Randomized Phase 2 Clinical Trial of Repeated Intratumoral and Cervical Perilymphatic Lerapolturev Injections Versus Lomustine in Recurrent Glioblastoma (GBM)

The purpose of this research study is to determine the safety and efficacy of administering two doses of lerapolturev in residual disease (within tumor margins) after surgery, followed later by repeated injections of lerapolturev in the subcutaneous area (under the skin) around the lymph nodes of the head and neck for adult patients diagnosed with recurrent glioblastoma at the Preston Robert Tisch Brain Tumor Center (PRTBTC) at Duke.

开始日期2024-07-15

申办/合作机构

Duke University

[+1]

NCT04690699

/ Terminated临床1/2期

LUMINOS-103: A Basket Trial Evaluating the Safety and Efficacy of Lerapolturev (PVSRIPO) and Lerapolturev in Combination With Anti-PD-1/L1 Checkpoint Inhibitors in Patients With Advanced Solid Tumors

This is a Phase 1/2, open-label, multi-center, single arm basket study evaluating the administration of lerapolturev ± anti programmed cell death protein 1 (PD 1)/programmed death-ligand 1 (PD L1) monoclonal antibody (mAb) (which will be referred to throughout this protocol as "anti-PD-1/L1 therapy") therapy in adult patients with solid tumor cancers. Non-muscle invasive Bladder Cancer has been selected as the tumor specific cancer of interest for enrollment.

开始日期2021-08-01

申办/合作机构

Istari Oncology, Inc.

NCT04577807

/ Completed临床2期

Lerapolturev (Formerly Known as PVSRIPO) With or Without Immune Checkpoint Blockade in Advanced PD-1 Refractory Melanoma

A Phase 2 study to investigate the efficacy and safety of lerapolturev alone or in combination with a programmed death receptor-1 (anti-PD-1) inhibitor.

开始日期2020-11-17

申办/合作机构

Istari Oncology, Inc.

100 项与 Lerapolturev 相关的临床结果

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100 项与 Lerapolturev 相关的转化医学

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100 项与 Lerapolturev 相关的专利（医药）

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项与 Lerapolturev 相关的文献（医药）

2025-12-01·CHILDS NERVOUS SYSTEM

The effect of oncolytic virotherapy on pediatric brain tumor- a systematic review

Review

作者: Srinivasan, Gurunathan ; Agrawal, Mansi ; Velammal, Praveen Nandha Kumar Pitchan ; Manickavelan, Hari Vorappan ; Varghese, Jonathan Roy ; Dhasakeerthi, Thirumalaivasan ; Veluswami, Keerthana

BACKGROUND:

Childhood mortality remains high among pediatric brain tumor (PBT) patients, and current treatments like surgery, chemotherapy, and radiotherapy have limitations. Oncolytic viral therapy (OVT) has emerged as a promising strategy in cancer treatment, including pediatric brain tumors. This study evaluates the clinical evidence on the use of OVT in PBT.

METHODS:

A systematic review was conducted following PRISMA guidelines, collecting clinical trial data up to December 2023 from English-language publications. Key search terms included "clinical trial," "oncolytic viruses," "glioma," "glioblastoma," "pediatric brain tumors," and "oncolytic virotherapy." Data on patient characteristics, interventions, survival outcomes, and adverse events were extracted by two independent researchers.

RESULTS:

Four clinical trials involving 40 pediatric patients (median age 14.5 years) with malignant gliomas were identified. Oncolytic agents studied included HSV G-207, DNX-2401, AdV-tk, and Lerapolturev. Reported tumor types included glioblastoma, diffuse intrinsic pontine glioma, anaplastic astrocytoma, recurrent ependymoma, and diffuse hemispheric glioma. Overall survival ranged from 4.1 to 47.7 months, and progression-free survival ranged from 1.7 to 47.7 months. Treatment was generally well tolerated; the most common adverse events were fever, headache, and nausea, while serious adverse events were infrequent and primarily related to disease progression. Many patients also received standard therapies such as surgery, radiotherapy, or chemotherapy.

CONCLUSION:

OVT appears safe and feasible in pediatric brain tumors, with signals of clinical benefit in selected patients. Larger, controlled trials are needed to clarify its survival impact and define optimal therapeutic strategies.

2024-04-01·Journal of neurosurgery. Pediatrics

The safety and accuracy of intratumoral catheter placement to infuse viral immunotherapies in children with malignant brain tumors: a multi-institutional study

Article

作者: Bernstock, Joshua D. ; Park, Christine ; Friedman, Allan ; Ashley, David M. ; Butler, Eric ; Friedman, Gregory K. ; Landi, Daniel ; Bigner, Darell ; Barkley, Ariana ; Thompson, Eric M. ; Johnston, James M.

OBJECTIVE:

Relatively little is known about the safety and accuracy of catheter placement for oncolytic viral therapy in children with malignant brain tumors. Accordingly, this study combines data from two phase I clinical trials that employed viral immunotherapy across two institutions to describe the adverse event profile, safety, and accuracy associated with the stereotactic placement and subsequent removal of intratumoral catheters.

