On June 15, 2022 Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical mid-stage biopharmaceutical company focused on Artificial Intelligence ("AI")-driven therapeutic drug development for the treatment of non-alcoholic steatohepatitis ("NASH") and hepatocellular carcinoma ("HCC"), reported that five abstracts have been accepted for poster presentations at the European Association for the Study of the Liver (EASL) International Liver Congress 2022 (ILC 2022) taking place June 22 – 26, 2022 in London, UK and digitally (Press release, Hepion Pharmaceuticals, JUN 15, 2022, View Source [SID1234616083]).

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The accepted abstracts for poster presentations are as follows:

Poster #: FRI590
Title: Synergistic anti-tumor activity with a combination of anti-PD1 antibody and the cyclophilin inhibitor, rencofilstat, in the Hep53.4 fatty liver model of hepatocellular carcinoma
Authors: D. Ure1, J. Leslie3, B. Variya1, R. Foster1, J. Mann2, D. Mann2,3
Presenter: Dr. Daren Ure
Session: Liver tumours: Experimental and pathophysiology
Date: 24/06/2022
Time: 09:00 – 18:00
Poster #: FRI591
Title: Rencofilstat, a pan-cyclophilin inhibitor, exerts diverse metabolic and transcriptional anti-tumor activities in a murine NASH-HCC model
Authors: D. Ure1, J. Kuo4, W. Stauffer4, L. Haddon1, C. Fu1, P. Mayo1, R. Foster1, P. Gallay4
Presenter: Dr. Daren Ure
Session: Liver tumours: Experimental and pathophysiology
Date: 24/06/2022
Time: 09:00 – 18:00
Poster #: SAT130
Title: Integrated transcriptomics of rencofilstat treatment in a Phase 2a NASH trial confirms anti-fibrotic effect of pan-cyclophilin inhibition and identifies rencofilstat-specific biomarkers
Authors: P. Mayo1, S. Harrison5, T. Hobbs1, D. Ure1, D. Trepanier1, E. Foster1, C. Zhao1, R. Foster1
Presenter: Dr. Patrick Mayo
Session: NFLD: Therapy
Date: 25/06/2022
Time: 09:00 – 18:00
Poster #: FRI568
Title: Cyclophilin D knockout promotes cell death pathways in preventing HCC development in a streptozotocin-induced mouse model of diabetes-linked NASH
Authors: W. Stauffer6, J. Kuo7, M. Bobardt6, D. Ure1, R. Foster1, P. Gallay6
Presenter: Dr. Winston Stauffer
Session: Liver tumours: Experimental and pathophysiology
Date: 24/06/2022
Time: 09:00 – 18:00
Poster #: THU004
Title: Cyclophilin inhibitor CRV431 as a potential therapy for Alcohol-related Liver Diseases
Authors: Elena Palma8,9, Sara Campinoti8,9, Una Rastovic8,9, Nicola Harris8,9, Omolola Ajayi8,9, Bruna Almeida8,9, Tsin Shue Koay8,9, Sandra Phillips8,9, Daren Ure1, Melissa Preziosi10, Rosa Miquel10, Andreas Prachalias10, Krishna Menon10, Nigel Heato10, Luca Urbani8,9, Shilpa Chokshi8,9
Presenter: Dr. Elena Palma
Session: Alcoholic Liver Disease
Date: 23/06/2022
Time: 09:00 – 18:00
1Hepion Pharmaceuticals; 2FibroFind Ltd; 3Newcastle University; 4Scripps Research Institute; 5Summit Clinical Research; 6Department of Immunology & Microbiology, Scripps Research; 7Arena Pharmaceuticals; 8The Roger Williams Institute of Hepatology, Foundation for Liver Research; 9King’s College London, Faculty of Life Sciences and Medicine; 10Institute of Liver Studies, King’s College London

On June 15, 2022 Coya Therapeutics, Inc. (Coya), a clinical-stage biotechnology company developing multiple first-in-class and best-in-class approaches that enhance regulatory T cells (Tregs) function in vivo, including autologous and allogeneic Treg-derived exosome therapeutics, and novel biologics, reported the execution of an option agreement for exclusive worldwide rights to a novel and proprietary technology platform enabling exosome engineering from Carnegie Mellon University (Press release, Coya Therapeutics, JUN 15, 2022, View Source [SID1234635089]).

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The exclusive option agreement involves the intellectual property rights to the research, development, and manufacturing of exosome-polymer hybrids (EPHs), a tether-based exosome functionalization strategy that enables Treg exosomes to be homed to proteins of interest, while delivering select payloads into those targeted cells.

