pharmaphorum

DECEMBER 17, 2020

France’s Valneva begun the phase 1/2 clinical study of the inactivated vaccine candidate VLA2001 in sites across the UK, supported by the National Institute for Health Research (NIHR). It is the first publicly announced inactivated COVID-19 vaccine candidate to begin clinical development in Europe.

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The Pharma Data

NOVEMBER 30, 2020

Therefore, the Company has been working closely with the FDA to complete trial-initiation gating activities related to its commercial-scale production at FUJIFILM Diosynth Biotechnologies in Research Triangle Park, North Carolina. Novavax will use vaccine material produced at commercial scale for this trial. Novavax was awarded $1.6

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Clinical Development Vaccine Vaccination Development 52

XTalks

NOVEMBER 6, 2020

We are exceptionally pleased to commence dosing of our oral DNA vaccine for COVID-19 as we continue scale-up and manufacturing activities for future clinical development,” Symvivo’s chief medical officer Eric Sievers said in a press release from the company. Related: Red Meat Allergy Test Gets FDA Clearance. “We

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Clinical Trials Clinical Trials Vaccine Vaccination 75

pharmaphorum

JUNE 28, 2022

The biotech has the option to share costs and profits for developing and commercialising the three product candidates in the US. Shares in Sutro rocketed in pre-market trading in the wake of the announcement, rising more than 50% before slipping back slightly to a 30% increase at the time of writing.

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Antibody Immune Response Gene Therapy Drugs 105

pharmaphorum

SEPTEMBER 24, 2020

That vaccine is top of the World Health Organization’s list of vaccines in clinical development, which shows there are 38 potential shots in human trials. Although controversial, as the subjects would be exposed to a potentially lethal virus, the trial could provide data about the immune response for any vaccine.

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Vaccine Vaccination Trials Immune Response 98

Worldwide Clinical Trials

JUNE 15, 2022

It really is—there has been a 10x increase in cell and gene therapies in the clinical development pipeline since 2012. Most of this pipeline focuses on oncology and rare disease investigational therapeutics, and most, unsurprisingly, are in the earlier phases of development. The cell and gene therapy pipeline is booming.

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Gene Therapy Gene Clinical Trials Clinical Trials 130

The Pharma Data

SEPTEMBER 25, 2020

Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. Interim analysis from Phase 1/2a First-in-Human trial supports further clinical development of investigational vaccine candidate JNJ-78436735 (also known as Ad26.COV2.S). Immune Response Data.

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Clinical Trials Clinical Trials Vaccine Vaccination 52

XTalks

SEPTEMBER 5, 2023

Xtalks spoke with Maria Reyes Boceta-Muñoz, Clinical Operations Head of Development R&D at GlaxoSmithKline in Spain, Portugal & Israel, to understand the current vaccine development climate and where the sector is headed. What are the major challenges you’re facing right now in vaccine development?

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Vaccine Vaccination Development Clinical Trials 96

Pfizer

JULY 26, 2022

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the companies have initiated a randomized, active-controlled, observer-blind, Phase 2 study to evaluate the safety, tolerability, and immune response of an enhanced COVID-19 mRNA-based vaccine candidate at a 30 µg dose level. INTERCHANGEABILITY.

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The Pharma Data

DECEMBER 3, 2020

Strong Th1 cell-mediated immune responses were also observed for the vaccine candidates with either adjuvant. Based on the positive Phase 1 results reported and the unprecedented need for COVID-19 vaccines, Clover and its partners are confident to enter late-stage clinical development for both adjuvanted vaccines.

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Vaccine Vaccination Immune Response Protein 52

pharmaphorum

OCTOBER 6, 2020

The CHMP begun its review of the vaccine, known as BNT162b2 based on preliminary results from pre-clinical and early clinical studies. These studies suggest BNT162b2 triggers the production of neutralising antibodies and T-cells that target SARS-CoV-2, the coronavirus that causes COVID-19.

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Vaccine Vaccination RNA Immune Response 59

Pharmaceutical Technology

APRIL 17, 2023

This collaboration is being made to combine the companies’ capabilities to develop novel therapeutic antibodies with applications in the two disease areas. In this collaboration, Genmab and argenx will use their proprietary antibody technologies to develop and commercialise new products.

