HPV E7

- Data show that Vaxart’s HPV vaccine constructs stimulate specific T cell immune responses, reduce tumor size, and increase survival in an animal model of human papillomavirus (HPV)-related tumorigenesis - - Results suggest that Vaxart’s mucosal vaccine platform holds promise in enabling a novel, non-invasive treatment for HPV-related cervical dysplasia - SOUTH SAN FRANCISCO, Calif., Aug. 28, 2024 (GLOBE NEWSWIRE) -- Vaxart, Inc. (Nasdaq: VXRT) today announced the publication of preclinical data demonstrating the potential of its mucosal vaccine technology platform in enabling therapeutic vaccination against HPV-related cervical dysplasia. The data show that Vaxart’s HPV vaccine constructs can stimulate a potent immune response against the HPV16 proteins E6 and E7 that are known to transform healthy cells into malignant cells. The data, reported in the current issue of Vaccines, also shows that administration of a mucosal vaccine against these proteins in mice with HPV-expressing tumors led to reductions in tumor size and increased survival. Persistent HPV infection plays a causative role in most cases of cervical dysplasia, which leads to cervical cancers if left untreated. While prophylactic HPV vaccines are highly effective if administered prior to infection; they have not demonstrated a therapeutic effect on established infections. “The preclinical data published in Vaccines demonstrate that our mucosal vaccines stimulate T cells to destroy HPV-expressing cells, reducing the size of HPV-derived tumors and increasing the survival of mice bearing these tumors,” said Dr. Sean Tucker, Vaxart’s Founder and Chief Scientific Officer. “While additional studies are needed to further characterize the immune stimulating and anti-tumor activity of our HPV-vaccine, these initial findings suggest that our mucosal vaccine platform could open the door to a non-invasive approach designed to prevent the progression to cervical cancer. As our mucosal vaccine candidates can be administered easily and are stable at room temperature, they also have potential to address global inequities associated with the treatment of HPV-related cancers.” In this study published in Vaccines, the therapeutic potential of this platform was assessed in mice bearing HPV-expressing tumors. Animals were treated with vaccine candidates expressing wildtype E6 and E7 antigens from HPV16, engineered E6 and E7 that disrupt their malignant transformation potential, and fragments of E6 and E7 predicted to stimulate an immune response. Key findings from the study include: All vaccines generated a specific T cell response to HPV16 E6 and E7 in mice.All vaccines caused significant reductions in tumor volume and increased survival compared to control groups.Concurrent administration of anti-PD-1 with vaccination further increased animal survival in small and large tumor models compared to vaccination alone.Vaccination led to significant increases in intra-tumoral T cells, including T cells that create a cytotoxic tumor environment, compared with an empty control vaccine.Vaccination led to the generation of antigen-specific cytotoxic T cells. These results suggest that rAd5 vaccines delivered to a mucosal surface may have therapeutic potential in the treatment of HPV-derived cervical dysplasia and might be used to stimulate immune responses against other cancer-related proteins. Vaxart is continuing to evaluate its HPV vaccine candidates. About Vaxart Vaxart is a clinical-stage biotechnology company developing a range of oral recombinant vaccines based on its proprietary delivery platform. Vaxart vaccines are designed to be administered using pills that can be stored and shipped without refrigeration and eliminate the risk of needle-stick injury. Vaxart believes that its proprietary pill vaccine delivery platform is suitable to deliver recombinant vaccines, positioning the company to develop oral versions of currently marketed vaccines and to design recombinant vaccines for new indications. Vaxart’s development programs currently include pill vaccines designed to protect against coronavirus, norovirus and influenza, as well as a therapeutic vaccine for human papillomavirus (HPV), Vaxart’s first immune-oncology indication. Vaxart has filed broad domestic and international patent applications covering its proprietary technology and creations for oral vaccination using adenovirus and dsRNA agonists. Note Regarding Forward-Looking StatementsThis press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Vaxart’s strategy, prospects, plans and objectives, results from preclinical and clinical trials and the timing of such results, vaccine efficacy and safety, commercialization agreements and licenses, and beliefs and expectations of management are forward-looking statements. These forward-looking statements may be accompanied by such words as “should,” “believe,” “could,” “potential,” “will,” “expected,” “anticipate,” “plan,” and