Clinical Catch-Up: July 5-9

Clinical Trial_Compressed

Last week presented a fair number of clinical trial news. Read on for more information.

COVID-19-Related

Bharat Biotech and Ocugen presented positive data from the Phase III trial of Covaxin, a whole virion inactivated COVID-19 vaccine candidate. The vaccine demonstrated 77.8% efficacy in mild, moderate, and severe COVID-19 disease and 93.4% against severe COVID-19 disease.

Cognivue initiated the COG-COVID19 study to evaluate the impact of COVID-19 on cognitive function. Investigators from the University of Southern California, Case Western Reserve University and the University of California Irvine are collaborating on a 24-month, 1000-person study. The primary endpoint is to evaluate the cognitive function of 500 participants who have been diagnosed, treated and recovered from COVID-19 compared to 500 uninfected participants.

ORYZON Genomics presented preliminary data from the Phase II ESCAPE trial on vafidemstat in COVID-19 patients. Vafidemstat is an oral, CNS optimized LSD1 inhibitor.

Non-COVID-19-Related

Athira Pharma initiated its open label extension study of its ongoing Phase II/III LIFT-AD and Phase II ACT-AD trials of ATH-1017 for mild-to-moderate Alzheimer’s disease. ATH-1017 is a small molecule designed to enhance the activity of Hepatocyte Growth Factor (HGF) and its receptor, MET, which are depleted in Alzheimer’s disease.

ALX Oncology presented updated clinical data from its ongoing ASPEN-01 trial of ALX148 in combination with trastuzumab and chemotherapy for gastric or gastroesophageal junction cancer. The new data showed the drug in combination with trastuzumab and chemotherapy is highly active and well-tolerated in patients with second-line or greater HER2+ gastric or gastroesophageal junction cancer.

Boehringer Ingelheim and Eli Lilly and Company announced topline results from the EMPEROR-Preserved Phase III trial. It demonstrated Jardiance (empagliflozin)’s efficacy in all forms of heart failure regardless of ejection fraction.

Kura Oncology and Novartis plan to collaborate on a Phase I/II KURRENT trial of tipifarnib plus alpelisib in the second half of this year in head and neck squamous cell carcinoma (HNSCC) whose tumors have HRAS overexpression or PIK3CA mutation and/or amplification. Tipifarnib is Kura’s farnesyl transferase inhibitor. Novartis’ alpelisib is an inhibitor of phosphatidylinositol-3-kinase (PI3K) with inhibitor activity, mostly against the PI3Kalpha isoform.

Arbutus Biopharma and Vaccitech entered into a collaboration to run a Phase IIa trial of Arbutus’s GalNAc delivered RNAi therapeutic AB-729 followed by Vaccitech’s VTP-300, an immunotherapy, in Nrtl-suppressed patients with chronic hepatitis B virus (HBV) infection. These patients are already receiving standard-of-care nucleoside reverse transcriptase inhibitor (Nrtl) therapy.

EyePoint Pharmaceuticals announced positive safety results from its Phase I trial of EYP-1901 in wet age-related macular degeneration (wet AMD). The drug is a potential twice-yearly sustained delivery anti-VEGF treatment.

Gadeta dosed the first patient in its Phase I/II trial of GDT-002 for multiple myeloma. The drug is a potential first-in-class cellular immunotherapy that uses specific γδ T-cell receptors (TCR).

APEIRON Biologics launched a Phase Ib trial of APN401 for solid tumors. APN401 inhibits the immune checkpoint Cbl-b.

Hutchmed initiated a Phase I trial of HMPL-295, which is being developed for advanced solid tumors. HMPL-295 is a highly selective oral inhibitor of ERK, which is a downstream component of the RAS-MAPK pathway signaling cascade.

Abeona Therapeutics updated Phase I/IIa trial results up to six years after treatment with EB-101 for recessive dystrophic epidermolysis bullosa (RDEB). The data showed that investigator assessment of wound healing of 50% or greater was present in 69% of treated wounds at three years, 93% at four years, 80% at five years, and 80% at six years. EB-101 is an autologous, gene-corrected cell therapy.

NGM Biopharmaceuticals dosed the first patient in its Phase I/II trial of NGM707 alone or in combination with Merck’s Keytruda (pembrolizumab) for advanced solid tumors. NGM707 is a dual antagonist antibody that inhibits the ILT2 and ILT4 receptors. Keytruda is an anti-PD-1 antibody checkpoint inhibitor.

Opiant Pharmaceuticals announced positive top-line data of its confirmatory pharmacokinetic study for OPNT003 for opioid overdose. The drug is a nasal formulation of nalmefene. The data demonstrated the drug achieved significantly higher plasma concentrations compared to an intramuscular injection.

aTyr Pharma announced the last patient had completed their last visit in its Phase Ib/IIa trial of ATYR1923 in pulmonary sarcoidosis, a major form of interstitial lung disease. ATYR1923 is a fusion protein made up of the immuno-modulatory domain of histidyl-tRNA synthetase fused to the FC region of a human antibody. It is a selective modulator of neuropilin-2 that downregulates the innate and adaptive immune response in inflammatory disease states.

Evaxion Biotech announced results from both its Phase I/IIa trial of EVX-01 in metastatic melanoma and interim Phase I/IIa trial of EVX-02 in adjuvant melanoma. EVX-01 is a patient-specific cancer neoepitope immunotherapy. In a combination with a PD-1 checkpoint inhibitor, it demonstrated a safety profile with only Grade 1 and 2 adverse events. It demonstrated an ORR of 67% in all nine patients compared with historical data of 40% with an anti-PD1 treatment alone. EVX-02 was also evaluated with a checkpoint inhibitor. The first patients in the EVX-02 trial showed T-cell activation.

AiCuris Anti-Infective Cures AG initiated a Phase III trial of pritelivir for Herpes Simplex Virus (HSV) infections in immunocompromised patients. Pritelivir is a novel helicase-primase inhibitor.

Xeltis started the first-ever pivotal trial for a synthetic restorative pulmonary valve. RVOT reconstruction (right ventricular outflow tract) is a procedure needed to correct certain congenital heart defects. The Xplore2/Pivotal is a prospective, non-randomized study to evaluate safety and efficacy of the restorative pulmonary valve in up to 50 patients undergoing RVOT reconstruction.

Quantum Genomics enrolled the first patient in its REFRESH Phase III study of firibastat in difficult-to-treat and resistant hypertension. The study will enroll 750 patients in 96 sites in Europe, Canada, U.S., Taiwan, and South Korea.

Morphic Therapeutic presented positive results from its Phase I trial of MORF-057 for inflammatory bowel disease. The drug is an oral small molecule inhibitor of the alpha4beta7 integrin. The data included a favorable safety profile, predictable PK nad excellent PD results.

MediWound published the results of a Phase II trial of EscharEx, the company’s wound debriding product candidate. The study was run at 15 sites in Israel and Europe, and compared EscharEx to a hydrogel vehicle in a variety of chronic and hard-to-heal wounds. The EscharEx arm had a significantly higher incidence of complete debridement, hitting the primary endpoint.

Molecular Templates dosed the first patient in its Phase I study of MT-6402 in patients with PD-L1-positive solid tumors. The drug is an ETB made up of a single chain variable fragment (scFv) with affinity for PD-L1, fused to the enzymatically active de-immunized Shiga-like toxin-A subunit (SLTA) and a class I antigen derived from the human cytomegalovirus (HCMV) pp65 protein.

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