METHODS:

Children with progressive/recurrent supratentorial malignant tumors were enrolled in two clinical trials (NCT03043391 and NCT02457845) and treated with either the recombinant polio:rhinovirus (lerapolturev) or the genetically modified oncolytic herpesvirus (G207). Age, sex, race, tumor diagnosis, and tumor location were analyzed. Events related to the catheter placement or removal were categorized. A catheter that was either pulled back or could not be used was defined as "misplaced." Neuronavigation software was used to analyze the accuracy of catheter placement for NCT03043391. Descriptive statistics were performed.

RESULTS:

Nineteen patients were treated across the two completed trials with a total of 49 catheters. The mean ± SD (range) age was 14.1 ± 3.6 (7–19) years. All tumors were grade 3 or 4 gliomas. Nonlobar catheter tip placement included the corpus callosum, thalamus, insula, and cingulate gyrus. Six of 19 patients (31.6%) had minor hemorrhage noted on CT; however, no patients were symptomatic and/or required intervention related to these findings. One of 19 patients had a delayed CSF leak after catheter removal that required oversewing of the surgical site. No patients developed infection or a neurological deficit. In 7 patients with accuracy data, the mean ± SD distance of the planned trajectory (PT) to the catheter tip was 1.57 ± 1.6 mm, the mean angle of the PT to the catheter was 2.43° ± 2.1°, and the greatest distance of PT to the catheter in the parallel plane was 1.54 ± 1.5 mm. Three of 49 (6.1%) catheters were considered misplaced.

CONCLUSIONS:

Although instances of minor hemorrhage were encountered, they were clinically asymptomatic. One of 49 catheters required intervention for a CSF leak. Congruent with previous studies in the literature, the stereotactic placement of catheters in these pediatric tumor patients was accurate with approximately 95% of catheters having been adequately placed.

2023-07-01·The Lancet. Child & adolescent health

Recombinant polio–rhinovirus immunotherapy for recurrent paediatric high-grade glioma: a phase 1b trial

Article

作者: Friedman, Allan H ; Brown, Michael C ; Friedman, Henry S ; Threatt, Stevie ; Lipp, Eric ; McKay, Zachary ; Schroeder, Kristin ; Bolognesi, Dani P ; Jaggers, Denise ; Thompson, Eric M ; Desjardins, Annick ; Walter, Ashley ; McLendon, Roger ; Buckley, Evan ; Gromeier, Matthias ; Bigner, Darell D ; Landi, Daniel ; Becher, Oren J ; Herndon, James E ; Ashley, David M

BACKGROUND:

Outcomes of recurrent paediatric high-grade glioma are poor, with a median overall survival of less than 6 months. Viral immunotherapy, such as the polio-rhinovirus chimera lerapolturev, is a novel approach for treatment of recurrent paediatric high-grade glioma and has shown promise in adults with recurrent glioblastoma. The poliovirus receptor CD155 is ubiquitously expressed in malignant paediatric brain tumours and is a treatment target in paediatric high-grade glioma. We aimed to assess the safety of lerapolturev when administered as a single dose intracerebrally by convection enhanced delivery in children and young people with recurrent WHO grade 3 or grade 4 glioma, and to assess overall survival in these patients.

METHODS:

This phase 1b trial was done at the Duke University Medical Center (Durham, NC, USA). Patients aged 4-21 years with recurrent high-grade malignant glioma (anaplastic astrocytoma, glioblastoma, anaplastic oligoastrocytoma, anaplastic oligodendroglioma, or anaplastic pleomorphic xanthoastrocytoma) or anaplastic ependymoma, atypical teratoid rhabdoid tumour, or medulloblastoma with infusible disease were eligible for this study. A catheter was tunnelled beneath the scalp for a distance of at least 5 cm to aid in prevention of infection. The next day, lerapolturev at a dose of 5 × 10⁷ median tissue culture infectious dose in 3 mL infusate loaded in a syringe was administered via a pump at a rate of 0·5 mL per h as a one-time dose. The infusion time was approximately 6·5 h to compensate for volume of the tubing. The primary endpoint was the proportion of patients with unacceptable toxic effects during the 14-day period after lerapolturev treatment. The study is registered with ClinicalTrials.gov, NCT03043391.

FINDINGS:

Between Dec 5, 2017, and May 12, 2021, 12 patients (11 unique patients) were enrolled in the trial. Eight patients were treated with lerapolturev. The median patient age was 16·5 years (IQR 11·0-18·0), five (63%) of eight patients were male and three (38%) were female, and six (75%) of eight patients were White and two (25%) were Black or African American. The median number of previous chemotherapeutic regimens was 3·50 (IQR 1·25-5·00). Six of eight patients had 26 treatment-related adverse events attributable to lerapolturev. There were no irreversible (ie, persisted longer than 2 weeks) treatment-related grade 4 adverse events or deaths. Treatment-related grade 3 adverse events included headaches in two patients and seizure in one patient. Four patients received low-dose bevacizumab on-study for treatment-related peritumoural inflammation or oedema, diagnosed by both clinical symptoms plus fluid-attenuated inversion recovery MRI. The median overall survival was 4·1 months (95% CI 1·2-10·1). One patient remains alive after 22 months.

