Immunology

Allergy & Asthma Network Announces National Trusted Messengers Project to Address Health Inequities

Tuesday, October 27, 2020 - 11:00am

AAN piloted the Trusted Messengers project model in Atlanta, hosting two community screening events on September 19 and 26.

Key Points: 
  • AAN piloted the Trusted Messengers project model in Atlanta, hosting two community screening events on September 19 and 26.
  • "It's encouraging to see people coming out and getting tested, and to know that the Trusted Messengers project will continue to help them throughout their health journey."
  • Allergy & Asthma Network's Not One More Life Trusted Messengers project aims to address health inequities and increase access to important health information and screenings for those who are at greater risk from COVID-19.
  • For more information about the Atlanta health screenings, please call Allergy & Asthma Network at 800-878-4403 or visit www.TrustedMessengers.org .

FDA Grants Priority Review and EMA Accepts Regulatory Submission for Pfizer’s Abrocitinib, an Oral Once-Daily JAK1 Inhibitor, for Patients 12 and Up with Moderate to Severe Atopic Dermatitis

Tuesday, October 27, 2020 - 10:55am

The study also included an active control arm, dupilumab, a biologic treatment administered by subcutaneous injection, compared with placebo.

Key Points: 
  • The study also included an active control arm, dupilumab, a biologic treatment administered by subcutaneous injection, compared with placebo.
  • Many patients with moderate to severe atopic dermatitis have poorly controlled disease.
  • Abrocitinib has demonstrated strong efficacy at relieving the signs and symptoms of atopic dermatitis, including rapid reduction of itch, across multiple clinical trials.
  • Abrocitinib received Breakthrough Therapy designation from the FDA for the treatment of patients with moderate to severe AD in February 2018.

Sapreme Appoints Miriam Bujny as Chief Development Officer

Tuesday, October 27, 2020 - 10:00am

Sapreme , a biotechnology company focused on improving the delivery and efficacy of macromolecule therapeutics, today announced the appointment of Miriam Bujny, Ph.D., as Chief Development Officer.

Key Points: 
  • Sapreme , a biotechnology company focused on improving the delivery and efficacy of macromolecule therapeutics, today announced the appointment of Miriam Bujny, Ph.D., as Chief Development Officer.
  • With over ten years of experience in drug discovery, translational science and early stage clinical development, Dr. Bujny will apply her expertise in RNA and antibody therapeutic development to further advance Sapremes proprietary endosomal escape platform through preclinical development.
  • Throughout my career, I have seen the limitations of developing promising therapeutic candidates due to the lack of delivery into key cells, commented Dr. Bujny, Chief Development Officer of Sapreme.
  • Before that, she worked on anti-viral antibody therapy development and contributed to early clinical development as preclinical in vitro lead.

Global Coalition for Adaptive Research, Amgen, and Eisai Announce First Patient Enrolled in International COVID-19 Trial

Monday, October 26, 2020 - 11:00pm

This trial is a multicenter, randomized platform study, with treatments tested within groupings or domains based on pathway or mechanism of action.

Key Points: 
  • This trial is a multicenter, randomized platform study, with treatments tested within groupings or domains based on pathway or mechanism of action.
  • Eritoran is Eisais in-house discovered and developed investigational TLR4 (Toll-Like Receptor 4) antagonist created with natural product organic synthesis technology.
  • Global Coalition for Adaptive Research (GCAR) is the US Sponsor of REMAP-COVID and is guiding efforts to facilitate the inclusion of multiple pharma partners in REMAP-COVID globally.
  • Eisai Co., Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan.

In A Brand First, Garden of Life® Launches An Exciting New Line Of Dr. Formulated Supplements Available Only At Target

Monday, October 26, 2020 - 2:17pm

Everyone is paying closer attention to immune health these days than any other time that I can remember," he states.

Key Points: 
  • Everyone is paying closer attention to immune health these days than any other time that I can remember," he states.
  • "But at Garden of Life, our mission has always been to empower extraordinary health.
  • "We are very excited to work closely with Target on the introduction of our newest line of Dr.
  • Formulated collection from Garden of Life, everyone can more fully embrace the season and their lives with smart, healthy immune-system solutions.

