2018, Immune Response and Licensing - Drug Discovery Digest

Gamma delta T cells: a rising star in cancer therapy

Drug Target Review

FEBRUARY 28, 2024

gammadelta T cells link innate and adaptive immune responses. Trends Immunol 39(6):446-459 (2018). Nat Commun 9(1):1760 (2018). Normality sensing licenses local T cells for innate-like tissue surveillance. J Front Immunol 9:1409 (2018). Holtmeier W, Kabelitz D. Chem Immunol Allergy 86:151-183 (2005).

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Sanofi and Translate Bio initiate Phase 1/2 clinical trial of mRNA COVID-19 vaccine candidate

The Pharma Data

MARCH 11, 2021

Clinical trial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels. MRT5500 is being developed under a collaboration and license agreement between Sanofi Pasteur and Translate Bio. Expected to enroll 415 participants; interim results expected in Q3 2021.

Clinical Trials

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Sanofi and Translate Bio initiate Phase 1 clinical trial of mRNA influenza vaccine

The Pharma Data

JUNE 26, 2021

We believe that mRNA technology could have several advantages for a seasonal flu application including the potential ability to demonstrate robust immune responses based on preclinical data to date, enable antigen specificity within a short timeframe from seasonal virus strain selection, and deploy agile manufacturing capacity.

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Bridging Innovation & Patient Care: The Growing Role of AI

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Where's the Synthetic Blood?

Codon

JULY 14, 2024

This is particularly beneficial for those who need chronic transfusions and are therefore at risk of developing an immune response to transfusion products from other people, or for those with religious beliefs, like Jehovah’s Witnesses, whose faith prohibits blood transfusions from another person. Science Robotics (2018).

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Tezepelumab granted Priority Review by U.S. FDA

The Pharma Data

JULY 8, 2021

Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) and granted Priority Review for tezepelumab in the treatment of asthma. Tezepelumab was granted an FDA Breakthrough Therapy Designation for patients with severe asthma without an eosinophilic phenotype in September 2018. 2018; 10 (1): 34-45.

FDA

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AZD7442 PROVENT Phase III prophylaxis trial met primary endpoint in.

The Pharma Data

AUGUST 22, 2021

More than 75% of participants had co-morbidities, which include conditions that have been reported to cause a reduced immune response to vaccination. Under the terms of the licensing agreement with Vanderbilt, AstraZeneca will pay single-digit royalties on future net sales. 2018; 37(9): 886-892. About AstraZeneca.

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U.S. FDA Approves PREVNAR 20™, Pfizer’s Pneumococcal 20-valent Conjugate Vaccine for Adults Ages 18 Years or Older

The Pharma Data

JUNE 18, 2021

On September 20, 2018, Pfizer announced the U.S. PREVNAR 20 is a vaccine indicated for active immunization for the prevention of pneumonia and invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in adults 18 years of age and older.

Vaccine

Vaccine FDA Approval FDA Disease

Tonix Pharmaceuticals Enrolls First Participant in the PRECISION Study, an Observational Study to Facilitate Development of Precision Medicine Techniques for COVID-19 Vaccines and Therapeutics

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. 2018) PLoS One.

Vaccine

Vaccine Pharmaceuticals Small Molecule Virus

Tezepelumab NAVIGATOR Phase 3 Trial Met Primary Endpoint Of A Statistically Significant And Clinically Meaningful Reduction In Exacerbations In A Broad Population Of Patients With Severe Asthma

The Pharma Data

NOVEMBER 9, 2020

2018 for patients with severe asthma, without an eosinophilic phenotype. TSLP is released in response to multiple triggers associated with asthma exacerbations, including allergens, viruses and other airborne particles. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures.

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Update On SOURCE Phase 3 Trial For Tezepelumab In Patients With Severe, Oral Corticosteroid-Dependent Asthma

The Pharma Data

DECEMBER 21, 2020

In September 2018 , the US Food and Drug Administration granted Breakthrough Therapy Designation for tezepelumab in patients with severe asthma, without an eosinophilic phenotype. TSLP is released in response to multiple triggers associated with asthma exacerbations, including allergens, viruses and other airborne particles.

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Update on Remestemcel-L For the Treatment of COVID-19 ARDS and Steroid-Refractory Acute GVHDQuarterly Activity Report

The Pharma Data

OCTOBER 28, 2020

Mesoblast has formally requested a Type A meeting with the FDA to discuss a potential accelerated approval of the Biologics License Application (BLA) for remestemcel-L for the treatment of SR-aGVHD in children, with an additional randomized controlled study in patients 12 years and older as a post-approval requirement. TEMCELL ® HS Inj.

Treatment

Treatment Trials Disease Production

Sanofi delivered close to double-digit Q4 2020

The Pharma Data

FEBRUARY 8, 2021

In Europe, where the product is commercially available in several countries and has a temporary license to be sold in France, sales were €12 million. The CRL refers to certain deficiencies identified by the agency during a pre-license inspection of a third-party facility responsible for manufacturing. glucosidase deficiency).

Vaccine

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Sanofi delivered close to double-digit Q4 2020 business EPS(1) growth at CER

The Pharma Data

FEBRUARY 4, 2021

In Europe, where the product is commercially available in several countries and has a temporary license to be sold in France, sales were €12 million. The CRL refers to certain deficiencies identified by the agency during a pre-license inspection of a third-party facility responsible for manufacturing. glucosidase deficiency).

Vaccine

Vaccine Production FDA Therapies

Sanofi continued its growth trajectory. Strong increase in Q1 2021 business EPS(1) at CER

The Pharma Data

APRIL 27, 2021

MRT5500 (SP0254), an mRNA vaccine candidate against SARS-CoV-2, entered Phase 1/2 to assess safety, immune response and reactogenicity. On January 12, 2021 Sanofi entered into a global licensing agreement with Biond Biologics for BND-22, a novel immune checkpoint inhibitor targeting the ILT2 receptor. Collaborations.

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Drug Discovery Digest

Gamma delta T cells: a rising star in cancer therapy

Sanofi and Translate Bio initiate Phase 1/2 clinical trial of mRNA COVID-19 vaccine candidate

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Sanofi and Translate Bio initiate Phase 1 clinical trial of mRNA influenza vaccine

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Where's the Synthetic Blood?

Tezepelumab granted Priority Review by U.S. FDA

AZD7442 PROVENT Phase III prophylaxis trial met primary endpoint in.

U.S. FDA Approves PREVNAR 20™, Pfizer’s Pneumococcal 20-valent Conjugate Vaccine for Adults Ages 18 Years or Older

Tonix Pharmaceuticals Enrolls First Participant in the PRECISION Study, an Observational Study to Facilitate Development of Precision Medicine Techniques for COVID-19 Vaccines and Therapeutics

Tezepelumab NAVIGATOR Phase 3 Trial Met Primary Endpoint Of A Statistically Significant And Clinically Meaningful Reduction In Exacerbations In A Broad Population Of Patients With Severe Asthma

Update On SOURCE Phase 3 Trial For Tezepelumab In Patients With Severe, Oral Corticosteroid-Dependent Asthma

Update on Remestemcel-L For the Treatment of COVID-19 ARDS and Steroid-Refractory Acute GVHDQuarterly Activity Report

Sanofi delivered close to double-digit Q4 2020

Sanofi delivered close to double-digit Q4 2020 business EPS(1) growth at CER

Sanofi continued its growth trajectory. Strong increase in Q1 2021 business EPS(1) at CER

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