INTERPRETATION:

Convection enhanced delivery of lerapolturev is safe enough in the treatment of recurrent paediatric high-grade glioma to proceed to the next phase of trial.

FUNDING:

Solving Kids Cancer, B+ Foundation, Musella Foundation, and National Institutes of Health.

项与 Lerapolturev 相关的新闻（医药）

2023-05-01

·PRNewswire

Significant Positive Shift in the Glioma Market with 13% CAGR During the Study Period (2019-2032) Expected by Analysts at DelveInsight

The dynamics of the glioma market are anticipated to change in the coming years owing to the positive outcomes of the emerging pipeline candidates during the developmental stage by key players, such as Bayer, VBL Therapeutics, Candel Therapeutics, AstraZeneca, DNAtrix, DelMar Pharmaceuticals, Chimerix, KaryoPharma, VBI Vaccines, Kazia Therapeutics, and others LAS VEGAS, May 1, 2023 /PRNewswire/ -- DelveInsight's Glioma Market Insights report includes a comprehensive understanding of current treatment practices, glioma emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into 7MM [the United States, the EU-4 (Italy, Spain, France, and Germany), the United Kingdom, and Japan]. Key Takeaways from the Glioma Market Report As per DelveInsight analysis, the glioma market size in the 7MM was approximately USD 1 billion in 2022. According to the assessment done by DelveInsight, the estimated total incident glioma cases in the 7MM were approximately 47K in 2022. Leading glioma companies such as Bayer, Chimerix, Aivita Biomedical, Denovo Biopharma, Northwest Therapeutics, VBL Therapeutics, Laminar Pharmaceuticals, MedImmune, DNAtrix, Immunomic Therapeutics, Imvax, MimiVax, CNS Pharmaceuticals, Epitopoietic Research Corporation (ERC), Istari Oncology, SonALAsense, Kintara Therapeutics, Bristol Myers Squibb, Medicenna Therapeutics, BioMimetix, Eisai and Merck Sharp & Dohme, Kazia Therapeutics, Oblato, Genenta Science, Enterome, Inovio Pharmaceuticals, Karyopharm Therapeutics, VBI Vaccines, TME Pharma, Day One Biopharmaceuticals, Servier, Orbus Therapeutics, TVAX Biomedical, AnHeart Therapeutics, Beigene, SpringWorks Therapeutics, Forma Therapeutics, Hoffmann-La Roche, Incyte Corporation, Eli Lilly, and others are developing novel glioma drugs that can be available in the glioma market in the coming years. The promising glioma therapies in the pipeline include Regorafenib, ONC201, AV-GBM-1, Enzastaurin (DB-102), DCVax-L, Ofranergene Obadenovec (VB-111), LAM561 (2-OHOA), MEDI4736 (durvalumab), Tasadenoturev (DNX-2401), ITI-1000 (pp65 DC Vaccine), IGV-001, SurVaxM, Berubicin, GLIOVAC (Sitoiganap), Lerapolturev + Pembrolizumab, SONALA-001 + Exablate 2.0 Device, VAL-083 (dianhydrogalactitol), Pomalidomide, MDNA55, BMX-001, Lenvatinib ± Pembrolizumab, Paxalisib (GDC-0084), OKN-007, Temferon, EO2401, INO-5401+ INO-9012+ LIBTAYO (cemiplimab), Selinexor (KPT-330), Olutasidenib (FT-2102), VBI-1901, NOX-A12 (Olaptesed Pegol), Tovorafenib (DAY101), Vorasidenib (AG-881), Eflornithine, TVI-Brain-1, AB-218, BGB-290, Mirdametinib, FT-2102 (Olutasidenib), Vinblastine + Bevacizumab, Cobimetinib, PEMAZYRE (Pemigatinib), VERZENIO (abemaciclib) , and others. In December 2022, Chimerix announced the successful launch of the ONC201 Phase III ACTION study in patients with H3 K27M-mutant glioma. In June 2022, Day One Biopharmaceuticals announced positive initial data from its pivotal Phase II (FIREFLY-1) study with tovorafenib (DAY101) in relapsed pediatric low-grade glioma (pLGG). Discover which therapies are expected to grab the major glioma market share @ Glioma Market Report Glioma Overview Glioma is the most common kind of glial cell tumor in the central nervous system (CNS). Gliomas are infiltrative tumors that affect the brain tissue surrounding them. Glioblastoma is the most hazardous type of brain tumor, whereas pilocytic astrocytomas are the least dangerous. Previously, diffuse gliomas were classified into subgroups and grades depending on histopathologies, such as diffuse astrocytomas, oligodendrogliomas, or mixed gliomas/oligoastrocytomas. The specific etiology of glioma, like other primary brain tumors, remains unknown. However, certain variables may increase the risk of getting a brain tumor. Glioma symptoms vary depending on tumor type, size, location, and growth rate. Some common glioma