Avrobio taps Magenta’s ADC; Eli Lilly ramps up; FDA postpones decision; CSL gears up to fight pandemic,

Posted on May 7, 2020 by Delveinsight

pharma-news

Avrobio taps ADC of Magenta for enhancing gene therapy conditioning

Avrobio is working to make conditioning safer. The company is collaborating with Magenta Therapeutics to check antibody-drug conjugate.

Under the agreement, the partners will evaluate Magenta’s lead conditioning program, MGTA-117, with at least one of the gene therapies of Avrobio. Each company will have the rights for their respective programs, but Avrobio will pick up for clinical trials, including MGTA-117.

The lead program of Avrobio is a gene therapy for Fabry disease named AVR-RD-01. It is based on CD34+ stem cells, which have been modified utilizing a lentiviral vector to express the gene that codes for the enzyme, which is missing in Fabry disease. It is working on treatments for Gaucher disease, Cystinosis and Pompe disease as well.

Eli Lilly ramps up to combat the virus with neutralizing antibodies 

Many drug makers are opting to produce neutralizing antibodies, which aim the spike protein on the surface of SARS-CoV-2, which causes the COVID-19. Eli Lilly partners with AbCellera to develop neutralizing antibodies to combat the novel coronavirus, Eli Lilly has inked a second partner for defeating the virus.   

Eli Lilly has confirmed to reimburse USD 10 million upfront and up to USD 245 million for ex-China rights to co-develop and sell neutralizing antibodies from Junshi Biosciences (China). The lead candidate of Junshi, named as JS016, is a recombinant fully human monoclonal antibody. The pair targets to commence a clinical trial in the U.S.

The agreement marks the latest of at least five other programs focused at developing neutralizing antibodies against the SARS-CoV-2 spike protein, which binds to the host cell surface receptor ACE2 to aid the virus to enter and affect human cells. The aim is that neutralizing antibodies will be able to prevent that interaction, even if the virus mutates to a more virulent strain.

FDA postpones decision on approval of CAR-T

The FDA has postponed its decision on whether to give a green signal to Bristol Myers Squibb’s CAR-T cell therapy by three months. Bristol Myers credited the delay to its submission of additional information upon the request of the FDA.

Lisocabtagene maraleucel, which is also known as liso-cel, is one of the CAR-T therapies that emerged at Juno Therapeutics and ended up at Bristol Myers through its acquisition of Celgene. In February, the FDA granted priority review to a filing for approval of the anti-CD19 CAR-T, setting Bristol Myers up to obtain an approval decision from the agency by mid-August.

The FDA has currently thrown that target action date. Instead, the agency is now targeting to decide on whether to approve liso-cel in adults with relapsed or refractory large B-cell lymphoma after at least two prior therapies by mid-November.

CSL Behring gears up to fight pandemic through R&D    

The largest Australian biotech company CSL said that it is working on a plasma-based therapy for patients with more severe forms of COVID-19.

CSL Behring Australia, a subsidiary of CSL Limited, informed regarding that it would commence quick onshore development of an anti-SARS-CoV-2 plasma product with the potential for the treatment of people with severe complications of COVID-19, mainly of those whose illness is developing towards the need for ventilation.  

The experimental therapy, known as COVID-19 Immunoglobulin, will be produced by CSL Behring Australia. The giant apprised the need for blood plasma donations from about 800 people that will be collected by the Australian Red Cross, in order for treatment around 100 patients in the trial.

In the first phase of its testing, a small batch of COVID-19 Immunoglobulin will be made and utilized to develop tests to identify the presence of the antibodies that fight SARS-CoV-2, the virus causing COVID-19.

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