Oropharyngeal Neoplasms

Study done in collaboration with Memorial Sloan Kettering and led by Dr. Winston Wong, Head and Neck Oncologist and Dr. Alan Ho, Chief of the Head and Neck Oncology Service IIT will evaluate eseba-vec in patients who are HPV16+ after treatment for curative intent Potential to expand the eseba-vec HNSCC opportunity into adjuvant care Initial safety and efficacy data from IIT expected in 2026 NEW YORK and VIENNA, Oct. 30, 2024 (GLOBE NEWSWIRE) -- HOOKIPA Pharma Inc. (NASDAQ: HOOK) (”HOOKIPA” or the “Company”), a clinical-stage biopharmaceutical company developing next generation immunotherapeutics for the treatment of cancer and serious infectious diseases, today announced that researchers at Memorial Sloan Kettering Cancer Center (MSKCC) have dosed the first patients in an investigator initiated trial (IIT) of eseba-vec, HOOKIPA’s human papillomavirus type 16 (HPV16+)-targeted investigational immunotherapeutic agent, in patients with minimal residual disease positive (MRD+) HPV-driven head and neck cancer. “Based on the positive Phase 2 data generated to date in recurrent/metastatic (R/M) HNSCC, we believe eseba-vec has broad potential across HPV16+ cancers. We are enthusiastic to explore the potential of eseba-vec as an adjuvant treatment for patients with locally advanced HNSCC and continue our collaboration with Drs. Wong and Ho and the team at MSKCC,” said Mark Winderlich, PhD, Chief Research and Development Officer at HOOKIPA. “We believe eseba-vec can help address unmet needs within the adjuvant setting and pave the way for us to help more patients with HNSCC.” Malte Peters, Chief Executive Officer of HOOKIPA added, “Eseba-vec was well tolerated and has demonstrated compelling efficacy in combination with pembrolizumab in HPV+ (R/M) HNSCC. We look forward to building on these promising findings with the expansion into adjuvant care. Our eseba-vec clinical development program in HNSCC continues to advance and we are on track to initiate our pivotal AVALON-1 Phase 2/3 study in the front-line setting for patients with HPV16+ oropharyngeal squamous cell carcinoma (OPSCC) in the fourth quarter of 2024. We expect initial safety and efficacy data from the IIT in 2026.” Winston Wong, MD, commented, “Targeted immunotherapeutic agents can play an important role in the care of patients with HPV16+ HSNCC. I am encouraged by the potential for eseba-vec in this setting based on promising Phase 2 combination data with pembrolizumab in the first line setting presented at this year’s American Society for Clinical Oncology annual meeting showing rapid and durable activation of antigen-specific CD8+ T cells and promising clinical response rates, especially in the CPS 20 or higher subgroup. Patients who are HPV16+ after receiving standard of care treatment for curative intent may also benefit from an immunotherapy treatment and we are currently testing whether eseba-vec may be a new, effective adjuvant treatment option.” The Phase 2, randomized, double-blind, placebo-controlled study (NCT06373380) will evaluate the use of eseba-vec in patients with minimal residual disease positive (MRD+) HPV-driven head and neck cancer. The primary endpoint of the study is disease-free survival. Secondary endpoints include an assessment of safety and tolerability. The study is expected to enroll approximately 50 patients. 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 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”, “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, HOOKIPA’s plans, strategies, expectations and anticipated milestones for its preclinical and clinical programs, including the timing of initiating clinical trials and patient enrollment, the availability and timing of results from preclinical studies and clinical trials and the expected safety profile of HOOKIPA’s product candidates. 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, 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 Securities and Exchange Commission, 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

