A Phase I/IIa Study to Evaluate the Efficacy of DB107-RRV (Formerly Toca511), Administered to Subjects At Time of Resection and Intravenously Thereafter, in Combination with DB107-FC (Formerly Toca FC) and Radiation Therapy or DB107-FC, Temozolomide (TMZ) and Radiation Therapy in Patients with Newly Diagnosed High Grade Glioma

This is a multicenter, open-label study of DB107-RRV (formerly Toca 511) and DB107-FC (formerly Toca FC) when administered following surgical resection in newly diagnosed High Grade Glioma (HGG) patients. The study is designed to evaluate whether treatment with DB107-RRV in combination with DB107-FC when added to standard of care provides clinical benefit to newly diagnosed HGG when compared to historical performance previously determined in well controlled clinical trials published in the peer reviewed literature. This study is going to be conducted in newly diagnosed HGG patients receiving with maximum surgical resection treatment followed by radiation and temozolomide treatment using the established Stupp Protocol for O6-methylguanine-DNA methyl-transferase (MGMT) methylated patients or radiation therapy for MGMT unmethylated patients.

Start Date08 Jan 2025

Sponsor / Collaborator

The University of California, San Francisco

[+2]

NCT06264388

/ RecruitingPhase 2IIT

A Biomarker-Guided Phase 2 Study of DB107-RRV (Retroviral Replicating Vector) Combined With DB107-Flucytosine Extended-Release Tablets in Patients With Recurrent Glioblastoma or Anaplastic Astrocytoma

The purpose of this study is to determine if the investigational products, DB107-RRV and DB107-FC, as a combination treatment will shrink high-grade glioma (HGG) in patients with recurrent/progressive, resectable or unresectable disease and increase the time that disease is controlled.

Start Date01 May 2024

Sponsor / Collaborator

University of Miami

[+2]

NCT04089163

/ WithdrawnPhase 1

Toca 8: A Multicenter, Open-Label, Phase 1 Study to Evaluate the Safety and Tolerability of Toca 511, a Retroviral Replicating Vector, Combined With Toca FC in Patients With Recurrent High Grade Non-Muscle Invasive Bladder Cancer

This is a Phase 1, multicenter, open-label study of intravesical Toca 511 followed by oral Toca FC in patients with high grade (HG) non-muscle invasive bladder cancer (NMIBC), with cohort expansion at the recommended Phase 2 dose. Patients with recurrent HG NMIBC who are undergoing planned transurethral resection of bladder tumor (TURBT) will be enrolled into the study, subject to meeting all entry criteria.

Start Date01 Dec 2019

Sponsor / Collaborator

Tocagen, Inc.

100 Clinical Results associated with Vocimagene amiretrorepvec

100 Translational Medicine associated with Vocimagene amiretrorepvec

100 Patents (Medical) associated with Vocimagene amiretrorepvec

279

Literatures (Medical) associated with Vocimagene amiretrorepvec

25 Feb 2025·Journal of Virology

Generation of chimeric forms of rhesus macaque rhadinovirus expressing KSHV envelope glycoproteins gH and gL for utilization in an NHP model of infection

Article

Author: Li, Helen ; McDonald, Kaidlyn A. ; Wong, Scott W. ; Estep, Ryan D. ; Axthelm, Michael K. ; Govindan, Aparna N.

