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

Drug Target Review

APRIL 3, 2024

Our research demonstrated that GDF-15 acts as a versatile tool for tumours to inhibit the mounting of an effective antitumoral immune response at various steps of its process, including antigen presentation, immune cell activation, and their migration and infiltration into the tumour.

Science

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. Select Safety Information for PNEUMOVAX 23.

Vaccine

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. For more information about the COVE study, click here. About Moderna.

Vaccine

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. Takeda will assume responsibility for funding all development and commercialization activities.

Therapies

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.” About CEPI.

Clinical Trials

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.

Vaccine

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.

Clinical Trials

The Pharma Data

OCTOBER 21, 2020

The active IND enables the Company to initiate the first-in-human clinical trial to assess safety and efficacy of ADI-001 in NHL patients. The clearance of the IND for ADI-001 by the FDA is a significant milestone in the development of CAR ?? For more information, please visit our website at [link]. Forward-Looking Statements.

FDA

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.

Vaccine

The Pharma Data

OCTOBER 27, 2020

Adagrasib is an investigational small molecule and selective KRAS G12C inhibitor in clinical development as a monotherapy and in combinations. MRTX1133 is an investigational small molecule and selective KRAS G12D inhibitor in preclinical development. View original content to download multimedia: [link].

Small Molecule

The Pharma Data

JANUARY 3, 2021

We are very honored to have someone of Dr. Zeldis’ caliber lead our scientific research and clinical development teams. The backbone of NexImmune’s approach is its proprietary Artificial Immune Modulation (AIM TM ) nanoparticle technology platform. For more information, visit www.neximmune.com. . GAITHERSBURG, Md.,

Immune Response

The Pharma Data

NOVEMBER 9, 2020

The trial will serve as a foundation in demonstrating the potential of IP-001 to ignite the immune system, transforming a routine tumor ablation into a systemic immunotherapy,” said Lu Alleruzzo, CEO of Immunophotonics. “IP-001 undertakes no duty to update such information, except as required under applicable law. Markus Jörger, M.D.,

Clinical Trials

The Pharma Data

OCTOBER 9, 2021

The primary endpoint of the trial is clinical remission (using the modified Mayo score) at Week 12. Secondary endpoints include clinical response (using the modified Mayo score), endoscopic response, and histological improvement at Week 12. More information can be found on www.clinicaltrials.gov (NCT03934216).

Disease

The Pharma Data

MAY 15, 2023

The acquisition complements Gilead’s existing clinical development priorities by adding additional pipeline assets for well-validated targets in oncology and inflammation. Both programs have the potential to address multiple indications, offering broad development opportunities alone and in combination with Gilead’s portfolio.

Small Molecule

The Pharma Data

SEPTEMBER 9, 2020

producing CD8+ T cell responses, which is thought to promote an anti-viral effect. In a preclinical murine model, a single IM immunization of BNT162b2 (0.2, CD4+ and CD8+ T-cells from splenocytes isolated from BNT162b2-immunized mice were strongly positive for IFN? For more information, please visit www.BioNTech.de.

Vaccine

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. Alector Conference Call Information. In addition, Alector will be eligible to receive up to an additional $1.5

Disease

The Pharma Data

AUGUST 20, 2020

These results informed the selection of the BNT162b2 candidate for the pivotal Phase 2/3 global study in up to 30,000 participants that started in July 2020, which has to date enrolled more than 11,000 participants, including in areas with significant SARS-CoV-2 transmission. This press release features multimedia. and Germany.

Vaccine

The Pharma Data

JANUARY 31, 2021

Delivery of viral antigens in potent vaccine vectors to elicit a strong immune response is a cornerstone of successful infectious disease vaccines,” said Karin Jooss, PhD, Executive Vice President of Research and Chief Scientific Officer of Gritstone. For more information, please visit gritstoneoncology.com. Source link.

Vaccine

The Pharma Data

DECEMBER 11, 2020

Please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Full EUA Prescribing Information available at www.cvdvaccine.com. A breakdown of the diversity of clinical trial participants can be found here from more than 150 clinical trial sites in the U.S.,

Vaccine

The Pharma Data

JANUARY 17, 2021

REX-001, Ixaka’s lead MCT product, is an autologous cell-based product in clinical development for the treatment of CLTI. REX-001 is currently being evaluated in the pivotal Phase III SALAMANDER clinical trial at multiple sites across Europe. For more information, please visit www.ixaka.com.

