A Randomized Double-blinded Phase 2/3 Study of HB-202/HB-201 Alternating 2-Vector Therapy With Pembrolizumab Versus Pembrolizumab-Only for First Line HPV16+ High PD-L1 CPS Recurrent and/or Metastatic Oropharyngeal Squamous Cell Carcinoma

This is a study of HB-202/HB-201 alternating 2-vector therapy with pembrolizumab (also known as Keytruda®) in people with human papillomavirus subtype 16 positive (HPV16+) head and neck cancer starting in the middle part of the throat, who have not yet received systemic treatment after their cancer spread (metastatic) and/or returned (recurrent) and who are eligible to receive pembrolizumab.
Doctors already use pembrolizumab therapy (with or without chemotherapy) to treat head and neck cancer. However, the treatment does not work well in most people with this type of cancer. HB-202/HB-201 alternating 2-vector therapy with pembrolizumab, which is designated to stimulate a stronger immune attack against HPV16+ tumors, was shown to be safe and suggested to work better than pembrolizumab-only in a small number of participants with HPV16+ head and neck cancer (see H-200-001, NCT04180215).
This trial studies HB-202/HB-201 alternating 2-vector therapy with pembrolizumab in a much larger number of participants from different countries to confirm its benefits for people with HPV16+ head and neck cancer that started in the middle part of the throat compared with pembrolizumab-only therapy. This trial studies whether administering HB-202/HB-201 alternating 2-vector therapy with pembrolizumab works better in more participants by shrinking their tumors and makes them live longer than pembrolizumab-only therapy.
Participants will receive the study treatments by injection into a vein every 3 weeks during the first 3 months and then every 6 weeks until up to about 2 years, which will be followed by a long observation period to continue looking at the safety and clinical benefits after the last dose of study treatment.

Start Date01 Dec 2024

Sponsor / Collaborator

Hookipa Biotech GmbH

NCT05108870 / RecruitingPhase 1/2IIT

A Randomized Phase I/II Trial of TheraT® Vectors Expressing HPV16 Specific Antigens in Combination With Neoadjuvant Chemotherapy Followed by Transoral Robotic Surgery or Risk/Response Stratified Chemoradiotherapy for Locoregional HPV16+ Oropharyngeal Cancer

Doctors leading this study hope to learn about the safety and effectiveness of combining medications HB-201 and HB-202 (also known as TheraT® vectors) with chemotherapy using carboplatin and paclitaxel in the beginning of the study (induction) and if combining these medications can increase tumor shrinkage after therapy and reduce the amount of radiotherapy and chemotherapy that will later be needed.
In addition, the study is looking at ways to reduce side effects overall using robotic surgery, chemotherapy and radiotherapy, or radiotherapy alone. Your participation in this research will last about 2 years.
HB-201 and HB-202 are experimental (meaning the US Food and Drug Administration (FDA) has not approved these drugs), and therefore they can only be given in a research study.

Start Date17 Jul 2024

Sponsor / Collaborator

The University of Chicago

NCT06373380 / RecruitingPhase 2IIT

Phase II Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy of HB-200 in Patients With Positive TTMV-HPV DNA After Definitive Treatment for HPV16 Positive HNSCC

The researchers are doing this study to find out if HB-202/HB-201 is an effective treatment for people with HPV 16-positive head and neck squamous cell cancer (HPV 16+ HNSCC) who have received standard treatment for their disease but then tested positive for HPV 16-related tumor DNA in the blood through a test called NavDx. Participants will have no evidence of cancer on imaging scans (radiographically) or by medical examination (clinically). Past studies have shown that a positive NavDx test strongly suggests the possible presence of microscopic cancer, though we do not know if testing positive will definitely lead to the cancer coming back (recurrence). The NavDx blood test has not been approved by the FDA and is considered investigational.

Start Date15 Apr 2024

Sponsor / Collaborator

Memorial Sloan Kettering Cancer Center

[+2]

100 Clinical Results associated with Eseba-Vec

100 Translational Medicine associated with Eseba-Vec

100 Patents (Medical) associated with Eseba-Vec

Literatures (Medical) associated with Eseba-Vec

01 Oct 2021·ChemosphereQ2 · ENVIRONMENTAL SCIENCE & ECOLOGY

Magnetic nanostructured material as heterogeneous catalyst for degradation of AB210 dye in tannery wastewater by electro-Fenton process