ABSTRACT Kaposi’s sarcoma-associated herpesvirus (KSHV) is a human gammaherpesvirus associated with Kaposi’s sarcoma and B cell malignancies. Like all herpesviruses, KSHV contains conserved envelope glycoproteins (gps) involved in virus binding, entry, assembly, and release from infected cells, which are also targets of the immune response. Due to the lack of a reproducible animal model of KSHV infection, the precise functions of the KSHV gps during infection in vivo are not completely known. Fortunately, a nonhuman primate (NHP) model of KSHV infection and disease has been established utilizing closely related rhesus macaque rhadinovirus (RRV) that naturally infects rhesus macaques (RM) and possesses analogous gps to KSHV. To address the roles conserved envelope gps gH and gL play during KSHV infection in vivo , we utilized the pathogenic RRV 17577 BAC to generate chimeric forms of RRV expressing KSHV gL or KSHV gH/gL, as well as an RRV mutant lacking gL expression. These viruses incorporate KSHV gH and gL into infectious virions, and although they display variable replication and differing plaque phenotypes in primary rhesus fibroblasts, they retain the ability to infect human B cells in vitro . Importantly, we also demonstrate that RRV gp chimeras can infect RM and induce the development of antibodies against KSHV. Overall, this work demonstrates that RRV gp chimeras can serve as important tools to assess the role of KSHV gH/gL in infection and disease while also providing an NHP model for testing the efficacy of KSHV gH and gL neutralizing antibodies and vaccine strategies to prevent and treat KSHV infection. IMPORTANCE Rhesus macaque rhadinovirus (RRV) is a rhesus macaque homolog of KSHV and serves as a model system for examining Kaposi’s sarcoma-associated herpesvirus (KSHV) infection and pathogenesis in vivo . KSHV and RRV both encode conserved herpesvirus envelope glycoproteins, including gH and gL, that are important for regulating entry into host cells. In this study, we utilized the RRV BAC system to generate chimeric forms of RRV expressing KSHV gH and gL, as well as a mutant form of RRV lacking gL expression. Although these mutant and chimeric viruses can replicate in vitro , they do display growth properties different from wild-type RRV. Importantly, we demonstrate that RRV gp chimeras are capable of infecting rhesus macaques in vivo , inducing B cell hyperplasia, and promoting the development of anti-viral antibody responses that can also recognize KSHV antigens. RRV gp chimeras provide a novel system that allows for the examination of the role of KSHV gH and gL during infection in vivo .

11 Dec 2024·mBio

Type I interferon signaling in dendritic cells limits direct antigen presentation and CD8 ⁺ T cell responses against an arthritogenic alphavirus

Article

Author: Wang, Leran ; Liu, Tian-Tian ; Ohara, Ray A. ; Bullock, Christopher B. ; Handley, Scott A. ; Diamond, Michael S. ; Morrison, Thomas E. ; Peters, Bjoern ; Desai, Pritesh ; Murphy, Kenneth M. ; Ware, Brian C. ; Wagoner, Ngan

ABSTRACT Ross River virus (RRV) and other alphaviruses cause chronic musculoskeletal syndromes that are associated with viral persistence, which suggests deficits in immune clearance mechanisms, including CD8 + T-cell responses. Here, we used a recombinant RRV-gp33 that expresses the immunodominant CD8 + T-cell epitope of lymphocytic choriomeningitis virus (LCMV) to directly compare responses with a virus, LCMV, that strongly induces antiviral CD8 + T cells. After footpad injection, we detected fewer gp33-specific CD8 + T cells in the draining lymph node (DLN) after RRV-gp33 than LCMV infection, despite similar viral RNA levels in the foot. However, less RRV RNA was detected in the DLN compared to LCMV, with RRV localizing principally to the subcapsular region and LCMV to the paracortical T-cell zones. Single-cell RNA-sequencing analysis of adoptively transferred gp33-specific transgenic CD8 + T cells showed rapid differentiation into effector cells after LCMV but not RRV infection. This defect in RRV-specific CD8 + T effector cell maturation was corrected by local blockade of type I interferon (IFN) signaling, which also resulted in increased RRV infection in the DLN. Studies in Wdfy4−/− , CD11c-Cre B2mfl/fl , or Xcr1-Cre Ifnar1fl/fl mice that respectively lack cross-presenting capacity, MHC-I antigen presentation by dendritic cells (DCs), or type I IFN signaling in the DC1 subset show that RRV-specific CD8 + T-cell responses can be improved by enhanced direct antigen presentation by DCs. Overall, our experiments suggest that antiviral type I IFN signaling in DCs limits direct alphavirus infection and antigen presentation, which likely delays CD8 + T-cell responses. IMPORTANCE Chronic arthritis and musculoskeletal disease are common outcomes of infections caused by arthritogenic alphaviruses, including Ross River virus (RRV), due to incomplete virus clearance. Unlike other viral infections that are efficiently cleared by cytotoxic CD8 + T cells, RRV infection is surprisingly unaffected by CD8 + T cells as mice lacking or having these cells show similar viral persistence in joint and lymphoid tissues. To elucidate the basis for this deficient response, we measured the RRV-specific CD8 + T-cell population size and activation state relative to another virus known to elicit a strong T-cell response. Our findings reveal that RRV induces fewer CD8 + T cells due to limited infection of immune cells in the draining lymph node. By increasing RRV susceptibility in antigen-presenting cells, we elicited a robust CD8 + T-cell response. These results highlight antigen availability and virus tropism as possible targets for intervention against RRV immune evasion and persistence.

