Pharmaceutical Technology

MAY 22, 2023

SM17 is a humanised IgG4-k monoclonal antibody that targets IL-17RB to treat asthma, idiopathic pulmonary fibrosis (IPF), atopic dermatitis (AD) and other immunological disorders. SinoMab BioScience intends to commence a Phase I clinical trial in China to evaluate SM17’s safety profile.

Immune Response 273

Immune Response Clinical Trials Clinical Trials Antibody 273

Drug Discovery World

DECEMBER 8, 2023

ONK Therapeutics and NAYA Biosciences have agreed to develop a combination therapy of ONK’s optimally-engineered natural killer (NK) cell therapies and NAYA’s FLEX-NK bispecific antibodies. The post Partners explore NK cell therapy and bispecific antibodies combination appeared first on Drug Discovery World (DDW).

Antibody 52

Antibody Gene Editing Clinical Trials Clinical Trials 52

Drug Discovery World

JULY 26, 2023

A Cancer Research UK-funded clinical trial has shown, for the first time, that a new class of antibody could benefit cancer patients whose existing treatments have stopped working. The drug, MOv18 IgE, was developed by researchers at King’s College London.

Antibody 52

Antibody Drugs Clinical Trials Clinical Trials 52

pharmaphorum

SEPTEMBER 4, 2020

Sanofi and GlaxoSmithKline have begun clinical trials of their coronavirus vaccine, as AstraZeneca expanded studies of its rival into Japan. They said the trials would involve 440 adults at 11 sites across the US. If trials go well the companies could request regulatory approval in the first half of 2021.

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Clinical Trials Clinical Trials Vaccination Vaccine 87

pharmaphorum

MARCH 12, 2021

Sanofi and Translate BIO have begun a clinical trial of their potential mRNA COVID-19 shot, as the French pharma struggles to keep pace with rivals despite its background in vaccines. A joint development team is working on a -20C storage temperature for late-stage clinical development and at launch.

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Clinical Trials Clinical Trials Trials Vaccination 52

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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Clinical Trials Clinical Trials Vaccination Vaccine 76

Pharmaceutical Technology

MAY 25, 2023

Apexigen discovers and develops a new generation of antibody therapeutics to treat cancer, along with new immuno-oncology products to harness the immune system to combat and eradicate cancer.

Antibody 130

Antibody Clinical Trials Clinical Trials Clinical Development 130

Pharmaceutical Technology

MAY 2, 2023

Pamrevlumab, a human monoclonal antibody targeting connective tissue growth factor, is currently undergoing clinical trials for the treatment of conditions including idiopathic pulmonary fibrosis, locally advanced unresectable pancreatic cancer, metastatic pancreatic cancer and Duchenne muscular dystrophy.

Clinical Trials 130

Clinical Trials Clinical Trials Clinical Development Antibody 130

Drug Discovery World

APRIL 14, 2023

Dr Schon is applying his broad expertise from lead discovery to manufacture in order to progress differentiated, safe and developable bi-specific therapeutic ADC candidates to clinical development. This is even more relevant for combination therapies or bispecific antibodies.

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Antibody Development Drugs Manufacturing 52

The Pharma Data

MARCH 11, 2021

Clinical trial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels. The Companies expect interim results from this trial in the third quarter of 2021. About the Phase 1/2 clinical trial. About previously-published preclinical results.

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Clinical Trials Clinical Trials Vaccination Vaccine 52

The Pharma Data

AUGUST 7, 2020

The governing body claims this proposal could have positive effects on mitigating burdensome requirements for gene therapy clinical trials in the future. In this light, Pharma IQ’s weekly round-up focuses on advancing therapies and clinical trials to combat Covid-19.

Clinical Trials 52

Clinical Trials Clinical Trials Gene Trials 52

Pharmaceutical Technology

FEBRUARY 24, 2023

Amlitelimab is under clinical development by Kymab and currently in Phase II for Asthma. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. It is developed based on Kymouse technology.

