Drug Target Review

NOVEMBER 6, 2023

For example, combining IO agents with ADCs to mount a two-pronged attack against cancer by activating an anti-cancer immune response and directly killing cancer cells may drive stronger and more durable responses in the clinic.

Small Molecule 111

Small Molecule Therapies Treatment Disease 111

Codon

SEPTEMBER 29, 2024

The average pass rate of phase I trials went up by 5 percent. Their pipelines were bursting with promising candidates, and their success rates in clinical trials were astronomical compared to the industry standard of just a few years back. Internally, they had a simplified architecture.

Engineering 137

Engineering Virus DNA Therapies 137

Drug Target Review

OCTOBER 17, 2024

While its involvement in the do-not-eat-me signal from cancer has inspired therapeutic development of this pathway for oncology, the function of the innate immune checkpoint we identified in 2009 1 extends to both innate and adaptive immune responses. Biomarkers are the holy grail of clinical trials. References Chen GY.,

Immune Response 52

Immune Response Clinical Trials Trials Therapies 52

The Pharma Data

NOVEMBER 18, 2020

. “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.

Vaccine 52

Vaccine Small Molecule Immune Response Hospitals 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. Discov Oncol.

Therapies 98

Therapies Treatment Clinical Trials Drugs 98

The Pharma Data

NOVEMBER 27, 2020

One dose of the Sputnik V vaccine will cost less than $10 for international markets. The Russian Direct Investment Fund (RDIF) has announced the cost of the Russian Sputnik V vaccine for international markets will cost less than US$10 per dose and will be free of charge for all Russian citizens.

Virus 52

Virus Vaccine International Immune Response 52

The Pharma Data

DECEMBER 20, 2020

“This clinical trial approval sets the stage to further broaden BioInvent’s promising clinical pipeline. Philippe Archinard , PhD, Chairman and CEO of Transgene, said: “We are pleased that we have received a first approval to initiate the Phase l/lla trial of BT-001. LUND, Sweden and STRASBOURG, France , Dec.

Virus 40

Virus Trials Clinical Trials Clinical Development 40

Drug Target Review

OCTOBER 10, 2024

What are the risks of over-reliance on healthy donor material in early-stage research, and how can decision-makers ensure a balanced integration of diseased material to avoid potential gaps when transitioning to clinical trials?

Therapies 52

Therapies Immune Response Clinical Trials Disease 52

Codon

FEBRUARY 13, 2024

A BBC documentary on ‘The Virus that Cures’ was broadcast around the world in 1997, and in the former communist party headquarters in Georgia, American investors helped organize the first major international conference on phage therapy since the 1930s. Still, researchers are trying.

Therapies 124

Therapies Virus DNA Clinical Trials 124

The Pharma Data

JANUARY 19, 2021

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. TC-110 is in a Phase I/II trial for CD19-positive adult acute lymphoblastic leukemia (aALL) and with aggressive or indolent non-Hodgkin lymphoma (NHL).

Small Molecule 52

Small Molecule Trials Laboratories Immune Response 52

The Pharma Data

DECEMBER 23, 2020

Joseph Kim , President and CEO of INOVIO, said, “We are very pleased to share peer-reviewed Phase 1 clinical data for INO-4800 published in The Lancet’s EClinicalMedicine , and are grateful for the support of all participants and investigator staff involved in the clinical trial.” mg and 2.0 mg and 2.0 The 1.0

DNA 40

DNA Vaccine Clinical Trials Immune Response 40

The Pharma Data

OCTOBER 14, 2020

We are evaluating APX005M in a broad clinical program that includes more than 10 clinical trials in various indications and therapeutic combinations,” said Xiaodong Yang , MD, PhD, Chief Executive Officer of Apexigen. APX005M is a novel, humanized monoclonal antibody that stimulates the anti-tumor immune response.

Treatment 40

Treatment Immune Response Clinical Trials Clinical Development 40

The Pharma Data

MARCH 3, 2022

Pfizer will publish outcomes from this clinical trial at a future date. After this important discovery, Pfizer tested numerous versions of the viral protein, and identified those that elicited a strong anti-viral immune response in pre-clinical evaluation. Pfizer will publish outcomes from this clinical trial at a future date.

