Pharmaceutical Technology

JUNE 28, 2022

Astellas and Sutro will expedite the development of iADCs for three different biological targets. Sutro will oversee the research and preclinical research to detect candidate compounds and subsequently Astellas will carry out the clinical development. Furthermore, the company is entitled to get up to $422.5m

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Development Antibody Immune Response Production 264

The Pharma Data

NOVEMBER 30, 2020

NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein adjuvanted with Novavax’ patented saponin-based Matrix-M to enhance the immune response and stimulate high levels of neutralizing antibodies.

Clinical Development 52

Clinical Development Vaccination Vaccine Development 52

Pharmaceutical Technology

JUNE 5, 2023

Kid EDV is under clinical development by ImmunityBio and currently in Phase I for Pediatric Diffuse Intrinsic Pontine Glioma. 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.

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Immune Response Clinical Trials Clinical Trials Development 130

Pharmaceutical Technology

DECEMBER 6, 2022

Under a possible development and commercialisation agreement in the future for the CMV vaccine candidate discovered by the parties, Evaxion will be entitled to receive upfront and milestone payments from ExpreS 2 ion. A herpesvirus family member, CMV is spread through body fluids.

Vaccination 130

Vaccination Vaccine Development Immune Response 130

Scienmag

APRIL 22, 2021

Dose-sparing regimens and intradermal delivery have important implication for rapid clinical development of effective, well-tolerated and easy-to-distribute vaccines against MERS and other emerging coronaviruses.

DNA 61

DNA Vaccination Vaccine Immune Response 61

Drug Discovery World

MARCH 30, 2023

According to GlobalData’s Pharma Intelligence Center, there are currently four personalised cancer vaccines in clinical development in China. Most of these vaccines have a subcutaneous mode of administration and are subunit vaccines, except LK101, which is dendritic cell-based mRNA vaccine.

Regulation 52

Regulation Vaccination Vaccine Trials 52

Pharmaceutical Technology

FEBRUARY 26, 2023

Cellular Immunotherapy for Non-Small Cell Lung Cancer is under clinical development by Iovance Biotherapeutics and currently in Phase II for Non-Small Cell Lung Cancer.

Immune Response 100

Immune Response Production Clinical Trials Clinical Trials 100

Camargo

JULY 27, 2021

When developing a clinical development program for these increasingly popular therapies, it is important that sponsors use modeling and pharmacokinetic (PK) analysis to evaluate parameters that can be measured while dosing with gene therapy drugs, to characterize exposure-response data and inform rational dosing.

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Gene Therapy Gene Gene Editing Genetics 238

pharmaphorum

DECEMBER 11, 2020

Sanofi and GlaxoSmithKline have said their COVID-19 vaccine has hit a snag in clinical development, prompting analysts to note this could delay delivery of potentially more than a billion shots globally by up to nine months.

Immune Response 72

Immune Response Trials Vaccination Vaccine 72

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

Clinical Trials 75

Clinical Trials Clinical Trials Vaccination Vaccine 75

pharmaphorum

DECEMBER 4, 2020

Valneva is paying 30% of development costs and in return Pfizer will pay tiered royalties starting at 19% and will lead late-stage development. VLA15 is the only active Lyme disease vaccine in clinical development today, and covers six strains that are prevalent in North America and Europe.

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Drug Discovery World

JULY 26, 2023

Dr Nigel Blackburn, Director of Cancer Research UK’s Centre for Drug Development, said: “We’re incredibly proud to have played a pivotal role in bringing the first ever IgE antibody into clinical trials.

Antibody 52

Antibody Drugs Clinical Trials Clinical Trials 52

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.

Vaccination 105

Vaccination Vaccine Trials Immune Response 105

pharmaphorum

SEPTEMBER 1, 2020

AstraZeneca has expanded development of COVID-19 vaccine AZD1222 into the US, beginning a phase 3 clinical trial across all adult age groups. The UK pharma said that the trial will recruit up to 30,000 adults aged 18 years or over to assess the safety, efficacy and immune response.

