Antibody, Development and Trials - Clinical Research Informer

AstraZeneca to deliver Covid-19 antibody therapy doses to Switzerland

Pharmaceutical Technology

JULY 21, 2022

AstraZeneca has signed a deal with the Federal Office of Public Health (FOPH) of Switzerland to deliver over 1,200 doses of antibody therapy, tixagevimab and cilgavimab combination (AZD7442), for Covid-19 prevention and treatment. In May, the company supplied the first doses of the antibody therapy to Swiss hospitals for Covid-19 prevention.

Antibody

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BioNTech and OncoC4 sign deal to co-develop antibody for solid tumours

Pharmaceutical Technology

MARCH 20, 2023

BioNTech has signed an exclusive worldwide licence and collaboration agreement with OncoC4 to co-develop and commercialise a new checkpoint antibody in multiple solid tumour indications. BioNTech will solely develop all the combinations other than the PD-1 inhibition.

Antibody

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US FDA approves Eisai-Biogen’s antibody for Alzheimer’s

Pharmaceutical Technology

JANUARY 9, 2023

Eisai and Biogen have received approval for their antibody Leqembi (lecanemab-irmb) , 100mg/mL injection for intravenous use, from the US Food and Drug Administration (FDA) under the Accelerated Approval Pathway to treat Alzheimer’s disease (AD). The regulatory approval is based on the data obtained from the Phase II trial.

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TORL BioTherapeutics raises funds to develop new oncology therapies

Pharmaceutical Technology

APRIL 14, 2023

Clinical-stage biopharmaceutical company TORL BioTherapeutics has raised $158m in a Series B financing round for advancing the development of new biologics for cancer treatment. TORL BioTherapeutics is a newly formed, US-based company focused on the development of novel antibody-based therapeutics for cancer patients.

Development

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Umoja and IASO partner to develop therapies for haematological malignancies

Pharmaceutical Technology

NOVEMBER 22, 2022

Umoja Biopharma has signed a research agreement with IASO Biotherapeutics (IASO Bio) to develop off-the-shelf therapies for haematological malignancies. The post Umoja and IASO partner to develop therapies for haematological malignancies appeared first on Pharmaceutical Technology.

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Astellas to support development of Taysha’s gene therapy programmes

Pharmaceutical Technology

OCTOBER 25, 2022

Ast ellas Pharma has announced plans to make a strategic investment to back the development of Taysha Gene Therapies’ adeno-associated virus (AAV) development programmes for Rett syndrome and giant axonal neuropathy (GAN). This would allow the companies to boost the development of new therapy options for Rett syndrome and GAN patients.

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FDA rejects Regeneron lymphoma drug, setting back company’s oncology push

Bio Pharma Dive

MARCH 25, 2024

The agency wants Regeneron to make more progress with a confirmatory trial before clearing odronextamab, a “bispecific” antibody being developed for multiple blood cancers.

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Antibody Drugs Trials Development

Tourmaline shifts focus to developing anti-IL6 antibody following merger

Pharmaceutical Technology

OCTOBER 20, 2023

The company plans to initiate the Phase II trial of anti-IL-6 antibody in atherosclerotic cardiovascular disease in 2024.

Antibody

Antibody Development Trials

Gilead partners with MacroGenics for bispecific antibody development

Pharmaceutical Technology

OCTOBER 18, 2022

Gilead Sciences has entered an exclusive option and partnership agreement with MacroGenics for developing bispecific antibodies. Under the deal, the companies will leverage MacroGenics’ DART platform to develop MGD024 as well as two further bispecific research programmes.

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Rilzabrutinib Sets a New Benchmark in Immune Thrombocytopenia Trials

XTalks

DECEMBER 10, 2024

In the trial, platelet response, defined as achieving at least 50,000 platelets per microliter or doubling baseline counts, was seen in 65 percent of patients on rilzabrutinib, compared to 33 percent on placebo. Recent advancements in ITP treatments include CM313, an anti-CD38 monoclonal antibody that achieved a 95.5

Trials

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A worrisome side effect stalls a closely watched multiple myeloma drug

Bio Pharma Dive

MAY 4, 2021

Pfizer halted a key trial of one of the most advanced bispecific antibody drugs in development for the blood cancer after several cases of peripheral neuropathy.

