On March 9, 2023 Servier, a global pharmaceutical group, reported it has entered into a strategic partnership with QIAGEN, a leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life, to develop a companion diagnostic test that detects IDH1 mutations (Press release, Servier, MAR 9, 2023, View Source [SID1234628479]). This test will be for use with Servier’s marketed and investigational targeted treatments in Acute Myeloid Leukemia (AML).

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QIAGEN and Servier are collaborating to develop a PCR-based companion diagnostic test that can be used to rapidly identify AML patients with IDH1 gene mutations. This partnership comes in the light of the published pivotal clinical phase 3 data of the AGILE study which showed that ivosidenib in combination with azacitidine as a first-line treatment for intensive chemotherapy ineligible AML patients with IDH1 gene mutations shows superior results compared to treatment with azacitidine alone.1 The partnership with QIAGEN will lead to the development of a specific diagnostic test for IDH1 gene mutations with a rapid turnaround time.

Brian Lockhart, Global Head of Companion Diagnostics at Servier, said: "In order to expand the global access for ivosidenib for patients, it is imperative that we leverage a partner such as QIAGEN with an established global footprint in oncology-driven diagnostics, and a proven expertise in companion diagnostics development and approvals."

Jonathan Arnold, Vice President, Head of Partnering for Precision Diagnostics at QIAGEN, said: "We are pleased to support Servier with a companion diagnostic in their mission to propose innovative treatment for IDH1 mutated AML patients. At the same time, we are further strengthening our role in developing companion diagnostics for the ever-growing number of biomarkers being discovered in onco-hematology."

Under the Master Collaboration Agreement, QIAGEN will develop and validate a real-time PCR-based in vitro diagnostic test that can be used to detect IDH1 gene mutations in whole blood and bone marrow aspirates in AML.

The companion diagnostic will run on the QIAGEN Rotor-Gene Q MDx device, which is widely used by labs worldwide. QIAGEN’s experienced regulatory teams will support clinical validation of the companion diagnostic and its approval in the US, the European Union and Japan.

Fabien Schmidlin, Global Head of Translational Medicine at Servier, concluded: "Early biomarker testing for an IDH1 mutation has grown in importance for targeted therapies and can play a critical role in the treatment of acute myeloid leukemia (AML). This partnership with QIAGEN will help us further our mission to improve outcomes for patients with AML who test positive for an IDH1 mutation in both the relapsed/refractory and newly diagnosed intensive chemotherapy ineligible setting and for investigational purposes in AML patients in the front-line setting."

Press contact

Sonia Marques (France): [email protected] I Tel. +33 (0)1 55 72 40 21
Julia Ferreira (U.S.): [email protected] I Tel. 857 262 3852

On March 9, 2023 Alverno Laboratories, a provider of high-quality diagnostic testing services and one of the largest integrated laboratory networks in the United States, and Ibex Medical Analytics, the leader in AI-powered cancer diagnostics, reported a new agreement to expand the deployment of Ibex’s Galen suite of Artificial Intelligence (AI) solutions to the entire Alverno network across Illinois and Indiana (Press release, Ibex Medical Analytics, MAR 9, 2023, View Source [SID1234628478]). The deployment includes AI-powered solutions for cancer diagnosis across multiple tissue types and will support Alverno pathologists in providing the utmost quality of care for their patients.

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Under the new expansion agreement, Alverno will make Ibex’s solutions available to all pathologists in its network, which includes more than 30 hospital laboratories and touches over eight million patients’ lives per year across Indiana and Illinois. Building on its earlier investment in digital pathology infrastructure, Alverno is among the first laboratories in the U.S. to digitize its pathology services, harnessing the high-throughput capabilities of the Philips IntelliSite Pathology Solution, and is the first to offer this AI-supported cancer diagnosis in the Midwest region of the United States.

"Alverno will expand the reach of Ibex’s AI technology across our network, providing the most innovative tools to our team of pathologists. With an increasing demand for high-quality cancer testing, Alverno continues to invest in technology to support our growth while remaining focused on high quality patient care," said Sam Terese, CEO & President of Alverno Laboratories. "Our partnership with Ibex enables Alverno to offer a new level of care to the physicians who treat their patients in our communities, and that is aligned with our mission to continually improve the delivery of quality diagnostic data and laboratory service to our partners and caregivers."

