Scleroderma

aTyr Pharma Announces Howard University President Emeritus Dr. Wayne A. I. Frederick as Advisor

Retrieved on: 
Thursday, January 18, 2024

Dr. Frederick is President Emeritus of Howard University, having served as President from 2014 to 2023.

Key Points: 
  • Dr. Frederick is President Emeritus of Howard University, having served as President from 2014 to 2023.
  • “We are honored to welcome a distinguished physician executive such as Dr. Frederick as an advisor to aTyr,” said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr.
  • He is also the distinguished Charles R. Drew Professor of Surgery at the Howard University College of Medicine and a practicing cancer surgeon at Howard University Hospital.
  • Dr. Frederick earned a B.S., M.D., and completed his surgical residency training at Howard University Hospital.

Calluna Pharma Launches and Announces EUR 75 Million Series A Financing to Develop Novel Therapies for Inflammatory and Fibrotic Diseases

Retrieved on: 
Tuesday, January 23, 2024

Calluna has raised EUR 75 million in a series A financing and is backed by Oxitope and Arxx’s existing lead investors, Forbion, Sarsia, p53, and Investinor.

Key Points: 
  • Calluna has raised EUR 75 million in a series A financing and is backed by Oxitope and Arxx’s existing lead investors, Forbion, Sarsia, p53, and Investinor.
  • Calluna is developing novel therapies that harness the transformative potential of the body's immune system.
  • As a result, Calluna has developed a robust pipeline of selective antibodies, targeting immunological diseases.
  • The Company is raising further financing to develop its pipeline to multiple key clinical milestones over the next 2.5 years.

The Scleroderma Research Foundation Appoints Dr. Gregory Gordon as Chief Medical Officer

Retrieved on: 
Thursday, January 25, 2024

SAN FRANCISCO, Jan. 25, 2024 /PRNewswire/ -- The Scleroderma Research Foundation (SRF)— the nation's largest non-profit funder of scleroderma research—announces the appointment of Gregory Gordon, MD, JD as its first Chief Medical Officer (CMO). As CMO, Dr. Gordon will provide both strategic management and operations oversight for the recently announced global clinical trial program CONQUEST, which will involve 130 medical centers in 22 countries. He will also liaise with CONQUEST's two pharmaceutical partners—Sanofi and Boehringer Ingelheim—as well as any other partners that opt to bring innovative therapies to the CONQUEST platform. Dr. Gordon's contributions are expected to add focus to the ongoing work of SRF—in particular regarding its efforts to bring new and innovative therapeutic alternatives to scleroderma patients and the scleroderma community worldwide.

Key Points: 
  • SAN FRANCISCO, Jan. 25, 2024 /PRNewswire/ -- The Scleroderma Research Foundation (SRF)— the nation's largest non-profit funder of scleroderma research—announces the appointment of Gregory Gordon, MD, JD as its first Chief Medical Officer (CMO).
  • "Dr. Gordon, with his impressive track record spanning over fifteen years in pivotal leadership roles in the biotechnology industry, brings a unique and vital perspective to the Scleroderma Research Foundation.
  • "With CONQUEST, the Scleroderma Research Foundation is deepening its commitment and support for research that addresses the high unmet needs of scleroderma patients.
  • Before attending medical school at the State University of New York at Stony Brook, Dr. Gordon earned a J.D.

Boehringer expands production site in Greece for new medicine

Retrieved on: 
Thursday, January 11, 2024

Boehringer Ingelheim, a leading research-driven biopharmaceutical company, today announced a further expansion and upgrade of its plant in Koropi, Greece.

Key Points: 
  • Boehringer Ingelheim, a leading research-driven biopharmaceutical company, today announced a further expansion and upgrade of its plant in Koropi, Greece.
  • Greek Prime Minister Kyriakos Mitsotakis attended the groundbreaking ceremony at the Koropi site today, alongside the Minister of State, the Minister of Health and the Minister of Development.
  • In 2020, the company announced multi-year investments to expand the site and its production capacity.
  • The Koropi plant is the only industrial facility of a multinational pharmaceutical company in Greece producing innovative medicines.

Cabaletta Bio Receives Additional FDA Fast Track Designations for CABA-201 in Dermatomyositis and Systemic Sclerosis

Retrieved on: 
Monday, January 8, 2024

PHILADELPHIA, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted separate Fast Track Designations to CABA-201, an investigational 4-1BB-containing fully human CD19-CAR T cell therapy, for the treatment of patients with dermatomyositis to improve disease activity and for the treatment of patients with systemic sclerosis (SSc) to improve associated organ dysfunction.

