dm+d

Unassigned

New Medicines

Viralym-MVirus-associated haemorrhagic cystitis - after allogeneic hematopoietic stem cell transplant

Information

Viralym-M
New molecular entity
AlloVir
AlloVir

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials
Yes
Oct 21Granted orphan drug status in US for virus-associated HC [3].

Category

Human leucocyte antigen (HLA) matched multivirus-specific T cell therapy. An allogeneic, off-the-shelf, ready to administer single T-cell product, developed by mixing donor T-cells with peptides from targeted viruses.
Haemorrhagic cystitis (HC) caused by viral infections such as BK virus, cytomegalovirus, and/or adenovirus after allo-HCT causes morbidity and mortality, affects quality of life, and poses a substantial burden to the health care system. HC occurs in 8% to 25% and 7% to 54% of pediatric and adult patients, respectively, following allo-HCT. It occurs between 2 and 8 weeks after allo-HCT, with lower urinary tract symptoms incl. severe abdominal pain [1].
Virus-associated haemorrhagic cystitis - after allogeneic hematopoietic stem cell transplant
Intravenous infusion

Trial or other data

Mar 22PIII trial (NCT04390113) is recruiting [2].
Mar 21PIII trial to evaluate posoleucel (ALVR105) for the treatment of virus-associated HC starts (NCT04390113). 125 participants aged at least 1 year who have had an allo-HCT performed ≥21 days and ≤1 year prior to randomisation will be recruited in the US, Italy, Republic of Korea, Spain, Sweden and UK (sites are Queen Elizabeth University Hospital in Glasgow and Nottingham University Hospitals). Patients will be randomised to a 2-4mL infusion of posoleucel or placebo. Primary outcome is time until urine is visually clear of haematuria; collection of these data is due to complete Jun 23 [2].

Viralym-MPrevention of clinically significant multi-virus infection in high risk allogenic hematopoietic stem cell transplant patients

Information

Viralym-M
New molecular entity
AlloVir
AlloVir

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials
Yes
Jan 22FDA grants Regenerative Medicine Advanced Therapy (RMAT) designation to posoleucel for the treatment of adenovirus infections in adults and children following allogeneic hematopoietic stem cell transplant (allo-HCT). The designation is based on positive results from the phase II CHARMS study [1]
Mar 20EMA grants orphan drug designation to posoleucel for the treatment of viral diseases and infections including adenovirus infection, BK virus (polyomavirus infections), cytomegalovirus, Epstein-barr virus, JC virus (polyomavirus infections) and human herpesvirus-6 in patients undergoing hematopoietic stem cell transplantation (HSCT) [1]
Feb 20EMA grants Priority Medicines (PRIME) designation to posoleucel for the treatment of serious infections with BK virus, cytomegalovirus, human herpes virus-6, Epstein Barr virus, and/or adenovirus, following allogenic hematopoietic stem cell transplantation (HSCT). The designation was issued based on the preliminary positive results from a phase II trial [1]

Category

Human leucocyte antigen (HLA) matched multivirus-specific T cell therapy. An allogeneic, off-the-shelf, ready to administer single T-cell product, developed by mixing donor T-cells with peptides from targeted viruses. Given as 7 doses over 12 weeks.
Prevention of clinically significant multi-virus infection in high risk allogenic hematopoietic stem cell transplant patients
Intravenous infusion

Trial or other data

Apr 22UK sites recruiting to the the PIII Prevent trial (NCT05305040) are Bristol Haematology and Oncology Centre, Queen Elizabeth University Hospital in Glasgow, and King ´s College Hospital in London [5].
Mar 22AlloVir initiates PIII trial (NCT05305040) of posoleucel for the prevention of clinically significant infections and end-organ diseases from six potentially life-threatening viruses – adenovirus (AdV), BK virus (BKV), cytomegalovirus (CMV), Epstein-Barr virus (EBV), human herpesvirus-6 (HHV-6) and JC virus (JCV) – in high-risk allogeneic hematopoietic cell transplant (allo-HCT) patients. The global, multi-center, randomized, double-blind, placebo-controlled study will enroll approximately 300 adult and pediatric patients and will evaluate the number of clinically significant infections or episodes of end-organ disease through the primary endpoint of the 14-week dosing interval [2,3]
Jan 22AlloVir initiates PIII trial (NCT05179057) to evaluate the safety and efficacy of posoleucel for the treatment of adenovirus infection in paediatric and adult allogeneic haematopoietic cell transplant (allo-HCT) recipients receiving standard of care. The multicenter, randomized, double-blind, placebo-controlled study intends to enrol 80 participants in the US with a primary completion date Jan 24 [1,4]
Dec 20PII trial (NCT04693637) to compare posoleucel with placebo for prevention of BK virus infections, JC virus infections, Epstein Barr virus infections, cytomegalovirus infections, adenovirus infections, human herpes virus-6 infections in high-risk patients post-allogeneic haematopoietic cell transplant initiated. The study achieved primary and secondary endpoints of the study [1]
Dec 19Proof-of-concept PII CHARMS trial that determined the safety and efficacy of a single infusion of posoleucel for the treatment of adenovirus infection, BK virus, cytomegalovirus, epstein-barr virus and human herpesvirus-6 in patients that have received an allogeneic stem cell transplant (H-3390; NCT02108522) completed. This open-label trial was initiated in June 2014 and enrolled 59 patients in the US. In July 2017, efficacy data of t-cell therapy demonstrated safety in patients with viral infections [1]