Q2 · ENVIRONMENTAL SCIENCE & ECOLOGY

Article

Author: Daiane R.S. Cruz ; Luciane P.C. Romão ; Wenes R. Silva ; Gleyce K. de Jesus ; Clecia A. Santos ; Graziele C. Cunha ; Alberto Wisniewski

Degradation of the Acid Black 210 dye (AB210) in synthetic and industrial effluent samples was performed, for the first time, using a heterogeneous electro-Fenton (EF) process with a CoFe₂O₄/NOM magnetic hybrid catalyst (Hb200). The technique was compared with electrochemical oxidation using electrogenerated hydrogen peroxide (AO-H₂O₂). The catalyst was synthesized by the sol-gel technique, using water with a high content of natural organic matter (NOM) as an eco-friendly solvent. Analyses using XRD, FTIR, and TEM showed the formation of hybrid nanostructures with average size of 4.85 nm. Electrochemical assays were performed with a GDE/BDD electrode pair, electrogenerated H₂O₂, and current density of 45.4 mA cm^-2. For the synthetic solution of AB210 at pH 3, the EF process presented higher efficiency, compared to AO-H₂O₂, with the optimum condition achieved using a lower mass of the catalyst (30 mg) and a higher concentration of the dye (55 mg L^-1). The EF method also showed superior performance in the treatment of an industrial effluent with high organic load, at pH 6, with almost complete mineralization of AB210 (95%) in 7 h, while the AO-H₂O₂ process achieved 82% mineralization. The Hb200 hybrid maintained excellent catalytic activity during reuse in 3 cycles, with only 10% lower mineralization efficiency in the last cycle. GC-MS analysis showed that most of the contaminants in the effluent, including bis(2-ethylhexyl) phthalate, one of the most toxic, were eliminated or transformed after the EF treatment with Hb200.

01 Apr 2011·Journal of the American Veterinary Medical AssociationQ2 · AGRICULTURAL & FORESTRY SCIENCE

Evaluation of the effects of bovine hemoglobin glutamer-200 on systolic arterial blood pressure in hypotensive cats: 44 cases (1997–2008)

Q2 · AGRICULTURAL & FORESTRY SCIENCE

Article

Author: Rudloff, Elke ; Kirby, Rebecca ; Wehausen, Conni E.

Abstract:

Objective—To determine effects of bovine hemoglobin glutamer-200 (Hb-200) solution on systolic arterial blood pressure (SAP) in hypotensive cats and describe potential adverse effects associated with this treatment.Design—Retrospective case series.Animals—44 cats.Procedures—Medical records of hypotensive (Doppler SAP ≤ 80 mm Hg) cats that received Hb-200 treatment were reviewed. Volume and rate of Hb-200 administration, treatments for hypotension given prior to Hb-200 administration, changes in SAP, potential adverse effects, and short-term outcome were evaluated.Results—44 cats were included in the study. Mean ± SD SAP prior to Hb-200 administration was 52 ± 11 mm Hg, despite other treatments. Forty-three cats received Hb-200 via IV bolus administration (mean ± SD volume, 3.1 ± 2.2 mL/kg [1.41 ± 1.0 mL/lb] over 25.17 ± 17.51 minutes); 1 cat received a continuous rate infusion (CRI) only. The SAP increased to > 80 mm Hg in 33 of 44 (75%) cats. The SAP increased > 20 mm Hg above baseline value in 29 of these 33 cats and in 4 cats in which SAP did not exceed 80 mm Hg. A CRI (mean ± SD rate, 0.8 ± 0.5 mL/kg/h [0.36 ± 0.23 mL/lb/h]) of Hb-200 was administered to 37 cats (after bolus infusion in 36). Mean SAP during the CRI was 92 ± 18 mm Hg. Adverse effects included respiratory changes (n = 8 cats), vomiting (2), and pigmented serum (30). Seventeen (39%) cats survived to discharge from the hospital, 6 died, and 21 were euthanized.Conclusions and Clinical Relevance—Hb-200 effectively increased SAP in hypotensive cats with few adverse effects.