symptoms include headache, nausea or vomiting, memory loss, urine incontinence, speech problems, and others. A medical history and a physical examination are used for glioma diagnosis. Glioma Epidemiology Segmentation DelveInsight estimates that there were approximately 47K incident cases of glioma in the 7MM in 2022. As per our analysis, the United States contributed to the largest incident population of glioma, acquiring ~40% of the 7MM in 2022. The glioma market report proffers epidemiological analysis for the study period 2019–2032 in the 7MM segmented into: Total glioma incident cases Glioma grade-specific cases Glioma age-specific cases Glioma type-specific cases Download the report to understand which factors are driving glioma epidemiology trends @ Glioma Epidemiological Insights Glioma Treatment Market Glioma treatment is based on the type of glioma, its size and location, and the patient's unique characteristics. Chemotherapy and radiation therapy will be administered after surgery, particularly in individuals when the tumor cannot be removed entirely because it has invaded critical parts of the brain or is inaccessible. The typical glioma treatment protocol comprises surgery, chemotherapy, and radiation. Chemotherapy may include carmustine (BCNU), lomustine (CCNU), or gleostine (generic), cisplatin, carboplatin, etoposide, and irinotecan in case of low-grade glioma whereas temozolomide (TEMODAR) is the standard chemotherapy used in case of high-grade glioma majorly, Gliadel wafer implants (biodegradable discs injected with BCNU) are usually given as adjunctive treatment after surgery, although usage of Gliadel wafers remains a point of controversy due to its questionable survival benefits. Avastin (Genentech) and Temodar/Temodal (Merck), among others, are approved medications for HGG. However, due to patent expiration, the generic version of Temodar and biosimilars of Avastin are available on the glioma market. As generics and biosimilars are more cost-effective for patients than new medicines, intense competition exists among them. Furthermore, due to a lack of knowledge concerning bevacizumab's overall survival benefit, it is not recommended in unselected patients with newly diagnosed GBM. Currently, only one medication for LGG is approved, Tafinlar (dabrafenib) plus Mekinist (trametinib). Moreover, the current therapeutic market lacks a viable method for curing glioblastoma; therefore, the survival rate of people diagnosed with glioma remains poor. Glioma is incurable, and treatment choices are limited. Furthermore, the tumor has a high recurrence rate and a poor patient prognosis. In addition, there is currently no approved therapy for the unmethylated MGMT patient pool. To know more about glioma treatment guidelines, visit @ Glioma Management Glioma Therapies and Key Companies Regorafenib: Bayer ONC201: Chimerix AV-GBM-1: Aivita Biomedical Enzastaurin (DB-102): Denovo Biopharma DCVax-L: Northwest Therapeutics Ofranergene Obadenovec (VB-111): VBL Therapeutics LAM561 (2-OHOA): Laminar Pharmaceuticals MEDI4736 (durvalumab): MedImmune Tasadenoturev (DNX-2401): DNAtrix ITI-1000 (pp65 DC Vaccine): Immunomic Therapeutics IGV-001: Imvax SurVaxM: MimiVax Berubicin: CNS Pharmaceuticals GLIOVAC (Sitoiganap): Epitopoietic Research Corporation (ERC) Lerapolturev + Pembrolizumab: Istari Oncology SONALA-001 + Exablate 2.0 Device: SonALAsense VAL-083 (dianhydrogalactitol): Kintara Therapeutics Pomalidomide: Bristol Myers Squibb MDNA55: Medicenna Therapeutics BMX-001: BioMimetix Lenvatinib ± Pembrolizumab: Eisai and Merck Sharp & Dohme Paxalisib (GDC-0084): Kazia Therapeutics OKN-007: Oblato Temferon: Genenta Science EO2401: Enterome INO-5401+ INO-9012+ LIBTAYO (cemiplimab): Inovio Pharmaceuticals Selinexor (KPT-330): Karyopharm Therapeutics VBI-1901: VBI Vaccines NOX-A12 (Olaptesed Pegol): TME Pharma Tovorafenib (DAY101): Day One Biopharmaceuticals Vorasidenib (AG-881): Servier Eflornithine: Orbus Therapeutics TVI-Brain-1: TVAX Biomedical AB-218: AnHeart Therapeutics BGB-290: Beigene Mirdametinib: SpringWorks Therapeutics FT-2102 (Olutasidenib): Forma Therapeutics Vinblastine + Bevacizumab: Hoffmann-La Roche Cobimetinib: Hoffmann-La Roche PEMAZYRE (Pemigatinib): Incyte Corporation VERZENIO (abemaciclib): Eli Lilly Learn