Antibody and Trials - Clinical Research Informer

Regeneron antibody cuts risk of COVID-19 death in UK study

Bio Pharma Dive

JUNE 16, 2021

The biotech said it will seek an expanded FDA clearance after results from the RECOVERY trial showed its antibody can lower mortality among certain hospitalized COVID-19 patients.

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GSK antibody drug reduces COPD attacks in trial

Bio Pharma Dive

SEPTEMBER 6, 2024

New trial results could offer support for an expansion of Nucala’s label after U.S. regulators rejected GSK’s submission in 2018.

Trials

Trials Antibody Regulation Drugs

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 June 2020, these antibodies, discovered at Vanderbilt University Medical Center, were licensed to AstraZeneca.

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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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AstraZeneca and Amgen’s Tezspire succeeds in Phase III nasal polyps trial

Pharmaceutical Technology

NOVEMBER 8, 2024

A Phase III trial with the companies’ monoclonal antibody in patients with chronic rhinosinusitis with nasal polyps met its primary endpoint.

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Merck antibody reduces RSV-related disease, hospitalizations in trial

Bio Pharma Dive

OCTOBER 18, 2024

Detailed data from a Phase 2b/3 study of Merck’s treatment clesrovimab should support the company’s efforts to win approval by the 2025-2026 season.

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Novavax details trial results for omicron-targeting booster shots

Bio Pharma Dive

NOVEMBER 8, 2022

A reformulated booster aimed at an earlier omicron subvariant outperformed Novavax’s current vaccine, but a bivalent version did not significantly raise antibody levels.

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Bispecific antibody startup Bambusa raises $90m to fund clinical trials

Pharmaceutical Technology

FEBRUARY 17, 2025

Two of Bambusas bispecific antibody candidates for immunological and inflammatory disorders are set to enter the clinic in 2025.

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AbbVie, Genmab, with new data, prep FDA application for dual-acting cancer drug

Bio Pharma Dive

APRIL 14, 2022

Fresh trial results intensify competition with Roche to deliver the first lymphoma drug that marries antibody technology with an immunotherapy pathway.

Drugs

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GSK, Vir build case for COVID-19 antibody drug with new study data

Bio Pharma Dive

JUNE 21, 2021

Final clinical trial results confirmed treatment dramatically reduced the risk of hospitalization and death among adults with mild-to-moderate COVID-19.

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Sanofi, Regeneron surge as Dupixent scores in COPD trial

Bio Pharma Dive

MARCH 23, 2023

The two companies gained billions of dollars in market value after their antibody drug succeeded against a disease that’s been difficult to treat with biologic medicines.

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EHA 2024: Monoclonal antibodies continue to dominate multiple myeloma treatments

Pharmaceutical Technology

JUNE 21, 2024

Trial investigators anticipate that the FDA will decide on approval for linvoseltamab in relapsed/refractory multiple myeloma by the end of 2024.

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Lilly's antibody drug prevents COVID-19 in study, but hurdles to use remain

Bio Pharma Dive

JANUARY 20, 2021

Results from a clinical trial in nursing home residents and staff offered the first evidence Lilly's bamlanivimab could protect against, as well as treat, COVID-19

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Merck, facing threat to Keytruda, buys into new kind of cancer immunotherapy

Bio Pharma Dive

NOVEMBER 14, 2024

The company is paying China-based biotech LaNova Medicines $588 million for the type of dual-pronged antibody drug that recently bested Keytruda in a clinical trial.

Clinical Trials

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Seagen trial data impresses at ESMO, lifting Merck, Pfizer in the process

Bio Pharma Dive

OCTOBER 23, 2023

A combination of Seagen and Astellas’ antibody-drug conjugate Padcev with Merck’s Keytruda dramatically improved survival in first-line bladder cancer.

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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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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. Datroway leverages DXd technology to precisely target cancer cells.

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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.

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Key trial test begins for plasma-based COVID-19 therapy from Takeda, CSL

Bio Pharma Dive

OCTOBER 9, 2020

The medicine, a concentrated infusion of blood antibodies, is different than the convalescent plasma that was recently cleared for emergency use by the FDA.

