and the median viral load was 190,546 copies/mL at Day 1. Among the 14 patients who had reached the Week 12 timepoint at the time of this analysis, the median viral load had declined to 27,542 copies/mL. Exploratory study endpoints include posoleucel persistence by T cell receptor (TCR)-beta sequencing and the assessment of T cell expansion by ELISpot. Posoleucel VSTs were detected in the seven patients with available TCR sequencing data during the infusion period and for up to 12 weeks after the last infusion. Expansion of functional BK-specific VSTs were confirmed in six of these seven patients. Due to the long-term immunosuppression required to prevent graft rejection, solid organ transplant recipients are at high risk for reactivating common viruses that are typically controlled by the body’s natural immune system. Uncontrolled, these viruses can have devastating consequences. BK viremia is detected in up to 20% of kidney transplant recipients, with the majority of BK viremia occurring within the first one to two years post-transplant. Approximately half of patients with high-level BK viremia develop BKV nephropathy (BKVN), which can lead to decreased kidney survival and a return to end-stage renal disease and dialysis. There are no approved or effective antiviral treatments for BK viremia. Reduction in immunosuppression to allow the body’s immune system to fight the virus can also lead to graft rejection and the development of donor-specific antibodies. Data suggest that VST therapy may play a role in managing BK viremia and BKVN. Kidney transplant recipients who do not develop BKVN have been shown to have approximately 10-fold higher BKV-specific T-cell responses versus those with BKVN. Kidney transplant recipients with BK viremia who develop robust BKV-specific T-cell responses have also been shown to clear the virus, while those who progressed to BKVN required interventions such as reduction in immunosuppression. AlloVir’s lead product, posoleucel (Viralym-M, ALVR105), 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 virus (BKV), cytomegalovirus (CMV), Epstein-Barr virus (EBV), human herpesvirus-6 (HHV-6) and JC virus (JCV). In the positive, Phase 2, proof-of-concept CHARMS treatment study in allo-HCT patients, more than 90% of patients who did not respond to or could not tolerate conventional treatment had a complete or partial clinical response after receiving posoleucel. Of the 20 patients with BKV-associated hemorrhagic cystitis (HC) who were treated with posoleucel in the CHARMS study, 75% had resolution of HC by Week 6. In the ongoing Phase 2 study evaluating posoleucel for the prevention of clinically significant infections and disease caused by AdV, BKV, CMV, EBV, HHV-6 and JCV in allo-HCT patients, no patients developed BKV-associated HC. A Phase 3 trial of posoleucel for multi-virus prevention is ongoing.

Tillkännagivande • Feb 12

Allovir Announces Results of A Subgroup Analysis from A Phase 2, Proof-Of-Concept Study

