HOOK HOOKIPA Pharma Inc.

6.53
-0.23  -3%
Previous Close 6.76
Open 6.75
52 Week Low 6.01
52 Week High 20
Market Cap $195,196,479
Shares 29,892,721
Float 22,524,370
Enterprise Value $102,920,321
Volume 203,276
Av. Daily Volume 272,816
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Upcoming Catalysts

Drug Stage Catalyst Date
HB-200
HPV16+ Cancer
Phase 1
Phase 1
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HB-201 and HB-202
Treatment-refractory HPV16+ cancers
Phase 1/2
Phase 1/2
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HB-101
Cytomegalovirus (CMV)
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
HB-200 in combination with KEYTRUDA (pembrolizumab)
head and neck squamous cell carcinoma (HNSCC)
Phase 2
Phase 2
Phase 2 trial to commence in 2022.

Latest News

    • Clinical collaboration to assess HB-200 in combination with KEYTRUDA® (pembrolizumab) as first-line treatment

    • HOOKIPA poised to advance clinical development program with
      randomized Phase 2 study in 2022

    NEW YORK and VIENNA, Austria, Sept. 15, 2021 (GLOBE NEWSWIRE) -- HOOKIPA Pharma Inc. (NASDAQ:HOOK, ‘HOOKIPA'))), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, today announced it has entered into a clinical collaboration and supply agreement with Merck & Co., Inc., Kenilworth, NJ., USA (known as MSD outside of the United States and Canada) to evaluate the combination of HB-200, a novel arenaviral immunotherapeutic, and Merck & Co., Inc., Kenilworth, NJ., USA's anti-PD-1 therapy, KEYTRUDA®

    • Clinical collaboration to assess HB-200 in combination with KEYTRUDA® (pembrolizumab) as first-line treatment



    • HOOKIPA poised to advance clinical development program with

      randomized Phase 2 study in 2022

    NEW YORK and VIENNA, Austria, Sept. 15, 2021 (GLOBE NEWSWIRE) -- HOOKIPA Pharma Inc. (NASDAQ:HOOK, ‘HOOKIPA'))), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, today announced it has entered into a clinical collaboration and supply agreement with Merck & Co., Inc., Kenilworth, NJ., USA (known as MSD outside of the United States and Canada) to evaluate the combination of HB-200, a novel arenaviral immunotherapeutic, and Merck & Co., Inc., Kenilworth, NJ., USA's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) as first-line treatment for patients with advanced head and neck squamous cell carcinoma (HNSCC).

    "Our collaboration with Merck & Co., Inc., Kenilworth, NJ., USA, a proven immuno-oncology leader, is an important step as we advance our HB-200 program for the treatment of Human Papillomavirus 16-positive (HPV16+) cancers and seek to introduce a new class of immunotherapeutics," said Joern Aldag, Chief Executive Officer at HOOKIPA. "There remains considerable unmet treatment need for people with metastatic head and neck cancers, and we believe the combination of HB-200 and KEYTRUDA may offer hope. We have seen encouraging early responses in heavily pre-treated patients with the addition of KEYTRUDA in our ongoing HB-200 trial. We are excited to explore the potential benefit of HB-200 as a first-line treatment in combination with KEYTRUDA, a leading anti-PD-1 inhibitor globally, and the possibility of making a meaningful impact on patients' lives."

    The collaboration has been initiated based on promising data from the ongoing HB-200 Phase 1/2 clinical trial (NCT04180215) in advanced HPV16+ cancers. As reported at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, 15 patients with metastatic head and neck cancers were eligible for the efficacy analysis, as of data cut-off. HB-201 monotherapy showed an 18 percent overall response rate and median progression-free survival of 3.45 months in heavily pretreated head and neck cancer patients, better than current 2nd-line treatment. In addition, preliminary data on HB-201/HB-202 therapy showed a disease control rate of 100 percent (4/4 patients). Importantly, the Phase 1 data on 38 evaluable patients showed that HB-200 therapy has a favorable safety profile in heavily pre-treated patients with HPV16+ cancers, underlining its potential as a monotherapy and in possible combination with checkpoint inhibitors.

    With a HB-200 program data read-out anticipated by Q4 2021, HOOKIPA anticipates initiating a Phase 2 trial with HB-200 in combination with KEYTRUDA in 2022. Additional Phase 2 expansion cohorts are also planned to start in Q1 2022.

    KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.



    About HB-200

    HB-201 and HB-202 are HOOKIPA's lead oncology candidates engineered with the company's proprietary replicating arenaviral vector platform. Each single-vector compound uses a different arenavirus backbone (Lymphocytic choriomeningitis virus for HB-201 and Pichinde virus for HB-202), while expressing the same antigen, an E7E6 fusion protein derived from HPV16. In pre-clinical studies, alternating administration of HB-201 and HB-202 resulted in a ten-fold increase in immune response and better disease control than either compound alone. HB-201 is being tested clinically as a single vector therapy and also in an alternating vector combination with HB-202.

    About Human Papillomavirus

    Human Papillomavirus, or HPV, is estimated to cause about 5 percent of the worldwide burden of cancers. This includes approximately 99 percent of cases in cervical, up to 60 percent of head and neck, 70 percent of vaginal and 88 percent 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 focused on developing novel immunotherapies that mobilize and amplify targeted T cells and antibodies, the body's natural infection killers, to fight or prevent serious disease.

    HOOKIPA is developing a broad pipeline of potential first-in-class arenaviral immunotherapies in oncology and infectious disease. We are leveraging our proprietary, versatile platform to engineer arenaviral therapeutics that induce robust antigen-specific CD8+ T cells and pathogen-neutralizing antibodies to a broad range of self and non-self antigens, including viral antigens, tumor-associated antigens and neoantigens. Our immunotherapies are designed to use either non-replicating or replicating viral vectors based on the target disease, with the potential to induce CD8+ T cell response levels previously not achieved by other immunotherapy approaches.

    HOOKIPA's pipeline include ongoing clinical trials in Human Papilloma Virus 16-positive cancers and Cytomegalovirus, as well as preclinical research in prostate cancer, HIV and Hepatitis B. The latter two are in collaboration with Gilead Sciences, Inc.

    Find out more about HOOKIPA online at www.hookipapharma.com.

    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 annual report on Form 10-Q for the financial year ended June 30, 2021 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:

    MediaInvestors
    Astrid Van ErvenMatt Beck
    Senior Manager - CommunicationsExecutive Director - Investor Relations
    astrid.vanErven@hookipapharma.commatthew.beck@hookipapharma.com
      
    Media inquiries 
    Instinctif Partners 
    hookipa@instinctif.com 
    +44 (0)20 7457 2020 


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  1. NEW YORK and VIENNA, Austria, Sept. 07, 2021 (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 and present at the following upcoming virtual investor conferences:

    • Morgan Stanley 19th Annual Global Healthcare Conference, September 9 – 10 and 13 – 15, 2021
      Fireside Chat: September 10, 8:45am ET
    • H.C. Wainwright 23rd Annual Global Investment Conference, September 13 – 15, 2021
      Presentation: September 13, 7:00am ET
    • 2021 Cantor Virtual Global Healthcare Conference, September 27 – 30, 2021
      Presentation: September 28, 8:00-8:30am ET in Track 7

    Webcasts will be available within…

    NEW YORK and VIENNA, Austria, Sept. 07, 2021 (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 and present at the following upcoming virtual investor conferences:

    • Morgan Stanley 19th Annual Global Healthcare Conference, September 9 – 10 and 13 – 15, 2021

      Fireside Chat: September 10, 8:45am ET

    • H.C. Wainwright 23rd Annual Global Investment Conference, September 13 – 15, 2021

      Presentation: September 13, 7:00am ET
    • 2021 Cantor Virtual Global Healthcare Conference, September 27 – 30, 2021

      Presentation: September 28, 8:00-8:30am ET in Track 7

    Webcasts will be available within the Investors & Media section of HOOKIPA's website at https://ir.hookipapharma.com/events. Archived replays will be accessible for 30 days following each event.

    About HOOKIPA

    HOOKIPA Pharma Inc. (NASDAQ:HOOK) is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies that mobilize and amplify targeted T cells and antibodies, the body's natural infection killers, to fight or prevent serious disease.

    HOOKIPA is developing a broad pipeline of potential first-in-class arenaviral immunotherapies in oncology and infectious disease. We are leveraging our proprietary, versatile platform to engineer arenaviral therapeutics that induce robust antigen-specific CD8+ T cells and pathogen-neutralizing antibodies to a broad range of self and non-self antigens, including viral antigens, tumor-associated antigens and neoantigens. Our immunotherapies are designed to use either non-replicating or replicating viral vectors based on the target disease, with the potential to induce CD8+ T cell response levels previously not achieved by other immunotherapy approaches.

