Dark Matter Blog

JULY 16, 2021

My last stop at Arrakis Therapeutics is with a company targeting RNA with small molecules. 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 small molecules.

Small Molecule 52

Small Molecule RNA Clinical Trials DNA 52

The Pharma Data

DECEMBER 15, 2020

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. Small Molecule Inhibitors. Oral, Small Molecules.

Disease 52

Disease Clinical Trials Small Molecule Trials 52

The Pharma Data

NOVEMBER 18, 2020

.” Ming-Tain Lai, PhD, Chief Scientific Officer at OBI Pharma stated, “In the trial, OBI-833 demonstrated a favorable safety profile and generated detectable anti-Globo H IgM/IgG responses. ” Presentation number: 397P / Poster: ID 680. Additional information can be found at www.obipharma.com.

Vaccine 52

Vaccine Small Molecule Immune Response Hospitals 52

The Pharma Data

MAY 15, 2023

The acquisition complements Gilead’s existing clinical development priorities by adding additional pipeline assets for well-validated targets in oncology and inflammation. About XinThera XinThera is a private biotechnology company whose mission is to develop best-in-class small molecule drugs to treat cancer and immunologic diseases.

Small Molecule 40

Small Molecule DNA Immune Response Science 40

The Pharma Data

OCTOBER 27, 2020

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).

Small Molecule 52

Small Molecule Immune Response Clinical Development Clinical Trials 52

New Drug Approvals

DECEMBER 16, 2023

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 immune responses against pathogens. of patients experienced a sustained hemoglobin improvement without transfusions respectively.

FDA 62

FDA Small Molecule FDA Approval Treatment 62

The Pharma Data

SEPTEMBER 9, 2020

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.

Vaccine 52

Vaccine Clinical Trials RNA Trials 52

The Pharma Data

SEPTEMBER 9, 2020

“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 billion doses by the end of 2021.

Vaccine 52

Vaccine Clinical Trials Trials Government 52

The Pharma Data

OCTOBER 27, 2020

An expanded Series A will support Orbus’ ongoing STELLAR study, a Phase III clinical trial studying eflornithine in patients with anaplastic astrocytoma, a type of brain tumor, whose cancer has recurred following radiation and adjuvant chemotherapy. Orbus Therapeutics . The $71 million funding includes an initial financing of $32.5

Small Molecule 52

Small Molecule Immune Response Therapies Clinical Development 52

The Pharma Data

FEBRUARY 24, 2022

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.

Vaccine 52

Vaccine FDA Small Molecule Immune Response 52

The Pharma Data

AUGUST 20, 2020

The companies are continuing to analyze data from the Phase 1 trials in the U.S. T cell immune responses elicited by BNT162b2 are being evaluated in the German study and the companies expect to submit the data for peer review and potential publication. This press release features multimedia. View the full release here: [link].

Vaccine 52

Vaccine Clinical Trials Trials Immune Response 52

The Pharma Data

DECEMBER 11, 2020

Pfizer and BioNTech appreciate the continued participation of the approximately 44,000 trial volunteers and remain committed to the companies’ pledge to always make their safety and well-being the companies’ top priority. About the Phase 2/3 Study. Germany, Turkey, South Africa, Brazil and Argentina.

Vaccine 52

Vaccine Clinical Trials Trials Licensing 52

The Pharma Data

MAY 7, 2021

Pfizer and BioNTech initiated the BLA by submitting the nonclinical and clinical data needed to support licensure of the COVID-19 vaccine for use in individuals 16 years of age and older. The companies will submit the required manufacturing and facility data for licensure in the coming weeks to complete the BLA.

Licensing 52

Licensing Licensing Vaccine FDA Approval 52

The Pharma Data

JULY 21, 2021

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response 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.

Vaccine 52

Vaccine Clinical Trials Licensing Licensing 52

The Pharma Data

MAY 6, 2021

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response 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.

Vaccine 52

Vaccine Clinical Trials Licensing Licensing 52

The Pharma Data

AUGUST 16, 2021

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. Source link: [link] nvestor.lilly.com/.

Trials 40

Trials Clinical Trials Small Molecule Disease 40

The Pharma Data

OCTOBER 14, 2020

(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 immune responses to COVID-19 in healthy volunteers who have recovered from COVID-19 or were asymptomatic. 1 Noyce RS, et al.

Vaccine 40

Vaccine Pharmaceuticals Small Molecule Virus 40

The Pharma Data

DECEMBER 27, 2020

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.

Therapies 40

Therapies Clinical Trials Production Treatment 40

Agency IQ

JUNE 9, 2023

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.

FDA 40

FDA Science Small Molecule Immune Response 40

Advarra

JANUARY 11, 2024

After injection of such a vaccine, the mRNA instructs cells to produce proteins designed to stimulate an immune response against these same protein targets when they show up in viruses or in tumor cells. Immunomodulatory Proteins Immunomodulators are molecules influencing the pathways regulating the body’s immune system activities.

