Food Allergy Awareness Week 2024: How can new treatments target an unmet need?
Pharmaceutical Technology
MAY 16, 2024
IgGenix is planning to initiate a clinical trial later this year investigating its peanut allergy monoclonal antibody IGXN001.
Combination treatment could be more effective for cat allergy
Drug Discovery World
OCTOBER 13, 2022
New research has shown that standard cat allergy treatment can be enhanced to make it more effective and faster acting, and the benefits last for a year after treatment ends. The findings of the study, supported by the National Institutes of Health, were published in the Journal of Allergy and Clinical Immunology. .
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Antibody treatment improves chronic food allergy symptoms in young adults, study finds
Medical Xpress
DECEMBER 22, 2022
A weekly dose of dupilumab, a monoclonal antibody, led to a reduction of symptoms and tissue improvement in young adults and adolescents with eosinophilic esophagitis (EoE), according to a new study published in the New England Journal of Medicine.
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NIAID drops Lilly antibody from ACTIV-3 COVID-19 trial
pharmaphorum
OCTOBER 27, 2020
Eli Lilly says no more patients will be treated with its COVID-19 therapy bamlanivimab in a trial run by the US National Institute of Allergy and Infectious Diseases (NIAID), as results to date suggest it is unlikely to be effective. The post NIAID drops Lilly antibody from ACTIV-3 COVID-19 trial appeared first on.
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Large NIH clinical trial will test polyclonal antibody therapeutic for COVID-19
Scienmag
APRIL 21, 2021
Credit: NIAID A Phase 2/3 trial to evaluate a new fully-human polyclonal antibody therapeutic targeted to SARS-CoV-2, called SAB-185, has begun enrolling non-hospitalized people with mild or moderate cases of COVID-19.
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NIAID Halts Eli Lilly COVID-19 Antibody Trial
The Pharma Data
OCTOBER 27, 2020
The NIH’s National Institute of Allergy and Infectious Diseases (NIAID) has halted a clinical trial evaluating Eli Lilly’s investigational monoclonal antibody, LY-CoV555 (bamlanivimab), in combination with remdesivir for the treatment of COVID-19 patients. Source link.
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Monoclonal antibody could transform malaria prevention
Drug Discovery World
NOVEMBER 2, 2022
One dose of an antibody drug safely protected healthy, non-pregnant adults from malaria infection during an intense six-month malaria season in Mali, Africa. . The antibody was up to 88.2% The Phase II NIAID-USTTB trial evaluated a one-time, intravenous infusion of a monoclonal antibody called CIS43LS. .
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Temperature-stable tuberculosis vaccine safe, prompts immune response in first-in-human trial
Medical Xpress
MARCH 6, 2023
A clinical trial testing a freeze-dried, temperature-stable experimental tuberculosis (TB) vaccine in healthy adults found that it was safe and stimulated both antibodies and responses from the cellular arm of the immune system. A non-temperature stable form of the candidate previously had been tested in several clinical trials.
US experts trial AZ’s long-acting COVID-19 antibody combination
pharmaphorum
FEBRUARY 9, 2021
An international trial led by US experts is to begin testing AstraZeneca’s long-acting antibody combination therapy to treat COVID-19. The combination known as AZD7442 is to be added to the phase 3 adaptive trial called ACTIV-3, where investigators add new sub-studies of investigational new agents.
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US buys Lilly COVID antibody, as effectiveness questions remain
pharmaphorum
OCTOBER 28, 2020
Our goal is to ensure that Lilly antibody treatments are available to patients who need them, no matter where they live. “As As long as supply of neutralising antibodies is constrained, we believe the only way to ensure equitable access is for Lilly to contract directly with governments and pan-national philanthropic organisations. “As
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Nanoparticle universal flu vaccine enters Phase I trials
Drug Discovery World
SEPTEMBER 25, 2023
Enrolment in a Phase I trial of a new investigational universal influenza vaccine candidate has begun at the National Institutes of Health’s Clinical Center in Bethesda, Maryland, US. With each new universal influenza vaccine candidate and clinical trial, we take another step closer to that goal,” said Acting NIAID Director Hugh Auchincloss.
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Trial of Antibody Drug for COVID-19 Stopped for Lack of Effectiveness
The Pharma Data
OCTOBER 27, 2020
Trial of Antibody Drug for COVID-19 Stopped for Lack of Effectiveness. 27, 2020 — Testing of the Eli Lilly antibody drug for hospitalized COVID-19 patients has been halted because the treatment does not help them recover from their infection. Professional. TUESDAY, Oct. But the U.S.
