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Phase I

Drug Development
Amgen and Allergan’s Biosimilar to Rituxan Looks Good in Phase I/III Trial
Amgen and Allergan announced positive top-line results from a Phase I/Phase III trial of their biosimilar candidate, ABP 798, to Genentech and Biogen’s Rituxan (rituximab).
January 24, 2019
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3 min read
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Mark Terry
Drug Development
ADC Therapeutics Announces First Patient Dosed in Phase I Clinical Trial of ADCT-601 in Advanced Solid Tumors
Pyrrolobenzodiazepine-based antibody drug conjugate targets AXL, a receptor tyrosine kinase highly expressed in solid tumors
January 17, 2019
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3 min read
Drug Development
CarThera obtains ANSM approval to launch its Phase I-II clinical trial for the SonoCloud-9 device in the treatment of recurrent glioblastoma
CarTher today announces it has secured approval from the French National Agency for Medicines and Health Products Safety (ANSM) to start a Phase I-II clinical trial of its SonoCloud-9 device in the treatment of recurrent glioblastoma.
January 15, 2019
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5 min read
Bio NC
Your Feedback Matters! Topics in 2019
As a valued member of our BioSpace community, we are eager to hear more from you and other readers in 2019. Let us know which topics you want to hear more about.
January 8, 2019
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1 min read
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BioSpace Staff
Drug Development
Galapagos starts first Phase 1 trial with Toledo compound
Novel target class with dual action in inflammatory disorders
January 7, 2019
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4 min read
Ultragenyx Pharmaceutical Inc. Logo
Drug Development
Ultragenyx Announces Positive Topline Results from First Cohort of Phase 1/2 Clinical Study of DTX401 Gene Therapy in Glycogen Storage Disease Type Ia
DTX401 Response Observed in All Three Patients, with Two Patients Demonstrating Clinically Meaningful Improvement in Time to Hypoglycemia
January 7, 2019
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7 min read
Drug Development
ADC Therapeutics Doses First Patient in Phase Ib Clinical Trial of ADCT-301 in Patients with Advanced Solid Tumors
Potential for new immune-oncology therapy using an antibody drug conjugate that targets regulatory T cells
January 7, 2019
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4 min read
Drug Development
Adocia Announces a Clinical Trial Evaluating BioChaperone® Lispro and Other Rapid-Acting Insulin Analogs Using iLetTM Bionic Pancreas
ADOCIA announced today the first home-use trial to test Adocia’s BioChaperone® Lispro in Beta Bionics autonomous insulin delivery system, the iLetTM.
January 7, 2019
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5 min read
Drug Development
Gossamer Bio Plans to Raise $264.5 Million with IPO
Gossamer Bio, headquartered in San Diego, announced plans for its initial public offering (IPO) just before Christmas.
December 26, 2018
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2 min read
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Mark Terry
Drug Development
Medigene AG: Medigene publishes topline interim data from ongoing Phase I/II clinical trial with DC vaccines in AML patients
Topline-data from first half of treatment period (one year)
December 20, 2018
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6 min read
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PRESS RELEASES
Drug Development
Bolt Biotherapeutics Announces First Patient Dosed in Phase 1/2 Study of BDC-3042 in Patients with Advanced Cancers
October 17, 2023
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6 min read
Drug Development
Gamida Cell Reports Preliminary Data from Phase 1 Study of Natural Killer (NK) Cell Therapy Candidate GDA-201
October 16, 2023
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6 min read
Drug Development
MBX Biosciences Presents Positive Results from Phase 1 Study of MBX 2109 in Late-Breaking Oral Presentation at the American Society for Bone and Mineral Research Annual Meeting
October 16, 2023
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4 min read
Drug Development
OrsoBio to Present Phase 1 Data for the Liver-Targeted Mitochondrial Protonophore TLC-6740 in Development for the Treatment of Obesity at ObesityWeek® 2023
October 16, 2023
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5 min read
Drug Development
I-Mab Announces Phase 1 Data of Givastomig at ESMO 2023
October 16, 2023
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4 min read
Drug Development
Terns Pharmaceuticals Announces Global Phase 1 Clinical Trial Design of TERN-701 for the Treatment of Chronic Myeloid Leukemia
October 16, 2023
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9 min read
Drug Development
Theriva™ Biologics Announces Presentation at ESMO Congress 2023 Featuring Survival Outcomes in Phase 1 Study Evaluating VCN-01 in Combination with Durvalumab in Patients with Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck
October 16, 2023
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8 min read
Drug Development
Elixirgen Therapeutics Announces Promising Phase 1/2 Data on EXG-5003, a Controllable Self-Replicating RNA (c-srRNA) Vaccine Against SARS-CoV-2
October 16, 2023
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4 min read
Drug Development
ContraFect Announces FDA Clearance of CF-370 IND Application to Proceed With Phase 1 Clinical StudyCF-370 is the first engineered lysin therapeutic targeting Gram-negative pathogens allowed to enter a human trial
October 16, 2023
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8 min read
Drug Development
Trevena Reports Favorable TRV045 Topline Safety and Tolerability Data from Proof-of-Concept Studies
October 16, 2023
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6 min read
Drug Development
NanoViricides, Inc. Has Filed its Annual Report: Broad-spectrum Antiviral NV-387 (NV-CoV-2) in Phase 1a/1b Clinical Trial is Highly Active Against Coronaviruses as well as RSV
October 16, 2023
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14 min read
Drug Development
OSE Immunotherapeutics Presents First Positive Clinical Results With its anti-PD1 OSE-279 in Advanced Solid Tumors
October 16, 2023
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7 min read
Drug Development
Samsung Bioepis Presents Phase 1 and 3 Clinical Results for SB16, a Proposed Biosimilar to Proliaⁱ (denosumab), at ASBMR 2023
October 15, 2023
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4 min read
Drug Development
Immunic Presents Data From Phase 1b Clinical Trial of IMU-856 in Celiac Disease at the United European Gastroenterology Week 2023
October 15, 2023
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7 min read
Drug Development
Ankyra Therapeutics Presents Preliminary Phase 1 Canine Clinical Data Evaluating cANK-101 to Treat Advanced Malignant Melanoma in Dogs
October 14, 2023
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4 min read
Drug Development
New Phase 1 Dose Escalation Cohorts Data for Aulos Bioscience’s AU-007 Show Favorable Pharmacodynamic Effects at 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics
October 14, 2023
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5 min read
Drug Development
Puma Biotechnology Announces Presentation of Findings from a Phase I/II Study of Alisertib and Pembrolizumab for Rb-Deficient Head and Neck Squamous Cell Carcinomas at the 2023 AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics Meeting
October 14, 2023
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6 min read
Drug Development
Black Diamond Therapeutics Presents Dose Escalation Data Demonstrating Durable Responses in Patients with NSCLC from Phase 1 Trial of BDTX-1535
October 14, 2023
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8 min read
Drug Development
Kronos Bio Presents Positive Preliminary Data from Phase 1 Dose Escalation Portion of Phase 1/2 KB-0742 Study at AACR-NCI-EORTC
October 13, 2023
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9 min read
Drug Development
Repare Therapeutics Announces Positive Initial Data from Phase 1 MYTHIC Clinical Trial Evaluating Lunresertib Alone and in Combination with Camonsertib
October 13, 2023
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11 min read
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