AlloVir announced results of a subgroup analysis from a Phase 2, proof-of-concept study (CHARMS) evaluating the company’s lead product candidate, Viralym-M (ALVR105), an allogeneic, off-the-shelf, multi-virus specific investigational T-cell therapy (VST), in allogeneic hematopoietic stem cell transplant (allo-HSCT) recipients with virus-associated hemorrhagic cystitis (V-HC). These data are being presented in an oral presentation during the Transplantation & Cellular Therapy (TCT) Meeting of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood & Marrow Transplant Research (CIBMTR). Additionally, two separate oral presentations characterize the high economic and clinical burden of V-HC and double-stranded (ds) DNA viral infections in allo-HSCT recipients. Preclinical data was also presented in a poster presentation on ALVR109, AlloVir’s virus-specific T-cell therapy targeting SARS-CoV-2, the virus responsible for COVID-19. Data of Viralym-M in fifty-eight allo-HSCT recipients with at least one treatment-refractory viral infection caused by BK virus (BKV), cytomegalovirus (CMV), adenovirus (AdV), Epstein Barr virus (EBV), human herpesvirus 6 (HHV-6), and/or JC virus (JCV) were evaluated in the CHARMS Phase 2 study. The subgroup analysis presented at TCT included 26 patients who received intravenous VST infusions for the treatment of V-HC due to infection with BKV (n=23), AdV (n=2) and BKV and AdV (n=1). Infusions were well tolerated with mild, grade 1, de novo skin rash from graft-versus-host disease (GVHD) occurring in 15% of patients (n=4). In the 20 patients with available V-HC grading, resolution of macroscopic hematuria was observed in 60% and 80% of patients at two- and six-weeks post-infusion, respectively. In comparison, resolution of macroscopic hematuria was observed in <10% and 30% of patients at weeks two and six, respectively, in a contemporary cohort of allo-HSCT recipients (n=33) with V-HC who were not treated with Viralym-M. Health economic outcomes data was also presented in two separate oral presentations at the conference. The two presentations analyzed U.S. claims data to compare health care reimbursement, health resource utilization, and clinical outcomes in pediatric and adult allo-HSCT recipients with V-HC and those without V-HC, and allo-HSCT recipients with or without dsDNA infections, respectively. Both studies found that allo-HSCT recipients with V-HC and those with any dsDNA infection had higher reimbursement costs, increased hospital and ICU length of stay, and increased hospital readmission rates. The presence of V-HC or any dsDNA viral infection was associated with a higher risk of mortality. In addition, a poster presentation at the conference demonstrated the in vitro effector and safety profile of ALVR109, an allogeneic, off-the-shelf investigational VST therapy designed to target SARS-CoV-2, the virus that causes the severe and life-threatening viral disease, COVID-19. These data suggest the potential for using these VSTs to treat COVID-19 in hospitalized high-risk patients to prevent the development of severe disease. A clinical trial evaluating these banked, off-the-shelf SARS-CoV-2 specific T cells has been initiated at the Center for Cell and Gene Therapy, Baylor College of Medicine (BCM), Texas Children's Hospital, and Houston Methodist Hospital. In healthy individuals, virus-specific T cells (VSTs) from the body’s natural defense system provide protection against numerous disease-causing viruses. However, in patients with a weakened immune system these viruses may be uncontrolled. Viral diseases are common and can cause potentially devastating and life-threatening consequences in immunocompromised patients. For example, up to 90% of patients will reactivate at least one virus following an allogeneic stem cell transplant and two-thirds of these patients reactivate more than one virus, resulting in significant and prolonged morbidity, hospitalization, and premature death. Typically, when viruses infect immunocompromised patients, standard antiviral treatment does not address the underlying problem of a weakened immune system and therefore many patients suffer with life-threatening outcomes such as multi-organ damage and failure, and even death. Viralym-M (ALVR105) is an allogeneic, off-the-shelf, multi-virus specific investigational T-cell therapy targeting five devastating viral pathogens: BK virus, cytomegalovirus, adenovirus, Epstein-Barr virus, and human herpesvirus 6. Viralym-M has the potential to transform care for transplant recipients as well as individuals who are at high risk for opportunistic viral infections by reducing or preventing disease morbidity and dramatically improving patient outcomes. Three pivotal and proof-of-concept clinical (POC) trials are ongoing and actively recruiting patients in indications such as treatment of virus-associated hemorrhagic cystitis and multi-virus prevention following allo-HSCT, and preemptive treatment of BK viremia in adult kidney transplant recipients. Additional pivotal and POC trials are expected to initiate for the treatment of CMV and the treatment of AdV in allo-HSCT recipients and in CMV for solid organ transplant recipients, respectively. For more information on the ongoing clinical trials visit clinicaltrials.gov. Viralym-M has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA), as well as PRIority MEdicines (PRIME) and Orphan Drug Designations (ODD) from the European Medicines Agency.

