A Phase 2b, Open-label Study to Evaluate the Efficacy, Safety, Tolerability, Immunogenicity and Treatment Regimens of VTP-300 Combined With Low-dose Nivolumab in Chronic Hepatitis B Infection

This is an open-label study to determine the efficacy, safety, tolerability and immunogenicity of ChAdOx1-HBV and MVA-HBV, together VTP-300, in combination with low-dose nivolumab, in patients with chronic HBV who are virally suppressed with oral anti-viral therapies.

开始日期2022-09-21

申办/合作机构

Vaccitech (UK) Ltd.

NCT04778904 / Completed临床1/2期

A Phase 1b/2a, Open-Label Study to Evaluate the Safety, Tolerability and Immunogenicity of VTP-300 With or Without Nivolumab in Participants With Chronic Hepatitis B Infection

This is an open-label study to determine the safety, tolerability and immunogenicity of ChAdOx1-HBV and MVA-HBV vaccines, with or without nivolumab, in patients with chronic HBV who are virally suppressed with oral anti-viral therapies.

开始日期2020-12-22

申办/合作机构

Vaccitech (UK) Ltd.

100 项与 MVA-HBV(Vaccitech) 相关的临床结果

登录后查看更多信息

100 项与 MVA-HBV(Vaccitech) 相关的转化医学

登录后查看更多信息

100 项与 MVA-HBV(Vaccitech) 相关的专利（医药）

登录后查看更多信息

项与 MVA-HBV(Vaccitech) 相关的文献（医药）

2024-12-01·Journal of Hepatology

Phase Ib/IIa randomized study of heterologous ChAdOx1-HBV/MVA-HBV therapeutic vaccination (VTP-300) as monotherapy and combined with low-dose nivolumab in virally-suppressed patients with CHB

Article

作者: Anderson, Katie ; Agarwal, Kaushik ; Lo, Gin-Ho ; Kolenovska, Radka ; Chuang, Wan-Lobg ; Lim, Young-Suk ; Vardeu, Antonella ; Tak, Won Young ; Barnes, Ellie ; Kopycinski, Jakub ; Bussey, Louise ; Brown, Anthony ; Chen, Chi-Yi ; O'Brien, Susanne ; Tseng, Kuo-Chih ; Evans, Thomas ; Tria, A ; Teoh, Sui Lynn ; Heo, Jeong

BACKGROUND & AIMSThe induction of effective CD8+ T cells is thought to play a critical role in the functional cure of chronic hepatitis B (CHB). Additionally, the use of checkpoint inhibitors is being evaluated to overcome T-cell dysfunction during CHB.METHODSA chimpanzee adenoviral vector (ChAdOx1-HBV) and a Modified vaccinia Ankara boost (MVA-HBV) encoding the inactivated polymerase, core, and S region from a consensus genotype C HBV were studied. Fifty-five patients with virally suppressed CHB and HBsAg <4,000 IU/ml were enrolled. Group 1 received MVA-HBV intramuscularly on Day 0 and 28, Group 2 received ChAdOx1-HBV on Day 0 and MVA-HBV on Day 28 (VTP-300), Group 3 received VTP-300 + low-dose nivolumab (LDN) on Day 28, and Group 4 received VTP-300 plus LDN with both injections.RESULTSVTP-300 alone and in combination with LDN was well tolerated with no treatment-related serious adverse events. Reductions of HBsAg were demonstrated in Group 2: 3 of 18 patients with starting HBsAg <50 IU/ml had durable log₁₀ declines of >0.7 log₁₀ at 2 months after the last dose. Group 3 (n = 18) had mean reductions in HBsAg of 0.76 log₁₀ and 0.80 log₁₀ (p <0.001) at 2 and 7 months after the last dose. Two patients developed persistent non-detectable HBsAg levels. CD4+ and CD8+ antigen-specific T-cell responses were generated and there was a correlation between IFN-γ ELISpot response and HBsAg decline in Group 2.CONCLUSIONSVTP-300 induced CD4+ and CD8+ T cells and lowered HBsAg in a subset of patients with baseline values below 100 IU/ml. The addition of LDN resulted in significant reduction in surface antigen. VTP-300 is a promising immunotherapeutic that warrants further development alone or in combination therapies.IMPACT AND IMPLICATIONSThe induction of potent, durable CD8+ T cells may be critical to achieving a functional cure in chronic HBV infection. A prime-boost immunotherapeutic consisting of an adenoviral-vector encoding hepatitis B antigens followed by a pox virus boost was shown to induce CD8+ T cells and to lower HBsAg, either alone or more impactfully when administered in conjunction with a checkpoint inhibitor, in patients with chronic hepatitis B. The use of immunotherapeutics in this setting warrants further evaluation.CLINTRIALSNCT047789.

2021-11-01·Molecular Immunology3区 · 医学

MVAΔ008 viral vector encoding the model protein OVA induces improved immune response against the heterologous antigen and equal levels of protection in a mice tumor model than the conventional MVA

3区 · 医学

Article

作者: Maizon, Daniel Omar ; Calamante, Gabriela ; Gherardi, María Magdalena ; Molinari, Paula ; Gravisaco, María José ; Del Médico Zajac, María Paula ; Morón, Gabriel

Modified vaccinia Ankara virus (MVA) is extensively used as a vaccine vector. We have previously observed that MVAΔ008, an MVA lacking the gene that codes for interleukin-18 binding protein, significantly increases CD8+ and CD4+ T-cell responses to vaccinia virus (VACV) epitopes and recombinant HIV antigens. However, the efficacy of this vector against pathogens or tumor cells remains unclear. Thus, the aim of this study was to evaluate the cellular immune response and the protection induced by recombinant MVAs encoding the model antigen ovalbumin (OVA). We used the MO5 melanoma tumor model (OVA-expressing tumor) as an approach for evaluating the vector-induced efficacy. Our results show that MVAΔ008-OVA (optimized vector) induced higher in vivo specific cytotoxicity and ex vivo T-cell IFN-γ responses against OVA than the conventional MVA vector. Importantly, the recombinant vectors were capable of controlling MO5 tumor growth. Indeed, the administration of MVAΔ008-OVA or MVA-OVA in prophylactic and therapeutic schemes provided total protection and longer survival of mice, respectively. Overall, our results demonstrate the improved immunogenicity and the protective capacity of MVAΔ008 against a heterologous model antigen. These findings suggest that MVAΔ008 constitutes an excellent candidate for vaccine development against pathogens or cancer therapy.