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pharmaphorum

OCTOBER 21, 2022

Hookipa’s proprietary arenavirus platform is based on engineering arenaviruses to carry and deliver virus-specific or tumour-specific genes directly in patients in order to evoke an immune response by T cells, also known as CD8+ T cells.

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Licensing Licensing Immune Response Engineer 52

The Pharma Data

JANUARY 12, 2021

“The T-cell and NK-cell target discovery approach complements our portfolio aimed at turning cold tumors hot and redirecting the innate immune system to elicit a sustained and durable immune response against tumors. KSQ is also eligible to receive tiered royalties on net sales of each approved product.

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pharmaphorum

JANUARY 4, 2023

They both also include tiered royalties on sales of any products emerging from the partnerships. The hypothesis is that it will induce immune tolerance by stimulating anti-inflammatory regulatory T- (Treg) cells and cytokines that dampen down the immune response.

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Immune Response Engineer Licensing Licensing 52

The Pharma Data

OCTOBER 19, 2020

Immune responses following vaccination with PNEUMOVAX 23 (month 13) were comparable in both vaccination groups for the 15 serotypes in V114. Results from both studies are based on opsonophagocytic activity (OPA) responses – a measure of vaccine-induced functional antibodies.

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XTalks

MARCH 13, 2023

Hart added that there are cases where the product in development is thought to mostly help patients with early or more moderate disease. Safety Monitoring in Gene Therapy Clinical Trials A thorough evaluation of safety is needed for gene therapy products in both early and late-phase clinical trials.

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Gene Therapy Gene Clinical Trials Clinical Trials 52

pharmaphorum

JANUARY 31, 2022

They can not only reduce direct hospital costs but also improve patients’ quality of life, ability to function, and productivity. Partly as a result of these developments, vaccine innovation has grown by leaps and bounds in just the past year. Vaccines are essential for public health on a global scale. Innovation at Pfizer.

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XTalks

SEPTEMBER 21, 2023

The trial’s primary objective is to assess the safety of VIR-1388 and its capacity to stimulate a specific immune response against HIV in study participants. This vaccine utilizes the human CMV vector platform and is designed to prompt the production of T cells within the body. Vir Biotechnology, Inc.,

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The Pharma Data

OCTOBER 21, 2020

“The clearance of the IND for ADI-001 by the FDA is a significant milestone in the development of CAR ?? T cell therapies by Adicet, and marks the beginning of clinical development of a deep pipeline of “off-the-shelf” ?? T cell products,” said Chen Schor, President and Chief Executive Officer of Adicet. “We

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Immune Response Engineer Clinical Trials Clinical Trials 40

The Pharma Data

JANUARY 3, 2021

. Both will help NexImmune advance current early-stage clinical trials and will guide Company’s translational efforts to develop new immunotherapy products. We are very honored to have someone of Dr. Zeldis’ caliber lead our scientific research and clinical development teams. GAITHERSBURG, Md.,

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Immune Response Clinical Trials Clinical Trials Development 40

The Pharma Data

DECEMBER 10, 2020

The vaccine targeted both the inner nucleocapsid (N) and the outer spike (S) proteins of the virus to maximize the immune response. The study showed this broad immune response led to the complete clearance of the virus in a matter of days after infection of previously-vaccinated primates. and its affiliate NantKwest, Inc.

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Vaccine Vaccination Immune Response Protein 52

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. These findings give confidence that Clover’s COVID-19 vaccine candidates are suitable for further clinical development.”

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Clinical Trials Clinical Trials Vaccine Vaccination 52

The Pharma Data

MARCH 11, 2021

Clinical trial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels. The joint development team is working on improving the temperature stability of the mRNA vaccine candidate and targeting a -20°C storage temperature for late-stage clinical trials and at launch.

