Interleukin

EQS-News: Formycon and Fresenius Kabi reach settlement agreement for ustekinumab biosimilar candidate FYB202 in Europe and Canada

Retrieved on: 
Wednesday, April 10, 2024
Ulcerative colitis, Psoriasis, Ustekinumab, Patient, EMA, Interleukin, European Medicines Agency, Fresenius (company), Cytokine, Johnson & Johnson, FDA, Food, Pharmaceutical industry

Press release // March 18, 2024

Key Points: 
  • Press release // March 18, 2024
    Munich, Germany – Formycon AG (FSE: FYB) and its commercialization partner Fresenius Kabi today announced the signing of a settlement agreement with Johnson & Johnson concerning the commercialization of FYB202, a biosimilar to Stelara®1 (ustekinumab), in Europe and Canada.
  • It was agreed to keep the terms of the agreement confidential.
  • Our aim is to make a significant difference in patients' lives by providing them with reliable, high-quality, and affordable treatment options.
  • In February 2023, Formycon and Fresenius Kabi had entered into a global license agreement for the ustekinumab biosimilar candidate FYB202, under which FYB202 will be marketed by Fresenius Kabi in key global markets following successful approval.

FibroBiologics Presents Data from Dermal Fibroblast Spheroid-based Treatment of Chronic Wounds in a Diabetes Mouse Model at Advanced Wound Care Summit USA

Retrieved on: 
Thursday, April 4, 2024
Diabetes, Fibroblast, EGFR, Warfarin necrosis, Risk, Communication, IL-6, Form, Diabetic foot ulcer, Conditional sentence, Patient, Research, Mouse, Gamma ray, Trial of the century, HDF, Hyperglycemia, Acceleration, Wound healing, Cytokine, Therapy, Cellular senescence, Interleukin, VEGF, Pharmaceutical industry

These findings will be presented via an oral and poster presentation at the Advanced Wound Care Summit USA in Boston, MA, April 16-17.

Key Points: 
  • These findings will be presented via an oral and poster presentation at the Advanced Wound Care Summit USA in Boston, MA, April 16-17.
  • Diabetic foot ulcers (DFUs) are prevalent in individuals with diabetes, with approximately 33 million people impacted globally.
  • FibroBiologics' research aims to address this issue by investigating the potential of using human dermal fibroblast (HDF) spheroids in promoting and accelerating the wound healing process in diabetic patients.
  • "These results support the potential of HDF spheroids to expedite the healing process of chronic wounds associated with diabetes," said Dr. Khoja.

Krystal Biotech to Present at the American Association for Cancer Research 2024 Annual Meeting

Retrieved on: 
Thursday, April 4, 2024
Poster, Annual general meeting, KRYS, Interleukin, AACR

PITTSBURGH, April 04, 2024 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company, announced today that the Company will be presenting new preclinical data on local and systemic immune activation following intratumoral injection of the Company’s platform technology encoding murine interleukin-12 (IL-12) and interleukin-2 (IL-2), the species matched equivalent to the Company’s clinical-stage oncology product candidate KB707, at the American Association for Cancer Research (AACR) 2024 Annual Meeting being held from April 5-10, 2024 in San Diego, California.

Key Points: 
  • PITTSBURGH, April 04, 2024 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company, announced today that the Company will be presenting new preclinical data on local and systemic immune activation following intratumoral injection of the Company’s platform technology encoding murine interleukin-12 (IL-12) and interleukin-2 (IL-2), the species matched equivalent to the Company’s clinical-stage oncology product candidate KB707, at the American Association for Cancer Research (AACR) 2024 Annual Meeting being held from April 5-10, 2024 in San Diego, California.
  • Poster presentation details are as follows:
    The poster will be available to conference attendees.
  • Following the presentation, the poster will also be available to view online on the Investor section of the Company’s website .

Global IgG Mediated Autoimmune Diseases Biologic Drugs Research Report 2024: A Highly Competitive Market with Pharmaceutical and Biotechnology Firms Competing for the $197.75 Billion Market Share - ResearchAndMarkets.com

Retrieved on: 
Tuesday, March 12, 2024
Biotechnology, Pharmaceutical, Health, Psoriasis, Warfarin necrosis, Rheumatoid arthritis, Prevalence, Growth, Porter's five forces analysis, Lupus, Incidence, Inflammation, SWOT, Multiple sclerosis, Humanized antibody, ILS, Autoimmune disease, Immune system, Cytokine, Inflammatory bowel disease, USD, Immunoglobulin G, Interleukin, Ageing, Vaccine

The Global IgG Mediated Autoimmune Diseases Biologic Drugs market showcased growth at a CAGR of 7.25% during 2019-2022.