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NIAID Halts Eli Lilly COVID-19 Antibody Trial | 2020-10-28
The Pharma Data
OCTOBER 26, 2020
The NIH’s National Institute of Allergy and Infectious Diseases (NIAID) has halted a clinical trial evaluating Eli Lilly’s investigational monoclonal antibody, LY-CoV555 (bamlanivimab), in combination with remdesivir for the treatment of COVID-19 patients. The trial was paused earlier this month due to a safety issue.
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HIV vaccines suffer setbacks but new approaches could turn the tide
Pharmaceutical Technology
FEBRUARY 3, 2023
Only a few weeks into the new year, the prospect of getting a successful advanced HIV vaccine shrank after the discontinuation of yet another late-stage trial. This marks the second time one of Janssen’s HIV vaccines failed after another showed disappointing results in the Phase IIb Imbokodo trial in August 2021.
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Encouraging trial findings renew hope for HIV vaccine
Drug Discovery World
DECEMBER 6, 2022
While scientists have struggled in the past to create an effective vaccine against HIV, a novel vaccine design strategy shows new promise, according to data from a first-in-human clinical trial. . The Phase I trial (IAVI G001) tested the first stage in a multi-stage HIV vaccine regimen the researchers are developing.
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Are we entering the era of biologics for COPD?
Pharmaceutical Technology
JANUARY 8, 2023
In 2023, the pharmaceutical industry will mark 20 years since Xolair, an anti-IgE antibody, became the first biologic approved to treat asthma. Since then, the US FDA, EMA, and other agencies have approved several biologic antibodies targeting the inflammatory cytokines IL-4, IL-13, IL-5, and others for asthma.
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Zydus starts Phase II COVID-19 vaccine trial; Taysha raises $95M; FDA declines DBV’s peanut allergy patch; Combating COVID-19 with decoy target
Delveinsight
AUGUST 6, 2020
Zydus starts phase 2 COVID-19 vaccine trial after clearing safety test. Zydus Cadila has finished a phase 1 clinical trial of its COVID-19 vaccine ZyCoV-D, setting it up to move straight into a 1,000-subject phase 2 study. Zydus has only said that the vaccine was well tolerated by people who received it in the first phase of the trial.
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Dupixent falls short in phase 3 chronic spontaneous urticaria trial
pharmaphorum
FEBRUARY 18, 2022
Sanofi and Regeneron have reported disappointing results in a trial of Dupixent in people with chronic spontaneous urticaria (CSU) who don’t respond to the only approved biologic treatment, Novartis/Roche’s Xolair. . The post Dupixent falls short in phase 3 chronic spontaneous urticaria trial appeared first on.
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UTHealth joins trial to test antibodies and other experimental outpatient COVID treatments
Scienmag
SEPTEMBER 15, 2020
A study on the effectiveness of multiple treatments, including laboratory-made antibodies, at preventing mild COVID-19 from advancing to severe illness in the outpatient setting is underway by researchers at The University of Texas Health Science Center at Houston (UTHealth). Johnson Hospital.
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Gritstone bio supports mRNA Covid-19 vaccine plans with Phase I publication
Pharmaceutical Technology
JUNE 8, 2023
The Phase I CORAL-BOOST dose-escalation trial (NCT05148962) evaluated Gritstone’s samRNA candidate (GRT-R910) in previously vaccinated healthy older adults. GlobalData is the parent company of Clinical Trials Arena. The samRNA is delivered in a lipid nanoparticle (LNP) formulation. of these are in the pre-clinical stage.
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Team assessing if dual-antibody injection prevents COVID-19 illness
Scienmag
SEPTEMBER 25, 2020
A combination antibody treatment for preventing COVID-19 illness in individuals who have had sustained exposure to someone with the virus is being studied by researchers at The University of Texas Health Science Center at Houston (UTHealth). The clinical trial is enrolling patients at Harris Health System’s Lyndon B.
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Topline Results from NIH-Sponsored Clinical Trial of Investigational COVID-19 Hyperimmune Globulin Medicine
The Pharma Data
APRIL 3, 2021
The CoVIg-19 Plasma Alliance today announced that the Phase 3 Inpatient Treatment with Anti-Coronavirus Immunoglobulin (ITAC) clinical trial sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), did not meet its endpoints. About the ITAC Trial.