Drugs

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Datroway’s Approval in Breast Cancer Solidifies Daiichi Sankyo’s Leadership in ADCs

XTalks

JANUARY 21, 2025

The FDA has approved Datroway (datopotamab deruxtecan-dlnk), a TROP2-directed antibody-drug conjugate (ADC) for adults with unresectable or metastatic HR-positive, HER2-negative breast cancer, developed through a global collaboration between Daiichi Sankyo and AstraZeneca. months for Datroway and 18.3 months for chemotherapy.

Antibody

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FDA Animal Testing Phase-Out Targets Monoclonal Antibodies

XTalks

APRIL 14, 2025

The roadmap initially targets monoclonal antibodies (mAbs) and similar biologic therapies drugs engineered to bind precise disease targets before expanding to other drug classes. FDA Commissioner Martin Makary expects that the change could speed up development and reduce animal testing.

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Innovation in Autoimmune and Bone Health Research: Driving Progress for Better Patient Outcomes

Worldwide Clinical Trials

OCTOBER 14, 2024

With the support of global networks like ours at Worldwide Clinical Trials (Worldwide), autoimmune and bone health research is accelerating, providing new solutions to patients around the world. Given the complexity and widespread impact of autoimmune and bone health conditions, developing new therapies is essential.

Research

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New inhaled SARS-CoV-2 antibody treatment set to enter clinical trials

BioPharma Reporter

DECEMBER 13, 2021

Memo Therapeutics AG will receive CHF 10.5m (US $11.4m) from the Swiss government to clinically develop a SARS-CoV-2 antibody against COVID-19, allowing it to start Phase 1 studies in Q1, 2022.

Antibody

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Alzheimer’s disease biomarkers galvanise rocky drug development space

Pharmaceutical Technology

DECEMBER 7, 2022

Last week, the quest for an effective Alzheimer’s disease therapy received a notable fillip at the Clinical Trials on Alzheimer’s Disease (CTAD) Conference 2022, with new data on Eisai’s disease-modifying therapy lecanemab. Developing treatment biomarkers and diagnostic biomarkers may help achieve these goals.

Development

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Innovating in Autoimmune and Bone Health Research: Driving Progress for Better Patient Outcomes

Worldwide Clinical Trials

OCTOBER 14, 2024

With the support of global networks like ours at Worldwide Clinical Trials (Worldwide), autoimmune and bone health research is accelerating, providing new solutions to patients around the world. Given the complexity and widespread impact of autoimmune and bone health conditions, developing new therapies is essential.

Research

Research Clinical Trials Clinical Trials Immune Response

WHO recommends antibody therapies to treat Ebola virus

Pharmaceutical Technology

AUGUST 22, 2022

The World Health Organization (WHO) has made new recommendations for the usage of two monoclonal antibodies to treat the Ebola virus in its first published guideline. mAb114 (Ansuvimab; Ebanga) and REGN-EB3 (Inmazeb) are the two monoclonal antibody treatments recommended by the WHO.

Antibody

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Monoclonal antibodies challenge marketed small-molecule Alzheimer’s dominance

Pharmaceutical Technology

DECEMBER 6, 2022

The three leading Alzheimer’s disease (AD) drugs currently in development are all monoclonal antibodies—donanemab by Eli Lilly , lecanemab by Eisai and Biogen , and gantenerumab by Roche. Monoclonal antibodies make up half of these, with an 11% share of all AD approvals.

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Alzheimer’s disease biomarkers galvanize rocky drug development space

Pharmaceutical Technology

DECEMBER 7, 2022

Last week, the quest for an effective Alzheimer’s disease therapy received a notable fillip at the Clinical Trials on Alzheimer’s Disease (CTAD) Conference 2022, with new data on Eisai’s disease-modifying therapy lecanemab. Developing treatment biomarkers and diagnostic biomarkers may help achieve these goals.

