As per an announcement, the meeting proffered guidance on the Phase IIb protocol design submitted by Algernon and the endpoints, which were chosen. Moreover, the FDA sought completion of standard genotoxicity testing before initiating the trial, which Algernon anticipates to need nearly 90 days to finish.
The company had asked for the pre-IND meeting to advance the Phase IIb trial of the therapy for treating chronic cough in the US. In September last year, the company declared a positive trend in the interim results from the chronic cough portion of a Phase II trial, which is set in Australia and New Zealand and for idiopathic pulmonary fibrosis (IPF) and chronic cough.
Pieris doses the first subject in Phase II gastric cancer drug trial
Pieris Pharmaceuticals has declared the dosing of the first subject in Phase II clinical trial of the drug candidate, cinrebafusp alfa (PRS-343), for treating human epidermal growth factor receptor 2 (HER2)-expressing gastric cancer.
A 4-1BB/HER2 fusion protein, cinrebafusp alfa, comprises 4-1BB-targeting Anticalin proteins, anan antibody, which acts on HER2. The drug is currently being evaluated in a Phase II trial for treating HER2-expressing solid tumors.
The multicentre, two-arm, open-label trial will evaluate the safety, efficacy, and tolerability of cinrebafusp alfa plus ramucirumab and paclitaxel in HER2-high gastric cancer patients, and along with tucatinib in HER2-low gastric cancer patients. Trial subjects will be given an 18mg/kg loading dose in weeks one and three and subsequently 8mg/kg maintenance doses once every two weeks (Q2W).
In the HER2-low group, Pieris expects an ORR of a minimum of 40% and significant durability, with results anticipated later this year. The company focuses on an ORR of a minimum of 50% with considerable durability for the HER2-high arm, with data expected next year.
Gaumard Scientific unveils multidisciplinary patient simulator HAL S5301
Gaumard Scientific has revealed an advanced multidisciplinary patient simulator HAL S5301, which offers robotics, AI-powered speech, and simulated physiology.
HAL S5301 is offered with a life-like movement feature to simulate symptoms of stroke and traumatic brain injury (TBI). More features of the new patient simulator comprise conversational speech and next-generation simulated physiology. HAL S5301 is also the first simulator for brain injury training with advanced motor movements.
The company said that HAL S5301 also proffers advanced anatomy and physiology in simulated cardiac, respiratory, and vascular physiology, comprising arterial access, lung compliance, and high fidelity auscultation. The company is exhibiting the new patient simulator at the International Meeting on Simulation in Healthcare (IMSH) in Los Angeles, held between 15 and 19 January.
Gaumard designs and manufactures simulators for militaries, emergency medical services, major teaching hospitals, and nursing schools. The company produces simulators at its global headquarters in Miami and sells them directly in the US and via distributors in 70 countries. Gaumard’s product portfolio comprises NOELLE maternal and neonatal care simulators and HAL simulators with fully tetherless technology.
Hekka Labs rolls out decentralized healthcare ecosystem
UK-based Hekka Labs has introduced a decentralized healthcare ecosystem to enable effective health record management.
With an aim in Southeast Asia, the company will initially start the new ecosystem in India, where it will establish a sizable chronic disease data management network. It plans to expand the offering to the rest of the world through the design and implementation of the Distributed Ledger Technology (DLT).
Hekka has entered initial partnerships with three Indian healthcare solution providers to implement the decentralized healthcare ecosystem. Hekka has collaborated with Curisin, a healthcare company with a network of 30 million patients and 40,000 partner doctors, to offer at least 1.5 million medical records in 2022.
Moreover, it will receive up to 20 different blood biomarkers and Covid 19 data on 100,000 patients to bolster initial trials for its blockchain audit trail platform. Immunidex, a healthcare solution provider offering AI-powered tests and applications, has agreed to capture quality data for the Hekka network.
Telemedicine Indian Company, a start-up that proffers telemedicine services, blood tests, and health screening, has also signed agreements with the company for data generation. With the integration of DLT, Hekka is expected to provide a turnkey solution that enables easy interaction with the HEKKA ecosystem without interruption. The new ecosystem is said to solve the inherent problems in the healthcare industry, such as inefficient biomarker management, document hogging, and improper data management. Hekka Labs aims to become a sizable chronic illness and immunology platform in India.