KØBENHAVN, Denmark I October 07, 2024 I FluoGuide A/S (STO:FLUO) Copenhagen, Denmark – FluoGuide A/S (“FluoGuide” or the “Company”),a biothech company specializing in precision cancer surgery, today announced the submission of the Clinical Trial Application (CTA) for phase II trial in head and neck cancer (oral squamous cell carcinoma cancer). Redeye will host a live streaming event regarding the head and neck trial on 18 October 2024, at 10:00 am CET. The CTA submission follows strong clinical topline data for FG001 tested in a proof-of-concept phase II clinical trial in patients with head and neck cancer and is a step on the path to the patients and commercialization. Feedback from and discussions with key opinion leaders around the globe, has confirmed the ample needs patients with head and neck cancers have and led to a detailed understanding of the clinical trial design. Additionally, the Company obtained feedback on how to optimize the positioning of FG001 from a regulatory, partnering and commercial perspective to fully utilize the opportunities, condensed in the design of the trial (CT-005). Regulatory and clinical evaluation and discussions with Principal Investigator, Prof. Dr. Max Witjes, has led to the submitted trial design. The phase II trial (CT-005) is designed as a single center trial to: First interim data are expected in H2 2025. Depending on data from the trial and feedback from regulatory authorities, the Company is planning to do a multisite registration trial as the next step supporting approval and subsequent commercialization. FluoGuide will review the trial and its outlook at a live streaming event hosted by Redeye on 18 October 2024, at 10:00 am CET, where Redeye analyst Christian Binder will interview CEO Morten Albrechtsen and CSO Andreas Kjær. About FluoGuide FluoGuide is a biotech company specializing in precision cancer surgery. FluoGuide’s lead product, FG001, is designed to enhance surgical accuracy by illuminating cancer cells intraoperatively using fluorescent light, which binds to the uPAR receptor, widely expressed in most solid cancer types. It is anticipated that FG001 will decrease both the incidence of local recurrence after surgery and surgical complications, improving cancer treatment and outcomes for patients, while also reducing healthcare costs. Moreover, FluoGuide’s technology platform may also be utilized for photothermal therapy (PTT), which kills cancer cells through heating them with the use of near-infrared light. A technique that spares healthy surrounding tissue from damage, offering a direct therapeutic effect of FG001, further benefiting patients undergoing cancer surgery. FluoGuide is listed on the Nasdaq First North Growth Market in Stockholm under the ticker symbol “FLUO”. For more information about FluoGuide’s pipeline, technology, and upcoming events, visit www.fluoguide.com About head and neck cancer Head and neck cancer includes cancers in the head and neck region of the body. Head and neck cancers are frequently not completely removed or removed with insufficient margins to the surrounding normal tissue and requires follow up treatment with chemoradiotherapy. Chemoradiotherapy causes both short- and long-term side effects that can be avoided if the surgical removal of the cancer is complete the first time. Head and neck cancers are often occurring in close anatomical proximity to small vital structures such as blood vessels supplying the brain and many important nerves. Further, cosmetic considerations are important for most locations of head and neck cancers. Surgical precision is therefore essential for surgical removal of head and neck cancers. Most head and neck cancers arise from squamous cells and are called squamous cell carcinomas. It is the 6th most common cancer. Worldwide, head and neck cancer accounts for approximately 950,000 newly diagnosed patients (incidence) annually and approximately 450,000 patients die annually due to head and neck cancer. In USA and EU head and neck cancer accounts for approximately 63,000 and 136,000 newly diagnosed patients annually, respectively. Head neck cancer in rest of the world accounts for approximately 750,000 cases annually. Sources: World Health Organization (International Agency for Research on Cancer), Global Cancer Observatory (iarc.fr) , Gal TJ et al. Treatment trends in oropharyngeal carcinoma: Surgical technology meets the epidemic. Oral Oncology, Vol 97, 2019, p 62-68 (2) Cramer JD et al. The changing therapeutic landscape of head and neck cancer. Nat. Rev. Clin. Oncol. 16, 669-683 (2019); For more information on the Company, its uPAR technology platform and pipeline, please visit www.fluoguide.com SOURCE: FluoGuide

