Drug Discovery World

OCTOBER 11, 2023

Collaborators Boehringer Ingelheim and CDR-Life have commenced a Phase I evaluation of BI 771716, their antibody fragment-based treatment developed to preserve the vision of people with geographic atrophy (GA). The company’s first therapeutic candidate, CDR404, targets MAGE-A4 and is expected to enter the clinic in 2024.

Clinical Trials 52

Clinical Trials Clinical Trials Antibody Trials 52

Drug Discovery World

JUNE 1, 2023

Antibody-drug conjugates (ADCs) are biopharmaceutical products in which a monoclonal antibody (mAB) is linked to a small molecule drug with a stable linker 1. To overcome this challenge, Synaffix has developed an innovative technology platform that can rapidly and efficiently convert any antibody into an ADC.

Antibody 98

Antibody Marketing Drugs Licensing 98

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. Currently, all antibodies approved for the treatment of cancer belong to a class known as IgG.

Antibody 52

Antibody Drugs Clinical Trials Clinical Trials 52

XTalks

MAY 2, 2022

This year, the monoclonal antibody lecanemab is approaching final stages of investigation as a treatment for targeting the A? The Phase IIb clinical trial focused on the long-term clinical outcomes and safety for patients with MCI and amyloid pathology (early AD). The main pathological markers of AD are beta-amyloid (A?)

Clinical Trials 98

Clinical Trials Clinical Trials Antibody Trials 98

Drug Discovery World

JANUARY 3, 2023

A monoclonal antibody to prevent Covid-19 in vulnerable patients, AZD3152, has entered clinical trials less than 12 months after discovery. . The commencement of the trial triggers a $5 million milestone payment to RQ Bio and will enable the company to execute its four scientific programmes focused on viral diseases. .

Antibody 52

Antibody Development Immune Response Clinical Trials 52

The Pharma Data

MARCH 31, 2023

AstraZeneca has completed an exclusive global license agreement with KYM Biosciences Inc. i for CMG901, a potential first-in-class antibody drug conjugate (ADC) targeting Claudin 18.2, CMG901 is currently being evaluated in a Phase I trial for the treatment of Claudin 18.2-positive and consists of an anti-Claudin 18.2

Licensing 40

Licensing Licensing Antibody Drugs 40

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. The global arthritis monoclonal antibodies market grew from $49.44 billion in 2022 to $53.81

Antibody 59

Antibody Development FDA Approval Trials 59

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. The drug also proved ineffective in an earlier trial in patients with progressive supranuclear palsy (PSP), another neurodegenerative disorder.

Antibody 98

Antibody Protein Licensing Licensing 98

pharmaphorum

FEBRUARY 9, 2021

An international trial led by US experts is to begin testing AstraZeneca’s long-acting antibody combination therapy to treat COVID-19. The combination known as AZD7442 is to be added to the phase 3 adaptive trial called ACTIV-3, where investigators add new sub-studies of investigational new agents.

Antibody 52

Antibody Trials Allergies Engineer 52

pharmaphorum

JUNE 24, 2021

Armed with a positive mid-stage trial readout in lung cancer, Arcus Biosciences will expand a phase 3 programme for domvanalimab, its anti-TIGIT antibody. Zimberelimab “showed activity similar to that of marketed anti-PD-1 antibodies studied in this setting,” said Arcus’ chief medical officer Bill Grossman.

Antibody 58

Antibody Trials Licensing Licensing 58

BioTech 365

MARCH 7, 2021

Lee’s Pharmaceutical Announces its Anti-PD-L1 Antibody Socazolimab, Licensed From Sorrento Therapeutics, Receives Clearance to Start Phase 3 Trial as a First-line Treatment of Extensive-stage Small-Cell Lung Cancer Lee’s Pharmaceutical Announces its Anti-PD-L1 Antibody Socazolimab, Licensed From Sorrento Therapeutics, Receives Clearance … Continue (..)

Licensing 40

Licensing Licensing Antibody Trials 40

The Pharma Data

JANUARY 11, 2021

a San Diego-based biotechnology company with an array of technology platforms for antibody discovery and optimization, and novel NK and T cell engager generation, today announced licensing of a panel of its anti-SARS-CoV-2 antibody clones to IGM Biosciences for COVID-19 therapy development.

