This site uses cookies to improve your experience. To help us insure we adhere to various privacy regulations, please select your country/region of residence. If you do not select a country, we will assume you are from the United States. Select your Cookie Settings or view our Privacy Policy and Terms of Use.
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Used for the proper function of the website
Used for monitoring website traffic and interactions
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Strictly Necessary: Used for the proper function of the website
Performance/Analytics: Used for monitoring website traffic and interactions
By Allessandra DiCorato October 4, 2023 Credit: AbbVie The new smallmolecule inhibitor (green) sits inside the PTPN2 protein, where acidic sites are marked in red and basic sites are marked in blue. A new small-molecule drug candidate being tested in an early-stage clinical trial aims to improve patient responses to immunotherapy.
Involved in various physiological processes, such as vision, taste, smell, immuneresponse and neurotransmission, GPCRs are activated by various molecules including hormones, neurotransmitters and environmental stimuli, which trigger a cascade of cellular events that help regulate bodily functions.
These regimens frequently include one or two smallmolecule inhibitors and immuno-oncology (IO) therapies, such as monoclonal antibodies and T-cell engagers. To bring us closer to curing cancer, a combination of effective drugs with non-overlapping mechanisms of action is required.
NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced positive results from a Phase 2/3 clinical trial evaluating the safety, tolerability and immunogenicity of a 10-µg booster (third) dose of the Pfizer-BioNTech COVID-19 vaccine in healthy children 5 through 11 years of age. About the Phase 1/2/3 Trial in Children. Pfizer Inc.
It is a synthetic smallmolecule that would be self-administered via nasal spray, taken once or twice a week for the prevention of COVID-19. If all goes to plan in upcoming toxicity studies and regulatory approval, the company is hoping to be ready to test INNA-051 in human trials in less than four months.
These targeted therapies revolutionized treatment, offering relief to severe cases by specifically addressing the underlying immuneresponses causing the disease.
This blog will outline three characteristics of a successful nonclinical program to support entry into clinical trials for a cell or gene therapy product. Prior to clinical trials, the focus is typically on evaluating safety. Can you identify a safe AND efficacious clinical dose?
. “Based upon our anti-Globo H targeted approaches in cancers of high unmet needs, OBI Pharma is proud to have presentations on the progress of our trial presented at ESMO-Asia 2020 for our novel therapeutic cancer vaccine, OBI-833.” Title: A phase I cohort expansion trial of OBI-833 in non-small cell lung cancer patients.
In a Phase 2/3 clinical trial, the Pfizer-BioNTech COVID-19 Vaccine elicited a strong immuneresponse in this age group Three 3-µg doses had favorable safety profile similar to placebo in young children ages 6 months through 4 years in Phase 2/3 clinical trial Pfizer-BioNTech COVID-19 Vaccine now authorized in the U.S.
My last stop at Arrakis Therapeutics is with a company targeting RNA with smallmolecules. I was enticed by Arrakis’ founder Jen Petter to serve in one more operational role, leading the research group at Arrakis as the company launched as one of the first biotechs to target RNA with drug-like smallmolecules.
Mirati is advancing a novel pipeline to treat large patient populations across multiple programs and tumor types, including two programs, adagrasib and sitravatinib, in registration-enabling studies to treat non-small cell lung cancer (NSCLC).
SetPoint Medical received FDA Investigational Device Exemption (IDE) approval for a multicenter, double-blind, randomized, sham-controlled pivotal trial that will enroll up to 250 patients at 40 clinical trial sites in the U.S. SmallMolecule Inhibitors. Oral, SmallMolecules.
Through the acquisition, Gilead gains rights to a portfolio of smallmolecule inhibitors targeting PARP1 for oncology and MK2 for inflammatory diseases that could enter clinical trials later this year. Executive Vice President, Research, Gilead Sciences. The company was founded in 2021 by Stephen Kaldor, Ph.D., Qing Dong, Ph.D.,
TC-210 is currently in a Phase I/II trial for mesothelin-positive non-small cell lung cancer (NSCLC), ovarian cancer, malignant pleural/peritoneal mesothelioma, and cholangiocarcinoma. Its lead candidate is CLN-081, an oral smallmolecule designed to be a next-generation, irreversible EGFR inhibitor.