Virus 52

Virus Vaccine Clinical Trials Trials 52

The Pharma Data

JANUARY 17, 2021

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 immune responses. HFrEF was formerly known as systolic heart failure.

FDA 52

FDA Small Molecule Immune Response Hospitals 52

Vial

DECEMBER 11, 2023

Other inhibitors, currently in different stages of development (including clinical trials ), mainly target viral non-structural proteins or the internal ribosome entry site (IRES). Participants are deliberately exposed to the pathogen in these trials after receiving a vaccine candidate or placebo. Zhao et al. Bilinski et al.

Clinical Research 52

Clinical Research Therapies Research Vaccine 52

The Pharma Data

AUGUST 11, 2020

.–( BUSINESS WIRE )– Bristol Myers Squibb (NYSE: BMY) today announced the Phase 3 CheckMate -577 trial evaluating Opdivo (nivolumab) as an adjuvant therapy for patients with resected esophageal or gastroesophageal junction (GEJ) cancer met its primary endpoint of disease-free survival (DFS) at a pre-specified interim analysis.

Therapies 52

Therapies Trials Disease Treatment 52

The Pharma Data

JANUARY 5, 2021

Food and Drug Administration said Monday that any American who gets the Moderna or Pfizer coronavirus vaccines must get two full doses, despite international debate on possible ways to stretch vaccine supply. “These are all reasonable questions to consider and evaluate in clinical trials. TUESDAY, Jan.

Vaccine 52

Vaccine FDA Virus Immune Response 52

The Pharma Data

NOVEMBER 1, 2020

Trial facilitated with coll a boration of Harvard Medical School and one of the world’s top Neurologist, Dr. Howard Weiner. This clinical trial will be coordinated by the team at the INTRIALS, a leading, full-service Latin America Clinical Research Organization (CRO), based in Sao Paulo City, Brazil.

Clinical Trials 40

Clinical Trials Trials Medical Schools Hospitals 40

The Pharma Data

SEPTEMBER 7, 2021

The mAb duo is part of the National Institutes of Health’s (NIH) Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program and the Phase 2 trial (ACTIV-2) began enrolling in May. and Puerto Rico personnel are required to be vaccinated to interact with customers, vendors and people at our clinical trial sites.

Clinical Trials 52

Clinical Trials Vaccine Virus Trials 52

The Pharma Data

SEPTEMBER 30, 2021

The review, published within the Lancet, summarises the currently available evidence from randomised controlled trials and observational studies published in peer-reviewed journals and pre-print servers. Considerations in boosting COVID-19 vaccine immune responses. The Lancet, 2021. doi: 10.1016/S0140-6736(21)02046-8.

Vaccine 52

Vaccine Immune Response Disease International 52

The Pharma Data

AUGUST 22, 2021

Typically, to find out whether a drug is effective in treating a particular medical condition, scientists develop prospective clinical trials. One of the most dangerous phenomena COVID-19 can trigger in your body is something called a cytokine storm, which is a potentially fatal amplification of an immune response.

Doctors 52

Doctors Drugs Immune Response Virus 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. The maximum achievable ACR CRISS score is 1.0.

Disease 52

Disease Clinical Trials Small Molecule Trials 52

The Pharma Data

SEPTEMBER 17, 2020

The Elecsys Anti-SARS-CoV-2 serology test can be used to quantitatively measure antibodies in people who have been exposed to the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and can play an important part in characterising a vaccine-induced immune response. said Thomas Schinecker, CEO Roche Diagnostics.

Vaccine 52

Vaccine Virus Clinical Trials Immune Response 52

The Pharma Data

AUGUST 11, 2020

The safety profiles of Opdivo and chemotherapy in this trial are reflective of the known safety profiles of Opdivo and chemotherapy in first-line gastric and esophageal cancers. The company remains blinded to data from this arm and the trial continues in follow-up to allow the data to mature. PRINCETON, N.J.–(

Treatment 52

Treatment Trials Therapies Clinical Trials 52

The Pharma Data

MAY 15, 2023

Through the acquisition, Gilead gains rights to a portfolio of small molecule inhibitors targeting PARP1 for oncology and MK2 for inflammatory diseases that could enter clinical trials later this year. XinThera is backed by a group of international investors including Foresite Capital, OrbiMed Advisors, LLC and TTM Capital.

