Clinical Catch-Up: Anixa, Palisade and Genexine Launch New Trials

Cancer research

Novartis' canakinumab failed again in non-small cell lung cancer (NSCLC), and Anixa Biosciences, Palisade Bio and Genexine kicked off new trials. For that and more clinical news, keep reading.  

Novartis reported that its Phase III CANOPY-A trial of canakinumab for adults with NSCLC failed to hit its primary efficacy endpoint. The drug is a human monoclonal antibody targeting interleukin-1ß. The trial evaluated almost 1,400 patients with stage II-IIIA and IIIB NSCLC whose tumors had been completely resected. The primary endpoint was disease-free survival (DFS). Marketed as Ilaris, the drug is indicated for cryopyrin-associated autoinflammatory syndromes in children and adults, systemic juvenile idiopathic arthritis and three other periodic fever syndromes. It is also approved to treat adult-onset Still's disease.

Anixa Biosciences treated the first patient at the H. Lee Moffitt Cancer Center & Research Institute with its CAR-T therapy for ovarian cancer. The Phase I dose-escalation study will include 48 patients. The treatment leverages Anixa's chimeric endocrine receptor T-cell (CER-T) because the engineered T-cells target an endocrine receptor. The endocrine receptor target is a follicle-stimulating hormone receptor (FSHR), which is exclusively expressed on ovarian cells in healthy adult females.

Palatin Technologies announced a planned interim analysis of its Phase III MELODY-1 trial of PL9643 for dry eye disease. The interim analysis included the independent Data Monitoring Committee (DMC) evaluation of the first 120 patients who completed the treatment. The DMC recommended the trial continue with a study sample size target of 350 patients. No safety concerns were identified. PL9643 is a melanocortin agonist.

Palisade Bio dosed the first patient in a Phase III trial of LB1148, which aims to accelerate the return of bowel function in adults undergoing gastrointestinal surgery. The drug is a novel oral liquid formulation of the digestive enzyme inhibitor tranexamic acid. Palisade believes it has the potential to decrease abdominal adhesions and help restore bowel function after surgery. It neutralizes the activity of potent digestive proteases released from the gut during surgery.

Genexine dosed the first patient in a Phase II trial of triple combination therapy in patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC). The treatment consists of two of Genexine's drugs, GX-188E and GX-17. GX-188E is a first-in-class DNA vaccine, while GX-17 is a first-in-class long-acting interleukin 7. The third drug is Bristol Myers Squibb's anti-PD-1 checkpoint inhibitor Opdivo (nivolumab). The study is being run in South Korea and will evaluate the combination in 21 patients with HPV-16 or 18-positive recurrent/metastatic head and neck squamous cell carcinoma.

PharmaJet and the University of Adelaide launched a human clinical trial of a DNA-based COVID-19 vaccine booster using the PharmaJet Tropis Needle-free Injection System (NFIS). The vaccine targets the Omicron variant and, as a DNA vaccine, can be modified easily to future variants. The partners chose the PharmaJet Tropis NFIS based on preclinical and clinical data showing improved immunogenicity when administering DNA vaccines.

CSL announced positive topline results for its Phase III trial of garadacimab for hereditary angioedema (HAE). The drug is a first-in-class monoclonal antibody inhibiting Factor XIIa. The trial hit the primary and secondary efficacy endpoints and demonstrated a favorable safety profile. HAE is a rare, genetic and potentially life-threatening disease that causes painful, debilitating and unpredictable swelling of the abdomen, larynx, face and extremities.

Valo Health dosed the first patient in its Phase II trial of oral OPL-0401 in patients with mild, moderate and severe non-proliferative diabetic retinopathy. OPL-0401 is a small molecule Rho kinase 1/2 inhibitor and a potential first-in-class oral option compared to current intravitreal injections, surgery, or laser treatment options. The study was designed using the company's Opal Computational Platform, allowing real-world data analyses to identify patient populations that might benefit from early treatment.

Lundbeck reported that Vyepti (eptinezumab) failed to show statistical superiority over placebo at reducing the number of monthly migraine days. The drug was approved in the United States in 2020 as a preventive measure against migraine. The Phase III Sunlight trial was designed to set the drug up for accelerated approval in China.

Sorrento Therapeutics received clearance from the Chinese regulatory authority to initiate a Phase I trial of its oral main viral protease inhibitor, STI-1558, in COVID-19 patients. A single ascending dose (SAD) portion of the trial was completed in Australia with no serious adverse events or severe treatment-emergent adverse events. Pharmacokinetics were dose proportional. In the China trial, the drug will be given to patients with COVID-19 in multiple ascending doses with three dose cohorts.

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