Hives

Jasper Therapeutics Reports Third Quarter 2023 Financial Results and Provides Business Update

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星期四, 十一月 9, 2023
CSU, FDA, Research, Trial of the century, IND, Anemia, CD117, Syndrome, Fanconi anemia, Risk, Chairperson, Hives, Stanford University, Omalizumab, Therapy, Patient, Pharmaceutical industry, Cryptocurrency, Jasper, EU

We also continued to strengthen our board of directors and senior leadership team with multiple key additions during the period.

Key Points: 
  • We also continued to strengthen our board of directors and senior leadership team with multiple key additions during the period.
  • Jasper expects to enroll the first patient by the end of 2023 and to report interim data on multiple cohorts by mid-2024.
  • Jasper continued to strengthen the organization with the appointment of Thomas Wiggans as Chairperson of the Board of Directors and Herb Cross as Chief Financial Officer.
  • Jasper reported a net loss of $17.5 million, or basic and diluted net loss per share attributable to common stockholders of $0.16, for the three months ended September 30, 2023.

Celldex Therapeutics Presents Positive Data from Prurigo Nodularis Phase 1b Study Demonstrating Meaningful Reduction in Itch and Skin Clearing with Single Dose 3.0 mg/kg Barzolvolimab

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星期日, 十一月 5, 2023
Survival, Patient, KIT, WCI, Social isolation, PN, Itch, Neuron, B cell, Skin, Conference, Sleep, Bleeding, Abstract (summary), CQD, Quality of life, Neuroinflammation, IGA, Prurigo nodularis, Disease, Hives, Depression, Safety, Anxiety, Mast cell, Therapy, Pain, Conference call, Vaccine, Pharmaceutical industry, Dermatology

HAMPTON, N.J., Nov. 05, 2023 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced data from the Company’s Phase 1b study of barzolvolimab in prurigo nodularis (PN). Barzolvolimab is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity, which is required for the function and survival of the mast cell. Mast cells are believed to play an important role in amplifying chronic itch and neuroinflammation, including in PN. This study is the first to demonstrate that barzolvolimab, a mast cell depleting agent, can potentially be used to treat PN and other chronic itch indications. The data will be presented in an oral presentation during the “Hot Topics” Session at the 12th World Congress on Itch (WCI) 2023 on Tuesday, November 7th by Martin Metz, M.D., Professor of Dermatology and Allergy at Charité - Universitätsmedizin in Berlin. Abstracts accepted for presentation at the meeting were released today.

Key Points: 
  • - Conference call to be held on Monday, November 6th at 8:00 am ET to discuss study results -
    HAMPTON, N.J., Nov. 05, 2023 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced data from the Company’s Phase 1b study of barzolvolimab in prurigo nodularis (PN).
  • Mast cells are believed to play an important role in amplifying chronic itch and neuroinflammation, including in PN.
  • This study is the first to demonstrate that barzolvolimab, a mast cell depleting agent, can potentially be used to treat PN and other chronic itch indications.
  • The Phase 1b double-blind, single intravenous (IV) dose study randomized 24 adults (evaluable: n=23 safety; n=22 efficacy) with moderate to severe PN across three arms: (1) barzolvolimab 3.0 mg/kg (n=9), barzolvolimab 1.5 mg/kg (n=7) and placebo (n=8).

argenx Highlights Data Evaluating VYVGART in Neuromuscular Autoimmune Disease at AANEM and MGFA Scientific Sessions

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星期三, 十一月 1, 2023
Hives, Headache, Incidence, Alfa Romeo, Erythema, Vaccine, Immunization, Itch, Respiratory tract infection, Infection, Quality of life, Periodic breathing, Bruise, Milk, Infant, Rash, Vaccination, Acetylcholine receptor, Antibody, Risk, Immunoglobulin G, Angioedema, Urinary tract infection, Efgartigimod alfa, Safety, Pain, Pharmaceutical industry, Health care, Birth control, Patient, Life, Tolerability, Neurology

Delay the administration of VYVGART or VYVGART HYTRULO in patients with an active infection until the infection has resolved; monitor for clinical signs and symptoms of infections.

