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.

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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. .

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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

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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. Treating HER2-Positive Metastatic Breast Cancer.

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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. .

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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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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?)

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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. That came a few weeks after Bristol-Myers Squibb paid $200 million upfront for rights to AGEN1777, a TIGIT drug developed by Agenus in a deal that could be worth up to $1.56

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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.

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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. Jazz acquired rights to Sativex when it completed its $7.2 billion takeover of Sativex’ developer GW Pharma earlier this year.

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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).

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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. The drug became a blockbuster last year, with sales reaching $1.9bn, up from $599m in 2021.

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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.

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Drug Discovery World

JULY 28, 2023

To coincide with the publication of the DDW eBook ‘ Antibody discovery: Breakthroughs accelerating therapeutic antibodies ’, our news highlights this week all focus on antibodies, particularly the recommendation by the EU’s CHMP for two bispecific antibodies that treat multiple myeloma and lymphoma.

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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).

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pharmaphorum

FEBRUARY 24, 2022

Clinical stage pharmaceutical company Cantex Pharmaceuticals has obtained a global licence from Harvard University’s Office of Technology Development to develop the small-molecule drug azeliragon into a treatment for inflammatory lung diseases, including COVID-19. said Cantex CEO Stephen Marcus.

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pharmaphorum

APRIL 9, 2021

The FDA says it has uncovered “deficiencies” in the marketing application for Provention Bio’s much-anticipated drug teplizumab for the prevention of type 1 diabetes (T1D) that could delay its review. The study was a key element of the FDA filing, and the first ever evidence that a drug therapy could delay the onset of T1D.

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XTalks

FEBRUARY 29, 2024

Two years after its approval in 2021 , Biogen has decided to pull the plug on its Alzheimer’s drug Aduhelm (aducanumab). In a statement , the company said it will discontinue Aduhelm to focus efforts on its other amyloid beta-directed antibody Leqembi (lecanemab) for Alzheimer’s and focus on developing other new treatments.

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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.

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Pharmaceutical Technology

APRIL 5, 2023

The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) to InflaRx’s Gohibic (vilobelimab) to treat critically ill hospitalised Covid-19 adult patients. It is a first-in-class monoclonal anti-human complement factor C5a antibody.

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pharmaphorum

APRIL 14, 2022

billion alliance with Genmab to find new cancer therapies, AbbVie has said it is ready to start talking to regulators about filing for approval of the lead drug in the partnership – epcoritamab for large B-cell lymphoma (LBCL). The post AbbVie preps filings for lymphoma bispecific licensed from Genmab appeared first on.

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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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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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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 .

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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. In the EU, loncastuximab tesirine has orphan drug designation for the treatment of DLBCL, a form of non-Hodgkin lymphoma (NHL).

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Drug Discovery World

FEBRUARY 28, 2024

Lu Rahman selects some of the year’s interesting and noteworthy advances in cancer research drug discovery and development. As always, a year within cancer drug discovery and development brings with it significant breakthroughs, and 2023 has been no exception. Research into new cancer drugs remain strong. expressing cancers.

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pharmaphorum

NOVEMBER 10, 2021

Pfizer has bolstered its central nervous system (CNS) drugs portfolio with a $1.2 The drug was the first in the oral CGRP inhibitor class to get an prevention indication approved by the FDA in May, and that has helped accelerate its rollout, bringing in $336 million in US sales for Biohaven so far this year.

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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.

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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. | Meanwhile, AstraZeneca and Daiichi's TROP2 ADC disappointed in a lung cancer trial. And GSK in-licensed an ADC from China's Hansoh Pharma.

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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.

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Pharmaceutical Technology

AUGUST 8, 2022

AstraZeneca and Daiichi Sankyo ’s Enhertu (trastuzumab deruxtecan) has received expanded approval from the US Food and Drug Administration (FDA) to treat adults with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer. Enhertu-treated subjects had a median overall survival (OS) of 23.4 months compared with 16.8

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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 billion bundle – including $1.3

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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). It brought in $4.7

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Pharmaceutical Technology

FEBRUARY 21, 2023

The US Food and Drug Administration (FDA) has accepted a priority review of the biologics license application (BLA) for Regeneron Pharmaceuticals ’ pozelimab to treat children and adults with ultra-rare CHAPLE disease. The antibody is developed using the company’s VelocImmune technology.

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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.

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Drug Discovery World

AUGUST 25, 2023

The headline news this week reflects the high level of interest and investment in neuroscience drug discovery, particularly neurodegenerative diseases like Alzheimer’s; including positive clinical trial results for new immunotherapy and biotherapeutic candidates, and hopes that existing medications could slow the progression of dementia.

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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.

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