Small Molecule 40

Small Molecule DNA Immune Response Science 40

NIH Director's Blog: Drug Development

OCTOBER 27, 2020

With the aim of developing such protein-targeted antiviral drugs, a large, international team of researchers, funded in part by the NIH, has precisely and exhaustively mapped all of the interactions that take place between SARS-CoV-2 proteins and the human proteins found within infected host cells.

Drug Development 52

Drug Development Drugs Virus Science 52

NIH Director's Blog: Drug Development

MARCH 18, 2021

These days, the Veesler lab has been hard at work to understand SARS-CoV-2 and the human immune response to the virus. He’s also a member of the international research team that identified a human antibody, called S309, from a person who’d been infected with SARS in 2003.

Virus 52

Virus Immune Response Clinical Trials Treatment 52

The Pharma Data

JANUARY 31, 2021

Gritstone’s vaccine technology has the potential to educate the immune system to specifically recognize and destroy HIV-infected cells by leveraging SAM and adenoviral vectors.

Vaccine 52

Vaccine Science Clinical Trials Licensing 52

The Pharma Data

SEPTEMBER 15, 2020

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.

Vaccine 52

Vaccine Therapies Trials Clinical Trials 52

PLOS: DNA Science

JANUARY 4, 2024

The microbes deploy them to dismantle the genetic material of infecting viruses, a little like an immune response. My book The Forever Fix: Gene Therapy and the Boy Who Saved It , describes early gene therapy attempts, beginning with the first clinical trial in 1990. So far clinical trials have had mostly discouraging results.

FDA Approval 52

FDA Approval DNA Therapies Clinical Trials 52

The Pharma Data

MARCH 16, 2021

1.351 carries another spike mutation E484K, which appears to evade the body’s immune response, possibly diminishing vaccine efficacy. 1 has been circulating in the Amazon region as of late 2020 and is thought to evade immunity generated after infection by other variants. 2,3 Another variant, B.1.351, 4 Variant P.1,

Clinical Trials 52

Clinical Trials Laboratories Virus Vaccine 52

NIH Director's Blog: Drug Development

MAY 21, 2020

In work described in the journal Nature , an international research team started with a set of neutralizing antibodies previously identified in a blood sample from a person who’d recovered from a different coronavirus-caused disease, called severe acute respiratory syndrome (SARS), in 2003 [3]. In the U.S. In the U.S. medRxiv.

Virus 52

Virus Vaccine Laboratories Small Molecule 52

The Pharma Data

NOVEMBER 29, 2020

HB-101, a non-replicating arenavirus vaccine, is being investigated in a double-blind Phase 2 clinical trial (NCT03629080) to assess safety, immunogenicity and efficacy in individuals receiving a kidney transplant from a living donor. Safety and tolerability were evaluated in 69 participants who were enrolled in the trial by the cut-off date.

Vaccine 40

Vaccine Clinical Trials Disease Therapies 40

The Pharma Data

OCTOBER 20, 2020

Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting significant unmet needs in the treatment of tumors and viruses, announced results from an independent laboratory validating internal animal studies showing the ability of Annamycin to target lung localized tumors.

Clinical Trials 40

Clinical Trials Pharmaceutical Companies Treatment Immune Response 40

Codon

DECEMBER 12, 2024

Those shots were shipped and ready for Phase I clinical trials on February 24, a total of 45 days after the SARS-CoV-2 sequence was initially uploaded online. After years of debate, an international pact limiting emissions of ozone-depleting substances was signed in 1987.

DNA 102

DNA RNA Vaccine Virus 102

Agency IQ

APRIL 12, 2024

Not only are assays useful tools for characterizing products early in development; they can also be used to set “benchmarks,” allowing sponsors to verify that the lots of the product used during clinical trials and eventually, for commercial distribution, continue to adhere to the same standards specified in the original product’s design.

Production 40

Production FDA Therapies Biochemical Assays 40

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. percent, a decrease of 0.3

Production 52

Production Marketing Research DNA 52