more about the FDA-approved drugs for glioma @ Drugs for Glioma Treatment Glioma Market Dynamics Glioma market growth can be ascribed to various factors, including an aging population, evolving research, better diagnostic tests, developing surgical procedures, improved radiotherapy techniques, and novel systemic medicines. Commercially, there is a greater emphasis on high-grade glioma than low-grade glioma because patients with low-grade glioma often live longer than those with high-grade glioma. As a result, just a few therapies are in late-stage studies, while the majority are in early-stage trials. In the case of GBM, on the other hand, the pipeline is robust, with numerous potential therapies in late and mid-stage research that have yet to be marketed. The pipeline includes drugs with varied modes of action and administration routes. It is interesting to note that the emerging market of glioma includes budding gene therapy, i.e., ofranergene obadenovec (VB-111) by VBL Therapeutics, followed by four vaccine/immunotherapy candidates such as VBI-1901, AV-GBM-1 and ITI-1000 (pp65 DC Vaccine), tasadenoturev (DNX-2401) by VBI Vaccines, Aivita Biomedical, Immunomic Therapeutics, and DNAtrix, respectively, and these therapies are going to alter the glioma market dynamics in the upcoming years. The current glioma market has been categorized based on the dominant treatment pattern across the 7MM, which shows slight variances in the overall prescription pattern. The forecast model considers surgery, chemotherapy/radiation therapy, bevacizumab + radiotherapy/chemotherapy, and OPTUNE with temozolomide. The anticipated launch of new therapies and improved integration of early patient screening, medication in secondary care and other clinical settings, research on optimum implementation methods, and increased awareness may eventually facilitate the development of successful treatment alternatives. However, there are a few challenges to the timely identification and treatment of these patients, such as a lack of a reliable biomarker that can aid in diagnosis and patient classification and identifying recurrence and signaling medication response. Furthermore, the failure rate of high-phased drug trials is significant, making it impossible to predict trial success, exacerbating the need for medicines that could assist ease the patient segment with this severe kind of cancer. Scope of the Glioma Market Report Therapeutic Assessment: Glioma current marketed and emerging therapies Glioma Market Dynamics: Conjoint Analysis of Emerging Glioma Drugs Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's Views, Analyst's Views, Glioma Market Access and Reimbursement Discover more about glioma drugs in development @ Glioma Clinical Trials Table to Contents Related Reports Glioma Epidemiology Forecast Glioma Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted glioma epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Glioma Pipeline Glioma Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key glioma companies, including PTC Therapeutics, Ono Pharmaceuticals, Philogen, SpringWorks Therapeutics, Xennials Therapeutics, AnHeart Therapeutics, Istari Oncology, among others. High-Grade Glioma Pipeline High-Grade Glioma Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key high-grade glioma companies, including PTC Therapeutics, Aadi, Lee's Pharmaceutical, among others. Malignant Glioma Pipeline Malignant Glioma Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key malignant glioma companies, including Bexion Pharmaceuticals, Inc., Lee's Pharmaceutical Limited, Merck & Co, Oblato, Inc., OncoSynergy, Inc, among others. Recurrent Malignant Glioma Pipeline Recurrent Malignant Glioma Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key recurrent malignant glioma companies, including Bexion Pharmaceuticals, Inc., Merck, Oblato, OncoSynergy, Inc, among others. Glioblastoma Pipeline Glioblastoma Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key glioblastoma companies, including AstraZeneca, BioNTech, Merck, Pfizer, Roche, among others. 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It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Connect with us on LinkedIn |Facebook|Twitter Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