01 Jan 2009·Journal of biomedical opticsQ3 · MEDICINE

Broadband diffuse optical spectroscopy assessment of hemorrhage- and hemoglobin-based blood substitute resuscitation

Q3 · MEDICINE

ArticleOA

Author: Mahon, Sari ; Goldberg, Robert ; Saltzman, Darin ; Mukai, David ; Lee, Jangwoen ; Tromberg, Bruce J. ; Kim, Jae G. ; Patino, Renee ; Brenner, Matthew ; Kreuter, Kelly

Hemoglobin-based oxygen carriers (HBOCs) are solutions of cell-free hemoglobin (Hb) that have been developed for replacement or augmentation of blood transfusion. It is important to monitor in vivo tissue hemoglobin content, total tissue hemoglobin [THb], oxy- and deoxy-hemoglobin concentrations ([OHb], [RHb]), and tissue oxygen saturation (S(t)O(2)=[OHb][THb]x100%) to evaluate effectiveness of HBOC transfusion. We designed and constructed a broadband diffuse optical spectroscopy (DOS) prototype system to measure bulk tissue absorption and scattering spectra between 650 and 1000 nm capable of accurately determining these tissue hemoglobin component concentrations in vivo. Our purpose was to assess the feasibility of using DOS to optically monitor tissue [OHb], [RHb], S(t)O(2), and total tissue hemoglobin concentration ([THb]=[OHb]+[RHb]) during HBOC infusion using a rabbit hypovolemic shock model. The DOS prototype probe was placed on the shaved inner thigh muscle of the hind leg to assess concentrations of [OHb], [RHb], [THb], as well as S(t)O(2). Hemorrhagic shock was induced in intubated New Zealand white rabbits (N=6) by withdrawing blood via a femoral arterial line to 20% blood loss (10-15 cckg). Hemoglobin glutamer-200 (Hb-200) 1:1 volume resuscitation was administered following the hemorrhage. These values were compared against traditional invasive measurements, serum hemoglobin concentration (sHGB), systemic blood pressure, heart rate, and blood gases. DOS revealed increases of [THb], [OHb], and tissue hemoglobin oxygen saturation after Hb-200 infusion, while blood total hemoglobin values continued did not increase; we speculate, due to hyperosmolality induced hemodilution. DOS enables noninvasive in vivo monitoring of tissue hemoglobin and oxygenation parameters during shock and volume expansion with HBOC and potentially enables the assessment of efficacy of resuscitation efforts using artificial blood substitutes.

News (Medical) associated with Eseba-Vec

21 Nov 2024

·firstwordpharma.com

HOOKIPA axes 80% of staff to zero in on KRAS drug

HOOKIPA Pharma is implementing a dramatic restructuring plan that will shrink its workforce by about 80% and pause clinical development of its human papillomavirus (HPV)-related cancer programme, while pivoting toward its KRAS-mutant cancer treatment.The company disclosed the changes in an SEC filing dated Nov. 18. According to the filing, HOOKIPA expects to begin the process this quarter and complete it by the first half of 2025.As part of its restructuring plan and focus on oncology, the company said it will halt clinical development of its eseba-vec programme for HPV16+ head-and-neck cancers, including ending its ongoing Phase I/II trial for these cancers. HOOKIPA noted the move was "not due to lack of efficacy or adverse safety profiles."HOOKIPA recently shared "encouraging" Phase II data for the combination of eseba-vec with Keytruda (pembrolizumab) in HPV16+ relapsed or metastatic head-and-neck squamous cell carcinoma (HNSCC). The combo "could lead to improved clinical outcomes and survival in patients with HPV16+ R/M HNSCC CPS>20 in the first-line setting," R&D chief Mark Winderlich said after the data were presented at the Society for Immunotherapy in Cancer (SITC) conference last week.Despite this pause, HOOKIPA emphasised its commitment to exploring potential partnerships for the eseba-vec programme while prioritising its HB-700 candidate targeting KRAS mutant cancers. The company received IND clearance from the FDA in April for HB-700, which targets KRAS mutations in lung, colorectal, and pancreatic cancers.Meanwhile, HOOKIPA will maintain ongoing clinical activities for two other assets: the Phase Ib HB-500 HIV programme and the HB-400 hepatitis B programme, both being developed under a 2018 partnership with Gilead Sciences.

Phase 2INDImmunotherapy

14 Nov 2024

·www.globenewswire.com

HOOKIPA Pharma Reports Third Quarter 2024 Financial Results and Provides Recent Business Updates

