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BioWorld - Sunday, April 5, 2026
Home » Topics » Cell therapy, BioWorld Science

Cell therapy, BioWorld Science
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Illustration of pancreas, close up of islet
Endocrine/metabolic

Seraxis gains IND clearance for islet replacement therapy

Oct. 16, 2024
Seraxis Inc. has obtained IND clearance from the FDA for a phase I/II study of its novel islet replacement therapy SR-02 for type 1 diabetes. SR-02 is comprised of allogeneic pancreatic endocrine cell clusters that, when implanted to the omentum, form a functional endocrine pancreas outside of the native pancreas.
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Enara’s ‘dark antigen’ work draws more pharma backing in series B

Oct. 4, 2024
By Nuala Moran
Dark genome miner Enara Bio Ltd. has closed a $32.5 million series B that will see the lead program targeting the first of a novel class of cancer antigens it has discovered through to the clinic. Enara calls these cancer antigens “dark antigens” (the name is trademarked). It says they can be found in solid tumors irrespective of the immune phenotype, and are often expressed at high prevalence across multiple different tumors.
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Cells, DNA illustration
Endocrine/metabolic

Papillon’s PPL-002 awarded US orphan drug designation for Danon disease

Oct. 2, 2024
The FDA has awarded orphan drug designation to Papillon Therapeutics Inc.’s PPL-002, an experimental gene-modified CD34+ hematopoietic stem and progenitor cell (HSPC) therapy, for the treatment of Danon disease.
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Gold dollar sign inside gold cog
Cancer

Prime’s $3.61B Bristol Myers deal is year’s fourth largest

Oct. 1, 2024
By Lee Landenberger
In the year’s fourth-largest deal, Prime Medicine Inc. will collaborate with Bristol Myers Squibb Co. in a research collaboration and license agreement totaling $3.61 billion. The two companies plan to develop reagents for ex vivo T-cell therapies. While the programs and targets have yet to be disclosed, BMS is expanding its CAR T development, begun more than five years ago, with this deal.
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Illustration of women's reproductive organs
Immuno-oncology

Cartherics raises funding to advance TAG-72 CAR NK into clinic

Oct. 1, 2024
Cartherics Pty Ltd. has raised over its target of AU$15 million (US$10.3 million) in an oversubscribed private financing round. Funding will support a clinical trial for CTH-401, the company’s lead cell therapy for ovarian cancer, and expand its pipeline to include other diseases.
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Nervous system illustration
Neurology/psychiatric

KYV-101 demonstrates CAR-mediated, CD19-dependent activity across neurological indications in vitro

Sep. 30, 2024
Researchers from Kyverna Therapeutics Inc. presented preclinical data for KYV-101, a first-in-class, fully human autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy being developed for the treatment of patients with B-cell-driven neurologic autoimmune diseases, including multiple sclerosis and myasthenia gravis.
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Cell research illustration
Neurology/psychiatric

PPL-001 gets US orphan drug designation for Friedreich’s ataxia

Sep. 18, 2024
Papillon Therapeutics Inc.’s PPL-001 has been awarded orphan drug designation by the FDA for Friedreich’s ataxia. PPL-001 is an experimental gene-corrected CD34+ hematopoietic stem and progenitor cell (HSPC) therapy.
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Doctor examining child in wheelchair
Neurology/psychiatric

Somite’s SMT-M01 awarded US orphan drug designation for Duchenne muscular dystrophy

Sep. 17, 2024
Somite Therapeutics Inc.’s lead program, SMT-M01, has been awarded orphan drug and rare pediatric disease designations by the FDA for the treatment of Duchenne muscular dystrophy (DMD). The program leverages the company’s proprietary Alphastem artificial intelligence (AI) platform to develop a novel cell replacement therapy for DMD.
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Colorized transmission electron micrograph of mpox virus particles found within an infected cell.
Infection

TC Biopharm plans preclinical studies of TCB-008 to treat mpox

Sep. 9, 2024
TC Biopharm (Holdings) plc has announced plans to begin proof-of-concept preclinical studies for its lead therapeutic, TCB-008, for the treatment of mpox.
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Cancer cell, dropper, test tubes
Immuno-oncology

Medigene’s TCR T therapy MDG-1015 gets green light for clinic in US

Sep. 6, 2024
Medigene AG has obtained FDA clearance of its IND application for lead program MDG-1015 for the treatment of advanced gastric cancer, ovarian cancer, myxoid/round cell liposarcoma and synovial sarcoma.
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