Ibex’s Galen suite of solutions will support Alverno pathologists in a variety of tasks during routine review of breast, prostate, and gastric biopsies, including case prioritization, AI-powered cancer detection and reporting, and help optimize IHC workflows and drive other productivity-enhancing tools. This implementation of AI on a large scale across the entire laboratory network has the potential to improve pathologists’ productivity and user experience, reduce operational costs and improve overall service levels. Galen is the most widely deployed AI technology in pathology and is used as part of everyday clinical practice at laboratories, hospitals and health systems worldwide. Galen demonstrated outstanding outcomes across multiple clinical studies performed on various tissue types and diagnostic workflows1,2,3,4,5.

"We look forward to our continued collaboration with Alverno, providing its team of expert pathologists with the most advanced AI-powered solutions and supporting diverse patient communities across rural, suburban and large-metro populations," said Justin McCarthy, Head of U.S. sales at Ibex Medical Analytics. "With over 100,000 new cancer cases expected in the Midwest region in 20236, Ibex is committed to advancing the implementation of AI in pathology to support the growing demand for quality diagnostics."

On March 9, 2023 Avenge Bio, Inc. ("Avenge"), a clinical stage, oncology-focused biotechnology company developing the LOCOcyte Immunotherapy platform for the precision administration of potent immune effector molecules to treat solid tumors, reported that it completed a pre-Investigational New Drug (IND) meeting with the U.S. Food and Drug Administration ("FDA") with respect to AVB-001 for the treatment of pleural malignant mesothelioma, and provided a corporate update (Press release, Avenge Bio, MAR 9, 2023, View Source [SID1234628477]).

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AVB-001, developed in the LOCOcyte platform, consists of proprietary engineered allogeneic human cells. The cells are encapsulated in a pro-inflammatory biomaterial that are delivered to the local tumor environment and generate high, sustained concentrations of human IL-2. The product initiates a robust and durable, local and systemic immune response while avoiding toxicities associated with systemic immunotherapies.

Pipeline Updates:

Preliminary feedback received from the FDA on future development of AVB-001 for the treatment of pleural malignant mesothelioma. Avenge obtained guidance from the FDA on its preclinical and clinical development plans and remains on track to submit an IND in the second half of 2023. Avenge previously published preclinical data establishing the efficacy and safety of pleural administered AVB-001 for the treatment of pleural malignant mesothelioma. The manuscript, entitled "Activation of adaptive and innate immune cells via localized Interleukin-2 cytokine factories eradicates mesothelioma tumors," and can be viewed on the Clinical Cancer Research website.
Continue to enroll patients in ongoing Phase 1/2 clinical trial evaluating AVB-001 for the treatment of refractory ovarian cancer. In January 2023, Avenge announced the dosing of the first patient in a first-in-human, single-arm, open-label, dose-escalation and expansion study (NCT05538624) designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity. In this clinical trial, AVB-001 is delivered intraperitoneally (IP) to patients with high grade serous adenocarcinoma of the ovary, primary peritoneum, or fallopian tube. Avenge plans to provide an update on the program in the second half of 2023.
Continued advancement of additional development programs leveraging LOCOcyte platform. Avenge continues to advance additional development programs in preclinical studies including AVB-002, an IL-12 program in development for multiple peritoneal cancers such as pancreatic cancer. In addition, Avenge is building out its pipeline via applying its LOCOcyte technology to a number of additional targets.
"We greatly appreciate the FDA’s guidance as we continue to advance AVB-001 for the treatment of pleural malignant mesothelioma, a disease with significant unmet medical need", said Michael Heffernan, Co-Founder and Chief Executive Officer of Avenge Bio. "2023 is a transformational year for Avenge as we continue to enroll patients for our lead clinical program in refractory ovarian cancer and further build our pipeline of products leveraging the LOCOcyte technology."