Key Points: 
  • “The additional Fast Track Designations for CABA-201 in both dermatomyositis and systemic sclerosis, the second and third Fast Track Designations for CABA-201, provide the opportunity for expedited development and review of CABA-201 for the treatment of these autoimmune indications where there is a significant unmet need, despite currently available therapies,” said David J. Chang, M.D., Chief Medical Officer of Cabaletta.
  • “We believe these designations potentially accelerate our ability to launch the first targeted, and potentially curative, cell therapy for autoimmune diseases driven by B cells.
  • To date, Cabaletta has received clearance from the FDA for Investigational New Drug (IND) applications for CABA-201 in multiple autoimmune conditions including systemic lupus erythematosus (SLE), myositis, SSc and generalized myasthenia gravis (gMG).
  • Cabaletta is conducting four Phase 1/2 clinical trials with a total of nine cohorts that can advance simultaneously, employing a similar parallel cohort design and starting dose of 1 x 106 cells/kg without a dose escalation requirement.

Zura Bio Continues to Strengthen Leadership with Appointment of Robert Lisicki as President and Kiran Nistala as CMO

Retrieved on: 
Monday, January 8, 2024

Mr. Lisicki will be responsible for developing and driving the business plan and strategic initiatives as Zura Bio builds a leading immunology company.

Key Points: 
  • Mr. Lisicki will be responsible for developing and driving the business plan and strategic initiatives as Zura Bio builds a leading immunology company.
  • Mr. Lisicki and Dr. Nistala have successfully worked on or led in the development of multiple drugs within the auto-immune therapeutic area.
  • These executives position Zura Bio to deliver on the promise of their innovative medicines for patients in need of better clinical outcomes.
  • View the full release here: https://www.businesswire.com/news/home/20240108851979/en/
    “I am very pleased to welcome Rob and Kiran to Zura Bio as members of the Executive Team.

Adicet Provides Corporate Update and Highlights Strategic Priorities for 2024

Retrieved on: 
Thursday, January 4, 2024

Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer and autoimmune diseases, today provided corporate updates and highlighted upcoming priorities for its pipeline programs in 2024.

Key Points: 
  • Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer and autoimmune diseases, today provided corporate updates and highlighted upcoming priorities for its pipeline programs in 2024.
  • “In 2024, we aim to make significant strides across our pipeline of differentiated gamma delta T cell therapies through our strategic and disciplined approach,” said Chen Schor, President and Chief Executive Officer at Adicet Bio.
  • Initiate Phase 1 clinical trial of ADI-001 for the treatment of lupus nephritis in the second quarter of 2024.
  • The Company remains on track to provide an ADI-001 clinical update in the second half of 2024.

Akari Therapeutics Appoints Experienced Life Sciences Entrepreneur Samir R. Patel, M.D. to Board of Directors

Retrieved on: 
Friday, December 1, 2023

NEW YORK and BOSTON, Dec. 01, 2023 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, today announced the appointment of experienced life sciences entrepreneur Samir R. Patel, M.D.

Key Points: 
  • NEW YORK and BOSTON, Dec. 01, 2023 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, today announced the appointment of experienced life sciences entrepreneur Samir R. Patel, M.D.
  • to the Akari Board of Directors.
  • “Samir is a long-time investor in Akari and brings to us broad life sciences experience and a track record of multiple successful startup companies.
  • I am pleased to welcome him to our Board of Directors at this important time in our company’s development,” said Ray Prudo, M.D., Akari Chairman.

Certa Therapeutics presents positive data from a Phase 2 clinical study highlighting the potential benefit of FT011 as a novel treatment for scleroderma

Retrieved on: 
Wednesday, November 15, 2023

The study safety profile demonstrated that FT011 was safe and well tolerated, with no differences in adverse event (AE) rates between the treatment arms.

Key Points: 
  • The study safety profile demonstrated that FT011 was safe and well tolerated, with no differences in adverse event (AE) rates between the treatment arms.
  • There were no serious AEs reported in the study, nor any AEs resulting in study drug interruption, withdrawal or discontinuation.
  • This suggests that FT011 may have a positive effect for scleroderma patients by reducing the inflammation and fibrosis associated with the disease.
  • It is important to advance safe and effective treatments through clinical development, given the limited therapeutic options for scleroderma patients.

aTyr Pharma Presents Poster Demonstrating Preclinical Effects of Efzofitimod in Rheumatoid Arthritis and Rheumatoid Arthritis-Associated ILD at the ACR Convergence 2023

Retrieved on: 
Monday, November 13, 2023

The poster will be available on the aTyr website once presented.

Key Points: 
  • The poster will be available on the aTyr website once presented.
  • The poster presents findings from preclinical models of rheumatoid arthritis (RA) and RA-associated ILD (RA-ILD), where NRP2, efzofitimod’s binding partner, is known to be expressed on pro-inflammatory synovial macrophages.
  • An animal knockout model for NRP2 demonstrated that NRP2 deficiency exacerbated disease pathology in preclinical models of inflammatory disease.
  • These forms of ILD have limited therapeutic options and there is a need for safer and more effective, disease-modifying treatments that improve outcomes.