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.

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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.

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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.

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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).

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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.

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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.

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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.

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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.

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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.

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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.

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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)).

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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.

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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.

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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.

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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.

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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.”.

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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.”

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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The Pharma Data

JANUARY 27, 2021

As a clinician, healthcare administrator, biotech entrepreneur and venture capital investor, Steve’s leadership and breadth of experience in the clinical development of cell and gene therapies will be invaluable to PlateletBio as we progress our cell therapy platform into the clinic later this year,” said Sam Rasty, Ph.D.,

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PerkinElmer

MAY 6, 2022

A team of scientists at Codiak Biosciences recently explored the potential of exoSTING, an engineered extracellular vesicle (EV) exogenously loaded with CDN, to enhance the delivery of STING agonists.

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The Pharma Data

JULY 22, 2021

“Building on Pfizer’s established leadership position in breast cancer science and CDK 4/6 inhibition, we are excited to work with Arvinas to maximize ARV-471, the first PROTAC for breast cancer with encouraging early clinical data and a potential novel hormonal therapy backbone for HR+ breast cancer,” said Jeff Settleman, Ph.D.,

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The Pharma Data

DECEMBER 8, 2020

Now poised to advance a robust therapeutics pipeline to clinical development, Nuance will use the funds for ongoing R&D of existing products and business development of potential new assets. Through its Shielded Living Therapeutics platform, the company is developing functional cures for chronic diseases.

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Precision for Medicine

JUNE 26, 2023

Precision applies a transformational approach to clinical research that integrates clinical trial design and execution with deep scientific knowledge, laboratory expertise, data sciences and advanced manufacturing solutions. This convergence is driving faster clinical development and approval. Bethesda, Md.,

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The Pharma Data

JANUARY 7, 2021

NST) is a Dutch biotech company focused on developing structurally engineered fatty acids (‘SEFAs’) for the treatment of inflammatory, metabolic, and liver diseases. I look forward to the final results from this trial.”. – Ends – Notes to Editors. About NorthSea Therapeutics. NorthSea Therapeutics B.V.(NST)

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The Pharma Data

NOVEMBER 11, 2020

A former Eli Lilly research fellow, he holds 45 patents in his field, including a third-generation taxane anticancer agent currently in clinical development, and an 8-aminoquinoline antimalarial with the potential to address hemolytic toxicity during malaria treatment. Source link.

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Drug Target Review

SEPTEMBER 10, 2024

Drug developer companies across the pharma industry report notable reductions in drug development timelines where 10 to 12 months, from lead monoclonal antibody (mAb) identification to IND application, is the new norm and in which earlier Tox material generation has been a critical component for shortening IND timelines.

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Advarra

NOVEMBER 29, 2022

Bottlenecks in the manufacturing process, supply chain issues such as accessibility of good manufacturing practice (GMP)-grade reagents, and shortages of qualified scientists and engineers have caused many therapies to fail at critical stages of the clinical development pipeline.

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The Pharma Data

OCTOBER 26, 2020

These mAbs are already of human origin and functionally optimized for high potency by the donor’s immune system; hence, they technically do not require genetic engineering or further optimization to achieve full functionality. The Company’s pipeline is highlighted below: Aridis’ Pipeline. AR-301 (VAP). AR-101 (HAP).

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The Pharma Data

JUNE 2, 2022

Immatics will be responsible for preclinical development of the initial two Bristol Myers Squibb-owned programs and will receive additional payment for certain activities that Immatics could perform at Bristol Myers Squibb’s request.

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Drug Target Review

SEPTEMBER 26, 2023

The CiPA initiative aims to engineer an assay to assess the proarrhythmic potential of new drugs with improved specificity compared to current methods. 1-4 This approach saves time, money, and resources, and ultimately leads to safer medicines going forward to the clinic.

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