One of the other Cidara’s Cloudbreak antiviral conjugates (AVCs), CD388 is under rigorous trials for serious fungal and viral infections, and also possesses the powers to prevent the advent of flu. The advantage the therapy holds over available marketed vaccines for the same-says the company is that its tolerability, safety and efficacy to be used in populations of all age groups. Further, the therapy may also have therapeutic prowess same as that of widely-used Tamiflu.
FDA’s Go-ahead to Supernus’s novel ADHD drug, Qelbree
Supernus became the spearhead in the industry after the USFDA gave green signal to its novel non-stimulant therapy, Qelbree, for attention-deficit hyperactivity disorder (ADHD) in pediatric patients falling in the age group of 6 to 17 years.
Earlier known as SPN-812, Qelbree, is a serotonin norepinephrine modulating agent, and the first non-stimulant treatment for ADHD to get approval. The active ingredient in the therapy (viloxazine hydrochloride) has an extensive safety record in Europe, where it was previously marketed for many years as an antidepressant, the company said.
As per the data from the trials, the therapy was investigated in more than 1,000 pediatric patients in four phase III clinical trials and showed efficacy on both hyperactivity/impulsivity and inattention subscales with statistical significance in patients. The news was a huge relief after the regulatory agency issued a Complete Response Letter in sight of concerns related to the relocation of the company’s in-house laboratory.
Rain Therapeutics’ Newest Adventure, Plans USD 100 Million IPO
California-based oncology company, Rain Therapeutics, recently filed for a USD 100 million IPO to boost the clinical development and manufacturing of its lead MDM2 inhibitor to the late-stage of testing.
The new program of the company, RAIN-32, has successfully completed phase I clinical stage in solid tumors and lymphomas and plans to advance it to the phase III stage of clinical testing in liposarcoma, and two more Phase II trials in solid tumors and intimal sarcoma, respectively.
Looks like Rain Therapeutics is collecting cash to strengthen and expand its pipeline. Not less than a year ago, the company pulled in a research program from Drexel University, a Phase II-ready drug from Daiichi followed with another hefty funding of USD 63 million.
Antengene Announces NMPA Approval of IND Application for ATG-019
Antengene Corporation announced the approval of the Investigational New Drug (IND) application for a Phase I clinical trial to test the safety and efficacy of ATG-019 (monotherapy or combined with niacin ER) in patients with advanced solid tumors or non-Hodgkin’s lymphoma (NHL) in China from the National Medical Products Administration (NMPA).
ATG-019 is an orally bioavailable dual PAK4/NAMPT inhibitor that facilitates antitumor activity, inhibits DNA repair, hampers cell cycle progression, and ultimately leads to cell apoptosis. The drug can produce anti-tumor activities in both hematological and solid tumor cells that are dependent on PAK4 and NAMPT pathways; and this makes the drug an interesting and promising therapy.
Antengene is conducting a Phase I clinical trial (TEACH) of ATG-019 in advanced solid tumors and NHL in Taiwan and plans to further proceed with trials testing its combination potential with other agents.
