HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing
a new class of immunotherapeutics targeting infectious diseases and
cancers based on its proprietary arenavirus platform, today
announced positive interim results on its prophylactic
Cytomegalovirus (CMV) vaccine candidate HB‑101. HB‑101 is being
investigated in a double-blind Phase 2 clinical trial (NCT03629080)
to assess safety, immunogenicity and efficacy in patients receiving
a kidney transplant from a live donor. HOOKIPA reported interim
data on the trial’s primary endpoints, safety and B cell and T cell
immunogenicity.
Trial participants were blinded and randomized
2:1 to receive either HB‑101 or placebo. Patients received either 2
or 3 doses prior to transplantation, depending on the
transplantation time schedule.
Tolerability profile of
HB‑101Safety and tolerability were evaluated in 51
CMV-negative patients prior to kidney transplantation. Of the 51
patients, only eight patients (16%) across the combined, blinded
HB-101 and placebo groups showed adverse events related to the
administration. Most of these adverse events were of mild
intensity, indicating that HB‑101 is generally well tolerated in
this patient population. Of note, this target patient population
reported fewer adverse events than the 54 healthy volunteers in
HOOKIPA’s recently published Phase 1 trial results1.
CMV-neutralizing antibody response to
HB‑101For the interim analysis, CMV-neutralizing antibody
titers on the day of transplantation were evaluated in all of the
30 CMV-negative patients who had been transplanted by the cutoff
date and had valid results. Nineteen of the 30 patients received
HB-101 and eleven received placebo. All five patients (100%) who
received three doses of HB‑101 mounted CMV-neutralizing antibodies.
Three of the fourteen patients (21%) who received only two doses of
HB‑101 also mounted CMV-neutralizing antibodies. The antibody
response of the kidney transplant recipients who completed the
three-dose regimen was comparable to the antibody response observed
in the Phase 1 trial.
T cell responses to
HB-101Cellular immune responses to CMV on the day of
transplantation were evaluated in 25 CMV-negative patients who had
been transplanted in time for this interim analysis. Technically
valid results from T cell assays on the day of transplantation were
available for seven recipients (as a consequence of sample
logistics and assay performance). Two of the seven patients
received placebo and five received HB‑101. All three patients
(100%) who received three doses of HB‑101 and one of the two
patients who received only two doses (50%) mounted a CMV-specific
cellular immune response.
Conclusions: The interim data
demonstrate that HB‑101 is well tolerated with fewer adverse events
in patients with end-stage kidney disease than in the previous
healthy volunteer trial. Patients who received three doses of
HB‑101 show comparable immunogenicity to healthy volunteers in
HOOKIPA’s Phase 1 clinical trial of HB‑101.
“The interim results demonstrate that the
vaccine is well-tolerated and immunogenic in patients with
end-stage kidney disease,” said Joern Aldag, CEO. “We are excited
that we are seeing strong antibody and T cell responses, in
particular in patients who received three administrations. We
continue patient accrual and plan to report preliminary efficacy
data and updated safety and immunogenicity data by the end of
2020.”
About
Cytomegalovirus
Cytomegalovirus, or CMV, is a virus that is
commonly transmitted in childhood and early adulthood.
Approximately 60% of the U.S. population has been exposed and is
latently infected. Worldwide data indicate that half the people in
industrialized countries and up to 99% of people in developing
countries, including China and India, have been infected.
Infections typically result in lifelong latent persistence of the
virus with few symptoms, if any. However, in unborn children, when
infected in utero, CMV infection can lead to significant morbidity
and mortality. In addition, in immunosuppressed patients, such as
transplant recipients, primary CMV infection or reactivation of CMV
causes significant morbidity, mortality and graft rejection.
About
HOOKIPA
HOOKIPA Pharma Inc. (NASDAQ: HOOK) is a clinical
stage biopharmaceutical company developing a new class of
immunotherapeutics targeting infectious diseases and cancers based
on its proprietary arenavirus platform that is designed to
reprogram the body’s immune system.
