HOOK HOOKIPA Pharma Inc.
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
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HB-201 and HB-202 (alone and double)
Treatment-refractory HPV16+ cancers
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Phase 1/2
Phase 1/2
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Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
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HB-101
Cytomegalovirus (CMV)
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Phase 2
Phase 2
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Phase 2 preliminary efficacy and updated safety and immunogenicity data released November 30, 2020. 48% reduction in CMV viremia.
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Latest News
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- Early interim data show Cytomegalovirus (CMV)-negative kidney transplant recipients vaccinated with three doses of HB-101 had reduced incidence of CMV viremia, reduced antiviral use and no CMV disease
- Observed CMV-neutralizing antibody responses and tolerability profile are consistent with previous interim results
- CMV can cause severe complications in kidney transplant recipients including organ rejection and death
NEW YORK and VIENNA, Austria, Nov. 30, 2020 (GLOBE NEWSWIRE) -- HOOKIPA Pharma Inc. (NASDAQ:HOOK, ‘HOOKIPA'))), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, today announced positive interim efficacy results, as well as additional safety and immunogenicity data, for its prophylactic Cytomegalovirus (CMV) vaccine candidate HB-101. HB-101, a non-replicating arenavirus vaccine, is being investigated in a double-blind Phase 2 clinical trial (NCT03629080) to assess safety, immunogenicity and efficacy in individuals receiving a kidney transplant from a living donor. HOOKIPA will host a conference call and live audio webcast today at 8:30am EST.
CMV infection is one of the most common complications affecting solid organ transplant recipients and can result in serious conditions like hepatitis and pneumonia, as well as increase the likelihood of transplant rejection and graft-versus-host disease. Antiviral therapies are used to help control disease, but they are limited by toxicity and the emergence of viral resistance.1
The interim efficacy analysis includes data from 41 participants as of the cut-off date; 8 were vaccinated with three doses of HB-101 pre-transplant, 19 were vaccinated with two doses and 14 received placebo.
Compared to placebo, participants vaccinated with three HB-101 doses had:
- a 48 percent reduction in CMV viremia (presence of CMV DNA in the blood);
- a 42 percent reduction in the use of antiviral therapy; and
- no CMV disease (compared to 2 out of 14 cases in the placebo group)
Response to a two-dose schedule did not show an improvement compared to placebo, which is consistent with the low levels of CMV-neutralizing antibody in the two-dose group as well as with the T cell data reported in June 2020 for the two-dose group.
"While these interim data are from a small group of patients, they offer early insight into the potential of a three-dose schedule of HB-101 to help protect kidney transplant recipients against CMV disease," said Joern Aldag, Chief Executive Officer of HOOKIPA. "If these trends continue, HB-101 may be a promising first-in-class vaccine candidate to help address an unmet need in this vulnerable patient population. We are excited to explore a path to a Phase 3 CMV vaccine program, as well as to see how these early efficacy signals with our non-replicating arenavirus technology may translate to our replicating technology in oncology."
The interim immunogenicity analysis also included CMV-neutralizing antibody data assessed from 33 individuals, a subset of the 41 included in the efficacy analysis. 21 participants were vaccinated with HB-101 and 12 received placebo. In line with previous interim data, 100 percent of the participants who received three doses of HB-101 mounted CMV-neutralizing antibodies.
Safety and tolerability were evaluated in 69 participants who were enrolled in the trial by the cut-off date. HB-101 was generally well tolerated with a low incidence of side effects, which were mostly mild to moderate. Specifically, 17 percent of participants across the combined HB-101 and placebo groups showed side effects related to vaccine administration. Three cases of human leukocyte antigen (HLA)-sensitization have been reported, two as serious adverse events. HLA-sensitization can cause the recipient to identify the donor kidney as foreign and may require a new donor to be identified. HLA-sensitization is a known complication of dialysis patients waiting for kidney transplantation, affecting an estimated 4% of this patient population2.