Enrollment of 68 patients completed Phase 2 study for eseba-vec + pembrolizumab in HPV+ HNSCC four months ahead of schedule SITC 2024 late-breaking poster highlights Phase 2 eseba-vec data updates for increased number of patients reflecting ORR and durability in line with prior data First patients dosed in Phase 2 investigator led study with MSKCC in new clinical setting as adjuvant therapy for head and neck cancer Strength of HB-700 KRAS-inhibitor program highlighted by preclinical dataset presented at recent RAS Targeted Drug Development Summit NEW YORK and VIENNA, Austria, Nov. 14, 2024 (GLOBE NEWSWIRE) -- HOOKIPA Pharma Inc. (NASDAQ: HOOK, “HOOKIPA”, the “Company”), a clinical-stage biopharmaceutical company developing next generation immunotherapeutics for the treatment of cancer and serious infectious disease, today reported financial results for the third quarter ended September 30, 2024 and provided recent business highlights, including an update on the progress of the lead clinical program, eseba-vec. “HOOKIPA made excellent progress across each program in our pipeline in the third quarter,” said Malte Peters, MD, Chief Executive Officer of HOOKIPA. “We advanced the development of eseba-vec for HPV16+ head and neck squamous cell carcinoma (HNSCC), through the start of an investigator-initiated study in the new clinical setting of adjuvant care, and presented continued positive, updated data from our Phase 2 study in first-line recurrent/metastatic disease as a late breaking abstract at SITC 2024. In parallel, we have made significant progress with our review of the business strategy and operations, having implemented a number of initiatives to optimize spending and ensure prioritization of resources.” Recent Developments OncologyEseba-vec: Pivotal-trial ready immunotherapy for human papilloma virus type 16 positive (HPV16+) cancers, including head and neck squamous cell carcinoma (HNSCC) and oropharyngeal squamous cell carcinoma (OPSCC). HOOKIPA owns all rights to this program. Enrollment completed in the Phase 2 H200-001 study for eseba-vec in combination with pembrolizumab in HPV+ HNSCC with 68 patients enrolled as of October 2024.First Patients Dosed in Phase 2 Adjuvant Therapy IIT with MSKCC: On October 30, 2024, HOOKIPA announced that researchers at Memorial Sloan Kettering Cancer Center (MSKCC) dosed the first patients in an investigator-initiated trial (IIT) evaluating eseba-vec in patients with minimal residual disease positive (MRD+) HPV-16+ driven, locally advanced HNSCC, following treatment for curative intent. The study could pave the way to broaden the eseba-vec HNSCC opportunity into adjuvant care.Updated Phase 2 Data Presented as SITC 2024 Late-Breaker: On November 9, 2024, HOOKIPA’s clinical collaborator, Alan Ho, MD, PhD, Chief of the Head and Neck Oncology Service at MSKCC, presented a late-breaking poster at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC 2024). The presentation provided updated results, including data from additional patients enrolled in the Phase 2 trial evaluating eseba-vec plus pembrolizumab as 1L treatment of recurring/metastatic HPV16+ HNSCC in patients with PD-L1 CPS levels of greater than or equal to 20. Eseba-vec treatment resulted in continued, durable clinical responses and antigen-specific T cell responses. HB-700: The HB-700 program is a novel Phase 1-ready immunotherapy for KRAS-mutated cancers, including pancreatic, colorectal and lung cancer. The investigational therapy was designed to target the most prevalent KRAS mutations of these cancers in a single therapy. HOOKIPA owns all rights to this program and the Investigational New Drug Application (IND) received FDA clearance in April 2024. Presentation of Strong Preclinical Dataset: On September 25, 2024, HOOKIPA presented the preclinical proof-of-concept dataset for HB-700 at the 6th Annual RAS-Targeted Drug Development Summit. The dataset demonstrated that HB-700 induced target-specific CD8+ T cells and target cell killing in several different animal and translational models. Infectious DiseasesHOOKIPA is advancing two independent anti-viral programs (HB-400 for HBV and HB-500 for HIV-1) through a collaboration and license agreement with Gilead Sciences, Inc. (Gilead). HB-400: An investigational therapeutic vaccine for the treatment of chronic hepatitis B (CHB). Enrollment Completed in Phase 1a/1b Clinical Trial: The vaccine is being evaluated in a Phase 1a/1b clinical