other words and terms of similar meaning. Examples of such statements include, but are not limited to, statements relating to Vaxart’s ability to develop and commercialize its product candidates, including its vaccine booster products; Vaxart’s expectations regarding clinical results and trial data, and the timing of receiving and reporting such clinical results and trial data; and Vaxart’s expectations with respect to the effectiveness of its product candidates. Vaxart may not actually achieve the plans, carry out the intentions, or meet the expectations or projections disclosed in the forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations, and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Vaxart makes, including uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement, and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates, and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from the clinical studies; decisions by regulatory authorities impacting labeling, manufacturing processes, and safety that could affect the availability or commercial potential of any product candidate, including the possibility that Vaxart’s product candidates may not be approved by the FDA or non-U.S. regulatory authorities; that, even if approved by the FDA or non-U.S. regulatory authorities, Vaxart’s product candidates may not achieve broad market acceptance; that a Vaxart collaborator may not attain development and commercial milestones; that Vaxart or its partners may experience manufacturing issues and delays due to events within, or outside of, Vaxart’s or its partners’ control; difficulties in production, particularly in scaling up initial production, including difficulties with production costs and yields, quality control, including stability of the product candidate and quality assurance testing, shortages of qualified personnel or key raw materials, and compliance with strictly enforced federal, state, and foreign regulations; that Vaxart may not be able to obtain, maintain, and enforce necessary patent and other intellectual property protection; that Vaxart’s capital resources may be inadequate; Vaxart’s ability to resolve pending legal matters; Vaxart’s ability to obtain sufficient capital to fund its operations on terms acceptable to Vaxart, if at all; the impact of government healthcare proposals and policies; competitive factors; and other risks described in the “Risk Factors” sections of Vaxart’s Quarterly and Annual Reports filed with the SEC. Vaxart does not assume any obligation to update any forward-looking statements, except as required by law. Contacts Vaxart Media Relations:Mark HerrVaxart, Incmherr@vaxart.com(203) 517-8957 Investor Relations:Matt SteinbergFINN PartnersIR@vaxart.com(646) 871-8481

Prioritizing autoimmune programs aims to focus upon near-term and intermediate value creation potential, while retaining oncology programs as promising clinical data continues to mature - Company anticipates annualized capital and workforce requirements to be reduced by approximately 25 percent BOSTON, July 25, 2024 (GLOBE NEWSWIRE) -- Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage and modulate disease-specific T cells, today announced the strategic prioritization of its autoimmune programs and organizational restructuring to strengthen operational efficiencies while enabling its encouraging oncology survival data to continue to mature. “We have made substantial progress advancing the development of our autoimmune program CUE-401 through our partnership with Ono Pharmaceutical, Co., Ltd. and demonstrable preclinical progress advancing CUE-501, our program for depleting autoreactive B cells,” said Daniel Passeri, chief executive officer of Cue Biopharma. “I believe each of these autoimmune programs has the potential to address multiple diseases and create near-term and intermediate value creation opportunities. While we plan to focus our resources on our novel autoimmune programs, we intend to preserve the potential value of our clinical oncology programs by retaining requisite clinical capabilities to enable maturation of clinical survival data in the current ongoing Phase 1 trials of CUE-101 and CUE-102. As such, we are actively pursuing third party support through partnerships and collaborations to further develop these programs. We believe the strategic measures we are taking will strengthen operational efficiencies and extend our capital runway.” Through strategic realignment and prioritizing autoimmune programs, along with associated organizational restructuring, Cue Biopharma expects to reduce its fiscal year 2025 operating expenses by approximately 25%, to a projected annual cash burn, based upon current assumptions, of approximately $30 million. Cue Biopharma continues to pursue additional partnership support to further improve operational efficiencies and decrease capital requirements. To achieve its strategic objectives, Cue