"CMV is a key threat to the health and overall prognosis of kidney transplant recipients," said Paul Griffiths, MD DSc FRCPath, Professor of Virology, Institute of Immunity & Transplantation at University College London. "While antivirals are an important tool, we need better interventions to reduce the risk of CMV disease in this vulnerable population. These preliminary data highlight the potential for a new standard of care in the management of kidney transplant recipients."
About the trial
This double-blind Phase 2 clinical trial is designed to assess safety, immunogenicity and efficacy in individuals receiving a kidney transplant from a live donor to measure the decrease of post-transplant viremia in the absence and presence of antivirals. Among CMV-negative participants, individuals are blinded and randomized 2:1 to receive either HB-101 or placebo. Depending on the transplantation time schedule, participants are vaccinated with either two or three doses prior to transplantation. Participants receive either pre-emptive or prophylactic antiviral therapy post-transplant and are followed for a 12-month observation period. Among CMV-positive participants, individuals receive either two or three doses of HB-101, pre-emptive or prophylactic antiviral therapy, and are followed for a 12-month observation period.Conference call
HOOKIPA will host a conference call and live audio webcast today at 8:30am EST to discuss the CMV data. To access the conference call, please dial +1 877 870 9135 (from the US) or +44 2071 928338 (international) and refer to conference ID 4469307. The webcast and the presentation will be available within the Investors & Media section of HOOKIPA's website at https://ir.hookipapharma.com/events. An archived replay will be accessible for 30 days following the event.About Cytomegalovirus
Cytomegalovirus, or CMV, is a type of herpesvirus that infects the majority of people over the course of their lifetime. The U.S. Centers for Disease Control and Prevention estimates that more than half of adults have been infected with CMV by age 40.3 The majority of CMV infections are not serious, and the virus can lay dormant in the body for years. However, CMV infection poses a considerable risk to infants in utero, as well as immune-compromised individuals, such as solid organ transplant recipients. There are currently more than 90,000 people on the kidney transplant waiting list in the United States.4CMV is one of the most common complications affecting solid organ transplant recipients.5 Despite active monitoring and antiviral therapy, CMV infection occurs in 20-70 percent of transplant recipients the first year after transplant.6 Within this population, CMV disease most commonly causes fever, low white blood cell count (leukopenia), low platelet levels (thrombocytopenia) and elevated liver function. It also can cause more serious conditions like hepatitis and pneumonia, which often require hospitalization, as well as increase the likelihood of transplant rejection and graft-versus-host disease.7
About HOOKIPA
HOOKIPA Pharma Inc. (NASDAQ:HOOK) is a clinical stage biopharmaceutical company developing a new class of immunotherapeutics based on its proprietary arenavirus platform that reprograms the body's immune system. HOOKIPA's proprietary arenavirus-based technologies, non-replicating (VaxWave®) and replicating (TheraT®), induce robust antigen-specific CD8+ T cells and pathogen-neutralizing antibodies. HOOKIPA's viral vectors target antigen presenting cells in vivo to activate the immune system. Both technologies enable repeat administration to augment and refresh immune responses. As a monotherapy, our replicating arenavirus technology has the potential to induce CD8+ T cell response levels previously not achieved by other immuno-therapy approaches.HOOKIPA's non-replicating prophylactic cytomegalovirus (CMV) vaccine candidate is currently in a Phase 2 clinical trial for patients awaiting kidney transplantation. To expand its infectious disease portfolio, HOOKIPA entered into a collaboration and licensing agreement with Gilead Sciences, Inc. to research arenavirus-based 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 lead replicating arenavirus oncology product candidates, HB-201 and HB-202, are in development for the treatment of Human Papilloma Virus 16-positive cancers in a Phase 1/2 clinical trial.