    HOOKIPA's pipeline includes ongoing clinical trials in Human Papilloma Virus 16-positive cancers and Cytomegalovirus, as well as preclinical research in prostate cancer, HIV and Hepatitis B. The latter two are in collaboration with Gilead Sciences, Inc.

    Find out more about HOOKIPA online at www.hookipapharma.com.

    For further information, please contact: 
      
    MediaInvestors
    Astrid van ErvenMatt Beck
    Senior Manager - CommunicationsExecutive Director - Investor Relations
    astrid.vanerven@hookipapharma.commatthew.beck@hookipapharma.com



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    • Phase 1 HB-200 data recognized at premier oncology meetings, highlighting potential of novel arenaviral platform to deliver a new class of immunotherapeutics

    • HOOKIPA on track to report comprehensive data from oncology and infectious disease programs in the second half of 2021

    NEW YORK and VIENNA, Austria, Aug. 12, 2021 (GLOBE NEWSWIRE) -- HOOKIPA Pharma Inc. (NASDAQ:HOOK, ‘HOOKIPA'))), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, today reported financial results and business highlights for the second quarter of 2021.

    "During the second quarter, we gained considerable momentum in highlighting the promise of our novel arenaviral platform to redefine success in cancer immunotherapy. Our…

    • Phase 1 HB-200 data recognized at premier oncology meetings, highlighting potential of novel arenaviral platform to deliver a new class of immunotherapeutics



    • HOOKIPA on track to report comprehensive data from oncology and infectious disease programs in the second half of 2021

    NEW YORK and VIENNA, Austria, Aug. 12, 2021 (GLOBE NEWSWIRE) -- HOOKIPA Pharma Inc. (NASDAQ:HOOK, ‘HOOKIPA'))), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, today reported financial results and business highlights for the second quarter of 2021.

    "During the second quarter, we gained considerable momentum in highlighting the promise of our novel arenaviral platform to redefine success in cancer immunotherapy. Our HB-200 program in advanced Human Papillomavirus 16-positive (‘HPV16+') cancers was featured prominently at both AACR and ASCO, with compelling tumor antigen-specific T cell responses and tumor control that replicate pre-clinical results," said Joern Aldag, Chief Executive Officer at HOOKIPA. "We are focused on advancing our oncology and infectious disease programs through the second half of the year, as we aim to deliver first-in-class arenaviral immunotherapies that induce potent, targeted immune responses to fight or prevent serious disease."

    Quarter Highlights

    • At the virtual American Association for Cancer Research (‘AACR') Annual Meeting in April 2021, HOOKIPA presented positive preliminary Phase 1 immunogenicity data for HB-200 for the treatment of advanced HPV16+ cancers. These data demonstrated a robust increase in HPV16+-specific T cells, including an increase of up to 8% of antigen-specific circulating CD8+ T cells, after one dose of HB-201 or HB-202. Early HB-201 monotherapy data also highlighted immune system activation of increasing interferon-gamma and other immune stimulatory cytokines with a single dose.



    • In June, HOOKIPA reported positive Phase 1 data from the ongoing Phase 1/2 study of HB-200 for the treatment of advanced HPV16+ cancers. The clinical data, presented as an oral presentation at the American Society of Clinical Oncology (‘ASCO') Annual Meeting, showed HB-200 is highly immunogenic, inducing unprecedented levels of activated, tumor antigen-specific CD8+ T cells (an average of 6 percent and up to 40 percent of the T cell pool). In addition, HB-201 monotherapy showed an 18 percent overall response rate and median progression-free survival of 3.45 months in heavily pre-treated head and neck cancer patients who progressed on standard of care, including checkpoint inhibitors.



    • HOOKIPA completed enrollment in the Phase 2 clinical trial of its prophylactic Cytomegalovirus (‘CMV'), vaccine candidate, HB-101; the last patient was enrolled in June 2021. We expect to report additional safety, immunogenicity, and efficacy data from evaluable patients in the second half of 2021, with final top-line data readout in the first half of 2023. The protocol requires a 12-month follow up after transplantation, which is typically two to three months after enrollment.