2021-07-01·Journal for ImmunoTherapy of Cancer2区 · 医学

Statins act as transient type I interferon inhibitors to enable the antitumor activity of modified vaccinia Ankara viral vectors

2区 · 医学

ArticleOA

作者: Ardaiz, Nuria ; Di Trani, Claudia Augusta ; Tenesaca, Shirley ; Otano, Itziar ; Fernandez-Sendin, Myriam ; Aranda, Fernando ; Bella, Angela ; Medina-Echeverz, José ; Vasquez, Marcos ; Berraondo, Pedro ; Gomar, Celia ; Melero, Ignacio ; Alvarez, Maite

BackgroundModified vaccinia virus Ankara (MVA) are genetically engineered non-replicating viral vectors. Intratumoral administration of MVA induces a cyclic GMP-AMP synthase-mediated type I interferon (IFN) response and the production of high levels of the transgenes engineered into the viral genome such as tumor antigens to construct cancer vaccines. Although type I IFNs are essential for establishing CD8-mediated antitumor responses, this cytokine family may also give rise to immunosuppressive mechanisms.MethodsIn vitro assays were performed to evaluate the activity of simvastatin and atorvastatin on type I IFN signaling and on antigen presentation. Surface levels of IFN α/β receptor 1, endocytosis of bovine serum albumin-fluorescein 5 (6)-isothiocyanate, signal transducer and activator of transcription (STAT) phosphorylation, and real-time PCR of IFN-stimulated genes were assessed in the murine fibroblast cell line L929. In vivo experiments were performed to characterize the effect of simvastatin on the MVA-induced innate immune response and on the antitumor effect of MVA-based antitumor vaccines in B16 melanoma expressing ovalbumin (OVA) and Lewis lung carcinoma (LLC)-OVA tumor models. RNAseq analysis, depleting monoclonal antibodies, and flow cytometry were used to evaluate the MVA-mediated immune response.ResultsIn this work, we identified commonly prescribed statins as potent IFNα pharmacological inhibitors due to their ability to reduce surface expression levels of IFN-α/β receptor 1 and to reduce clathrin-mediated endocytosis. Simvastatin and atorvastatin efficiently abrogated for 8 hours the transcriptomic response to IFNα and enhanced the number of dendritic cells presenting an OVA-derived peptide bound to major histocompatibility complex (MHC) class I. In vivo, intraperitoneal or intramuscular administration of simvastatin reduced the inflammatory response mediated by peritumoral administration of MVA and enhanced the antitumor activity of MVA encoding tumor-associated antigens. The synergistic antitumor effects critically depend on CD8+cells, whereas they were markedly improved by depletion of CD4+lymphocytes, T regulatory cells, or NK cells. Either MVA-OVA alone or combined with simvastatin augmented B cells, CD4+lymphocytes, CD8+lymphocytes, and tumor-specific CD8+in the tumor-draining lymph nodes. However, only the treatment combination increased the numbers of these lymphocyte populations in the tumor microenvironment and in the spleen.ConclusionIn conclusion, blockade of IFNα functions by simvastatin markedly enhances lymphocyte infiltration and the antitumor activity of MVA, prompting a feasible drug repurposing.

项与 MVA-HBV(Vaccitech) 相关的新闻（医药）

2023-11-09

·BioSpace

Barinthus Bio Presents Interim Data from Phase 2b HBV003 Trial and Phase 2a AB-729-202 Trial in Collaboration with Arbutus Biopharma in Chronic HBV Patients at AASLD