05 Dec 2024·Neuro-Oncology

Interferon regulatory factor 8-driven reprogramming of the immune microenvironment enhances antitumor adaptive immunity and reduces immunosuppression in murine glioblastoma

Article

Author: Montoya, Megan ; Yamamichi, Akane ; Kasahara, Noriyuki ; Okada, Hideho ; Collins, Sara A ; Patel, Trishna S ; Nejo, Takahide ; Chuntova, Pavlina

AbstractBackgroundGlioblastoma (GBM) has a highly immunosuppressive tumor immune microenvironment (TIME), largely mediated by myeloid-derived suppressor cells (MDSCs). Here, we utilized a retroviral replicating vector (RRV) to deliver Interferon Regulatory Factor 8 (IRF8), a master regulator of type 1 conventional dendritic cell (cDC1) development, in a syngeneic murine GBM model. We hypothesized that RRV-mediated delivery of IRF8 could “reprogram” intratumoral MDSCs into antigen-presenting cells and thereby restore T-cell responses.MethodsEffects of RRV-IRF8 on survival and tumor growth kinetics were examined in the SB28 murine GBM model. The immunophenotype was analyzed by flow cytometry and gene expression assays. We assayed functional immunosuppression and antigen presentation by ex vivo T-cell-myeloid co-culture.ResultsIntratumoral injection of RRV-IRF8 in mice bearing intracerebral SB28 glioma significantly suppressed tumor growth and prolonged survival. RRV-IRF8 treated tumors exhibited significant enrichment of cDC1s and CD8+ T-cells. Additionally, myeloid cells derived from RRV-IRF8 tumors showed decreased expression of the immunosuppressive markers Arg1 and IDO1 and demonstrated reduced suppression of naïve T-cell proliferation in ex vivo co-culture, compared to controls. Furthermore, DCs from RRV-IRF8 tumors showed increased antigen presentation compared to those from control tumors. In vivo treatment with azidothymidine (AZT), a viral replication inhibitor, showed that IRF8 transduction in both tumor and non-tumor cells is necessary for survival benefit, associated with a reprogrammed, cDC1- and CD8 T-cell-enriched TIME.ConclusionsOur results indicate that reprogramming of glioma-infiltrating myeloid cells by in vivo expression of IRF8 may reduce immunosuppression and enhance antigen presentation, achieving improved tumor control.

