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 Sprint Bioscience CEO Erik Kinnman presented the company at BioStock Life Science Spring Summit, June 8-9, 2022 (Presentation, Sprint Bioscience, JUN 15, 2022, View Source [SID1234616438]).

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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 Gnubiotics Sciences, a biotech company pioneering immunomodulatory glycopeptides, reported an agreement with the University of Pennsylvania to explore combining CAR-T therapy with Gnubiotics’ GLAAD technology to enhance efficacy in solid tumors through company-sponsored pre-clinical research studies in the laboratory of Avery Posey, PhD, an assistant professor of Systems Pharmacology and Translational Therapeutics at the Perelman School of Medicine at Penn (Press release, Gnubiotics Sciences, JUN 15, 2022, View Source [SID1234616041]). Gnubiotics presented compelling data recently at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting showing the effect of its glycopeptides platform in driving directed and robust T-cell immune responses against PD-1 resistant solid tumors in a colorectal cancer mouse model.

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While CAR-T has been effective in treating certain blood cancers, numerous studies have shown that many solid tumors do not respond well to CAR-T therapy. "We are excited about the promise of combining CAR-T with glycopeptide strategies like our GLAAD platform which will hopefully lead to the application of new modalities for patients left with few alternative treatments," stated Yemi Adesokan, Ph.D., Gnubiotics’s Chief Executive Officer.

About GLAAD

Glycopeptides are the foundation of Gnubiotics’ GLAAD molecules. GLAAD relies on glycopeptides as providers of antigenicity and adjuvanticity to the immune system. Gnubiotics’ GLAAD candidates are made of a range of glycans uniquely bound to peptides and can act directly on immune cells and modulate the microbiome. Combined, these modes of action influence the immune system responses which opens new ways to address areas where the immune system plays a role, including oncology, inflammatory and infectious diseases.

On June 15, 2022 Lonza, a global development and manufacturing partner to the pharma, biotech and nutrition industries, and French pharmaceutical group Pierre Fabre reported that the companies have entered into a manufacturing agreement (Press release, Lonza, JUN 15, 2022, View Source [SID1234616025]).

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This collaboration is aimed at manufacturing W0180, an innovative monoclonal antibody discovered by Pierre Fabre targeting the VISTA checkpoint, currently being investigated as a single agent and in combination with pembrolizumab in a Phase I clinical trial (NCT04564417) in various solid tumors.

Lonza will provide cGMP drug product (DP) manufacturing services for clinical supply from its fill and finish facility at Stein, Switzerland. Lonza’s ability to provide exemplary drug product development and manufacturing services offers customers innovative solutions and the possibility to supply high-quality products for clinical use.

Jean-Luc Lowinski, Pierre Fabre Medical Care CEO, said: "We are delighted to entrust the production of the W0180 Drug Product to Lonza. Its Drug Product Services are well-suited for our innovative therapy manufacturing needs. The W0180 will be manufactured in Lonza’s GS Xceed Expression CHO System, also successfully used for the IGF1R and cMet antibodies discovered by Pierre Fabre."

About W0180

W0180 is a first-in-class antibody targeting VISTA (V-domain Ig suppressor of T cell Activation). VISTA is a negative checkpoint regulator of T cell response. VISTA is expressed within the tumor microenvironment, where its inhibition can enhance antitumor immune responses. Furthermore, an increase in VISTA expression has been reported after treatment with anti-PD1/L1 and anti-CTLA4. This confirms that VISTA may play a key role as a mechanism of resistance to the currently used immunotherapies. W0180 given to patients as a single agent or in combination with anti-PD1/L1 therapy has a potential in multiple cancer indications, including those with myeloid immunosuppressive infiltrates where the VISTA pathway is expressed.