Find out more about HOOKIPA online at www.hookipapharma.com._____________________________________________________
1 Gilbert C and Boivin G. Human Cytomegalovirus Resistance to Antiviral Drugs. Antimicrobial Agents and Chemotherapy. 2005; 49(3):873-883. Available at: https://aac.asm.org/content/aac/49/3/873.full.pdf
2 Nephrol Dial Transplant (2013) 28: 2908–2918
3 Centers for Disease Control and Prevention. About Cytomegalovirus (CMV). Available at: https://www.cdc.gov/cmv/overview.html
4 Organ Procurement and Transplantation Network. Kidney transplant waiting list. Available at: https://optn.transplant.hrsa.gov/data/
5 Kotton CN et al. The Third International Consensus Guidelines on Management of Cytomegalovirus in Solid-organ Transplantation. Transplantation. 2019; 102: 900-931. Available at: https://journals.lww.com/transplantjournal/Fulltext/2018/06000/The_Third_International_Consensus_Guidelines_on.13.aspx
6 Cui X, CM Snapper. "Development of novel vaccines against human cytomegalovirus." Human Vaccines & Immunotherapeutics. 2019, vol 15, no 11, 2673-2683. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6930071/pdf/khvi-15-11-1593729.pdf
7 Kotton CN et al. The Third International Consensus Guidelines on Management of Cytomegalovirus in Solid-organ Transplantation. Transplantation. 2019; 102: 900-931. Available at: https://journals.lww.com/transplantjournal/Fulltext/2018/06000/The_Third_International_Consensus_Guidelines_on.13.aspxHOOKIPA 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 September 30, 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 [email protected] [email protected] Media enquiries Instinctif Partners [email protected] +44 (0)20 7457 2020 
- Early interim data show Cytomegalovirus (CMV)-negative kidney transplant recipients vaccinated with three doses of HB-101 had reduced incidence of CMV viremia, reduced antiviral use and no CMV disease
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NEW YORK and VIENNA, Austria, Nov. 12, 2020 (GLOBE NEWSWIRE) -- HOOKIPA Pharma Inc. (NASDAQ:HOOK, ‘HOOKIPA'))), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, today reports its financial results for the third quarter ended September 30, 2020 and provides a corporate update.
"The third quarter saw continued advancement and validation of our clinical development programs, with a focus on our oncology pipeline of replicating arenavirus-based therapeutic candidates," commented Joern Aldag, Chief Executive Officer of HOOKIPA. "We continue to gain momentum as we expanded our ongoing Phase 1/2 HPV trial to explore HB-202/HB-201 as an alternating vector therapy with the first patient dosed with HB-202. We are also pleased that preclinical immunogenicity data from HB-201, our lead oncology candidate, was recognized in OncoImmunology, further demonstrating the potential of our arenavirus-based therapies to combat cancer. Additionally, I am proud that Professor Jean-Charles Soria, a globally recognized scientist and oncologist, who is General Director of Gustave Roussy, the leading European Cancer Center, joined our Board of Directors. His expertise will enhance our efforts as we seek to advance new, much needed cancer therapies."
R&D Pipeline Update and Clinical Progress
HB-101, lead product candidate in infectious diseases
HOOKIPA's prophylactic Cytomegalovirus (CMV) vaccine candidate, HB‑101, is in a randomized, double‑blinded Phase 2 clinical trial in patients awaiting kidney transplantation who are at risk for CMV-associated complications post-transplant. In June 2020, HOOKIPA announced positive Phase 2 interim data on the trial's primary endpoints: safety, and B cell and T cell immunogenicity. The interim data demonstrated that HB‑101 was well tolerated, with a lower rate of adverse events in patients with end-stage kidney disease than in the Phase 1 healthy volunteer trial. Patients who received the sponsor recommended three doses of HB‑101 showed comparable immunogenicity levels to those measured in the Phase 1 healthy volunteer trial. HOOKIPA continues to accrue patients and plans to report preliminary efficacy and updated safety and immunogenicity data by the end of 2020.HB-201 and HB-202, lead programs in immuno-oncology treating Human Papillomavirus-positive cancers
HOOKIPA's lead oncology product candidates, HB‑201 and HB‑202, are in development for the treatment of Human Papillomavirus 16‑positive (HPV16+) cancers. In December 2019, HOOKIPA initiated the Phase 1/2 clinical trial with endpoints of safety, immunogenicity and efficacy. The open label, dose escalating Phase 1/2 clinical trial in HPV16+ cancers is currently evaluating HB-201 alone and subsequently in combination with an approved checkpoint inhibitor. Accrual of patients for the first and the second dose levels at a three-week dosing frequency has been completed without safety concerns. Additional dose schedules and levels are being investigated to identify the recommended Phase 2 dose. HOOKIPA expects to report preliminary safety and efficacy data in late 2020 or early 2021.A peer reviewed article in OncoImmunology issued in September 2020 recognized that HB-201 preclinical results demonstrated high immunogenicity. The paper verified that systemically administered HB-201 leads to dose-dependent induction of a robust, systemic cytotoxic T cell response directed against HPV16 proteins, tumor infiltration of HPV16 specific cytotoxic T cells, as well as significantly delayed tumor growth or complete tumor clearance accompanied with prolonged survival.
