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HOOKIPA Pharma Inc. (NASDAQ: HOOK), an organization creating a brand new class of immunotherapeutics based mostly on its proprietary arenavirus platform, right this moment introduced optimistic interim efficacy outcomes, in addition to further security and immunogenicity information, for its prophylactic Cytomegalovirus (CMV) vaccine candidate HB-101. HB-101, a non-replicating arenavirus vaccine, is being investigated in a double-blind Section 2 medical trial (NCT03629080) to evaluate security, immunogenicity and efficacy in people receiving a kidney transplant from a residing donor. HOOKIPA will host a convention name and dwell audio webcast right this moment at 8:30am EST.
CMV an infection is likely one of the commonest issues affecting stable organ transplant recipients and can lead to severe situations like hepatitis and pneumonia, in addition to enhance the chance of transplant rejection and graft-versus-host illness. Antiviral therapies are used to assist management illness, however they’re restricted by toxicity and the emergence of viral resistance.1
The interim efficacy evaluation contains information from 41 individuals as of the deadline; Eight had been vaccinated with three doses of HB-101 pre-transplant, 19 had been vaccinated with two doses and 14 acquired placebo.
In comparison with placebo, individuals vaccinated with three HB-101 doses had:
- a 48 p.c discount in CMV viremia (presence of CMV DNA within the blood);
- a 42 p.c discount in using antiviral remedy; and
- no CMV illness (in comparison with 2 out of 14 circumstances within the placebo group)
Response to a two-dose schedule didn’t present an enchancment in comparison with placebo, which is according to the low ranges of CMV-neutralizing antibody within the two-dose group in addition to with the T cell information reported in June 2020 for the two-dose group.
“Whereas these interim information are from a small group of sufferers, they provide early perception into the potential of a three-dose schedule of HB-101 to assist defend kidney transplant recipients towards CMV illness,” mentioned Joern Aldag, Chief Govt Officer of HOOKIPA. “If these tendencies proceed, HB-101 could also be a promising first-in-class vaccine candidate to assist handle an unmet want on this susceptible affected person inhabitants. We’re excited to discover a path to a Section three CMV vaccine program, in addition to to see how these early efficacy alerts with our non-replicating arenavirus expertise might translate to our replicating expertise in oncology.”
The interim immunogenicity evaluation additionally included CMV-neutralizing antibody information assessed from 33 people, a subset of the 41 included within the efficacy evaluation. 21 individuals had been vaccinated with HB-101 and 12 acquired placebo. In keeping with earlier interim information, 100 p.c of the individuals who acquired three doses of HB-101 mounted CMV-neutralizing antibodies.
Security and tolerability had been evaluated in 69 individuals who had been enrolled within the trial by the deadline. HB-101 was typically effectively tolerated with a low incidence of negative effects, which had been largely gentle to reasonable. Particularly, 17 p.c of individuals throughout the mixed HB-101 and placebo teams confirmed negative effects associated to vaccine administration. Three circumstances of human leukocyte antigen (HLA)-sensitization have been reported, two as severe hostile occasions. HLA-sensitization may cause the recipient to establish the donor kidney as international and should require a brand new donor to be recognized. HLA-sensitization is a recognized complication of dialysis sufferers ready for kidney transplantation, affecting an estimated 4% of this affected person population2.
“CMV is a key menace to the well being and general prognosis of kidney transplant recipients,” mentioned Paul Griffiths, MD DSc FRCPath, Professor of Virology, Institute of Immunity & Transplantation at College School London. “Whereas antivirals are an necessary device, we want higher interventions to cut back the chance of CMV illness on this susceptible inhabitants. These preliminary information spotlight the potential for a brand new commonplace of care within the administration of kidney transplant recipients.”
In regards to the trialThis double-blind Section 2 medical trial is designed to evaluate security, immunogenicity and efficacy in people receiving a kidney transplant from a dwell donor to measure the lower of post-transplant viremia within the absence and presence of antivirals. Amongst CMV-negative individuals, people are blinded and randomized 2:1 to obtain both HB-101 or placebo. Relying on the transplantation time schedule, individuals are vaccinated with both two or three doses previous to transplantation. Members obtain both pre-emptive or prophylactic antiviral remedy post-transplant and are adopted for a 12-month statement interval. Amongst CMV-positive individuals, people obtain both two or three doses of HB-101, pre-emptive or prophylactic antiviral remedy, and are adopted for a 12-month statement interval.
Convention nameHOOKIPA will host a convention name and dwell audio webcast right this moment at 8:30am EST to debate the CMV information. To entry the convention name, please dial +1 877 870 9135 (from the US) or +44 2071 928338 (worldwide) and check with convention ID 4469307. The webcast and the presentation can be obtainable inside the Traders & Media part of HOOKIPA’s web site at https://ir.hookipapharma.com/occasions. An archived replay can be accessible for 30 days following the occasion.
About CytomegalovirusCytomegalovirus, or CMV, is a kind of herpesvirus that infects nearly all of individuals over the course of their lifetime. The U.S. Facilities for Illness Management and Prevention estimates that greater than half of adults have been contaminated with CMV by age 40.three Nearly all of CMV infections should not severe, and the virus can lay dormant within the physique for years. Nevertheless, CMV an infection poses a substantial threat to infants in utero, in addition to immune-compromised people, akin to stable organ transplant recipients. There are presently greater than 90,000 individuals on the kidney transplant ready record in america.4
CMV is likely one of the commonest issues affecting stable organ transplant recipients.5 Regardless of energetic monitoring and antiviral remedy, CMV an infection happens in 20-70 p.c of transplant recipients the primary 12 months after transplant.6 Inside this inhabitants, CMV illness mostly causes fever, low white blood cell depend (leukopenia), low platelet ranges (thrombocytopenia) and elevated liver operate. It can also trigger extra severe situations like hepatitis and pneumonia, which regularly require hospitalization, in addition to enhance the chance of transplant rejection and graft-versus-host illness.7About HOOKIPAHOOKIPA Pharma Inc. (NASDAQ: HOOK) is a medical stage biopharmaceutical firm creating a brand new class of immunotherapeutics based mostly on its proprietary arenavirus platform that reprograms the physique’s immune system. HOOKIPA’s proprietary arenavirus-based applied sciences, non-replicating (VaxWave®) and replicating (TheraT®), induce sturdy antigen-specific CD8+ T cells and pathogen-neutralizing antibodies. HOOKIPA’s viral vectors goal antigen presenting cells in vivo to activate the immune system. Each applied sciences allow repeat administration to reinforce and refresh immune responses. As a monotherapy, our replicating arenavirus expertise has the potential to induce CD8+ T cell response ranges beforehand not achieved by different immuno-therapy approaches.
HOOKIPA’s non-replicating prophylactic cytomegalovirus (CMV) vaccine candidate is presently in a Section 2 medical trial for sufferers awaiting kidney transplantation. To increase its infectious illness portfolio, HOOKIPA entered right into a collaboration and licensing settlement with Gilead Sciences, Inc. to analysis arenavirus-based useful cures for HIV and persistent Hepatitis B infections.
As well as, HOOKIPA is constructing a proprietary immuno-oncology pipeline by concentrating on virally mediated most cancers antigens, self-antigens and next-generation antigens. The lead replicating arenavirus oncology product candidates, HB-201 and HB-202, are in growth for the remedy of Human Papilloma Virus 16-positive cancers in a Section 1/2 medical trial.