Low on antibodies, blood cancer patients can fight off COVID-19 with T cells
Scienmag
MAY 27, 2021
New Penn Medicine study shows how T cells compensate when other immune cells go down PHILADELPHIA–Antibodies aren’t the only immune cells needed to fight off COVID-19 — T cells are equally important and can step up to do the job when antibodies are depleted, suggests a new Penn Medicine study of blood cancer patients with […]. (..)
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Promising Interim Results from Clinical Trial of NIH-Moderna COVID-19 Vaccine
The Pharma Data
NOVEMBER 16, 2020
November 16, 2020 — An independent data and safety monitoring board (DSMB) overseeing the Phase 3 trial of the investigational COVID-19 vaccine known as mRNA-1273 reviewed trial data and shared its interim analysis with the trial oversight group on Nov. 37% of trial volunteers are from racial and ethnic minorities.
First patients in NIH ACTIV-3 clinical trial enroll in Dallas
Scienmag
AUGUST 11, 2020
Baylor Scott & White Research Institute becomes first site in the world to conduct new trial testing experimental monoclonal antibodies as a treatment for hospitalized COVID-19 patients Credit: Baylor Scott & White Research Institute DALLAS, Texas – On Wednesday, August 5, in Dallas, just one day after the initiative was launched by (..)
Keeping tabs on Covid-19: Cell and gene clinical trials advance despite Covid-19…
The Pharma Data
AUGUST 7, 2020
The governing body claims this proposal could have positive effects on mitigating burdensome requirements for gene therapy clinical trials in the future. In this light, Pharma IQ’s weekly round-up focuses on advancing therapies and clinical trials to combat Covid-19.
COVID-19 antibody tests, even rapid finger pricks, are effective, new study finds
Scienmag
MARCH 31, 2021
New findings from a Michigan Medicine study reveal that antibody testing is predictive of prior COVID-19 infection, and rapid screening methods – even from finger pricks – are effective testing tools. Researchers analyzed antibody tests conducted on more than 500 subjects […].
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SARS-CoV-2 antigen levels could predict patient outcomes
Drug Discovery World
AUGUST 31, 2022
The amount of SARS-CoV-2 antibodies in the blood of patients hospitalised with Covid-19 could be used to predict illness severity and other clinical outcomes. . The study authors suggest that antigen levels could help determine those patients most likely to benefit from therapies directed at fighting the virus. .
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The Lancet: Preliminary results from Russian trials find that vaccine candidates led to no serious adverse events and elicit antibody response
Scienmag
SEPTEMBER 4, 2020
The new paper reports the findings of two open-label, non-randomised phase 1/2 trials looking at a frozen formulation and a freeze-dried formulation of a two-part vaccine.
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Moderna’s COVID-19 vaccine trial; Freenome secures $270 M; CRISPR treats obesity in mice; Breast cancer research updates
Delveinsight
AUGUST 27, 2020
The phase 1 study that is being run by the National Institute of Allergy and Infectious Diseases tests three dose levels of the vaccine, mRNA-1273, given in two injections a month apart in 120 adults. Freenome secures USD 270 Million to boost its colorectal cancer blood test.
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AZ, Amgen get speedy FDA review for asthma drug tezepelumab
pharmaphorum
JULY 8, 2021
The FDA has started a priority review of AstraZeneca and Amgen’s severe asthma antibody tezepelumab, setting a date for a decision in the first quarter of 2022. Overall, the antibody cut the annual asthma exacerbation rate (AAER) by 56% over 52 weeks, which was consistent with the benefit seen in the phase 2 PATHWAY trial.
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World AIDS Day 2023: New and Promising Treatments for HIV/AIDS
XTalks
NOVEMBER 30, 2023
The safety and efficacy of Cabenuva were established through two randomized, open-label, controlled clinical trials involving 1,182 HIV-infected adults who were virologically suppressed (HIV-1 RNA less than 50 copies/mL) before initiating Cabenuva treatment. The Phase I trial for HB-500 is scheduled to start in the first half of 2024.
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AZD1222 US Phase III trial met primary efficacy endpoint in preventing COVID-19 at interim analysis
The Pharma Data
MARCH 22, 2021
The AstraZeneca US Phase III trial of AZD1222 demonstrated statistically significant vaccine efficacy of 79% at preventing symptomatic COVID-19 and 100% efficacy at preventing severe disease and hospitalisation. The trial had a 2:1 randomisation of vaccine to placebo. The specific search for CVST found no events in this trial.
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And then there were none: Regeneron cans last late-stage NGF drug
pharmaphorum
NOVEMBER 3, 2022
As of a September update, AstraZeneca was still developing MEDI7352, a bispecific antibody that combines NGF and TNF inhibition, potentially targeting both pain and inflammation associated with osteoarthritis. The demise of fasinumab draws a line under the NGF inhibitor class, although there could be footnote.
