Autoimmune disease

Immix Biopharma Awarded European Union Orphan Drug Designation for NXC-201 in AL Amyloidosis

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수요일, 2월 7, 2024

Los Angeles, Feb. 07, 2024 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“Immix Biopharma”, “Company”, “We” or “Us”, Nasdaq:IMMX), a clinical-stage biopharmaceutical company trailblazing cell therapies in autoimmune disease, today announced that the European Commission (EC) has granted orphan drug designation to NXC-201 for the treatment of AL Amyloidosis.

Key Points: 
  • European Orphan Drug Designation (“ODD”) qualifies NXC-201 for:
    Reduced fees for EU protocol assistance, marketing authorization applications, inspections before authorization, applications for changes to marketing authorizations made after approval, and reduced annual fees
    U.S. observed prevalence of relapsed/refractory AL Amyloidosis is growing 12% per year according to Staron, et al Blood Cancer Journal, estimated to reach 29,712 patients in 2023
    Los Angeles, Feb. 07, 2024 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“Immix Biopharma”, “Company”, “We” or “Us”, Nasdaq:IMMX), a clinical-stage biopharmaceutical company trailblazing cell therapies in autoimmune disease, today announced that the European Commission (EC) has granted orphan drug designation to NXC-201 for the treatment of AL Amyloidosis.
  • “European Union orphan drug designation for NXC-201 represents an important milestone in our global strategy,” said Ilya Rachman, MD PhD, Chief Executive Officer, Immix Biopharma.
  • To qualify for orphan drug designation, a candidate therapy must be intended for the treatment, prevention or diagnosis of a life-threatening or chronically debilitating disease that occurs in not more than five in 10,000 people in the EU.
  • The designation provides regulatory, financial and commercial incentives to develop therapies for rare diseases where there are either no satisfactory treatment options or significant benefit to those affected by the disease.

First Carbonhand prescribed to a US Veteran

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수요일, 2월 7, 2024

KISTA, Sweden, Feb. 7, 2024 /PRNewswire/ -- Mr. Lamb has inclusion body myositis (IBM), a rare autoimmune disease that primarily affects skeletal muscles with reduced muscle strength and endurance as characteristic symptoms. IBM differs from other types of autoimmune diseases with slowly progressive muscle weakness and muscle atrophy, finger flexor weakness is a central and early presenting symptom. Patients experience challenges in many areas of their lives. Gripping and holding objects as well as fine-motor activities are major parts of the challenges they face. Individuals with advanced IBM have difficulties holding utensils, gripping a glass to drink, holding a toothbrush, dressing and undressing as well as many other activities of daily living requiring grip. 

Key Points: 
  • Carbonhand is available to all US veterans through a network of sales agents covering over 80% of VA Medical Centers across the US.
  • This first prescription paves the way for other US Veterans with impaired hand function to regain hand function and become more independent.
  • I am very grateful for this opportunity and look forward to having a more active life again," says John Lamb, US Veteran.
  • "Carbonhand is fully covered by Veteran Affairs, and since its introduction in the US, we have met many veterans with different diagnoses whom can benefit from improved grip through the use of Carbonhand.

Immix Biopharma Announces Proposed Public Offering of Common Stock

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월요일, 2월 5, 2024

LOS ANGELES, Feb. 05, 2024 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (Nasdaq: IMMX) (the “Company”), a clinical-stage biopharmaceutical company trailblazing cell therapies in autoimmune disease, today announced that it intends to offer and sell shares of its common stock in an underwritten public offering.

Key Points: 
  • LOS ANGELES, Feb. 05, 2024 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (Nasdaq: IMMX) (the “Company”), a clinical-stage biopharmaceutical company trailblazing cell therapies in autoimmune disease, today announced that it intends to offer and sell shares of its common stock in an underwritten public offering.
  • All of the shares of common stock in the underwritten public offering are to be sold by the Company.
  • The Company also expects to grant the underwriters a 30-day option to purchase additional shares of common stock offered in the public offering.
  • A shelf registration statement relating to the shares of common stock to be issued in the proposed offering was filed with the Securities and Exchange Commission (“SEC”) and declared effective by the SEC.