Key Points: 
  • Delay the administration of VYVGART or VYVGART HYTRULO in patients with an active infection until the infection has resolved; monitor for clinical signs and symptoms of infections.
  • If serious infection occurs, administer appropriate treatment and consider withholding treatment with VYVGART or VYVGART HYTRULO until the infection has resolved.
  • Because VYVGART and VYVGART HYTRULO cause a reduction in immunoglobulin G (IgG) levels, vaccination with live-attenuated or live vaccines is not recommended during treatment with VYVGART or VYVGART HYTRULO.
  • If a hypersensitivity reaction occurs during VYVGART or VYVGART HYTRULO administration, discontinue use and institute appropriate supportive measures if needed.

Aiolos Bio Launches with $245 Million Series A Investment to Advance Development of Novel, Phase 2-Ready TSLP Antibody

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星期二, 十月 24, 2023
Science, Other Science, Biotechnology, Research, Pharmaceutical, General Health, Health, Other Health, CSU, FDA, Hives, Atlas Venture, Bio, Roflumilast, Injection, Rheumatoid arthritis, IPF, Gilead Sciences, RA, Drug development, Senior, Pharmacokinetics, Gilead, Caregiver, Partnership, Asthma, Roche, Genentech, Safety, Therapy, Immunology, Patient, Atlas, COPD, TSLP, Pharmaceutical industry, Aeolus

Aiolos launches with an oversubscribed $245 million Series A investment co-led by Atlas Venture, Bain Capital Life Sciences, Forbion, and Sofinnova Investments with additional investment from RA Capital Management (collectively the “Investor Group”).

Key Points: 
  • Aiolos launches with an oversubscribed $245 million Series A investment co-led by Atlas Venture, Bain Capital Life Sciences, Forbion, and Sofinnova Investments with additional investment from RA Capital Management (collectively the “Investor Group”).
  • The Company will advance its lead drug candidate, AIO-001, into a Phase 2 clinical trial in moderate-to-severe asthma patients and is actively evaluating additional development opportunities.
  • AIO-001 is an anti-thymic stromal lymphopoietin (TSLP) monoclonal antibody that has the potential to be administered only twice per year due to its differentiated potency and long half-life.
  • Aiolos Bio acquired exclusive rights for global development and commercialization of the drug outside of greater China from Jiangsu Hengrui Pharmaceuticals Co., Ltd (“Hengrui”) in August 2023.

Jasper Therapeutics to Host Key Opinion Leader Webinar on the Potential of Briquilimab for Chronic Urticaria on October 11, 2023

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星期一, 十月 9, 2023
CSU, Basophil, Antibody, Biology, Inflammation, Apoptosis, Risk, Rockefeller, KOL, Stanford University School of Medicine, Survival, FCR, Microbiology, B cell, Transplant, Patient, Stem cell factor, Infection, Therapy, Stanford Institutes of Medicine Summer Research Program, CD117, Fraunhofer Society, Berlin, Immunology, Immunity, S-1 Executive Committee, Hives, Syndrome, Pharmacology, SCF, Rockefeller University, FC, Executive Committee, Translational medicine, Vaccine, Pathology, Dermatology, Allergy, Jasper

Jasper’s leadership team will also provide an overview of upcoming clinical studies which will evaluate briquilimab’s potential as a therapeutic for both CSU patients and CIndU patients.

Key Points: 
  • Jasper’s leadership team will also provide an overview of upcoming clinical studies which will evaluate briquilimab’s potential as a therapeutic for both CSU patients and CIndU patients.
  • Briquilimab is an unconjugated aglycosylated anti-c-Kit antibody that blocks the interaction of the c-Kit receptor from its ligand, stem cell factor (SCF).
  • This mechanism of action disrupts the critical survival signal, leading to mast cell apoptosis thereby removing the underlying source of the inflammatory response in chronic urticaria.
  • He is also a member of the Executive Committee of the Stanford Institute for Immunity, Transplantation and Infection.