trial (NCT05770895) in 83 subjects to assess the safety and immune response induced by HB400 in healthy participants and in participants with CHB on oral antiviral therapy. HB-500: An investigational therapeutic vaccine for the treatment of human immunodeficiency virus-1 (HIV-1). Ongoing Phase 1b Clinical Trial: The vaccine is being evaluated in a Phase 1b clinical trial (NCT06430905) to assess the safety and magnitude of cellular immune response against HIV-1 induced by HB-500 in people living with HIV who are taking anti-retroviral treatment. Under the collaboration agreement with Gilead, HOOKIPA received a $5 million milestone payment associated with dosing of the first subject in this trial in July 2024. Corporate and Financial Updates Corporate Highlights Board of Director Changes: On August 30, 2024, Director Julie O’Neill was appointed to be Non-Executive Chair of the Company’s Board of Directors, succeeding Jan van de Winkel, who decided to step down from the Board due to increased time commitments from other executive responsibilities. Tim Reilly also stepped down from the Board to dedicate more time to his other professional responsibilities. HOOKIPA is grateful for the years of service each Director dedicated to the Company. Leadership Changes: On July 22, 2024, the Board of Directors appointed Malte Peters, MD, as Chief Executive Officer and Terry Coelho as Executive Vice President and Chief Financial Officer to lead the Company through its next phase of development and to realize the significant opportunity of HOOKIPA’s pipeline. Board Appointment: On July 22, 2024, Sean Cassidy was appointed to the Board of Directors. Mr. Cassidy serves as the chair of the Audit Committee and as a member of the Compensation and the Nominating and Corporate Governance Committees.Reverse Split: On July 9, 2024, the Company effected a reverse stock split of the outstanding shares of its common stock on a one-for-ten (1:10) basis. The reverse stock split is part of the Company’s plan to regain compliance with the minimum bid price requirement for continued listing on the Nasdaq Capital Market. Financial Highlights: Milestone Payments Gilead: In July, HOOKIPA received a $5.0 million milestone payment under its collaboration and license agreement with Gilead. The success-based milestone payment was achieved in connection with the dosing of the first subject in the Phase 1b clinical trial of HB-500 for the treatment of HIV-1, initiated on July 1, 2024. Third Quarter 2024 Financial Results Cash Position: HOOKIPA’s cash, cash equivalents and restricted cash as of September 30, 2024 was $60.0 million, compared to $117.5 million as of December 31, 2023. The decrease was primarily attributable to cash used in operating activities, partially offset by cash received relating to milestone achievements under our collaboration agreements with Roche and Gilead. Revenue: Revenue was $4.7 million for the three months ended September 30, 2024, compared to $6.9 million for the same period in 2023. The decrease was primarily due to lower partnering revenues as a result of the termination of the Roche collaboration agreement. Research and Development Expenses: HOOKIPA’s research and development expenses were $15.6 million for the three months ended September 30, 2024, compared to $24.6 million for the same period in 2023. The primary changes in research and development expenses were lower personnel-related and laboratory-related expenses as well as lower manufacturing and research expenses resulting from the pause in development activities related to HB-300 announced in January 2024, partially offset by higher clinical study expenses for the eseba-vec program. General and Administrative Expenses: General and administrative expenses amounted to $6.7 million for the three months ended September 30, 2024, compared to $4.9 million for the same period in 2023. The primary drivers of the increase in general and administrative expenses were an increase in personnel-related expenses and an increase in professional and consulting fees incurred in connection with management transitions during the third quarter of 2024. Restructuring Expenses: Restructuring expenses amounted to $0.9 million for the three months ended September 30, 2024, and resulted from severance and other personnel costs as well as professional fees related to a reduction in workforce and related activities conducted in the third quarter of 2024. Impairment Expenses: Impairment expenses amounted to $0.2 million for the three months ended September 30, 2024, and resulted from write-downs related to laboratory equipment. Net Loss: HOOKIPA’s net loss was $13.8 million for the three months ended September 30, 2024, compared to a net loss of $19.1 million for the same period in 2023. 