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Shuttle Pharmaceuticals Engages UI Pharmaceuticals for Formulation and Clinical Batch Manufacture of Ropidoxuridine for Brain Tumor Clinical Trial

On March 9, 2023 Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH), a discovery and development stage specialty pharmaceutical company focused on improving the outcomes of cancer patients treated with radiation therapy (RT), reported it has signed an agreement with the University of Iowa (UI) Pharmaceuticals for formulation development and clinical batch manufacture of drug capsules of Ropidoxuridine (Press release, Shuttle Pharmaceuticals, MAR 9, 2023, View Source [SID1234628481]). This is expected to be the final step required in the drug manufacturing process for use in Shuttle Pharma’s upcoming Phase II clinical trial evaluating Ropidoxuridine in combination with radiation therapy for the treatment of glioblastoma.

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Shuttle Pharma has worked with TCG GreenChem, Inc. to complete the campaign to manufacture 25 kg of the drug product for Ropidoxuridine, and approximately 10,000 capsules, to complete the Phase II trial. Shuttle Pharma is preparing the Investigational New Drug application for the study with an expectation of final submission to the FDA at the end of the second quarter of 2023.

UI Pharmaceuticals is a university-affiliated CDMO offering pharmaceutical product development, manufacturing (sterile and non-sterile products), and analytical services. As an FDA-registered Drug Product Manufacturing and Testing Facility, UI Pharmaceuticals can produce and test products intended for both clinical studies and commercial sales.

"We continue to execute on the necessary steps to advance Ropidoxuridine, our lead clinical sensitizer drug candidate, towards the commencement of our upcoming Phase II clinical trial in brain cancer patients undergoing radiation therapy," commented Shuttle Pharma’s Chairman and CEO, Anatoly Dritschilo, M.D. "We look forward to working with TCG GreenChem and UI Pharmaceuticals going forward to advance our clinical work."

Shuttle Pharma’s platform of sensitizers offers a pipeline of product candidates designed to address the urgent clinical need for new radiation sensitizer agents. The Company’s pipeline includes Ropidoxuridine, its lead clinical sensitizer drug candidate, to sensitize rapidly growing cancer cells and selective histone deacetylase inhibitors to sensitize cancer cells and stimulate the immune system. In addition, the Company has also pursued research related to the development of human cell cultures for health disparities studies and predictive biomarkers of radiation responses and late effects through awards received from the National Institutes of Health’s National Cancer Institute for Phase I and II Small Business Innovation Research contracts.

More than 800,000 patients are treated with radiation therapy for their cancers in the US on a yearly basis. According to the American Society of Radiation Oncologists, about 50% are treated with curative intent and the balance for palliative care. The market opportunity for radiation sensitizers lies with the 400,000 patients treated with curative intent.

PathAI Announces Early Adoption of its Digital Pathology Platform and Algorithms by Leading Anatomic Pathology Laboratories

On March 9, 2023 PathAI, a global leader in AI-powered pathology, reported the launch of AISight, PathAI’s digital pathology platform, and the AIM-PD-L1 NSCLC RUO algorithm1, which quantitates the percent of PD-L1 positive tumor and immune cells in non-small cell lung cancer (NSCLC) samples across the whole slide image (WSI), in 13 leading academic medical centers, health systems, reference laboratories, and independent pathology organizations across the United States (Press release, PathAI, MAR 9, 2023, View Source [SID1234628480]). These organizations are part of PathAI’s Early Access Program to gather real-world evidence about the use of digital pathology tools to advance precision medicine for the benefit of patients around the world.

"We’re pleased to bring our technology and the advantages of a digital pathology workflow directly to some of the country’s leading laboratories," said Andrew Beck, MD, PhD, co-founder and CEO of PathAI. "This network of laboratories will serve as pioneers in transforming anatomic pathology and will be the first to access PathAI’s extensive and growing menu of algorithm products across oncology and non-oncology indications."