Jasper Therapeutics Announces IND Clearance for Phase 1b/2a Study of Subcutaneous Briquilimab in Chronic Spontaneous Urticaria

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星期一, 十月 9, 2023
CSU, Food, Pharmacokinetics, Trial of the century, Risk, Safety, European Medicines Agency, B cell, Patient, FDA, Therapy, CD117, Clinical trial, Hives, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Syndrome, Omalizumab, Pharmaceutical industry, IND, EU, Jasper

REDWOOD CITY, Calif., Oct. 09, 2023 (GLOBE NEWSWIRE) -- Jasper Therapeutics, Inc. (Nasdaq: JSPR) (Jasper), a biotechnology company focused on the development of briquilimab, a novel antibody therapy targeting c-Kit (CD117) to address mast cell driven diseases such as chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU), as well as lower to intermediate risk myelodysplastic syndromes (LR-MDS) and novel stem cell transplant conditioning regimens, today announced that its investigational new drug (IND) application for a Phase 1b/2a repeat dose clinical study of subcutaneous briquilimab in the treatment of CSU has been cleared by the U.S. Food and Drug Administration (FDA).

Key Points: 
  • “We’re very excited to be advancing briquilimab into clinical studies for chronic urticaria patients,” said Edwin Tucker, Chief Medical Officer of Jasper.
  • “The clearance to proceed by the FDA for our IND allows us to move quickly to commence our CSU study in patients who are ineligible for, or refractory to, omalizumab, which is a patient population of high unmet need.
  • “Clearance of the IND for the CSU study is a critical milestone for Jasper, which represents the first step in building out our pipeline with a focus on treating mast cell diseases with briquilimab,” said Ronald Martell, President and Chief Executive Officer of Jasper.
  • “In parallel with our preparations for the CSU study, the team was also developing a proof of concept study in CIndU to further expand our mast cell franchise.

Escient Pharmaceuticals Initiates Clinical Proof-of-Concept Study of EP262, a First-in-Class Oral MRGPRX2 Antagonist, in Chronic Spontaneous Urticaria

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星期四, 十月 12, 2023
Health, Neurology, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, CSU, Pharmacokinetics, Therapy, Atopic dermatitis, Safety, Dermatitis, Disease, B cell, Escient, UAS7, Hives, Patient, MRGPRX2, Pharmaceutical industry, Vaccine

Escient Pharmaceuticals, a clinical-stage drug development company advancing novel small molecule therapeutics for systemic neuro-immune disorders, today announced that the first subject has been dosed in CALM-CSU, a Phase 2 clinical proof-of-concept study of EP262 in subjects with chronic spontaneous urticaria (CSU).

Key Points: 
  • Escient Pharmaceuticals, a clinical-stage drug development company advancing novel small molecule therapeutics for systemic neuro-immune disorders, today announced that the first subject has been dosed in CALM-CSU, a Phase 2 clinical proof-of-concept study of EP262 in subjects with chronic spontaneous urticaria (CSU).
  • By blocking activation of MRGPRX2 and degranulation of mast cells, EP262 has the potential to effectively treat multiple mast cell mediated diseases with an initial focus on chronic urticaria (hives) and atopic dermatitis (eczema).
  • EP262 represents a novel, targeted approach to the treatment of these disorders with the potential for once-daily oral administration without the side effects observed with other approaches.
  • The primary efficacy endpoint is the change from baseline in the urticaria activity score over 7 days (UAS7), a validated and widely used measure of disease activity.

Stigmatisation a major impact of skin diseases across Europe, reveals JEADV study

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星期日, 十月 8, 2023
European Academy of Allergy and Clinical Immunology, STD, Research, Advocacy, Prevalence, Burden, Skin, Atopic dermatitis, Stigmata, Psoriasis, Disease, Skin condition, Mental health, Journal of the European Academy of Dermatology and Venereology, Journal, Policy, Vertically transmitted infection, Hives, Life, Hair, Acne, Patient, Quality of life, Nursing, Dermatology, Venereology

Published today in the Journal of the European Academy of Dermatology and Venereology (JEADV), the diseases examined in the study included acne, atopic dermatitis, alopecia, psoriasis and sexually transmitted diseases (STDs).