"This collaboration with Carnegie Mellon University further solidifies Coya’s thought leadership in the global exosome therapeutics field, beyond Treg-derived exosomes alone," stated Howard Berman, Ph.D., CEO of Coya Therapeutics. "Nanoengineering exosomes with such manufacturing efficiency to produce EPHs that can be customized to any surface protein, delivering growth factors or drugs, while enhancing cellular uptake and bioactivity is the future of targeted therapies."

Previously, most techniques to modify exosomes relied on complex molecular biology tools or degradation of exosomes innate functionality. EPHs overcome many of these limitations by creating a method that rapidly and efficiently modifies exosomes with a DNA-cholesterol tether. The technology leverages single stranded synthetic DNA with attached cholesterol, binding a complementary strand of DNA linked to a bioactive agent. As a result, a number of different types of cargos can be readily attached to the exosome surface while also tethering immune modulating cargoes inside the exosome.

"The next step of our development program will be to leverage EPHs to validate functional activity of our Treg-derived exosomes that home in and bind to high profile protein targets that drive specific disease processes. Additionally, these EPHs will be loaded with identified payloads to enhance efficacy," stated Adrian Hepner, M.D., Ph.D., Chief Medical Officer of Coya Therapeutics.

Drs. Subha Das and Phil Campbell of Carnegie Mellon University added: "Targeted Treg exosome therapeutics that are directed to epitopes and proteins of interest, while delivering potent growth factors, drugs or other cargo, represent an innovative platform that is advantageous on many fronts relative to other CAR Treg directed platforms. We are excited and committed in joining this collaboration with Coya Therapeutics."

On June 15, 2022 Jazz Pharmaceuticals (NASDAQ: JAZZ) and Redx (AIM: REDX) reported the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for JZP815, a pan-RAF inhibitor for the treatment of solid tumors and hematologic malignancies that contain mutations in the MAPK pathway, enabling Jazz to proceed with initiating a clinical trial for JZP815 (Press release, Redx Pharma, JUN 15, 2022, View Source [SID1234616005]). As a result, a milestone payment of USD $5 million from Jazz payable to Redx has been triggered.

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The milestone payment was triggered under the Agreement in which Jazz acquired Redx’s pan-RAF inhibitor programme, announced on 10 July 2019. Redx carried out development activities up to the completion of IND-enabling studies. Today’s milestone is on top of USD $6.5 million already received under the collaboration and Redx remains entitled to development, regulatory and commercial milestone payments as well as incremental tiered royalties in mid-single digit percentages, based on any future net sales.

Preclinical data from this pan-RAF programme was recently presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) conference in March. JZP815 is a precision pan-RAF inhibitor with a differentiated mechanism of action, and Jazz expects to assess its utility in treating several types of difficult-to-treat solid tumours where there remains significant unmet patient needs. Jazz expects to advance JZP815 into a Phase 1 clinical programme and, when initiated, JZP815 will be the fifth compound discovered by Redx to enter the clinic.

Lisa Anson, Chief Executive Officer of Redx, commented: "I am delighted that the IND application for the pan-RAF inhibitor, JZP815, has been accepted. When Jazz commence the clinical programme this will become the fifth drug candidate discovered by Redx to enter the clinic, further validating our world-class research and development capabilities. We value the strong relationship we have built with Jazz Pharmaceuticals and look forward to continuing our work together."

Rob Iannone, M.D., M.S.C.E., Executive Vice President, Global Head of Research and Development of Jazz Pharmaceuticals, commented: "We’re excited to advance JZP815, a precision pan-RAF inhibitor with a differentiated mechanism of action, into a clinical trial programme. JZP815 may represent a significant advancement in the pan-RAF inhibitor class by not inducing paradoxical pathway activation that can stimulate the growth of certain cancers. The JZP815 programme exemplifies our continued progress in expanding our early-stage oncology pipeline, and in developing therapies with the potential to address unmet patient need. Redx has an exceptional team of research and development scientists and together we have formed an outstanding collaboration, leveraging the strengths of both companies."

Jazz and Redx also have a separate collaboration agreement to discover and develop drug candidates in the RAS-RAF-MAP kinase (MAPK) pathway, where Redx is again responsible for research and preclinical development activities up to IND application to the FDA.

About Pan-RAF inhibitors
Mutations leading to uncontrolled signalling in the RAS-RAF-MAPK pathway are seen in around one third of all cancers. The Company’s pan-RAF inhibitor programme aims to overcome resistance mechanisms associated with clinically approved B-RAF selective drugs.

The RAF kinases A-RAF, B-RAF and C-RAF are an integral part of the RAS-RAF-MAPK pathway, with B-RAF mutations commonly seen in the clinic. Although most B-RAFV600E/K mutant skin cancers are initially sensitive to approved B-RAF selective drugs, treatment resistance often develops leading to disease progression. Moreover, B-RAFV600E mutant colorectal cancers are surprisingly insensitive to these B-RAF selective drugs as single agents due to the compensatory functions of other RAF family members. Importantly, B-RAF selective therapies fail to show clinical benefit against the more prevalent RAS-mutated tumours.

