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.

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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]. Source link.

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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.

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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 ?? T cell therapy development activities. T cell therapy in NHL patients.

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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. Under the terms of the collaboration agreement, Alector will receive $700 million in upfront payments. About Alector.

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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].

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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? The study is an event-driven trial. Argentina and Brazil.

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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.

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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.

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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. In addition to Milciclib, the Company is also developing Foralumab for liver diseases.

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The Pharma Data

DECEMBER 11, 2020

A breakdown of the diversity of clinical trial participants can be found here from more than 150 clinical trial 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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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.,

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The Pharma Data

MAY 7, 2021

Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer- BioNTech COVID-19 Vaccine. anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 Vaccine.

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The Pharma Data

JULY 21, 2021

Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer-BioNTech COVID-19 Vaccine. Vaccination providers must report Adverse Events in accordance with the Fact Sheet to VAERS online at [link].

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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. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

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The Pharma Data

MAY 6, 2021

Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer-BioNTech COVID-19 Vaccine. anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 Vaccine.

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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.

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The Pharma Data

DECEMBER 27, 2020

(NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today provided a year-end review and an outline of its plans for 2021. An additional objective this year will be to build greater awareness for our past achievements and our future plans. Source link.

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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.

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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.

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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., This press release contains forward-looking statements.

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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.,

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The Pharma Data

DECEMBER 10, 2020

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. Rates of serious adverse events were similar between vaccine and placebo groups (0.6% kg/m2); and 21% had at least one underlying comorbidity.

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The Pharma Data

NOVEMBER 1, 2020

Furthermore, nasal anti-CD3 dampens cytotoxic CD8 T cell responses shown to cause lung damage in COVID-19. This scientific advancement provides the basis to move forward with clinical development of nasally administered Foralumab in COVID-19 disease.”

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The Pharma Data

APRIL 11, 2021

Opdivo plus chemotherapy also demonstrated improvements in key secondary endpoints, including major pathological response (MPR). Grade 3–4 treatment-related adverse events were reported in 34% vs. 37% in the Opdivo plus chemotherapy vs. chemotherapy alone arms, respectively. About CheckMate -816. About Lung Cancer.

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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.

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The Pharma Data

APRIL 16, 2021

The EC’s decision is based on results from the Phase 3 CheckMate -9ER trial, which demonstrated superior efficacy with Opdivo in combination with Cabometyx versus sunitinib across three key endpoints: progression-free survival (PFS), the primary endpoint, and objective response rate (ORR) and overall survival (OS). vs. 27.1%).

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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.

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The Pharma Data

JANUARY 3, 2021

Dr. Kimble Matos, the lead coordinating physician of the study, commented: “The observations made during the Clinical study did not show any adverse events.”. The clinical study enrolled a total of 39 patients with moderate to severe COVID-19 who did not require the use of a ventilator at the beginning of the study.

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The Pharma Data

NOVEMBER 29, 2020

Three cases of human leukocyte antigen (HLA)-sensitization have been reported, two as serious adverse events. An archived replay will be accessible for 30 days following the event. HOOKIPA’s viral vectors target antigen presenting cells in vivo to activate the immune system.

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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.

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The Pharma Data

AUGUST 11, 2020

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

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The Pharma Data

AUGUST 11, 2020

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

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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.

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The Pharma Data

OCTOBER 26, 2020

In addition, the observed median PFS shows that the regimen can induce a sustained and durable response, which is also shown consistently by the induction of a specific immune response.

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The Pharma Data

APRIL 4, 2023

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, can affect more than one body system simultaneously, and can occur at any time after starting treatment or after discontinuation of treatment. All patients with a recurrence of ALT ≥3 ULN subsequently recovered from the event.

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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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