TIM3 agonists(Hepatitis A virus cellular receptor 2 agonists), TIMD4 agonists(T cell immunoglobulin and mucin domain containing 4 agonists), Immunomodulators

Therapeutic Areas

Immune System DiseasesNervous System DiseasesNeoplasms+ [4]

Active Indication

Arthritis, PsoriaticRheumatoid ArthritisMultiple Sclerosis+ [2]

Inactive Indication-

Originator Organization

LAPIX Therapeutics, Inc.

Active Organization

LAPIX Therapeutics, Inc.

Inactive Organization-

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

Clinical Trials associated with LPX-TI641

NCT06628206 / Not yet recruitingPhase 1

Phase 1b Randomized, Double Blind, Placebo-controlled Study to Evaluate Safety, Tolerability and Pharmacokinetics of LPX-TI641 in Patients with Rheumatoid Arthritis and Psoriatic Arthritis

The goal of this clinical trial is to study the drug LPX-TI641 in patients with rheumatoid arthritis and psoriatic arthritis. We will compare the safety and tolerability of LPX-TI641 to placebo( a look-alike solution) that contains no drug). We will also evaluate the plasma pharmacokinetics of LPX-TI641. LPX-TI641 (or placebo) will be administered as an oral solution for 28 days.

Start Date15 Nov 2024

Sponsor / Collaborator

LAPIX Therapeutics, Inc.

NCT05853835 / RecruitingPhase 1

A Phase I First in Human, Randomized, Double-blind, Placebo- Controlled Study in Healthy Adult Volunteers to Evaluate Safety, Tolerability and Pharmacokinetics of LPX-TI641 After Single and Multiple Oral Doses.

A Phase I First-in-Human, Randomized, Double-Blind, Placebo-Controlled Study in Healthy Adult Volunteers to Evaluate Safety, Tolerability, and Pharmacokinetics after Single and Multiple Oral Dose of LPX-TI641.

Start Date30 Oct 2023

Sponsor / Collaborator

LAPIX Therapeutics, Inc.

100 Clinical Results associated with LPX-TI641

100 Translational Medicine associated with LPX-TI641

100 Patents (Medical) associated with LPX-TI641

News (Medical) associated with LPX-TI641

07 Feb 2024

·www.globenewswire.com

LAPIX Therapeutics Strengthens Board of Directors with Appointments of Pharmaceutical Industry Veterans Henry A. McKinnell, Ph.D., Anthony Gibney, and Francisco Leon, MD, Ph.D.

BOSTON, Feb. 07, 2024 (GLOBE NEWSWIRE) -- LAPIX Therapeutics, Inc. (“LAPIX”), a biopharmaceutical company focused on developing novel, orally bioavailable immune system restoration therapies for autoimmune diseases, today announced the appointments of Henry A. McKinnell, Ph.D., and Anthony Gibney to its Board of Directors and Francisco Leon, MD, Ph.D. as a Board Observer. These appointments bring more than five decades of scientific acumen and growth-focused leadership to LAPIX as the company works to transform how medical communities treat and support patients diagnosed with serious and complex autoimmune diseases. “We are thrilled to announce the appointment of our newest board members, whose arrivals mark a pivotal moment for LAPIX, especially as we complete the ongoing Phase I study and move LPX-TI641 towards Phase II,” said Anas M. Fathallah, Ph.D., Chief Executive Officer and co-founder of LAPIX. “Dr. McKinnell, Mr. Gibney and Dr. Leon are exceptionally well-equipped to contribute to LAPIX's strategic vision, providing insights that will undoubtedly shape the future trajectory of our company and our pursuit of immune restoration strategies.” Dr. McKinnell is the former Chairman and CEO of Pfizer, Inc., former chairman of Moody’s, and co-founder and past Chairman of the Infectious Disease Institute in Kampala, Uganda. He is a member of the boards of directors of Nexcella and the Science and Technology in Society Forum. He serves as chairman emeritus of the Connecticut Science Center, the Business Roundtable, the Pharmaceutical Research Manufacturers Association, the Food and Drug Law Institute, and the Medical Device Manufacturers Association. He also currently serves as a Senior Advisor to Quris AI and Spire. Dr. McKinnell holds a Bachelor of Commerce in business from the University of British Columbia and MBA and Ph.D. degrees from Stanford Graduate School of Business. Bringing over 25 years of life-science and investment banking experience to Lapix, Mr. Gibney has previously held Chief Financial Officer and/or Chief Business Officer positions at Iveric Bio (acquired by Astellas Pharma), FogPharma, and Achillion Pharmaceuticals (acquired by Alexion). His dual expertise in finance and biotech uniquely positions his insights at the intersections of financial strategy and operational expertise. He also served as Managing Director and Co-Head of the Biotechnology Investment Banking Team at Leerink Partners, and lead the East Coast effort at Merrill Lynch as a Managing Director. Mr. Gibney holds a Bachelor of Arts in Economics and in History from Yale University. Joining the Board as a Board Observer, Dr. Leon will lend his significant expertise in clinical immunology, translational medicine and as a successful drug developer. Dr. Leon is currently the founder and CEO of Tolerance Bio and previously served as the Chief Scientific Officer and cofounder at Provention Bio (acquired by Sanofi), co-founder and CEO of Celimmune (acquired by Amgen) and Vice President & Head, Immunology Translational Medicine J&J/Janssen amongst other endeavors. He has played a pivotal role in the development and success of these organizations and has been responsible for the translational strategies and early clinical development of biologic and small molecule therapies for immune-mediated diseases. His dedication to immunology spans 30 years, culminating in the FDA approval of teplizumab/TZIELD®, the first-ever non-chronic immune resetting agent in T cell autoimmunity. He earned a Ph.D. in Mucosal Immunology from the Universidad Autónoma de Madrid and completed a Specialist program in Clinical Immunology at Hospital Ramon y Cajal, Madrid. He earned a MD from the Universidad Autónoma de Madrid. "I am honored to welcome new colleagues to the board,” added Dr. Fathallah. "Their considerable and demonstrated capacity to offer strategic guidance to companies poised for growth is an invaluable asset as we collectively navigate the intricate challenges of developing cures for autoimmune diseases." About LAPIX Therapeutics LAPIX Therapeutics Inc. is a Boston, MA-based company in the biopharma sector, focused on developing novel, orally bioavailable immune system restoration therapies, including immune tolerance restoration therapy for autoimmune diseases and immune function restoration therapies for oncology. To learn more, visit www.lapix.com or follow us on LinkedIn and Twitter. Contact:Anas M. Fathallah, Ph.D.CEO and Co-Founderinfo@lapixtherapeutics.com

