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BioWorld - Friday, September 22, 2023
Home » Topics » Immune, BioWorld Asia

Immune, BioWorld Asia
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Stem cells

Mesoblast’s hopes dashed again with second FDA complete response letter for remestemcel-L

Aug. 8, 2023
By Tamra Sami
No Comments
Regenerative medicine company Mesoblast Ltd.’s stock sank nearly 57% on the news that it received a second U.S. FDA complete response letter (CRL) following the resubmission of its BLA for allogeneic stem cell treatment remestemcel-L in children with steroid-refractory acute graft-vs.-host disease. In the CRL, issued a few days after the Aug. 2 PDUFA date, the agency said it requires more data to support approval.
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Yen-Yuan currency symbol

Worg Pharma nets $152M in series C for allergy and autoimmune diseases

July 11, 2023
By Doris Yu
No Comments
Worg Pharmaceuticals (Zhejiang) Co. Ltd. raised ¥1.1 billion (US$152 million) in a series C round to develop its therapies for allergy and autoimmune diseases, as well as to expand into the global market.
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Glass yen/yuan symbol

Lynk nets $28M to develop JAK inhibitors for autoimmune diseases

June 13, 2023
By Doris Yu
No Comments
Lynk Pharmaceuticals Co. Ltd. raised ¥200 million (US$28 million) in a series C1 financing round to accelerate the clinical development of its second-generation and third-generation JAK inhibitors for cancer and autoimmune diseases.
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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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Daewoong_4-28.jpg

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

May 2, 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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FDA accepts Mesoblast’s BLA resubmission for remestemcel-L in pediatric GVHD

March 14, 2023
By Tamra Sami
No Comments
The U.S. FDA has accepted Mesoblast Ltd.’s BLA resubmission for its allogeneic stem cell treatment remestemcel-L in children with steroid-refractory acute graft-vs.-host disease (SR-aGVHD). Mesoblast received a complete response letter from the FDA in October 2020 for remestemcel-L even though approval was highly anticipated after the FDA’s Oncologic Drugs Advisory Committee voted 9-1 that the stem cell therapy showed evidence of efficacy as a treatment for SR-aGVHD in children.
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Biogen terminates collaboration with Innocare on orelabrutinib

Feb. 21, 2023
By Doris Yu
No Comments
Innocare Pharma Ltd. said it is open to new collaborations after partner Biogen Inc. decided to terminate a global deal to develop and commercialize BTK inhibitor orelabrutinib, in development for multiple sclerosis and other autoimmune diseases. Notice of the termination, disclosed in Biogen’s fourth-quarter 2022 financial report, was “based on the contract term of ‘terminate for convenience,’” Innocare told BioWorld. “We do not know their internal decision-making process.”
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IPO money

South Korea’s GI Innovation to raise up to $34M in IPO on the Kosdaq exchange

Feb. 14, 2023
By Tamra Sami
No Comments
South Korea’s GI Innovation Inc. announced its IPO on the Kosdaq market with plans to raise up to $34 million in March 2023. Funds raised from the IPO will go toward phase I/II clinical trials of immunotherapy agent GI-101 in the U.S. and Korea, and a phase I trial of allergy treatment GI-301 (also known as YH-35324) in Korea.
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Hand pain

Certa gears up for phase III trials following positive phase II results for FT-011 in scleroderma

Feb. 7, 2023
By Tamra Sami
No Comments
Certa Therapeutics Pty Ltd. is progressing antifibrotic agent FT-011 to phase III trials following positive results in a phase II trial that showed clinically meaningful improvements for more than 60% of patients with scleroderma in 12 weeks. FT-011 targets a previously undrugged G protein-coupled receptor, and these early efficacy outcomes in scleroderma suggest potential for FT-011 to treat other indications in Certa’s pipeline, including diabetic retinopathy and other forms of chronic kidney disease.
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Peanut allergy

Aravax raises $20M series B round to take peanut allergy immunotherapy to phase II

Dec. 27, 2022
By Tamra Sami
No Comments
With $20 million raised in a series B round led by Brandon Capital and Tenmile, Aravax Pty Ltd. is poised to begin phase II trials of its immunotherapy, PVX-108, for peanut allergy.
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