Drug Target Review

DECEMBER 13, 2023

42 genes were found to be potentially tractable for novel drug discovery approaches for long COVID, of these 13 genes have drugs in clinical development pipelines. She is a computational biologist with a background in bioprocess engineering and biotechnology. Can you elaborate on how these antagonists may help with long COVID?

Bioinformatics 145

Bioinformatics Disease Regulations Immune Response 145

Drug Target Review

APRIL 22, 2024

What are the primary methods used for bioconjugation in antibody drug-conjugate (ADC) development, and how do they influence the stability and efficacy of the resulting ADCs? Site-specific conjugation methods are primarily utilised for a significant portion of ADCs in clinical developments.

Pharmacokinetics 75

Pharmacokinetics Drugs Organic Chemistry Engineering 75

Plenge Gen

MARCH 10, 2021

As a post-doc and, eventually, head of clinical development at a now defunct Bay Area biotech company in the 1990’s, she did research on genetically engineered T cells and hematopoietic stem cells to redirect the immune system to specifically target and kill cancer and HIV-infected cells.

Clinical Development 52

Clinical Development Therapies Engineering Research 52

The Pharma Data

DECEMBER 13, 2020

HMBD-001 is a uniquely differentiated anti-HER3 neutralizing antibody that was developed using Hummingbird’s proprietary Rational Antibody Discovery platform. HMBD-001 has been immune-engineered to bind with high affinity to the HER3 dimerization interface and block HER3 growth signals to the cancer. ” About NRG1 fusions.

Clinical Development 40

Clinical Development Clinical Trials Therapies Trials 40

The Pharma Data

DECEMBER 31, 2020

where he led global clinical development programs including clinical strategy, clinical development, and regulatory affairs. Prior to Taiho, he held the positions of senior vice president of Clinical Oncology and CMO at Geron Corporation. and CMO for Taiho Oncology, Inc.

Engineering 52

Engineering Pharmaceuticals Clinical Development Virus 52

FDA Law Blog: Drug Discovery

JANUARY 4, 2023

Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and contr­­ols (CMC).

Therapies 59

Therapies Engineering Production FDA 59

The Pharma Data

DECEMBER 22, 2020

Merck will assist with preclinical development and has the option to exclusively develop, manufacture and commercialize the candidate following Phase 1. The company engineers T cells that target the loss of genetic material in tumors, enabling the selective killing of tumor cells while leaving normal cells unharmed.

Therapies 52

Therapies Research Laboratories Engineering Laboratories 52

Alta Sciences

FEBRUARY 8, 2024

The FDA guidance, Evaluating Drug Effects on the Ability to Operate a Motor Vehicle , indicates that testing in early-phase clinical development should emphasize sensitivity over specificity in CNS effects.

Clinical Trials 52

Clinical Trials Trials Clinical Pharmacology Clinical Development 52

Broad Institute

OCTOBER 11, 2023

Together, Haining, Manguso , and Yates went on to found the Tumor Immunotherapy Discovery Engine ( TIDE ) at the Broad Institute of MIT and Harvard in 2017 with support from Calico as a collaborating partner. “We wanted to see whether there were as yet undiscovered drug targets that would lead to amazing cancer immunotherapies,” Manguso said.

Research 137

Research Immune Response Clinical Trials Therapies 137

Drug Target Review

DECEMBER 28, 2023

Researchers believe there is potential for its use in other modalities such as clonal neoantigen cancer vaccines (mRNA vaccines or other vaccine platforms using highly immunogenic clonal neoantigens to improve efficacy) and T-cell receptor (TCR) therapy, wherein T cells could be engineered with receptors that target shared neoantigens.

Bioinformatics 105

Bioinformatics Immune Response DNA Vaccine 105

Codon

MARCH 20, 2023

🧪 Papers AI + Bio Protein-specific signal peptides for mammalian vector engineering. Biological Engineering Generation of functional oocytes from male mice in vitro. Marine biofilm engineered to produce current in response to small molecules. Marine biofilm engineered to produce current in response to small molecules.

Virus 52

Virus Engineering RNA Small Molecule 52

The Pharma Data

AUGUST 24, 2020

This requires an 11-day programme which involves extracting blood from an HIV patient and separating their T cells, which are then engineered in a lab to make them immune to HIV. In a paper published in Molecular Therapy: Methods & Clinical Development , the team discussed why they choose this type of gene therapy to treat HIV.

FDA Approval 52

FDA Approval Therapies Trials FDA 52

Codon

MARCH 24, 2024

In the first real test of delivering a complex biomolecule to over a billion people, little has changed from how Genentech first approached manufacturing in the 1980s; Cells are genetically engineered and then grown in steel tanks. To make matters worse, many companies struggled with engineering problems on the path to scale.