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Antibody Clinical Trials Clinical Trials Drugs 100

Pharmaceutical Technology

AUGUST 25, 2022

The treatment is indicated for patients with no history of Factor VIII inhibitors and any detectable antibodies to adeno-associated virus serotype 5 (AAV5). The approval is based on comprehensive data from the clinical development programme of Roctavian, including two-year findings from the international Phase III GENEr8-1 clinical trial.

Gene Therapy 264

Gene Therapy Gene Clinical Trials Clinical Trials 264

Drug Discovery World

APRIL 12, 2024

The Food and Drug Administration (FDA) has cautioned that continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. This latest approval means that Enhertu now has five approved indications, including for breast cancer. In DESTINY-Lung01, ORR of 52.9%

Antibody 52

Antibody Clinical Trials Clinical Trials Trials 52

Pharmaceutical Technology

AUGUST 11, 2022

The proceeds from the business combination will be utilised to advance the pipeline of Disc to clinical trials and offer funding into 2025. Disc focuses on discovering and developing new therapies for patients with serious haematologic ailments. In-licensed from AbbVie in 2019, DISC-0974 is a monoclonal antibody.

Medicine 147

Medicine Clinical Trials Clinical Trials Licensing 147

The Pharma Data

JANUARY 10, 2021

Because ASLAN004 is the only clinical stage monoclonal antibody targeting IL-13R?1, ASLAN004 is a first-in-class monoclonal antibody that binds to the IL-13 receptor ?1 1, we believe it has the potential to be best-in-disease which may result in improved safety and efficacy over other biologics in the class. 1 subunit (IL-13R?1),

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pharmaphorum

OCTOBER 18, 2022

Gilead Sciences has made yet another rush into the oncology category, licensing a bispecific antibody from MacroGenics in development as a treatment for CD123-positive blood cancers, including acute myeloid leukaemia (AML) and myelodysplastic syndromes (MDS). Along with the signing fee, there is another $1.7 It brought in $4.7

Antibody 52

Antibody Sales Clinical Trials Clinical Trials 52

The Pharma Data

NOVEMBER 30, 2020

Two of the three planned late-stage efficacy trials for NVX-CoV2373 sponsored by Novavax are fully enrolled, and more than 20,000 participants have been dosed to-date. In alignment with Novavax’ commitment to transparency, Phase 3 clinical trial protocols are posted to the company’s website at Novavax.com/resources upon finalization.

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Clinical Development Vaccination Vaccine Development 52

Drug Discovery World

JULY 13, 2022

Novo Nordisk has announced positive interim results for its Mim8 antibody which is being as a treatment for haemophilia A. . The study is assessing the safety and clinical use of Mim8 in patients with haemophilia A. Zero bleeds were reported in the eight participants treated with the therapy once monthly. . Official comments .

Antibody 52

Antibody Clinical Trials Clinical Trials Medicine 52

Drug Discovery World

FEBRUARY 27, 2024

The results support the continued clinical development of VXX-401 as a candidate for the treatment of hypercholesterolemia and prevention of atherosclerotic cardiovascular disease. VXX-401 is currently in a Phase I clinical trial for safety and tolerability, with topline data expected in mid-2024.

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Vaccination Vaccine Antibody Clinical Trials 104

The Pharma Data

NOVEMBER 25, 2020

26, 2020 /PRNewswire/ — Cantargia AB (OMXS: CANTA) and BioInvent International AB (OMXS: BINV), today announced that BioInvent has been contracted as manufacturer of Cantargia’s antibody CAN10 in preclinical development for the treatment of systemic sclerosis and myocarditis. LUND, Sweden , Nov. About Cantargia.

Antibody 52

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XTalks

JULY 17, 2023

In a significant development, Astellas Pharma announced that the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) had accepted their applications for Priority Review and Marketing Authorization respectively for zolbetuximab. In both trials, approximately 38 percent of the screened patients had CLDN18.2-positive

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Clinical Trials Clinical Trials Trials Antibody 95

Pharmaceutical Technology

OCTOBER 25, 2022

Additionally, Astellas will obtain an exclusive option for licencing two clinical-stage programmes of Taysha, namely TSHA-102 and TSHA-120, for Rett syndrome and GAN, respectively. Astellas will also receive specific rights linked to any possible change of Taysha’s control.