HOOKIPA’s proprietary arenavirus-based
technologies, VaxWave®, a replication-deficient viral vector, and
TheraT®, a replication-attenuated viral vector, are designed to
induce robust antigen specific CD8+ T cells and
pathogen-neutralizing antibodies. Both technologies are designed to
allow for repeat administration to augment and refresh immune
responses. TheraT® has the potential to induce CD8+ T cell response
levels previously not achieved by other immuno-therapy approaches.
HOOKIPA’s “off-the-shelf” viral vectors target dendritic cells in
vivo to activate the immune system.
HOOKIPA’s VaxWave®-based prophylactic
Cytomegalovirus (CMV) vaccine candidate is currently in a Phase 2
clinical trial in CMV-negative patients awaiting kidney
transplantation from living CMV-positive donors as well as
CMV-positive patients awaiting kidney transplantation from
CMV-positive or -negative donors. To expand its infectious disease
portfolio, HOOKIPA has entered into a collaboration and licensing
agreement with Gilead Sciences, Inc. to jointly research and
develop functional cures for HIV and chronic Hepatitis B
infections.
In addition, HOOKIPA is building a proprietary
immuno-oncology pipeline by targeting virally mediated cancer
antigens, self-antigens and next-generation antigens. The TheraT®
based lead oncology product candidates, HB-201 and HB-202, are in
development for the treatment of Human Papilloma Virus 16-positive
cancers. The Phase 1/2 clinical trial for HB-201 was initiated in
December 2019. The HB-202 IND application was cleared by the FDA in
June 2020.
Find out more about HOOKIPA online at
www.hookipapharma.com.
HOOKIPA Forward Looking
Statements
Certain statements set forth in this press
release constitute “forward-looking” statements within the meaning
of the Private Securities Litigation Reform Act of 1995, as
amended. Forward-looking statements can be identified by terms such
as “believes,” “expects,” “plans,” “potential,” “would” or similar
expressions and the negative of those terms. Such forward-looking
statements involve substantial risks and uncertainties that could
cause HOOKIPA’s research and clinical development programs, future
results, performance or achievements to differ significantly from
those expressed or implied by the forward-looking statements. Such
risks and uncertainties include, among others, the uncertainties
inherent in the drug development process, including HOOKIPA’s
programs’ early stage of development, the process of designing and
conducting preclinical and clinical trials, the regulatory approval
processes, the timing of regulatory filings, the challenges
associated with manufacturing drug products, HOOKIPA’s ability to
successfully establish, protect and defend its intellectual
property, risks relating to business interruptions resulting from
the coronavirus (COVID-19) disease outbreak or similar public
health crises, the impact of COVID-19 on the enrollment of patients
and timing of clinical results for HB-101 and other programs, and
other matters that could affect the sufficiency of existing cash to
fund operations and HOOKIPA’s ability to achieve the milestones
under the agreement with Gilead. HOOKIPA undertakes no obligation
to update or revise any forward-looking statements. For a further
description of the risks and uncertainties that could cause actual
results to differ from those expressed in these forward-looking
statements, as well as risks relating to the business of the
company in general, see HOOKIPA’s quarterly report on Form 10-Q for
the quarter ended March 31, 2020 which is available on the Security
and Exchange Commission’s website at www.sec.gov and HOOKIPA’s
website at www.hookipapharma.com.
Investors and others should note that we
announce material financial information to our investors using our
investor relations website (https://ir.hookipapharma.com/), SEC
filings, press releases, public conference calls and webcasts. We
use these channels, as well as social media, to communicate with
our members and the public about our company, our services and
other issues. It is possible that the information we post on social
media could be deemed to be material information. Therefore, we
encourage investors, the media, and others interested in our
company to review the information we post on the U.S. social media
channels listed on our investor relations website.
For further information, please contact:
Media |
Investors |
Nina Waibel |
Matt Beck |
Senior Director - Communications |
Executive Director - Investor Relations |
nina.waibel@hookipapharma.com |
matthew.beck@hookipapharma.com |
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Media enquiries |
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Instinctif Partners |
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hookipa@instinctif.com |
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________________
1 Schwendinger M, et al. J Infect Dis. 2020. pii: jiaa121. doi:
10.1093/infdis/jiaa121
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