Drug Discovery World

AUGUST 9, 2023

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted Aleta Biotherapeutics a clinical trial authorisation (CTA) to evaluate biologic ALETA-001 in a Phase I/II clinical trial in patients with B-cell malignancies who are relapsed/refractory to CD19 CAR T cell therapy.

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Pharmaceutical Technology

MARCH 30, 2023

Biogen/Eisai’s newly approved drug, Leqembi (lecanemab), gained FDA approval in January 2023 for the treatment of Alzheimer’s disease. The breakthrough drug is predicted to be a blockbuster, generating total forecast sales of $12.9bn between 2023 and 2028. Leqembi is currently pending approval in the EU and Japan.

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Sales Drugs Antibody FDA Approval 147

Worldwide Clinical Trials

SEPTEMBER 29, 2022

Preclinical assays designed to assess drug toxicity and safety must detect total drug. For studies of humanized therapeutics (monoclonal antibodies [mAb], fusion protein, antibody-drug conjugates [ADC], bispecific antibodies, etc.), anti-human IgG).

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Pharmaceutical Technology

NOVEMBER 14, 2022

The US Food and Drug Administration (FDA) has granted accelerated approval for ImmunoGen’s Elahere (mirvetuximab soravtansine-gynx) to treat adults with folate receptor alpha (FR?)-positive, binding antibody, a cell-surface protein which is greatly expressed in ovarian cancer, as well as the maytansinoid payload DM4.

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Pharmaceutical Technology

MARCH 30, 2023

Biogen/Eisai’s newly approved drug, Leqembi (lecanemab), gained FDA approval in January 2023 for the treatment of Alzheimer’s disease. The breakthrough drug is predicted to be a blockbuster, generating total forecast sales of $12.9bn between 2023 and 2028. Leqembi is currently pending approval in the EU and Japan.

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Sales Drugs Antibody FDA Approval 130

pharmaphorum

JUNE 17, 2021

Biogen has four other Alzheimer’s candidates in its clinical pipeline behind recently-approved Aduhelm, but one of them – anti-tau antibody gosuranemab – has just been canned. In Alzheimer’s, the protein runs amok, forming tangles that have been linked to cell damage and neuronal death.

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Antibody Protein Licensing Licensing 98

Drug Discovery World

NOVEMBER 14, 2023

DDW’s Megan Thomas looks at how different diseases will benefit from the success of therapeutic antibodies. Cancer Monoclonal antibodies (mAbs) are a type of targeted drug therapy, and as such are often used to treat cancer. This is not only made clear by the fact that the global cancer mAbs market size was valued at $55.6

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Antibody Development FDA Approval Trials 59

pharmaphorum

SEPTEMBER 17, 2020

Eli Lilly has followed up supportive data from its Olumiant in COVID-19 with results of a study showing its antibody treatment could help prevent hospitalisation from the disease. The double-blind placebo-controlled antibody study involved patients with symptoms outside hospitals, who were treated with four different dose strengths.

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Roots Analysis

AUGUST 9, 2023

Novel antibody therapies are chimeric proteins having antibodies attached lethal effector molecules. Multiple novel antibody formats have been engineered to enhance therapeutic efficacy. Around 50% of the articles focused on novel antibody therapies were published post-2020.

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Pharmaceutical Technology

JANUARY 19, 2023

The US Food and Drug Administration (FDA) has granted Fast Track designation for Avidity Biosciences’ AOC 1020 to treat facioscapulohumeral muscular dystrophy (FSHD). This DUX4 protein abnormal expression leads to modifications in gene expression in muscle cells which are associated with progressive muscle function loss in FSHD patients.

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Gene Expression Gene Protein RNA 246

Drug Discovery World

JUNE 28, 2023

In pregnant women, MinervaX is currently progressing two Phase II clinical vaccine trials for the prevention of life-threatening infections in newborns. The trials are demonstrating that the vaccine has an acceptable safety profile, is highly immunogenic and gives rise to functionally active antibodies.