    • Jean-Charles Soria resigned as a Non-Executive Director of HOOKIPA's Board of Directors to avoid any conflicts of interest following a decision to join Amgen as senior vice president and lead of the oncology therapeutic area.

    Upcoming Milestones

    • Additional HB-201/HB-202 Phase 1/2 data in HPV16+ cancers and recommended Phase 2 dose for the HB-200 program in the fourth quarter of 2021
    • HB-101 CMV Phase 2 data in the second half of 2021
    • Advancing our HB-300 program to IND for the treatment of metastatic prostate cancer
    • HBV and HIV collaboration with Gilead Sciences advancing towards clinical studies

    Second Quarter 2021 Financial Results

    Cash Position: HOOKIPA's cash, cash equivalents and restricted cash as of June 30, 2021 was $102.9 million compared to $143.2 million as of December 31, 2020. The decrease was primarily attributable to cash used in operating activities.

    Revenue was $5.4 million for the three months ended June 30, 2021, and $6.7 million for the three months ended June 30, 2020. The decrease was primarily due to receipt of a $1.0 million milestone payment under the Gilead collaboration during this time period in 2020, but not in 2021.

    Research and Development Expenses: HOOKIPA's research and development expenses were $19.6 million for the three months ended June 30, 2021, compared to $11.6 million for the three months ended June 30, 2020.

    The primary drivers of the increase in direct research expenses were an increase in manufacturing and quality control expenses of $1.6 million, and an increase in clinical operations expenses of $1.4 million, along with a general increase in other direct research and development expenses and laboratory expenses of $2.4 million. These expenses were mainly due to the progress in our HB-201 and HB-202 clinical trial, in particular for monitoring and testing activities, and manufacturing and quality control work in preparation of a further extension of the trial. Manufacturing and quality control expenses were also driven by the progress towards clinical development in our Gilead-partnered programs.

    Internal research and development expenses increased by $2.6 million, mainly due to our increased research and development headcount.

    General and Administrative Expenses: General and administrative expenses for the three months ended June 30, 2021 were $5.1 million, compared to $4.3 million for the three months ended June 30, 2020. The increase was primarily due to an increase in personnel-related expenses, partially offset by a decrease in professional and consulting fees. The increase in personnel-related expenses resulted from a growth in headcount along with increased salaries in our general and administrative functions, and increased stock compensation expenses.

    Net Loss: HOOKIPA's net loss was $17.2 million for the three months ended June 30, 2021, compared to a net loss of $7.1 million for the three months ended June 30, 2020. This increase was due to an increase in research and development expenses, an increase in general and administrative expenses, a decrease in revenues from collaboration and licensing and a decrease in other income, partially offset by an increase in grant income.

    About HOOKIPA

    HOOKIPA Pharma Inc. (NASDAQ:HOOK) is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies that mobilize and amplify targeted T cells and antibodies, the body's natural infection killers, to fight or prevent serious disease.

    HOOKIPA is developing a broad pipeline of potential first-in-class arenaviral immunotherapies in oncology and infectious disease. We are leveraging our proprietary, versatile platform to engineer arenaviral therapeutics that induce robust antigen-specific CD8+ T cells and pathogen-neutralizing antibodies to a broad range of self and non-self antigens, including viral antigens, tumor-associated antigens and neoantigens. Our immunotherapies are designed to use either non-replicating or replicating viral vectors based on the target disease, with the potential to induce CD8+ T cell response levels previously not achieved by other immunotherapy approaches.

    HOOKIPA's pipeline includes ongoing clinical trials in Human Papilloma Virus 16-positive cancers and Cytomegalovirus, as well as preclinical research in prostate cancer, HIV and Hepatitis B. The latter two are in collaboration with Gilead Sciences, Inc.