In October 2020, HOOKIPA announced the dosing of the first patient with HB-202. HB-202 is part of a sequential alternating vector regimen of HB-202/HB-201 for the treatment of HPV16+ cancers in the ongoing HB-201 Phase 1/2 trial. In pre-clinical studies, alternating administration of HB-202 and HB-201 resulted in a ten-fold increase in immune response and better disease control than either compound alone. The Company expects to provide interim safety, dose escalation, and efficacy data on the HB-202/HB-201 arm of the ongoing Phase 1/2 study in mid-2021.
Strategic Collaborations
Gilead Sciences Collaboration for HIV and HBV Therapeutic Vaccines
Since the start of the collaboration in 2018, HOOKIPA has received $21.0 million in upfront and milestone payments from Gilead for the delivery of research vectors and for advancing the programs towards clinical trials, including a milestone payment of $4.0 million, which the Company received in early 2020. Based on preclinical data generated to date, Gilead committed to advancing the HBV and HIV vectors toward development. To enable the development activities and expanded research programs, Gilead agreed to reserve manufacturing capacity and increase reimbursement planned for the Company's expanded resources allocated to the Gilead collaboration.Others
In October 2020, Professor Jean-Charles Soria, M.D., Ph.D., was appointed to HOOKIPA's Board of Directors. Jean-Charles Soria is Professor of Medicine and Medical Oncology at the University of Paris-Saclay and currently serves as General Director of the Gustave Roussy Cancer Center, one of the world's leading cancer research institutes.COVID-19
HOOKIPA continues to monitor the COVID-19 pandemic closely and adapt to COVID-19 measures and recommendations issued by the U.S. and Austrian governments. For disclosures of risks and uncertainties resulting from the COVID-19 disease outbreak, including the impact on the enrollment of patients and timing of clinical results, see HOOKIPA's quarterly reports on Form 10-Q for the quarters ended June 30, 2020 and September 30, 2020.Third Quarter 2020 Financial Results
Cash Position:
HOOKIPA's cash, cash equivalents and restricted cash as of September 30, 2020 was $82.3 million compared to $113.6 million as of December 31, 2019. The decrease was primarily attributable to cash used in operating activities.
Revenue was $4.0 million for the three months ended September 30, 2020 compared to $2.0 million for the three months ended September 30, 2019. The increase was primarily due to higher cost reimbursements received under the collaboration agreement with Gilead following the expansion of the collaboration in the first half of 2020 and the partial recognition of a milestone payment we received from Gilead in February 2020.
Research and Development Expenses:
HOOKIPA's research and development expenses were $16.0 million for the three months ended September 30, 2020 compared to $11.0 million for the three months ended September 30, 2019. The primary drivers of the increase compared to 2019 were an increase in clinical trial expenses of $2.7 million and an increase in internal research and development expenses of $2.3 million.General and Administrative Expenses:
General and administrative expenses amounted to $4.4 million for the three months ended September 30, 2020 compared to $4.6 million for the three months ended September 30, 2019. The decrease was primarily due to a decrease in personnel-related expenses of $0.1 million, a decrease in professional and consulting fees of $0.5 million, partially offset by an increase of other general and administrative expenses of $0.4 million.