Key Points: 
  • The Global IgG Mediated Autoimmune Diseases Biologic Drugs market showcased growth at a CAGR of 7.25% during 2019-2022.
  • The increasing incidence and prevalence of IgG mediated autoimmune diseases such as rheumatoid arthritis, lupus, and psoriasis are major drivers for the growth of biologic drugs.
  • The global market for IgG mediated autoimmune diseases biologic drugs is highly competitive, with numerous pharmaceutical companies and biotechnology firms competing for market share.
  • The report analyses the IgG Mediated Autoimmune Diseases Biologic Drugs Market By Antibody Source (Humanized, Fully Human, Chimeric, Other Antibody Sources)
    The report analyses the IgG Mediated Autoimmune Diseases Biologic Drugs Market By Indication (Rheumatoid Arthritis, Systemic Lupus Erythematosus, Multiple Sclerosis and Other Indications).

Monte Rosa Therapeutics Announces Initiation of IND Enabling Studies for MRT-8102, A First-in-Class NEK7 Directed Molecular Glue Degrader and NLRP3/IL-1β Pathway Inhibitor

Retrieved on: 
Monday, March 11, 2024
Diabetes, Liver disease, Inflammation, Obesity, Cardiovascular disease, Growth, NLRP3, NIMA, Pericarditis, Gout, Therapy, CNS, Interleukin, DSM-IV codes, IND, MGD, Central nervous system disease, Pharmaceutical industry

BOSTON, March 11, 2024 (GLOBE NEWSWIRE) -- Monte Rosa Therapeutics, Inc. (Nasdaq: GLUE), a clinical-stage biotechnology company developing novel molecular glue degrader (MGD)-based medicines, today announced a novel development candidate, MRT-8102, a potent, highly selective and orally bioavailable NIMA related kinase 7 (NEK7)-directed MGD. MRT-8102 is expected to be developed for the treatment of inflammatory diseases driven by interleukin-1β (IL-1β) and the NLRP3 inflammasome, which are critical elements of the inflammatory process. This is the first development candidate to be declared from the Company’s NEK7 development program.

Key Points: 
  • This is the first development candidate to be declared from the Company’s NEK7 development program.
  • “In preclinical non-human primate studies, MRT-8102 has demonstrated potent and selective degradation of NEK7, reducing downstream IL-1β.
  • We believe MRT-8102 has the potential to be developed in multiple inflammatory diseases, including gout, pericarditis and other cardiovascular diseases.
  • IND-enabling studies are underway, and we plan to file our first IND for the program in the first quarter of 2025.

Increasing Incidence of Pancreatic Cancer Leading to a $6.85 Billion Dollar Market Size for New Treatments

Retrieved on: 
Tuesday, March 5, 2024
MRK, Hospital, News, FOLFIRINOX, Growth, AbbVie, PR, Neutrophil, Poster, Diagnosis, Pancreatic cancer, HBV, Incidence, Cancer, TME, Hepatology, Interleukin, Therapy, Prostate cancer, Liver, Immune system, Partnership, Merck & Co., AIO, PSMA, Inflammation, Safety, TILS, GPCR, Tumor microenvironment, Research, Medication, PALM, ABBV, Merck, Macrophage, Blood, FDA, TSX, Food, Ageing, Pembrolizumab, Pancreatic Cancer Action Network, Government, Prevalence, Ocean Biomedical, LAVA, PDAC, Patient, MHRA, Disease, ONC, PEI, Pharmaceutical industry

Thus, an increase in the geriatric population is one factor driving the pancreatic cancer treatment market growth.

Key Points: 
  • Thus, an increase in the geriatric population is one factor driving the pancreatic cancer treatment market growth.
  • The incidence is significantly higher in the geriatric population above 65 years of age compared to other types of cancers.
  • A report from Fortune Business Insights said that: “the pancreatic cancer treatment market size is projected to grow to USD 6.85 billion by 2029, exhibiting a CAGR of 15.7% during 2022-2029.
  • Companies engaged in manufacturing cancer drugs have increased their focus on R&D activities to develop new drugs for pancreatic cancer treatment.

Indapta Therapeutics Receives U.S. FDA Fast Track Designation for Lead Clinical Drug Candidate IDP-023 for Non-Hodgkin’s Lymphoma and Myeloma

Retrieved on: 
Thursday, February 29, 2024
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, FDA, Clinical Trials, Fast Track, CMV, BLA, Cell, Biologics license application, Cytomegalovirus, Interleukin, Safety, Therapy, Cytokine, Accelerated approval (FDA), Patient, NK, Clinical trial, Multiple myeloma, Rituximab, Lymphoma, Cancer, Priority review, Pharmaceutical industry

Companies granted Fast Track designation may be eligible for more frequent interactions with the FDA, Accelerated Approval and Priority Review, and Rolling Review of a Biologic License Application (BLA).