Executive ChangeDrug ApprovalPhase 1Immunotherapy

07 Nov 2023

·www.biospace.com

LAPIX Therapeutics Inc. Announces First Subjects Dosed in its First-in-Human Clinical Study of its Treg-expanding Tim3/4 Agonist LPX-TI641 to Treat Multiple Sclerosis and other Autoimmune Conditions

BOSTON, Nov. 07, 2023 (GLOBE NEWSWIRE) -- LAPIX Therapeutics, Inc. (“LAPIX”), a biopharmaceutical company focused on developing novel, orally bioavailable immune system restoration therapies for autoimmune diseases, today announced that the first participants have been dosed in the Phase 1 study of the Company’s LPX-TI641therapy. LPX-TI641 is a novel, and proprietary first-in-class orally bioavailable small molecule designed as a T cell immunoglobulin and mucin domain-containing protein (Tim) 3/4 receptor agonist. The Tim family of receptors plays an important role in autoimmunity. LPX-TI641 restores the balance of regulatory immune cells (T- and B-regs) to autoreactive T-cells reestablishing immune tolerance. It is being developed for the treatment of Multiple Sclerosis (MS) and potentially other autoimmune diseases such as rheumatoid arthritis and lupus. “The dosing of the first participants is a major milestone in the clinical development of LPX-TI641,” said Anas M. Fathallah, Ph.D., Chief Executive Officer and co-founder of LAPIX. “We are excited to begin the clinical evaluation of our antigen-agnostic immune tolerance restoration therapy. We look forward to evaluating the therapeutic potential of LPX-TI641 and believe it will be a transformative and safer option for patients suffering from MS and other autoimmune diseases. The design of the Phase I study will allow us the flexibility to leverage the clinical data for other indications, enabling rapid pivots into other autoimmune diseases,” added Dr. Fathallah. The study is a randomized, double-blind, placebo-controlled study in healthy adult volunteers to evaluate the safety, tolerability, and pharmacokinetics of LPX-TI641 after single ascending oral doses. Exploratory pharmacodynamic and biomarker analysis will also be evaluated as part of this study. More information about the study can be found at NCT05853835 About LPX-TI641 LPX-TI641’s primary pharmacology is the upregulation of Foxp3+/CD4+ T-cells (T-regs) and of Tim1+/CD25+/CD19+ (B-regs) and inhibition/downregulation of Th17. The combined effects of LPX-TI641’s pharmacology is to allow the adaptive immune system to re-establish self-tolerance (T-reg/Th17 balance and B-regs) without affecting the innate immune system. The efficacy of LPX-TI641 versus standards of care has been evaluated in several animal models of MS and those models have shown favorable efficacy of LPX-TI641 in treatment escalation and treatment induction/maintenance paradigms mimicking current clinical management paradigms of MS without inducing neutropenia or lymphocytopenia suggesting better safety as well. It is currently under development for neuro-autoimmune indications such as MS, with the intent to expand into rheumatoid arthritis and lupus amongst other autoimmune conditions. About LAPIX Therapeutics LAPIX Therapeutics Inc. is a Boston, MA-based company in the biopharma sector, focused on developing novel, orally bioavailable immune system restoration therapies, including immune tolerance restoration therapy for autoimmune diseases, immune tolerance induction therapies for gene therapy, and immune function restoration therapies for oncology. To learn more, visit or follow us on LinkedIn and X. Contact: Anas M. Fathallah, Ph.D. CEO and Co-Founder info@lapixtherapeutics.com