Biopharma has realigned its workforce requirements resulting in an approximately 25% reduction of staff across research, development and general and administrative resources. This workforce realignment along with the implementation of focused operational efficiencies is expected to extend the company’s cash runway into mid-year 2025. About CUE-401CUE-401, partnered with Ono Pharmaceutical Co., Ltd., is a preclinical, bispecific fusion protein designed to induce and expand regulatory T cells (Tregs) through the delivery of transforming growth factor beta (TGF-β) and interleukin 2 (IL-2) with therapeutic potential across a range of T-cell mediated autoimmune and inflammatory diseases. About CUE-501CUE-501 is a bispecific designed to selectively harness the protective anti-viral T cell repertoire (virus-specific T cells, or VSTs) and redirect them to target and deplete B cells. Deploying a biologic to selectively redirect “killer” T cells, while avoiding the systemic engagement and activation of all T cells, to accomplish T cell-mediated B cell depletion addresses the important mechanism of autoimmune diseases and may offer significant advantages over current cell therapy-based strategies and bispecifics. About the CUE-100 Series The CUE-100 series consists of Fc-fusion biologics that present two signals to T cells. Signal #1 is a tumor-specific peptide linked to a major histocompatibility complex (pMHC) to enable selectivity and specificity. Signal #2 is a rationally engineered interleukin 2 (IL-2) molecule to trigger T cell activation. These singular biologics are anticipated to selectively target, activate and expand a robust repertoire of tumor-specific T cells directly in the patient’s body. The binding affinity of IL-2 for its receptor has been deliberately attenuated to achieve preferential selective activation of tumor-specific effector T cells while reducing the potential for effects on regulatory T cells (Tregs) or broad systemic activation, potentially mitigating the dose-limiting toxicities associated with current IL-2-based therapies. About CUE-101 and the Phase 1 TrialCUE-101 is Cue Biopharma’s lead clinical drug candidate from the CUE-100 series of interleukin 2 (IL-2)-based biologics. It is designed to activate and expand HPV16 tumor-specific T cells by presenting the HPV E7 protein to the HPV-specific T cell receptor. CUE-101 is currently being evaluated in a fully enrolled Phase 1 open label, dose escalation and expansion study, for the treatment of HPV16+ driven recurrent/metastatic head and neck squamous cell carcinoma in second line (2L) and beyond patients as a monotherapy, and as a first line (1L) therapy in combination with pembrolizumab (KEYTRUDA®). About CUE-102 and the Phase 1 TrialCUE-102 is Cue Biopharma’s second lead clinical drug candidate from the CUE-100 series of interleukin 2 (IL-2)-based biologics. It is designed to activate and expand Wilms’ Tumor 1 (WT1)-specific T cells by presenting the WT1 peptide to the WT1- specific T cell receptor. WT1 is a well-recognized onco-fetal protein known to be over-expressed in a number of cancers, including solid tumors and hematologic malignancies. CUE-102 is being evaluated in a Phase 1 open label, two-part dose escalation and expansion study, for patients with late-stage colorectal, gastric/gastroesophageal junction, pancreatic and ovarian cancers that express WT1. About Cue BiopharmaCue Biopharma, a clinical-stage biopharmaceutical company, is developing a novel class of injectable biologics to selectively engage and modulate disease-specific T cells directly within the patient’s body. The company’s proprietary platform, Immuno-STAT™ (Selective Targeting and Alteration of T cells) and biologics are designed to harness the curative potential of the body’s intrinsic immune system through the selective modulation of disease-specific T cells without the adverse effects of broad systemic immune modulation. Headquartered in Boston, Massachusetts, we are led by an experienced management team and independent Board of Directors with deep expertise in immunology and immuno-oncology as well as the design and clinical development of protein biologics. For more information please visit www.cuebiopharma.com and follow us on X and LinkedIn. Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, those regarding: the company’s belief regarding the potential benefits and applications of its drug candidates and programs; the near-term and intermediate value creation potential of its autoimmune programs; the company’s intention to preserve the value of its oncology programs; the company’s business strategies, plans and prospects, including those related to the prioritization of CUE-401 and CUE-501, partnering opportunities and the potential benefits of the company’s program prioritization and realignment and workforce reduction on its burn rate; and the company’s projections regarding its annualized capital requirements, cash burn rate, cash burn rate reductions, 2025 cash burn rate, workforce reductions and cash runway. Forward-looking statements, which are based on certain assumptions and describe the company’s future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as “believe,” “expect,” “may,” “will,” “should,” “would,” “could,” “seek,” “intend,” “plan,” “goal,” “project,” “estimate,” “anticipate,” “strategy,” “future,” “likely,” “promise” or other comparable terms, although not all forward-looking statements contain these identifying words. All statements other than statements of historical facts included in this press release regarding the company’s strategies, prospects, financial condition, operations, costs, plans and objectives are forward-looking statements. Important factors that could cause the company’s actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the company’s ability to shift its focus to its autoimmune assets and achieve the cost savings that it is projecting; the company’s limited operating history, limited cash and a history of losses; the company’s ability to achieve profitability; potential setbacks in the company’s research and development efforts including negative or inconclusive results from its preclinical studies or clinical trials or the company’s ability to replicate in later clinical trials positive results found in preclinical studies and early-stage clinical trials of its product candidates; serious and unexpected drug-related side effects or other safety issues experienced by participants in clinical trials; its ability to secure required U.S. Food and Drug Administration (“FDA”) or other governmental approvals for its product candidates and the breadth of any approved indication; adverse effects caused by public health pandemics, including possible effects on the company’s operations and clinical trials; delays and changes in regulatory requirements, policy and guidelines including potential delays in submitting required regulatory applications to the FDA; the company’s reliance on licensors, collaborators, contract research organizations, suppliers and other business partners; the company’s ability to obtain adequate financing to fund its business operations in the future and ability to continue as a going concern; the company’s ability to maintain and enforce necessary patent and other intellectual property protection; competitive factors; general economic and market conditions and the other risks and uncertainties described in the Risk Factors and Management's Discussion and Analysis of Financial Condition and Results of Operations sections of the company’s most recently filed Annual Report on Form 10-K and any subsequently filed Quarterly Report(s) on Form 10-Q. Any forward-looking statement made by the company in this press release is based only on information currently available to the company and speaks only as of the date on which it is made. The company undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. Investor Contact Marie Campinell Senior Director, Corporate CommunicationsCue Biopharma, Inc.mcampinell@cuebio.com Media ContactJonathan PappasLifeSci Communicationsjpappas@lifescicomms.com

TUESDAY, July 9, 2024 -- A new urine test might help doctors more easily screen for cervical cancer, researchers report. The test looks for proteins generated by a type of cancer-causing human papillomavirus, HPV 16. HPV strains 16 and 18 are responsible for nearly all cervical cancers, according to the National Cancer Institute. These proteins, called E7 proteins, are associated with a high risk of cervical cancer, researchers said. “Our new urine test can detect HPV16 E7 proteins, which are critical markers of cervical cancer risk, at extremely low levels,” said lead researcher Etsuro Ito , a professor of biology at Waseda University in Japan. “This means that women may be able to screen for cervical cancer without the discomfort and inconvenience of a traditional Pap test.” The test detected E7 proteins in 80% of women with Stage 1 cervical intraepithelial neoplasia (CIN), a precursor to cervical cancer. It also found the proteins in 71% of women with Stage 2 CIN and 38% of women with Stage 3 CIN, results show. “We believe that the E7 oncoprotein is critical in the early stages of HPV-related cervical carcinogenesis and E7 may play a more significant role in the progression of CIN1 and CIN2 than in CIN3,” Ito said in a university news release. The availability of a simple urine test could aid efforts to eradicate cervical cancer by eliminating barriers related to screening, researchers said. “This new method holds great promise for early detection and prevention of cervical cancer,” Ito said. “We are optimistic that further development and validation of this assay will lead to its widespread use in clinical settings.” The study was recently published in the journal Microorganisms . Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.