Initial data from the combination of imdusiran and VTP-300 show meaningful reductions of HBsAg levels that were maintained well below baseline. In HBV003, 31% of participants with screening HBsAg level of ≤200 IU/mL had >1 log HBsAg reductions. VTP-300 was generally well-tolerated in both trials. OXFORD, United Kingdom, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Barinthus Biotherapeutics plc (NASDAQ: BRNS), formerly Vaccitech plc, today announced the presentation of data from two HBV clinical trials at The American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting® 2023. The presentations include an oral presentation of data from HBV003, an ongoing Phase 2b trial designed to further evaluate the safety and efficacy of VTP-300 when combined with a low-dose anti-PD-1 antibody, and standard-of-care (SoC) nucleos(t)ide analogue (NUC) therapy. Alongside this, a late-breaking poster presentation with interim data from patients with chronic hepatitis B (CHB) from the Phase 2a AB-729-202 trial combining Arbutus Biopharma Corporation’s (NASDAQ: ABUS) RNAi therapeutic candidate, imdusiran (AB-729), with Barinthus Bio’s T cell stimulating immunotherapeutic candidate, VTP-300, and SoC NUC therapy. Barinthus Bio is a clinical-stage biopharmaceutical company developing novel T cell immunotherapeutic candidates designed to guide the immune system to overcome chronic infectious diseases, autoimmunity, and cancer. “We believe these early data are very encouraging. In HBV003, VTP-300 in combination with nivolumab continues to show meaningful and sustained HBsAg declines across all treatment groups, with the most prominent declines occurring in patients with lower baseline HBsAg levels at screening,” said Bill Enright, Chief Executive Officer of Barinthus Bio. Regarding the combination trial imdusiran with VTP300, Bill added “Although these are preliminary data, we can already see that VTP-300 appears to show a meaningful impact in sustaining low HBsAg in patients after imdusiran treatment, with clear differences shown between placebo and VTP-300. It’s very positive that we are seeing that all participants treated with imdusiran and VTP-300 have qualified to stop NUC therapy, which really highlights VTP-300’s potential as an important component of a functional cure regimen.” Study HBV003: VTP-300 and Low-dose Nivolumab HBV003 is designed to obtain critical information on treatment dosing regimen with patients receiving VTP-300 and low-dose nivolumab. All Groups receive ChAdOx at Day 1, Groups 1 & 2 receive MVA with nivolumab at Day 29 with Group 2 being dosed again at Day 85, Group 3 receives only MVA at Day 29, followed by nivolumab at Day 36 and a second MVA dose at Day 85 to evaluate PD-1 inhibition timing. Seventy-four out of a planned 120 virally suppressed CHB patients on stable NUC therapy have been enrolled in the trial and 57 have reached Day 113. VTP-300 in combination with nivolumab led to HBsAg declines in all treatment groups, particularly in participants with screening HBsAg levels ≤200 IU/mL. >0.5 and >1 log drops have been observed in all groups at Day 113 in 23% and 9% of participants, respectively. Participants with an HBsAg level of ≤200 IU/mL at screening were more likely to have >1 log HBsAg reductions (31%) compared to those with HBsAg levels >200 IU/mL at Day 1 (2%). Greater mean HBsAg log reductions were observed in Group 2 (ChAdOx-HBV Day 1; MVA-HBV and nivolumab Day 29 and Day 85) but insufficient data for definitive conclusion. Seven participants have met the criteria for NUC discontinuation; three have discontinued and two have restarted NUC therapy. Preliminary safety data suggest VTP-300 in combination with nivolumab has been generally well tolerated, with no treatment-related SAEs observed or reported. Thyroid dysfunction reported in seven participants attributed to nivolumab administration which has returned to normal in four patients. The HBV003 trial protocol is currently being amended to include only participants with screening HBsAg ≤200 IU/mL. Participants with screening HBsAg ≤200 IU/mL have been observed to benefit the most in the preliminary data, with the trial protocol amendment being focused on improving the overall risk/benefit ratio. People with thyroid autoantibodies, family history of autoimmune thyroiditis, or abnormal thyroid levels will be excluded from trial eligibility to minimize the risk of thyroiditis. Study AB-729-202: VTP-300 in Combination with Imdusiran (AB-729) Clinical trial AB-729-202 enrolled forty non-cirrhotic, virally suppressed CHB patients that were on stable NUC therapy. The patients initially received imdusiran (60mg every 8 weeks) for 24 weeks and were then randomized to receive either VTP-300 or placebo at week 26 and 30 (and conditionally at week 38 if they experienced a >0.5 log10 decline in HBsAg between Weeks 26 and 34), in addition to ongoing NUC therapy. The preliminary data include a subset of patients that received the two dose VTP-300 regimen (28/40 patients) and available follow-up data to Week 48 (12/40 patients) and showed the following: Robust reductions of HBsAg were seen during the imdusiran treatment period (-1.86 log10 mean reduction from baseline after 24 weeks of treatment). This decline in HBsAg is comparable to the declines seen with imdusiran in other clinical trials conducted to date. 97% of the imdusiran treated patients (33/34) had HBsAg <100 IU/mL at the time of the first VTP-300/placebo dose. VTP-300 treatment appeared to contribute to the maintenance of low HBsAg levels in the early post-treatment period, as the mean HBsAg levels in the placebo group begin to increase starting approximately 12 weeks after the last dose of imdusiran. All VTP-300 treated patients have maintained HBsAg <100 IU/mL through week 48, 60% have maintained HBsAg <10 IU/mL, and all have qualified to stop NUC therapy. Preliminary immunology data suggests HBV-specific T cell IFN-γ production was enhanced in patients receiving imdusiran plus VTP-300 compared to placebo. The preliminary safety data from this trial demonstrate that imdusiran and VTP-300 were both generally well-tolerated. There were no serious adverse events, Grade 3 or 4 adverse events or treatment discontinuations. Dr. Karen Sims, Chief Medical Officer of Arbutus Biopharma, commented, “Imdusiran consistently delivers compelling efficacy and safety data in multiple Phase 2a populations and combinations. In this trial, all but one patient reached surface antigen levels below 100 IU/mL and one reached <LLOQ (lower limit of quantification) with 24 weeks of imdusiran plus NUC therapy alone, which is a meaningful achievement as we believe lowering surface antigen is key to promoting host HBV-specific immune reawakening. As we continue to dose and follow these patients, I look forward to seeing the potential that imdusiran, VTP-300, and NUC therapy can have on achieving a functional cure for patients with CHB.” The presentation for HBV003 and poster for AB-729-202 can be found on the Barinthus Bio website at . About Barinthus Bio’s VTP-300 VTP-300 is an immunotherapeutic candidate consisting of an initial dose using the ChAdOx vector and a secondary dose(s) using the MVA vector, both encoding multiple hepatitis B antigens, including full-length surface, modified polymerase, and core antigens. VTP-300 is the first antigen-specific immunotherapy that has been shown to induce sustained reductions in HBsAg. Barinthus Bio is studying VTP-300 in combination with other agents, including siRNA and low-dose anti-PD-1 antibodies, to control the infection and counterbalance the immune suppression and T cell exhaustion in the liver caused by chronic HBV infection. About imdusiran (AB-729), Arbutus’ Lead RNAi Therapeutic Imdusiran is an RNA interference (RNAi) therapeutic specifically designed to reduce all HBV viral proteins and antigens including hepatitis B surface antigen, which is thought to be a key prerequisite to enable reawakening of a patient’s immune system to respond to the virus. Imdusiran targets hepatocytes using Arbutus’ novel covalently conjugated N-Acetylgalactosamine (GalNAc) delivery technology enabling subcutaneous delivery. Clinical data generated thus far has shown single and multiple doses of imdusiran to be generally safe and well-tolerated, while also providing meaningful reductions in hepatitis B surface antigen and hepatitis B DNA. Imdusiran is currently in multiple Phase 2a clinical trials. About Hepatitis B Virus (HBV) Globally it is estimated that there are more than 300 million people, including up to 2.4 million in the U.S. and 14 million in Europe, living with chronic HBV infection, with the highest prevalence in East Asia and Africa. Approximately 820,000 people die each year from HBV and related complications, such as liver cirrhosis and hepatocellular carcinoma. Due to low HBV diagnosis rates of about 10.5% aware of their infection coupled with strict treatment