About JZP815
JZP815 is an investigational, pre-clinical stage 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 tumours and targeted therapy.

On June 15, 2022 IceCure Medical Ltd. (NASDAQ: ICCM) (TASE: ICCM) ("IceCure" or the "Company"), developer of minimally-invasive cryoablation technology, the ProSense System that destroys tumors by freezing as an alternative to surgical tumor removal, reported ProSense was featured in a categorical course titled "Cryoablation for the Treatment of Breast Cancer: Breast Interventions for the Interventionalist" on Tuesday, June 14, 2022 at the Society of Interventional Radiology (SIR) Annual Scientific Meeting in Boston ("SIR 2022 Conference") (Press release, IceCure Medical, JUN 15, 2022, View Source [SID1234616021]).

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ProSense was well received by physicians, potential U.S.-based customers including medical clinics and hospitals, and international distributors interested in partnerships. The categorical course, which provided information and training on image guided breast cancer cryoablation, came on the same day that IceCure announced its cryoablation system will be distributed in mainland China by Shanghai Medtronic Zhikang Medical Devices Co. Ltd. ("Shanghai Medtronic"), an affiliate of Medtronic plc (NYSE: MDT), and Beijing Turing Medical Technology Co. Ltd. ("Turing"), with the first systems expected to be delivered in 2022.

The categorical course was presented at SIR 2022 Conference by a panel of experts in radiology and breast cancer, including:

Dr. Kenneth Tomkovich, Diagnostic and Interventional Radiologist at Princeton Radiology, Director of Breast Imaging and Interventions at CentraState Medical Center, and Co-lead Investigator of IceCure’s landmark ICE3 study of ProSense in the treatment of small, low-risk, early-stage malignant breast tumors;
Professor Eisume Fukuma, Director of Breast Cancer at Kameda Medical Center, Japan, a pioneer in the study of breast cancer cryoablation, and ProSense user;
Dr. Alexander Sevrukov, Assistant Professor, Director, Women’s Diagnostic Center at Methodist Hospital, a participant in the ICE3 trial, and ProSense user;
Dr. Monica L. Huang, Associate Professor, Department of Breast Imaging, Division of Diagnostic Imaging at the University of Texas MD Anderson Cancer Center;
Dr. Jason Shames, MD, MBS, Assistant Professor of Radiology, Associate Director of Research, Division of Breast Imaging, Co-Director, Breast Imaging Fellowship at Thomas Jefferson University; and
Dr. Gao-Jun Teng, Professor of Radiology at the Center of Interventional Radiology and Vascular Surgery, Department of Radiology, Zhongda Hospital, Medical School, Southeast University, and former President of the Chinese Society of Interventional Radiology
Dr. Tomkovich commented, "The inclusion of a categorical course on breast cancer cryoablation at the SIR 2022 Conference represents a major shift in the way the interventional and breast radiologist can approach the treatment of small, low-risk, breast cancers and highlights the interest of the professional community about how they can offer such treatments to their patients. The promising interim ICE3 clinical data continues to show that cryoablation for certain types of breast cancers is safe, effective, and is the future of breast cancer care."

IceCure CEO, Eyal Shamir, added, "On the heels of the announcement of our distribution agreement with Shanghai Medtronic and Turing, this is an ideal time for ProSense to be featured at the SIR 2022 Conference as we work toward regulatory approval in early-stage breast cancer following the filing of our pre-submission package to the U.S. Food and Drug Administration in November 2021. We extend our gratitude to the panel of experts who presented ProSense in the categorial course. Several of the doctors have been using ProSense and their perspective is invaluable for IceCure’s potential customers and partners."

On June 14, 2022 Patrys reported the publication of new data from a series of studies by our collaborators Dr James Hansen, of Yale School of Medicine and Dr Kim O’Sullivan, of Monash University, showing that PAT‑DX1 suppresses the formation of neutrophil extracellular traps (NETs), which may reduce metastasis in some cancers (Press release, Patrys, JUN 14, 2022, View Source [SID1234615955]).

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The paper, which is published in the peer-reviewed journal ImmunoHorizons, is the first study showing that PAT-DX1 may be used to regulate the formation of NETs, which are believed to contribute to immunity, inflammation and the pathophysiology of various inflammatory diseases and some cancers.

Patrys CEO and MD, Dr. James Campbell said:

"This is an unexpected and important discovery for Patrys, offering mechanistic rationale to the previously-described ability of PAT-DX1 to reduce cancer spread by metastasis, and opening the door to broader uses of deoxymabs in non-cancer indications, particularly chronic inflammatory conditions that are driven by NET formation."