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Clinical Trials Clinical Trials Vaccine Vaccination 52

The Pharma Data

JANUARY 19, 2021

Other products include SY-2101, a novel oral form of arsenic trioxide for acute promyelocytic leukemia, and SY-5609, a highly selective and potent oral CDK7 inhibitor for solid tumors. Ortho Clinical Diagnostics Holdings – Ortho launched its IPO of ordinary shares on January 19. This is planned to raise about $25 million.

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The Pharma Data

OCTOBER 25, 2020

We are advancing the clinical development of mRNA-1273 with our Phase 3 COVE study, which is now fully enrolled with a representative demography of participants across ages, ethnicities and high-risk populations. About Moderna.

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The Pharma Data

JANUARY 21, 2021

The company has six products in its pipeline, with the most advanced being AG019 for type 1 diabetes entering Phase III. The compound was developed in the laboratory of Richard Childs, chief of the Laboratory of Transplantation Immunotherapy with the National Heart, Lung, and Blood Institute (NHLBI).

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Immune Response Trials Development Drugs 52

The Pharma Data

AUGUST 6, 2020

Early clinical results showed AstraZeneca’s candidate, AZD1222, triggered both antibody and T-cell immune responses. China has several home-grown COVID-19 vaccines in clinical development. It also has a recombinant hepatitis B vaccine, as well as products for pneumococcal infections and measles and rubella.

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Vaccine Vaccination Antibody Licensing 52

The Pharma Data

NOVEMBER 9, 2020

(Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the U.S. Currently in late-phase clinical development, NVXCoV2373 is a stable, prefusion protein made using Novavax’ nanoparticle technology and includes its proprietary MatrixM adjuvant.

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Vaccine Vaccination Clinical Trials Clinical Trials 52

Pfizer

JULY 19, 2022

The companies’ previously announced safety, tolerability and immunogenicity data from a Phase 2/3 trial that found a 30 µg booster dose of the Omicron-adapted bivalent vaccine candidate elicited a superior immune response against Omicron BA.1 1 as compared to the companies’ current COVID-19 vaccine. INTERCHANGEABILITY.

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The Pharma Data

DECEMBER 17, 2020

Senior Vice President and Head of Global Clinical Development at Regeneron and lead author of the publication. patients under an Emergency Use Authorization, and we also continue a robust clinical development program.” and Roche will develop, manufacture and distribute it outside of the U.S.

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Antibody Medicine Production Trials 52

The Pharma Data

OCTOBER 28, 2020

“We continue to see the strongest effects in patients who are most at risk for poor outcomes due to high viral load, ineffective antibody immune response at baseline, or pre-existing risk factors. Senior Vice President and Head of Global Clinical Development at Regeneron. Yancopoulos , M.D., combined dose groups; 6.5%

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Pfizer

JULY 8, 2022

Following a third dose in this age group , the vaccine was found to elicit a strong immune response, with a favorable safety profile similar to placebo. Some people with weakened immune systems may have reduced immune responses to Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA).

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Vaccine Vaccination Clinical Trials Clinical Trials 81

Pfizer

JULY 8, 2022

The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. . INTERCHANGEABILITY.

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The Pharma Data

JANUARY 17, 2021

Joe Dupere, CEO of Ixaka, commented: “Ixaka’s broad offering of integrated cell and gene therapy capabilities, encompassing cell-based products and an innovative in vivo gene delivery platform, provides a strong foundation for our ambitions to become a leader in cell and gene therapies.

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Gene Therapy Gene In-Vivo Genetics 40

Pfizer

FEBRUARY 16, 2023

While VLA15 is still under investigation, to date the companies have been encouraged by the data from the Phase 2 clinical studies, which demonstrated strong immunogenicity and acceptable safety and tolerability profiles. 2-4 About VLA15 VLA15 is the only Lyme disease vaccine candidate currently in clinical development.

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Clinical Trials Clinical Trials Vaccine Vaccination 76

The Pharma Data

JULY 6, 2021

billion in clinical development, regulatory and commercial launch-related milestone payments. Alector will lead the global clinical development of AL001 and AL101 through Phase 2 proof-of-concept. Under the terms of the collaboration agreement, Alector will receive $700 million in upfront payments.

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Genetics Gene Antibody Development 52