eligibility guidelines, only 6.6 million (2.2%) people with chronic HBV are receiving treatment and less than 10% will achieve a functional cure with existing therapies. About Barinthus Bio Barinthus Bio is a clinical-stage biopharmaceutical company developing novel T cell immunotherapeutic candidates designed to guide the immune system to overcome chronic infectious diseases, autoimmunity, and cancer. Helping people living with serious diseases and their families is the guiding principle at the heart of Barinthus Bio. With a broad pipeline, built around four proprietary platform technologies: ChAdOx, MVA, SNAP-TI, and SNAP-CI; Barinthus Bio is advancing a pipeline of five product candidates across a diverse range of therapeutic areas, including: VTP-300, an immunotherapeutic candidate designed as a potential component of a functional cure for chronic HBV infection; VTP-200, a non-surgical product candidate for persistent high-risk human papillomavirus (HPV); VTP-1000, an autoimmune candidate designed to utilize the SNAP-TI platform to treat patients with celiac disease; VTP-850, a second-generation immunotherapeutic candidate designed to treat recurrent prostate cancer; and VTP-1100, a preclinical cancer candidate designed to utilize the SNAP-CI platform to treat patients with HPV-related cancer. Barinthus Bio’s proven scientific expertise, diverse portfolio and focus on pipeline development uniquely positions the company to navigate towards delivering treatments for people with infectious diseases, autoimmunity and cancers that have a significant impact on their everyday lives. For more information, visit . About Arbutus Arbutus Biopharma Corporation (Nasdaq: ABUS) is a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to identify and develop novel therapeutics with distinct mechanisms of action, which can be combined to provide a functional cure for patients with chronic hepatitis B virus (cHBV). Arbutus believes the key to success in developing a functional cure involves suppressing HBV DNA, reducing surface antigen, and boosting HBV-specific immune responses. Arbutus’ pipeline of internally developed, proprietary compounds includes an RNAi therapeutic, imdusiran (AB-729), and an oral PD-L1 inhibitor, AB-101. Imdusiran has generated meaningful clinical data demonstrating an impact on both surface antigen reduction and reawakening of the HBV-specific immune response. Imdusiran is currently in two Phase 2a combination clinical trials. AB-101 is currently being evaluated in a Phase 1a/1b clinical trial. Additionally, Arbutus has identified compounds in its internal PD-L1 portfolio that could also be used in oncology indications. For more information, visit . Barinthus Bio’s Forward-Looking Statements This press release contains forward-looking statements regarding Barinthus Bio within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, which can generally be identified as such by use of the words “may,” “will,” “plan,” “forward,” “encouraging,” “believe,” “potential,” and similar expressions, although not all forward-looking statements contain these identifying words. These forward-looking statements include, without limitation, express or implied statements regarding: Barinthus Bio’s plans and strategy with respect to its pipeline and product candidates, including VTP-300 and the HBV003 clinical trial, and the potential benefits of VTP-300 for the treatment of chronic HBV. Any forward-looking statements in this press release are based on Barinthus Bio management’s current expectations and beliefs and are subject to numerous risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks and uncertainties related to the success, cost and timing of Barinthus Bio’s pipeline development activities and planned and ongoing clinical trials, Barinthus Bio’s ability to execute on its strategy, regulatory developments, the risk that Barinthus Bio may not realize the benefits related to its rebranding and name change, Barinthus Bio’s ability to fund its operations and access capital, global economic uncertainty, including disruptions in the banking industry, the conflict in Ukraine, and the conflict in Israel and Gaza, and other risks identified in Barinthus Bio’s filings with the Securities and Exchange Commission (the “SEC”), including its Annual Report on Form 10-K for the year ended December 31, 2022, its Quarterly Reports on Form 10-Q and subsequent filings with the SEC. Barinthus Bio cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Barinthus Bio expressly disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Arbutus’ Forward-Looking Statements This press release contains forward-looking statements regarding Arbutus within the meaning of the Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and forward-looking information within the meaning of Canadian securities laws (collectively, forward-looking statements). Forward-looking statements in this press release include statements about Arbutus’ belief that the key to success in developing a functional cure for CHB involves suppressing HBV DNA, reducing surface antigen, and boosting HBV-specific immune responses; Arbutus’ future development plans for Arbutus’ product candidates; Arbutus’ program updates; the expected cost, timing and results of Arbutus’ clinical development plans and clinical trials with respect to Arbutus’ product candidates; Arbutus’ expectations with respect to clinical trial design and the release of data from Arbutus’ clinical trials and the expected timing thereof; Arbutus’ expectations and goals for Arbutus’ collaborations with third parties and any potential benefits related thereto, including with respect to the Phase 2a clinical trial combining imdusiran with VTP-300; and the potential for Arbutus’ product candidates to achieve success in clinical trials. With respect to the forward-looking statements contained in this press release, Arbutus has made numerous assumptions regarding, among other things: the effectiveness and timeliness of preclinical studies and clinical trials, and the usefulness of the data; the timeliness of regulatory approvals; the continued demand for Arbutus’ assets; and the stability of economic and market conditions. While Arbutus considers these assumptions to be reasonable, these assumptions are inherently subject to significant business, economic, competitive, market and social uncertainties and contingencies, including uncertainties and contingencies related to the ongoing patent litigation matters. Additionally, there are known and unknown risk factors which could cause Arbutus’ actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements contained herein. Known risk factors include, among others: the risk that anticipated pre-clinical studies and clinical trials may be more costly or take longer to complete than anticipated, and may never be initiated or completed, or may not generate results that warrant future development of the tested product candidate; Arbutus may elect to change its strategy regarding its product candidates and clinical development activities; Arbutus may not receive the necessary regulatory approvals for the clinical development of Arbutus’ products; economic and market conditions may worsen; uncertainties associated with litigation generally and patent litigation specifically; Arbutus and its collaborators may never realize the expected benefits of the collaborations, including with Barinthus Bio; and market shifts may require a change in strategic focus; and risks related to the sufficiency of Arbutus’ cash resources and its ability to obtain adequate financing in the future for its foreseeable and unforeseeable operating expenses and capital expenditures. A more complete discussion of the risks and uncertainties facing Arbutus appears in Arbutus’ Annual Report on Form 10-K, Arbutus’ Quarterly Reports on Form 10-Q and Arbutus’ continuous and periodic disclosure filings, which are available at and at All forward-looking statements herein with respect to Arbutus are qualified in their entirety by this cautionary statement, and Arbutus disclaims any obligation to revise or update any such forward-looking statements or to publicly announce the result of any revisions to any of the forward-looking statements contained herein with respect to Arbutus to reflect future results, events or developments, except as required by law. Barinthus Bio - Contacts: Investor Contacts: Christopher M. Calabrese  Managing Director  LifeSci Advisors +1 917-680-5608 ccalabrese@lifesciadvisors.com Kevin Gardner Managing Director LifeSci Advisors +1 617-283-2856 kgardner@lifesciadvisors.com Media contact: Audra Friis Sam Brown, Inc. +1 917-519-9577 audrafriis@sambrown.com Company contact: Jonothan Blackbourn IR & PR Manager Barinthus Biotherapeutics ir@barinthusbio.com Arbutus - Investors and Media Lisa M. Caperelli Vice President, Investor Relations Phone: 215-206-1822 Email: lcaperelli@arbutusbio.com