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Gene Therapy Gene Development Genetics 264

Pharmaceutical Technology

JUNE 10, 2023

RZ-358 is under clinical development by Rezolute and currently in Phase II for Hyperinsulinemia. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. It was also under development for the treatment of insulinomas.

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Insulin Antibody Clinical Trials Clinical Trials 100

Pharmaceutical Technology

JUNE 10, 2023

RZ-358 is under clinical development by Rezolute and currently in Phase II for Hyperinsulinemia. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. It was also under development for the treatment of insulinomas.

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Insulin Antibody Clinical Trials Clinical Trials 100

Pharmaceutical Technology

FEBRUARY 19, 2023

STRO-002 is under clinical development by Sutro Biopharma and currently in Phase I for Refractory Acute Myeloid Leukemia. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

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Antibody Protein Clinical Development Manufacturing 100

pharmaphorum

MAY 20, 2021

Switzerland’s Numab has raised 100 million Swiss francs – around $110 million – in Series C financing to develop bispecific antibodies for cancer and inflammation, with Novo Noldings and HBM Partners co-leading the investor syndicate. The post Numab raises $110m to develop cancer bispecific antibodies appeared first on.

Antibody 52

Antibody Development Clinical Development Life Science 52

Pharmaceutical Technology

FEBRUARY 19, 2023

AT-1412 is under clinical development by Kling Biotherapeutics and currently in Phase I for Solid Tumor. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. It acts by targeting cells expressing CD9 epitope.

Antibody 100

Antibody Clinical Trials Clinical Trials Clinical Development 100

Pharmaceutical Technology

FEBRUARY 25, 2023

ASP-2138 is under clinical development by Xencor and currently in Phase I for Metastatic Adenocarcinoma of The Pancreas. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. It is administered through intravenous drip route.

Antibody 100

Antibody Engineer Clinical Trials Clinical Trials 100

Pharmaceutical Technology

FEBRUARY 25, 2023

ASP-2138 is under clinical development by Xencor and currently in Phase I for Gastric Cancer. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. The therapeutic candidate is a bispecific antibody targeting CD3 and claudin 18.2

Antibody 100

Antibody Engineer Clinical Trials Clinical Trials 100

Pharmaceutical Technology

FEBRUARY 25, 2023

ASP-2138 is under clinical development by Xencor and currently in Phase I for Adenocarcinoma Of The Gastroesophageal Junction. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. It is administered through intravenous drip route.

Antibody 100

Antibody Engineer Clinical Trials Clinical Trials 100

Pharmaceutical Technology

JUNE 5, 2023

Izokibep is under clinical development by Acelyrin and currently in Phase II for Panuveitis. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. It is developed based on affibody technology.

Antibody 100

Antibody Development Clinical Trials Clinical Trials 100

XTalks

DECEMBER 10, 2021

Biohaven Pharmaceuticals revealed positive top line results from a late-stage trial which show that its migraine medication Zavegepant provides “ultra-rapid” pain relief in just 15 minutes. Zavegepant is an antibody drug that prevents binding of the calcitonin gene-related peptide (CGRP) to the CGRP receptor.

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FDA Approval Trials Drugs Sales 98

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. Clover plans to initiate a global phase 2/3 trial in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 52

pharmaphorum

MARCH 15, 2022

Sanofi has agreed a deal with life sciences investor Blackstone to help fund clinical trials of a new formulation of Sarclisa for blood cancer multiple myeloma, accelerating its development. Sanofi has partnered with drug delivery specialist Enable Injections to develop the subcutaneous formulation.

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Trials Sales Drug Delivery Antibody 86

Pharmaceutical Technology

FEBRUARY 19, 2023

Annexuzlimab is under clinical development by MedAnnex and currently in Phase I for Kidney Cancer (Renal Cell Cancer). GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

Antibody 100

Antibody Clinical Trials Clinical Trials Drugs 100

The Pharma Data

DECEMBER 29, 2020

As in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes. First antibody therapy to demonstrate anti-viral effect in patients hospitalized with COVID-19. Regeneron Pharmaceuticals, Inc. futility analysis). log 10 copies/mL for combined doses).

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Antibody Trials Production Clinical Trials 52