This site uses cookies to improve your experience. To help us insure we adhere to various privacy regulations, please select your country/region of residence. If you do not select a country, we will assume you are from the United States. Select your Cookie Settings or view our Privacy Policy and Terms of Use.
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Used for the proper function of the website
Used for monitoring website traffic and interactions
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Strictly Necessary: Used for the proper function of the website
Performance/Analytics: Used for monitoring website traffic and interactions
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted an investigational new drug application (IND) for SinoMab BioScience’s SM17 to treat asthma. It can suppress Th2 immuneresponses by binding to IL-17RB on Type 2 innate lymphoid cells (ILC2s).
Sutro will oversee the research and preclinical research to detect candidate compounds and subsequently Astellas will carry out the clinicaldevelopment. As per the deal, Sutro is eligible to get $90m in upfront cash payment for developing iADCs for three biological targets.
Influenza vaccine 2 is under clinicaldevelopment by Shanghai Institute of Biological Products and currently in Phase I for Pandemic Influenza. Influenza vaccine 2 overview Vaccine is under development for the prevention of infections caused by pandemic influenza virus.
Influenza vaccine 2 is under clinicaldevelopment by Shanghai Institute of Biological Products and currently in Phase I for Pandemic Influenza. Influenza vaccine 2 overview Vaccine is under development for the prevention of infections caused by pandemic influenza virus.
When developing a clinicaldevelopment 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.
By adding an additional pipeline targeting oncology and inflammation diseases, the company expects that the deal will complement its existing clinicaldevelopment priorities. The financial terms of the deal were not disclosed by the companies.
In March 2023, the FDA provided positive feedback on Avenge Bio’s preclinical and clinicaldevelopment initiatives for pleural malignant mesothelioma. This triggers a systemic immuneresponse, enabling the treatment of previously intractable cancers.
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.
Kid EDV is under clinicaldevelopment 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.
Proceeds from the IPO will fund preclinical and clinicaldevelopment for Polyrizon’s innovative hydrogel product candidates, supporting further research and development (R&D). The IPO, priced at $4.38 Trading began on the Nasdaq Capital Market under the ticker “PLRZ” on October 29, 2024.
Loxo Oncology at Lilly, a research and development group of Eli Lilly and Company (NYSE: LLY), and Kumquat Biosciences today announced an exclusive collaboration focused on the discovery, development and commercialization of potential novel small molecules that stimulate tumor-specific immuneresponses.
Cellular Immunotherapy for Non-Small Cell Lung Cancer is under clinicaldevelopment by Iovance Biotherapeutics and currently in Phase II for Non-Small Cell Lung Cancer. It developsproducts based on its tumor-infiltrating lymphocyte (TIL) technology.
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 clinicaldevelopment in Europe.
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
Sanofi and GlaxoSmithKline have said their COVID-19 vaccine has hit a snag in clinicaldevelopment, prompting analysts to note this could delay delivery of potentially more than a billion shots globally by up to nine months.
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 clinicaldevelopment,” Symvivo’s chief medical officer Eric Sievers said in a press release from the company. Related: Red Meat Allergy Test Gets FDA Clearance. “We
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.
That vaccine is top of the World Health Organization’s list of vaccines in clinicaldevelopment, 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 immuneresponse for any vaccine.
The cytokine release prompts T-cells so they can translate that first innate immuneresponse into a long-lasting adaptive immuneresponse. The quality of the science led us to really focus on key mechanisms and pathways in innate immunity.”. “The That’s what is most exciting about all this,” says Mahjoubi.
It really is—there has been a 10x increase in cell and gene therapies in the clinicaldevelopment 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.
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 clinicaldevelopment of investigational vaccine candidate JNJ-78436735 (also known as Ad26.COV2.S). ImmuneResponse Data.
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?
(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 immuneresponse of an enhanced COVID-19 mRNA-based vaccine candidate at a 30 µg dose level. INTERCHANGEABILITY.
Strong Th1 cell-mediated immuneresponses 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 clinicaldevelopment for both adjuvanted vaccines.
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.
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 immuneresponse.
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 immuneresponse by T cells, also known as CD8+ T cells.
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 immuneresponse against cancer and is fully owned by BioNTech. About BioNTech.
“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 immuneresponse against tumors. KSQ is also eligible to receive tiered royalties on net sales of each approved product.
Less than a month after Kadmon Pharma launched its first product – Rezurock for a complication of organ transplants – the New York company has agreed to be bought by Sanofi in a $1.9 billion deal. The merger agreement, which has been agreed by the boards of both companies, will see Sanofi pay $9.50
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 immuneresponse.
Immuneresponses 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.
Similarly, genetics, immuneresponse, and environmental factors also influence the occurrence of Neurological Conditions. BMedical Pty Ltd, Prolivio, Cirrus Healthcare Products, Cirrus Healthcare Products, and several others. The key companies in the Migraine medical devices segment include Cefaly, Neurolief Ltd.,
(Nasdaq: RIGL) today announced a global exclusive license agreement and strategic collaboration to co-develop and commercialize Rigel’s R552, a receptor-interacting serine/threonine-protein kinase 1 (RIPK1) inhibitor, for all indications including autoimmune and inflammatory diseases. vice president of immunology at Lilly.
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.
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.
The trial’s primary objective is to assess the safety of VIR-1388 and its capacity to stimulate a specific immuneresponse 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.,
“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 clinicaldevelopment of a deep pipeline of “off-the-shelf” ?? T cell products,” said Chen Schor, President and Chief Executive Officer of Adicet. “We
.
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 clinicaldevelopment teams.
GAITHERSBURG, Md.,
The vaccine targeted both the inner nucleocapsid (N) and the outer spike (S) proteins of the virus to maximize the immuneresponse. The study showed this broad immuneresponse led to the complete clearance of the virus in a matter of days after infection of previously-vaccinated primates. and its affiliate NantKwest, Inc.
Adjuvanted S-Trimer COVID-19 vaccine candidates demonstrated favorable safety and tolerability profiles and strong neutralizing immuneresponses in a phase 1 trial.
These findings give confidence that Clover’s COVID-19 vaccine candidates are suitable for further clinicaldevelopment.”
Clinical trial to assess safety, immuneresponse 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.
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.
We are advancing the clinicaldevelopment 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.
We organize all of the trending information in your field so you don't have to. Join 21,000+ users and stay up to date on the latest articles your peers are reading.
You know about us, now we want to get to know you!
Let's personalize your content
Let's get even more personalized
We recognize your account from another site in our network, please click 'Send Email' below to continue with verifying your account and setting a password.
Let's personalize your content