Key Points: 
  • Companies granted Fast Track designation may be eligible for more frequent interactions with the FDA, Accelerated Approval and Priority Review, and Rolling Review of a Biologic License Application (BLA).
  • “This designation highlights the promise of Indapta’s highly potent NK cell platform and will further accelerate clinical development of our lead drug candidate, IDP-023, for two of the largest unmet needs in B-cell driven blood cancers, non-Hodgkin’s lymphoma and multiple myeloma,” said Dr. Mark Frohlich, CEO of Indapta.
  • Patients being enrolled now in Indapta’s Phase 1 clinical trial are receiving up to three planned doses of IDP-023 with or without interleukin-2.
  • To generate IDP-023, Indapta preferentially expands g-NK cells from healthy donors with increased numbers of g-NK cells, with low donor-to-donor variability.

Krystal Biotech Receives FDA Fast Track Designation for Inhaled Oncology Candidate KB707 to Treat Solid Tumors of the Lung

Retrieved on: 
Tuesday, February 13, 2024
NCT, Lung, MD, Research and development, FDA, Food, Cancer, Ochsner, Metastasis, KRYS, Interleukin, Tumor microenvironment, Patient, Gene, Clinical trial, Disease, Suma, Pharmaceutical industry

PITTSBURGH, Feb. 13, 2024 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for inhaled KB707 for the treatment of patients with solid tumors with pulmonary metastases that are relapsed or refractory to standard of care therapy.

Key Points: 
  • “The therapeutic benefits of cytokine therapy for the treatment of solid tumors have long been recognized, but difficult to harness due to toxicities when given systemically.
  • In January 2024, the FDA cleared an amendment to the Company’s Investigational New Drug application to evaluate inhaled KB707 in a clinical trial to treat patients with locally advanced or metastatic solid tumors of the lung.
  • In July 2023, the FDA granted intratumoral KB707 Fast Track Designation for the treatment of anti-programmed cell death protein-1 relapsed/refractory locally advanced or metastatic melanoma.
  • “We look forward to the first patient being dosed with inhaled KB707 later this year.”

Rani Therapeutics Announces Positive Topline Results from Phase 1 Study of an Oral Anti-Interleukin 12/23 Antibody (RT-111)

Retrieved on: 
Monday, February 5, 2024
Pharmacokinetics, Peptide, Cytokine, Human, Trial of the century, Patient, Safety, Psoriasis, Interleukin, Ustekinumab, Biosimilar, Volunteering, Ulcerative colitis, Vaccine

ET / 5:30 a.m. PT –

Key Points: 
  • ET / 5:30 a.m. PT –
    SAN JOSE, Calif., Feb. 05, 2024 (GLOBE NEWSWIRE) -- Rani Therapeutics Holdings, Inc. (“Rani Therapeutics” or “Rani”) (Nasdaq: RANI), a clinical-stage biotherapeutics company focused on the oral delivery of biologics and drugs, today announced positive topline results from its Phase 1 clinical study of RT-111, a RaniPill® capsule containing an ustekinumab biosimilar, CT-P43.
  • In the study, RT-111 was well-tolerated and delivered ustekinumab with high bioavailability.
  • “We are highly encouraged by the positive results from our Phase 1 study for RT-111 – our third successfully completed Phase 1 trial using RaniPill® technology.
  • To our knowledge, RT-111 is the first ever oral monoclonal antibody to achieve high bioavailability in humans,” said Talat Imran, Chief Executive Officer of Rani.

Biosyngen Announces FDA Fast Track Designation for BST02 in Treatment of Liver Cancer

Retrieved on: 
Thursday, February 1, 2024
Multimedia, Hepatocellular carcinoma, Research, Patient, CDE, FDA, Marketing, Interleukin, FTD, Lymphocyte, Food, TIL, Hope, Liver cancer, Cancer, Cholangiocarcinoma

SINGAPORE, Feb. 1, 2024 /PRNewswire/ -- Biosyngen is proud to announce that its latest groundbreaking product, BST02, has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of all types of liver cancer, including hepatocellular carcinoma and cholangiocarcinoma.

Key Points: 
  • SINGAPORE, Feb. 1, 2024 /PRNewswire/ -- Biosyngen is proud to announce that its latest groundbreaking product, BST02, has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of all types of liver cancer, including hepatocellular carcinoma and cholangiocarcinoma.
  • This marks the first TIL cell therapy drug for liver cancer to progress to the clinical stage globally.
  • Furthermore, another product from Biosyngen, BRG01, was granted fast track designation in July 2023.
  • It holds promise for the treatment of all types of liver cancer, offering new hope for patients.