Drug Target Review

MARCH 21, 2024

There are a few approved therapies for DMD including four exon-skipping drugs and one AAV-microdystrophin drug, which uses a shortened version of dystrophin. AAV-based therapies often can’t be dosed more than once due to concerns about an immune response. Molecular Therapy-Nucleic Acids. Human molecular genetics.

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Drug Target Review

OCTOBER 26, 2023

Genome engineering and gene therapies that manipulate DNA sequences in cells have driven a biotechnological revolution over the past decade. 9 In addition, host immune responses further add to the complexity of developing cell-specific AAV capsids for clinical applications.

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Drug Target Review

OCTOBER 4, 2023

More recently, researchers have begun to look at conjugating immunomodulatory agents to antibodies to directly activate an immune response against the tumour. This approach – immune-stimulating antibody conjugates (ISACs) – uses a payload that stimulates the innate and adaptive immune responses, recruiting tumour-fighting T cells.

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Small Molecule Drugs Immune Response Targeted Protein Degradation 126

Broad Institute

OCTOBER 4, 2023

The molecule’s dual mechanism of action — targeting both tumor and immune cells — is unique compared to other cancer immunotherapies including PD-1 drugs, and the researchers think it could explain why the molecule was so effective on its own in animal models and may not even need to be used in combination with other drugs such as anti-PD-1 therapy.

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Drug Target Review

DECEMBER 5, 2024

Viral vectors have been crucial in transforming the gene therapy landscape due to their natural ability to infect cells. 1 In 2017, the US Food and Drug Administration (FDA) approved the first AAV-based gene replacement therapy (Luxturna), for Leber congenital amaurosis type 2.

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The Pharma Data

DECEMBER 17, 2020

“At Janux, we have developed a technology to engineer best-in-class T cell engagers that are potent and highly tumor-specific, which is essential for an immune response that kills tumor cells but spares healthy tissue,” David Campbell, president and chief executive officer of Janux Therapeutics said in a statement.

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Drug Target Review

NOVEMBER 7, 2024

Agonist antibodies of immune checkpoint regulators These represent a groundbreaking class of immunotherapeutic agents that mimic the natural function of endogenous ligands by binding to specific cell-surface receptors. Often immunological diseases involve deficiencies or dysregulation of immune function.

Disease 52

Disease Immune Response Regulations Engineering 52

Drug Target Review

APRIL 3, 2024

Our company has identified a new role for Growth Differentiation Factor 15 (GDF-15) as a potent local immunosuppressor mediating cancer resistance to therapy. in North America) in late 2017. I am currently working as Chief Scientific Officer at CatalYm, where we translate the latest scientific findings into clinical applications.

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Science Clinical Development Treatment DNA 105

The Pharma Data

DECEMBER 3, 2020

Strong Th1 cell-mediated immune responses were also observed for the vaccine candidates with either adjuvant. We are encouraged by the high level of neutralizing antibodies in combination with the strong Th1 response which we believe could play an important role in controlling infection.

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Vaccine Immune Response Virus RNA 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. CEPI has moved with great urgency and in coordination with WHO in response to the emergence of COVID-19. CHENGDU, China , Feb. About Dynavax.

Clinical Trials 52

Clinical Trials Vaccine Trials Virus 52

The Pharma Data

JANUARY 31, 2021

Clover’s S-Trimer antigen adjuvanted with CpG 1018 plus alum demonstrated low reactogenicity while providing high levels of neutralizing antibodies and a strong Th1-biased cell-mediated immune response. Dynavax developed CpG 1018 to provide an increased vaccine immune response, which has been demonstrated in HEPLISAV-B.

Vaccine 52

Vaccine Trials Virus RNA 52

The Pharma Data

NOVEMBER 10, 2020

We’re excited to be collaborating with Tiziana to support the development of a novel, oral therapy that could provide Crohn’s patients with another option in their repertoire of treatments to combat this devastating disease.”. Parexel is focused on supporting the development of innovative therapies to improve patient health.

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The Pharma Data

JUNE 18, 2021

Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for PREVNAR 20 for the prevention of invasive disease and pneumonia in adults age 18 years or older. The FDA previously granted Fast Track designation for PREVNAR 20 in September 2017 for use in adults aged 18 years or older. IMPORTANT SAFETY INFORMATION.

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Vaccine FDA Approval FDA Disease 52

The Pharma Data

DECEMBER 15, 2020

Daratumumab induced substantial clinical responses in the patients. The clinical responses were sustained by maintenance therapy with belimumab, an antibody to B-cell activating factor. 2 g/dl on three consecutive available visits during the 24-week treatment period, with the response not being attributed to rescue therapy.