临床2期临床结果

2022-11-10

·GlobeNewswire-Health Care

Vaccitech Reports Third Quarter 2022 Financial Results and Recent Corporate Developments

OXFORD, United Kingdom, Nov. 10, 2022 (GLOBE NEWSWIRE) -- Vaccitech plc (NASDAQ: VACC) today announced its financial results for the third quarter ended September 30, 2022 and provided an overview of the Company’s recent corporate developments. Vaccitech is a clinical-stage biopharmaceutical company engaged in the discovery and development of novel immunotherapeutics and vaccines for the treatment and prevention of infectious diseases, autoimmunity, and cancer. “This has been a very exciting quarter at Vaccitech. During the past three months we have made significant progress on our clinical programs, strengthened our balance sheet and leadership team, and continued to actively engage with investors,” remarked Bill Enright, CEO of Vaccitech. “We dosed the first patient in our Phase 2b clinical trial of VTP-300 in HBV and reported the findings of our Phase 1b/2a study of VTP-300 at the American Association for the Study of Liver Disease (AASLD) Liver meeting. In addition, we published a paper in Cell showing the activation of two key pathways with intravenous (IV) vaccination of a SNAPvax construct, which led to improved T cell mediated tumor killing in a pre-clinical model. We were also very pleased to announce the promotion of Gemma Brown to the role of CFO. I would also like to note that that this quarter’s royalty and milestone payments from the sales of Vaxzervria®, AstraZeneca’s COVID-19 vaccine, have assisted in extending our cash runway into the first quarter of 2025. All told, this was a very active quarter for us, and we look forward to continuing our progress and outreach in the coming quarter and year.” “We have made excellent progress in our clinical programs in the past quarter and expect to reach a number of important clinical milestones in 2023,” stated Dr. Meg Marshall, Chief Medical Officer of Vaccitech. “We expect to have initiated our Phase 1/2a clinical study in the fourth quarter of 2022 with the first patient first visit (FPFV) for VTP-850, our prostate cancer program, early in the first quarter of 2023, and FPFV for VTP-1100, our HPV-Cancer program, early in the third quarter of next year. FPFV for VTP-1000, our program in Celiac disease, is slated for the fourth quarter of 2023. We also plan to present data from multiple ongoing studies of VTP-300 in HBV next year as well. So, we are looking forward to a 2023 filled with exciting clinical advances.” Third Quarter 2022 Financial Highlights Cash position: As of September 30, 2022, cash and cash equivalents were $200.1 million, compared to $214.1 million as of December 31, 2021. The cash burn from operating activities was $43.9 million, being the net of R&D and G&A spend offset by the cash received from revenue recognized in respect of sales of Vaxzevria®. $5.2 million of net cash was used in investing activities, which includes the buildout of the state of the art laboratory and Corporate Headquarters in Harwell, United Kingdom, where the Company relocated in the third quarter of 2022.Revenues: Revenues comprised primarily of the Company’s share of milestone and royalty payments received by OUI from AstraZeneca related to commercial sales of Vaxzevria®. Revenues were $6.2 million in the third quarter of 2022 compared to $17.1 million in the second quarter of 2022, with the reduction attributable to no milestones being achieved in the third quarter of 2022.Research and development expenses: Research and development expenses were $9.7 million in the third quarter of 2022 compared to $9.7 million in the second quarter of 2022, showing consistent total spend as we continue to advance our pipeline. The quarter on quarter R&D expense per program is outlined in the following table. three months ended September 30, 2022three months ended June 30, 2022Change $000$000$000Direct research and development expenses by program: VTP-200 HPV 1,310 804 506VTP-300 HBV 2,418 4,361 - 1,943VTP-600 NSCLC1 111 77 34VTP-800/850 Prostate cancer 1,160 460 700Other and earlier stage programs 1,687 1,508 179Total direct research and development expenses 6,686 7,210 - 524Internal research and development expenses: Personnel-related (including share-based compensation) 2,626 2,197 429Facility related 308 240 68Other internal costs 124 73 51Total research and development expense 9,744 9,720 24 1 The VTP-600 NSCLC Phase 1/2a trial is sponsored by Cancer Research UK General and administrative expenses: General and administrative expenses were a gain of $11.1 million (after including a foreign exchange gain of $18.7 million) in the third quarter of 2022, compared to a gain of $6.4 million (after including a foreign exchange gain of $15.2 million) in the second quarter of 2022. Excluding the foreign exchange gain, G&A expenses were $7.6 million in the third quarter of 2022, which were mainly attributable to personnel expenses of $2.8 million, including the share-based payment charge of $0.6 million, insurance costs of $1.5 million, and legal and professional fees of $2.3 million. Excluding the foreign exchange gain, G&A expenses for the second quarter were $8.8 million and were mainly attributable to personnel expenses of $4.3 million, including the share-based payment charge of $2.1 million, insurance costs of $1.6 million, and legal and professional fees of $1.0 million.Net Income: For the third quarter of 2022, the Company generated a net income attributable to its shareholders of $8.2 million, or $0.22 both per fully diluted share and per basic share, compared to a net income attributable to shareholders of $15.7 million, or $0.41 per fully diluted share and $0.42 per basic share, for the second quarter of 2022. Recent Corporate Developments Clinical developments: On October 31, 2022, we announced the dosing of the first patient in HBV003, a phase 2b clinical trial of VTP-300 to evaluate the optimal timing of low dose nivolumab and impact of additional doses of the MVA boost for a sustained decline in HBsAG. Pre-clinical developments: On October 27, 2022, we announced the publication of research from VTP-1100 in Cell that demonstrates anti-tumor activity achieved with intravenous (IV) vaccination of a SNAPvax construct in an animal model. The study demonstrates that IV administration of SNAPvax primes and expands antigen-specific T cells and reverses suppression in the tumor microenvironment, which promotes T cell infiltration and tumor cell killing. An Investigational New Drug (IND) application submission is expected during the first half of 2023 for HPV related cancer.On November 7, 2022 Dr. Young-Suk Lim, Professor of Gastroenterology in the Liver Center at University of Ulsan College of Medicine, presented a poster reporting Phase 1b/2a clinical trial data on VTP-300 at AASLD. The poster presentation showed VTP-300 immunotherapy, as monotherapy and when combined with low dose nivolumab at the boosting time point, was immunogenic and showed a sustained reduction in HBsAg in well-controlled CHB patients, and was administered with no treatment related SAEs and infrequent transient transaminitis. Two of five patients dosed in cohort 3 (ChAdOx1-HBV + MVA-HBV with low dose nivolumab given at the boost) with starting HBsAg levels below 100 achieved non-detectable levels of surface antigen at the data cutoff. Company Leadership: On September 20, 2022, we announced the promotion of Gemma Brown to Chief Financial Officer. Upcoming Milestones In addition to the recent developments detailed above, in the fourth quarter of 2022 the Company expects to Open a Phase 1/2 clinical trial of VTP-850 in patients with prostate cancer In the first quarter of 2023, the Company Intends to conduct an interim efficacy review of HPV001, a Phase 1b/2 clinical trial of VTP-200, a potential treatment for low grade HPV-related cervical lesionsExpects to have FPFV for VTP-850 in our prostate cancer programIntends to move its U.S. team into a new, state of the art facility in Germantown, Maryland In 2023, the Company expects to Submit IND applications for its two lead SNAPvax candidates, VTP-1000 for the treatment of celiac disease and VTP-1100 for the treatment of HPV-associated cancersHave FPFV for VTP-1100 in our HPV cancer programHave FPFV for VTP-1000 in our Celiac disease