Engineering 85

Engineering Vaccine Production RNA 85

The Pharma Data

DECEMBER 10, 2020

Spending several years with Sanofi in Paris, France as a Global safety officer, he then relocated to New Jersey, USA to work in Early and Late Stage Clinical Development in Immunology, when he became the Global Project Head of Dupixent, a medicine that has revolutionized the field of allergic and atopic diseases. Source link.

Disease 52

Disease Research Doctors Clinical Development 52

The Pharma Data

OCTOBER 26, 2020

With a premiere synthetic biology platform that leverages a reproducible, modular approach to microbial engineering, Synlogic designs Synthetic Biotic therapeutics that target validated underlying biology to treat disease in new ways. About Synlogic Synlogic is bringing the transformative potential of synthetic biology to medicine.

Clinical Trials 52

Clinical Trials Clinical Development Trials Engineering 52

The Pharma Data

DECEMBER 17, 2020

Kurtz brings more than 26 years of experience in global manufacturing, engineering, supply chain, CMC development and program management for drugs and devices at various stages of development. Cadavid will be responsible for the strategy, direction and execution of the company’s clinical development programs.

Small Molecule 52

Small Molecule Engineering Clinical Development Pharmaceuticals 52

Drug Target Review

DECEMBER 13, 2024

7,8 The discovery of these biomarkers provides valuable insights into prognosis and disease progression, while also guiding the clinical development of new targeted immunotherapies. Engineering sites on the antibody to enable specific and consistent attachment of the cytotoxic drug to achieve an optimal drug-to-antibody ratio (DAR).

Therapies 98

Therapies Treatment Clinical Trials Drugs 98

The Pharma Data

DECEMBER 13, 2020

Nasdaq: SYBX ), a clinical stage company bringing the transformative potential of synthetic biology to medicine, today announced SYNB1891 has advanced into the combination therapy stage of the ongoing Phase 1 trial. CAMBRIDGE, Mass. , 14, 2020 /PRNewswire/ — Synlogic, Inc. Sokolovska, A., Nature Communications 11, 2739 (2020)).

Immune Response 40

Immune Response Treatment Engineering Clinical Trials 40

LifeSciVC

MAY 9, 2024

The world of cell therapy is another that has driven forward the I-O landscape, a scientific approach that involves engineering T cells to drive anti-tumor immune responses when infused into patients. A notable late-stage therapeutic candidate is Moderna and Merck’s mRNA-4157, which is advancing through Phase 3 clinical development.

Immune Response 78

Immune Response Vaccine Therapies Engineering 78

Advarra

AUGUST 10, 2023

This will aid clinical development and preparation for investigational new drug (IND) and biologics license application (BLA) submissions. The project should also help clinical research sponsors take advantage of various FDA pathways for accelerated review and approval.

Drug Development 52

Drug Development Disease Therapies Engineering 52

The Pharma Data

OCTOBER 21, 2020

(Nasdaq: SYBX), a clinical stage company bringing the transformative potential of synthetic biology to medicine, today announced that it will present a poster on SYNB8802, an investigational Synthetic Biotic medicine for the treatment of Enteric Hyperoxaluria (HOX), during the American Society of Nephrology (ASN) Kidney Week, Oct.

Clinical Trials 40

Clinical Trials Engineering Clinical Development Treatment 40

PPD

NOVEMBER 14, 2023

In this complex environment, functional service partnership (FSP) models have become a solution of choice for pharmaceutical and biotech companies navigating the challenges of clinical development. Here’s how we do it.

Clinical Research 52

Clinical Research Clinical Development International Engineering 52

The Pharma Data

MAY 31, 2022

BIIB122 is an investigational small molecule inhibitor of LRRK2 that was discovered and developed by Denali. Denali and Biogen are co-developing and co-commercializing BIIB122 for the potential treatment of Parkinson’s disease. Senior Vice President, Head of Neurodegeneration Development at Biogen.

Disease 52

Disease Small Molecule Engineering Treatment 52

The Pharma Data

OCTOBER 27, 2020

Clynes established the critical role of Fc receptor engagement underlying the efficacy of antitumor antibodies, providing the road map for the development of a new class of potency enhanced Fc engineered antibodies in cancer, including anti-CD20, anti-CD19 and anti-HER2 antibodies (obinutuzumab, tafacitamab, margetuximab).

Virus 40

Virus Engineering Clinical Development International 40

The Pharma Data

OCTOBER 21, 2020

T cell therapies by Adicet, and marks the beginning of clinical development of a deep pipeline of “off-the-shelf” ?? We are particularly excited to advance on our goal to exploit the therapeutic potential of our first in class engineered CAR ?? T cell products,” said Chen Schor, President and Chief Executive Officer of Adicet.