PARIS, France I October 04, 2024 I TheraVectys, a biotechnology company that designs and develops lentiviral vector-based vaccines and immunotherapies against infectious agents and cancers, announces that the first patient has been enrolled in the Phase I/IIa clinical trial evaluating the onco-therapeutic vaccine Lenti-HPV-07 for the treatment of human papillomavirus (HPV)-induced cancers. This study will include 36 patients in a dose-escalation protocol conducted at several cancer centers in the United States. Selection and inclusion of these patients are already underway. The Lenti-HPV-07 vaccine is based on the lentiviral vector technology platform developed by Pasteur-TheraVectys Joint Laboratory and pioneered by TheraVectysfor for nearly 20 years. The highly promising preclinical studies results on the Lenti-HPV-07 vaccine candidate, published in September 2023 in EMBO Molecular Medicine (1) and in June 2024 in NPJ Vaccines (2), showed that after a single intramuscular injection the vaccine was able to induce a strong cellular immune response against the E6 and E7 antigens of HPV16 and HPV18, resulting in: Aims and methodology of the human trial The open-label Phase I/IIa trial will evaluate the safety of ascending doses of Lenti-HPV-07, determine its immunogenicity profile and assess the preliminary efficacy through the Objective Response Rate. It will include two groups of patients with oropharyngeal or cervical cancers induced by HPV-16 or HPV-18, all of whom will be clinically and immunologically followed for one year. Group A will consist of patients with recurrent/metastatic cancers who have not responded to multiple lines of treatment, including immunotherapies. These patients will receive two intramuscular injections of Lenti-HPV-07, one month apart. Group B will be composed of patients with newly diagnosed, treatment-naïve, locally advanced cancers. Patients in Group B will receive a single intramuscular injection of Lenti-HPV-07. The trial comprises 2 parts: a dose escalation and dose expansion. In the dose escalation portion participants are enrolled successively to receive increasing doses of Lenti-HPV-07. Safety will be carefully monitored after each dose and before proceeding to enrolment at a higher dose. Enrolment and dose escalation in each arm A and B will be conducted independently. In each arm, when 18 participants will have received Lenti-HPV-07 treatment in the dose-escalation portion and the safety results will be satisfying, a dose-expansion portion of the trial will be open to treat 18 additional patients at the Optimal Biological Dose . In total, 72 patients with HPV + cancer will be enrolled in this Phase I/IIa clinical trial. In terms of safety, TheraVectys has already completed a Phase I clinical trial on a therapeutic HIV-1 vaccine based on an integrative lentiviral vector. Over a 5-year follow-up, this clinical trial revealed no notable side effects or genotoxicity. The ongoing Lenti-HPV-07 clinical trial uses a non-integrative lentiviral vector, which reinforces the safety of the approach. It should be noted that since group B patients are newly diagnosed and untreated, their immune systems will not have been affected by other chemo- or radiotherapy treatments. These patients will receive standard care, often including anti-PD1 treatments, one month after treatment with Lenti-HPV-07. TheraVectys has shown in animal models that the Lenti-HPV-07 vaccine acts synergistically with treatments such as anti-PD1, increasing the efficacy of anti-PD1 immunotherapy alone by a factor of 4 (1, 2). Professor Christian Bréchot, Medical Director of TheraVectys commented: “ The inclusion of the first patient in the Phase I/IIa trial represents a key milestone for TheraVectys. It is the achievement of more than 2.5 years of preparation, from first interaction with the FDA, production of the vaccine, performance of the preclinical studies, review and approval by the regulatory authorities till sites preparation. The careful selection of adequate partners and the development of a cooperative relationship have been key in successfully building the project.” Pierre Charneau, head of the Pasteur-TheraVectys Joint Laboratory and founder of TheraVectys, said : “With the launch of this study, we are proud to bring our product to a new phase of its development. We expect the preliminary results on safety and immunogenicity a couple of months after all patients in one group will have received their last injection.” HPV causes almost all cervical cancers, as well as many oropharyngeal and anogenital cancers. The preventive HPV vaccines currently available essentially induce HPV-neutralizing antibodies and thus prevent infection, but have no effect on chronic HPV infections or established tumors. In comparison to Lenti-HPV-07, the immunotherapeutic potential of mRNA-based vaccine technology has only been