On October 16, 2023 Ryvu Therapeutics (WSE: RVU), a clinical-stage drug discovery and development company focusing on novel small molecule therapies that address emerging targets in oncology, reported presentations of preclinical data from the PRMT5 program and synthetic lethality platform, as well as preclinical data on MEN1703 (SEL24) in B-cell lymphomas, at the 2023 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), taking place in Boston, Massachusetts (Press release, Ryvu Therapeutics, OCT 16, 2023, View Source [SID1234636030]).

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"We are pleased with preclinical data underscoring the promise of our synthetic lethality platform, as highlighted by our leading preclinical program on PRMT5 inhibitors," said Krzysztof Brzózka, Ph.D., Chief Scientific Officer of Ryvu Therapeutics. "With the growing evidence of the potential of PRMT5 as a cancer therapeutic target, we are excited to share updated data on our MTA-cooperative PRMT5 inhibitors showing high selectivity and efficacy in animal tumor models. Our potentially best-in-class MTA-cooperative PRMT5 inhibitors exhibit significantly improved pharmacokinetics relative to other PRMT5 inhibitors currently in development. Given their in vivo target engagement and remarkable anti-tumor efficacy, we anticipate further development and progression to IND-enabling studies in 2024. In addition, we presented our comprehensive primary colorectal cancer (CRC) cell models that not only mirror the molecular profile seen in patient-derived specimens but also surpass industry benchmarks in screenings, making them invaluable for future drug discovery."

Ryvu licensee, Menarini Group, and academic collaborators presented preclinical data on MEN1703 (SEL24), a first-in-class, oral, dual type I PIM/FLT3 inhibitor in B-cell lymphomas, where MEN1703 demonstrated promising anti-tumor activity. These data support the Phase II clinical program of MEN1703 in diffuse large B-cell lymphoma (DLBCL).

Details on the poster presentations are as follows:

Abstract Title: "Discovery of Novel MTA-cooperative PRMT5 Inhibitors as Targeted Therapeutics for MTAP-deleted Cancers"

Ryvu has developed potentially best-in-class MTA-cooperative PRMT5 inhibitors with outstanding drug-like physicochemical properties and the ability to block methyltransferase activity of PRMT5 with nanomolar IC50 values. The novel, optimized inhibitors exhibit a significantly improved PK profile, and in addition, the compounds show antitumor efficacy and target engagement in vivo, providing a strong foundation for further development.

Abstract Title: "A Comprehensive Platform for Unraveling the Molecular Mechanisms and Vulnerabilities of Colorectal Cancer: A Step Forward in Target Discovery"

Ryvu has pioneered an extensive platform that employs primary colorectal cancer (CRC) models, originated from human intestinal stem cells. This innovative approach enables high-throughput phenotypic assays and CRISPR/Cas9 genomic screenings, surpassing conventional industry standards. The robustness of these models has been confirmed through Ryvu’s proprietary ranking algorithm, which identifies potential synthetic lethal drug targets, particularly in KRAS-driven cells.

Abstract Title: "MEN1703/SEL24, A Potent PIM Inhibitor, Demonstrates Promising Anti-Tumor Activity in Activated B Cell Like DLBCL, Mantle Cell Lymphoma and Marginal Zone Lymphoma Cells"

Pharmacological inhibition with MEN1703 (SEL24), a first-in-class, oral, dual type I PIM/FLT3 inhibitor shows anti-proliferative effects in B cell lymphomas of various histotypes. Importantly, MEN1703 was effective in lymphoma cells resistant to other treatments inducing apoptosis in most cell lines. RNA-Seq indicated that the molecule modulates the transcriptome of highly responsive DLBCL cell lines differently from other, poorly responsive cells, providing clues to mechanisms involved in sensitivity to PIM inhibitors and supporting potential in treating B-cell lymphomas.

Posters are available on the Ryvu corporate website.

