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BioWorld - Thursday, June 8, 2023
Home » Topics » Immune, BioWorld

Immune, BioWorld
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William Cao, founder and CEO, Gracell Biotechnologies

Gracell enters autoimmune space with its dual-targeting CAR T

June 6, 2023
By Tamra Sami
No Comments
Gracell Biotechnologies Inc. is initiating two clinical trials in China in refractory systemic lupus erythematosus for lead candidate GC-012F, a CD19/B-cell maturation antigen dual-targeting CAR T. 
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T cells

Selection waits on efficacy data from trial of Kv1.3 ion channel blocker in atopic dermatitis

June 2, 2023
By Cormac Sheridan
No Comments
The coming months represent a crucial phase in the development of Selection Inc., a U.S.-German firm that is tackling a target in autoimmune disease that has evaded the best efforts of many other drug developers.
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Oral medication

Infection gains build on X4’s WHIM drug promise

May 17, 2023
By Caroline Richards
No Comments
Heightening prospects for an oral neutropenia therapy, X4 Pharmaceuticals Inc.’s lead CXCR4 antagonist mavorixafor slashed yearly infection rates in patients with WHIM syndrome by 58% in a pivotal phase III trial, an effect that was statistically significant.
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White Euro symbol on blue background
Newco news

Autoimmune disease company Dualyx raises $43.5M in series A

May 15, 2023
By Nuala Moran
No Comments
Regulatory T-cell specialist Dualyx NV has closed a €40 million (US$43.5 million) series A to progress the lead autoimmune disease program to the clinic and to take forward two other Treg-based therapies. The company brings together expertise in antibody design with understanding of the role Tregs play in supressing the immune response to maintain homeostasis and self-tolerance, preventing autoimmunity.
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Multiple sclerosis

Et tu, Bruton? New approach in MS gains ground despite Merck partial hold

May 9, 2023
By Randy Osborne
No Comments
Watchers of the Bruton’s kinase (BTK) inhibitor space may be casting renewed skepticism in that direction after Merck KGaA disclosed April 12 that the U.S. FDA placed a partial clinical hold on the sign-up of more patients in work testing evobrutinib in relapsing multiple sclerosis (MS) – but BTK efforts in MS continue in various quarters.
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COVID-19 mRNA vaccine vials, syringe
Cardiovascular

COVID vaccine myocarditis is due to inflammation

May 9, 2023
By Anette Breindl
No Comments
By analyzing a cohort of adolescents that developed myocarditis or pericarditis after vaccination against SARS-CoV-2 vaccination, researchers from Yale University School of Medicine were able to pinpoint the underlying mechanism as an overly active innate immune response to the vaccine that led to broad activation of T cells and natural killer (NK) cells. Myocarditis “has been seen in other vaccine contexts, though is most common after viral infection,” Carrie Lucas told reporters at a press conference announcing the findings.
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Daewoong_4-28.jpg

Vitalli Bio launches with $477M licensing deal with Daewoong for phase I-ready autoimmune disease candidate

April 28, 2023
By Tamra Sami
No Comments
Daewoong Pharmaceutical Co. Ltd. has out-licensed its phase I-ready autoimmune disease candidate, DWP-213388, to new spinout company Vitalli Bio in a deal worth up to $477 million.
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Orbital Therapeutics lands $270M series A round to join the next cycle of RNA innovation

April 26, 2023
By Cormac Sheridan
No Comments
Orbital Therapeutics Inc. raised $270 million in a series A round to fund a big push into the next generation of mRNA-based therapies. The Cambridge, Mass.-based firm is building out a comprehensive RNA platform from which it will launch programs in oncology, autoimmune disease and indications involving protein replacement approaches.
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Multiple sclerosis-damaged myelin

Pipeline strikes $1B deal with Janssen for myelin restoration candidate in MS

April 17, 2023
By Jennifer Boggs
No Comments
Pipeline Therapeutics Inc., which received U.S. FDA approval to move into a phase Ib/IIa study of PIPE-307 in relapsing-remitting multiple sclerosis (RRMS) last year, will be advancing the oral, small-molecule muscarinic M1 receptor antagonist in collaboration with Janssen Pharmaceutica NV in an agreement that could be worth more than $1 billion.
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FDA Approved stamp with pills

Pharming’s PI3K-delta inhibitor, Joenja, wins first FDA nod in APDS

March 24, 2023
By Jennifer Boggs and Karen Carey
No Comments
Pharming Group NV’s stock skyrocketed March 24 on news that the U.S. FDA approved Joenja (leniolisib) to treat activated phosphoinositide 3-kinase delta syndrome (APDS) for those ages 12 and older. The nod, which came a few days ahead of the March 29 PDUFA date, sent shares (NASDAQ:PHAR) up 33%, or $3.69, to end the day at $14.96.
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