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 Vaccination Vaccine 52

The Pharma Data

AUGUST 6, 2020

AstraZeneca reached a licensing deal with Chinese firm BioKangtai to help provide its adenovirus vector-based COVID-19 vaccine candidate, created by the University of Oxford, to China, AstraZeneca said (Chinese) in a social media post on Thursday. China has several home-grown COVID-19 vaccines in clinical development.

Vaccination 52

Vaccination Vaccine Antibody Licensing 52

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. This press release features multimedia.

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Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

DECEMBER 20, 2020

BT-001 is being co-developed through a 50/50 collaboration between BioInvent and Transgene. “This clinical trial approval sets the stage to further broaden BioInvent’s promising clinical pipeline. BT-001 is our fourth program in clinical development. The Company’s validated, proprietary F.I.R.S.T

Trials 52

Trials Antibody Clinical Trials Clinical Trials 52

The Pharma Data

MARCH 29, 2022

Discovered by Vanderbilt University Medical Center and licensed to AstraZeneca in June 2020, the human monoclonal antibodies bind to distinct sites on the SARS-CoV-2 spike protein16 and were optimised by AstraZeneca with half-life extension and reduction of Fc effector function. 1-3 Evusheld was generally well-tolerated in the trial.

Antibody 52

Antibody In-Vivo In-Vitro Vaccination 52

The Pharma Data

MAY 7, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine. The Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients.

Licensing 52

Licensing Licensing Vaccination Vaccine 52

The Pharma Data

JANUARY 4, 2021

We believe our allogenic CAR-T platform is significantly stronger with chPD1 target licensed from Longwood University. 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. “We believe Prof.

In-Vivo 40

In-Vivo Development Immune Response Big Data 40

The Pharma Data

DECEMBER 15, 2020

Anokion is responsible for preclinical activities and Phase I clinical development of partnered programs, and Bristol Myers Squibb will fund subsequent trials and commercial activities at clinical proof-of-concept.

Clinical Trials 52

Clinical Trials Clinical Trials Antibody Trials 52

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?

Vaccination 52

Vaccination Vaccine RNA Clinical Trials 52

Pfizer

FEBRUARY 16, 2023

The clinical trial remains ongoing with other sites not operated by the third party, and Pfizer continues to enroll new participants at those sites. The companies intend to work with regulatory authorities, and as previously announced, 1,2 aim for Pfizer to potentially submit a Biologics License Application (BLA) to the U.S.

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Clinical Trials Clinical Trials Vaccination Vaccine 76

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. 1 Noyce RS, et al.

Vaccination 40

Vaccination Vaccine Development Medicine 40

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. Emergency Use Authorization .

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Vaccination Vaccine Protein Immune Response 111

Pfizer

NOVEMBER 2, 2022

The vaccine candidate combines Pfizer’s quadrivalent modRNA-based influenza vaccine candidate, qIRV (22/23), which is currently in Phase 3 clinical development , and Pfizer and BioNTech’s authorized Omicron-adapted bivalent COVID-19 BNT162b2 (Original/Omicron BA.4/BA.5) a 2-dose primary series to individuals 5 years of age and older.

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Vaccination Vaccine Clinical Trials Clinical Trials 85

The Pharma Data

DECEMBER 29, 2020

(NASDAQ: REGN) today announced encouraging initial data from an ongoing Phase 1/2/3 clinical trial of the Regeneron antibody cocktail, casirivimab and imdevimab, in hospitalized COVID-19 patients requiring low-flow oxygen. Evaluation of its safety and efficacy is ongoing in multiple clinical trials. futility analysis). .

Antibody 52

Antibody Trials Production Clinical Trials 52

The Pharma Data

AUGUST 20, 2020

T cell immune responses elicited by BNT162b2 are being evaluated in the German study and the companies expect to submit the data for peer review and potential publication. trial and we look forward to sharing T cell immune response data from the German trial in the near future.”. “It View the full release here: [link].