Webinar on PRMT5 and synthetic lethality pipeline, including WRN project and target discovery efforts

Ryvu will host a webinar today at 9:30 am CEST to discuss the PRMT5 data. To join the webcast, please register here: https://bit.ly/3RL1YWp. A recording from the webinar will be available on the ‘Presentations’ section of the Ryvu website.

On October 16, 2023 IDEAYA Biosciences, Inc. (Nasdaq:IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported initiation of a Phase 2 expansion of the darovasertib and crizotinib combination in GNAQ/11 metastatic cutaneous melanoma (Press release, Ideaya Biosciences, OCT 16, 2023, View Source [SID1234636029]).

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"We are pleased to advance the darovasertib and crizotinib combination into a Phase 2 expansion for GNAQ/11 metastatic cutaneous melanoma, where there are currently no FDA approved therapies in this genetically-defined patient population highlighting the unmet medical need," said Dr. Darrin M. Beaupre, M.D., Ph.D., Chief Medical Officer, IDEAYA Biosciences. "As IDEAYA advances the registrational trial for darovasertib in first-line HLA-A2-negative metastatic uveal melanoma, it’s a strategic priority to expand the program’s clinical application in multiple solid tumor settings, including HLA-A2-positive metastatic uveal melanoma, neoadjuvant and adjuvant uveal melanoma, and GNAQ/11 cutaneous melanoma," said Yujiro S. Hata, Chief Executive Officer, IDEAYA Biosciences.

"The clinical efficacy observed in a GNAQ melanoma patient that progressed on immune checkpoint inhibitor therapies and treated in our clinic has been durable and well tolerated. This is a very important finding in this biomarker defined population," said Dr. Marcus Butler, M.D., Medical Oncologist, Tumor Immunotherapy Program, Melanoma/Skin Oncology Site Lead at Princess Margaret Cancer Centre in Toronto, Canada, and Ocular Melanoma Physician Task Force of Canada Co-Lead.

The Phase 2 darovasertib and crizotinib combination expansion is based on preliminary clinical efficacy observed in the GNAQ/11 metastatic cutaneous melanoma setting. The GNAQ/11 prevalence in cutaneous melanoma has been reported at approximately 5% in The Cancer Genome Atlas. The GNAQ/11 cutaneous melanoma estimated annual incidence is approximately 5,000 patients in the US and 8,000 patients in the EU28, and the estimated total prevalence of GNAQ/11 cutaneous melanoma is approximately 70,000 patients in the US and 110,000 patients in the EU28. It has been reported that approximately 12.5% to 15% of cutaneous melanoma patients have been reported to develop metastatic disease, whereas in uveal melanoma, a predominantly GNAQ/11 mediated cancer, the metastatic rate has been reported at approximately 50%. In addition, based on several metastatic cancer patient databases, including Memorial Sloan Kettering Cancer Center (MSKCC) Impact, we project GNAQ/11 metastatic cutaneous melanoma has the potential to double or more the annual addressable metastatic patient population of metastatic uveal melanoma alone. In addition, GNAQ/11 mutation patients are known to have low tumor mutational burden making these patients less likely to benefit from immune checkpoint inhibitor therapies.

Darovasertib (IDE196) is a potent, selective small molecule inhibitor of protein kinase C (PKC). Mutations in GNAQ or GNA11 (GNAQ/11) have been identified in approximately 90% of patients with metastatic uveal melanoma. These mutations are associated with activation of signaling pathways, including oncogenic RAS/RAF/MEK/ERK via PKC activation, driving tumor progression.

On October 16, 2023 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that the company, along with partners, will present six abstracts including data from trials of bispecific antibody zanidatamab and Zepzelca (lurbinectedin), as well as the study design for a Phase 1 trial of the pan-RAF inhibitor JZP815, at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023, taking place in Madrid, Spain, from October 20-24, 2023 (Press release, Jazz Pharmaceuticals, OCT 16, 2023, View Source [SID1234636028]).

