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. Moderna currently has strategic alliances for development programs with AstraZeneca PLC and Merck & Co.,

Vaccine 52

Vaccine Clinical Development RNA Clinical Trials 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. No serious adverse events related to the vaccine candidates studied were reported. CHENGDU, China , Feb. CHENGDU, China , Feb.

Clinical Trials 52

Clinical Trials Vaccine Trials Virus 52

The Pharma Data

OCTOBER 21, 2020

Nasdaq: ACET), a biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer and other diseases, today announced that the U.S. 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. MENLO PARK, Calif.

FDA 40

FDA Immune Response Engineering Clinical Trials 40

The Pharma Data

DECEMBER 20, 2020

In the first study, a phase 1/2 ‘basket’ trial of GPS in combination with the checkpoint inhibitor pembrolizumab (Keytruda), which is conducted under a Clinical Trial Collaboration and Supply Agreement with Merck & Co., Kenilworth, N.J., with a median follow-up of 9.4 Kenilworth, N.J.,

Immune Response 52

Immune Response Clinical Trials Therapies Trials 52

The Pharma Data

NOVEMBER 1, 2020

Highly innovative first-in-class study for treating COVID-19 disease with nasally administered drug. Clinical Data Expected by End of Year. Furthermore, nasal anti-CD3 dampens cytotoxic CD8 T cell responses shown to cause lung damage in COVID-19. NEW YORK and LONDON, Nov.

Clinical Trials 52

Clinical Trials Trials Medical Schools Hospitals 52

The Pharma Data

JANUARY 3, 2021

Preclinical data from our laboratory have shown that the nasal administration of anti-CD3 stimulates Tregs that can suppress inflammation and ameliorate inflammatory diseases. Furthermore, nasal anti-CD3 dampens cytotoxic CD8 T cell responses that are known to cause lung damage in COVID-19 patients.”. . NEW YORK and LONDON, Jan.

Clinical Trials 40

Clinical Trials Science Treatment Trials 40

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.” In the initial 275 patients, rates of adverse events (AEs) were similar among groups.

Hospitals 52

Hospitals Production Clinical Trials Virus 52

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. Similar clinical and virologic efficacy was observed for the high and low doses of the antibody cocktail.

Hospitals 52

Hospitals Trials Clinical Trials Production 52

The Pharma Data

JANUARY 20, 2021

INOVIO intends to use the net proceeds from this offering for the development of its clinical pipeline, including clinical development expenses relating to INO-4800 and research and development expenses, and for general corporate purposes, including working capital and general and administrative expenses.

DNA 40

DNA Immune Response Disease Clinical Trials 40

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].

Vaccine 52

Vaccine Clinical Trials Trials Immune Response 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. Serious adverse events were numerically more frequent with placebo than REGN-COV2 treatment (0.8% Yancopoulos , M.D.,

Virus 40

Virus Trials Clinical Trials Production 40

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.

Science 52

Science Vaccine Clinical Trials Pharmaceutical Companies 52

The Pharma Data

JULY 21, 2021

We believe that our mRNA technology can be used to develop vaccine candidates addressing other diseases as well. This is why we will continue to evaluate sustainable approaches that will support the development and production of mRNA vaccines on the African continent.”. “We CEO and Co-founder of BioNTech. “We

Vaccine 52

Vaccine Clinical Trials Licensing Licensing 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.

Science 52

Science Vaccine Clinical Trials Pharmaceutical Companies 52

The Pharma Data

NOVEMBER 29, 2020

Early interim data show Cytomegalovirus (CMV)-negative kidney transplant recipients vaccinated with three doses of HB-101 had reduced incidence of CMV viremia, reduced antiviral use and no CMV disease. Observed CMV-neutralizing antibody responses and tolerability profile are consistent with previous interim results.

Vaccine 52

Vaccine Clinical Trials Disease Therapies 52

The Pharma Data

DECEMBER 11, 2020

Centers for Disease Control and Prevention (CDC), will manage allocation and distribution of the vaccine in the U.S. This will be prioritized according to the populations identified by the CDC’s Advisory Committee on Immunization Practices (ACIP) guidelines. CEO and Co-founder of BioNTech.

Vaccine 52

Vaccine Clinical Trials Licensing Licensing 52

The Pharma Data

MAY 7, 2021

Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. AUTHORIZED USE IN THE U.S.:

Licensing 52

Licensing Licensing Vaccine FDA Approval 52

The Pharma Data

MAY 6, 2021

Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. AUTHORIZED USE IN THE U.S.:

Vaccine 52

Vaccine Clinical Trials Licensing Licensing 52

The Pharma Data

DECEMBER 10, 2020

These pivotal data demonstrate that our COVID-19 vaccine candidate is highly effective in preventing COVID-19 disease and is generally well-tolerated. The most common adverse events of BNT162b2 were transient, mild to moderate pain at the injection site, fatigue and headache, and these generally resolved within two days.

Vaccine 52

Vaccine Trials Clinical Trials Therapies 52

The Pharma Data

DECEMBER 27, 2020

To Our Shareholders, As we reach the end of an eventful 2020, we are inspired by the many healthcare providers and biopharmaceutical companies that worked to combat the COVID-19 pandemic. An additional objective this year will be to build greater awareness for our past achievements and our future plans. Forward-Looking Statements.

