Pharmaceutical Technology

MAY 19, 2023

OncoResponse has secured a $13m grant from the Cancer Prevention and Research Institute of Texas (CPRIT) and raised an additional $14m in funding from investors for advancing OR502 to investigational new drug (IND) and clinical trials. It is planned to enter clinical studies this year. ”

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Drug Discovery World

FEBRUARY 6, 2023

Taking a human-first approach, Infinimmune is leveraging single-cell technology to create truly human antibody-based therapeutics directly derived from the human immune system. MT: Can you provide me with an overview of what Infinimmune does currently and the potential it sees in the antibody-based therapeutics market?

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Drug Discovery World

APRIL 3, 2023

A team of researchers at the Keck School of Medicine of University of Southern California (USC) have found a drug with the potential for curbing painful hyperinflammation from osteoarthritis, according to results of an animal study. In trying to fix the problem, the immune system causes even more damage,” said Evseenko.

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Pharmaceutical Technology

APRIL 28, 2023

Therini Bio will use part of the funds to advance its potential first-in-class investigational antibody, THN391, into clinical trials. THN391 binds the inflammation-driving component of fibrin, known for activating the immune responses in neurodegenerative and ophthalmologic diseases.

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NY Times

MAY 11, 2022

Antibody levels rose in the children who received it, suggesting the vaccine protects against infection. But the data were gathered before the arrival of Omicron.

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STAT News

DECEMBER 23, 2022

Food and Drug Administration approved a new treatment for patients with follicular lymphoma, a slow-growing type of blood cancer, said Genentech , its maker and a subsidiary of Roche. In a clinical trial, 60% of patients with follicular lymphoma treated with Lunsumio achieved a complete response.

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Drug Discovery World

JUNE 28, 2023

In pregnant women, MinervaX is currently progressing two Phase II clinical vaccine trials for the prevention of life-threatening infections in newborns. The trials are demonstrating that the vaccine has an acceptable safety profile, is highly immunogenic and gives rise to functionally active antibodies.

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XTalks

JUNE 18, 2021

This is why Regeneron’s announcement of positive clinical trial results that show its antibody cocktail treatment can cut deaths among hospitalized patients is welcome news. It is the first trial to demonstrate that any antibody treatment could improve survival in patients hospitalized with COVID-19.

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Pharmaceutical Technology

JUNE 5, 2023

According to GlobalData, Phase I drugs for Pediatric Diffuse Intrinsic Pontine Glioma does not have sufficient historical data to build an indication benchmark PTSR for Phase I. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Kid EDV LoA Report. Buy the report here.

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Drug Discovery World

MARCH 26, 2024

The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) to half-life extended monoclonal antibody (mAb) Pemgarda (pemivibart, or VYD222) for the pre-exposure prophylaxis (prevention) of Covid-19.

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Drug Discovery World

FEBRUARY 28, 2024

Lu Rahman selects some of the year’s interesting and noteworthy advances in cancer research drug discovery and development. As always, a year within cancer drug discovery and development brings with it significant breakthroughs, and 2023 has been no exception. Research into new cancer drugs remain strong. expressing cancers.

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Pharmaceutical Technology

AUGUST 18, 2022

The company sought expanded provisional approval for the booster shots based on findings from its Phase II clinical trial carried out in Australia, another Phase II trial in South Africa and the COV-BOOST trial sponsored by the UK.

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Pfizer

FEBRUARY 16, 2023

These study participants, representing approximately half of the total recruited participants in the trial, are being discontinued following violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator.

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Drug Discovery World

FEBRUARY 19, 2024

Replicate Bioscience has shared positive results from the Phase I trial of RBI-4000, its srRNA-based rabies vaccine. In this clinical trial, evaluating safety and immunogenicity of RBI-4000 , participants received one or two doses of srRNA vaccine at low doses (0.1mcg, 1mcg or 10mcg).

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XTalks

NOVEMBER 22, 2022

Provention Bio’s Tzield (teplizumab) has won US Food and Drug Administration (FDA) approval to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients eight years of age and older who have stage 2 type 1 diabetes. In clinical trials, the treatment delayed stage 3 disease onset for about two years compared with the placebo.

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XTalks

AUGUST 8, 2022

MiroBio is a private biotech company based in the UK that focuses on developing checkpoint agonist antibodies, which are a new class of therapies that work to restore immune balance in patients with autoimmune and inflammatory diseases. PD-1 is a potent immune inhibitory receptor. MiroBio’s Research Pursuits.

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The Pharma Data

APRIL 15, 2022

Food and Drug Administration in the coming days with additional submissions to other regulatory agencies worldwide to follow. About the Phase 1/2/3 Trial in Children. Additional children have been enrolled in all age groups following study amendments and the trial currently includes more than 10,000 children. Pfizer Inc.

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pharmaphorum

JULY 6, 2021

It also said that the tumour response was aligned to the level of HER2-targeting antibodies generated by the vaccine, which is given as three doses over a 35-day period. ” The anti-HER2 market is advancing rapidly however, with a new generation of drugs coming through the industry pipeline.

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Drug Discovery World

SEPTEMBER 25, 2023

The trial is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, and will evaluate the investigational vaccine for safety and its ability to elicit an immune response. “An The vaccine produced robust antibody responses in animal testing.

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pharmaphorum

JUNE 30, 2021

Just a few months after starting clinical trials of its nasal spray vaccine for COVID-19, US biotech Altimmune is abandoning the project, saying that it generated weaker than expected immune responses in a phase 1 trial. .

