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BioWorld - Friday, April 24, 2026
Home » Topics » Cell therapy, BioWorld Science

Cell therapy, BioWorld Science
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Brain clay model
Neurology/psychiatric

FDA clears IND for Naturecell’s Astrostem-AU for autism

April 16, 2026
No Comments
Naturecell Co. Ltd.’s U.S. subsidiary, Naturecell America, has received IND clearance from the FDA for Astrostem-AU, an autologous adipose-derived mesenchymal stem cell therapy for adults with autism spectrum disorder (ASD).
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Immuno-oncology

Ernexa eyes clinic with ERNA-101 for ovarian cancer

April 2, 2026
No Comments
Ernexa Therapeutics Inc. is advancing its lead program, ERNA-101, toward an IND submission in the third quarter of this year and the initiation of a first-in-human trial in the fourth quarter for the treatment of platinum-resistant ovarian cancer.
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Blue-gray dollar sign
Cancer

Excalipoint closes $68.7M seed round for cancer T-cell engagers

March 19, 2026
By Marian (YoonJee) Chu
No Comments
Excalipoint Therapeutics Inc. launched with an oversubscribed $68.7 million seed financing round to advance a portfolio of T-cell engagers for solid tumors, marking one of the largest early stage financings in China biotech history.
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Brain and encephalography
Neurology/psychiatric

Unixell Biotech’s UX-GIP001 gains IND clearance for epilepsy

March 16, 2026
No Comments
Shanghai Unixell Biotechnology Co. Ltd. has obtained IND clearance from the FDA for UX-GIP001, its iPSC-derived allogeneic cell therapy for focal epilepsy. A phase I study will evaluate UX-GIP001 in patients with drug-resistant epilepsy.
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Pipet, test tubes, chemical structures
Cancer

C-Further unveils pediatric cancer programs

March 10, 2026
No Comments
C-Further, an international consortium supporting new therapeutics for pediatric cancers, has unveiled the first early-stage therapeutic programs in its pipeline. The company said it is advancing CF-012 and CF-033 through its collaborative model.
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Diagram of how cells take up glucose from the stomach and insulin from the pancreas
Endocrine/metabolic

Newcelx partners with Eledon to advance NCEL-101

March 9, 2026
No Comments
Newcelx Ltd. has entered into a collaborative research agreement with Eledon Pharmaceuticals Inc. with the aim of advancing its lead program, NCEL-101, for type 1 diabetes.
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Medical vector illustration showing cross section of an eyeball with close up of the macula
Ocular

Sanaregen Vision’s SVT-001 cleared for clinic for familial drusen

March 3, 2026
No Comments
Sanaregen Vision Therapeutics Inc. has received FDA clearance to conduct a phase I/II trial of SVT-001, an investigational cell therapy for individuals with familial drusen.
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CAR T cell attacking cancer cells
Immuno-oncology

HITting solid tumors with a closer look and a stronger CAR T cell

March 2, 2026
By Anette Breindl
No Comments
CAR T cells have been groundbreaking for the treatment of B-cell cancers. But 8 years after Kymriah (tisagenlecleucel, Novartis AG) became the first CAR T-cell therapy to be approved, there are no CAR Ts approved for solid tumors.
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T cells
Immuno-oncology

Zelluna’s ZI-MA4-1 gains UK CTA clearance for solid tumors

Feb. 23, 2026
No Comments
Zelluna ASA has received approvals from the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) and research ethics committee for its clinical trial application (CTA) for ZI-MA4-1, Zelluna’s lead T-cell receptor-based natural killer (TCR-NK) product candidate.
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Dollar sign droplet above test tube
Ocular

Financing at Gelmedix supports GMX-101 for geographic atrophy

Feb. 18, 2026
No Comments
Gelmedix Inc. has completed a $13 million seed financing to support progression of the company’s lead program, GMX-101, a retinal pigment epithelial (RPE) cell therapy to treat late-stage geographic atrophy.
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