Therapies 52

Therapies Clinical Trials Production Treatment 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. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines.

Vaccine 52

Vaccine Clinical Trials Trials Government 52

Drug Target Review

JANUARY 15, 2024

Antibodies in general cannot cross the plasma membrane or direct responses against intracellular targets, whereas many critical steps in oncogenesis and tumour pathology occur inside the cell, concealed from the protective effects of antibodies. Many potential candidate antigens are under consideration.

Engineering 108

Engineering DNA Virus Medical Schools 108

The Pharma Data

JULY 6, 2021

AL001 is also currently in a Phase 2 study in symptomatic FTD patients with a mutation in the C9orf72 gene and is planned to enter Phase 2 development for amyotrophic lateral sclerosis (ALS) in the second half of 2021. billion in clinical development, regulatory and commercial launch-related milestone payments. Outside the U.S.,

Disease 52

Disease Science Immune Response Clinical Development 52

The Pharma Data

MARCH 29, 2022

Application based on CheckMate -816, the only Phase 3 trial to demonstrate improved event-free survival and pathologic complete response with an immunotherapy-based combination in the neoadjuvant setting of NSCLC. Opdivo -based treatments have shown clinical benefit in four Phase 3 trials in earlier stages of cancer.

Treatment 52

Treatment Clinical Trials Trials Immune Response 52

The Pharma Data

SEPTEMBER 9, 2020

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced preliminary preclinical data in mouse and non-human primate models from their BNT162b2 mRNA-based vaccine program against SARS-CoV-2, the virus that causes COVID-19 disease. producing CD8+ T cell responses, which is thought to promote an anti-viral effect. Argentina and Brazil.

Vaccine 52

Vaccine RNA Clinical Trials Immune Response 52

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 40

FDA Small Molecule Science Immune Response 40

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.

Clinical Trials 52

Clinical Trials Vaccine Trials Immune Response 52

The Pharma Data

APRIL 11, 2021

Additionally, Opdivo plus chemotherapy was well tolerated and showed consistent improvements in pCR regardless of PD-L1 expression levels, histologies or stages of disease. The ultimate goal of treatment in earlier stages of cancer is to prevent the disease from coming back as we work towards a cure for these patients.

Trials 52

Trials Treatment Immune Response Clinical Trials 52

The Pharma Data

APRIL 16, 2021

Two Opdivo -based therapies are now authorized for first-line treatment of patients with advanced renal cell carcinoma in the European Union: Opdivo plus Yervoy , a standard of care in intermediate- or poor-risk disease, and Opdivo in combination with Cabometyx , approved regardless of risk status. PRINCETON, N.J.–(BUSINESS

Treatment 52

Treatment Trials Clinical Trials Immune Response 52

The Pharma Data

MARCH 31, 2023

months, Opdivo with chemotherapy reduced the risk of disease recurrence, progression or death by 32%, demonstrating a landmark three-year event-free survival (EFS) rate of 57% with Opdivo with chemotherapy compared to 43% with chemotherapy alone (Hazard Ratio [HR], 0.68; 95% Confidence Interval [CI], 0.49 With median follow up of 41.4

Trials 40

Trials Clinical Trials Treatment Immune Response 40

The Pharma Data

SEPTEMBER 15, 2020

Major revenue contributions through 2025 anticipated from Oncology, Vaccines, Rare Disease and Inflammation and Immunology. In addition to the COVID-19 vaccine program, Pfizer aims to deliver five innovative vaccines by 2025, subject to clinical success and regulatory approval. BNT162 mRNA-based Vaccine Program.

Vaccine 52

Vaccine Therapies Trials Clinical Trials 52

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 40

Vaccine Pharmaceuticals Small Molecule Virus 40

The Pharma Data

AUGUST 11, 2020

.–( BUSINESS WIRE )– Bristol Myers Squibb (NYSE: BMY) today announced the Phase 3 CheckMate -577 trial evaluating Opdivo (nivolumab) as an adjuvant therapy for patients with resected esophageal or gastroesophageal junction (GEJ) cancer met its primary endpoint of disease-free survival (DFS) at a pre-specified interim analysis.

Therapies 52

Therapies Trials Disease Treatment 52

The Pharma Data

OCTOBER 26, 2020

“The results we have announced today demonstrate the potential of the combination of TG4001 with an immune checkpoint inhibitor in this particularly severe disease setting. We observed very encouraging responses rates, as high as 34.8 % in patients who did not have liver metastases. Methods.

Vaccine 52

Vaccine Virus Trials Treatment 52

The Pharma Data

AUGUST 11, 2020

Responses to the current standard chemotherapy in patients are short lived, and less than 6% of patients with metastatic disease survive beyond five years,” said Yelena Y. All patients continued treatment for two years or until disease progression, unacceptable toxicity or withdrawal of consent. Janjigian, M.D., About Opdivo.

Treatment 52

Treatment Trials Therapies Clinical Trials 52

The Pharma Data

APRIL 4, 2023

Patients were treated until disease progression or unacceptable toxicity. Thirty-seven percent of patients had upper tract disease. Patients in the dose escalation cohort (n=5), Cohort A (n=40), and Cohort K (n=76) received enfortumab vedotin 1.25 A total of 121 patients received KEYTRUDA in combination with enfortumab vedotin.

FDA Approval 40

FDA Approval Treatment FDA Therapies 40