About LOCOcyte Platform
Our LOCOcyteTM allogeneic cell-based immunotherapy platform enables potent localized modulation of the immune system which also precipitates a systemic immune response, allowing us to treat previously intractable cancers. The technology leverage three unique advantages:

Potent immune effector molecules are generated by synthetically engineering allogeneic cells creating a ready-to-use therapy,
Therapy is localized in proximity to the primary tumor site and generates innate and adaptive immune response, and
The immunomodulator trains the patient’s immune system generating a robust immune response that seeks and eradicates distal metastasis without systemic toxicity.

On March 9, 2023 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, reported that the first patient in Switzerland has been enrolled in the Company’s ongoing potentially pivotal global trial evaluating Berubicin for the treatment of recurrent glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer (Press release, CNS Pharmaceuticals, MAR 9, 2023, View Source [SID1234628476]).

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The Company has opened 40 clinical trial sites of the 59 sites selected across the U.S., Italy, France, Spain, and Switzerland. A pre-planned, non-binding futility analysis will be performed after approximately 30 to 50% of all planned patients have reached the primary endpoint. This review will include additional evaluation of safety as well as secondary efficacy endpoints. Enrollment will not be paused during this interim analysis.

"The active patient enrollment we continue to build across our clinical trial sites in Europe is incredibly encouraging. Our team is laser focused on getting additional clinical trial sites online so that we can continue to advance toward our planned interim analysis, which we expect mid-year 2023. We are continually grateful to the institutions, clinicians and staff that are contributing to the conduct of this trial and are extremely grateful to the patients that choose to participate. There remains a significant unmet need in the treatment of GBM and we remain committed to advancing Berubicin to potentially offer a much-needed therapy for this devastating cancer," commented John Climaco, CEO of CNS Pharmaceuticals.

Professor Michael Weller, MD, University Hospital Zurich and National Coordinating Investigator for the potentially pivotal study, added, "I believe Berubicin has the potential to play an important role in the treatment of this devastating disease. We are committed to working alongside the CNS Pharmaceuticals team to advance the development of Berubicin and are pleased to commence patient enrollment at our site(s) in Switzerland."

Berubicin, is a novel anthracycline and the first anthracycline to appear to cross the blood-brain barrier. Berubicin is currently being evaluated in a potentially pivotal global study evaluating its efficacy and safety in the treatment of GBM. This trial is an adaptive, multicenter, open-label, randomized controlled study in adult patients with recurrent glioblastoma multiforme (WHO Grade IV) after failure of standard first-line therapy compared to the standard of care (SOC). The primary endpoint of the study is Overall Survival (OS), a rigorous endpoint that the FDA has recognized as the basis for approval of oncology drugs when a statistically significant improvement can be shown relative to a randomized control arm. Results from the trial will compare Berubicin to current SOC (Lomustine), with a 2 to 1 randomization of patients to receive either Berubicin or Lomustine. The recently amended protocol expands eligibility for the study to patients who have received additional treatments as part of the first line therapy for their disease considering advancements in this area. This change was made due to the complexity of new agents introduced as a component of first line therapy, which allows an additional group of patients that can enroll on the study after what may constitute multiple procedures as their initial treatment. For more information about this trial, visit clinicaltrials.gov and reference identifier NCT04762069.

The FDA has granted CNS Pharmaceuticals Fast Track Designation for Berubicin which enables more frequent interactions with them to provide guidance on expediting the development and review process. Additionally, the Company has received Orphan Drug Designation from the FDA which may provide seven years of marketing exclusivity upon approval of an NDA.

About Berubicin

Berubicin is an anthracycline, a class of anticancer agents that are among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to utilize natural processes to induce deoxyribonucleic acid (DNA) damage in targeted cancer cells by interfering with the action of topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin treatment of brain cancer patients appeared to demonstrate positive responses that include one durable complete response in a Phase 1 human clinical trial conducted by Reata Pharmaceuticals, Inc. Berubicin, was developed by Dr. Waldemar Priebe, Professor of Medicinal Chemistry at The University of Texas MD Anderson Cancer Center.

On March 9, 2023 REVEAL GENOMICS, S.L., a Barcelona-based biotechnology start-up seeking to revolutionize precision oncology through biomarker innovation, reported a new addition to its pipeline consisting of a novel biomarker approach in liquid biopsy for patients with advanced cancer (Press release, REVEAL GENOMICS, MAR 9, 2023, View Source [SID1234628475]). The main findings of this development were published in Nature Communications this month, in collaboration with several academic institutions, including the Hospital Clinic/IDIBAPS de Barcelona (Spain), University of Barcelona (Spain), Vall d’Hebrón Institute of Oncology (Barcelona, Spain), Hospital Universitario 12 de Octubre (Madrid, Spain), the Catalan Institute of Oncology (Badalona, Spain), and the University of North Carolina (Chapel Hill, USA).

