Tag Archives: clinical trial

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Ascletis Announces US IND Approval of ASC22 (Envafolimab), a Subcutaneously Administered PD-L1 Antibody for Functional Cure of Chronic Hepatitis B

Ascletis Pharma, Inc. announced the Investigational New Drug (IND) application approval by US FDA and initiation of global development of ASC22, a first-in-class, subcutaneously administered PD-L1 antibody for functional cure of chronic hepatitis B.

[Ascletis Pharma, Inc.]

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Xilio Therapeutics Announces Initiation of Patient Dosing in Phase 1/2 Clinical Trial of XTX202 for the Treatment of Patients with Solid Tumors

Xilio Therapeutics, Inc. announced that the first patient has been dosed in the company’s Phase I/II clinical trial evaluating XTX202 for the treatment of solid tumors. XTX202 is a modified form of IL-2 that is designed to localize activity in the tumor microenvironment.

[Xilio Therapeutics, Inc.]

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Publication

miR-204–Containing Exosomes Ameliorate GVHD-Associated Dry Eye Disease

Investigators reported that exosomes from MSCs administered as eye drops notably alleviated graft-versus-host disease-associated dry eye disease by suppressing inflammation and improving epithelial recovery in mice and humans.

[Science Advances]

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Full Article

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Brazilian Health Regulatory Agency (ANVISA) Authorizes Sorrento Phase II Clinical Trial of COVI-MSC in COVID-19 Patients with Persistent Pulmonary Compromise after Recovery (Long-Hauler)

Sorrento Therapeutics, Inc. announced receipt of clearance from ANVISA to proceed with a Phase IIa randomized, placebo-controlled study of intravenous allogeneic adipose-derived MSC to treat post COVID-19 “long haul” pulmonary compromise.

[Sorrento Therapeutics, Inc.]

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IMV Announces First Patient Dosed in the VITALIZE Phase IIB Clinical Study Evaluating its Lead Compound, MVP-S, in Combination with KEYTRUDA^® (pembrolizumab) in Patients with r/r DLBCL

IMV, Inc., a clinical-stage company developing a portfolio of immune-educating therapies based on its novel DPX platform to treat solid and hematologic cancers, announced a first patient dosed in the VITALIZE Phase IIB clinical trial.

[IMV Inc.]

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Sarepta Therapeutics’ Gene Therapy SRP-9001 Shows Statistically Significant Functional Improvements Compared to Pre-Specified Matched External Control in Part II of Study SRP-9001-102 for the Treatment of Duchenne Muscular Dystrophy

Sarepta Therapeutics, Inc. announced topline results from Part II of Study SRP-9001-102, an ongoing, randomized, double-blind, placebo-controlled clinical trial to evaluate the safety, efficacy and tolerability of a single dose of SRP-9001 in 41 patients with Duchenne muscular dystrophy.

[Sarepta Therapeutics]

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Rubius Therapeutics Announces Dosing of First Patient in Phase I/II Trial of RTX-224, a Broad Immune Agonist, for the Treatment of Certain Solid Tumors

Rubius Therapeutics, Inc. announced that the first patient has been dosed in its Phase I/II clinical trial of RTX-224 for the treatment of patients with certain relapsed/refractory or locally advanced solid tumors, including non-small cell lung cancer, cutaneous melanoma, head and neck squamous cell carcinoma, urothelia carcinoma and triple-negative breast cancer.

[Rubius Therapeutics, Inc.]

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Fate Therapeutics Announces FDA Clearance for FT536, a First-in-Class MICA/B-targeted CAR NK Cell Product Candidate for the Treatment of Solid Tumors

Fate Therapeutics, Inc. announced that the US FDA has cleared the company’s Investigational New Drug application for FT536, an off-the-shelf, multiplexed-engineered, iPSC-derived, chimeric antigen receptor NK cell product candidate.

[Fate Therapeutics, Inc.]

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Vaxxinity Announces First Parkinson’s Disease Patient Dosed in Part B of Phase I Clinical Trial of UB-312

Vaxxinity, Inc. announced that the first patient with Parkinson’s disease has been dosed with UB-312 in Part B of a double-blinded, placebo-controlled Phase I clinical trial, following completion of Part A of the Phase I trial in healthy volunteers.

[Vaxxinity, Inc.]

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PharmaTher Announces FDA Approval of Investigational New Drug (IND) Application for Ketamine to Treat ALS

PharmaTher Holdings Ltd. announced that the US FDA has accepted an investigator-initiated IND application to proceed with a Phase II clinical trial evaluating ketamine in the treatment of Amyotrophic Lateral Sclerosis (ALS).

[PharmaTher Holdings Ltd.]

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