临床3期临床2期疫苗免疫疗法

2023-01-31

·BioSpace

Istari Oncology Announces First Patient Dosed in the Non-Muscle-Invasive Bladder Cancer (NMIBC) Substudy of the LUMINOS-103 Basket Trial Evaluating Lerapolturev Monotherapy

DURHAM, N.C.--(BUSINESS WIRE)--Istari Oncology, Inc., a clinical-stage biotechnology company focused on development of the novel immune activator lerapolturev for the treatment of solid tumors, today announced the first patient has been dosed via intravesicular instillation in the non-muscle-invasive bladder cancer (NMIBC) cohort of the LUMINOS-103 basket trial. LUMINOS-103 is a dynamic phase 1/2 open-label basket trial evaluating the administration of lerapolturev with or without PD-1/L1 inhibitors in adult subjects with solid cancers. “We know that NMIBC tissue expresses the poliovirus receptor, CD155 and is responsive to immunotherapy, providing the rationale for intravesicular lerapolturev for patients with low to intermediate risk BCG-naïve NMIBC,” said W. Garrett Nichols, MD, MS, Chief Medical Officer at Istari Oncology. “Approximately 60,000 patients with low to intermediate risk NIMBC are identified each year in the US alone; these patients could benefit from a well-tolerated immunotherapy such as lerapolturev as a replacement for repeat resections and intravesicular chemotherapy.” This substudy is designed to test the intravesical instillation of lerapolturev and its ability to infect tumor cells and infiltrating APCs within tumor tissue lining the bladder mucosa. To facilitate efficient enrollment, a heterogenous population of patients is being recruited (prior history of stage Ta, T1, or Tis urothelial carcinoma of the bladder; recurrent disease requiring TURBT or cystectomy). If successful, the planned patient population for phase 2 will be patients with low- to intermediate-risk BCG-naïve disease. “We’re pleased to be the exclusive site for the NMIBC sub-study,” said Dr. Neal Shore principal investigator and Director, Carolina Urologic Research Center. “This is a largely unaddressed population of NMIBC patients that, if we can identify and intervene early and effectively with a therapy like lerapolturev, can avoid progression and repeated surgeries or treatment with BCG, which has experienced severe shortages.” Recruiting for the NMIBC substudy is ongoing and is expected to reach full enrollment by mid-year. For more information about Istari Oncology and their ongoing clinical trials, visit . About Lerapolturev Lerapolturev is an investigational immunotherapy based on the live attenuated Sabin type 1 polio vaccine genetically modified for safety. Lerapolturev has a distinct target (the poliovirus receptor CD155), which is widely expressed in neoplastic cells of most solid tumors. Via CD155, Lerapolturev targets tumors with three key mechanisms: 1) engagement and activation of antigen presenting cells (APCs), leading to T cell priming and sustained, systemic anticancer immunity; 2) direct tumor cell killing and antigen release; and 3) amplification of the immune response via recall of polio vaccine-specific T cells. Lerapolturev has been granted Breakthrough Therapy and Orphan Drug Designation status by the U.S. Food and Drug Administration in recurrent glioblastoma, and Fast Track and Orphan Drug Designation status in refractory melanoma. About Istari Oncology Istari Oncology, Inc., headquartered in Research Triangle Park, North Carolina, is a privately held clinical-stage biotechnology company focused on development of the novel immune activator lerapolturev for the treatment of solid tumors. Istari has licensed a broad range of patents and patent applications and has access to additional intellectual property to continue clinical and commercial development of lerapolturev. For more information, please visit: .