Primary and all key secondary endpoints including itch, interference of itch on sleep and quality of life were met at Week 16 in two pivotal Phase 3 trials in lebrikizumab clinical trial program – Safety profile consistent with prior lebrikizumab studies in atopic dermatitis. Almirall S.A.’s
3 Additionally, iptacopan has the benefit of targeting factor B, which only affect the alternative complement pathway, leaving the classic and lectin pathway untouched for the body to still mount adequate immuneresponses against pathogens. of patients experienced a sustained hemoglobin improvement without transfusions respectively.
Foghorn is anticipating filing an IND later this year for its lead candidate to begin a Phase I trial for the treatment of uveal melanoma, a cancer of the eye. . Primmune’s early data shows the potential for PRTX007 to drive the natural innate immuneresponse to combat systemic diseases. . Scorpion Therapeutics .
producing CD8+ T cell responses, which is thought to promote an anti-viral effect. In a preclinical murine model, a single IM immunization of BNT162b2 (0.2, CD4+ and CD8+ T-cells from splenocytes isolated from BNT162b2-immunized mice were strongly positive for IFN? The study is an event-driven trial. Argentina and Brazil.
The positive opinion adopted by the CHMP is based on an evaluation of interim safety and efficacy data from a clinical trial of a booster dose of the vaccine in those aged 16 and over, together with published literature and post authorisation data plus real-world evidence from the use of booster doses in young patients in Israel.
Phase 1 trial for the BNT162b2 vaccine candidate, which at 30 ?g The companies are continuing to analyze data from the Phase 1 trials in the U.S. T cell immuneresponses elicited by BNT162b2 are being evaluated in the German study and the companies expect to submit the data for peer review and potential publication.
“We have activated our supply chain, most importantly our site in Belgium, and are starting to manufacture so that our vaccine would be available as soon as possible, if our clinical trials prove successful and regulatory approval is granted.”. “As About the Phase 2/3 Study. billion doses by the end of 2021. billion doses by the end of 2021.
All trial participants will continue to be monitored to assess long-term protection and safety for an additional two years after their second dose. The participants in our COVID-19 vaccine clinical trial are courageous volunteers who have made a personal and important choice to help make a difference during this pandemic.
(Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that the first participant was enrolled in the observational PRECISION study (TNX-C002), to examine the immuneresponses to COVID-19 in healthy volunteers who have recovered from COVID-19 or were asymptomatic. About TNX-1800.
regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data.”. This includes the most recent analyses from the pivotal Phase 3 clinical trial, where the vaccine’s efficacy and favorable safety profile were observed up to six months after the second dose. “We are pleased to work with U.S.
Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immuneresponse to the Pfizer-BioNTech COVID-19 Vaccine. Procedures should be in place to avoid injury from fainting. The Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients. myocarditis and pericarditis.
Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immuneresponse to the Pfizer-BioNTech COVID-19 Vaccine. Severe allergic reactions have been reported following the Pfizer-BioNTech COVID-19 Vaccine during mass vaccination outside of clinical trials.
This year has been difficult, but it has reinforced the importance of our mission: to treat and potentially even reverse the effects of serious diseases and conditions by advancing our novel cell therapy product candidates through clinical trials and into the hands of physicians.
However, nonclinical studies are not conducted exclusively before human trials begin; they usually continue throughout the early phases of clinical trials to further assess a product’s performance on different metabolic pathways and at different doses.
(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the New England Journal of Medicinehas published safety and final efficacy results from the pivotal Phase 3 trial of BNT162b2, their mRNA-based COVID-19 vaccine candidate. Chief Medical Officer and Co-founder of BioNTech. There were no COVID-19 related deaths.
Adoptive T Cell therapies, therapeutic antibodies, and immunomodulatory proteins represent just some of the potentially beneficial treatment strategies for successful mRNA cancer trials. Immunomodulatory Proteins Immunomodulators are molecules influencing the pathways regulating the body’s immune system activities.