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"The compelling data being presented at ESMO (Free ESMO Whitepaper) by Jazz and partners, in particular for zanidatamab in biliary tract and gastric cancers, demonstrate the clinical potential of our solid tumor oncology development programs to raise the standard of care for some of the most difficult-to-treat cancers," said Rob Iannone, M.D., M.S.C.E., executive vice president, global head of research and development of Jazz Pharmaceuticals. "Through our expanding research in solid tumors – including targeted therapies and immuno-oncology – Jazz is advancing novel investigational therapies that target specific proteins like HER2 and important signaling pathways such as the RAS-RAF-MAPK pathway."

Notable presentations include:

A poster presentation featuring progression-free survival (PFS) and duration of response (DoR) results from a Phase 1b/2 study of zanidatamab plus chemotherapy in combination with tislelizumab for the first-line treatment of HER2-positive gastric/gastroesophageal junction adenocarcinoma (G/GEJC). The study, sponsored by BeiGene, Ltd., showed zanidatamab plus chemotherapy and tislelizumab produced antitumor activity with a confirmed objective response rate (ORR) of 75.8% and median PFS of 16.7 months; and safety was consistent with previous findings.1
A poster presentation featuring quality-of-life data from a Phase 2b study of zanidatamab for the second-line treatment of HER2-amplified biliary tract cancers (BTC), finding that patients with HER2-positive BTC who responded to zanidatamab reported improved health-related quality of life (HRQoL) compared with baseline. Overall, zanidatamab led to a meaningful clinical benefit, which may reduce disease burden and potentially result in improved patient HRQoL compared with baseline.2
A mini oral presentation highlighting results of the Phase 1/2 LUPER study evaluating the efficacy of lurbinectedin in combination with pembrolizumab for the second-line treatment of small cell lung cancer (SCLC), which includes the following data: preliminary ORR of 46.4%, median DoR of 11.4 months, median PFS of 5.3 months and median OS of 11.1 months; the combination resulted in a manageable safety profile.3
The full ESMO (Free ESMO Whitepaper) abstracts are available at: View Source

The full list of Jazz or partner-supported presentations at the 2023 ESMO (Free ESMO Whitepaper) Annual Meeting includes:

Zanidatamab Presentations

Presentation Title

Author

Presentation Details

Zanidatamab (zani) plus chemotherapy
(chemo) and tislelizumab (TIS) as first-
line (1L) therapy for patients (pts) with
advanced HER2-positive (+)
Gastric/gastroesophageal junction
adenocarcinoma (GC/GEJC): updated
results from a phase 1b/2 study

Keun-Wook Lee,
et al.

Type: Poster Session

Date: Monday, October 23;
12:00-1:00 PM CEST

Abstract Number:1518P

Quality of life (QoL) outcomes in
patients (pts) with zanidatamab (zani)-
treated HER2-positive (HER2+) biliary
tract cancer (BTC) in the Phase 2b
HERIZON-BTC-01 study

Harpreet Wasan,
et al.

Type: Poster Session

Date: Monday, October 23;
12:00-1:00 PM CEST

Abstract Number: 101P

Zepzelca Presentations

Presentation Title

Author

Presentation Details

Lurbinectedin (LUR) in combination with
pembrolizumab (PBL) in relapsed small
cell lung cancer (SCLC): the phase 1/2
LUPER study [PharmaMar-supported IST]

Antonio
Calles, et
al.

Type: Mini Oral

Session: Mini Oral Session 1 –
Non-Metastatic NSCLC and Other
Thoracic Malignancies

Date: Sat, October 21; 2:50-2:55 PM CEST

Abstract Number: 1989MO

Lurbinectedin (LRB) pharmacokinetics
(PK) and safety when co-
administered with itraconazole (ITZ)
in patients with advanced solid tumor

Irene
Moreno, et
al.