免疫疗法孤儿药快速通道疫苗临床研究

2022-10-18

·BioSpace

Istari Oncology Announces Presentation of Clinical Responses from LUMINOS- 102, an ongoing Phase 2 Trial of Lerapolturev in anti-PD-1 Refractory Metastatic Melanoma at the Society for Melanoma Research (SMR) 2022 Congress

Among subjects receiving an enhanced dosing regimen of lerapolturev, a complete response and clinical benefit rate (CBR) of 71% has been observed Anti-tumor responses seen in both injected and non-injected lesions (e.g., abscopal response) including complete resolution of a non-injected lung metastasis Istari will continue enrolling patients to the enhanced dosing regimen with confirmatory data expected in Q2 2023 DURHAM, N.C.--(BUSINESS WIRE)-- Istari Oncology, Inc., a clinical-stage biotechnology company focused on development of the novel immune activator lerapolturev for the treatment of solid tumors, today announced a poster presentation of new data from an enhanced dosing cohort within the LUMINOS-102 phase 2 clinical trial, which is assessing the safety and efficacy of lerapolturev (formerly PVSRIPO) alone or in combination with a programmed death receptor-1 (PD-1) inhibitor in patients with metastatic melanoma who have progressed on an anti-PD-1 containing regimen, and BRAF/MEK inhibitors if BRAF mutation positive. The presentation is being made at the Society for Melanoma Research (SMR) Congress being held in Edinburgh October 17 - 20, 2022. Lerapolturev is a novel viral immunotherapy that activates the innate and adaptive immune system to produce a functional, systemic anticancer CD8+ T cell response. Following positive phase 1 monotherapy results,1 the LUMINOS-102 phase 2 multicenter trial (NCT04577807) was initiated to further explore lerapolturev’s impact on this tough-to-treat population of anti-PD-1 relapsed/refractory metastatic melanoma patients. “LUMINOS-102 initially used the lerapolturev dose that yielded a 67% (4/6) response rate in the phase 1 single-center trial,” said Garrett Nichols, MD, MS, Chief Medical Officer at Istari Oncology. “Following DSMB review and protocol amendment, a new dosing regimen was implemented for LUMINOS-102 in March 2022. Our poster presentation at SMR highlights the exciting responses we’ve seen among subjects treated with the new regimen. We are optimistic that we’ve now optimized the dosing regimen and are continuing to enroll subjects at this dose to confirm these encouraging results.” The dosing regimen now in place comprises a higher dose of lerapolturev with or without an “induction schedule” of weekly injections for seven weeks, followed by maintenance injections dictated by the cadence of anti-PD-1 infusions (every 2 or 3 weeks). Since implementation, seven (7) patients have been treated with the higher lera dose, with 3 subjects (those who were consented from the start of treatment under the protocol amendment) also receiving the induction dosing schedule. Among these patients, a clinical benefit rate (CR, PR or SD > 6 months) of 71% (5/7) has been observed, including a pathologic complete response (pCR). All subjects were heavily pretreated and had previously failed at least one anti-PD-1 therapy. Some participants had also failed anti-CTLA-4 and BRAF/MEK therapies. “We are pleased to see lerapolturev treatment yield responses, including responses in non- injected lesions”, remarked Yana G. Najjar, MD Assistant Professor of Medicine and Director, Clinical and Translational Center at the UPMC Hillman Cancer Center and Principal Investigator for LUMINOS-102. “Metastatic melanoma patients with anti-PD-1 relapsed/refractory disease have limited options and we’ve recently seen multiple investigational therapies fail in this setting. We’re hopeful that the responses seen with the new lera dosing strategy will be validated with additional patients and lead to further development”. LUMINOS-102 remains open to enrollment, with updates to be presented at an oncology congress in 2023. If successful, Istari plans to leverage its Orphan and Fast Track status in unresectable anti-PD-1 refractory melanoma by collaborating with regulators on a registration strategy. To view the poster and for more information about Istari Oncology and their ongoing clinical trials, visit . About Lerapolturev Lerapolturev is an investigational immunotherapy based on the live attenuated Sabin type 1 polio vaccine genetically modified for safety. Lerapolturev has a distinct target (the poliovirus receptor CD155), which is widely expressed in neoplastic cells of most solid tumors. Via CD155, lerapolturev targets tumors with three key mechanisms: 1) engagement and activation of antigen presenting cells (APCs), leading to T cell priming and sustained, systemic anticancer immunity; 2) direct tumor cell killing and antigen release; and 3) amplification of the immune response via recall of polio vaccine-specific T cells. Lerapolturev has been granted Breakthrough Therapy and Orphan Drug Designation status by the U.S. Food and Drug Administration in recurrent glioblastoma, and Fast Track and Orphan Drug Designation status in refractory melanoma. About Melanoma There are estimated to be over 12,000 new and recurrent cases of advanced, unresectable melanoma diagnosed in the U.S. each year, and around 7,000 deaths. While immune checkpoint inhibitors have dramatically improved the outlook for advanced melanoma patients today, most patients treated with these immunotherapies are either primary nonresponders or eventually develop immune-refractory progressive disease and require additional options, which are poor. About Istari Oncology Istari Oncology, Inc., headquartered in Research Triangle Park, North Carolina, is a privately held clinical-stage biotechnology company focused on development of the novel immune activator lerapolturev for the treatment of solid tumors. Istari has licensed a broad range of patents and patent applications and has access to additional intellectual property to continue clinical and commercial development of lerapolturev. For more information, please visit: . References Beasley GM, Nair SK, Farrow NE, et al. A phase I trial of intratumoral LERAPOLTUREV in patients with unresectable, treatment-refractory melanoma. J Immunother Cancer. 2021 [in press].