programPresent data from multiple ongoing clinical studies at AASLD and The European Association for the Study of the Liver (EASL) conferences About Vaccitech Vaccitech plc (“the Company”) is a clinical-stage biopharmaceutical company engaged in the discovery and development of novel immunotherapeutics and vaccines for the treatment of chronic infectious diseases, cancer, autoimmunity, and other diseases where the T cell arm of the immune system is believed to play an important role. The company’s proprietary platforms include modified simian adenoviral vectors (ChAdOx1 and ChAdOx2), other viral vectors including the well-validated Modified vaccinia Ankara (MVA), and synthetic nano-particle technologies (SNAPvax™ and Syntholytic™). The combination of different technologies in a mix and match approach (heterologous prime-boost) consistently generates significantly higher magnitudes of T cells compared with other technologies and approaches. The Company has a broad pipeline of both clinical and preclinical stage therapeutic programs to treat solid tumors, chronic viral infections as well as additional prophylactic viral vaccine programs. Vaccitech co-invented a COVID-19 vaccine, Vaxzevria®, with the University of Oxford, now approved for use in many territories and exclusively licensed worldwide to AstraZeneca through OUI. Vaccitech is entitled to receive a share of all milestone and royalty income received by OUI from AstraZeneca related to Vaxzevria®. Forward Looking Statements This press release contains forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, which can generally be identified as such by use of the words “would,” “forward,” “expect,” “plan,” “intend,” “believe,” “potential,” “continue,” and similar expressions, although not all forward-looking statements contain these identifying words. These forward looking statements include express or implied statements regarding the Company’s future expectations, plans and prospects, and include, without limitation, statements regarding the timing and advancement of the Company’s programs, including the clinical trials of VTP-200, VTP-300, and VTP-850, statements regarding the timing for the initiation of dosing of VTP-300, VTP-850, and the Company’s two lead SNAPvax candidates, VTP-1000 and VTP-1100, statements regarding the timing for the potential IND applications for VTP-1000 and VTP-1100, statements regarding the presentation of data at future conferences, and statements regarding the Company’s capital. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to numerous risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks and uncertainties related to: the success, cost and timing of the Company’s product development activities and planned and ongoing clinical trials, the Company’s ability to execute on its strategy, regulatory developments, the Company’s ability to fund its operations, global economic uncertainty and the impact that the current ongoing COVID-19 pandemic will have on the Company’s clinical trials, preclinical studies and access to capital and other risks identified in the Company’s filings with the Securities and Exchange Commission (the “SEC”), including its Annual Report on Form 10-K for the year ended December 31, 2021, its Quarterly Report on Form 10-Q for the second quarter of 2022 and subsequent filings with the SEC. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. The Company expressly disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. VACCITECH PLCCONDENSED CONSOLIDATED BALANCE SHEETS(IN THOUSANDS, EXCEPT NUMBER OF SHARES AND PER SHARE AMOUNTS)(UNAUDITED) September 30, 2022 December 31, 2021ASSETS Current assets: Cash and cash equivalents $200,104 $ 214,054 Accounts receivable 26 20 Accounts receivable - related parties 6,152 - Research and development incentives receivable 4,091 6,229 Prepaid expenses and other current assets 8,248 6,462 Total current assets 218,621 226,765 Goodwill 12,630 12,630 Property and equipment, net 6,766 1,829 Intangible assets, net 29,059 31,430 Right of use assets, net 7,558 7,257 Other assets 847 804 Total assets $275,481 $280,715 LIABILITIES AND SHAREHOLDERS’ EQUITY Current liabilities: Accounts payable $2,411 $2,419 Accrued expenses and other current liabilities 11,323 7,875 Deferred revenue 111 182 Operating lease liability – current 186 523 Debt - 159 Total current liabilities 14,031 11,158 Operating lease liability – non current 8,071 6,540 Contingent consideration 2,836 2,371 Deferred tax liability, net 5,680 8,084 Other non-current liabilities 711 - Total liabilities $31,329 $28,153 Commitments and contingencies Shareholders’ equity: Ordinary shares, £0.000025 nominal value; 37,291,492 shares authorized, issued and outstanding (December 31, 2021: authorized, issued and outstanding: 37,188,730) 1 1 Deferred A shares, £1 nominal value; 63,443 shares authorized, issued and outstanding (December 31, 2021: authorized, issued and outstanding: 63,443) 86 86 Deferred B shares, £0.01 nominal value; 570,987 shares authorized, issued and outstanding (December 31, 2021: authorized, issued and outstanding: 570,987) 8 8 Deferred C shares, £0.000007 nominal value, 27,828,231 shares authorized, issued and outstanding (December 31, 2021: authorized, issued and outstanding: 27,828,231) 01 01 Additional paid-in capital 376,939 369,103 Accumulated deficit (82,054) (108,585) Accumulated other comprehensive loss – foreign currency translation adjustments (51,143) (8,488) Total shareholders’ equity attributable to Vaccitech plc shareholders’ 243,837 252,125 Noncontrolling interest 315 437 Total shareholders’ equity $244,152 $252,562 Total liabilities and shareholders’ equity $275,481 $280,715 1 indicates amount less than thousand VACCITECH PLC CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (IN THOUSANDS, EXCEPT NUMBER OF SHARES AND PER SHARE AMOUNTS) (UNAUDITED) Three months ended Nine months ended September 30, 2022 September 30, 2021 September 30, 2022 September 30, 2021License revenue 1$6,165 16 38,237 48 Service revenue - - - 21 Research grants and contracts - 3 9 200 Total revenue 6,165 19 38,246 269 Operating expenses Research and development 9,744 4,371 30,165 13,490 General and administrative (11,132) 1,184 (13,914) 15,332 Total operating expenses 1,388 5.555 16,251 28,822 Income/ (loss) from operations 7,553 (5,536) 21,995 (28,553)Other income (expense): Change in fair value of derivatives embedded in convertible loan notes - - - 5,994 Change in fair value of contingent consideration (317) - (943) - Unrealized exchange gain on convertible loan notes - - - 209 Loss on extinguishment of convertible loan notes - - - (13,789) Interest income 1,024 - 1,776 2 Interest expense 11 - 3 (2,650) Research and development incentives (724) 959 1,150 2,789 Other - - 51 (3) Total other (expense)/ income (6) 959 2,037 (7,448)Tax benefit 674 7 2,452 60 Net income/(loss) 8,221 (4,570) 26,484 (35,941) Net loss attributable to noncontrolling interest 21 13 47 189 Net income/(loss) attributable to Vaccitech plc shareholders 8,242 (4,557) 26,531 (35,752) Weighted-average ordinary shares outstanding, basic 37,247,123 34,843,154 37,213,787 22,697,462 Weighted-average ordinary shares outstanding, diluted 38,156,564 34,843,154 38,226,092 22,697,462 Net income/(loss) per share attributable to ordinary shareholders, basic$0.22 (0.13) 0.71 (1.58)Net income/(loss) per share attributable to ordinary shareholders, diluted$0.22 (0.13) 0.69 (1.58) Net income/(loss)$8,221 (4,570) 26,484 (35,941)Other comprehensive loss – foreign currency translation adjustments (19.940) (6,473) (42,730) (7,803)Comprehensive loss (11,719) (11,043) (16,246) (43,744)Comprehensive loss attributable to noncontrolling interest 51 25 122 194 Comprehensive loss attributable to Vaccitech plc shareholders$(11,668) (11,018) (16,124) (43,550) 1Includes license revenue from related parties for the three and nine month periods ended September 30, 2022, of $6.2 million and $38.2 million, respectively. IR contacts: Christopher M. Calabrese  Kevin Gardner Managing Director  Managing Director LifeSci Advisors LifeSci Advisors 917-680-5608 617-283-2856 ccalabrese@lifesciadvisors.com kgardner@lifesciadvisors.com     Media contact:   Mike Beyer SAM BROWN, INC 312-961-2502 mikebeyer@sambrown.com     Company contact: Jonothan Blackbourn IR & PR Manager Vaccitech IR@vaccitech.co.uk