AISight is a digital pathology platform that was designed with input from more than 200 pathologists and can be used by physicians, academic institutions, biopharma companies, and CROs to support AI-driven research. The AIM-PD-L1 NSCLC RUO algorithm was built using a series of convolutional neural networks, each trained on a diverse real-world dataset consisting of more than 5,000 samples with inputs from 350,000+ cell and tissue-level annotations from 50+ pathologists. The algorithm analyzes NSCLC surgical specimens stained with any of the four major clones and provides quantification and visualizations of PD-L1 positivity on tumor and immune cells for use in immune oncology research applications.

"We recognize the benefits that digital pathology will provide to pathologists, oncologists and other clinicians, but there are still barriers to its adoption that need to be overcome such as cost and confidence in algorithm performance," said Douglas Hartman, MD, Vice Chair of Pathology Informatics at The University of Pittsburgh Medical Center (UPMC), a world-renowned health system headquartered in Pittsburgh, Pennsylvania that operates 40 hospitals and more than 700 doctors’ offices and outpatient centers. "PathAI has a deep understanding of these obstacles, as shown by their significant investment in creating a simple and intuitive user interface to easily interpret the outputs of their algorithms. We’re pleased to be part of this first cohort of leading institutions to help advance the understanding and use of this technology."

PathAI previously published validation data for the AIM-PD-L1 NSCLC Algorithm that was presented at the 2022 AACR (Free AACR Whitepaper) Annual Meeting. As part of the AISight Early Access Network, participating laboratories will be building on this work to test the performance of the AIM-PD-L1 NSCLC algorithm on real-world data. These labs will also be able to access a suite of additional immunohistochemistry (IHC) quantitation algorithms across Breast Cancer, Urothelial Carcinoma, Head and Neck Squamous Cancer, and Melanoma. PathAI has previously published data in Modern Pathology highlighting the potential for AI-powered PD-L1 algorithms to identify more patients who would benefit from treatment with immuno-oncology therapy compared with current guidelines using manual assessment.

"As a leader in precision medicine and digital pathology, PathGroup is committed to transforming patient care and providing our clients with cutting-edge technology," stated Derek Welch, MD, FCAP, Chief Medical Officer of Anatomic Pathology at PathGroup, one of the largest independent anatomic pathology laboratories in the United States serving more than 200 hospitals and 15,000 referring physicians. "Our partnership with PathAI allows us to deploy their AI-powered algorithms in our work to enhance our industry-leading efficiency and accuracy and improve outcomes for the patients who are at focus of everything we do."

Reference Laboratories

Caris Life Sciences (National)
NeoGenomics Laboratories (National)
TriCore Inc. (New Mexico)
Independent Pathology Laboratories

Celligent Diagnostics (North and South Carolina)
PathAI Diagnostics (National)
PathGroup (National)
Academic Medical Centers & Health Systems

Baylor Scott & White Health (Texas)
Cleveland Clinic (Ohio)
Inova Health (Virginia)
Medstar Health (District of Columbia)
Penn State Health (Pennsylvania)
SUNY Upstate Medical University (New York)
University of Pittsburgh Medical Center (Pennsylvania)
To learn more about PathAI, AISight, and the AIM-PD-L1 NSCLC Algorithm, stop by Booth #639 at USCAP or register for an upcoming webinar on March 22nd, 2023. For more information regarding the AISight Early Access Network, please contact [email protected].

Servier Announces Partnership with QIAGEN to Develop New mIDH1 Companion Diagnostic Test to Support Servier’s Onco-hematology Portfolio

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).

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

Ibex and Alverno Laboratories Sign Multi-Year, Multi-Tissue Expansion Agreement of AI for Cancer Diagnosis

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.

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."

Avenge Bio Receives Positive Feedback from Pre-IND FDA Meeting on Development Path for AVB-001 Mesothelioma Program and Provides Pipeline Update

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]).

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.