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
多形性胶质母细胞瘤	临床2期	美国	Istari Oncology, Inc.	2024-07-15
多形性胶质母细胞瘤	临床2期	美国	Duke University	2024-07-15
晚期恶性实体瘤	临床2期	美国	Istari Oncology, Inc.	2021-08-01
非肌层浸润性膀胱肿瘤	临床2期	美国	Istari Oncology, Inc.	2021-08-01
难治性黑色素瘤	临床2期	美国	Istari Oncology, Inc.	2020-11-17
复发性胶质母细胞瘤	临床2期	美国	Istari Oncology, Inc.	2020-10-21
复发性胶质瘤	临床2期	-	Istari Oncology, Inc.	2020-02-01
复发性恶性胶质瘤	临床2期	美国	Istari Oncology, Inc.	2017-06-01
浸润性乳腺癌	临床1期	美国	Istari Oncology, Inc.	2019-06-30
不可切除的黑色素瘤	临床1期	美国	Istari Oncology, Inc.	2018-11-26

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04577807 (LUMINOS-102, CTgov)	临床2期	难治性黑色素瘤	27	lerapolturev (Arm 1: Lerapolturev QW)	醖鹹齋願鹽築鏇淵鹹獵 = 夢鑰積壓憲範廠鬱築膚顧壓顧壓鏇鏇衊淵觸網 (遞願獵網鏇選鬱壓憲積, 鑰糧憲鏇糧範廠艱觸願 ~ 範膚觸繭齋襯獵構壓艱) 更多	-	2025-09-19
				lerapolturev (Arm 1: Lerapolturev Q3W)	醖鹹齋願鹽築鏇淵鹹獵 = 蓋繭願鑰築鏇糧願淵廠顧壓顧壓鏇鏇衊淵觸網 (遞願獵網鏇選鬱壓憲積, 網糧艱積鬱鹽淵簾醖鹹 ~ 鹹衊淵淵淵醖壓廠築糧) 更多
NCT02986178 (CTgov)	临床2期	复发性恶性胶质瘤	121	lerapolturev (Lerapolturev)	艱網顧築醖膚艱選遞範 = 構膚構蓋鑰構鹽觸遞選構鏇鬱膚鏇選鑰窪艱積 (憲顧襯繭艱鬱鏇願襯繭, 糧鑰獵築艱範網餘窪築 ~ 製觸獵築壓衊鹹淵築夢) 更多	-	2025-07-11
				lerapolturev+Lomustine (Lerapolturev + Lomustine)	艱網顧築醖膚艱選遞範 = 積齋鹹願簾鹽鏇網醖齋構鏇鬱膚鏇選鑰窪艱積 (憲顧襯繭艱鬱鏇願襯繭, 選範繭憲繭鹽鬱製醖製 ~ 衊簾膚觸獵淵醖鹽壓積) 更多
NCT04479241 (LUMINOS-101, CTgov)	临床2期	复发性胶质母细胞瘤	25	lerapolturev+pembrolizumab	遞蓋衊簾蓋醖遞鑰鏇夢 = 願鹹壓艱餘簾願構艱蓋網獵顧選範艱齋淵壓蓋 (築壓鑰夢餘繭製衊網網, 淵餘願築鬱鑰構蓋廠積 ~ 壓繭製顧淵齋淵憲築範) 更多	-	2025-03-25
NCT04690699 (LUMINOS-103, CTgov)	临床1/2期	晚期恶性实体瘤 \| 非肌层浸润性膀胱肿瘤	4	Lerapolturev (Cohort E: Lerapolturev)	願膚獵願構壓觸鑰壓網 = 艱製鬱鹽蓋鹽衊衊餘淵糧獵窪衊齋餘獵顧鑰鏇 (壓鹹夢簾餘選構繭膚範, 獵淵衊齋網築鑰鬱淵觸 ~ 網願製醖築鏇顧廠獵憲) 更多	-	2024-10-24
				5% DDM+Lerapolturev (Cohort F: Lerapolturev + 5% DDM)	願膚獵願構壓觸鑰壓網 = 鏇壓構鬱遞鹽鏇夢範廠糧獵窪衊齋餘獵顧鑰鏇 (壓鹹夢簾餘選構繭膚範, 製鹹範繭築夢繭餘範簾 ~ 醖範觸膚範顧構衊襯鹹) 更多
NCT03712358 (302, CTgov)	临床1期	不可切除的黑色素瘤	12	PVSRIPO (Cohort 0 (PVSRIPO))	憲鏇觸糧鑰鹹餘憲鬱選 = 餘積鬱遞廠淵積製範襯餘選鹽糧遞積鏇蓋積齋 (糧鏇獵築蓋顧鏇範鹽觸, 襯鏇糧範顧廠顧選範製 ~ 衊壓壓憲衊範窪觸鑰淵) 更多	-	2024-09-19
				PVSRIPO (Cohort 1 (PVSRIPO))	憲鏇觸糧鑰鹹餘憲鬱選 = 簾夢願積鑰廠簾淵簾艱餘選鹽糧遞積鏇蓋積齋 (糧鏇獵築蓋顧鏇範鹽觸, 夢壓願鹽餘簾醖憲窪築 ~ 築糧鹹餘鬱選簾糧壓醖) 更多
NCT03043391 (CTgov)	临床1期	室管膜瘤 \| 神经胶质肉瘤 \| 胶质母细胞瘤 ... 更多	8	lerapolturev	齋蓋選顧膚積構膚繭鑰 = 鑰糧觸窪鏇鹹膚艱觸壓艱鑰餘願憲膚鹹膚糧鏇 (鑰餘蓋淵顧範遞衊網醖, 範鬱齋鑰觸壓簾鹹繭鏇 ~ 淵壓構窪簾齋膚構遞觸) 更多	-	2024-04-08
NCT03043391 (Pubmed)	临床1期	脑癌	19	viral immunotherapies (Recombinant polio:rhinovirus (lerapolturev))	蓋觸範構淵餘鬱願築廠(繭夢鏇膚齋鹽鹽鏇獵糧) = One of 19 patients had a delayed CSF leak after catheter removal that required oversewing of the surgical site. 鏇壓壓範顧願築糧繭夢 (鹽廠淵鹽膚窪廠襯膚願 ) 更多	-	2024-04-01
				viral immunotherapies (Genetically modified oncolytic herpesvirus (G207))
NCT03564782 (P612, CTgov)	早期临床1期	浸润性乳腺癌	5	lerapolturev	蓋襯膚遞糧艱衊艱窪夢(鹹製齋醖選願遞餘憲簾) = 鏇壓夢範構遞憲齋鹹醖淵廠選築糧顧衊醖夢衊 (衊衊構獵觸淵遞願襯膚, 1.3) 更多	-	2024-02-08
IMMU-26 (SNO2021)	临床2期	复发性胶质母细胞瘤 CD155	149	PVSRIPO 5x10^7 TCID50	窪艱網鏇築觸衊鏇鬱膚(餘鹽餘築蓋觸遞積醖簾) = Neurologic symptoms related to peritumoral edema were most common (> 90% patients) and were effectively managed with low-dose bevacizumab/corticosteroids 顧艱繭壓衊膚構選廠顧 (積鬱齋餘鏇製餘淵願壓 ) 更多	积极	2021-11-12
				Other doses of PVSRIPO
NCT04479241 (LUMINOS-101, AACR2021)	临床2期	复发性胶质母细胞瘤	-	PVSRIPO	鏇願願築鹹築選顧鏇觸(艱鹽鏇遞積積夢顧壓簾) = 憲齋鬱製願製觸觸艱鬱鏇醖蓋鏇積觸鏇鹹壓選 (鹹襯鹹齋獵鹹淵觸膚遞, 36 ~ 60 months)	-	2021-07-01