Phase 1Immunotherapy

20 Sep 2023

·www.globenewswire.com

LAPIX Therapeutics Inc. Announces FDA Clearance of IND Application for its Treg-expanding Tim3/4 Agonist LPX-TI641 to Treat Multiple Sclerosis

LAPIX Therapeutics, Inc. (“LAPIX”), a biopharmaceutical company focused on developing novel, orally bioavailable immune system restoration therapies for autoimmune diseases, today announced that it has received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to initiate a Phase 1 clinical trial for its first-in-class, immune tolerance restoration small molecule, LPX-TI641, for the treatment of multiple sclerosis (MS). The clinical trial is expected to begin dosing in 4Q 2023. “We believe in empowering and restoring the immune system to fight disease and the FDA clearance of our IND application for LPX-TI641 represents momentum in our technology and scientific approach,” said Anas M. Fathallah, Ph.D., Chief Executive Officer and co-founder of LAPIX. “We are excited to begin our first-in-human clinical study evaluating LPX-TI641 and its potential to be a first of its kind non-immune suppressive therapeutic option for autoimmune diseases.” The Phase 1 trial is designed to evaluate the safety, tolerability, and pharmacokinetics of LPX-TI641 in healthy subjects after a single ascending dose. Data from the Phase 1 study along with LPX-TI641’s antigen-agnostic versatility could allow for the rapid pivot to other autoimmune indications such as rheumatoid arthritis. “We aspire to transform how the medical field treats patients diagnosed with serious and complex immune diseases and we are deeply committed to helping as many people as possible,” added Dr. Fathallah. “Our antigen-agnostic immune tolerance restoration approach centered on developing Tim (T-cell immunoglobulin and mucin domain) agonists, along with our in-depth knowledge of immunology and immune tolerance are the keys to unlocking transformative therapies for patients with additional consideration for their quality of life.” About LPX-TI641 LPX-TI641 is an investigational, novel, and proprietary orally bioavailable small molecule T cell immunoglobulin and mucin domain-containing protein (TIM) 3/4 receptor agonist. The TIM family of receptors play an important role in autoimmunity. LPX-TI641’s primary pharmacology is the upregulation of Foxp3+/DC4+ T-cells (T-regs) and of Tim1+/CD25+/CD19+ (B-regs) and inhibition/downregulation of Th17. The combined effects of LPX-TI641’s pharmacology is to allow the adaptive immune system to re-establish self-tolerance (T-reg/Th17 balance and B-regs) without affecting the innate immune system. The efficacy of LPX-TI641 versus standards of care has been evaluated in several animal models of MS and those models have shown favorable efficacy of LPX-TI641 in treatment escalation and treatment induction/maintenance paradigms mimicking current clinical management paradigms of MS without inducing neutropenia or lymphocytopenia. It is currently under development for neuro-autoimmune indications such as MS, with the intent to expand into rheumatoid arthritis amongst other autoimmune conditions. About LAPIX Therapeutics LAPIX Therapeutics Inc. is a Boston, MA-based company in the biopharma sector, focused on developing novel, orally bioavailable immune system restoration therapies, including immune tolerance restoration therapy for autoimmune diseases, immune tolerance induction therapies for gene therapy, and immune function restoration therapies for oncology. To learn more, visit www.lapix.com or follow us on LinkedIn and Twitter. The content above comes from the network. if any infringement, please contact us to modify.

INDImmunotherapyPhase 1

100 Deals associated with LPX-TI641

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Arthritis, Psoriatic	Phase 1	-	LAPIX Therapeutics, Inc.	15 Nov 2024
Rheumatoid Arthritis	Phase 1	-	LAPIX Therapeutics, Inc.	15 Nov 2024
Multiple Sclerosis	Phase 1	JO	LAPIX Therapeutics, Inc.	30 Oct 2023
Multiple Sclerosis	Phase 1	US	LAPIX Therapeutics, Inc.	30 Oct 2023
Neuromyelitis Optica	Phase 1	US	LAPIX Therapeutics, Inc.	-
Myelin oligodendrocyte glycoprotein antibody-associated disease	Preclinical	US	LAPIX Therapeutics, Inc.	03 Aug 2023

Clinical Result

Indication

Phase

Evaluation

View All Results

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis

LPX-TI641

Overview

Basic Info

Related

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation