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Artax Granted Clinical Trial Authorization for AX-158 Phase 2a Psoriasis Study

By Artax Biopharma, Press Release, Private Companies
Press Release.

 

Patient Enrollment Expected to Begin by Year End

Phase 2a Study Seeks to Demonstrate the Safety and Efficacy of AX-158 in Patients with Mild-to-Moderate Psoriasis, Further Advancing a New Approach to Address Autoimmune Diseases

Globally Nearly 125 Million People Live with Psoriasis

CAMBRIDGE, Mass.Nov. 9, 2023 /PRNewswire/ — Artax Biopharma, Inc., a clinical-stage biotechnology company focused on transforming the treatment of T Cell-mediated diseases, today announces that the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted clinical trial authorization (CTA) to evaluate AX-158 in a Phase 2a psoriasis study.

This authorization marks the initiation of the clinical trial process, allowing initial patient enrollment by the end of 2023.  The clinical trial sites are located throughout the United Kingdom.

The study, A Phase 2a, Proof of Concept Study Evaluating the Safety and Tolerability of AX-158 in Patients With Mild to Moderate Plaque Psoriasis (NCT-05725057) will evaluate the safety and efficacy of AX-158 versus placebo.

“We are proud to announce the clinical progress of AX-158 and the potential that it may provide a novel treatment to patients managing psoriasis,” stated Artax Biopharma Chief Executive Officer Joseph Lobacki. “Additionally, we are excited by the promise of AX-158 as a new standard of care in treating a broad range of autoimmune diseases.  In particular, we believe that AX-158 will offer the opportunity to provide a convenient once daily oral therapy that will treat disease while not impairing the ability of the patient’s immune system to function properly.”

Prof. Menno de Rie, MD, Department of Dermatology, Amsterdam UMC, The Netherlands, and an Artax Scientific Advisory Board member, commented: “As a physician and as a researcher treating psoriasis for decades, I can attest to the dire need for safe, effective, and tolerable therapies that will truly help patients manage their disease. I am excited about the innovation and tremendous science AX-158 represents for the many people with psoriasis. Managing autoimmune disease without inducing the profound immunosuppression associated with current conventional or biological therapies will be transformative for the immunology field.”

About AX-158
Immunomodulation assists the immune system in maintaining healthy control and addresses the underlying driver of T Cell-mediated diseases. AX-158 is an investigational oral, small molecule immunomodulator with a novel first-in-class mechanism that selectively modulates, or adjusts, T cell responses which play a critical role in healthy immune system function. By acting at the T Cell Receptor (TCR), AX-158 modulates multiple disease-causing cytokines without immunosuppression. It can be taken with or without food, and may be used as a monotherapy, or in combination.

About Psoriasis
Psoriasis is a common, immune-mediated disease that affects 125 million people globally.  In the US 3.0% of the adult population, or more than 7.5 million adults, are affected.  Psoriasis patients may exhibit visible signs of inflammation anywhere on the body as raised plaques and scales on the skin. Plaques may appear as few small patches or can affect large areas. It is possible to have psoriasis plaques and scales on more than one location on the body at a time.  Treating psoriasis can help improve symptoms as well as lower the risk of developing other health conditions such as psoriatic arthritis, heart disease, obesity, diabetes, and depression.

About Artax Biopharma and Immunomodulation
Artax Biopharma is a clinical-stage biotechnology company transforming the treatment of T Cell-driven autoimmune diseases through innovative small molecules delivering immune system modulation without immunosuppression. Immunomodulation maintains healthy control of the immune system and addresses the underlying source of T Cell-driven diseases. Central to a well-functioning immune system is the T Cell Receptor (TCR).  When TCR signaling becomes dysregulated, it causes T Cell-driven conditions, including autoimmune diseases, and induced T Cell pathologies where medical treatments result in immune reactions (such as stem cell transplants resulting in acute graft-versus-host-disease or immuno-oncology treatments resulting in immune related-adverse events). We believe the immunomodulation mechanism offered by our investigational agents holds broad potential to revolutionize how these T Cell-driven autoimmune diseases are addressed, while not impairing the ability of a patient’s immune system to function properly. artaxbiopharma.com

For Phase 2a study inquiries, please contact: ax-158-1011@artaxbiopharma.com

Artax Biopharma Announces Positive Phase 1 Results for AX-158, Company’s First-in-Class Oral Immunomodulator Developed to Treat T Cell-Mediated Diseases

By Artax Biopharma, Press Release, Private Companies
Press Release.

 

Artax Biopharma Announces Positive Phase 1 Results for AX-158, Company’s First-in-Class Oral Immunomodulator Developed to Treat T Cell-Mediated Diseases

 

Phase 1 Findings Demonstrated that Investigational Agent AX-158 Was Well Tolerated at All Doses, with a Profile that Strongly Supports Further Clinical Development Efforts

AX-158 is Being Developed for Once Daily Oral Dosing to Address Autoimmune Diseases by Providing Immunomodulation without Immunosuppression

 

Cambridge, Mass., June 1, 2023 – Artax Biopharma, Inc., a clinical-stage biotechnology     company focused on transforming the treatment of T Cell-mediated diseases, today announces positive Phase 1 clinical trial results for AX-158, the Company’s first-in-class oral small molecule immunomodulator to enter clinical development to treat T Cell-mediated diseases.

 

The Phase 1 clinical trial findings demonstrated that AX-158:

  • had no related adverse events in the clinical trial;
  • was well tolerated at all doses, up to the maximum of 50mg QD in the single ascending dose cohorts and up to the maximum of 15mg QD for 10 days in the multiple ascending dose cohorts; and
  • had a consistent, predictable pharmacokinetic (PK) profile and bioavailability among healthy volunteers, which supports the use of AX-158 as a once daily oral dosing regimen, which can be dosed independently of food.

 

Importantly, these positive results support the further evaluation of AX-158 at a once daily dose of 10mg in a Phase 2 clinical trial. AX-158 employs a first-in-class mechanism of action that selectively modulates T cell responses that play a critical role in healthy immune system function. AX-158 has the potential to treat T Cell-mediated diseases through immunomodulation without the risk of immunosuppression.

 

“With these strong Phase 1 results suggesting AX-158’s clean safety profile, we are eager to further evaluate safety and efficacy in Phase 2 clinical studies, and to ultimately making AX-158 available to patients managing complex T Cell-driven conditions, including autoimmune diseases, and induced T Cell pathologies,” stated Artax Biopharma Chief Executive Officer Joseph Lobacki. “AX-158 has the potential   to positively impact health outcomes through rebalancing immune system function, while maintaining a strong response to foreign pathogens and infections – providing true immunomodulation without immunosuppression.”

 

About Artax Science and Immunomodulation

A healthy immune system eliminates harmful foreign pathogens, while being tolerant of self-tissues and organs. The T Cell Receptor (TCR) is central to healthy T Cell function and a well-functioning immune system. When TCR signaling becomes dysregulated, T Cells behave abnormally. This behavior results in T Cell-driven conditions, including autoimmune diseases, and induced T Cell pathologies in which medical treatments result in immune reactions (such as stem cell transplants resulting in acute graft-versus-host- disease or immuno-oncology treatments resulting in immune related-adverse events). Artax believes immunomodulation – a mechanism through which our investigational agents assist in modulating the immune system to ameliorate T Cell-mediated diseases while not impacting patients’ ability to properly fight foreign pathogens – holds great potential.

About Artax-158

AX-158 is a first-in-class, oral small molecule immunomodulating agent in clinical development for the treatment of T Cell-mediated diseases. AX-158 employs a novel mechanism of action that selectively modulates, or adjusts, T Cell responses that play a critical role in immune system function. Nck is a protein that naturally amplifies T Cell signaling directly at the TCR, contributing to T Cell mediated disease. AX-158 is a Nck SH3.1 domain inhibitor which selectively blocks the role of Nck in T Cells.  Immunomodulation assists the immune system to maintain healthy control and eliminates the underlying driver of T Cell-mediated diseases. Importantly, Artax believes that preclinical data suggests AX-158 will not be immunosuppressive and so will not impact the immune system’s ability to mount a strong response to foreign pathogens and infections.

About Artax Biopharma

Artax Biopharma is a clinical-stage biotechnology company transforming T Cell-mediated disease treatment by developing innovative small molecules that modulate the immune system without causing immunosuppression. Artax science holds broad potential to treat T Cell-mediated diseases such as autoimmune diseases, induced T cell pathologies (such as acute graft versus host disease and immune- oncology treatment-related adverse events) and T Cell malignancies, while simultaneously allowing the body to fight foreign pathogens. For more information, please visit www.artaxbiopharma.com.

                                                                #  #  #

Contacts:

Maria Nichol, DPhil, EPA, CPA

Vice President, Business Development

+44 7901 666564

mnichol@artaxbiopharma.com

Media:

Linda Phelan Dyson

+1 973-986-5873

lpdyson@verizon.net

Artax Biopharma Expands Company’s Scientific Advisory Board

By Artax Biopharma, Press Release, Private Companies
Press Release.

 

Company Welcomes James G. Krueger, M.D., Ph.D., and Ajay Nirula, M.D., Ph.D., Both Experts in T-Cell-Mediated Diseases.

Cambridge, MA, November 15, 2022 – Artax Biopharma, Inc., a clinical stage biotechnology company focused on transforming the treatment of T-cell-mediated diseases, today announces the Company is strengthening its Scientific Advisory Board (SAB) with the appointments of James G. Krueger, M.D., Ph.D., and Ajay Nirula, M.D., Ph.D.

Artax Biopharma has an ongoing Phase 1 clinical trial evaluating AX-158, the Company’s first-in-class, oral small molecule immunomodulating agent that selectively acts at the T-cell receptor to lower self-antigen triggered cytokines, a known cause of autoimmune disease. Importantly, AX-158 has the potential to treat T-cell-mediated diseases without immunosuppression.

“We are honored to welcome global experts Drs. Krueger and Nirula to our Scientific Advisory Board, as they each bring unique research and extensive clinical experience across T-cell-mediated diseases,”

said D. Scott Batty, Jr., M.D., Artax Biopharma’s Chief Medical Officer.

“Drs. Krueger and Nirula bring a profound understanding of T-cell biology and pathophysiology and have success in bringing these effective treatments to patients who need them most. We are very grateful for their expert guidance and developmental insights as we progress AX-158 through clinical trials,”

Dr. Batty, Jr. added.

Dr. Krueger serves as Head of the Laboratory for Investigative Dermatology and as the D. Martin Carter Professor in Clinical Investigation and Dermatology at The Rockefeller University. He is co-director for the Center for Clinical and Translational Science at The Rockefeller University Hospital and has been serving as the Hospital’s Chief Executive Officer since July of 2008. Dr. Krueger uses psoriasis as a model to study inflammatory diseases that involve Th17 cells, a subset of T cells. His work has formed the scientific basis for the highly successful treatment of psoriasis with a range of biologic immune drugs that target the “Type 17” inflammatory immune axis.

Dr. Krueger earned his bachelor’s degree from Princeton University and his Ph.D. degree in Virology and Cell Biology from The Rockefeller University. He received his medical degree from Cornell University Medical College, where he also completed an internship in internal medicine and a residency in dermatology. Dr. Krueger is board certified in dermatology by the American Board of Dermatology and has been the recipient of numerous notable academic and industry honors throughout his career.

Dr. Nirula is Senior Vice President, Immunology, for Eli Lilly and Company based at the Lilly Biotechnology Center in San Diego. Dr. Nirula joined Eli Lilly in 2015 and is responsible for the Company’s discovery, research, and early phase clinical development in immunology. He has also served as the medical leader for Eli Lilly’s work during the COVID pandemic that led to emergency authorization for the Company’s multiple therapeutic neutralizing antibodies. Prior to joining Eli Lilly, Dr. Nirula held leadership positions at Amgen, and at Biogen Idec, and was involved in several research programs and regulatory filings spanning diseases such as rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis, psoriasis, and vasculitis.

Dr. Nirula earned his undergraduate degree in molecular biology from UC Berkeley, his medical degree from UCLA School of Medicine, and his Ph.D. degree from the University of Texas Southwestern Medical School. He subsequently joined the faculty in the Division of Rheumatology at UCSF Medical Center. Dr. Nirula has published extensively in premier peer-reviewed medical journals such as The New England Journal of Medicine, JAMA, and Nature Immunology.

 

Drs. Krueger and Nirula are welcomed by Artax’s current SAB members:

  • Balbino Alarcón, Ph.D., Artax Founder and Program Director at the National Research Council of Spain (CSIC) and Head of TCR-mediated Signal Transduction Laboratory;
  • Raif Geha, M.D., James L. Gamble Professor of Pediatrics at Harvard Medical School and Chief of the Allergy/Immunology/Rheumatology and Dermatology Division at Children’s Hospital in Boston;
  • Menno de Rie, M.D., Vice-Chair of the Department of Dermatology of the Amsterdam University Medical Centres /University of Amsterdam since 2012;
  • Lawrence Steinman, M.D., Professor of Neurology and Neurological Sciences, Pediatrics, and Genetics at Stanford University; and
  • Cox Terhorst, Ph.D., Professor of Immunology at Harvard Medical School and Chief, Immunology at the Beth Israel Deaconess Medical Center.

 

About Artax Science and Immunomodulation

Artax believes immunomodulation – selective targeting of specific functions and operations of the immune system – holds great potential to address tremendous unmet need in immunology. Our investigational immunomodulating agents act directly at the T-cell receptor (TCR) to selectively target inappropriately activated areas of the immune system, thus eliminating a cause of T-cell-driven diseases while not impacting a patient’s ability to effectively fight foreign pathogens and infections.

T-cells are the central, critical cells orchestrating the immune response, protecting the body against foreign pathogens, infections and malignancy while importantly not reacting to an individual’s tissues and organs. The TCR activates and controls the many functions and responses of the T-cell, serving a critical role for both healthy immune system and T-cell response.

Dysregulated TCR signaling results in increased cytokine signaling, a root cause of T-cell-mediated diseases, including autoimmune diseases. In addition to autoimmune diseases, T-cell-mediated diseases include T-cell malignancies, and induced T-cell pathologies where therapeutic treatments result in unwanted immune reaction side effects. Such induced T-cell immune reactions include stem cell transplants resulting in acute graft-versus-host-disease, and immuno-oncology treatments resulting in immune-related-adverse events. This central role of dysregulated TCR signaling across several disease states therefore makes the TCR a highly attractive target for therapeutic intervention.

 

About AX-158

AX-158 is a first-in-class, oral, small molecule immunomodulating agent in clinical development for the treatment of T-cell-mediated diseases. The immunomodulatory effect of AX-158 is designed to safely return the immune system to a state of rebalance without immunosuppression.

AX-158 is a highly specific (SH3.1 domain) inhibitor of Nck, a protein that naturally amplifies T-cell signaling caused by self-antigens at the TCR. AX-158 inhibits Nck at the TCR, resulting in less TCR activation and lowered self-antigen triggered cytokines, including Th-1, Th-17 and Th-2 type cytokines. High levels of such various cytokines are associated with a broad set of T-cell mediated autoimmune diseases, such as rheumatoid arthritis, psoriasis, atopic dermatitis, inflammatory bowel disease, and many others. Importantly, preclinical data suggests AX-158 is not immunosuppressive, and so does not impact the immune system’s ability to mount a strong response to foreign pathogens and infections.

 

About Artax Biopharma

Artax Biopharma is a clinical-stage biotechnology company transforming the treatment of T-cell-driven diseases through innovative small molecules that modulate the immune system. Artax’s disruptive science holds broad potential to treat T-cell-mediated diseases such as autoimmune diseases, induced T-cell pathologies (such as acute graft-versus-host disease, and immune-oncology treatment-related adverse events), and T-cell malignancies, while simultaneously allowing the body to fight foreign pathogens and infections. For more information, please visit www.artaxbiopharma.com and connect with us on LinkedIn.

 

Contacts:
Media:
Linda Phelan Dyson, MPH
Corporate Communications
lpdyson@verizon.net
M: 973-986-5973

Karen LaRochelle, MBA
Chief Business Officer
Artax Biopharma
klarochelle@artaxbiopharma.com

Artax Biopharma Closes Financing to Advance Clinical Stage First-in- Class Oral Immunomodulator to Treat T Cell-Mediated Diseases

By Artax Biopharma, Press Release, Private Companies
Press Release.

 

  • Close of $26 Million Funds Immunomodulation Candidate AX-158 Development
  • Adds New Investors Eli Lilly and Company and Sound Bioventures

 

Cambridge, MA, May 11, 2022 – Artax Biopharma, Inc., a clinical stage
biotechnology company focused on transforming the treatment of T Cell-mediated pathologies, today announces the close of a $26 million financing round to develop AX-158, the Company’s first oral small molecule immunomodulating agent. New investors, Eli Lilly and Company and Sound Bioventures, participated alongside existing investors Advent Life Sciences, Columbus Venture Partners, Belinda Termeer and other Company shareholders.

Artax will use these funds to support the clinical development of AX-158 in
autoimmune diseases, including the addition of key clinical development personnel. AX-158 employs a first-in-class mechanism of action that selectively modulates inappropriate T cell activation, a cause of autoimmune disease. AX-158 has the potential to treat T Cell-mediated diseases without the risk of immunosuppression.

Artax’s ongoing Phase 1 clinical trial is assessing the safety, exposure, and
pharmacokinetics of AX-158 in healthy volunteers and includes ex vivo stimulated measures of its pharmacodynamic activity. In preclinical studies, AX-158 demonstrated potential to treat T Cell-mediated diseases by decreasing key cytokines including INFγ, TNFα, IL-2, IL-1 and IL-6 in whole human blood samples.

“We are pleased to welcome Lilly and Sound Bioventures as new investors as we continue to develop our unique immunomodulating agent for patients with T Cell-driven conditions, including autoimmune diseases. We believe AX-158’s immunomodulating effect has the potential to make a transformative difference for patients living with T Cell-driven conditions, without impacting healthy immune system function,”

said Joseph Lobacki, Chief Executive Officer of Artax Biopharma.

“We are also excited to welcome Casper Breum, Managing Partner of Sound Bioventures, who will join the Artax Board of Directors,”

said Mr. Lobacki.

“Mr. Breum’s experience will be a valuable asset to guide the Company’s strategy.”

 

About Artax Science and Immunomodulation

A healthy immune system eliminates harmful foreign pathogens, while being
tolerant of self-tissues and organs. The T Cell Receptor (TCR) is central to healthy T Cell function and a well-functioning immune system. When TCR signaling becomes dysregulated, T Cells behave abnormally. This behavior results in T Celldriven conditions, including autoimmune diseases, T Cell malignancies (lymphomas), and induced T Cell pathologies in which medical treatments result in immune reactions (such as stem cell transplants resulting in acute graft-versus-hostdisease or immuno-oncology treatments resulting in immune related-adverse events). Artax believes immunomodulation – a mechanism through which our investigational agents assist in rebalancing the immune system and eliminating a cause of T Cell-mediated diseases, while not impacting patients’ ability to effectively fight foreign pathogens – holds great potential.

 

About AX-158

AX-158 is a first-in-class, oral small molecule immunomodulating agent in
clinical development for the treatment of T Cell-mediated diseases. AX-158
employs a novel mechanism of action that selectively modulates, or adjusts, T Cell responses that play a critical role in immune system function. AX-158 is a Nck SH3.1 domain inhibitor which selectively counteracts the role of Nck in T Cells. Nck is a protein that naturally amplifies T Cell signaling directly at the TCR, contributing to T Cell mediated disease. This process of  immunomodulation assists the immune system to maintain healthy control and eliminates a direct contributor to T Cell-mediated diseases. Importantly, Artax believes that preclinical data suggests AX-158 will not be immunosuppressive and so will not impact the immune system’s ability to mount a strong response to foreign pathogens and infections.

 

About Artax Biopharma

Artax Biopharma is a clinical-stage biotechnology company transforming
T Cell-mediated disease treatment by developing innovative small molecules that modulate the immune system. Artax science holds broad potential to treat T Cellmediated diseases such as autoimmune diseases; induced T cell pathologies (such as acute graft-versus-host disease and immune-oncology treatment-related adverse events); and T Cell malignancies, while simultaneously allowing the body to fight foreign pathogens. For more information, please visit: www.artaxbiopharma.com.

 

About Sound Bioventures

Sound Bioventures is a biotherapeutics focused venture fund, with a strong
foundation in the Nordic biotech ecosystem, that invests in clinical stage companies in EU, UK and USA. The fund invests in projects addressing significant unmet medical needs having the potential for a profound impact on human health and healthcare systems. Sound Bioventures was founded by a team of experienced life science investors and is backed by a strong investor syndicate comprising Novo Holdings, Saminvest, Vaekstfonden, the European Investment Fund, Ramsbury Invest and the founders. Sound Bioventures Fund I AB is a registered alternative investment fund, under the Swedish Alternative Investment Funds Managers Act.

For more information, please visit: www.soundbioventures.com.

 

Contacts:
Karen LaRochelle, MBA
Chief Business Officer
Artax Biopharma
klarochelle@artaxbiopharma.com

Artax Biopharma Announces First-in-Human Dosing in Phase 1 Clinical Trial for AX-158, Company’s First-in-Class Oral Immunomodulator to Treat T Cell-Mediated Diseases

By Artax Biopharma, Press Release, Private Companies
Press Release.

 

The Phase 1 Trial, Expected to Conclude in 2022, Will Evaluate Safety, Exposure, and Pharmacokinetics of AX-158 in Healthy Volunteers

AX-158, a Novel, Oral Small Molecule Immunomodulating Agent for the Treatment of T Cell-Mediated Diseases, Selectively Modulates T Cell Responses without Suppression of Immune System Function

Cambridge, Mass., December 15, 2021 – Artax Biopharma, Inc., a clinical-stage biotechnology company focused on transforming the treatment of T Cell-mediated diseases, today announces first-in-human dosing in a Phase 1 clinical trial for AX-158, the Company’s first-in-class oral small molecule immunomodulator. AX-158 is the Company’s first oral small molecule immunomodulating agent to enter clinical development for the treatment of T Cell-mediated diseases.

AX-158 employs a first-in-class mechanism of action that selectively modulates T cell responses that play a critical role in healthy immune system function. AX-158 has the potential to treat T Cell mediated diseases without the risk of immunosuppression.

The start of the Phase 1 clinical trial, which marks the beginning of Artax’s AX-158 clinical trial program, is expected to conclude in 2022. The Phase 1 clinical trial will assess the safety, exposure, and pharmacokinetics of AX-158 in healthy volunteers and will include ex-vivo stimulated measures of its pharmacodynamic activity. In preclinical studies, AX-158 demonstrated potential to treat T Cell mediated diseases by decreasing key cytokines including INFγ, TNFα and IL-2 in whole human blood samples.

“Artax has a unique opportunity to make a transformative difference for patients with T Cell-driven conditions, including autoimmune diseases, T Cell malignancies and induced T Cell pathologies – while not impacting the immune system’s ability to mount a strong response to foreign pathogens and infections,”

commented Artax Biopharma Chief Executive Officer Joseph Lobacki.

“We look forward to the results of this Phase 1 clinical study to inform our future clinical studies evaluating patients managing T Cell-mediated diseases.”

About Artax Science and Immunomodulation
A healthy immune system eliminates harmful foreign pathogens, while being tolerant of self-tissues and organs. The T Cell Receptor (TCR) is central to healthy T Cell function and a
well-functioning immune system. When TCR signaling becomes dysregulated, T Cells behave abnormally. This behavior results in T Cell-driven conditions, including autoimmune diseases, T Cell malignancies (lymphomas), and induced T Cell pathologies in which medical treatments result in immune reactions (such as stem cell transplants resulting in acute graft-versus-hostdisease or immuno-oncology treatments resulting in immune related-adverse events). Artax believes immunomodulation – a mechanism through which our investigational agents assist in rebalancing the immune system and eliminating a cause of T Cell-mediated diseases while not impacting patients’ ability to properly fight foreign pathogens – holds great potential.

About Artax-158
AX-158 is a first-in-class, oral small molecule immunomodulating agent in clinical development for the treatment of T Cell-mediated diseases. AX-158 employs a novel mechanism
of action that selectively modulates, or adjusts, T Cell responses that play a critical role in immune system function. Nck is a protein that naturally amplifies T Cell signaling directly at the TCR, contributing to T Cell mediated disease. AX-158 is a Nck SH3.1 domain inhibitor which selectively counteracts the role of Nck in T Cells. This process of immunomodulation assists the immune system to maintain healthy control and eliminates a direct contributor to T Cell-mediated diseases. Importantly, Artax believes that preclinical data suggests AX-158 will not be immunosuppressive and so will not impact the immune system’s ability to mount a strong response to foreign pathogens and infections.

About Artax Biopharma
Artax Biopharma is a clinical-stage biotechnology company transforming T Cell-mediated disease treatment by developing innovative small molecules that modulate the immune system.
Artax science holds broad potential to treat T Cell-mediated diseases such as autoimmune diseases, induced T cell pathologies (such as acute graft versus host disease and immuneoncology treatment-related adverse events) and T Cell malignancies, while simultaneously allowing the body to fight foreign pathogens. For more information, please visit
www.artaxbiopharma.com.

Contacts:
Karen LaRochelle
Chief Business Officer
Artax Biopharma
klarochelle@artaxbiopharma.com

Media:
Linda Phelan Dyson
+1 973-986-5873
ldyson@artaxbiopharma.com

Artax Biopharma Granted MHRA Clinical Trial Authorization for AX-158

By Artax Biopharma, Press Release, Private Companies
Press Release.

 

Authorization Represents Start of Clinical Program for Company’s
Global Platform of T Cell-Mediated Diseases

Phase 1 Clinical Trial Expected to Start in Second Half of this Year

Cambridge, Mass., July 13, 2021 – Artax Biopharma, Inc., a biotechnology company focused on transforming the treatment of T Cell-mediated diseases, today announced that the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted clinical trial authorization to evaluate AX-158 in a Phase 1 clinical trial for the treatment of T Cell-Mediated Diseases.

The MHRA authorization marks the start of Artax’s clinical trial program for its global platform of T Cell-mediated diseases. The AX-158 Phase 1 clinical trial is expected to start in the second half of this year.

Artax’s lead compound AX-158 is a first-in-class, oral small molecule immunomodulating agent for the treatment of T Cell-mediated diseases. AX-158 employs a novel mechanism of action that selectively modulates, or adjusts, T cell responses that play a critical role in immune system function. In preclinical studies, AX-158 decreased key cytokines including INFγ, TNFα and IL-2. Based on this activity, Artax is planning future clinical development in autoimmune diseases, T cell malignancies and other related T cell pathologies.

“This authorization to study the tremendous science behind AX-158 is fantastic news for the immunology field,”

said Dr. Lawrence Steinman, Stanford University Zimmerman Professor of Neurology and Neurosciences, Pediatrics, and Genetics and Artax Scientific Advisory Board member.

“Artax Biopharma’s Nck inhibitor AX-158 has shown impressive experimental biologic and mechanistic impact on T Cell modulation – managing autoimmune disease without inducing the profound immunosuppression associated with current conventional or biological therapies.”

“There is a great need for oral therapeutics that offer efficacy with fewer side effects for the many patients suffering from debilitating and life-threatening T Cell-mediated diseases including autoimmune diseases and T cell malignancies”

Artax Biopharma Chief Executive Officer Joseph Lobacki stated.

“The MHRA approval and opportunity to initiate clinical trials for AX-158 is a significant milestone, and we look forward to bringing this first-in-class treatment option to the clinic.”

About Artax Science and Immunomodulation
A healthy immune system eliminates harmful foreign pathogens, while being tolerant of self-tissues and organs. The T Cell Receptor (TCR) is central to healthy T Cell function and a well-functioning immune system. When TCR signaling becomes dysregulated, T Cells behave abnormally. This behavior results in T Cell-driven conditions including autoimmune diseases, T Cell malignancies (lymphomas), and induced T Cell pathologies in which medical treatments result in immune reactions (such as stem cell transplants resulting in acute graft-versus-host-disease or immune-oncology treatments resulting in immune related-adverse events). Artax believes immunomodulation – during which our medicines assist the immune system to maintain healthy control and eliminate a direct cause of T Cell-mediated diseases while not impacting patients’ ability to properly fight foreign pathogens – holds great potential.

About Artax-158
AX-158 is a first-in-class, oral small molecule immunomodulating agent in development for the treatment of T Cell-mediated diseases. AX-158 employs a novel mechanism of action that selectively modulates, or adjusts, T Cell responses that play a critical role in immune system function. Nck is a protein that naturally amplifies T Cell signaling directly at the TCR, contributing to pathogenic responses. AX-158 is a Nck SH3.1 domain inhibitor which selectively counteracts the role of Nck in T Cells. This process of immunomodulation eliminates a direct factor in T Cell-mediated diseases. Importantly, data suggest AX-158 is not immunosuppressive and does not impact the immune system’s ability to mount a strong response to foreign pathogens and infections.

About Artax Biopharma
Artax Biopharma is a biotechnology company transforming T Cell-mediated disease treatment by developing innovative small molecules that modulate the immune system. Artax science holds broad potential to treat T Cell-mediated diseases such as autoimmune diseases, induced T cell pathologies (such as acute graft versus host disease and immune-oncology treatment-related adverse events) and T Cell malignancies (lymphomas), while simultaneously allowing the body to fight foreign pathogens. For more information, please visit www.artaxbiopharma.com.

Contacts:
Karen LaRochelle
Chief Business Officer
Artax Biopharma
klarochelle@artaxbiopharma.com

Media:
Linda Phelan Dyson
+1 973-986-5873
ldyson@artaxbiopharma.com

Artax Biopharma Announces the Formation of Scientific Advisory Board to Advance Autoimmune Disease Therapy AX-158

By Artax Biopharma, Press Release, Private Companies
Press Release.

 

Renowned Global Leaders are Experts in Immunology, Autoimmune Disease, and T Cell Signaling

Cambridge, Mass., June 24, 2020 – Artax Biopharma, Inc., a biotechnology company focused on transforming autoimmune disease treatment, today announces the formation of their Scientific Advisory Board (SAB). The SAB is comprised of experts in Immunology, Autoimmune Disease, and T Cell Signaling, and was formed to guide the company as it proceeds into future clinical trials with a first-in-class, oral small molecule autoimmune disease immunomodulator AX-158.

Artax Biopharma is poised to enter clinical trials with the small molecule AX- 158, a novel approach to treat multiple autoimmune diseases without causing the immunosuppression commonly associated with current autoimmune disease therapies.

Balbino Alarcón, PhD, Chairman of Artax’s Scientific Advisory Board, commented,

“I am privileged to lead Artax’s Scientific Advisory Board, which mobilizes global leaders in Immunology, Autoimmune Disease, and T Cell Signaling. Collectively we are enthusiastic to collaborate on, and contribute to, important development initiatives related to Artax’s innovative approach to autoimmune disease treatment.”

“Artax Biopharma’s Nck inhibitor AX-158 has shown impressive experimental biologic and mechanistic impact on T cell modulation – managing autoimmune disease without inducing the profound immunosuppression or interference with memory response associated with conventional or biological therapies,”

stated Dr. Lawrence Steinman, Stanford University Zimmerman Professor of Neurology and Neurosciences, Pediatrics, and Genetics and Scientific Advisory Board member.

“Convening a Scientific Advisory Board is a critical step as we accelerate our clinical development program,”

stated Artax Biopharma Chief Executive Officer Joseph Lobacki.

“The clinical expertise and knowledge of these experts is unparalleled and will be instrumental in informing our development strategy across several autoimmune diseases.”

The SAB will be comprised of five experts, and is being led by
Professor Balbino Alarcón, PhD, co-founder of Artax Biopharma:

Balbino Alarcón, PhD
Dr. Alarcón is Program Director at the National Research Council of
Spain (CSIC) and Head of the TCR-mediated Signal Transduction
Laboratory.

Raif Geha, MD
Dr. Geha is the James L. Gamble Professor of Pediatrics at Harvard
Medical School and Chief of the Allergy/Immunology/Rheumatology and
Dermatology Division at Children’s Hospital in Boston.

Menno de Rie, MD
Prof. de Rie is a board-certified dermatologist and vice-chair of the
department of Dermatology of the Amsterdam University Medical Centres/
University of Amsterdam.

Lawrence Steinman, MD
Dr. Steinman is the George A. Zimmermann professor of Neurology
and Neurological Sciences, Pediatrics, and Genetics at Stanford University.

Cox Terhorst, PhD
Dr. Terhorst is Chief of Immunology at Beth Israel Deaconess Medical
Center and Professor at Harvard Medical School.

About Immunomodulation
A healthy immune system eliminates harmful foreign pathogens, while
being tolerant of self-tissues and organs. When the immune system
malfunctions, cells (T Cells) attack self-tissues and organs, causing
autoimmune disease. Current autoimmune disease therapies suppress the
immune system, helping to minimize these self-attacks, but also raise
susceptibility to harmful foreign pathogens. Immunomodulation, the process
in which the immune system reduces self-attacks while properly reacting to
fight foreign pathogens, holds great potential for autoimmune disease.

About Artax-158
AX-158 is a first-in-class, oral small molecule, preclinical
immunomodulating agent in development for the treatment of autoimmune
diseases. AX-158 employs a novel mechanism of action that selectively
modulates, or adjusts, T cell responses that play a critical role in immune
system function. By selectively inhibiting Nck, a protein, AX-158 selectively
modulates self-directed T Cell activation which is a cause of autoimmune
disease. Importantly, data suggest AX-158 is not immunosuppressive and
does not impact the immune system’s ability to mount a strong response to
foreign pathogens and infections. Further, AX-158’s ability to modulate T cell
responses allows the possibility to broadly target several autoimmune
diseases, therefore potentially transforming autoimmune disease treatment.

About Artax Biopharma
Artax Biopharma is a biotechnology company transforming
autoimmune disease treatment. Artax is a life science industry leader in
autoimmune disease immunomodulation science, developing an
innovative small molecule approach to treat autoimmune disease that
modulates the immune system to both treat autoimmune disease and
allow the body to fight foreign pathogens. The company is examining a
first-in-class oral immunomodulating agent as a new way to treat multiple
autoimmune diseases without causing the immune suppression commonly
associated with currently available autoimmune disease therapies. For
more information, please visit www.artaxbiopharma.com.

Contacts:
Karen LaRochelle, MBA
Chief Business Officer
Artax Biopharma
klarochelle@artaxbiopharma.com

Media:
Linda Phelan Dyson, MPH
+1 973-986-5873
ldyson@artaxbiopharma.com

Artax Biopharma Announces Series B Financing Extension to Advance First-in-Class Autoimmune Disease Therapy

By Artax Biopharma, Press Release, Private Companies
Press Release.

 

– Extension Brings in Additional Investor –

Cambridge, MA, June 4, 2020 – Artax Biopharma, Inc., a biotechnology company focused on transforming autoimmune disease treatment, today announces the completion of an extension to its Series B financing led by Columbus Venture Partners.

AX-158 is a first-in-class, oral small molecule, immunomodulating agent in development for the treatment of autoimmune diseases. AX-158 employs a novel mechanism of action that selectively modulates, or adjusts, T cell responses that play a critical role in immune system function.  Proceeds from the financing will be used to support activities for a planned Q4 2020 filing of a Clinical Trial Application (CTA) with the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) for AX-158.

“We are pleased to welcome Columbus Venture Partners as a new investor,”

said Joseph Lobacki, Chief Executive Officer of Artax Biopharma.

“The support of Columbus Venture Partners is a testament to the transformative potential of our science, which has the potential to address autoimmune disease without causing immunosuppression.

” Javier García, Founder and Partner with Columbus Venture Partners, stated, “Columbus Venture Partners is pleased to have led the extension to this round of financing. We believe Artax’s highly experienced leadership team is well positioned to deliver on a truly innovative therapeutic program.”

About Immunomodulation

A healthy immune system eliminates harmful foreign pathogens, while being tolerant of self-tissues and organs.  When the immune system malfunctions, cells (T Cells) attack self-tissues and organs, causing autoimmune disease. Current autoimmune disease therapies suppress the immune system, helping to minimize these self-attacks, but also raise susceptibility to harmful foreign pathogens.Immunomodulation, the process in which the immune system reduces self-attacks while properly reacting to fight foreign pathogens, holds great potential for autoimmune disease therapies.

About Artax-158

AX-158 is a first-in-class, oral small molecule, preclinical immunomodulating agent in development for the treatment of autoimmune diseases. AX-158 employs a novel mechanism of action that selectively modulates, or adjusts, T cell responses that play a critical role in immune system function. By selectively inhibiting Nck, a protein, AX-158 selectively modulates self-directed T Cell activation which is a cause of autoimmune disease. Importantly, data suggests that AX-158 is not immunosuppressive and does not impact the immune system’s ability to mount a strong response to foreign pathogens and infections. Further, AX-158’s ability to modulate  T  cell  responses  allows  the  possibility  to  broadly  target  several autoimmune diseases, therefore potentially transforming autoimmune disease treatment.

About Artax Biopharma

Artax Biopharma is a biotechnology company transforming autoimmune disease treatment.  Artax is a life science industry leader in autoimmune disease immunomodulation science, developing an innovative small molecule approach to treat autoimmune disease that modulates the immune system to both treat autoimmune disease and allow the body to fight foreign pathogens.  The company is examining a first-in-class oral immunomodulating agent as a new way to treat multiple  autoimmune  diseases  without  causing  the  immune  suppression commonly associated with currently available autoimmune disease therapies. For more information, please visit www.artaxbiopharma.com.

Contacts:
Karen LaRochelle, MBA
Chief Business Officer
Artax Biopharma
klarochelle@artaxbiopharma.com

Media:
Linda Phelan Dyson, MPH
+1 973-986-5873
ldyson@artaxbiopharma.com

Artax Biopharma Appoints Joseph Lobacki as Chief Executive Officer, Announces Expanded Management Team

By Artax Biopharma, Press Release, Private Companies
Press Release.

 

Autoimmune Disease Company Hires Life Science Industry Experts to Lead Company
Through Next Stage into Human Clinical Studies with Novel Oral Small Molecule AX-158

Cambridge, MA, May 13, 2020 – Artax Biopharma, Inc., a biotechnology company
focused on transforming autoimmune disease treatment, announces their
expanded management team, being led by newly appointed Chief Executive Officer
(CEO) Joseph Lobacki. Comprised of immunology industry leaders and scientists,
the team represents deep expertise in drug discovery, development and
collaborations from some of the world’s most prestigious institutions.

Artax Biopharma is poised to enter clinical trials with the small molecule AX-
158, a novel approach to treat multiple autoimmune diseases without causing the
immune suppression commonly associated with current autoimmune disease
therapies.

Joseph Lobacki assumes the helm of Artax Biopharma after more than three
decades of leadership including research, development, and commercial
experience in executive roles across large and small biopharmaceutical companies,
including Sanofi Genzyme, Medivation, Verastem, and Micromet. The former CEO,
Damia Tormo, will continue as a member of the Board of Directors and we thank
Dr. Tormo for his years of work in founding and building Artax.

“We are thrilled to have such a strategic and experienced leader as Joseph
Lobacki steering Artax from our new US headquarters at this seminal time,”

stated Artax Biopharma’s Executive Chairman of the Board Alan Walts, Ph.D.

“His deep experience will prove invaluable as Artax’s first oral agent to treat autoimmune
disease prepares to enters the clinic.”

The Artax Biopharma management team includes Joseph Lobacki, CEO; Chris
VanDeusen, Ph.D., Chief Scientific Officer (CSO); Richard P. Polisson, M.D., MHSc,Chief Medical Officer (CMO); Karen LaRochelle, MBA, Chief Business Officer (CBO), and Andres Gagete, Ph.D., Chief Operating Officer, (COO).

“I am excited to lead these incredibly talented and experienced professionals
in our Cambridge location as we fulfill the Artax mission to make our treatments
available as quickly as possible to patients who suffer from autoimmune diseases.
This team possesses the critical knowledge and experience to progress our novel
immunomodulator into clinical development and to drive this important mission
forward,”

added Mr. Lobacki.

Prior to Artax, Mr. Lobacki most recently served as Executive Vice President
and Chief Commercial Officer for Verastem, Inc.; Chief Operating Officer of Finch
Therapeutics Group, and Chief Commercial Officer and Executive Council Member
of Medivation, where he led a period of strong revenue growth for prostate cancer
treatment Xtandi®. Mr. Lobacki also held previous roles as Senior Vice President
and Chief Commercial Officer of Micromet, Inc., and Senior Vice President and
General Manager at Genzyme Corporation. Mr. Lobacki served as a director of
Celator Pharmaceuticals (acquired by Jazz Pharmaceuticals) and is currently on the
Boards of Sutro Biopharma and Artax Biopharma.

As CSO, Dr. VanDeusen will lead Artax’s scientific, research and translational
areas. Dr. VanDeusen brings more than 15 years of biopharmaceutical experience
and extensive expertise in drug discovery and development. He is also an inventor
and key contributor to multiple preclinical development compounds. Previously,
Dr. VanDeusen headed the chemistry division and was a global project team leader
within Tissue Protection and Repair at Sanofi Genzyme.
Dr. Polisson, in his role as Artax’s CMO, will direct the company’s clinical
development strategy. With 30 years of clinical and translational research
experience, Dr. Polisson joins Artax from the Sanofi Genzyme Research and
Development Center where he was Senior Vice President and Translational
Medicine Head directing discovery and translational medicine efforts across
multiple therapeutic areas. Previously, Dr. Polisson served as Associate Professor
of Medicine, Arthritis Unit Clinical Director at Massachusetts General Hospital and
Harvard Medical School.

As Chief Business Officer, Karen LaRochelle, MBA will lead all partner- and
investor-related interactions. With more than 25 years of biopharmaceutical
strategy and collaborations experience, her expertise in mergers & acquisitions
includes a deep history transacting for biotech companies, with several
transactions exceeding $1 billion. Prior to Artax, Ms. LaRochelle was Chief Business
Officer of PsiOxus Therapeutics. Previously in her career, Ms. LaRochelle spent
nearly 20 years with Bristol-Myers Squibb focused on strategy and transactions.

Dr. Gagete, as Artax’s COO, is currently coordinating research &
development and operations for Artax. Dr. Gagete has more than a decade of
experience in the biotech and academic sectors and was previously the Innovation
Director for Bioncotech Therapeutics.