News (Medical) associated with Vocimagene amiretrorepvec

07 Mar 2025

·pipelinereview.com

Anova Announces First Patient Enrolled to Phase 1/2a Study of DB107 for the Treatment of High-Grade Gliomas

LONDON, UK & CHICAGO, IL, USA I March 05, 2025 I Anova Enterprises, Inc. (Anova), a technology-enabled CRO dedicated to accelerating promising treatments, has announced enrollment of the first two patients in the highly anticipated study of DB107 for the treatment of brain tumors. The Phase 1/2a clinical trial is a multicenter, open-label study designed to confirm whether treatment DB107, when added to standard-of-care (SOC), provides clinical benefit to patients with newly diagnosed high-grade gliomas (HGG) when compared to historical performance. The study is funded with a California Institute for Regenerative Medicine (CIRM) grant to advance the development of DB107 in patients with newly diagnosed high-grade glioma. Led by Noriyuki Kasahara, MD, PhD, Principal Investigator, Brain Tumor Research Center (BTRC) at University of California, San Francisco (UCSF), the study is also enrolling at the University of Southern California (USC) and the University of California at San Diego UCSD, and will enroll 70 participants over the coming months. “Enrolling our first patients is an important milestone in our mission to advance treatment options for patients with high- grade glioma,” said Nicholas Butowski, MD, Neuro-Oncologist and Lead Investigator at UCSF. “We are optimistic this trial will provide valuable insights into how we can better treat patients and improve survival in newly diagnosed patients.” High- grade gliomas remain one of the most challenging cancers to treat, with limited treatment options and a high degree of complexity. Treatment for the disease has not changed in 20 years. DB107 is an investigational gene therapy being developed by Denovo Biopharma for the treatment of HGG, including glioblastoma multiforme (GBM). It comprises two components: DB107-RRV (vocimagene amiretrorepvec), a retroviral replicating vector designed to selectively infect and change cancer cells, and DB107-FC, an extended-release oral formulation of 5-fluorocytosine (5-FC), which is converted into a chemotherapeutic agent within the tumor. This combination aims to eradicate tumor cells while stimulating a robust and durable anti-cancer immune response with minimal toxicity. Chris Beardmore said, “This is revolutionary science where the treatment infects cancer cells and genetically changes them to make chemotherapy inside of the infected cells. This is known to reduce systemic toxicity commonly seen with systemic treatments. It also has a chance to infect cells that cannot be removed by surgery and other interventions to improve outcomes in newly diagnosed brain tumor patients.” The clinical trial is currently recruiting eligible patients who meet the study criteria at UCSF, USC and UCSD. Individuals interested in participating or learning more about the trial can contact the study team at info.us@anovaevidence.com . To find out more, contact info.us@anovaevidence.com . About Denovo’s RRV Platform and DB107 DB107 is an innovative approach utilizing a proprietary gene therapy platform, recombinant retroviral vector (RRV) bearing cytosine deaminase, combined with a prodrug of 5-FU (5-FC), to selectively infect and kill cancer cells while stimulating a robust and durable anti-cancer immune response against a tumor with minimal toxicity. DB107 has been tested clinically in solid tumors including recurrent high-grade GBM and colorectal cancer, most recently in a randomized 403-patient Phase 3 trial. DB107 received Orphan Drug Designation in GBM from the FDA and EMA, and Fast Track Designation from the FDA. About Anova Anova Enterprises, Inc. (Anova) is technology enabled concierge research organization committed to accelerating clinical development for start-up biopharmaceutical companies utilizing the company’s proprietary technology platform (AnovaOS™). For more information, please visit www.anovaevidence.com . About Denovo Biopharma Denovo Biopharma LLC (Denovo) is a clinical‑stage biopharmaceutical company that uses a novel biomarker discovery platform including whole genome sequencing (WGS) and artificial intelligence (AI) to find new genetic biomarkers predictive of drug efficacy, and then uses these biomarkers to execute efficient clinical trials in targeted patient populations to increase the probability of success. Denovo has eight late‑stage drugs in its pipeline addressing major unmet medical needs in oncology and central nervous system diseases; most of the pipeline are first‑in‑class drugs with global rights. Denovo recently announced a major breakthrough in treatment‑resistant depression (TRD) with its DGM4™ biomarker‑guided DB104 drug (liafensine, a potential first‑in‑class triple reuptake inhibitor for TRD). The global Phase 2b clinical trial of DB104 in DGM4‑positive patients with TRD demonstrated strikingly positive results, with highly significant improvements in symptoms of depression seen in DGM4‑positive patients. Visit www.denovobiopharma.com for additional information. About the California Institute for Regenerative Medicine (CIRM) The California Institute for Regenerative Medicine (CIRM) is a funding agency established by Californians to accelerate regenerative medicine research to deliver treatments for patients with unmet medical needs. Established in 2004 through the passage of Proposition 71, CIRM was initially funded with $3 billion from the state of California to support ongoing research, and in 2020, was funded again with another $5.5 billion through Proposition 14 to continue the Agency’s important work. CIRM has provided billions in funding to support stem cell, genetic research, and development programs in its portfolio. Through the Agency’s research, infrastructure, and education programs, CIRM aims to transform the field of regenerative medicine, stimulate economic growth, and improve the lives of diverse communities throughout the state. For more information go to cirm.ca.gov . SOURCE: Anova Enterprises