Vaccine 52

Vaccine Therapies Clinical Trials Small Molecule 52

The Pharma Data

DECEMBER 10, 2020

The ongoing Phase 3 clinical trial of BNT162b2, which is based on BioNTech’s proprietary mRNA technology, has enrolled more than 44,000 participants, the vast majority of whom have received their second dose. About the Phase 2/3 Study. Germany, Turkey, South Africa, Brazil and Argentina.

Vaccine 52

Vaccine Trials Clinical Trials Therapies 52

The Pharma Data

FEBRUARY 22, 2021

Pursuant to the collaboration, Lilly will also lead all clinical development of brain penetrating RIPK1 inhibitors in central nervous system (CNS) diseases. 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.

Clinical Development 40

Clinical Development Small Molecule Clinical Trials Immune Response 40

DrugBank

FEBRUARY 26, 2025

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.

Therapies 52

Therapies Pharmaceutical Companies Pharmacokinetics Treatment 52

Drug Target Review

MARCH 1, 2024

This antigen-spreading is critical to long-term protection because tumour often develop with inconsistent antigen expression – equipping the immune response to target many diverse tumour antigens may allow for more complete anti-tumour activity. Dr Haqq holds multiple patents and publications.

Immune Response 105

Immune Response Therapies Vaccine Small Molecule 105

The Pharma Data

MARCH 11, 2021

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.,

Vaccine 52

Vaccine Clinical Trials Hospitals Licensing 52

The Pharma Data

JANUARY 17, 2021

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 immune response that lasted at least 71 days. Here’s a look at last week’s news.

Immune Response 52

Immune Response Small Molecule Clinical Trials Trials 52

Codon

APRIL 30, 2023

In one experiment, the microneedle patches were used to deliver a SARS-CoV-2 vaccine into mice, producing immune responses similar to a traditional injection. Printed vaccines caused mice to have a faster immune response. But the printed vaccines are very good! Cell Systems. Nature Communications. .”

Vaccine 52

Vaccine DNA Engineering RNA 52

Codon

APRIL 30, 2023

In one experiment, the microneedle patches were used to deliver a SARS-CoV-2 vaccine into mice, producing immune responses similar to a traditional injection. Printed vaccines caused mice to have a faster immune response. But the printed vaccines are very good! Cell Systems. Nature Communications. .”

Vaccine 52

Vaccine DNA Engineering RNA 52

The Pharma Data

AUGUST 3, 2021

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.

Production 52

Production Marketing Research DNA 52

DrugBank

FEBRUARY 5, 2025

These ligands can be antibodies, peptides, aptamers, or small molecules. 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.

Drugs 52

Drugs Engineering Vaccine Treatment 52

The Pharma Data

JUNE 26, 2021

BNT111 is the lead product candidate from BioNTech’s FixVac platform that targets a fixed combination of mRNA-encoded, tumor-associated antigens with the objective of triggering a strong and precise immune response against cancer and is fully owned by BioNTech. About BioNTech.

Clinical Trials 52

Clinical Trials Trials Immune Response Vaccine 52

NIH Director's Blog: Drug Development

MAY 21, 2020

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 small molecules. In the U.S. In the U.S. Stay tuned for more information about these potentially significant advances in the next few months.

Virus 52

Virus Vaccine Laboratories Small Molecule 52

The Pharma Data

SEPTEMBER 15, 2020

The company announced the initiation of its Phase 1b clinical trial to evaluate the safety of a novel investigational therapeutic for COVID-19, PF-07304814. Based on the acceptable safety profile and the favorable immune response data, including the 4th dose response data, Pfizer received Breakthrough Therapy Designation.

Vaccine 52

Vaccine Therapies Trials Clinical Trials 52

Drug Target Review

DECEMBER 13, 2024

However, research and clinical trials of BiTEs in solid tumours, including NSCLC, are still in the early phases. 17 An interesting extension of BsAbs is trispecific antibodies (TsAbs), which, as the name suggests, engage three different targets – such as two immune-modulating components and a target antigen. BMC Cancer.

Therapies 98

Therapies Treatment Clinical Trials Drugs 98

Vial

DECEMBER 11, 2023

The Food and Drug Administration (FDA) approved and recommended dozens of small-molecule drugs. Other inhibitors, currently in different stages of development (including clinical trials ), mainly target viral non-structural proteins or the internal ribosome entry site (IRES). Zhao et al.

Clinical Research 52

Clinical Research Therapies Research Vaccine 52

The Pharma Data

JUNE 24, 2021

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer?BioNTech Procedures should be in place to avoid injury from fainting. BioNTech COVID-19 Vaccine. The Pfizer?BioNTech BioNTech COVID-19 Vaccine may not protect all vaccine recipients.

Government 52

Government Vaccine Clinical Trials Licensing 52

The Pharma Data

DECEMBER 27, 2020

Even with the holidays among us, there were a number of clinical trial announcements. Vir Biotechnology and GlaxoSmithKline dosed the first patient in a new sub-trial of a Phase III study of monoclonal antibody VIR-7831 for hospitalized adults with COVID-19. Here’s a look. COVID-19-Related.

Trials 52

Trials Clinical Trials Therapies RNA 52