Net Loss:
HOOKIPA's net loss was $13.6 million for the three months ended September 30, 2020 compared to a net loss of $11.4 million for the three months ended September 30, 2019.
About HOOKIPA
HOOKIPA Pharma Inc. (NASDAQ:HOOK) is a clinical stage biopharmaceutical company developing a new class of immunotherapeutics based on its proprietary arenavirus platform that reprograms the body's immune system.
HOOKIPA's proprietary arenavirus-based technologies, non-replicating (VaxWave®) and replicating (TheraT®), induce robust antigen-specific CD8+ T cells and pathogen-neutralizing antibodies. HOOKIPA's viral vectors target antigen presenting cells in vivo to activate the immune system. Both technologies enable repeat administration to augment and refresh immune responses. As a monotherapy, our replicating arenavirus technology has the potential to induce CD8+ T cell response levels previously not achieved by other immuno-therapy approaches.
HOOKIPA's non-replicating prophylactic Cytomegalovirus (CMV) vaccine candidate is currently in a Phase 2 clinical trial for patients awaiting kidney transplantation. To expand its infectious disease portfolio, HOOKIPA entered into a collaboration and licensing agreement with Gilead Sciences, Inc. to research arenavirus-based 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 lead replicating arenavirus oncology product candidates, HB-201 and HB-202, are in development for the treatment of Human Papilloma Virus 16-positive cancers in a Phase 1/2 clinical trial.
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 September 30, 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.
HOOKIPA Pharma Inc.
Consolidated Statements of Operations (Unaudited)
(In thousands, except share and per share data)Three months ended September 30, Nine months ended September 30, 2020 2019 2020 2019 Revenue from collaboration and licensing $ 4,040 $ 2,038 $ 14,421 $ 8,324 Operating expenses: Research and development (16,009 ) (11,025 ) (39,099 ) (35,133 ) General and administrative (4,437 ) (4,589 ) (13,413 ) (11,051 ) Total operating expenses (20,446 ) (15,614 ) (52,512 ) (46,184 ) Loss from operations (16,406 ) (13,576 ) (38,091 ) (37,860 ) Total interest, other income and taxes, net 2,817 2,191 6,483 5,067 Net loss $ (13,589 ) $ (11,385 ) $ (31,608 ) $ (32,793 ) Net loss per share — basic and diluted (0.53 ) (0.45 ) (1.23 ) (2.14 ) Weighted average common shares outstanding — basic and diluted 25,659,504 25,408,488 25,645,827 15,308,071 Condensed Balance Sheets (Unaudited)
(In thousands)As of As of September 30, December 31, 2020 2019 Cash, cash equivalents and restricted cash $ 82,259 $ 113,575 Total assets 121,272 143,745 Total liabilities 29,092 25,846 Total stockholders' equity 92,180 117,899 For further information, please contact: Media Investors Nina Waibel Matt Beck Senior Director - Communications Executive Director - Investor Relations [email protected] [email protected] Media enquiries Instinctif Partners [email protected] +44 (0)20 7457 2020 -
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NEW YORK and VIENNA, Austria, Nov. 11, 2020 (GLOBE NEWSWIRE) -- HOOKIPA Pharma Inc. (NASDAQ:HOOK, ‘HOOKIPA'))), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, today announced that HOOKIPA's management team will participate in two upcoming virtual investor conferences:
- The SVB Leerink Oncology 1x1 Day, November 19, 2020
- The Piper Sandler 32nd Annual Virtual Healthcare Conference, November 30 – December 3, 2020
HOOKIPA will participate in virtual one-on-one meetings during these events.