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Pharmaceutical Technology

JUNE 15, 2023

Alentis Therapeutics has received US Food and Drug Administration (FDA) clearance for its investigational new drug (IND) application for ALE.C04 to treat Claudin-1 positive (CLDN1+) tumours. ALE.C04 is an investigational antibody designed to target exposed CLDN1 in cancer cells.

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Pharmaceutical Technology

DECEMBER 7, 2022

Health Canada has granted approval for a supplement to a New Drug Submission (sNDS) of Novavax ’s Covid-19 vaccine (Recombinant protein, Adjuvanted), Nuvaxovid (NVX-CoV2373), for use in adolescents aged 12 to 17 years. The trial is designed to analyse the safety and effectiveness of the vaccine.

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Drug Discovery World

OCTOBER 20, 2023

The latest acquisitions and strategic partnerships in the drug discovery and development sector reveal the areas where companies predict significant growth in the near future: proteomics, CAR-T, antibody discovery, artificial intelligence (AI) and microbiomics. We aim to continue to ‘open up’ the druggable antibody space.”

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pharmaphorum

JANUARY 13, 2022

Sanofi has joined a growing list of drugmakers going after alpha-synuclein targeting drugs for Parkinson’s disease, licensing a bispecific antibody from South Korea’s ABL Bio in a deal that could be worth more than $1 billion.

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Antibody Drugs Protein Licensing 95

Pharmaceutical Technology

FEBRUARY 19, 2023

According to GlobalData, Phase I drugs for Refractory Acute Myeloid Leukemia have a 69% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how STRO-002’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

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XTalks

MAY 7, 2021

As Novavax awaits emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for its protein-based COVID-19 vaccine NVX-CoV2373, the company shared new data this week on the vaccine’s efficacy against the South African B.1.351 1.351 variant.

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Drug Discovery World

APRIL 26, 2023

Absci is a generative artificial intelligence (AI) drug creation company with goals of bringing better biologics to patients more quickly. Here, DDW Editor Reece Armstrong speaks to Sean McClain, the Founder and CEO of Absci about how generative AI is being used within drug discovery and the company’s work in the antibodies sector.

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Roots Analysis

FEBRUARY 27, 2024

On November 1, 2019, Avacta Group and ADC Therapeutics have announced a collaboration agreement for the development of novel drug candidates. The firm also has the right to obtain exclusive licenses to the Affimer proteins for clinical development and commercialization.

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Pharmaceutical Technology

APRIL 26, 2023

Biotechnology company Adcentrx Therapeutics has raised $38m in Series A+ financing to advance its pipeline of new antibody-drug conjugate (ADC) therapeutics into clinical development. Adcentrx Therapeutics is focused on developing protein conjugate therapeutics to treat cancer and other life-threatening diseases.

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Pharmaceutical Technology

JUNE 6, 2023

According to Globaldata, it is involved in 1 clinical trial, which is ongoing. The drug’s revenue forecasts along with estimated costs are used to measure the value of an investment opportunity in that drug, otherwise known as net present value (NPV). The drug candidate is administered by intravenous route.

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The Pharma Data

APRIL 15, 2022

A new protein-based antiviral nasal spray developed by researchers at Northwestern University, University of Washington and Washington University at St. Louis is being advanced toward Phase I human clinical trials to treat COVID-19. Food and Drug Administration (FDA). Diamond at WashU.

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XTalks

NOVEMBER 7, 2022

Gleich, MD, FACS, Senior Vice President, Medical Department, and Dr. Christopher Huth, PhD, Senior Clinical Trial Manager, Clinical Trial Management. Liquid Biopsy Use in Oncology Clinical Trials. Exosome-Based Liquid Biopsy in Oncology.

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Pfizer

FEBRUARY 16, 2023

These study participants, representing approximately half of the total recruited participants in the trial, are being discontinued following violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator.