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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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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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Lilly builds case for COVID-19 drug cocktail with new data

Bio Pharma Dive

MARCH 10, 2021

A low-dose combination of Lilly antibodies for COVID-19 reduced deaths and hospitalizations in a Phase 3 trial, a finding that could boost its use.

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AstraZeneca's coronavirus antibody drug cocktail begins human tests as rivals slip

Bio Pharma Dive

AUGUST 25, 2020

The British pharma has started a Phase 1 trial amidst reports that competing programs from Regeneron and Eli Lilly haven't met their projected timelines.

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FDA approves IND application for Nanjing Leads Biolabs’ bispecific antibody

Pharmaceutical Technology

JULY 31, 2023

US FDA and China’s NMPA have approved the Phase I trial of anti-GPRC5D/CD3 bispecific antibody (LBL-034) by Leads Biolabs.

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Disc wins orphan drug tag for rare blood cancer

Pharmaceutical Technology

FEBRUARY 12, 2024

The humanised monoclonal antibody DISC-3405 is under investigation in a Phase I clinical trial, with data expected this year.

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Pfizer, BioNTech say updated COVID booster raised omicron antibody levels in trial

Bio Pharma Dive

OCTOBER 13, 2022

The findings, which were disclosed in a press release without specific data, are the first immune response results in humans for the reformulated shot targeting the BA.4 5 substrains.

Immune Response

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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. MGD024 is an investigational bispecific antibody that attaches to CD123 and CD3. The post Gilead partners with MacroGenics for bispecific antibody development appeared first on Pharmaceutical Technology.

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Merck claims late-stage study success for RSV antibody

Bio Pharma Dive

JULY 23, 2024

The drug, a rival to Sanofi and AstraZeneca’s fast-selling Beyfortus, met its main goals in a Phase 3 trial. But undisclosed study results leave its full potential unclear.

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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. .

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HIV vaccines suffer setbacks but new approaches could turn the tide

Pharmaceutical Technology

FEBRUARY 3, 2023

Only a few weeks into the new year, the prospect of getting a successful advanced HIV vaccine shrank after the discontinuation of yet another late-stage trial. This marks the second time one of Janssen’s HIV vaccines failed after another showed disappointing results in the Phase IIb Imbokodo trial in August 2021.

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Summit, Akeso's antibody triumphs over Keytruda in China lung cancer trial, sending shares skyrocketing

Fierce Pharma

MAY 31, 2024

Just one week after Summit Therapeutics and Akeso’s bispecific antibody ivonescimab passed muster with Chinese regulators, the drug has pulled off another feat by staring down the PD-1 king Keytrud | In the phase 3 HARMONi-2 trial, solo ivonescimab delivered a statistically significant and clinically meaningful improvement in progression-free survival (..)

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STAT+: ‘We’ve got a new target’: Bispecific antibody for multiple myeloma succeeds in mid-stage trial

STAT News

DECEMBER 10, 2022

Now, the results of a Phase 2 study on a bispecific antibody targeting this protein offers confirmation. NEW ORLEANS — Researchers had hoped in recent years that a protein called GPRC5D might offer a new way to get the immune system to hunt down and destroy multiple myeloma cells.

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Are we entering the era of biologics for COPD?

Pharmaceutical Technology

JANUARY 8, 2023

In 2023, the pharmaceutical industry will mark 20 years since Xolair, an anti-IgE antibody, became the first biologic approved to treat asthma. Since then, the US FDA, EMA, and other agencies have approved several biologic antibodies targeting the inflammatory cytokines IL-4, IL-13, IL-5, and others for asthma. Ongoing efforts.

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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. One of the biggest hurdles in developing new therapies is recruiting diverse patients for clinical trials.

Research

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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

Trials Antibody Development

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

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Brii Bio introduces Covid-19 combination therapy in China

Pharmaceutical Technology

JULY 7, 2022

Brii Biosciences and TSB Therapeutics have commercially launched a long-acting neutralising antibody therapy combination, amubarvimab/romlusevimab, for Covid-19 in China. The two non-competing SARS-CoV-2 monoclonal neutralising antibodies, amubarvimab and romlusevimab are obtained from convalesced Covid-19 patients. 2 subvariants.

