BioStock Life Science Spring Summit

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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Hepion Pharmaceuticals to Present Five Posters at EASL International Liver Congress™ 2022

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

Gnubiotics Sciences and the University of Pennsylvania to Explore CAR-T Therapy in Combination with Glycopeptides Targeted to Solid Tumors?

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.

Pierre Fabre and Lonza Enter Manufacturing Agreement for W0180 Antibody Drug Product

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.

Kymera Therapeutics Doses First Patients in Phase 1 Oncology Trials of STAT3 and IRAKIMiD Degraders KT-333 and KT-413

On June 15, 2022 Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing targeted protein degradation to deliver novel small molecule protein degrader medicines, reported thyat it has recently dosed the first patients in separate Phase 1 clinical trials evaluating the STAT3 degrader KT-333 and the IRAKIMiD degrader KT-413 (Press release, Kymera Therapeutics, JUN 15, 2022, View Source [SID1234616024]). The KT-333 trial includes patients with relapsed/refractory liquid and solid tumors, including T cell lymphomas and leukemia, and the KT-413 study is enrolling patients with relapsed/refractory B cell lymphomas, including MYD88-mutant diffuse large B cell lymphoma (DLBCL).

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"These programs demonstrate the potential for targeted protein degradation to target critical nodes that traditional modalities can’t effectively address, offering a precision medicine approach to challenging cancers," said Nello Mainolfi, PhD, Co-Founder, President and CEO of Kymera Therapeutics. "The initiation of dosing in these studies represents important progress for Kymera toward understanding the pharmacology and safety of these first-in-class investigational medicines, and we look forward to sharing initial dose escalation clinical data later this year."

About the KT-333 Clinical Program

A target long considered "undruggable," STAT3 is a transcriptional regulator that has been linked to numerous cancers and other inflammatory and autoimmune diseases. KT-333 is a potent and selective heterobifunctional small molecule protein degrader of the STAT3 protein in development for oncology indications.

The Phase 1 trial will evaluate the safety, tolerability, PK/PD and clinical activity of KT-333 in adult patients with relapsed and/or refractory lymphomas and solid tumors. The first stage of the study will explore escalating doses of KT-333. The second stage will consist of four expansion cohorts to further characterize the safety, tolerability, PK/PD and antitumor activity of KT-333 in relapsed and/or refractory peripheral T-cell lymphoma (PTCL), cutaneous T-cell lymphoma (CTCL), large granular lymphocytic leukemia (LGL-L), and solid tumors.

KT-333 was recently granted Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of PTCL. This designation provides incentives to encourage the development of medicines for rare diseases.

About the KT-413 Clinical Program

KT-413 is a potent and selective heterobifunctional small molecule protein degrader being developed for MYD88-mutant B cell lymphomas that has the potential to be the first precision medicine for these cancers. KT-413 degrades interleukin-1 receptor associated kinase 4 (IRAK4) and the immunomodulatory imide drug (IMiD) substrates Ikaros and Aiolos. It is being developed initially for the treatment of relapsed/refractory MYD88-mutant DLBCL, with the potential to expand into other MYD88-mutant indications.

The Phase 1 trial will evaluate the safety, tolerability, and PK/PD of KT-413 in patients with relapsed and/or refractory B-cell non-Hodgkin’s lymphomas. The first stage will explore escalating doses of single-agent KT-413. The second stage will consist of two expansion cohorts to further characterize the safety, tolerability, PK/PD and antitumor activity of KT-413 in relapsed/refractory MYD88-mutant and MYD88 wild-type DLBCL.