Development

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FDA drug dosage optimisation guidelines signal clinical trial reform

Pharmaceutical Technology

FEBRUARY 17, 2023

The agency proposes that pharma move away from the common maximum tolerated dose (MTD) to trial designs that prioritise drug dosage optimisation at different stages. In clinical trials, dose-ranging is testing different drug doses against each other to establish which works best.

Clinical Trials

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China’s NMPA accepts IND for SinoMab BioScience’s SM17 to treat asthma

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

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FDA grants accelerated approval for ImmunoGen’s ovarian cancer ADC

Pharmaceutical Technology

NOVEMBER 14, 2022

The antibody-drug conjugate (ADC) treatment is indicated for such patients who have previously received one to three systemic therapy regimens, irrespective of the usage of Avastin priorly. Elahere obtained the approval based on the findings on objective response rate (ORR) and duration of response (DOR) reported in the SORAYA clinical trial.

Antibody

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iTeos and GSK hit enrolment milestone with Phase III TIGIT lung cancer trial

Pharmaceutical Technology

JULY 9, 2024

iTeos will receive $35m from GSK as the first patient is dosed in the Phase III trial of the jointly developed monoclonal antibody EOS-448.

Trials

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Early cell therapy successes start to turn the tide in lupus

Pharmaceutical Technology

NOVEMBER 14, 2022

In a field dominated by antibodies and small molecules, two cell-therapy based approaches have come under the spotlight for showing early signs of efficacy in treating lupus. Gary Gilkeson, the trial’s principal investigator, says the study is two-thirds of the way to finishing enrollment and should complete within the next 12 months.

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Japan’s MHLW approves Daiichi Sankyo’s breast cancer treatment

Pharmaceutical Technology

NOVEMBER 25, 2022

The latest development was based on the findings from the international, head-to-head, open-label, randomised Phase III DESTINY-Breast03 trial which analysed the efficacy and safety of Enhertu versus trastuzumab emtansine (T-DM1). In subjects who received Enhertu, the median progression-free survival (PFS) was not attained versus 6.8

Antibody

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Corbus and CSPC Megalith sign licence agreement for antibody drug conjugate

Pharmaceutical Technology

FEBRUARY 14, 2023

Precision oncology firm Corbus Pharmaceuticals and CSPC Megalith Biopharmaceutical have entered an exclusive licensing agreement for the latter’s new clinical stage antibody drug conjugate (ADC), CRB-701 (SYS6002). We look forward to working with CSPC to advance clinical development of this asset and realise its full potential.”

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IXCHIQ Chikungunya Vaccine Trial Shows Sustained Immune Response in Adolescents

XTalks

JANUARY 22, 2025

Valneva SE, who developed the worlds first FDA-approved chikungunya vaccine , has now unveiled promising Phase III data for its single-shot chikungunya vaccine, IXCHIQ, in adolescents aged 12 to 17. The VLA1553-321 trial, conducted in Brazil, was the first to assess the vaccine in an endemic region. The findings reveal a remarkable 98.3%

Immune Response

Immune Response Vaccination Vaccine Trials

US FDA grants fast track designation for Jasper’s antibody to treat SCID

Pharmaceutical Technology

SEPTEMBER 16, 2022

The US Food and Drug Administration (FDA) has granted fast track designation to Jasper Therapeutics’ antibody, JSP191, for the treatment of severe combined immunodeficiency (SCID) patients who undergo allogeneic hematopoietic stem cell transplant. . The antibody was also analysed in a total of more than 110 healthy subjects and patients. .

Antibody

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Strike two for Novartis’ lung cancer antibody canakinumab

pharmaphorum

OCTOBER 25, 2021

Expectations for Novartis’ canakinumab as a therapy for cancer have taken another dive, after a second phase 3 trial in non-small cell lung cancer (NSCLC) failed to meet its primary objectives. The post Strike two for Novartis’ lung cancer antibody canakinumab appeared first on.

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Adcentrx raises funds to advance ADCs into clinical development

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.

Clinical Development

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Artificial Intelligence for better antibody drugs: ready for prime time?

pharmaphorum

NOVEMBER 6, 2022

The potential of monoclonal antibodies (mAbs) as therapies is indisputable. Naturally, the pharma industry has seen an explosion of mAbs in the pipeline, which has led to the evolution of new methods for improving and refining the antibody pipeline. AI for accelerated antibody discovery.