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, 2024 2023 2024 2023 Revenue from collaboration and licensing $4,703 $6,867 $42,592 $12,722 Operating expenses: Research and development (15,565) (24,625) (55,482) (65,262)General and administrative (6,732) (4,912) (14,733) (14,259)Restructuring (878) — (2,201) — Impairment (172) — (172) — Total operating expenses (23,347) (29,537) (72,588) (79,521)Loss from operations (18,644) (22,670) (29,996) (66,799)Total interest, other income and taxes, net 4,803 3,604 11,443 10,037 Net loss $(13,841) $(19,066) $(18,553) $(56,762)Net loss per share — basic and diluted (1.10) (1.73) (1.48) (6.41) Condensed Balance Sheets (Unaudited)(In thousands) As of As of September 30, December 31, 2024 2023Cash, cash equivalents and restricted cash $59,957 $117,521 Total assets 109,730 161,337 Total liabilities 37,928 71,480 Total stockholders’ equity 71,802 89,857 About HOOKIPAHOOKIPA Pharma Inc. (NASDAQ: HOOK) is a clinical-stage biopharmaceutical company focused on developing next generation immunotherapeutics based on its proprietary arenavirus platform. The company’s product candidates are designed to induce specific, robust and durable CD8+ T cells and antibodies to eliminate cancers and serious infectious diseases. HOOKIPA’s pipeline includes biological therapies for oncology, targeting human papillomavirus type 16-positive (HPV16+) cancers, KRAS mutated cancers, and other targets. In addition, HOOKIPA has partnered with Gilead Sciences, Inc. to develop therapies that are intended to provide functional cures for hepatitis B virus (HBV) and human immunodeficiency virus-1 (HIV-1). Find out more about HOOKIPA online at www.hookipapharma.com. Forward Looking StatementsCertain 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 “anticipates”, “believes”, “could”, “expects”, “plans”, “potential”, “will”, “would” or similar expressions and the negative of those terms. Forward-looking statements in this press release include HOOKIPA’s statements regarding the potential of its product candidates to improve the care of the patients it seeks to treat, the potential of its Phase 2 IIT to support the use of eseba-vec in adjuvant care, and other statements that are not historical fact. 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, plans and timelines for the preclinical and clinical development of its product candidates, including the therapeutic potential, clinical benefits and safety thereof, expectations regarding timing, success and data announcements of current ongoing preclinical studies and clinical trials, the ability to initiate new clinical programs, the risk that the results of current preclinical studies and clinical trials may not be predictive of future results in connection with current or future preclinical studies and clinical trials, including those for eseba-vec (also known as HB200), HB-700, HB-400 and HB-500, 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, and HOOKIPA’s ability to continue as a going concern and other matters that could affect the sufficiency of existing cash to fund operations. 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-K for the year ended December 31, 2023, as well as discussions of potential risks, uncertainties, and other important factors in HOOKIPA’s subsequent filings with the U.S. Securities and Exchange Commission (SEC), which are available on the SEC’s website at https://sec.gov and HOOKIPA’s website at www.hookipapharma.com. All information in this press release is as of the date of the release, and HOOKIPA undertakes no duty to update this information unless required by law. Availability of Other Information About HOOKIPAInvestors and others should note that we announce material financial information to our investors using our investor relations website, www.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 investors and the public about our company, 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 social media channels listed on our investor relations website. For further information, please contact: Investors Chuck PadalaChuck@LifeSciAdvisors.com