AnaMar Announces US and EU Orphan Drug Designation for AM1476 for Treating Systemic Sclerosis

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월요일, 2월 5, 2024

AM1476 offers a unique dual-action approach to treat both skin and lung manifestations of systemic sclerosis.

Key Points: 
  • AM1476 offers a unique dual-action approach to treat both skin and lung manifestations of systemic sclerosis.
  • Systemic sclerosis is a chronic, progressive, autoimmune disease characterized by inflammation and fibrosis, i.e.
  • AnaMar's Chief Executive Officer, Dr. Ulf Ljungberg, said: “We are delighted with the FDA’s and EMA’s decisions to grant orphan drug designation to AM1476 for SSc.
  • Orphan drug designation provides certain benefits, including the potential for extensive marketing exclusivity following regulatory approval, reduction in regulatory fees and, in the case of EU, a centralized approval process.

Immutep Quarterly Activities Report Q2 FY24

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화요일, 1월 30, 2024

SYDNEY, AUSTRALIA, Jan. 30, 2024 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, provides an update on the ongoing development of its product candidates, eftilagimod alpha (efti) and IMP761 for the quarter ended 31 December 2023 (Q2 FY24).

Key Points: 
  • Cash receipts from customers in Q2 FY24 were $38k, compared to $132k in Q1 FY24.
  • The net cash used in G&A activities in the quarter was $0.8 million, compared to $1.6 million in Q1 FY24.
  • The net cash used in R&D activities in the quarter was $6.9 million, compared to $9.7 million in Q1 FY24.
  • Total net cash outflows used in operating activities in the quarter were $5.5 million compared to $12.9 million in Q1 FY24.

PolTREG CEO Trzonkowski co-authors peer-reviewed article showing scientific progress in T-reg autoimmune therapy

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화요일, 1월 30, 2024

PolTREG was the first company in the world to administer T-reg therapies to patients and the first to start receiving revenues from its lead product.

Key Points: 
  • PolTREG was the first company in the world to administer T-reg therapies to patients and the first to start receiving revenues from its lead product.
  • So far, PolTREG has successfully treated 27 patients with PTG-007 commercially under a hospital exemption program in Poland, where the company is completing its own state-of-the-art manufacturing facilities.
  • When found in the body, Treg cells are polyclonal, meaning they can react to a number of different antigenic triggers.
  • PolTREG (Gdańsk, Poland; WSA:PTG) is a global leader in developing autoimmune therapies based on T-regulatory cells (Tregs).

Autoimmune Disease and Pregnancy: ISB Study Challenges Prevailing Wisdom, Unveils Nuances

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수요일, 1월 31, 2024

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20240131144327/en/
    In a just-published study in the journal Lancet eClinical Health , researchers at the Institute for Systems Biology (ISB) and Providence showed nuanced pregnancy outcomes for pregnant individuals with autoimmune disease.
  • Each type of autoimmune disease is different, each person has their own medical history, and risk may change over the course of pregnancy.
  • This study highlights the importance of taking comorbidities into consideration,” said ISB Associate Professor Jennifer Hadlock, MD , who led the study.
  • “These results can help reshape discussions surrounding autoimmune disease and pregnancy, and bring fresh perspective to a traditionally understudied area in research,” Hadlock said.