Biotechs Tillväxt i branschen	17.04%
Intäkternas tillväxttakt	-109.06%
Avkastning på eget kapital	-51.87%
Nettomarginal	n/a
Senaste uppdateringen av resultatet	31 Dec 2024

Datum	Intäkter	Intäkter	G+A Kostnader	FoU-kostnader
31 Dec 24	0	-59	43	12
30 Sep 24	0	-100	34	45
30 Jun 24	0	-140	41	80
31 Mar 24	0	-180	46	115
31 Dec 23	0	-190	48	133
30 Sep 23	0	-169	50	128
30 Jun 23	0	-167	50	124
31 Mar 23	0	-166	51	121
31 Dec 22	0	-169	52	119
30 Sep 22	0	-189	55	132
30 Jun 22	0	-192	54	135
31 Mar 22	0	-185	53	129
31 Dec 21	0	-172	49	121
30 Sep 21	0	-139	44	96
30 Jun 21	0	-117	38	80
31 Mar 21	0	-91	29	63
31 Dec 20	0	-70	22	50
30 Sep 20	0	-53	16	40
30 Jun 20	0	-37	12	28
31 Mar 20	0	-31	12	22
31 Dec 19	0	-24	11	16
31 Dec 18	1	-8	3	2

Uppgifter	Senast uppdaterad (UTC-tid)
Analys av företag	2025/03/18 03:09
Aktiekurs vid dagens slut	2025/03/18 00:00
Intäkter	2024/12/31
Årlig intjäning	2024/12/31

Paket	Uppgifter	Tidsram	Exempel US-källa
Företagets finansiella ställning	10 år	Resultaträkning Kassaflödesanalys Balansräkning	SEC Form 10-K SEC Form 10-Q
Analytikernas konsensusuppskattningar	+3 år	Prognos för finansiella poster Analytikernas prismål	Rapporter från analytiker Blue Matrix
Marknadspriser	30 år	Aktiekurser Utdelningar, splittar och åtgärder	ICE Marknadsdata SEC Form S-1
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Viktiga utvecklingstendenser	10 år	Företagsmeddelanden	SEC Formulär 8-K

Analytiker	Institution
Jason Zemansky	BofA Global Research
Anupam Rama	J.P. Morgan
Christopher Raymond	Piper Sandler Companies

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Recent updates

New major risk - Market cap size

New major risk - Revenue and earnings growth

Kalaris Therapeutics, Inc. entered into an Agreement and Plan of Merger to acquire AlloVir, Inc. (NasdaqCM:ALVR) in a reverse merger transaction.

New minor risk - Share price stability

AlloVir (NASDAQ:ALVR) Will Have To Spend Its Cash Wisely

Price target decreased by 20% to US$0.80

Here's Why AlloVir (NASDAQ:ALVR) Must Use Its Cash Wisely

New major risk - Financial position

AlloVir, Inc., Annual General Meeting, Jun 06, 2024

New major risk - Revenue and earnings growth

Levi & Korsinsky, LLP Notifies Investors in Allovir, Inc. of a Class Action Securities Lawsuit

We Think AlloVir (NASDAQ:ALVR) Needs To Drive Business Growth Carefully

Robbins LLP Announces Class Action File Against AlloVir, Inc

Pomerantz Law Firm Announces the Filing of a Class Action Against AlloVir, Inc. and Certain Officers

Price target decreased by 71% to US$5.63

AlloVir, Inc. Provides Updates on Phase 3 Clinical Development Program for Posoleucel, an Allogeneic Virus-Specific T Cell Therapy

Here's Why We're Watching AlloVir's (NASDAQ:ALVR) Cash Burn Situation

Here's Why We're Watching AlloVir's (NASDAQ:ALVR) Cash Burn Situation

New major risk - Share price stability

AlloVir, Inc. Presents Positive Final Results from A Phase 2 Randomized, Placebo-Controlled Trial Evaluating Posoleucel Treatment of Bk Infection in Kidney Transplant Recipients At the American Transplant Congress

Allovir Announces Appointment of Cintia Piccina as Chief Commercial Officer

Is AlloVir (NASDAQ:ALVR) In A Good Position To Deliver On Growth Plans?