Phase 2Phase 1License out/inVaccineClinical Result

11 Nov 2024

·www.globenewswire.com

HOOKIPA Pharma’s Eseba-vec Highlighted in SITC Late-Breaker

Phase 2 trial evaluating eseba-vec/pembrolizumab combination resulted in a 52% ORR in PD-L1 CPS>20 patients and encouraging PFS and OS data, supported by highly durable and tumor-specific T cell response, with good overall safetyNEW YORK and VIENNA, Nov. 11, 2024 (GLOBE NEWSWIRE) -- HOOKIPA Pharma Inc. (NASDAQ: HOOK, “HOOKIPA”, the “Company”), a clinical-stage biopharmaceutical company developing next generation immunotherapeutics for the treatment of cancer and serious infectious disease, today announced that clinical collaborator Alan Ho, MD, PhD, Chief of the Head and Neck Oncology Service at Memorial Sloan Kettering Cancer Center, presented updated Phase 2 data from a study evaluating eseba-vec in combination with pembrolizumab as front line (1L) therapy in the setting of human papillomavirus type 16 positive (HPV16+) relapsed or metastatic head and neck squamous cell carcinoma (R/M HNSCC) at the 39th Annual Meeting for the Society for Immunotherapy in Cancer (SITC2024), being held in Houston Texas from November 8 – 10, 2024. The late-breaking poster presentation focused on results from a subset of patients (PD-L1 CPS >20, n=27, with 25 response evaluable patients). The data showed an overall response rate (ORR) of 52% for all eseba-vec doses tested, with a disease control rate (DCR) of 80%, as of the September 30, 2024 data cut-off. While progression free survival (PFS) and overall survival (OS) data are still maturing, preliminary median PFS is greater than 16 months, with a 12-month OS rate of 83%, and 66.7% of confirmed responders ongoing. In addition, the observed clinical activity is supported by a rapid, robust, and durable tumor antigen specific T-cell response. Data are generally consistent for the selected Phase 3 dose level, including a 55% ORR, which is an approximately 2-fold increase compared to historical pembrolizumab monotherapy data. Patients experienced manageable toxicity and a low level of serious treatment related adverse events (7.6%). “The expanded data presented at SITC 2024 are encouraging to HOOKIPA. They provide highly consistent proof-of-concept results which suggest that the combination treatment could lead to improved clinical outcomes and survival in patients with HPV16+ R/M HNSCC CPS>20 in the first line setting,” said Mark Winderlich, PhD, Chief Research and Development Officer. Dr. Ho commented, “As a medical oncologist who specializes in head and neck cancers, I am inspired by the results of the expanded eseba-vec/pembrolizumab Phase 2 study because of the potentially clinically meaningful response rate and encouraging PFS and OS data. In addition, the regimen has a manageable safety profile that ensures most patients can maintain treatment.” The late-breaking poster: Eseba-vec (HB-200) plus pembrolizumab as first-line treatment of recurrent/metastatic HPV16-positive head and neck cancer: updated results in PD-L1 CPS ≥20 patients will be available on November 11, 2024 on the HOOKIPA website on the “Scientific Publications” tab of the “Our Science” page. About Eseba-vecEseba-vec (also known as HB-200) is an investigational immunotherapeutic agent being evaluated for HPV16 positive cancers. The first indication for eseba-vec is for the potential treatment of patients with HPV16+ recurrent/metastatic oropharyngeal squamous cell carcinoma (R/M OPSCC) with a PDL1 CPS of 20 or higher, in combination with pembrolizumab, in the first line (1L) setting. Eseba-vec has received Fast Track Designation from the U.S. Food and Drug Administration and PRIME designation from the European Medicines Agency for the treatment of 1L HPV16+ OPSCC. Eseba-vec was developed using HOOKIPA’s proprietary arenavirus platform. About HOOKIPAHOOKIPA Pharma Inc. (NASDAQ: HOOK) is a clinical-stage biopharmaceutical company focused on developing next generation immunotherapeutics based on its proprietary arenavirus platform. The Company’s product candidates are designed to induce specific, robust and durable CD8+ T cells and antibodies to eliminate cancers and serious infectious diseases. HOOKIPA’s pipeline includes biological therapies for oncology, targeting human papillomavirus type 16-positive (HPV16+) cancers, KRAS mutated cancers, and other targets. In addition, HOOKIPA has partnered with Gilead Sciences, Inc. to develop therapies that are intended to provide functional cures for hepatitis B virus (HBV) and human immunodeficiency virus-1 (HIV-1). Find out more about HOOKIPA online at www.hookipapharma.com. Forward Looking StatementsCertain 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 “anticipates”, “believes”, “could”, “expects”, “plans”, “potential”, “will”, “would” or similar expressions and the negative of those terms. Forward-looking statements in this press release include HOOKIPA’s statements regarding the potential of its product candidates to improve the care of the patients it seeks to treat and the potential of eseba-vec in combination with pembrolizumab to improve clinical outcomes and survival in patients. 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, plans and timelines for the preclinical and clinical development of its product candidates, including the therapeutic potential, clinical benefits and safety thereof, expectations regarding timing, success and data announcements of current ongoing preclinical and clinical trials, the ability to initiate new clinical programs, the risk that the results of current preclinical studies and clinical trials may not be predictive of future results in connection with current or future preclinical and clinical trials, including those for eseba-vec (also known as HB200), HB-700, HB-400 and HB-500, 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, and HOOKIPA’s ability to continue as a going concern and other matters that could affect the sufficiency of existing cash to fund operations. 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-K for the year ended December 31, 2023, as well as discussions of potential risks, uncertainties, and other important factors in HOOKIPA’s subsequent filings with the U.S. Securities and Exchange Commission (SEC), which are available on the SEC’s website at https://sec.gov and HOOKIPA’s website at www.hookipapharma.com. All information in this press release is as of the date of the release, and HOOKIPA undertakes no duty to update this information unless required by law. Availability of Other Information About HOOKIPAInvestors and others should note that we announce material financial information to our investors using our investor relations website, www.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 investors and the public about our company, 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 social media channels listed on our investor relations website. For further information, please contact: Investors Chuck PadalaChuck@LifeSciAdvisors.com