Antibody 52

Antibody Licensing Licensing Development 52

Fierce Pharma

JANUARY 9, 2024

The FDA has sent a complete response letter to Astellas, rejecting zolbetuximab because of unresolved deficiencies identified in a pre-license inspection of a third-party manufacturing facility. But the Japanese company will have to clear up manufacturing issues first.

Manufacturing 89

Manufacturing Antibody Licensing Licensing 89

Drug Discovery World

OCTOBER 21, 2022

Under an exclusive agreement, Jazz Pharmaceuticals will acquire development and commercialisation rights to Zymeworks’ zanidatamab across all indications and all territories except for those Asia/Pacific territories previously licensed by Zymeworks. Zanidatamab is a HER2-targeted bispecific antibody with novel mechanisms of action.

Antibody 52

Antibody Licensing Licensing Sales 52

Pharmaceutical Technology

APRIL 6, 2023

The designation, under the regulator’s Innovative Licensing and Access Pathway (ILAP), will fast-track a potential route to market for AD04 by providing collaborative opportunities with UK institutes like the National Institute for Health and Care Excellence (NICE).

FDA Approval 264

FDA Approval Licensing Licensing Antibody 264

Pharmaceutical Technology

MAY 12, 2023

On 8 May 2023, China-based Bliss Biopharmaceutical (BlissBio) announced a clinical trial collaboration with Eisai to develop BB-1701, an antibody-drug conjugate (ADC) for multiple cancer types. Eisai signed a licensing agreement with BlissBio in 2018 for the Chinese companies’ exclusive right to use eribulin as their ADC payload.

Clinical Trials 162

Clinical Trials Clinical Trials Licensing Licensing 162

Drug Discovery World

JANUARY 17, 2023

Eisai and Biogen’s anti-amyloid beta (Aβ) monoclonal antibody (mAb), Leqembi (lecanemab), recently gained approval from the Food and Drug Administration (FDA) under the accelerated approval pathway for the treatment of Alzheimer’s disease (AD) in patients with early AD. . Risk of amyloid-related imaging abnormalities .

Antibody 52

Antibody Trials Clinical Trials Clinical Trials 52

pharmaphorum

APRIL 14, 2022

The drugmaker has reported top-line results from the phase 1/2 EPCORE trial of epcoritamab as a third-line therapy for relapsed/refractory LBCL, revealing an overall response rate of 63% and a median duration of response of 12 months. The post AbbVie preps filings for lymphoma bispecific licensed from Genmab appeared first on.

Licensing 62

Licensing Licensing Immune Response Antibody 62

pharmaphorum

APRIL 9, 2021

The issues are holding up discussions between the agency and company about labeling and post-marketing requirements for teplizumab, and are concentrated around the pharmacokinetics data for the antibody, and whether it is comparable to the drug that its original developer Eli Lilly entered into clinical trials.

Antibody 96

Antibody Insulin Trials Production 96

XTalks

JULY 25, 2022

Byondis announced that the US Food and Drug Administration (FDA) accepted their Biologics License Application (BLA) for [vic-]trastuzumab duocarmazine (SYD985), an investigational therapy being studied to treat HER2-positive unresectable locally advanced or metastatic breast cancer. Clinical Trial Results for [Vic-]Trastuzumab Duocarmazine

Antibody 59

Antibody Drugs Clinical Trials Clinical Trials 59

Pharmaceutical Technology

MAY 22, 2023

Lecanemab is an investigational anti-amyloid beta (Aβ) protofibril antibody that will be used to treat mild cognitive impairment caused due to AD and mild AD dementia in people with the confirmed presence of amyloid pathology in the brain. The regulator has also designated the therapy for the innovative licensing and access pathway (ILAP).

Marketing 130

Marketing Antibody Licensing Licensing 130

pharmaphorum

JULY 8, 2022

Swedish rare disease specialist Sobi is paying $55 million upfront to license rights to ADC Therapeutics’ lymphoma therapy Zynlonta – approved in the US last year – in Europe and other international markets. The post Sobi bolsters blood division via $435m ADC licensing deal appeared first on.