About HOOKIPA
HOOKIPA Pharma Inc. (NASDAQ:HOOK) is a clinical stage biopharmaceutical company developing a new class of immunotherapeutics based on its proprietary arenavirus platform that reprograms the body's immune system.HOOKIPA's proprietary arenavirus-based technologies, non-replicating (VaxWave®) and replicating (TheraT®), induce robust antigen-specific CD8+ T cells and pathogen-neutralizing antibodies. HOOKIPA's viral vectors target antigen presenting cells in vivo to activate the immune system. Both technologies enable repeat administration to augment and refresh immune responses. As a monotherapy, our replicating arenavirus technology has the potential to induce CD8+ T cell response levels previously not achieved by other immuno-therapy approaches.
HOOKIPA's non-replicating prophylactic Cytomegalovirus (CMV) vaccine candidate is currently in a Phase 2 clinical trial for patients awaiting kidney transplantation. To expand its infectious disease portfolio, HOOKIPA entered into a collaboration and licensing agreement with Gilead Sciences, Inc. to research arenavirus-based 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 lead replicating arenavirus oncology product candidates, HB-201 and HB-202, are in development for the treatment of Human Papilloma Virus 16-positive cancers in a Phase 1/2 clinical trial.
Find out more about HOOKIPA online at www.hookipapharma.com.
For further information, please contact:
Media Investors Nina Waibel Matt Beck Senior Director - Communications Executive Director - Investor Relations [email protected] [email protected] -
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NEW YORK and VIENNA, Austria, Nov. 03, 2020 (GLOBE NEWSWIRE) -- HOOKIPA Pharma Inc. (NASDAQ:HOOK, ‘HOOKIPA'))), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, today announced that it will release financial results for the third quarter ended September 30, 2020 before the market opens on Thursday, November 12, 2020.
The Company will not be conducting a conference call in conjunction with this earnings release. Until otherwise noted, the Company will only conduct an earnings conference call in conjunction with its fourth quarter earnings releases.
About HOOKIPA
HOOKIPA Pharma Inc. (NASDAQ:HOOK) is a clinical stage biopharmaceutical company developing a new class of immunotherapeutics based on its proprietary arenavirus platform that reprograms the body's immune system.HOOKIPA's proprietary arenavirus-based technologies, non-replicating (VaxWave®) and replicating (TheraT®), induce robust antigen-specific CD8+ T cells and pathogen-neutralizing antibodies. HOOKIPA's viral vectors target antigen presenting cells in vivo to activate the immune system. Both technologies enable repeat administration to augment and refresh immune responses. As a monotherapy, our replicating arenavirus technology has the potential to induce CD8+ T cell response levels previously not achieved by other immuno-therapy approaches.
HOOKIPA's non-replicating prophylactic Cytomegalovirus (CMV) vaccine candidate is currently in a Phase 2 clinical trial for patients awaiting kidney transplantation. To expand its infectious disease portfolio, HOOKIPA entered into a collaboration and licensing agreement with Gilead Sciences, Inc. to research arenavirus-based 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 lead replicating arenavirus oncology product candidates, HB-201 and HB-202, are in development for the treatment of Human Papilloma Virus 16-positive cancers in a Phase 1/2 clinical trial.
Find out more about HOOKIPA online at www.hookipapharma.com.
Media Investors Nina Waibel Matt Beck Senior Director - Communications Executive Director - Investor Relations [email protected] [email protected] Media enquiries Instinctif Partners [email protected] +44 (0)20 7457 2020 -
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- HB-202/HB-201 alternating two-vector therapy is added as an additional arm that expands the ongoing HB-201 clinical trial
- Pre-clinical data show that adding an additional arenaviral vector to achieve alternating two-vector therapy enhances immune response
NEW YORK and VIENNA, Austria, Oct. 29, 2020 (GLOBE NEWSWIRE) -- HOOKIPA Pharma Inc. (NASDAQ:HOOK), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, today announced the first patient dosed with HB-202, a replicating arenavirus therapy based on the Pichinde Virus (PICV). HB-202 is part of a sequential alternating regimen of HB-202/HB-201 for the treatment of Human Papillomavirus 16-positive (HPV16+) cancers in the ongoing HB-201 Phase 1/2 trial (NCT04180215).