Clinical ResultPhase 2ImmunotherapyFast Track

100 Deals associated with Eseba-Vec

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
HPV16 Infection	Phase 3	-	Hookipa Biotech GmbH	01 Dec 2024
HPV16 positive Oropharyngeal Cancer	Phase 3	-	Hookipa Biotech GmbH	01 Dec 2024
Squamous Cell Carcinoma of the Oropharynx	Phase 3	-	Hookipa Biotech GmbH	01 Dec 2024
Human Papillomavirus Infection	Phase 2	US	HOOKIPA Pharma, Inc.	10 Aug 2022
Human Papillomavirus Infection	Phase 2	ES	HOOKIPA Pharma, Inc.	10 Aug 2022
Squamous Cell Carcinoma of Head and Neck	Phase 2	US	HOOKIPA Pharma, Inc.	10 Aug 2022
Squamous Cell Carcinoma of Head and Neck	Phase 2	-	Merck & Co., Inc.	10 Aug 2022
Human Papillomavirus-Related Squamous Cell Carcinoma	Phase 2	US	Hookipa Biotech GmbH	11 Dec 2019
Human Papillomavirus-Related Squamous Cell Carcinoma	Phase 2	NL	Hookipa Biotech GmbH	11 Dec 2019
Human Papillomavirus-Related Squamous Cell Carcinoma	Phase 2	ES	Hookipa Biotech GmbH	11 Dec 2019

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04180215 (AVALON-1, SITC2024) Manual	Phase 2/3	Recurrent Squamous Cell Carcinoma of the Head and Neck First line PD-L1 High Expression	60	Eseba-vec + Pembrolizumab	coeayzzdlc(ivshdsmsbb) = ailaonflxw jiamnwrajf (onkhqbpfjk ) View more	Positive	05 Nov 2024
				Eseba-vec + Pembrolizumab (PD-L1 CPS ≥20)	sjwrzerpiw(jhlaratrgp) = thwqmbtrbf wcmxughevp (htqazfguzs ) View more
NCT04180215 (GlobeNewswire) Manual	Phase 2	Head and Neck Neoplasms First line HPV16 positive	46	HB-200 plus pembrolizumab	yzufeaqdrv(fobqlgfmxe) = bwcbwqihce ecxoyfcxay (aynqgrfasr ) View more	Positive	04 Jun 2024
				HB-200 plus pembrolizumab (CPS of 20 or higher)	yzufeaqdrv(fobqlgfmxe) = xqjoxegtlg ecxoyfcxay (aynqgrfasr ) View more
NCT04180215 (ASCO2024) Manual	Phase 2	Squamous Cell Carcinoma of Head and Neck First line PD-L1 Positive	42	HB-200 plus pembrolizumab	xbvojzdmrs(whxexfugyw) = uldfmiozqe yywnlfqtfw (xvbodojsab ) View more	Positive	24 May 2024
				HB-200 plus pembrolizumab (PD-L1 CPS ≥20)	abtfssqksy(djjzsrlhnx) = aejomovybx onlvyuyyni (yusmzeepbi ) View more
NCT05108870 (TARGET-HPV, ASCO2024) Manual	Phase 1	HPV16 positive Oropharyngeal Cancer Neoadjuvant HPV16+	21	HB-201 single vector with chemotherapy	mmhfetfztg(mjkebyqhye) = gvfpckyude zqrsflodmw (dwazyomsbm )	Positive	24 May 2024
				HB-202/201 alternating vector with chemotherapy	mmhfetfztg(mjkebyqhye) = qaialzatzr zqrsflodmw (dwazyomsbm )
NCT04180215 (SITC2023) Manual	Phase 1	Head and Neck Neoplasms Second line \| Last line \| Third line HPV16-positive	41	HB-200 monotherapy	pyltanxygy(lsrmihtrfk) = iouhemxnwe vzuvapyife (eruvuqzuzj )	Positive	02 Nov 2023
NCT04180215 (ASCO2022) Manual	Phase 1	HPV-related carcinoma HPV16 positive	65	HB-201	jrbigcghqk(vntwehyqzx) = Preliminary safety, efficacy, and immunogenicity data support IV injection of DL3 (5 × 107 units) every 3 weeks (Q3W) as the RP2D for HB-201 single-vector therapy. RP2D for HB-202/HB-201 will be determined in the very near future. btuuslhxxy (ijgfumuzku )	Positive	02 Jun 2022
				HB-202/HB-201
NCT04180215 (GlobeNewswire) Manual	Phase 1/2	HPV16 positive solid tumors	62	HB-201	ozzivldsmm(vidhepssil) = idkvofogkc iplonrhfzg (pagbqobhkx ) View more	Positive	09 Nov 2021
				HB-202/HB-201	ozzivldsmm(vidhepssil) = mbhxdepoqf iplonrhfzg (pagbqobhkx ) View more

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