MemorialCare Launches New Women's Heart Center and Recruits Nissi Suppogu, M.D. as Medical Director - Creating Sub-Specialized Women's Heart Health Center in Community

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목요일, 2월 1, 2024

FOUNTAIN VALLEY, Calif., Feb. 1, 2024 /PRNewswire/ -- MemorialCare, a prominent nonprofit Southern California integrated health system, has announced the launch of the Women's Heart Center at the MemorialCare Heart & Vascular Institute – a specialized center dedicated solely to expertise in education, prevention, early diagnosis, and timely management of women-specific cardiac presentations across their lifespan. The Women's Heart Center's first site will be in conjunction with Long Beach Medical Center and MemorialCare Medical Group, with future plans to expand to additional MemorialCare sites in Orange County.

Key Points: 
  • The Women's Heart Center's first site will be in conjunction with Long Beach Medical Center and MemorialCare Medical Group , with future plans to expand to additional MemorialCare sites in Orange County.
  • To lead a dynamic and distinctive program such as this, MemorialCare has recruited and appointed Nissi Suppogu, M.D.
  • as the medical director of the Women's Heart Center.
  • Dr. Suppogu is fellowship trained, meaning she has two years of additional sub-specialty training and education in women's heart health.

Ichnos and Glenmark take a collaborative leap to accelerate innovation in Cancer Treatment with their alliance - 'Ichnos Glenmark Innovation'

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화요일, 1월 30, 2024

This alliance brings together drug innovation capabilities of Ichnos and Glenmark to develop cutting-edge therapies for the treatment of hematological malignancies and solid tumors.

Key Points: 
  • This alliance brings together drug innovation capabilities of Ichnos and Glenmark to develop cutting-edge therapies for the treatment of hematological malignancies and solid tumors.
  • NEW YORK, Jan. 30, 2024 /PRNewswire/ -- Ichnos Sciences Inc. (Ichnos), a global, fully integrated, clinical-stage biotech company and Glenmark Pharmaceuticals Ltd. (Glenmark), a leading, research-driven, global pharmaceutical company, today announced the launch of their alliance – Ichnos Glenmark Innovation – to accelerate new drug discovery in cancer treatment.
  • "We are proud to announce the Ichnos Glenmark Innovation alliance, which brings together the legacy of Glenmark and passion of Ichnos to accelerate the search for curing cancer.
  • remarked Glenn Saldanha, Chairman and Managing Director, Glenmark Pharmaceuticals Ltd.
    Cyril Konto, President and CEO, Ichnos Glenmark Innovation, said, "Ichnos Glenmark Innovation is a collaborative venture backed by a strong, collective pipeline of novel multispecifics and small molecules.

Lupus Research Alliance 2023 Dr. William E. Paul Distinguished Innovator Award Granted to Yale School of Medicine Researcher Akiko Iwasaki, Ph.D.

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화요일, 1월 30, 2024

NEW YORK, Jan. 30, 2024 /PRNewswire/ -- The Lupus Research Alliance (LRA) is pleased to grant the 2023 Dr. William E. Paul Distinguished Innovator Award (DIA) to Akiko Iwasaki, Ph.D., Sterling Professor of Immunobiology at the Yale School of Medicine. Dr. Iwasaki will investigate a possible cause of lupus – remnants of ancient viruses that have been integrated into our genome called endogenous retroviruses. The DIA provides investigators up to $1 million over four years to explore bold, paradigm-shifting ideas that could lead to groundbreaking discoveries in lupus research.

Key Points: 
  • NEW YORK, Jan. 30, 2024 /PRNewswire/ -- The Lupus Research Alliance (LRA) is pleased to grant the 2023 Dr. William E. Paul Distinguished Innovator Award (DIA) to Akiko Iwasaki , Ph.D., Sterling Professor of Immunobiology at the Yale School of Medicine.
  • Dr. Iwasaki will investigate a possible cause of lupus – remnants of ancient viruses that have been integrated into our genome called endogenous retroviruses.
  • The DIA provides investigators up to $1 million over four years to explore bold, paradigm-shifting ideas that could lead to groundbreaking discoveries in lupus research.
  • With this award, we will probe the link between the immune system reacting to viruses within us as a possible trigger of lupus disease," commented Dr. Iwasaki.