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Drug Discovery World

MARCH 27, 2023

The first subjects have been dosed in a Phase I clinical trial of VXX-401, an investigational vaccine designed to lower low-density lipoprotein (LDL) cholesterol, a known factor in heart disease. The drug works by targeting proprotein convertase subtilisin/kexin type 9 serine protease (PCSK9).

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The Pharma Data

SEPTEMBER 17, 2020

The new Elecsys Anti-SARS-CoV-2 S test can quantitatively measure the level of antibodies against SARS-CoV-2 in patients who have been exposed to the virus. The test targets antibodies against the spike protein. Food and Drug Administration (FDA). This is the focus of vaccines in development and convalescent plasma therapy.

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pharmaphorum

DECEMBER 17, 2020

UK-based EUSA Pharma has begun a late-stage trial of its antibody siltuximab in COVID-19, hoping that the IL-6 inhibitor will succeed where class rivals from Roche and Sanofi/Regeneron have failed. EUSA Pharma bought global rights to the drug from Janssen in $115 million.

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Drug Discovery World

SEPTEMBER 15, 2023

The trial, which marks the first time a human has been dosed with Replicate’s srRNA technology, will serve as a benchmark for utility in this indication and other complex infectious diseases and provide foundational insights to inform future clinical trials, most notably in oncology and autoimmune disease.

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Drug Discovery World

OCTOBER 27, 2023

HB-400, a novel arenaviral therapeutic vaccine developed by HOOKIPA Pharma and Gilead Sciences, has been shown to generate robust T cell responses specific to hepatitis B virus with high antibody levels in a preclinical setting. A Phase I clinical trial to evaluate the safety and tolerability of HB‑400 in humans is ongoing.

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XTalks

MAY 24, 2024

The US Food and Drug Administration (FDA) has approved Amgen’s Imdelltra (tarlatamab-dlle) for the treatment of extensive-stage small cell lung cancer (ES-SCLC) in patients who have experienced disease progression after platinum-based chemotherapy. About 40 percent of patients saw significant shrinkage.

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pharmaphorum

SEPTEMBER 15, 2020

Humanigen is hoping for emergency use authorisation in the US for an antibody to treat severe COVID-19 before the end of 2020, and has teamed up with Swiss contract manufacturer Lonza to make sure it can meet demand. They looked at safety as well as carrying out a futility analysis to gauge whether the drug was working as expected.

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Advarra

JANUARY 11, 2024

While mRNA usage has played several roles in clinical research , oncology researchers in particular are eager to explore the possibilities of mRNA-based cancer vaccines. Additionally, personalized medicine tends to be more difficult to manufacture because of regulatory requirements beyond traditional drug manufacturing requirements.

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XTalks

NOVEMBER 30, 2023

New FDA-Approved Treatments For HIV HIV treatment involves the administration of combined antiretroviral therapy (ART) to effectively suppress the viral load, maintain or enhance immune function and reduce the risk of opportunistic infections and cancers commonly associated with HIV. percent in the placebo group.

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The Pharma Data

JANUARY 31, 2021

Adjuvanted S-Trimer COVID-19 vaccine candidates demonstrated favorable safety and tolerability profiles and strong neutralizing immune responses in a phase 1 trial. The phase 1 clinical trial was a randomized, double-blind and placebo-controlled study in 150 adult and elderly participants.

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Drug Discovery World

JANUARY 18, 2024

Market opportunity estimated at over US$1 billion Largely due to the CRS risk (which can be life threatening), administration of cancer immunotherapies, such as bispecific antibodies, is currently restricted to specialist cancer centres which limits uptake of these therapies. million cases of cancer by 2030 1,2.

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Camargo

DECEMBER 13, 2021

Like with small molecules, clinical trials of biologics are designed to determine pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy. Bispecific antibodies, antibody-drug conjugates, and gene therapies all have their own specific features that must be taken into account.

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The Pharma Data

OCTOBER 14, 2020

a clinical-stage biopharmaceutical company focused on discovering and developing a new generation of antibody therapeutics for oncology, announced today that the U.S. APX005M is a novel, humanized monoclonal antibody that stimulates the anti-tumor immune response. SAN CARLOS, Calif. , About APX005M. About Apexigen.

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The Pharma Data

JANUARY 11, 2021

a San Diego-based biotechnology company with an array of technology platforms for antibody discovery and optimization, and novel NK and T cell engager generation, today announced licensing of a panel of its anti-SARS-CoV-2 antibody clones to IGM Biosciences for COVID-19 therapy development.

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pharmaphorum

APRIL 14, 2022

billion alliance with Genmab to find new cancer therapies, AbbVie has said it is ready to start talking to regulators about filing for approval of the lead drug in the partnership – epcoritamab for large B-cell lymphoma (LBCL). Two years after signing a $3.9 Analysts at Jefferies have previously said they think epcoritamab could become a $1.5

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The Pharma Data

DECEMBER 29, 2020

As in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes. First antibody therapy to demonstrate anti-viral effect in patients hospitalized with COVID-19. Regeneron Pharmaceuticals, Inc. futility analysis).

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pharmaphorum

NOVEMBER 30, 2020

Neutralising antibodies (NAbs) present a unique challenge to researchers looking to treat patients with AAV treatment. As AAV is a virus derived from the common cold, the immune system can easily have levels of pre-existing NAbs that will recognise and neutralise AAV, rendering it ineffective.

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