FDA 40

FDA Immune Response Clinical Trials Engineering 40

The Pharma Data

MAY 31, 2022

Senior Vice President, Clinical Development, BlueRock Therapeutics. “We We are excited that our Phase 1 clinical trial has completed enrollment and believe it is a critical next step toward the development of a novel cell therapy that has the potential to transform the treatment landscape for this devastating disease.”.

Trials 52

Trials Disease Clinical Trials Engineering 52

The Pharma Data

APRIL 15, 2022

” Jewett is a professor of chemical and biological engineering at Northwestern’s McCormick School of Engineering and director of Northwestern’s Center for Synthetic Biology. When we put the spike protein and our antiviral therapeutic in a test tube together for a week, they stayed connected and never fell apart.”

Treatment 52

Treatment Virus Laboratories Engineering 52

The Pharma Data

NOVEMBER 18, 2020

SEFA’ stands for Structurally Engineered Fatty Acid, i.e. chemically engineered fatty acids, to generate compounds with differentiated physiochemical properties. The Company’s third SEFA, 6179, is expected to enter the clinic in the first half of 2021, targeting IFALD, for which no treatment is currently available.

Trials 40

Trials Engineering Pharmacokinetics Therapies 40

The Pharma Data

JANUARY 12, 2021

KSQ and Takeda can collaborate on IND-enabling activities, with clinical development led by Takeda to explore multiple modalities. Takeda will assume responsibility for funding all development and commercialization activities. KSQ is also eligible to receive tiered royalties on net sales of each approved product.

Therapies 52

Therapies Immune Response Research Engineering 52

The Pharma Data

OCTOBER 27, 2020

Sirnaomics is the only biopharma conducting R&D and clinical development in the field of RNAi therapeutics in both the U.S. Be Bio plans to use their $52 million Series A to precisely engineer B cells to treat a range of diseases. The bladder cancer therapy is expected to be in the clinic by 2022.

Small Molecule 52

Small Molecule Immune Response Therapies Clinical Development 52

Vial

APRIL 10, 2024

IQVIA’s core strengths lie in its specialized global IT infrastructure tailored for healthcare, analytics-driven clinical development, a robust ecosystem of real-world solutions, and an expanding suite of proprietary clinical and commercial applications.

Clinical Trials 52

Clinical Trials Trials Clinical Research Compliance 52

The Pharma Data

JUNE 2, 2022

The innovative antibodies from A*STAR can potentially enable the development of safer, more efficacious therapies as they selectively bind to antigens that are highly expressed on tumor cells but are absent on normal healthy tissues. . For ongoing news, visit www.a-star.edu.sg. star.edu.sg. Source link: [link].

Licensing 52

Licensing Licensing Therapies Science 52

The Pharma Data

NOVEMBER 9, 2020

(Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the U.S. Currently in late-phase clinical development, NVXCoV2373 is a stable, prefusion protein made using Novavax’ nanoparticle technology and includes its proprietary MatrixM adjuvant.

Vaccine 52

Vaccine FDA Clinical Trials Immune Response 52

Vial

MARCH 25, 2024

Vial is a tech-first CRO reimagining clinical trials to deliver faster, more efficient trial results at dramatically lower costs for biotech sponsors. In the past three years, Worldwide has collaborated on 105 oncology studies supported by a global team of oncology clinical development experts.

Clinical Trials 52

Clinical Trials Trials Clinical Development Clinical Research 52

The Pharma Data

JANUARY 13, 2021

Harpoon has four drug product candidates in clinical development for the treatment of solid and hematologic malignancies based on its proprietary TriTAC platform. T cell engagers are engineered proteins that direct a patient’s own T cells to kill target cells that express specific proteins, or antigens, carried by the target cells.

Treatment 52

Treatment FDA Clinical Trials Trials 52

The Pharma Data

NOVEMBER 10, 2020

Growing into a biopharmaceutical company, Innovent has built an integrated platform covering from drug discovery, CMC, clinical development and commercialization. As the powerful discovery engine of the company, Innovent Academy is committed to focusing on the first-in-class innovation with unmet medical need.

Biosimilars 52

Biosimilars Clinical Trials International Clinical Development 52

Precision for Medicine

JANUARY 23, 2023

Precision applies novel biomarker approaches to clinical research that integrate clinical trial design and execution with deep scientific knowledge, laboratory expertise and advanced data sciences. This convergence of trials, labs and data sciences is driving faster clinical development and approval.

Clinical Research 40

Clinical Research Research Engineering Clinical Development 40