Clinical ResultPhase 2Orphan DrugFast TrackPhase 3

30 Apr 2024

·www.prnewswire.com

CIRM Awards $11.8 Million Grant for Clinical Trial in High-Grade Glioma Including Glioblastoma Using DB107, a Novel DGM7™ Genetic Biomarker-Guided Gene Therapy

SAN DIEGO, April 30, 2024 /PRNewswire/ -- Denovo Biopharma LLC (Denovo), a pioneer in applying precision medicine to the development of innovative therapies, today announced that the California Institute for Regenerative Medicine (CIRM) has awarded a $11.8M grant for further development of DB107, Denovo's DGM7™ biomarker–guided late–stage gene therapy, for high–grade glioma (HGG) including glioblastoma (GBM), a malignant brain cancer. CIRM has awarded the grant to Dr. Noriyuki Kasahara, MD, PhD, at the University of California San Francisco (UCSF) and a group of investigators at California universities to conduct a Phase 1/2 clinical trial studying DB107 in patients with newly–diagnosed HGG. Continue Reading The trial, titled "A Phase I/IIa Study to Evaluate the Efficacy of DB107–RRV, Administered to Subjects at Time of Resection and Intravenously Thereafter, in Combination with DB107–FC and Radiation Therapy or DB107–FC, Temozolomide (TMZ) and Radiation Therapy in Patients with Newly–Diagnosed High–Grade Glioma," plans to enroll up to 70 patients. The trial aims to demonstrate improvements in progression–free survival. We are thrilled to continue the clinical development of our biomarker-guided DB107 gene therapy in HGG including GBM. Post this DB107 consists of two components: DB107–RRV (vocimagene amiretrorepvec) as a prodrug activator gene therapy and DB107–FC (extended-release 5–fluorocytosine [5–FC]) as an oral prodrug. DB107–RRV, a retroviral replicating vector (RRV) administered intratumorally and intravenously, converts the orally administered 5–FC into the potent chemotherapy agent 5–fluorouracil (5–FU) locally at the tumor sites. This enables intratumoral concentrations 30–50 times of those achievable by 5–FU systemic administration, killing tumor cells while minimizing the systemic exposure and off–target toxicities of 5–FU. Using its proprietary biomarker discovery platform including whole genome sequencing (WGS) and artificial intelligence (AI), Denovo discovered the novel germline genetic biomarker, Denovo Genomic Marker 7 (DGM7), which is located in the SHROOM3 gene intron. Retrospective analysis of an earlier randomized clinical trial in patients with recurrent HGG suggested improved overall survival in DGM7–positive patients treated with DB107. "We are excited to conduct this novel trial which will be investigating several new approaches for the first time in patients with newly–diagnosed high–grade glioma. In addition to DB107–RRV being administered both intratumorally and intravenously to provide more exposure, this study will also use the RRV in conjunction with radiation therapy and chemotherapy with temozolomide. In addition to the direct therapeutic effect of gene therapy, glioma cells will be sensitized to these standard therapies by 5–FU generated directly within the patient's tumor from DB107–FC. We are also excited to test the DGM7 biomarker to see if we can identify patients who may benefit the most from this unique gene therapy approach," said Dr. Kasahara. DGM7 status will be determined at the time of enrollment to prospectively assess the effect of the biomarker on clinical outcomes. The study will be conducted at UCSF (Dr. Noriyuki Kasahara, MD, PhD, and Dr. Nicholas Butowski, MD), University of Southern California (USC) (Dr. Thomas Chen, MD, PhD), and University of California San Diego (UCSD) (Dr. David Piccioni, MD, PhD), and will be managed by Anova Enterprises, Inc. "We are thrilled to continue the clinical development of our biomarker–guided DB107 gene therapy in patients with HGG including GBM, a major unmet medical need with less than 5% of GBM patients surviving 5 years," said Dr. Matthew A. Spear, MD, Denovo's Chief Medical Officer and Chief Development Officer. "Alongside our recent announcement of positive results in a Phase 2b clinical trial of our DGM4 biomarker–guided DB104 drug (liafensine) in treatment–resistant depression, the CIRM grant provides continued validation of Denovo's approach to discovering new genetic biomarkers and developing biomarker–guided therapies." About HGG and GBM The most common type of high–grade glioma (HGG) is glioblastoma (GBM), which is also the most common type of adult primary brain cancer, with 18,000 newly–diagnosed patients in the US and 13,000 deaths annually. Standard treatments for patients with newly–diagnosed GBM can include surgery followed by radiation and chemotherapy, but treatment options are limited. The 5–year survival rate of patients with GBM is less than 5%. About DB107 and the DGM7™ Biomarker DB107 is an investigational combination product consisting of the DB107–RRV (vocimagene amiretrorepvec) gene therapy and DB107–FC (extended–release 5–fluorocytosine) oral prodrug. DB107–RRV, an innovative proprietary retroviral replicating vector (RRV), is combined with DB107–FC to selectively infect and kill cancer cells while stimulating a robust and durable anti–cancer immune response against a tumor with minimal toxicity. DB107 has been tested clinically in solid tumors including recurrent high–grade glioma (rHGG) and colorectal cancer, most recently in a randomized 403–patient Phase 2/3 trial in rHGG including glioblastoma (GBM). Using its proprietary biomarker discovery platform, Denovo discovered the novel genetic biomarker, DGM7, which has been shown to be associated with treatment response to DB107 in patients with rHGG including GBM. DB107 has received Fast Track Designation and Breakthrough Therapy Designation from the FDA, as well as Orphan Drug Designations from the FDA and EMA. About Denovo Biopharma Denovo Biopharma LLC (Denovo) is a clinical–stage biopharmaceutical company that uses a novel biomarker discovery platform including whole genome sequencing (WGS) and artificial intelligence (AI) to find new genetic biomarkers predictive of drug efficacy, and then uses these biomarkers to execute efficient clinical trials in targeted patient populations to increase the probability of success. Denovo has eight late–stage drugs in its pipeline addressing major unmet medical needs in oncology and central nervous system diseases; most of the pipeline are first–in–class drugs with global rights. Denovo recently announced a major breakthrough in treatment–resistant depression (TRD) with its DGM4™ biomarker–guided DB104 drug (liafensine, a potential first–in–class triple reuptake inhibitor for TRD). The global Phase 2b clinical trial of DB104 in DGM4–positive patients with TRD demonstrated strikingly positive results, with highly significant improvements in symptoms of depression seen in DGM4–positive patients. Visit for additional information. Contact Michael F. Haller, Chief Business Officer Denovo Biopharma LLC [email protected] SOURCE Denovo Biopharma LLC