The NDA was built on data from the Phase III VICTORIA trial. The NDA was supported by results from two pivotal trials, Phase III AURORA and Phase II AURA-LV. By inhibiting calcineurin, the drug blocks IL-2 expression and T-cell mediated immuneresponses. HFrEF was formerly known as systolic heart failure.
Rigel’s lead RIPK1 inhibitor, R552, has completed Phase 1 clinical trials and will begin Phase 2 clinical trials in 2021 as part of the collaboration. In necroptosis, cells rupture leading to the dispersion of cell contents which can trigger an immuneresponse and enhance inflammation. About Rigel.
Clinical trials are currently evaluating bacteriophage therapy for MDR infections, including MRSA and Pseudomonas aeruginosa. Developing Antimicrobial Peptides and Biomolecules In addition to traditional small-molecule antibiotics, researchers are exploring the potential of antimicrobial peptides (AMPs) and other biomolecules.
This antigen-spreading is critical to long-term protection because tumour often develop with inconsistent antigen expression – equipping the immuneresponse to target many diverse tumour antigens may allow for more complete anti-tumour activity. Dr Haqq holds multiple patents and publications.
The year is starting to pick up in terms of clinical trial announcements. Johnson & Johnson published interim Phase I/IIa data in the New England Journal of Medicine showing its single-dose COVID-19 vaccine candidate created an immuneresponse that lasted at least 71 days. Here’s a look at last week’s news.
The company announced positive top-line results from the SURPASS-4 Phase 3 clinical trial of tirzepatide in adults with type 2 diabetes, evaluating A1C and body weight reductions from baseline. The trial compared tirzepatide to insulin glargine in adults with type 2 diabetes and increased cardiovascular risk.
We are extremely encouraged that the real-world effectiveness data coming from Israel are confirming the high efficacy demonstrated in our Phase 3 clinical trial and showing the significant impact of the vaccine in preventing severe disease and deaths due to COVID-19,” said Luis Jodar, Ph.D.,
In one experiment, the microneedle patches were used to deliver a SARS-CoV-2 vaccine into mice, producing immuneresponses similar to a traditional injection. Printed vaccines caused mice to have a faster immuneresponse. It’s gonna be used for phase 3 trials of a C. But the printed vaccines are very good!
In one experiment, the microneedle patches were used to deliver a SARS-CoV-2 vaccine into mice, producing immuneresponses similar to a traditional injection. Printed vaccines caused mice to have a faster immuneresponse. It’s gonna be used for phase 3 trials of a C. But the printed vaccines are very good!
Australian biotech Ena Respiratory has revealed new data demonstrating that its novel nasal spray almost halted replication of the SARS-CoV-2 in animals when used as a prophylactic, showing potential to improve immuneresponse when used alongside COVID-19 vaccines. . We’ve been amazed with just how effective our treatment has been.
These ligands can be antibodies, peptides, aptamers, or smallmolecules. This targeted approach has demonstrated significant benefits in clinical trials, leading to improved patient outcomes and reduced side effects, reinforcing the transformative potential of targeted drug delivery in improving therapeutic outcomes.
BioNTech SE (NASDAQ: BNTX, “BioNTech” or “the Company”), announced that the first patient has been treated in its BNT111 Phase 2 cancer vaccine trial (2020-002195-12; NCT04526899). The trial is enrolling a total of 120 patients and will evaluate the effects of the combination as well as single agents alone.
One advantage of this class of therapeutics is that the timelines for their development, testing, and approval are typically shorter than those for drugs made of chemical compounds, called smallmolecules. In the U.S. In the U.S. Stay tuned for more information about these potentially significant advances in the next few months.
Limited blinded tolerability data from the ongoing Phase 3 trial, confirming the mostly mild to moderate tolerability profile as was observed in Phase 1. In the blinded data presented, 50% of trial participants received placebo and 50% received BNT162b2. Protease Inhibitor Program. Penta was well tolerated.
We organize all of the trending information in your field so you don't have to. Join 15,000+ users and stay up to date on the latest articles your peers are reading.
You know about us, now we want to get to know you!
Let's personalize your content
Let's get even more personalized
We recognize your account from another site in our network, please click 'Send Email' below to continue with verifying your account and setting a password.
Let's personalize your content