疫苗财报免疫疗法

2021-11-15

·BioSpace

Clinical Catch-Up: November 8-12

It was another busy week for clinical trial news. Here’s a look. COVID-19-Related Boehringer Ingelheim enrolled the first patient in a new clinical trial in COVID-19 patients with respiratory failure. Weill Cornell Medicine and New York-Presbyterian Hospital are leading the study in whether these patients are more susceptible to developing progressive Interstitial Lung Disease (scarring of the lungs). Synairgen reported it had hit its recruitment target of 610 participants for its global Phase III SPRINTER trial of SNG001 for hospitalized COVID-19 patients. The study is being run in 17 countries. The drug is an inhaled formulation of interferon beta, a broad-spectrum antiviral protein. A topline readout is expected in early 2022, and if successful, the company plans to an Emergency Use Authorization (EUA) in the U.S. GlaxoSmithKline and Vir Biotechnology announced headline data from the COMET-TAIL Phase III trial of IM sotrovimab for mild-to-moderate COVID-19 in high-risk, non-hospitalized adults and adolescents. It was non-inferior to IV administration. Sotrovimab is a SARS-CoV-2 neutralizing monoclonal antibody. Non-COVID-19-Related Bristol Myers Squibb’s Phase III CheckMate -816 trial hit the primary endpoint in an interim analysis. The study was evaluating the company’s checkpoint inhibitor Opdivo (nivolumab) and chemotherapy in patients with resectable stage IB to IIIA non-small cell lung cancer (NSCLC), which is a neoadjuvant setting—a first step to shrink a tumor before the main treatment, typically surgery. The combination demonstrated a statistically significant and clinically meaningful improvement in event-free survival (EFS) compared to chemotherapy alone when dosed before surgery. GlaxoSmithKline announced positive results in its Phase III trials of daprodustat. The drug, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor met the primary and secondary endpoints in the ASCEND-ND and ASCEND-D trials for anemia due to chronic kidney disease. Novartis announced results from a pooled post-hoc analysis of Phase III ORION-9, -10, and -11 trials. The studies were looking at the impact of body mass index (BMI) levels on the safety and efficacy of twice-yearly Leqvio (inclisiran). The drug was well-tolerated and demonstrated effective and sustained reduction of about 50% in low-density lipoprotein cholesterol (LDL-C) when used with other lipid-lowering therapies. The company also presented positive Phase III results from the JUNIPERA study in support of Cosentyx (secukinmab) in pediatric patients with juvenile psoriatic arthritis (JPsA) and enthesitis-related arthritis (ERA). The drug significantly delayed time to flare versus placebo. The company also published data from HER-MES, a Phase IV study that compares Aimovig (erenumab) with an oral prophylactic migraine treatment (topiramate). Aimovig has a superior efficacy versus topiramate with patients having a significantly higher probability of having a clinically meaning improvement in migraine frequency. Prelude Therapeutics reported the FDA had accepted its Investigational New Drug (IND) application for PRT2527. The company hopes to start a Phase I trial of the drug by the end of the year. PRT2527 is a potent and selective CDK9 inhibitor being developed for patients with selected solid tumors, including sarcoma, prostate cancer, breast cancer, and other cancers with genomic alterations that lead to MYC dependence. TFF Pharmaceuticals completed dosing in the Phase Ib study of Voriconazole Inhalation Powder for treatment and prevention of Invasive Pulmonary Aspergillosis. The drug is a next-generation, direct-to-lung, inhaled dry powder version of voriconazole. Selecta Biosciences announced topline results from a joint Selecta and AskBio Phase I trial of its ImmTOR platform to mitigate the formation of neutralizing antibodies against an adeno-associated viral serotype 8 serotype capsid used in gene therapies. At day 30, in patients receiving a single 0.3 mg/kg dose of ImmTOR, the company observed a median anti-AAV8 neutralizing antibody titer of 1:5, a 250-fold lower level than in subjects dosed with AAV8 capsid alone. AstraZeneca presented three new sub-analyses from the DAPA-CKD Phase III trial of Farxiga (dapagliflozin). The drug is a sodium-glucose cotransporter 2 (SGLT2) inhibitor. The data supports the consistency of the drug’s cardiorenal and mortality benefits in treating chronic kidney disease with and without type 2 diabetes. Crinetics Pharmaceuticals presented new data from ACROBAT Advance, the ongoing open label extension (OLE) trial of paltusotine in patients with acromegaly. ACROBAT Edge and Evolve are two separate Phase II studies. Treatment with paltusotine resulted in median serum insulin-like growth factor-1 (IGF-1) levels that were lower than those observed in the untreated period in the parent studies and were stably maintained at levels achieved on prior SRL therapy for up to 51 weeks. Affimed and NKGen Biotech initiated patient recruitment in the Phase I/IIa trial of the innate cell engager (ICE) AFM2 (Affimed’s tetravalent, bispecific EGFR and CD16A-binding ICE) in combination with SNK01, NKGen’s ex vivo expanded and activated autologous NK cell therapy. iOnctura fully enrolled the metastatic uveal melanoma expansion cohort of the DIONE-01 trial of IOA-244. IOA-244 is a selective PI3Kδ inhibitor. AbbVie presented integrated data from two Phase II trials, KEEPsAKE 1 and 2, of Skyrizi (risankizumab) in adults with active psoriatic arthritis. The data demonstrated that 24-weeks of treatment with the drug caused greater improvements in PsA signs and symptoms compared to placebo. Eli Lilly reported sub-analysis of the EMPEROR-Preserved Phase III trial of Jardiance (empagliflozin) for adults with heart failure with left ventricular ejection fraction (LVEF) over 40%. The drug decreased the risk for the composite primary endpoint of cardiovascular death or hospitalization for heart failure and slowed kidney function decline regardless of chronic kidney disease status at baseline. Rain Therapeutics plans to initiate a Phase II MANTRA-3 trial of milademetan as a monotherapy for Merckel cell carcinoma patients refractory to immune checkpoint inhibition. The drug is an oral mouse double minute 2 (MDM2) inhibitor. The trial is expected to start mid-2022. SCYNEXIS completed its Phase I trial of a liposomal IV formulation of ibrexafungerp. The data support the safety of the liposomal IV formulation. Ibrexafungerp is an antifungal agent, a novel class of structurally distinct glucan synthase inhibitors, triterpenoids. Neuroplast announced positive Phase I results in patients suffering from Traumatic Spinal Cord Injury (TSCI). The company’s Neuro-Cells appeared safe and well tolerated. The treatment uses the patient’s own stem cells to prevent further loss of function after sustaining TSCI. Noxopharm initiated patient enrollment in its DARRT-2 Phase II trial. DARTT is an experimental immunotherapy based on Veyonda combining with a well-tolerated, low dosage of external beam radiotherapy to trigger an immune response. Jasper Therapeutics and AVROBIO are collaborating on using Jasper’s JSP191, an anti-CD117 monoclonal antibody as a targeted conditioning agent for patients with Fabry disease and/or Gaucher disease type 1 who are receiving one of AvroBio’s ex vivo lentiviral gene therapies. JSP191 blocks stem cell factor receptor signaling. Immutep announced final OS data from its Phase IIb AIPAC trial. The study evaluated eftilagimod alpha in combination with paclitaxel in metastatic breast cancer. The data supported Phase III development, with an OS benefit trend with median survival benefit of +2.9 months. Oncorus presented Phase I data on ONCR-177 in advanced injectable tumors. ONCR-177 is an oncolytic herpes-simplex virus-1 expressing five immunomodulatory transgenes. OncoC4 presented preliminary clinical data from the ongoing Phase Ia PRESERVE-001 trial of ONC-392 in cancer patients. ONC-392 is a nextgen anti-CTLA-4 monoclonal antibody. Aravive announced positive new data from the Phase Ib portion of its open-label Phase Ib/II trial of batiraxcept (AVB-500) in combination with cabozantinib in clear cell renal cell carcinoma. Batiraxcept is a therapeutic recombinant fusion protein that neutralizes GAS6 activity by binding to GAS6, selectively inhibiting the GAS6-AXL signaling pathway, which is upregulated in multiple cancers including ovarian, renal and pancreatic. CureVac announced promising data from the completed dose-escalation portion of the Phase I trial of CV8102. CV8102 is a single-stranded non-coding RNA optimized to maximize activation of cellular receptors that normally detect viral pathogens entering cells but is designed to recruit and activate antigen-presenting cells at the site of injection to present tumor antigens released from tumor cells to T cells in the draining lymph node. 89bio presented a sub-analysis of its Phase Ib/IIa proof-of-concept study of BIO89-100 in non-alcoholic steatohepatitis (NASH), looking at the correlation of liver fat and spleen volume. BIO89-100 is a potential best-in-class fibroblast growth factor 21 (FGF21) analog. Athira Pharma presented an overview and updates from two ongoing Phase III trials, ACT-AD and LIFT-AD of ATH-1017 in mild-to-moderate Alzheimer’s disease. ATH-1017 is a small molecular designed to enhance the activity of Hepatocyte Growth Factor (HGF) and its receptor, MET. AC Immune announced that Genentech presented the full topline data from the Phase III LAURIET trial of semorinemab in mild-to-moderate Alzheimer’s disease. The drug is an investigational anti-Tau monoclonal antibody. As previously announced, the trial hit one of two co-primary endpoints, demonstrating statistically significant 43.6% reduction in rate of cognitive decline, but missed the Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) or the secondary efficacy endpoints. Yumanity Therapeutics announced that YTX-7739 hit the primary endpoints in its Phase Ib trial in Parkinson’s disease. The drug is a potential first-in-class disease-modifying mechanism of action that inhibits stearoyl-CoA desaturase (SCD). It was generally well tolerated and demonstrated favorable PK/PD and safety pro Apellis Pharmaceuticals presented data from the Phase III DERBY and OAKS trials of pegcetacoplan in geographic atrophy (GA) secondary to age-related macular degeneration. The drug is a targeted C3 therapy. It hit the primary endpoint in the OAKS study of significantly reducing GA lesion growth compared to pooled sham at 12 months. The DERBY study narrowly missed the primary endpoint, demonstrating a decrease in GA lesions growth with monthly and every-other-month treatment compared to pooled sham at 12 months. Lindis Blood Care published results from the clinical pilot study of Catuvab for the removal of tumor cells from surgical blood. The results in 16 cancer patients undergoing abdominal tumor resection demonstrated efficacy and feasibility with no residual malignant cells detected in the final erythrocyte concentrates after the procedure. Catuvab is a medical device used to remove EpCAM-positive tumor cells from surgical blood and is designed to enable the use of machine autotransfusion technology (MAT). Nouscom announced promising interim safety, immunogenicity, PK/PD and clinical activity data from the Phase I trial of NOUS-209. The drug is an off-the-shelf cancer vaccine based on shared neoantigens, administered in combination with Merck’s Keytruda (pembrolizumab) for Microsatellite Instable High (MSI-H) gastric, colorectal and gastro-esophageal junction solid tumors. Finch Therapeutics reported positive topline data from PRISM-EXT, an open-label extension of its PRISM3 Phase II trial of CP101 for prevention of recurrent C. difficile infection. There were no treatment-related serious adverse events, and the drug showed an overall safety pro with what was seen in PRISM3. Freeline Therapeutics announced new data from its ongoing Phase I/II MARVEL-1 dose-finding trial of FLT190 for Fabry disease. The data of the trial has seen expression of alpha-galactosidase A reaching near-normal levels. HOOKIPA Pharma advanced HB-201 to Phase II. The drug is being evaluated in combination with Merck’s Keytruda (pembrolizumab) as a first or second-line treatment for HPV16+ squamous cell head and neck cancers (NHSCC). HB-201 is a single-vector compound with an arenavirus backbone that expresses an E7E6 fusion protein derived from HPV16. Rafael Pharmaceuticals enrolled the first patient in the APOLLO 613 Phase I/II trial of CPI-613 (devimistat) in combination with hydroxychloroquine in patients with clear cell sarcoma at City of Hope in Duarte, Calif. Two other sites, Cleveland Clinic Children’s and University of Michigan’s Rogel Cancer Center have also been opened. Adaptimmune Therapeutics reported updated clinical and translational data from its SPEARHEAD-1 Phase III trial of afamitresgene autoleucel in advanced synovial sarcoma or myxoid/round cell liposarcoma. Based on the reported overall response rate, it is expected to meet its primary endpoint in the final analysis planned later this year. Merck initiated the VICTOR Phase III trial of Verquvo (vericiguat) in patients with chronic heart failure and reduced ejection fraction of 40% or less who have not had a recent worsening heart failure event. The drug is already approved in the U.S. to reduce the risk of CV death and heart failure hospitalization following a hospitalization for heart failure or need for outpatient IV diuretics in adults with symptomatic chronic heart failure and ejection fraction less than 45%. Eisai and Biogen presented results of sensitivity analyses evaluating the consistency of lecanemab efficacy across multiple statistical models in patients with Mild Cognitive Impairment (MCI) due to Alzheimer’s disease and mild AD. Lecanemab is an anti-amyloid beta protofibril antibody. Biogen also reported that its Aduhelm (aducanumab) significantly lowered plasma p-tau181, a biomarker of tau in Alzheimer’s disease. This was from two Phase III trials. They say change in plasma p-tau181 was significantly correlated with change in amyloid beta plaque, and it reduced cognitive and functional decline on all primary and secondary Alzheimer’s measurements. Horizon Therapeutics enrolled the first patient in a Phase IIb trial of hZN-825 for diffuse cutaneous systemic sclerosis, a subset of systemic sclerosis (scleroderma). The drug is a lysophosphatidic acid receptor 1 (LPAR1) antagonist. Ikena Oncology presented data from their IK-175 AHR antagonist program. The ongoing trial is recruiting patients in both monotherapy and combination cohorts with nivolumab. It is being evaluated in multiple tumor types, including urothelial carcinoma, a type of bladder cancer. Vaccitech reported results from ongoing Phase I and Phase Ib/IIa trials of VTP-300 for chronic hepatitis B infection. The drug is a heterologous prime-boost vector combination of ChAdOx1-HBV + MVA-HBV. It induced robust T cells against targeted HBV antigens. Cue Biopharma presented updated interim data from its ongoing trial of CUE-101 as a monotherapy for recurrent/metastatic HPV+ head and neck cancer. The drug is a Fc-fusion biologic that incorporates peptide-major histocompatibility complex molecules with engineered IL2.

抗体小分子药物First in Class细胞疗法疫苗

100 项与 MVA-HBV(Vaccitech) 相关的药物交易

登录后查看更多信息