"We are excited to expand our ongoing Phase 1/2 trial in HPV to explore the potential of combining HB-202 and HB-201 as an alternating two-vector therapy to enhance and focus the immune response against HPV16+ cancers," said Joern Aldag, Chief Executive Officer of HOOKIPA. "HPV-associated cancers remain an area of unmet need and a key focus for our oncology efforts. The start of this HB-202/HB-201 arm of our trial is an important achievement in our clinical development of improved therapeutics for people with HPV16+ cancers."
HB-202 and HB-201 are engineered using HOOKIPA's replicating arenaviral vector platform. They are designed to use different arenavirus backbones (PICV for HB-202 and LCMV for HB- 201), while expressing the same antigen, an E7/E6 fusion protein derived from HPV16. In pre-clinical studies, alternating administration of HB-202 and HB-201 resulted in a ten-fold increase in immune response and better disease control than either compound alone.
The alternating, sequential HB-202/HB-201 two-vector therapy has been incorporated into the ongoing Phase 1/2 trial (NCT04180215). As such, the first patient dosed in the alternating HB-202/HB-201 arm received Dose Level 1 of HB-202 and is scheduled to receive Dose Level 2 of HB-201. This Phase 1/2 clinical trial is an open-label dose-escalation and dose-expansion trial in patients with treatment-refractory HPV16+ cancers. In addition to the newly added HB-202/HB-201 therapy option, patients will continue to be enrolled into the HB-201 dose groups.
The primary endpoint of the Phase 1 is a recommended Phase 2 dose based on safety and tolerability. Secondary endpoints include anti-tumor activity as defined by RECIST 1.1 and immunogenicity. Patients will receive HB-202/HB-201 via intravenous dosing or, for patients with an accessible lesion, the first dose of HB-201 will be delivered via intratumoral injection and the remaining doses of HB-202 and HB-201 will be administered intravenously.
The Phase 2 portion of the trial will investigate the efficacy of our arenaviral regimens alone and also in combination with a PD-1 inhibitor. While HOOKIPA intends to release preliminary data for the HB-201 arm of the trial in late 2020 or early 2021, the Company expects to provide interim safety, dose escalation, and efficacy data on the HB-202/HB-201 arm in mid-2021.
About Human Papillomavirus
Human Papillomavirus, or HPV, is estimated to cause about 5% of the worldwide burden of cancers. This includes approximately 99% of cases in cervical, up to 60% of head and neck, 70% of vaginal, and 88% of anal cancers.The majority of these cancers are caused by the HPV serotype 16. Most infections with HPV are cleared from the body with no lasting consequences. However, in some cases, HPV DNA becomes integrated into chromosomal DNA. When host cells take up this DNA, they express the HPV E6 and E7 proteins. This uptake can potentially lead to cancer since expression of these proteins leads to alterations in cell cycle control, which in turn predisposes these cells to become cancerous.
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 reprograms the body's immune system.HOOKIPA's proprietary arenavirus-based technologies, non-replicating (VaxWave®) and replicating (TheraT®), induce robust antigen-specific CD8+ T cells and pathogen-neutralizing antibodies. HOOKIPA's viral vectors target antigen presenting cells in vivo to activate the immune system. Both technologies enable repeat administration to augment and refresh immune responses. As a monotherapy, our replicating arenavirus technology has the potential to induce CD8+ T cell response levels previously not achieved by other immuno-therapy approaches.
HOOKIPA's non-replicating prophylactic Cytomegalovirus (CMV) vaccine candidate is currently in a Phase 2 clinical trial for patients awaiting kidney transplantation. To expand its infectious disease portfolio, HOOKIPA entered into a collaboration and licensing agreement with Gilead Sciences, Inc. to research arenavirus-based 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 lead replicating arenavirus oncology product candidates, HB-201 and HB-202, are in development for the treatment of Human Papilloma Virus 16-positive cancers in a Phase 1/2 clinical trial.
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 June 30, 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 [email protected] [email protected] Media enquiries Instinctif Partners [email protected] +44 (0)20 7457 2020