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Health Canada gives approval to Enhertu for breast cancer treatment

Pharmaceutical Technology

JANUARY 13, 2023

Being co-developed and co-marketed by Daiichi Sankyo along with AstraZeneca , Enhertu is a specifically engineered HER2-directed antibody-drug conjugate (ADC). Enhertu’s safety profile was consistent with the previous clinical trials.

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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. One of the biggest hurdles in developing new therapies is recruiting diverse patients for clinical trials.

Research

Research Clinical Trials Clinical Trials Immune Response

FDA lifts two-year clinical hold on CytoDyn’s HIV trial

Pharmaceutical Technology

MARCH 1, 2024

US FDA placed a partial clinical hold on HIV programme and a full hold on Covid-19 trials for CytoDyn’s monoclonal antibody, leronlimab.

Trials

Trials Antibody

Blackstone-backed biotech launches with up to $300M for immune drug

Bio Pharma Dive

MAY 15, 2024

Uniquity Bio emerged from stealth mode ready to begin Phase 2 trials of an antibody targeting the protein TSLP in asthma and COPD.

Protein

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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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Feinstein Institutes researchers discover new protein for sepsis treatment

Pharmaceutical Technology

FEBRUARY 6, 2023

It explores the monoclonal antibody detection that may work against procathepsin-L (pCTS-L), a pro-inflammatory protein mediator, as the potential remedy. These anti-pCTS-L monoclonal antibodies may help in providing effective treatments for human sepsis as well as other infectious diseases, such as Covid-19.

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FDA lifts clinical hold on Avidity’s lead antibody conjugate therapy trial

Pharmaceutical Technology

OCTOBER 4, 2024

Two years after the FDA placed partial clinical hold, Avidity can resume research of del-desiran as a treatment for myotonic dystrophy type 1.

Antibody

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Regeneron antibody cuts risk of COVID-19 death in UK study

GSK antibody drug reduces COPD attacks in trial

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AstraZeneca to deliver Covid-19 antibody therapy doses to Switzerland

Webinars

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

AstraZeneca and Amgen’s Tezspire succeeds in Phase III nasal polyps trial

Merck antibody reduces RSV-related disease, hospitalizations in trial

Novavax details trial results for omicron-targeting booster shots

Bispecific antibody startup Bambusa raises $90m to fund clinical trials

AbbVie, Genmab, with new data, prep FDA application for dual-acting cancer drug

GSK, Vir build case for COVID-19 antibody drug with new study data

Sanofi, Regeneron surge as Dupixent scores in COPD trial

EHA 2024: Monoclonal antibodies continue to dominate multiple myeloma treatments

Lilly's antibody drug prevents COVID-19 in study, but hurdles to use remain

Merck, facing threat to Keytruda, buys into new kind of cancer immunotherapy

Seagen trial data impresses at ESMO, lifting Merck, Pfizer in the process

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

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

Tourmaline shifts focus to developing anti-IL6 antibody following merger

Key trial test begins for plasma-based COVID-19 therapy from Takeda, CSL

Monoclonal antibodies challenge marketed small-molecule Alzheimer’s dominance

A worrisome side effect stalls a closely watched multiple myeloma drug

Lilly builds case for COVID-19 drug cocktail with new data

AstraZeneca's coronavirus antibody drug cocktail begins human tests as rivals slip

FDA approves IND application for Nanjing Leads Biolabs’ bispecific antibody

Disc wins orphan drug tag for rare blood cancer

Pfizer, BioNTech say updated COVID booster raised omicron antibody levels in trial

Gilead partners with MacroGenics for bispecific antibody development

Merck claims late-stage study success for RSV antibody

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

HIV vaccines suffer setbacks but new approaches could turn the tide

Summit, Akeso's antibody triumphs over Keytruda in China lung cancer trial, sending shares skyrocketing

STAT+: ‘We’ve got a new target’: Bispecific antibody for multiple myeloma succeeds in mid-stage trial

Are we entering the era of biologics for COPD?

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

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

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

Brii Bio introduces Covid-19 combination therapy in China

Health Canada gives approval to Enhertu for breast cancer treatment

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

FDA lifts two-year clinical hold on CytoDyn’s HIV trial

Blackstone-backed biotech launches with up to $300M for immune drug

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

Feinstein Institutes researchers discover new protein for sepsis treatment

FDA lifts clinical hold on Avidity’s lead antibody conjugate therapy trial

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