    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 materially 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 annual report on Form 10-Q for the financial year ended June 30, 2021 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 June 30,  Six months ended June 30, 
     2021     2020     2021     2020 
    Revenue from collaboration and licensing$5,378  $6,685  $10,679  $10,381 
    Operating expenses:              
    Research and development (19,572)  (11,564)  (39,736)  (23,090)
    General and administrative (5,095)  (4,347)  (9,404)  (8,976)
    Total operating expenses (24,667)  (15,911)  (49,140)  (32,066)
    Loss from operations (19,289)  (9,226)  (38,461)  (21,685)
    Total interest, other income and taxes, net 2,136   2,134   4,070   3,667 
    Net loss$(17,153) $(7,092) $(34,391) $(18,018)
    Net loss per share — basic and diluted (0.52)  (0.28)  (1.05)  (0.70)
                    



    Condensed Balance Sheets (Unaudited)

    (In thousands)

          
     As of    As of
     June 30,  December 31, 
     2021 2020
    Cash, cash equivalents and restricted cash$102,953 $143,177
    Total assets 166,156  187,817
    Total liabilities 40,222  31,694
    Total stockholders' equity 125,934  156,123



     
    For further information, please contact:
    MediaInvestors
    Nina WaibelMatt Beck
    Senior Director - CommunicationsExecutive Director - Investor Relations
    nina.waibel@hookipapharma.commatthew.beck@hookipapharma.com
      
    Media enquiries 
    Instinctif Partners 
    hookipa@instinctif.com 
    +44 (0)20 7457 2020 


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    • HOOKIPA's arenaviral platform technology demonstrated ability to modulate the tumor microenvironment and induce potent melanoma-specific T cell responses

    • A single, intra-tumoral injection of the arenaviral immunotherapeutic resulted in tumor regression in all mice and tumor cures in about 60 percent of recipients

    • Publication adds to the growing body of evidence supporting the potential of HOOKIPA's novel arenaviral therapeutics in cancer

    NEW YORK and VIENNA, Austria, Aug. 05, 2021 (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 pre-clinical data on its replicating Lymphocytic choriomeningitis (LCMV) arenaviral-based…

    • HOOKIPA's arenaviral platform technology demonstrated ability to modulate the tumor microenvironment and induce potent melanoma-specific T cell responses



    • A single, intra-tumoral injection of the arenaviral immunotherapeutic resulted in tumor regression in all mice and tumor cures in about 60 percent of recipients



    • Publication adds to the growing body of evidence supporting the potential of HOOKIPA's novel arenaviral therapeutics in cancer

    NEW YORK and VIENNA, Austria, Aug. 05, 2021 (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 pre-clinical data on its replicating Lymphocytic choriomeningitis (LCMV) arenaviral-based immunotherapeutic has been published in the peer-reviewed journal, Nature Communications. The data demonstrate that HOOKIPA's LCMV-based vector, designed to target melanoma, modulated the tumor microenvironment and induced potent, tumor antigen-specific T cell responses, resulting in tumor regression and tumor cures in a pre-clinical setting. The publication is available online.

    "The pre-clinical data published in Nature Communications add to the growing body of evidence on our arenaviral therapeutics' ability to induce potent T cell responses and drive tumor regression and, in many cases, tumor cures," said Joern Aldag, Chief Executive Officer at HOOKIPA. "We're pleased to see parallels in significant T cell responses, even after a single administration, between these data in melanoma and the HPV data we've reported in both pre-clinical and clinical settings. We believe our novel, versatile platform has the potential to redefine success in cancer immunotherapy, and we continue to drive our lead HPV program forward while exploring additional indications to address unmet needs."

    Pre-clinical data featured in the article showed that replicating LCMV-based arenaviral vector administered as a monotherapy led to melanoma tumor regression in all mice, with tumor cures in about 60 percent of recipients after a single, intra-tumoral administration. Importantly, a single, local injection of the vector into the tumor also led to systemic immune responses, significantly reducing the number of lung metastases.

    Other key highlights from the paper include findings that HOOKIPA's single-vector therapy:

    • Modulated the tumor micro-environment, producing a shift towards immune-stimulatory cells
    • Produced a significant increase in tumor antigen-specific CD8+ T cells, known as killer cells, which are critical for effective tumor control
    • Reduced T cell exhaustion, resulting in better functional CD8+ T cells within the tumor, as well as more immune-stimulatory CD4+ T cells
    • Induced long-term memory and protection against melanoma tumor re-challenge
    • Demonstrated the ability of the arenaviral platform to break tolerance in a difficult-to-treat, poorly immunogenic melanoma model, highlighting the potential of this approach more broadly

    These data reinforce the promise of HOOKIPA's arenaviral immunotherapeutic technology to activate and mobilize anti-tumor T cells, as well as overcome some of the challenges of oncolytic virus technology.