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XTalks

JUNE 18, 2021

This is why Regeneron’s announcement of positive clinical trial results that show its antibody cocktail treatment can cut deaths among hospitalized patients is welcome news. It is the first trial to demonstrate that any antibody treatment could improve survival in patients hospitalized with COVID-19.

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Advarra

JANUARY 11, 2024

While mRNA usage has played several roles in clinical research , oncology researchers in particular are eager to explore the possibilities of mRNA-based cancer vaccines. Additionally, personalized medicine tends to be more difficult to manufacture because of regulatory requirements beyond traditional drug manufacturing requirements.

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Drug Discovery World

MARCH 29, 2023

A Phase I clinical trial has begun evaluating Direct Biologics’ ExoFlo for the treatment of patients with medically refractory ulcerative colitis (UC). The secondary objective is to evaluate the efficacy of intravenous ExoFlo in inducing clinical remission, clinical response, and improvement in patient reported outcomes.

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Pharmaceutical Technology

FEBRUARY 20, 2023

According to GlobalData, Phase II drugs for Solid Tumor have a 10% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how ABN-401’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

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Pharmaceutical Technology

JUNE 15, 2023

Chugai Pharmaceutical has submitted a new drug application (NDA) to Japan’s Ministry of Health, Labour and Welfare (MHLW) for crovalimab to treat paroxysmal nocturnal haemoglobinuria (PNH), a rare blood disorder in which parts of the immune system attack and damage red blood cells and platelets.

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Pharmaceutical Technology

JULY 29, 2022

The Food and Drug Administration (FDA) has acc epted to review ImmunityBio’s Biologics License Application (BLA) for N-803 to treat Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) carcinoma in situ (CIS) patients with or without Ta or T1 disease.

Trials 264

Trials Clinical Trials Clinical Trials Licensing 264

pharmaphorum

MAY 10, 2021

The EMA has begun a rolling review of a COVID-19 antibody developed by GlaxoSmithKline and Vir BioTech which could become the fourth drug of its type cleared for early use in the EU. . Other data such as final clinical trial results will be assessed in due course. — Stella Kyriakides (@SKyriakidesEU) May 7, 2021.

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Pharmaceutical Technology

NOVEMBER 29, 2022

For this approach, the team leveraged an oncolytic herpes simplex virus for releasing chemokines, which are signalling proteins that aid in attracting immune cells to tumours. This chemokine is connected to the epidermal growth factor receptor (EGFR) antibody causing attachment to tumour cells.

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Drug Discovery World

AUGUST 14, 2023

It has been approved in patients who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Among patients receiving the 0.8mg/kg SC biweekly dose, an estimated 85% of responders maintained response for at least nine months.

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Pharmaceutical Technology

OCTOBER 20, 2022

The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for Novavax ’s adjuvanted Covid-19 vaccine, NVX-CoV2373, as a booster for use in people aged 18 years and above. In the Phase III trial, the vaccine booster was given to healthy adult subjects nearly eight or 11 months following the primary regimen.

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pharmaphorum

AUGUST 10, 2020

Biogen’s Alzheimer’s drug aducanumab could be on the market in the next few months after the FDA accepted a clinical trial dossier and granted a fast Priority Review. The FDA reserves these quick reviews for drugs that have the potential to improve care standards for serious diseases.

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Pharmaceutical Technology

SEPTEMBER 13, 2022

The multi-year investment, covering the development of drug substances as well as drug products, will be implemented across the current locations of the company in Switzerland, Austria and Slovenia. For this purpose, the company will create a completely integrated scientific environment.

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The Pharma Data

AUGUST 15, 2021

Now, researchers reporting in ACS Central Science have immunized mice with nanoparticles that mimic SARS-CoV-2 by displaying multiple copies of the receptor binding domain (RBD) antigen, showing that the vaccine triggers robust antibody and T cell responses. Although the first vaccines to receive Emergency Use Authorization by the U.S.

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