Disease 52

Disease Clinical Trials Small Molecule Trials 52

The Pharma Data

SEPTEMBER 15, 2020

Based on the acceptable safety profile and the favorable immune response data, including the 4th dose response data, Pfizer received Breakthrough Therapy Designation. These data represent the longest period of durability observed to date by a gene therapy for hemophilia B patients.

Vaccine 52

Vaccine Therapies Trials Clinical Trials 52

The Pharma Data

APRIL 7, 2023

Patients were treated with Imfinzi in combination with chemotherapy and bevacizumab followed by Imfinzi , Lynparza and bevacizumabas maintenance therapy. Since the first approval in May 2017, more than 150,000 patients have been treated with Imfinzi.

Trials 40

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The Pharma Data

SEPTEMBER 10, 2021

Imfinzi is the only approved immunotherapy in the curative-intent setting of unresectable, Stage III NSCLC after chemoradiation therapy and is the global standard of care based on the PACIFIC Phase III trial. Since the first approval in May 2017, more than 100,000 patients have been treated with Imfinzi. for chemotherapy.

Treatment 52

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The Pharma Data

JANUARY 3, 2021

Based on animal studies, the nasal and oral administration of Foralumab offers the potential for the immunotherapy of autoimmune and inflammatory diseases in a safe manner by the induction of Tregs.

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Clinical Trials Science Treatment Trials 40

The Pharma Data

JULY 23, 2021

Opdivo was first granted this indication in 2017 under the FDA’s accelerated approval program, making it the first immunotherapy agent to be approved for use in this setting. The accelerated approval was based on tumor responses from the Phase 1/2 CheckMate -040 trial. About Opdivo.

Treatment 52

Treatment Trials Therapies Disease 52

The Pharma Data

OCTOBER 28, 2020

Adults with COVID-19 ARDS As cases of COVID-19 surge in the United States and globally, deaths continue to increase from ARDS in ventilator-dependent patients as a result of an overactive immune response in the lungs to COVID-19. AHA’s 2017 Heart Disease and Stroke Statistics 7.Decision CDC Facts and Figures 2015.

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Treatment Trials Disease Production 40

The Pharma Data

NOVEMBER 1, 2020

Based on animal studies, the nasal and oral administration of Foralumab offers the potential for the immunotherapy of autoimmune and inflammatory diseases in a safe manner by the induction of Tregs.

Clinical Trials 40

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The Pharma Data

MARCH 11, 2021

In 2017, Opdivo was granted accelerated approval by the FDA as a single agent for patients with HCC who have been previously treated with sorafenib. The accelerated approval was based on tumor responses from the Phase 1/2 CheckMate -040 trial. This indication is approved under accelerated approval based on overall response rate.

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Treatment Trials Therapies FDA Approval 52

The Pharma Data

NOVEMBER 9, 2020

Food and Drug Administration Breakthrough Therapy Designation granted to tezepelumab in Sept. TSLP is released in response to multiple triggers associated with asthma exacerbations, including allergens, viruses and other airborne particles. It’s a commitment that extends beyond introducing novel therapies.

Trials 52

Trials Production Clinical Trials Government 52

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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Trials Production Clinical Trials Therapies 40

The Pharma Data

MARCH 16, 2021

1,2 TREMFYA is the first and only IL-23 inhibitor therapy approved in the U.S. for the treatment of adults with moderate to severe plaque PsO in July 2017 and in July 2020 for adults with active PsA. to treat both adults with active PsA and adults with moderate to severe plaque psoriasis (PsO). TREMFYA was approved in the U.S.

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Treatment Disease Pharmacokinetics Therapies 52

The Pharma Data

OCTOBER 26, 2020

. An overall response rate of 23.5% 8 patients achieved confirmed response, including 1 complete response and 7 partial responses (according to RECIST 1.1). Responses were observed in all primary tumor types and across all lines of prior therapy. months versus 0% and a PFS of 1.4

Vaccine 40

Vaccine Trials Treatment Virus 40

Broad Institute

NOVEMBER 6, 2024

Motivated to make immunotherapy safer, Reynolds teamed up with researcher Alexandra-Chloé Villani to launch the Severe Immunotherapy Complications (SIC) Service and Clinical-Translational Research Effort in 2017. These are home-run, breakthrough therapies, and quite an amazing success story. How did you go about launching this effort?

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Research Immune Response Hospitals Therapies 131

Broad Institute

NOVEMBER 6, 2024

By Leah Eisenstadt November 6, 2024 Credit: Ricardo Job-Reese, Broad Communications Despite being one of the rarer complications from immune checkpoint inhibitors, myocarditis is the most deadly. This work provides a biological foundation for testing more targeted therapies for myocarditis due to an immune checkpoint inhibitor.

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