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical 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%

Antibody 40

Antibody Trials Production Clinical Trials 40

The Pharma Data

SEPTEMBER 15, 2020

In addition to the COVID-19 vaccine program, Pfizer aims to deliver five innovative vaccines by 2025, subject to clinical success and regulatory approval. Based on the acceptable safety profile and the favorable immune response data, including the 4th dose response data, Pfizer received Breakthrough Therapy Designation.

Gene Therapy 52

Gene Therapy Vaccination Vaccine Trials 52

The Pharma Data

NOVEMBER 29, 2020

HOOKIPA’s viral vectors target antigen presenting cells in vivo to activate the immune system. Both technologies enable repeat administration to augment and refresh immune responses. To expand its infectious disease portfolio, HOOKIPA entered into a collaboration and licensing agreement with Gilead Sciences, Inc.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

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. Food and Drug Administration (FDA), based on preliminary data from Phase 1/2 studies that are currently ongoing in the U.S. and Germany as well as animal immunogenicity studies.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

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.” “The investigational cocktail is now available to indicated high-risk U.S.

Antibody 52

Antibody Medicine Production 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

The Pharma Data

APRIL 26, 2022

STRIDE regimen of a single priming dose of tremelimumab added to Imfinzi is the first dual immune checkpoint blockade regimen to improve overall survival in a Phase III trial in this setting. Tremelimumab blocks the activity of CTLA-4, contributing to T-cell activation, priming the immune response to cancer and fostering cancer cell death.

Immune Response 52

Immune Response Trials Protein Antibody 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. among adults 65 years of age or older.

Vaccination 52

Vaccination Vaccine Immune Response Containment 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. Emergency Use Authorization.

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Vaccination Vaccine Medicine Clinical Trials 100

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).

Vaccination 81

Vaccination Vaccine Clinical Trials Clinical Trials 81

Pfizer

JULY 8, 2022

Food and Drug Administration (FDA) approved the companies’ supplemental Biologics License Application (sBLA) for their COVID-19 vaccine, known as COMIRNATY® (COVID-19 Vaccine, mRNA), to include individuals 12 through 15 years of age. NEW YORK and MAINZ, GERMANY, July 8, 2022 — Pfizer Inc. have completed a primary series.

FDA Approval 102

FDA Approval Vaccination Vaccine Clinical Trials 102

The Pharma Data

DECEMBER 11, 2020

Pfizer and BioNTech expect to file a Biologics License Application for possible full regulatory approval in 2021. A breakdown of the diversity of clinical trial participants can be found here from more than 150 clinical trial sites in the U.S., NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today that the U.S.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

MAY 6, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine. The Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

JULY 21, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine. Procedures should be in place to avoid injury from fainting.

Vaccination 52

Vaccination Vaccine Manufacturing Clinical Trials 52

The Pharma Data

DECEMBER 20, 2020

“We are encouraged by the data shown in these two studies of GPS in combination with checkpoint inhibitors and look forward to additional data from these studies,” stated Dragan Cicic, MD, Senior Vice President, Clinical Development of SELLAS. “We Kenilworth, N.J.,

Life Science 52

Life Science Immune Response Trials Clinical Trials 52

The Pharma Data

DECEMBER 10, 2020

A breakdown of the diversity of clinical trial participants can be found here from approximately 150 clinical trials sites in the U.S., The Phase 3 trial is designed as a 1:1 vaccine candidate to placebo, randomized, observer-blinded study to obtain safety, immune response, and efficacy data needed for regulatory review.

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Vaccination Vaccine Trials Medicine 52

The Pharma Data

SEPTEMBER 8, 2020

Together, these nine companies have collectively developed more than 70 novel vaccines that have helped to eradicate some of the world’s most complex and deadly public health threats, underscoring their experience in clinical development and regulatory rigor, as well as their longstanding commitments to patient safety and public health.

Vaccination 52

Vaccination Vaccine Containment Clinical Trials 52

The Pharma Data

SEPTEMBER 8, 2020

Together, these nine companies have collectively developed more than 70 novel vaccines that have helped to eradicate some of the world’s most complex and deadly public health threats, underscoring their experience in clinical development and regulatory rigor, as well as their longstanding commitments to patient safety and public health.

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Vaccination Vaccine Containment Clinical Trials 52