High number of new directors

Price target decreased by 7.6% to US$21.25

AlloVir Announces Positive Final Results from Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of Posoleucel in Kidney Transplant Recipients with BK Viremia

Price target decreased by 13% to US$23.00

CEO & Director notifies of intention to sell stock

AlloVir, Inc. Announces Plans to Complete Enrollment in Three Phase 3 Posoleucel Studies in 2023

AlloVir, Inc. Announces Positive Final Results in Phase 2 Posoleucel Multi-Virus Prevention Study

Consultant notifies of intention to sell stock

Allovir, Inc. Announces the Resignation of Jeroen Van Beek as Executive Vice President and Chief Commercial Officer, Effective November 23, 2022

General Counsel & Secretary notifies of intention to sell stock

Is AlloVir (NASDAQ:ALVR) In A Good Position To Deliver On Growth Plans?

AlloVir, Inc. Announces That Final Data from the Phase 2 Study of Posoleuce

Chief Accounting Officer recently sold US$99k worth of stock

Executive Chairman of the Board notifies of intention to sell stock

Chief Accounting Officer recently sold US$99k worth of stock

Executive Chairman of the Board recently sold US$2.9m worth of stock

Chief Commercial Officer recently sold US$129k worth of stock

Price target decreased to US$27.50

AlloVir GAAP EPS of $0.69 beats by $1.42

AlloVir stock surges on $126.6M securities offering

Is AlloVir (NASDAQ:ALVR) In A Good Position To Invest In Growth?

AlloVir, Inc.(NasdaqGS:ALVR) dropped from Russell 2000 Growth Index

AlloVir, Inc. Reports Blinded, Preliminary, Phase 2 Data Supporting the Ongoing Study of Posoleucel, a Multi-Virus-Specific T Cell Therapy, for the Treatment of BK Viremia in Kidney Transplant Recipients

Chief Commercial Officer recently sold US$67k worth of stock

Price target decreased to US$32.00

FDA Grants Regenerative Medicine Advanced Therapy to Allovir's Posoleucel for Prevention of Multiple Life-Threatening Infections from Six Viruses in Allogeneic Hematopoietic Cell Transplant Patients

AlloVir, Inc., Annual General Meeting, May 17, 2022

AlloVir Announces Appointment of Shawn Tomasello to its Board of Directors

Here's Why We're Not Too Worried About AlloVir's (NASDAQ:ALVR) Cash Burn Situation

Chief Commercial Officer recently sold US$128k worth of stock

AlloVir: A Comparative Study Of Its Manufacturing Process

Price target decreased to US$38.75

Insider notifies of intention to sell stock

President recently sold US$56k worth of stock

AlloVir, Inc. Announces U.S. Food and Drug Administration Grant Lead Multi-Virus Specific T Cell (VST) Therapy, Posoleucel (Viralym-M, ALVR105), Regenerative Medicine Advanced Therapy (RMAT) Designation for the Treatment of Adenovirus (AdV) Infection

Price target decreased to US$42.75

AlloVir Announces Positive Preliminary Data from the Ongoing Phase 2 Posoleucel Multi-Virus Prevention Study at the 63rd American Society of Hematology Annual Meeting

Chief Commercial Officer recently sold US$321k worth of stock

Chief Scientific Officer notifies of intention to sell stock

We're Not Very Worried About AlloVir's (NASDAQ:ALVR) Cash Burn Rate

High number of new directors

Independent Non-Executive Director notifies of intention to sell stock

Insider recently sold US$447k worth of stock

AlloVir, Inc.: Creating Solutions For Stem Cell Transplant Issues

Insider notifies of intention to sell stock

AlloVir, Inc.'s (NASDAQ:ALVR) Intrinsic Value Is Potentially 24% Below Its Share Price

We Think AlloVir (NASDAQ:ALVR) Can Afford To Drive Business Growth

AlloVir, Inc.(NasdaqGS:ALVR) dropped from Russell 3000E Value Index

Chief Scientific Officer recently sold US$3.4m worth of stock

AlloVir (NASDAQ:ALVR) Is In A Good Position To Deliver On Growth Plans

Insider notifies of intention to sell stock

Independent Non-Executive Director notifies of intention to sell stock