Phase 2Orphan DrugFast TrackClinical ResultGene Therapy

01 Jul 2021

·www.biospace.com

Denovo Biopharma In-Licenses Late-Stage Alzheimer's Disease Asset from Lundbeck

SAN DIEGO, July 1, 2021 /PRNewswire/ -- Denovo Biopharma LLC, a pioneer in applying precision medicine to develop innovative therapies, today announced it has licensed global rights for idalopirdine from H. Lundbeck A/S, including all rights to develop, manufacture and commercialize idalopirdine for all indications. Lundbeck received options to re-acquire idalopirdine for predetermined undisclosed financial terms, with Denovo and Lundbeck sharing China rights in the event Lundbeck's options are exercised and Denovo retaining all global rights in the event Lundbeck's options are not exercised. Terms of the agreement were not disclosed. Idalopirdine (now DB109) is an oral antagonist of the serotonin (5-HT6) receptor, which is primarily expressed in the brain and is hypothesized to be involved in Alzheimer's Disease, schizophrenia, and other indications. DB109 has been extensively evaluated in numerous clinical studies encompassing more than 2500 subjects. Although Phase 3 trial results were negative, subsets of patients who showed signs of beneficial activity of DB109 were identified. Despite the recent approval of aducanumab, Alzheimer's Disease remains one of the toughest diseases to conquer as countless drug have failed to demonstrate efficacy. While precision medicine has proved to vital to the many breakthroughs in oncology drug development in the last decade, the lack of pharmacogenomic biomarkers could be one of the main reasons of these failures in Alzheimer's Disease. Denovo plans to use its unique biomarker platform to search for pharmacogenomic predictors of DB109's efficacy. "Alzheimer's Disease remains an area of significant unmet need in neurological disease, and the rich idalopirdine data set that has been generated permits Denovo to fully leverage its experience in novel biomarker discovery to potentially identify patients for which idalopirdine may have benefit," said Michael F. Haller, Ph.D., Denovo's Chief Business Officer. "Denovo discovered the first known genetic biomarker for drug efficacy in a CNS disorder, for our DB104 asset in treatment-resistant depression, and we hope to have similar success for DB109." "We are excited to collaborate with Denovo Biopharma and build upon the efforts of our employees, investigators, and patients who participated in our clinical trials to potentially develop a personalized medicine for Alzheimer's Disease," said Keld Flintholm Jørgensen, CBO at Lundbeck. About Denovo Biopharma LLC Denovo Biopharma is a clinical-stage biopharmaceutical company that applies novel biomarker approaches to re-evaluate medicines that have failed in broad patient populations. The company seeks to discover genomic biomarkers correlated with patients' responses to drug candidates retrospectively. Denovo then designs and executes efficient clinical trials in targeted patient populations to optimize the probability of a successful trial. Denovo has completed enrollment of patients in the U.S. and China with diffuse large B-cell lymphoma (DLBCL) in a Phase 3 clinical trial and has an ongoing Phase 3 trial in Glioblastoma (GBM) for its lead product candidate, DB102 (enzastaurin), which was in-licensed from Eli Lilly & Co. The company has seven additional late-stage programs targeting major unmet needs: DB103 (pomaglumetad methionil) for schizophrenia, DB104 (liafensine) for depression, DB105 (ORM-12741) for Alzheimer's Disease, DB106 (vosaroxin) for acute myeloid leukemia (AML), DB107 (Toca 511 and Toca FC) for recurrent high grade glioma, DB108 (endostatin) for non-small cell lung cancer (NSCLC), and DB109 (idalopirdine) for Alzheimer's Disease. For additional information please visit . Contact: Michael F. Haller, Chief Business Officer Denovo Biopharma LLC mhaller@denovobiopharma.com

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100 Deals associated with Vocimagene amiretrorepvec

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KEGG	Wiki	ATC	Drug Bank
D10328	-	-	DB15331