Vaccination 69

Vaccination Vaccine Trials Immune Response 69

pharmaphorum

FEBRUARY 10, 2022

AstraZeneca confirmed today that it has discontinued clinical development of a follow-up to its COVID-19 vaccine Vaxzevria targeted at the Beta variant of the virus, which started development before the emergence of the Delta and Omicron strains. ” Vaxzevria added almost $4 billion to its revenues last year, including $1.8

Vaccination 52

Vaccination Vaccine Development Immune Response 52

pharmaphorum

AUGUST 5, 2022

It reckons that its antibodies will be able to target the underlying cause of autoimmune diseases, unlike current therapies such as steroids or TNF and interleukin inhibitors that while effective are non-selective, so suppress both appropriate and inappropriate immune responses.

Antibody 105

Antibody Immune Response Development Medicine 105

pharmaphorum

JUNE 28, 2022

. “iADCs hold promise well beyond the existing success of ADCs,” said Sutro’s chief executive William Newell, pointing to the technology’s ability to bind two separate components to a tumour-targeting antibody – one that delivers a cell-killing payload and another that can help drive an immune response.

Antibody 105

Antibody Immune Response Gene Therapy Drugs 105

pharmaphorum

APRIL 12, 2021

The adenosine pathway has emerged as an attractive target for immuno-oncology R&D because it is thought to reduce the activity of misfunctioning regulatory T-cells that inhibit the immune response against cancers. Exscientia will lead the clinical development of the A2A drug, with Evotec retaining co-ownership rights.

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Trials Clinical Trials Clinical Trials Immune Response 127

pharmaphorum

MARCH 12, 2021

However the companies also expanded their collaboration midway through last year to cover development of mRNA across all infectious disease areas, focusing on the long game once the pandemic has receded. A joint development team is working on a -20C storage temperature for late-stage clinical development and at launch.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Vaccination 52

The Pharma Data

JULY 18, 2021

Clinical Data Supporting Approval Demonstrated Non-Inferior Immune Responses for the Serotypes Shared with PCV13 (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F). VAXNEUVANCE Elicited Superior Immune Responses for Serotypes 3, 22F and 33F Compared to PCV13, Which Are Major Causes of Disease.

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Immune Response Vaccination Vaccine FDA Approval 52

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.

Vaccination 52

Vaccination Vaccine Immune Response Protein 52

pharmaphorum

NOVEMBER 20, 2022

Without sacrificing on the robust science of R&D, teams were able to accelerate overall development schedules by removing lags in clinical trial phase timelines. This enables sponsors to look ahead to the upcoming milestones and plan accordingly; pitfalls can make or break a vaccine development programme.

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Vaccination Vaccine Development Clinical Development 98

Drug Discovery World

NOVEMBER 8, 2022

Personalised cancer vaccines are designed to prime the immune system so that a patient can generate a tailored antitumor response to their tumor mutation signature to treat their cancer. mRNA-4157/V940 is designed to stimulate an immune response by generating T cell responses based on the mutational signature of a patient’s tumour. .

Vaccination 52

Vaccination Vaccine Development Immune Response 52

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.

Licensing 52

Licensing Licensing Immune Response Engineer 52

The Pharma Data

SEPTEMBER 29, 2020

from Australian investors to progress the INNA-051 clinical development programme. By boosting the natural immune response of the ferrets with our treatment, we’ve seen a rapid eradication of the virus,” said Christophe Demaison, managing director of Ena Respiratory. So far, Ena has raised AU$11.7m

Immune Response 52

Immune Response Clinical Development Scientist Development 52

The Pharma Data

OCTOBER 14, 2020

APX005M is a novel, humanized monoclonal antibody that stimulates the anti-tumor immune response. APX005M targets CD40, a co-stimulatory receptor that is essential for activating both innate and adaptive immune systems. Binding of APX005M to CD40 on antigen presenting cells (i.e.,

Immune Response 40

Immune Response Drugs Antibody Clinical Trials 40

The Pharma Data

DECEMBER 13, 2020

SYNB1891 is an investigational drug for the intra-tumoral treatment of solid tumors and lymphoma, composed of an engineered Synthetic Biotic designed to activate the STING pathway in the tumor microenvironment in order to upregulate the patient’s immune response. SYNB1891 is being evaluated in a Phase 1 clinical trial.

