Cell – Talk Bio

FDA Lifts Partial Hold on Merck and Daiichi Sankyo’s B7-H3 ADC Trial for Lung Cancer[6]

2 weeks ago talkbio0Tagged CD276 gene, Daiichi, Deruxtecan, I-DXd, IDeate-Lung02, ifinatamab, Lifting, Merck, Sankyo, Small cell carcinoma of lung, therapeutic autologous dendritic cells, United States Food and Drug Administration

FDA; partial hold lifted; Merck; Daiichi Sankyo; ifinatamab deruxtecan; I-DXd; B7-H3 ADC; small cell lung cancer; IDeate-Lung02

FDA Announces Flexible Manufacturing Approach for Cell and Gene Therapies on January 11, 2026

2 weeks ago talkbio0Tagged calcium glucarate, Candidiasis, Chronic Mucocutaneous, Cells, gene therapy, Manufacturing, Pliability, requirements, United States Food and Drug Administration

FDA; cell and gene therapies; CGT; manufacturing flexibility; CMC requirements; Marty Makary

Roche returns to Chinese biotech MediLink for another ADC pact

2 weeks ago talkbio0Tagged Antibody-Drug Conjugates, CD276 gene, China, Neoplasms, Platform, Roche (company), Small cell carcinoma of lung, small-cell lung cancer, Solid Neoplasm, therapeutic autologous dendritic cells, TMALIN, YL201

Roche; MediLink Therapeutics; YL201; antibody-drug conjugate; ADC; B7-H3; TMALIN platform; small-cell lung cancer; SCLC; solid tumors; licensing deal; oncology; China biotech

Exclusive: Charles Fuchs departs Roche to become Chief Medical Officer at Tubulis, steering ADC pipeline after $401M Series C

2 weeks ago talkbio0Tagged Antibody-Drug Conjugates, Cambridge office, Charles Fuchs, Chief Medical Officer, genentech, Hematology (discipline), NaPi2b, Neoplasms, pipeline, Roche (company), Series C financing, Solid Neoplasm, therapeutic autologous dendritic cells, TPBG gene, TUB-030, TUB-040, Tubulis

Charles Fuchs; Tubulis; Roche; Genentech; chief medical officer; antibody-drug conjugates; ADC pipeline; TUB-040; TUB-030; Series C financing; oncology; hematology; solid tumors; NaPi2b; 5T4; Cambridge office

Spotlight On: Five key oncology stories to watch in 2026

3 weeks ago talkbio0Tagged 2026, Antibody-Drug Conjugates, cancer research trends, CAR-T, Cell Therapy, Liquid Biopsy, Lymphocytes, Tumor-Infiltrating, mRNA cancer, Neoplasms, oncology decisions, precision oncology, Radiopharmaceuticals, T-Cell Receptor, United States Food and Drug Administration, Vaccines

oncology 2026; cancer research trends; FDA oncology decisions 2026; antibody-drug conjugates; radiopharmaceuticals; liquid biopsy; mRNA cancer vaccines; AI in oncology; cell therapies CAR-T TIL TCR; precision oncology

Berkeley startup raises $106.5M for all‑RNA ‘jumping gene’ therapies

1 month ago talkbio0Tagged Berkeley, Cells, Funding, gene therapy, jumping gene, M financing, programmable RNA medicines, Radar Therapeutics, RNA gene, Series A

Radar Therapeutics; Berkeley startup; $106.5M financing; Series A; jumping gene; RNA gene insertion; programmable RNA medicines; cell and gene therapy; biotech funding

Sanofi returns to Dren Bio for another B‑cell depletion therapy with $100M upfront

1 month ago talkbio0Tagged Antibodies, Bispecific, Autoimmune Diseases, B-Lymphocytes, Depletion, Dren Bio, Immunology, Myeloid cell engager, sanofi, strategic collaboration, upfront

Sanofi; Dren Bio; B-cell depletion; autoimmune diseases; strategic collaboration; bispecific antibody; myeloid cell engager; immunology; $100M upfront; licensing deal

FDA Signals Higher Efficacy Bar for New CAR‑T Cancer Therapies

2 months ago talkbio0Tagged CAR-T, Cells, Chimeric Antigen Receptor T-Cell Therapy, gene therapy, Hematologic Neoplasms, Neoplasms, Overall Survival, Randomized Controlled Trials as Topic, regulatory standards, superiority trials, United States Food and Drug Administration

FDA; CAR-T; chimeric antigen receptor T-cell therapy; oncology; regulatory standards; superiority trials; randomized controlled trials; overall survival; hematologic malignancies; cell and gene therapy

AstraZeneca’s dual-targeting CAR-T AZD0120 shows similar response rates in Western and Chinese patients

2 months ago talkbio0Tagged AstraZeneca, Autologous Bispecific BCMA/CD19-targeted CAR-T Cells GC012F, AZD0120, BCMAxCD19, CAR-T, China, Clinical Trials, dual-targeting CAR-T, DURGA-1, Frequency of Responses, Multiple Myeloma, Western patients

AstraZeneca; AZD0120; GC012F; dual-targeting CAR-T; BCMAxCD19; multiple myeloma; DURGA-1; China; Western patients; response rate; clinical trial; CAR-T

Crescent Biopharma and Kelun-Biotech Announce Reciprocal Licensing Pact for PD-1xVEGF and ADC Cancer Therapies

2 months ago talkbio0Tagged Antibodies, Bispecific, China, CR-001, Crescent Biopharma, Kelun-Biotech, Licensing, oncology partnership, PD-1xVEGF, Reciprocal, SKB105, therapeutic autologous dendritic cells

Crescent Biopharma; Kelun-Biotech; PD-1xVEGF; CR-001; SKB105; reciprocal licensing; oncology partnership; China; ADC; bispecific antibody