Licensing 52

Licensing Licensing Sales Marketing 52

Delveinsight

JANUARY 12, 2021

Medivir, IGM Biosciences enters into an exclusive licensing agreement for Birinapant. Medivir AB has entered into an exclusive licensing agreement with IGM Biosciences to receive global, exclusive development rights for Birinapant. million after Birinapant successfully becomes a part of the Phase I trials.

Licensing 52

Licensing Licensing Antibody Gene Therapy 52

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

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). It brought in $4.7

Antibody 52

Antibody Sales Clinical Trials Clinical Trials 52

Pharmaceutical Technology

APRIL 5, 2023

It is a first-in-class monoclonal anti-human complement factor C5a antibody. The regulator granted the EUA based on data obtained from the multicentre Phase III PANAMO trial, which was conducted in Covid-19 patients who are invasively mechanically ventilated in intensive care units.

Licensing 246

Licensing Licensing Antibody Regulation 246

pharmaphorum

AUGUST 10, 2021

Seagen is a specialist in antibody-drug conjugates, but has looked to Chinese biotech RemeGen for a HER2-targeting candidate that could challenge rival drugs from AstraZeneca/Daiichi Sankyo and Roche. While the licensing deal with Seagen tops up its finances, the scale well below the $6.9 RemeGen #oncology #AntibodyDrugConjugates.

Licensing 52

Licensing Licensing Antibody Sales 52

Pharmaceutical Technology

OCTOBER 31, 2022

Simultaneously, Genmab has submitted a biologics license application (BLA) to the US Food and Drug Administration (FDA) for the investigational subcutaneous IgG1-bispecific antibody to treat R/R large B-cell lymphoma (LBCL) patients.

Antibody 130

Antibody Licensing Licensing Trials 130

pharmaphorum

FEBRUARY 24, 2022

It is currently the only oral small molecule RAGE inhibitor in human clinical trials. According to Cantex, azeliragon has previously been tested for Alzheimer’s disease and diabetic nephropathy, where the drug demonstrated high levels of safety in phase 3 clinical trials involving more than 2,000 patients.

Licensing 62

Licensing Licensing Development Drugs 62

Roots Analysis

FEBRUARY 27, 2024

Currently, product licensing agreements, technology licensing agreements, research and development agreements and clinical trial agreements are the common types of partnerships inked by developers that are currently focused on the development of ADCs pipeline.

Antibody 52

Antibody Licensing Licensing Contract Manufacturing 52

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

Fierce Pharma

OCTOBER 26, 2023

In a busy week for the antibody-drug conjugate (ADC) field, Merck signed a three-drug deal with Daiichi Sankyo but abandoned two preclinical assets from Kelun-Biotech. | In a busy week for the antibody-drug conjugate (ADC) field, Merck signed a three-drug deal with Daiichi Sankyo but abandoned two preclinical assets from Kelun-Biotech.

Antibody 52

Antibody Licensing Licensing Drugs 52

Pharmaceutical Technology

AUGUST 8, 2022

The approval was based on findings from the international, randomised, open-label Phase III DESTINY-Breast04 clinical trial. Furthermore, Enhertu’s safety profile was in line with prior clinical trials without any new safety concerns detected. Enhertu-treated subjects had a median overall survival (OS) of 23.4 months compared with 16.8

FDA Approval 264

FDA Approval HR Clinical Trials Clinical Trials 264

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

Antibody Manufacturing Clinical Trials Clinical Trials 52

pharmaphorum

NOVEMBER 28, 2021

An investigator-led trial of Jazz Pharma’s cannabis extract-based drug Sativex in glioblastoma – an aggressive form of brain cancer – will get underway in the UK next year. The post Trial of Jazz’ cannabis drug in glioblastoma will start next year appeared first on.

Trials 133

Trials Drugs Clinical Trials Clinical Trials 133

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).

Antibody 52

Antibody Trials Production Clinical Trials 52

Pharmaceutical Technology

JUNE 2, 2023

Switzerland-based company Lonza has boosted its antibody-drug conjugates (ADCs) offering with the acquisition of Dutch biotechnology company Synaffix for a total consideration of $172m (€160m). This is expected to streamline the path for ADCs to clinical trial and commercialisation.

Licensing 130

Licensing Licensing Gene Therapy Clinical Trials 130