Key Points: 
  • Published today in the Journal of the European Academy of Dermatology and Venereology (JEADV), the diseases examined in the study included acne, atopic dermatitis, alopecia, psoriasis and sexually transmitted diseases (STDs).
  • 88% patients with skin disease considered their disease to be embarrassing in their personal life, with 83% reporting the same in their working life.
  • The prevalence of skin diseases is likely to be significantly higher than this, as 40% of skin cancers and STD diagnoses remain unrecognised on first consultation.
  • Despite their high prevalence and psychological and physical impact, skin diseases receive limited policy, research and funding attention.

SCYNEXIS Issues a Voluntary Nationwide Recall of BREXAFEMME® (ibrexafungerp tablets) due to potential for cross contamination with a non-antibacterial ß-lactam drug substance

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星期四, 九月 28, 2023
Online, Completeness, Ibrexafungerp, Biconvex, Blister, Hives, Rash, NDC, Tablet, Swelling, Anaphylaxis, Knowledge, SCY, FDA, Letter, Sedgwick, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Pharmaceutical industry, Dietary supplement

During a review of manufacturing equipment and cleaning activities at a supplier, SCYNEXIS was made aware of potential cross-contamination risk with a non-antibacterial beta-lactam drug substance.

Key Points: 
  • During a review of manufacturing equipment and cleaning activities at a supplier, SCYNEXIS was made aware of potential cross-contamination risk with a non-antibacterial beta-lactam drug substance.
  • This press release provides additional details on the voluntary product recall recently disclosed by SCYNEXIS.
  • Risk Statement: The potential cross contamination with a non-antibacterial beta-lactam drug substance could lead to hypersensitivity reactions such as swelling, rash, urticaria and anaphylaxis, a potentially life-threatening adverse reaction.
  • To date, SCYNEXIS has not received any reports of adverse events established to be due to the possible beta-lactam cross contamination.

Inozyme Pharma Announces Positive Interim Data from Ongoing Phase 1/2 Trials of INZ-701 in Adults with ENPP1 Deficiency and ABCC6 Deficiency (PXE)

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星期二, 九月 26, 2023
PROMIS, BMC, Pros, Pediatric emergency medicine, Pediatrics, PD, Therapy, Hypophosphatemia, BSAP, Fatigue, Medicine, Phase II, New Çeltek events, Biomarker, BMD, Appetite, Hives, Pyrophosphate, Parallel Walk Test, Rapids, Alkaline phosphatase, Pain, Bruise, ET, Clinical trial, Bleeding, ADAS, Patient, Physician, PXE, Swelling, Itch, Erythema, Division, Adolescence, Osteomalacia, Infant, DEXA, Rickets, GIC, ADA, Diabetes, Titanium metallic discoloration, Safety, Dietary supplement, Pharmaceutical industry, Nursing, Medical imaging, Phosphorus, Birth control, Risk management, Vaccine, Endocrinology, News

BOSTON, Sept. 26, 2023 (GLOBE NEWSWIRE) -- Inozyme Pharma, Inc. (Nasdaq: INZY) (“Inozyme” or the “Company”), a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of pathologic mineralization and intimal proliferation, today announced positive interim safety, pharmacokinetic (PK), pharmacodynamic (PD) and exploratory efficacy data from the Company’s ongoing Phase 1/2 clinical trials of INZ-701 in adults with ENPP1 Deficiency and ABCC6 Deficiency (PXE, pseudoxanthoma elasticum).

Key Points: 
  • For trial design details, please see the section entitled “INZ-701 in ENPP1 Deficiency Phase 1/2 Clinical Trial Design” below.
  • Exploratory biomarker data were collected throughout the study to provide evidence of the potential for disease modification with ongoing treatment with INZ-701.
  • For trial design details, please see the section entitled “INZ-701 in ABCC6 Deficiency Phase 1/2 Clinical Trial Design” below.
  • PK properties were consistent with those observed in the Phase 1/2 clinical trial in adults with ENPP1 Deficiency.