Antibody

Antibody Drugs Protein Life Science

Maxion scoops £2m UK grant to develop autoimmune disease treatment

Pharmaceutical Technology

APRIL 20, 2023

The funds will support Maxion’s KnotBody platform to develop antibodies to treat autoimmune diseases. Antibody-based therapies provide enhanced efficacy and safety whilst reducing the need for frequent administration for autoimmune disease treatment.

Development

Development Antibody Engineer Clinical Trials

Merck agrees to acquire Prometheus Biosciences for $10.8bn

Pharmaceutical Technology

APRIL 17, 2023

Prometheus Biosciences uses precision medicine to discover, develop and commercialise new therapeutic and companion diagnostic products to treat immune-mediated diseases. PRA023, Prometheus’s lead candidate, is a humanised monoclonal antibody (mAb) targeting tumour necrosis factor (TNF)-like ligand 1A (TL1A).

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Janssen’s antibody drug shows phase 2 potential in rheumatoid arthritis

BioPharma Reporter

NOVEMBER 9, 2023

The proof-of-concept trial, dubbed IRIS-RA, is the first to investigate a treatment for rheumatoid arthritis that blocks a protein called neonatal Fc receptor (FcRn).

Antibody

Antibody Drugs Protein Trials

Alentis Therapeutics raises funds to develop medicines for CLAUDIN-1

Pharmaceutical Technology

APRIL 13, 2023

Alentis Therapeutics intends to use the funding for the Phase II and Phase I programmes of its lead investigational products ALE.F02 and ALE.C04, first-in-class anti-Claudin-1 (CLDN1) antibodies, respectively. With a silenced effector function, ALE.F02 has been designed for targeting the stiff ECM of fibrotic tissues and organs.

Medicine

Medicine Development Antibody Engineer

Therini Bio raises funds to develop neurodegenerative disease therapies

Pharmaceutical Technology

APRIL 28, 2023

Biotechnology company Therini Bio has raised $36m in a Series A financing round to develop fibrin-targeted therapies to treat neurodegenerative and retinal diseases. Therini Bio will use part of the funds to advance its potential first-in-class investigational antibody, THN391, into clinical trials.

Development

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Q32 Bio and Horizon partner to develop autoimmune disease treatment

Pharmaceutical Technology

AUGUST 16, 2022

Q32 Bio has signed a partnership and option agreement with Horizon Therapeutics for developing ADX-914 to treat autoimmune ailments. According to the deal, Horizon will provide the funding to develop the therapy until the conclusion of its two Phase II clinical trials. Q32 will also receive tiered royalty payments on net sales.

Development

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Sanofi and Innate Pharma extend cancer therapeutics partnership

Pharmaceutical Technology

DECEMBER 19, 2022

With the latest development, Sanofi will licence a NK cell engager programme that acts on B7H3 from the antibody-based NK cell engager therapeutics (ANKET) platform of Innate. On choosing the candidate, the company will oversee the complete development, production and marketing.

Development

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Upstream Bio raises funds to advance clinical development of UPB-101

Pharmaceutical Technology

JUNE 9, 2023

Upstream Bio will use the funds to advance its UPB-101 into Phase II trials to treat asthma and chronic rhinosinusitis with nasal polyps (CRSwNP). It is also preparing for a swift transition to Phase III development. It targets the human thymic stromal lymphopoietin receptor to inhibit signalling.

Clinical Development

Clinical Development Development Life Science Clinical Trials

Genmab and argenx team up to engineer novel antibody therapies

Pharmaceutical Technology

APRIL 17, 2023

Pharmaceutical company Genmab is entering a partnership with argenx to develop antibody therapies for oncology and immunology. This collaboration is being made to combine the companies’ capabilities to develop novel therapeutic antibodies with applications in the two disease areas.

Antibody

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Biologic Therapeutics Development, Part 2: Regulatory Pathways and Pharmacometric Analysis

Camargo

DECEMBER 13, 2021

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. One common characteristic for most if not all biologics is the triggering of an immune response or anti-drug antibodies.