Type: Poster Session

Date: Monday, October 23; 12:00-
1:00 PM CEST

Abstract Number: 679P

Supportive measures to control
myelosuppression and costs for patients
with SCLC with lurbinectedin, CAV
or topotecan with or without trilaciclib: a
review on the basis of clinical trials

Manuel
Dómine, et
al.

Type: Poster Session

Date: Saturday, October 21; 12:00-
1:00 PM CEST

Abstract Number: 2024P

JZP815 Presentations

Presentation Title

Author

Presentation Details

Phase 1, open-label, first-in-human (FIH)
study of JZP815 in advanced or
metastatic solid tumors
harboring mitogen-activated
protein kinase (MAPK) alterations

Abdul-
Rafeh
Naqash, et
al.

Type: Poster Session

Date: Monday, October 23; 12:00-
1:00 PM CEST

Abstract Number: 720TiP

About Zanidatamab
Zanidatamab is an investigational bispecific antibody that can simultaneously bind two non-overlapping epitopes of HER2, known as biparatopic binding. This unique design results in multiple mechanisms of action including dual HER2 signal blockade, increased binding and removal of HER2 protein from the cell surface, and potent effector function leading to encouraging antitumor activity in patients. Zanidatamab is being developed in multiple clinical trials as a targeted treatment option for patients with solid tumors that express HER2. Zanidatamab is being developed by Jazz and BeiGene, Ltd. (BeiGene) under license agreements from Zymeworks, which first developed the molecule.

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for zanidatamab in patients with previously treated HER2 gene-amplified biliary tract cancers (BTC), and two Fast Track designations for zanidatamab: one as a single agent for refractory BTC and one in combination with standard of care chemotherapy for first-line gastroesophageal adenocarcinoma (GEA). Additionally, zanidatamab has received Orphan Drug designations from FDA for the treatment of BTC and GEA, as well as Orphan Drug designation from the European Medicines Agency for the treatment of gastric cancer. Zanidatamab was also granted Breakthrough Therapy designation from the Center for Drug Evaluation (CDE) in China.

About Zepzelca (lurbinectedin)
Zepzelca is an alkylating drug that binds guanine residues within DNA. This triggers a cascade of events that can affect the activity of DNA binding proteins, including some transcription factors, and DNA repair pathways, resulting in disruption of the cell cycle and eventual cell death.4

The FDA approved Zepzelca under accelerated approval in June 2020 for the treatment of adult patients with metastatic SCLC with disease progression on or after platinum-based chemotherapy. The approval is based on overall response rate (ORR) and duration of response demonstrated in an open-label, monotherapy clinical study. In December 2021, Jazz and PharmaMar announced the initiation of LAGOON, a confirmatory Phase 3 clinical trial of Zepzelca for the treatment of patients with relapsed small cell lung cancer. If positive, LAGOON could confirm the benefit of Zepzelca in the treatment of small cell lung cancer (SCLC) when patients progress following 1L treatment with a platinum-based regimen and support full approval in the U.S.

Zepzelca is a prescription medicine used to treat adults with SCLC that has spread to other parts of the body (metastatic) and who have received treatment with chemotherapy that contains platinum, and it did not work or is no longer working. Zepzelca is approved based on response rate and how long the response lasted. Additional studies will further evaluate the benefit of Zepzelca for this use.

Important Safety Information for ZEPZELCA

Before receiving ZEPZELCA, tell your healthcare provider about all of your medical conditions, including if you:

have liver or kidney problems.
are pregnant or plan to become pregnant. ZEPZELCA can harm your unborn baby.
Females who are able to become pregnant:

Your healthcare provider should do a pregnancy test before you start treatment with ZEPZELCA.
You should use effective birth control (contraception) during treatment with and for 6 months after your final dose of ZEPZELCA.
Tell your healthcare provider right away if you become pregnant or think that you are pregnant during treatment with ZEPZELCA.
Males with female partners who are able to become pregnant should use effective birth control during treatment with and for 4 months after your final dose of ZEPZELCA.
Females who are breastfeeding or plan to breastfeed. It is not known if ZEPZELCA passes into your breastmilk. Do not breastfeed during treatment with ZEPZELCA and for 2 weeks after your final dose of ZEPZELCA. Talk to your healthcare provider about the best way to feed your baby during treatment with ZEPZELCA.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Certain other medicines may affect how ZEPZELCA works.