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Analysis of cell-free DNA (cfDNA), present in body fluids such as plasma, is broadly known as liquid biopsy. In oncological patients, cfDNA contains a fraction of tumor-derived genomic material (ctDNA), that has been proven as a valuable resource to identify tumor-borne genetic alterations. However, cancer is highly complex, and additional biological information is needed to refine the prediction of patient outcome and/or benefit from treatment.

Dr. Aleix Prat, Co-Founder and CSO of REVEAL GENOMICS and the lead author of the study, explained: "Our proprietary and novel supervised learning computational approach predicts complex tumor features including gene expression, protein and tumor histology using one data source: DNA sequencing. Here, we demonstrate that our approach is feasible in plasma cfDNA and that it provides clinically relevant information."

New product in the pipeline
Single DNA alterations in metastatic breast cancer, such as ESR1 or PIK3CA mutations, are valuable information but are not enough to predict the patient outcome. To address this issue, investigators from REVEAL GENOMICS sequenced cfDNA from 459 patients with metastatic breast cancer, including 245 patients with hormone receptor-positive/HER2-negative (HR+/HER2-) treated with endocrine therapy and a CDK4/6 inhibitor (i.e., palbociclib, ribociclib or abemaciclib).

Firstly, REVEAL GENOMICS’ proprietary machine-learning multi-gene signatures were applied in plasma and linked to DNA/RNA/protein data from tumor tissue (paired samples). The results showed, for the first time, that multi-gene signatures tracking complex biological features can be successfully identified in ctDNA. These complex biological features include, among others, measures of tumor proliferation and estrogen receptor signaling, similar to what is accomplished using direct tumor tissue DNA or RNA profiling. For example, one of REVEAL GENOMICS´ signatures in plasma ctDNA, known as the estrogen receptor (ER) signaling signature, predicted the ER status of the tumor tissue as determined by standard immunohistochemistry.

Secondly, the authors discovered that the combination of 150 biologically relevant signatures identified 4 new DNA-based molecular subtypes of breast cancer. More importantly, these 4 biological entities were strongly associated with survival outcome in patients with early-stage and/or metastatic HR+/HER2- breast cancer.

Finally, the investigators focused on a particular genomic signature called retinoblastoma loss-of-heterozygosity (RB-LOH), which was designed to capture tumor biological status induced by the loss of RB – a known key player in tumor cell division needed for CDK4/6 inhibitors to work. In patients with metastatic HR+/HER2- breast cancer treated with endocrine therapy and a CDK4/6 inhibitor, REVEAL GENOMICS’ ctDNA RB-LOH signature identified the 20-30% of patients who do not respond well to this treatment.

Dr. Ana Vivancos, Co-Founder and consultant of REVEAL GENOMICS, concluded: "Our novel approach can have huge implications in the clinical setting, and opens new opportunities for the discovery of multi-feature genomic predictors coming from ctDNA in breast cancer and other types of cancer."

About liquid biopsy
The liquid biopsy market in oncology can potentially become the future gold standard, considering its various advantages over conventional cancer diagnostic approaches. The global market boasts a total value of $4.3 billion in 2022 and a projected growth rate of 18.3%, reaching $10.0 billion by 2027. The market is driven by the rising incidence and prevalence of cancer in the developing world and the increasing preference for noninvasive treatment procedures.

Dr. Patricia Villagrasa, Co-Founder and CEO of REVEAL GENOMICS, concluded: "Our company is committed to creating and developing novel genomic-based assays in oncology and demonstrating their clinical utility as we have already done with our first product, the HER2DX, which is already impacting patient care in early-stage HER2-positive breast cancer. This new ctDNA-based assay, called DNADX, is our second product expected to be available in 2024." The Spanish Ministry of Science and Innovation has granted funding for this new product, validating DNADX as an innovative and clinically useful tool.