shown to be effective against very small HPV-related tumors, with early relapse in almost 50% of treated animals (3). In contrast, in the preclinical study conducted by Pasteur-TheraVectys Joint Laboratory, Lenti-HPV-07 immunotherapy was active against large tumors, which are notoriously more difficult to control, demonstrating the superior efficacy of the lentiviral vector-based vaccine platform. A recent publication of a cross-sectional comparison of the most relevant vaccine strategies tested to date in preclinical anti-HPV immuno-oncotherapy showed that lentiviral vector-based approaches were the most effective at eliminating tumors, while providing the longest-lasting memory (4). About lentiviral vector technology TheraVectys is Institut Pasteur’s exclusive licensee for all human and animal vaccine applications of lentiviral vectors worldwide. Thanks to its interaction with dendritic cells, this technology stimulates the body’s natural immune defenses, particularly T cells, more effectively than other vaccine strategies. The technology is based on the natural attraction of lentiviral vectors for dendritic cells and on their ability to induce directly in these cells a sufficiently long-lasting and highly effective endogenous antigenic presentation of the antigens encoded by the vector. Dendritic cells programmed in this way play a key and unique role in the development of T cell responses, the main effectors against tumor cells. About TheraVectys TheraVectys Biotech, specialist in immunotherapy, is based on more than 20 years of research on lentiviral vectors and brings an innovative technology to the field of vaccinology. Research is carried out in the Pasteur-TheraVectys Joint Laboratory under the scientific direction of Pierre CHARNEAU , inventor and pioneer of lentiviral technology, and Laleh MAJLESSI , Director of Research in Immunology. Christian BRECHOT , the former General Director of Institut Pasteur and INSERM, is the Medical Director of TheraVectys. Estelle BESSON , Director of Clinical Operations, coordinated and supervised the preparatory work required to obtain FDA approval, including production of the vaccine, regulatory preclinical studies, preparation of the IND filing, selection and implementation of the clinical trial in collaboration with TheraVectys’ partners. The biotech’s work is based on a proprietary platform for delivering cytotoxic T-cell vaccines in response to critical unmet medical needs. The technology used is at a clinical stage. TheraVectys’ technology and its worldwide license area address a broad spectrum of infectious diseases, cancers and viral cancers, positioning it at the origin of a genuine revolution in the field of vaccination. Our aim: To make profound improvements to global health. Our approach: Strategic industrial partnerships to take our vaccine candidates from proof of concept to clinical trials and marketing. TheraVectys S.A. 28 rue de Dr Roux, Institut Pasteur, Paris, France Chairman TheraVectys: Jean CHALOPIN – Scientific Director: Pierre CHARNEAU 1 Immune checkpoint inhibitors; PD1 = programmed cell death protein-1 References 1. Douguet L*, Fert I*, Lopez J*, Vesin B*, Le Chevalier F, Moncoq F, Authié P, Nguyen TM, Noirat A, Névo F,Blanc C, Bourgine M, Hardy D, Anna F, Majlessi L £ , Charneau P £ . (2023) Full Eradication of Pre-clinical Human PapillomaVirus-Induced Tumors by a Lentiviral Vaccine. EMBO Mol Med . *Co-first authors, £ Senior authors. https://www-embopress-org.libproxy1.nus.edu.sg/doi/full/10.15252/emmm.202317723 2. Fert I*, Douguet L*, Vesin B*, Moncoq F, Noirat A, Authié P, Ciret S, Le Chevalier F, Blanc C, Vitrenko Y, Charneau P £ , Majlessi L £ , Anna F £ . (2024) T-cell immunity induced and reshaped by an anti-HPV immuno-oncotherapeutic lentiviral vector. NPJ Vaccines. *Co-first authors, £ Senior authors. https://www-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/pmc/articles/PMC11164992/ 3. Ramos da Silva J, Bitencourt Rodrigues K, Formoso Pelegrin G, Silva Sales N, Muramatsu H, de Oliveira Silva M, Porchia B, Moreno ACR, Aps L, Venceslau-Carvalho AA et al (2023) Single immunizations of self-amplifying or non-replicating mRNA-LNP vaccines control HPV-associated tumors in mice. Sci Transl Med 15: eabn3464 4. Demidova A*, Douguet L*, Fert I*, Wei Y*, Charneau P, Majlessi L. (2024) Comparison of preclinical efficacy of immunotherapies against HPV-induced cancers. Exp Rev Vacc. *Co-first authors. https://www-tandfonline-com.libproxy1.nus.edu.sg/doi/full/10.1080/14760584.2024.2374287 . SOURCE: TheraVectys