About Immunomodulation

A healthy immune system eliminates harmful foreign pathogens, while being
tolerant of self-tissues and organs. When the immune system malfunctions, cells
(T Cells) attack self-tissues and organs, causing autoimmune disease. Current
autoimmune disease therapies suppress the immune system, helping to minimize
these self-attacks, but also raise susceptibility to harmful foreign pathogens.
Immunomodulation, the process in which the immune system reduces self-attacks
while properly reacting to fight foreign pathogens, holds great potential for
autoimmune disease.

About Artax-158

AX-158 is a first-in-class, oral small molecule, preclinical immunomodulating
agent in development for the treatment of autoimmune diseases. AX-158 employs
a novel mechanism of action that selectively modulates, or adjusts, T cell responses
that play a critical role in immune system function. By selectively inhibiting Nck, a
protein, AX-158 selectively modulates self-directed T Cell activation which is a
cause of autoimmune disease. Importantly, AX-158 is not immunosuppressive and
does not impact the immune system’s ability to mount a strong response to foreign
pathogens and infections. Further, AX-158’s ability to modulate T cell responses
allows the possibility to broadly target several autoimmune diseases, therefore
potentially transforming autoimmune disease treatment.

About Artax Biopharma

Artax Biopharma is a biotechnology company transforming autoimmune
disease treatment. Artax is a life science industry leader in autoimmune disease
immunomodulation science, developing an innovative small molecule approach to
treat autoimmune disease that modulates the immune system to both treat
autoimmune disease and allow the body to fight foreign pathogens. The company
is examining a first-in-class oral immunomodulating agent as a new way to treat
multiple autoimmune diseases without causing the immune suppression
commonly associated with currently available autoimmune disease therapies. For
more information, please visit www.artaxbiopharma.com.

Contacts:
Karen LaRochelle, MBA
Chief Business Officer
Artax Biopharma
klarochelle@artaxbiopharma.com

Media:
Linda Phelan Dyson, MPH
+1 973-986-5873
ldyson@artaxbiopharma.com

Artax Biopharma Funded to Clinically Develop Breakthrough Oral Therapies for Autoimmune Diseases

By Artax Biopharma, Press Release, Private Companies
Press Release.

 

Raises $10M Series B to fund Phase Ib-IIa clinical trials for AX-024, a novel oral treatment; and to further develop its pipeline of preclinical candidates

September 22, 2015 08:05 AM Eastern Daylight Time

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Artax Biopharma, a clinical stage biotechnology company developing first-in-class highly selective oral therapies for the treatment of autoimmune diseases, has secured a $10M Series B round of funding. The financing was led by Henri Termeer, former CEO of Genzyme, and Advent Life Sciences; with participation from A.M. Pappas and existing investors. In conjunction with the financing, Henri Termeer and Raj Parekh, General Partner at Advent Life Sciences, will join Artax’s Board of Directors.

Artax’s lead compound, AX-024, is a highly selective immunomodulator of T-cell Receptor (TCR) signaling in autoimmune T-cells. The new funding will be used to advance AX-024 through Phase Ib and IIa clinical trials for the treatment of autoimmune diseases, and to further develop selective Nck inhibitors in partnership with Dr. Balbino Alarcon. Dr. Alarcon’s lab discovered Nck’s role in T-cell activation at the Spanish National Council (CSIC). Nck is a member of the SH2/SH3 family of cytoplasmic adapter proteins involved in transducing signals from receptor tyrosine kinases to downstream effectors, which play a key role in T-cell activation.

“The selective inhibition of Nck is an area of tremendous therapeutic potential for treating autoimmune diseases and one where Artax leads the world’s research efforts. As our AX-024 program advances in the clinic, we continue developing additional Nck-specific compounds,”

said Damia Tormo, founder and CEO of Artax Biopharma.

“We are thrilled with the confidence the new investors have in Artax and its technology. They will help us realize the full potential of our products and enable us to bring them to patients in need.”

“Artax is pursuing breakthrough science: a targeted immunomodulatory approach for autoimmune diseases that does not compromise the protective function of T-cells to external threats,”

said Henri Termeer.

“Artax has the potential to treat a range of autoimmune conditions in which current therapies are not optimal and may result in serious side effects.”

“Artax’s compounds could have clinical utility in virtually any pathogenic T-cell mediated diseases,”

said Raj Parekh, General Partner at Advent Life Sciences.

“We are excited about the potential of this novel science and its broad clinical applications.”

Clinical Phase 1 Study: Excellent Safety and PK/PD Profile

In Phase I studies, orally dosed AX-024 was well tolerated in healthy volunteers even at very high doses. Experiments carried out ex vivo showed that treatment with AX-024 in humans has a significant immunomodulatory effect on T-cells, with dose-dependent behavior, measured either by inhibition of T-cell proliferation or by Th17, Th2 and Th1 cell cytokine secretion. Artax has validated the target and mechanism of action, and demonstrated preclinical proof of concept of AX-024 in various preclinical autoimmune disease (MS, Psoriasis, IBD, Type I diabetes) and GVHD models.

About Artax Biopharma

Artax Biopharma is a clinical stage biopharmaceutical company developing breakthrough therapies for autoimmune diseases. Its pipeline of drugs is based on novel science that targets the interaction between T-cell receptors (TCR) and Nck, a key protein involved in T-cell activation. Based in Cambridge, Massachusetts, more information on Artax Biopharma can be found at www.artaxbiopharma.com.

About Advent Life Sciences

Advent Life Sciences is one of Europe’s leading venture teams investing in life sciences businesses in the UK, Europe and US. The team consists of professionals with extensive scientific, medical and operational experience, and a long-standing track record of entrepreneurial and investment success across the UK, Europe and the US. The firm invests in a range of sectors within life sciences, principally in new drug discovery, enabling technologies and med tech. Realizations in the last three years include Algeta, Avila, CN Creative, EUSA and Micromet. Current investments include Acutus, Aura Biosciences, Biocartis, Cellnovo, f2G, GMP-Orphan, NeRRe, and Versartis. For more information, please visit www.adventls.com.

Contacts

 

For Artax Biopharma

Matt Burke, +1 603-315-0618

mattdavidburke@gmail.com