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Study abstracts released Thursday give investors and analysts a better look at cancer treatments recently licensed by Merck and BioNTech as well as fresh details on other closely watched ADC candidates.
Neurimmune, which will license to AstraZeneca an early-stage treatment for a rare form of cardiomyopathy, is probably best known for its invention of the antibody that became Biogen's Alzheimer's drug Aduhelm.
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.
Brii Biosciences (Brii Bio) has exercised an option for the acquisition of exclusive development and marketing rights for Vir Biotechnology’s investigational antibody, VIR-3434, for Hepatitis B in Greater China, under a partnership agreement. The mAb is presently in the Phase II development stage.
AbbVie has announced the acquisition of UK-based biotechnology firm DJS Antibodies for nearly $255m in cash at closing. DJS focuses on the discovery and development of antibody therapies that act on difficult-to-drug disease-causing proteins, such as G protein-coupled receptors (GPCRs).
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.
The startup, affiliated with China-based antibody designer Helixon Therapeutics, is developing bispecific drugs aimed at multiple popular immune disease targets, such as TL1A and IL23.
The license allows Sterling to manufacture antibody-drug conjugates (ADCs) for clinical use in its current Good Manufacturing Practices (cGMP) compliant manufacturing facility in Deeside, UK.
A subcutaneous version of Daiichi Sankyo’s AstraZeneca-partnered blockbuster antibody-drug conjugate (ADC) Enhertu could be in the works from Korea’s Alteogen following a licensing deal worth up to | Alteogen will use its human hyaluronidase hybridization platform to develop a subcutaneous formulation of the blockbuster antibody-drug conjugate.
LegoChem Biosciences and Amgen have signed a multi-target research collaboration and license agreement to develop antibody-drug conjugates (ADC). Till date, the company has signed a total of 12 ADC licensing deals, worth more than $5bn.
Elsewhere, Vanda rejected two takeover bids and Ashibio emerged from stealth with an antibodylicensed from Gilead. A medicine Jazz acquired in 2019 missed the goal of a Phase 2 study.
Precision oncology firm Corbus Pharmaceuticals and CSPC Megalith Biopharmaceutical have entered an exclusive licensing agreement for the latter’s new clinical stage antibodydrug conjugate (ADC), CRB-701 (SYS6002). The US Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for CRB-701.
Biogen has exercised an option to license Denali Therapeutics ’ (Denali) programme to develop immunotherapies for the treatment of Alzheimer’s disease. ATV: Aβ uses Denali’s ATV technology to cross the blood-brain barrier (BBB) and increase brain exposure to antibodies.
Ono Pharma and Boehringer Ingelheim both added to their cancer pipelines, licensingdrugs from LigaChem Bio and Circle Pharma, respectively.Ono's deal with South Korean antibody-drug conjugate (ADC) specialist LigaChem is worth up to $700 million and covers a license to a preclinical-stage candidate for solid tumours, as well as an R&D collaboration (..)
In January, amidst calls to improve patient safety by optimizing licenseddrug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage. The focus on identifying the ideal drug dosage is not new. What is drug dose optimisation?
The German mRNA giant BioNTech has sealed a pact worth up to $1 billion with Biotheus to develop the Chinese biotech companyâs bispecific antibody cancer drug PM8002 in all territories except for Greater China.
Ipsen has expanded its oncology pipeline by licensing rights to an antibody-drug conjugate (ADC) for solid tumours from Sutro Biopharma, its first drug in the category.
Biocytogen Pharmaceuticals and ADC Therapeutics have signed an assessment and option agreement for evaluating antibodies against three tumour targets. Under the deal, ADC Therapeutics will receive a licence from Biocytogen to evaluate the latter’s antibodies against the targets.
Danish biotech Adcendo has accelerated its progression to a clinical-stage biotech by licensing an antibody-drug conjugate (ADC) from China's Multitude Therapeutics with potential in various forms of cancer.Copenhagen-based Adcendo is paying what is rumours to be tens of millions of dollars in upfront fees for rights to Multitude's anti-tissue factor (..)
Danish biotech company Adcendo has entered into a licence agreement with Duality Biologics on the next-generation antibody-drug conjugates (ADC) platform. The post Adcendo and Duality Biologics sign license deal for ADC platform appeared first on Pharmaceutical Technology.
Provention Bio and Sanofi US have signed a co-promotion agreement to launch the former’s lead investigational drug candidate, teplizumab for the delay in the onset of clinical type 1 diabetes (T1D). The US Food and Drug Administration (FDA) is presently reviewing teplizumab for the delay of clinical T1D in people who are at risk.
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. .
In addition to new stock offerings, this week saw Merck license an antibodydrug conjugate and BARDA further work trying to innovate remote clinical trials.
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).
AbbVie is to begin clinical development of an antibody designed to neutralise the SARS-CoV-2 coronavirus after licensing the therapy in from Harbour BioMed and Utrecht University. AbbVie has begun a phase 1 clinical trial of the antibody, with clinical development beginning in the US and expanding into Europe.
While a rumoured takeover by Merck & Co has yet to materialise, Seagen is getting on with its own business development, including a just-agreed licensing deal for a cancer immunotherapy developed by Dutch biotech Lava Therapeutics. The post Lava fires up a $700m cancer licensing deal with Seagen appeared first on.
ImmunityBio has licensed technology underpinning a COVID-19 vaccine that could be administered orally rather than by injection from UK biotech iosBio. ImmunityBio’s vaccine design drives both antibody and T-cells to the spike (S) protein and nucleocapsid (N) protein.
Merck entered into a license and collaboration agreement with Chinese company Kelun-Biotech to develop seven antibody-drug conjugates candidates against oncology targets.
AstraZeneca and Sanofi said their Biologics License Application (BLA) for nirsevimab has been accepted for review by the US Food and Drug Administration (FDA).
Celleron Therapeutics signed a licensing agreement with Roche for the worldwide rights to cancer drug emactuzumab, a monoclonal antibody directed against colony-stimulating factor 1 (CSF-1R) expressed on macrophages.
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.
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 recommendation of the European Medicines Agency (EMA) for Roctavian to maintain orphan drug designation permitting a ten-year market exclusivity window was endorsed by the EC.
In June, the company signed a strategic collaboration and licensing agreement with Sutro Biopharma for discovering and developing new immunostimulatory antibody-drug conjugates. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.
AbCellera Biologics has been in the spotlight since coming up with Eli Lilly’s COVID-19 antibodydrug bamlanivimab, and looks set to capitalise on that exposure with a sizeable initial public offering. The drug is also being tested in other trials, including a phase 3 study looking at its role in prevention of SARS-CoV-2 infection.
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