What should I avoid while using ZEPZELCA?

Avoid eating or drinking grapefruit, or products that contain grapefruit juice during treatment with ZEPZELCA.

ZEPZELCA can cause serious side effects, including:

Low blood cell counts. Low blood counts including low neutrophil counts (neutropenia) and low platelet counts (thrombocytopenia) are common with ZEPZELCA, and can also be severe. Some people with low white blood cell counts may get fever, or an infection throughout the body (sepsis), that can cause death. Your healthcare provider should do blood tests before you receive each treatment with ZEPZELCA to check your blood cell counts.
Tell your healthcare provider right away if you develop:

fever or any other signs of infection
unusual bruising or bleeding
tiredness
pale colored skin
Liver problems. Increased liver function tests are common with ZEPZELCA, and can also be severe. Your healthcare provider should do blood tests to check your liver function before you start and during treatment with ZEPZELCA.
Tell your healthcare provider right away if you develop symptoms of liver problems including:

loss of appetite
nausea or vomiting
pain on the right side of your stomach area (abdomen)
Your healthcare provider may temporarily stop treatment, lower your dose, or permanently stop ZEPZELCA if you develop low blood cell counts or liver problems during treatment with ZEPZELCA.
The most common side effects of ZEPZELCA include:

Tiredness
low white and red blood cell counts
increased kidney function blood test (creatinine)
increased liver function blood tests
increased blood sugar (glucose)
nausea
decreased appetite
muscle and joint (musculoskeletal) pain
low level of albumin in the blood
constipation
trouble breathing
low levels of sodium and magnesium in the blood
vomiting
cough
diarrhea
These are not all of the possible side effects of ZEPZELCA.

Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Jazz Pharmaceuticals at 1-800-520-5568.

More information about Zepzelca, including Full Prescribing Information and Patient Information, is available here.

ZEPZELCA is a trademark of Pharma Mar, S.A. used by Jazz Pharmaceuticals under license.

About JZP815
JZP815 is an investigational pan-RAF kinase inhibitor that was discovered and developed using state-of-the-art screening methodologies and medicinal chemistry. JZP815 targets specific components of the mitogen-activated protein kinase (MAPK) pathway that, when activated by oncogenic mutations, can be a frequent driver of human cancer. JZP815 potently inhibits both monomer- and dimer-driven RAF signaling (e.g., RAS-induced), prevents paradoxical pathway activation induced by BRAF selective inhibition, and is active against class 1, class 2, and class 3 BRAF mutants, as well as BRAF fusions and CRAF mutants. JZP815 is not currently approved for use anywhere in the world. JZP815 is part of Jazz’s growing early-stage R&D pipeline focused on solid tumors and targeted therapy.

On October 16, 2023 I-Mab (Nasdaq: IMAB) (the "Company"), a global biotechnology company focused on bringing highly differentiated medicines to patients around the world through the discovery, development, and commercialization of novel immunotherapies and biologics, reported that the updated clinical results from its Phase 1 study of givastomig (also known as TJ-CD4B/ABL111) in advanced solid tumors will be reported in a poster presentation at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023, on Monday, October 23 at 12:00 p.m. CET (Press release, I-Mab Biopharma, OCT 16, 2023, View Source [SID1234636027]).