Arch Oncology to Present at Upcoming Conferences

Monday, October 26, 2020 - 1:47pm

The Companys next-generation anti-CD47 antibodies are highly differentiated, with the potential to improve upon the safety and efficacy profile relative to other agents in this class.

Key Points: 
  • The Companys next-generation anti-CD47 antibodies are highly differentiated, with the potential to improve upon the safety and efficacy profile relative to other agents in this class.
  • Arch Oncologys lead product candidate AO-176 is in Phase 1/2 clinical trials for the treatment of patients with select solid tumors and with multiple myeloma, both as monotherapy and in combination with standard therapies.
  • In addition, the Company is advancing a pipeline of antibody programs for the treatment of cancer.
  • For more information please visit www.archoncology.com .

  Forte Biosciences, Inc. Announces the FDA Has Granted Fast Track Designation to FB-401 for the Treatment of Atopic Dermatitis

Monday, October 26, 2020 - 12:30pm

Forte Biosciences, Inc. ( www.fortebiorx.com ) (NASDAQ: FBRX), a clinical-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to FB-401 for the treatment of atopic dermatitis.

Key Points: 
  • Forte Biosciences, Inc. ( www.fortebiorx.com ) (NASDAQ: FBRX), a clinical-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to FB-401 for the treatment of atopic dermatitis.
  • We are very appreciative of the decision by the FDA to grant FB-401 Fast Track designation, said Paul Wagner, Ph.D., President and Chief Executive Officer of Forte Biosciences.
  • Forte is currently enrolling a trial of FB-401 in atopic dermatitis.
  • There is a significant unmet need for safe and effective therapies particularly for pediatric atopic dermatitis patients.

Dupixent® (dupilumab) late-breaking pivotal data showing significant improvement in eosinophilic esophagitis signs and symptoms presented for the first time at scientific meetings

Monday, October 26, 2020 - 12:00pm

The use of Dupixent to treat EoE is investigational and has not been fully evaluated by any regulatory authority.

Key Points: 
  • The use of Dupixent to treat EoE is investigational and has not been fully evaluated by any regulatory authority.
  • These results also demonstrate that eosinophilic esophagitis is a disease caused by factors beyond just the presence of elevated eosinophils.
  • The Phase 3, randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of Dupixent in adolescents and adults with eosinophilic esophagitis.
  • With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Allakos Announces Results from a Phase 1 Study of Subcutaneously Administered Lirentelimab (AK002)

Monday, October 26, 2020 - 11:00am

Across all SC and IV lirentelimab cohorts there were no serious adverse events, no injection site reactions, no injection reactions and no infusion-related reactions.

Key Points: 
  • Across all SC and IV lirentelimab cohorts there were no serious adverse events, no injection site reactions, no injection reactions and no infusion-related reactions.
  • The Company will host a conference call and webcast with slides today at 8:00 a.m. Eastern Time / 5:00 a.m. Pacific Time.
  • The Companys lead antibody, lirentelimab (AK002), is being evaluated in a Phase 3 study in eosinophilic gastritis (EG) and/or eosinophilic duodenitis (EoD) and a Phase 2/3 study in eosinophilic esophagitis (EoE).
  • These documents contain and identify important factors that could cause the actual results forAllakosto differ materially from those contained in Allakos forward-looking statements.

Results from Prospective Prevalence Study Indicate that Eosinophilic Gastritis and Eosinophilic Duodenitis May be Significantly Underdiagnosed

Monday, October 26, 2020 - 11:00am

The results suggest that eosinophilic gastritis (EG) and/or eosinophilic duodenitis (EoD) are significantly underdiagnosed.

Key Points: 
  • The results suggest that eosinophilic gastritis (EG) and/or eosinophilic duodenitis (EoD) are significantly underdiagnosed.
  • This prospective, multi-center study assessed eosinophil and mast cell levels in biopsies obtained from patients with active, chronic unexplained gastrointestinal symptoms or FGIDs.
  • Published literature reports the prevalence of eosinophilic gastritis and eosinophilic duodenitis inthe United Statesto be approximately 50,000 people.
  • Lirentelimab has received orphan disease designation for eosinophilic gastritis, eosinophilic duodenitis/eosinophilic gastroenteritis and eosinophilic esophagitis.