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BioWorld - Thursday, March 23, 2023
Home » Topics » FDA, BioWorld Science

FDA, BioWorld Science
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Antibodies attacking cancer cell
Immuno-oncology

Centessa to advance conditionally tetravalent PD-L1xCD47 bispecific monoclonal antibody

Jan. 27, 2023
No Comments
Centessa Pharmaceuticals plc has received clearance of its IND application from the FDA to initiate a first-in-human phase I/IIa trial of LB-101 for the treatment of solid tumors.
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Immuno-oncology

Sana receives IND clearance for CAR T-cell therapy SC-291 for B-cell malignancies

Jan. 27, 2023
No Comments
Sana Biotechnology Inc. has received FDA clearance of its IND application to initiate a first-in-human study of SC-291 in patients with various B-cell malignancies. Initial clinical data from the study are expected later this year. SC-291 is a CD19-targeted allogeneic chimeric antigen receptor (CAR) T-cell therapy developed using Sana's hypoimmune platform.
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Gastrointestinal

Exegi Pharma cleared to study EXE-346 for management of IPAA patients

Jan. 27, 2023
No Comments
Exegi Pharma LLC has received FDA clearance of its IND application for EXE-346, allowing the company to initiate a clinical trial to evaluate EXE-346 in the management of excessive stool frequency in patients with an ileal pouch-anal anastomosis (IPAA, J-Pouch).
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Illustration of antibodies attacking nerve cells
Neurology/Psychiatric

Lapix receives support from FDA for IND-enabling plan for LPX-TI641

Jan. 27, 2023
No Comments
Lapix Therapeutics Inc. has announced the successful outcome of its pre-IND meeting request with the FDA to achieve alignment on the company's IND-enabling plan for LPX-TI641, being developed for neuro-autoimmune indications such as multiple sclerosis (MS), neuromyelitis optica spectrum disorders (NMOSD), and myelin oligodendrocyte glycoprotein antibody disease (MOGAD).
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Cancer cells
Cancer

Tango's PRMT5 inhibitors receive IND clearance, orphan drug designation

Jan. 26, 2023
No Comments
The FDA has cleared Tango Therapeutics Inc.'s IND application for TNG-462, a next-generation methylthioadenosine-cooperative (MTA) inhibitor of protein arginine methyl transferase 5 (PRMT5) for the treatment of cancers with methylthioadenosine phosphorylase (MTAP) deletion.
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Cancer cell and target
Immuno-oncology

FDA approves Tscan's INDs for T-Plex and MAGE-targeting TCR-T products

Jan. 25, 2023
No Comments
Tscan Therapeutics Inc. has received FDA clearance of its IND applications for T-Plex, TSC-204-A0201 and TSC-204-C0702.
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Immuno-oncology

Immpact's bispecific CAR T-cell therapy IMPT-314 cleared to enter clinic for B-cell lymphoma

Jan. 25, 2023
No Comments
Immpact Bio USA Inc. has announced clearance of its IND application by the FDA for IMPT-314, a bispecific OR-Gate autologous chimeric antigen receptor (CAR) T-cell therapy targeting the B-cell antigens CD19 and CD20.
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Non-Hodgkin lymphoma cells in the blood flow
Immuno-oncology

Cullinan's T-cell engager CLN-978 cleared by FDA to begin clinical studies for B-cell NHL

Jan. 25, 2023
No Comments
The FDA has cleared Cullinan Oncology Inc.'s IND application for CLN-978, a CD19/CD3 T-cell engaging antibody construct with a human serum albumin (HSA) binding domain to increase serum half-life.
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Cancer

Kura to advance next-generation farnesyl transferase inhibitor KO-2806

Jan. 25, 2023
No Comments
The FDA has cleared Kura Oncology Inc.'s IND...
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CAR T cell attacking cancer cells
Immuno-oncology

Carina gives update on LGR5-targeted CAR T therapy for colorectal cancer

Jan. 25, 2023
No Comments
Carina Biotech Pty Ltd. has received FDA...
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