Therapies

The Pharma Data

SEPTEMBER 9, 2020

During preclinical and clinical studies, BNT162b1 and BNT162b2 emerged as strong candidates based on assessments of safety and immune response. We routinely post information that may be important to investors on our website at www.Pfizer.com. The information contained in this release is as of September 7, 2020.

Vaccine

The Pharma Data

MAY 7, 2021

Please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Full EUA Prescribing Information available at www.cvdvaccine-us.com. IMPORTANT SAFETY INFORMATION FROM U.S. The information contained in this release is as of May 7, 2021. Pfizer Disclosure Notice.

Licensing

The Pharma Data

JULY 21, 2021

Please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Full EUA Prescribing Information available at www.cvdvaccine-us.com. IMPORTANT SAFETY INFORMATION FROM U.S. AUTHORIZED USE IN THE U.S.: Procedures should be in place to avoid injury from fainting.

Vaccine

The Pharma Data

MAY 6, 2021

Please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) including Full EUA Prescribing Information available at www.cvdvaccine.com. IMPORTANT SAFETY INFORMATION FROM U.S. The information contained in this release is as of May 6, 2021.

Vaccine

The Pharma Data

JANUARY 4, 2021

Barber’s work will give Kiromic a significant acceleration in the clinical development of its therapy platform and an even more significant advantage over its competitors. Chimeric PD-1 T-cells also release cytokines to further initiate immune responses to eradicate the tumor cells. “We believe Prof.

Therapies

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.” AUTHORIZED USE AND IMPORTANT SAFETY INFORMATION.

Hospitals

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%

Virus

The Pharma Data

NOVEMBER 10, 2020

Oral administration of anti-CD3 monoclonal antibody is a novel approach to induce an anti-inflammatory immune response to suppress inflammation by inducing T regulatory (Tregs) cells in animal studies 3 ,4. This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.

Clinical Trials

The Pharma Data

OCTOBER 14, 2020

(Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that the first participant was enrolled in the observational PRECISION study (TNX-C002), to examine the immune responses to COVID-19 in healthy volunteers who have recovered from COVID-19 or were asymptomatic.

Vaccine

The Pharma Data

DECEMBER 27, 2020

These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Forward-Looking Statements.

Therapies

Agency IQ

APRIL 12, 2024

For therapeutic protein products , a critical use of assays is the detection and assessment of potential anti-drug antibody (ADA) formation, signaling a product’s potential to induce an unwanted immune response. In short, the Society argued that establishing the potency of CGT products, particularly in early development, is difficult.

Production

Drug Target Review

JANUARY 15, 2024

The Class I HLA system presents fragments of intracellular antigens to CD8 T cells and allows the immune system to monitor intracellular events, thus providing an essential component of immunity against cancer. CD8+ T cells are a type of lymphocyte that specialises in scanning information presented by HLA Class I.

Engineering

Drug Target Review

OCTOBER 10, 2024

In the context of preclinical research, using healthy cells to study disease-specific mechanisms, cell-cell interactions, and immune responses can result in faulty data, missed therapeutic targets, and unanticipated immune responses. Furthermore, fostering cross-industry collaboration is essential.

Therapies

Agency IQ

JUNE 9, 2023

For this reason, animal models are still used both during drug discovery and the more intensive nonclinical studies conducted during clinical development. Finally, in either scenario, sponsors should consider adverse effects directly related to the product’s interaction with a biological component of the immune system (e.g.,

FDA

The Pharma Data

SEPTEMBER 8, 2021

. “These biomarker data provide direction for continued research into characterizing mutation profiles associated with sotorasib treatment response to help guide clinical practice and inform innovative combination approaches to overcome potential mechanisms of resistance.” About LUMAKRAS TM (sotorasib). In the U.S.,

Trials

The Pharma Data

DECEMBER 10, 2020

Data from this study, including longer term safety, comprehensive information on duration of protection, efficacy against asymptomatic SARS-CoV-2 infection, and safety and immunogenicity in adolescents 12 to 15 years of age will be gathered in the months ahead. The information contained in this release is as of December 10, 2020.

Vaccine