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Presentation details:

Abstract Title:

First-In-Human Phase I Study of Givastomig, A Novel Claudin 18.2/4-1BB Bispecific Antibody in Advanced Solid Tumors

Presentation Number:

1039P

Presenter:

Dr. Geoffrey Ku, Memorial Sloan Kettering Cancer Center

Session:

Poster Presentation: Investigational Immunotherapy

Location:

Hall 8, IFEMA Madrid, Spain

Presentation Date/Time:

Monday, October 23, 2023, 12:00 p.m. – 1:00 p.m. Central European Time

The abstract is currently available on the ESMO (Free ESMO Whitepaper) website. Please visit the following link to read the full abstract.

About Givastomig

Givastomig, also known as TJ-CD4B/ABL111, is a bispecific antibody designed to bind to Claudin 18.2 (CLDN 18.2) as a tumor engager and 4-1BB as a conditional T-Cell activator. It binds to tumor cells expressing various levels of CLDN18.2, i.e., gastric cancer and pancreatic cancer cells, and conditionally activates intra-tumoral T cells at the tumor site through the 4-1BB arm. Givastomig appears to effectively maintain a strong tumor binding property and anti-tumor activity attributable to a synergistic effect of both CLDN18.2 antibody and 4-1BB antibody while avoiding or minimizing liver toxicity and systemic immunotoxicity commonly seen with 4-1BB antibodies as a drug class. Being developed under collaboration between I-Mab and ABL Bio, a clinical-stage biotechnology company in South Korea, givastomig is currently being investigated in a Phase 1 clinical study in the U.S. and China. In March 2022, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for givastomig for the treatment of gastric cancer, including cancer of the gastroesophageal junction.

On October 16, 2023 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition"), a multi-national epigenetics company, reported that it is presenting three scientific abstracts at ESMO (Free ESMO Whitepaper) 2023, the annual congress of the European Society for Medical Oncology (Press release, VolitionRX, OCT 16, 2023, View Source [SID1234636026]).

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Dr. Jake Micallef, Chief Scientific Officer at Volition, said: "We are delighted to be attending ESMO (Free ESMO Whitepaper) 2023 and have the opportunity to share exciting new data in lung cancer and glioblastoma, and introduce what we believe to be an entirely new method for the detection of cancer."

On Saturday 21st October, Dr. Dorian Pamart, Head of Technology and Service Unit at Volition, will present a poster (205P) titled ‘A novel immunoprecipitation/PCR method for detection of plasma cfDNA fragments selectively occupied by CTCF in cancer’.

On Sunday 22nd October, Dr. Pei-Hsing Chen from National Taiwan University Hospital will present a mini oral session (133MO) titled ‘Differentiation of malignant and benign lung nodules using epigenetically modified nucleosomes in plasma’ in the Santander Auditorium, hall 9 at 9.30 am. The study was undertaken by Volition and the National Taiwan University Hospital and is part of a longer-term research collaboration.

In addition, Jonathan Decarpentrie, from the Research Institute for Life Sciences, University of Namur will present a poster (524P) titled ‘Cell line study of nucleosome-based biomarkers in the diagnosis and detection of relapses in glioblastoma’. Volition and biotechnology company, Qualiblood have worked in collaboration with University of Namur on this latest study.

Abstract summary:

Date

Presentation Title

Presentation
Number

Presentation
type

Sat 21st
October

A novel immunoprecipitation/PCR method for
detection of plasma cfDNA fragments selectively
occupied by CTCF in cancer’.

205P

Poster

Sun 22nd
October

Differentiation of malignant and benign lung nodules
using epigenetically modified nucleosomes in
plasma.

133MO

Mini oral
session

Sun 22nd
October

Cell line study of nucleosome-based biomarkers in
the diagnosis and detection of relapses in
glioblastoma

524P

Poster

Volition is developing simple, easy-to-use, cost-effective blood tests to help diagnose and monitor a range of life-altering diseases in both humans and animals. For more information about Volition’s technology go to: www.volition.com