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Glioblastoma	Discovery	Israel	Tocagen, Inc.	30 Nov 2015
Glioblastoma	Discovery	United States	Tocagen, Inc.	30 Nov 2015
Glioblastoma	Discovery	Canada	Tocagen, Inc.	30 Nov 2015
Glioblastoma	Discovery	South Korea	Tocagen, Inc.	30 Nov 2015
Glioblastoma Multiforme	Discovery	Canada	Tocagen, Inc.	30 Nov 2015
Glioblastoma Multiforme	Discovery	United States	Tocagen, Inc.	30 Nov 2015
Glioblastoma Multiforme	Discovery	South Korea	Tocagen, Inc.	30 Nov 2015
Glioblastoma Multiforme	Discovery	Israel	Tocagen, Inc.	30 Nov 2015
Recurrent Malignant Glioma	Discovery	South Korea	Tocagen, Inc.	30 Nov 2015
Recurrent Malignant Glioma	Discovery	Israel	Tocagen, Inc.	30 Nov 2015

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASGCT2023	Not Applicable	Lung Cancer	-	Toca 511Toca 511 (vocimagene amiretrorepvec)5-FCimagene amiretrorepvec) (Toca 511/5-FC treatment)	sicmvggykc(ndkziuhydj) = ttcfazqzoe vihqcizurp (ticumdmqff ) View more	-	01 May 2023
				Toca 511 (vocimagene amiretrorepvec) (Control group)	sicmvggykc(ndkziuhydj) = xhneybgwuy vihqcizurp (ticumdmqff ) View more
NCT02576665 (Toca 6, ASCO_GI2020)	Phase 1	Colorectal Cancer	17	Toca 511 & Toca FC	(bdesgfkjyo) = udxcwwhsns nnuwyfmndh (zzkievctrm )	Positive	04 Feb 2020
NCT02576665 (Toca 6, SITC2019)	Phase 1	Solid tumor	21	Toca 511	etzreewssx(zkezgzflkk) = no related Grade 4 adverse events owcclrdbdw (fpfzeoczwe )	Positive	01 Nov 2019
NCT02414165 (Toca5, Biospace) Manual	Phase 3	Brain Cancer	-	Fluorouracil+Vocimagene amiretrorepvec	(devzrphkst) = lsjuiteozw bapcpqtncz (abajdojfnb )	Negative	12 Sep 2019
				Standard of Care	(devzrphkst) = uwaybeczse bapcpqtncz (abajdojfnb )
ASGCT2019	Not Applicable	Esophageal Carcinoma	-	Toca 511	omvmhbpauc(vuqltcqnnf) = tumor growth in Toca 511/5-FC treated group was significantly inhibited compared to control group abartovicy (kgkgzloyto ) View more	-	22 Apr 2019
				Toca FC
NCT01470794 (Pubmed \| Neuro Oncol) Manual	Phase 1	Recurrent Malignant Glioma	56	5-fluorocytosine+Vocimagene amiretrorepvec (IDH1 mutant and wild-type tumors)	(jsfywfpkpm) = jgvddxuxyd dqzeezgtra (btuouhwdjn ) View more	Positive	03 Sep 2018
NCT02414165 (Pubmed \| Sci Transl Med) Manual	Phase 1	Recurrent Malignant Glioma	45	5-fluorocytosine+vocimagene amiretrorepvec	(kaaxtwcowh) = vfatussryh ecsimadkek (vzaxegmxhv, 10.8 - 20.0)	Positive	01 Jun 2016
				5-fluorocytosine+subgroup from an external control	-
NCT01156584 \| NCT01985256 \| NCT01470794 (ASCO2014)	Phase 1	Recurrent Malignant Glioma	-	Toca 511	atgcnpsxub(gosbcblkyz) = consistent with tumor regression pmoqvujbto (ctbqnilmqm )	-	20 May 2014
				Toca FC
NCT01156584 \| NCT01470794 (Toca 511, ASGCT2014)	Phase 1	Recurrent Malignant Glioma	-	Toca 511	qeolzglssj(zqaossfxzh) = ygektfvzwo erkjdmxrfu (eqvsqbagvh )	Positive	01 May 2014
				Toca FC	qeolzglssj(zqaossfxzh) = tvkfxesatl erkjdmxrfu (eqvsqbagvh )

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