Development

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City of Hope researchers develop new brain cancer therapy

Pharmaceutical Technology

NOVEMBER 29, 2022

Researchers at City of Hope in the US have developed a new potential therapy to treat glioblastoma multiforme (GBM), a kind of brain cancer. This chemokine is connected to the epidermal growth factor receptor (EGFR) antibody causing attachment to tumour cells. These viruses are engineered genetically for killing cancer.

Development

Development Research Antibody Engineer

SAB secures FDA breakthrough therapy status for influenza immunotherapy

Pharmaceutical Technology

APRIL 19, 2023

The newly granted status allows SAB to speed up the development and review of SAB-176, which is currently being studied for use in post-exposure prophylaxis for Type A and Type B influenza in high-risk patients, including those with anti-viral resistant strains.

Antibody

Antibody Development Trials Drugs

AstraZeneca to deliver Covid-19 antibody therapy doses to Switzerland

BioNTech and OncoC4 sign deal to co-develop antibody for solid tumours

Webinars

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US FDA approves Eisai-Biogen’s antibody for Alzheimer’s

Webinars

TORL BioTherapeutics raises funds to develop new oncology therapies

Umoja and IASO partner to develop therapies for haematological malignancies

Astellas to support development of Taysha’s gene therapy programmes

FDA rejects Regeneron lymphoma drug, setting back company’s oncology push

Tourmaline shifts focus to developing anti-IL6 antibody following merger

Gilead partners with MacroGenics for bispecific antibody development

Rilzabrutinib Sets a New Benchmark in Immune Thrombocytopenia Trials

A worrisome side effect stalls a closely watched multiple myeloma drug

Datroway’s Approval in Breast Cancer Solidifies Daiichi Sankyo’s Leadership in ADCs

FDA Animal Testing Phase-Out Targets Monoclonal Antibodies

Innovation in Autoimmune and Bone Health Research: Driving Progress for Better Patient Outcomes

New inhaled SARS-CoV-2 antibody treatment set to enter clinical trials

Alzheimer’s disease biomarkers galvanise rocky drug development space

Innovating in Autoimmune and Bone Health Research: Driving Progress for Better Patient Outcomes

WHO recommends antibody therapies to treat Ebola virus

Monoclonal antibodies challenge marketed small-molecule Alzheimer’s dominance

Alzheimer’s disease biomarkers galvanize rocky drug development space

FDA drug dosage optimisation guidelines signal clinical trial reform

China’s NMPA accepts IND for SinoMab BioScience’s SM17 to treat asthma

FDA grants accelerated approval for ImmunoGen’s ovarian cancer ADC

iTeos and GSK hit enrolment milestone with Phase III TIGIT lung cancer trial

Early cell therapy successes start to turn the tide in lupus

Japan’s MHLW approves Daiichi Sankyo’s breast cancer treatment

Corbus and CSPC Megalith sign licence agreement for antibody drug conjugate

IXCHIQ Chikungunya Vaccine Trial Shows Sustained Immune Response in Adolescents

US FDA grants fast track designation for Jasper’s antibody to treat SCID

Strike two for Novartis’ lung cancer antibody canakinumab

Adcentrx raises funds to advance ADCs into clinical development

Artificial Intelligence for better antibody drugs: ready for prime time?

Maxion scoops £2m UK grant to develop autoimmune disease treatment

Merck agrees to acquire Prometheus Biosciences for $10.8bn

Janssen’s antibody drug shows phase 2 potential in rheumatoid arthritis

Alentis Therapeutics raises funds to develop medicines for CLAUDIN-1

Therini Bio raises funds to develop neurodegenerative disease therapies

Q32 Bio and Horizon partner to develop autoimmune disease treatment

Sanofi and Innate Pharma extend cancer therapeutics partnership

Upstream Bio raises funds to advance clinical development of UPB-101

Genmab and argenx team up to engineer novel antibody therapies

Biologic Therapeutics Development, Part 2: Regulatory Pathways and Pharmacometric Analysis

City of Hope researchers develop new brain cancer therapy

SAB secures FDA breakthrough therapy status for influenza immunotherapy

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