Immune Response 40

Immune Response Engineer Clinical Trials Clinical Trials 40

The Pharma Data

JANUARY 12, 2021

Ben-Moshe told BioSpace that BND-22 differs from traditional immunotherapy in that it can elicit a more total immune response. . “It It is a new immune checkpoint that is expressed on three different immune cells: Macrophages, [Natural Killer] NK cells, and T cells. [It]

Immune Response 52

Immune Response Clinical Trials Clinical Trials Development 52

pharmaphorum

JANUARY 4, 2023

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. It already has a pipeline of drug candidates in this area, including IRAK4 inhibitor GS-5718 that has advanced into early clinical development for lupus and RA.

Immune Response 52

Immune Response Engineer Licensing Licensing 52

Drug Discovery World

MARCH 24, 2023

Efti As a first-in-class soluble LAG-3 protein targeting MHC Class II ligands on antigen-presenting cells (APC), efti is positioned to improve clinical outcomes from standard-of-care chemotherapy. Its activation of APCs (e.g., month median overall survival (mOS) improvement, statistically significant mOS improvements between 4.2

Trials 52

Trials Immune Response HR Clinical Development 52

The Pharma Data

SEPTEMBER 2, 2020

The vaccine candidate, developed in partnership by the firms, is based on the recombinant protein-based technology used in Sanofi’s seasonal influenza vaccines and GSK’s pandemic adjuvant technology. First results are expected early December and, if positive, will pave the way for initiation of a Phase III trial in the same month. “Our

Vaccination 52

Vaccination Vaccine Trials Immune Response 52

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

pharmaphorum

JANUARY 25, 2021

The company – known as MSD outside North America – said that although the vaccines were well tolerated, the immune responses seen were weaker than natural immunity and those reported for other SARS-CoV-2 vaccines.

Vaccination 52

Vaccination Vaccine Immune Response Clinical Trials 52

pharmaphorum

DECEMBER 15, 2020

Proceeds will advance the clinical development of MinervaX’s novel GBS vaccine through phase 2 clinical trials, as well as manufacturing and regulatory preparation for phase 3. GBS is responsible for nearly half of all life-threatening infections in newborns. The post Minervax raises €47.4m

Bacteria 52

Bacteria Vaccination Vaccine Immune Response 52

pharmaphorum

FEBRUARY 8, 2022

The initial assessment of AT845 is based on four patients who received two doses of the gene therapy, with no evidence of serious adverse events, according to Astellas’ head of clinical development for gene therapies Weston Miller.

Gene Therapy 52

Gene Therapy Gene Immune Response Licensing 52

pharmaphorum

NOVEMBER 12, 2020

The phase 2 FIGHT trial testing bemarituzumab plus chemotherapy as a front-line therapy for advanced gastric and gastroesophageal junction cancer met all its efficacy objectives, with significant improvements in overall survival, progression-free survival and overall response rate compared to chemo alone.

Drugs 52

Drugs Antibody Immune Response Clinical Development 52

pharmaphorum

OCTOBER 6, 2020

The vaccine is based on different technology from AZ’s rival: while AZ’s uses a weakened and genetically modified cold virus to prime the immune system, BNT162b2 is based on a string of RNA. According to latest figures from the World Health Organization, there are 42 potential COVID-19 vaccines in clinical development.

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Vaccination Vaccine RNA Immune Response 59