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DUPIXENT® (DUPILUMAB) LATE-BREAKING PHASE 3 COPD RESULTS PRESENTED AT ATS AND SIMULTANEOUSLY PUBLISHED IN THE NEW ENGLAND JOURNAL OF MEDICINE
The Pharma Data
MAY 22, 2023
These results will also be presented in the “Breaking News: Clinical Trial Results in Pulmonary Medicine” session on May 22. “I’ve MSPH, Associate Professor at the University of Alabama at Birmingham Division of Pulmonary, Allergy, and Critical Care Medicine, and a co-principal investigator of the trial. “I’ve
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Biopharma Update on the Novel Coronavirus: October 27
The Pharma Data
OCTOBER 26, 2020
Diagnostics Update : To-date the FDA has authorized 284 individual EUAs, which include 221 molecular tests, 56 antibody tests and 7 antigen tests. . Only a fraction of intravenous antibody treatments will make their way to the lungs of COVID-19 patients, which is where the infection is primarily located. Please read more here. .
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FDA clears Dupixent as first drug for rare skin disorder
pharmaphorum
SEPTEMBER 29, 2022
The disorder – driven by type 2 inflammation characterised by an antibody-based immune response – causes hard lumps or nodules to form on the skin that are so itchy they can lead patients to scratch themselves to the point of bleeding or pain. Development in peanut allergy has also been discontinued, said Sanofi in its second-quarter update.
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Unshackling TP53 in leukaemia with a novel combo; Merus receives funds for cancer research pact; Vera Therapeutics bags $80M; Gritstone appends COVID-19 to the pipeline.
Delveinsight
JANUARY 21, 2021
Eli Lilly, via its Loxo Oncology biotech unit, is enlisting to a three-therapy pact with Merus concentrated on T-cell redirecting bispecific antibody work. These will come out of Merus’ so-called Biclonics platform that develops CD3-engaging, T-cell redirecting bispecific antibody therapies. billion in total for three drugs.
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Leo puts target on Dupixent in US as FDA clears tralokinumab
pharmaphorum
DECEMBER 29, 2021
Sanofi and Regeneron have another challenger to their big-selling drug Dupixent for atopic dermatitis, now that the FDA has approved Leo Pharma’s rival antibody tralokinumab. In trials, tralokinumab improved upon placebo on a range of outcome measures, including clearance of skin lesions and reduction of itch after 16 weeks.
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New Research Shows IBS Symptoms May be Caused by Gut Infections
XTalks
JANUARY 20, 2021
However, IBS patients do not have allergies to any given foods, nor any gastrointestinal conditions, such as celiac disease. Ovalbumin led to increased dietary-antigen-specific IgE antibodies in the mice that were limited to the intestine. Moreover, the response did not induce symptoms typical of a food allergy.
Top 5 Most Promising FDA New Drug Approvals Expected in the Second Half of 2024
XTalks
MAY 2, 2024
Some treatments already on the market have grabbed additional approvals in 2024, including Novo Nordisk’s Wegovy (semaglutide) for cardiovascular risk reduction, Dupixent (dupilumab) for eosinophilic esophagitis (EoE) in young children and Xolair (omalizumab) for food allergies. Karuna also has ongoing long-term extension trials.
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Sanofi eyes 2022 filing for haemophilia drug fitusiran, despite safety issue
pharmaphorum
APRIL 28, 2021
Sanofi has since revised the dosing protocol for the fitusiran trials to a 50 mg dose administered every other month, which it thinks should keep most patients in the 15% to 35% AT range. The update on fitusiran came as Sanofi reported a 2.4% increase in first-quarter sales to €8.59 billion (around $10.4
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Experimental malaria monoclonal antibody prevents infection
Drug Discovery World
MAY 1, 2024
A single injection of an experimental monoclonal antibody called L9LS was 77% effective at preventing malaria infection in children in Mali, according to the results of a mid-stage clinical trial. The antibody was modified with a mutation that prolonged its durability in the bloodstream following administration.
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Immunocompromised pediatric patients showed T-cell activity and humoral immunity against SARS-CoV-2
Scienmag
MAY 13, 2021
New study suggests COVID vaccines may still be helpful for patients with antibody deficiency disorders According to data from a cohort of adult and pediatric patients with antibody deficiencies, patients that often fail to make protective immune responses to infections and vaccinations showed robust T-cell activity and humoral immunity against SARS-CoV-2 (..)
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