    HOOKIPA is evaluating its single-vector and alternating 2-vector technologies in cancer in an ongoing Phase 1/2 clinical trial with HB-201 and HB-202. Each single-vector compound uses a different arenavirus backbone (Lymphocytic Choriomeningitis Virus for HB-201 and Pichinde Virus for HB-202), while expressing the same antigen, an E7E6 fusion protein derived from HPV16. Phase 1 data on HB-200 has shown outstanding CD8+ T cell responses, preliminary efficacy as monotherapy in heavily pre-treated head and neck cancer patients who progressed on standard of care, including checkpoint inhibitors, and favorable tolerability. HOOKIPA's HB-300 program for prostate cancer also uses the LCMV and PICV arenaviral backbones directed against three validated antigens for prostate cancer: PAP, PSA, and PSMA.

    About HOOKIPA

    HOOKIPA Pharma Inc. (NASDAQ:HOOK) is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies that mobilize and amplify targeted T cells and antibodies, the body's natural infection killers, to fight or prevent serious disease.

    HOOKIPA is developing a broad pipeline of potential first-in-class arenaviral immunotherapies in oncology and infectious disease. We are leveraging our proprietary, versatile platform to engineer arenaviral therapeutics that induce robust antigen-specific CD8+ T cells and pathogen-neutralizing antibodies to a broad range of self and non-self antigens, including viral antigens, tumor-associated antigens and neoantigens. Our immunotherapies are designed to use either non-replicating or replicating viral vectors based on the target disease, with the potential to induce CD8+ T cell response levels previously not achieved by other immunotherapy approaches.

    HOOKIPA's pipeline includes ongoing clinical trials in Human Papilloma Virus 16-positive cancers and Cytomegalovirus, as well as preclinical research in prostate cancer, HIV and Hepatitis B. The latter two are in collaboration with Gilead Sciences, Inc.

    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 annual report on Form 10-Q for the financial year ended March 31, 2021 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.

    MediaInvestors
    Nina WaibelMatt Beck
    Senior Director - CommunicationsExecutive Director - Investor Relations
    nina.waibel@hookipapharma.commatthew.beck@hookipapharma.com
      
    Media enquiries 
    Instinctif Partners 
    hookipa@instinctif.com 
    +44 (0)20 7457 2020 


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  2. NEW YORK and VIENNA, Austria, Aug. 03, 2021 (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 second quarter 2021 financial results and recent highlights before the market opens on Thursday, August 12, 2021.

    The Company will not be conducting a conference call in conjunction with this earnings release.

    About HOOKIPA
    HOOKIPA Pharma Inc. (NASDAQ:HOOK) is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies that mobilize and amplify targeted T cells and antibodies, the body's natural infection killers, to fight or prevent serious disease.

    HOOKIPA is developing…

    NEW YORK and VIENNA, Austria, Aug. 03, 2021 (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 second quarter 2021 financial results and recent highlights before the market opens on Thursday, August 12, 2021.

    The Company will not be conducting a conference call in conjunction with this earnings release.

    About HOOKIPA

    HOOKIPA Pharma Inc. (NASDAQ:HOOK) is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies that mobilize and amplify targeted T cells and antibodies, the body's natural infection killers, to fight or prevent serious disease.

    HOOKIPA is developing a broad pipeline of potential first-in-class arenaviral immunotherapies in oncology and infectious disease. We are leveraging our proprietary, versatile platform to engineer arenaviral therapeutics that induce robust antigen-specific CD8+ T cells and pathogen-neutralizing antibodies to a broad range of self and non-self antigens, including viral antigens, tumor-associated antigens and neoantigens. Our immunotherapies are designed to use either non-replicating or replicating viral vectors based on the target disease, with the potential to induce CD8+ T cell response levels previously not achieved by other immunotherapy approaches.

    HOOKIPA's pipeline include ongoing clinical trials in Human Papilloma Virus 16-positive cancers and Cytomegalovirus, as well as preclinical research in prostate cancer, HIV and Hepatitis B. The latter two are in collaboration with Gilead Sciences, Inc.

    Find out more about HOOKIPA online at www.hookipapharma.com.

    For further information, please contact: 
    MediaInvestors
    Nina WaibelMatt Beck
    Senior Director - CommunicationsExecutive Director - Investor Relations
    nina.waibel@hookipapharma.commatthew.beck@hookipapharma.com

     



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