Clinical update of MCLA-129 presented at the 34th EORTC/NCI/AACR (ENA) Symposium on Molecular Targets and Cancer Therapeutics
– Zenocutuzumab (Zeno) Regulatory update: FDA recommends additional enrollment in eNRGy trial to support potential BLA filingAcutus Medical, Inc. (“Acutus” or the “Company”) (Nasdaq: AFIB), an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated, today announced that the Company has achieved the first milestone under the asset purchase agreement of its left-heart access portfolio with Medtronic. This triggers a $20 million earnout payment from Medtronic to Acutus and allows Acutus to become an original equipment manufacturer (OEM) for Medtronic. Acutus will continue selling the left-heart access portfolio until commercial distribution is transitioned to Medtronic.
https://finance.yahoo.com/news/acutus-medical-achieves-oem-qualification-120000076.html
Companies to combine their clinical programs (AFM13, AB-101) to address high unmet need of CD30-positive lymphoma patients
Affimed’s AFM13 in combination with cord blood-derived NK cells demonstrated exceptionally high response rates in relapsed and refractory CD30-positive lymphoma patients
AB-101 is a clinical-stage, cryopreserved, off-the shelf, non-genetically modified, allogeneic cord blood-derived NK cell manufactured at large scale via Artiva’s AlloNKTM platform as a universal ADCC-enhancing cell therapy
In preclinical studies, the combination of AFM13 and AB-101 demonstrated potent anti-tumor activity
An investigational new drug (IND) submission to the U.S. Food and Drug Administration (FDA) is planned for the first half of 2023
Affimed to receive 67% of the combination therapy revenues, and Artiva to receive 33%
Conference call and webcast scheduled for November 3, 2022 at 10:30 a.m. EDT/15:30 CET
Affimed and Artiva will host a conference call and webcast on November 3, 2022, at 10:30 a.m. EDT / 15:30 CET to discuss this partnership and next steps in the development of AFM13 in combination with AB-101. The conference call will be available via phone and webcast. A live audio webcast of the conference call will be available in the “Webcasts” section on the “Investors” page of the Affimed website at https://www.affimed.com/investors/webcasts-and-corporate-presentation/.
To access the call by phone, please use link https://register.vevent.com/register/BIca92c598dd7a41319b8a09f5f7ce08bf, and you will be provided with dial in details and a pin number.
Note: To avoid delays, we encourage participants to dial into the conference call 15 minutes ahead of the scheduled start time.
A replay of the webcast will be accessible at the same link for 30 days following the call.
https://finance.yahoo.com/news/affimed-artiva-biotherapeutics-announce-partnership-131500531.html
NeuroMetrix, Inc. (Nasdaq: NURO) today announced the strategic launch of its Quell® Fibromyalgia device through the Pathfinder Program. Quell Fibromyalgia is the first and only medical device authorized by the U.S. Food and Drug Administration (FDA) to help reduce the symptoms of fibromyalgia.
The Pathfinder Program is designed to validate and further refine the commercial process for Quell Fibromyalgia in anticipation of a full commercial launch in Q2 of 2023. Pathfinder starts on December 1, 2022 and will be limited to 25 key-opinion leaders in fibromyalgia practice across the United States. The guidance of these key physicians will be significant to the Company’s ability to effectively communicate the benefits of Quell to patients and healthcare professionals.
https://finance.yahoo.com/news/neurometrix-announces-strategic-launch-quell-130000491.html
Co-primary endpoint measuring >50% wound healing, other endpoints measuring >75% and complete wound healing at six months all met
Co-primary endpoint measuring pain reduction at six months met; greater magnitude of pain reduction benefit was observed in post-hoc analysis of EB-101 treated wounds with severe baseline pain
EB-101 was well-tolerated with no serious treatment-related adverse events, consistent with past clinical experience
Plans to submit Biologics License Application (BLA) to U.S. FDA
Conference call on November 3, 2022 at 8:30 a.m. EDT
Abeona Therapeutics will host a conference call and webcast on Thursday, November 3, 2022, at 8:30 a.m. EDT, to discuss the positive topline results from the VIITAL study. To access the call, dial 888-506-0062 (U.S. toll-free) or 973-528-0011 (international) and Entry Code: 844393 five minutes prior to the start of the call. A live, listen-only webcast and archived replay of the call can be accessed on the Investors & Media section of Abeona’s website at www.abeonatherapeutics.com. The archived webcast replay will be available for 30 days following the call.
https://finance.yahoo.com/news/abeona-therapeutics-announces-positive-topline-113000527.html
In an encouraging development for the fight against antimicrobial resistance (AMR), GSK’s novel antibiotic gepotidacin has shown efficacy in two phase 3 trials, setting up regulatory filings.
If approved, gepotidacin (GSK2140944) could become the first drug in a new class of oral antibiotics for uncomplicated urinary tract infections (UTIs) in more than 20 years, according to the pharma group, which plans to submit the data to the FDA in the first half of next year.
Crucially, gepotidacin has an entirely new mechanism of action, which should avoid resistance to current antibacterials, inhibiting DNA replication via two different type II topoisomerase enzymes which should make it harder for pathogens to develop resistance.
A study by the Pew Charitable Trust published in 2020 found that the triazaacenaphthylene drug was one of just three antibiotics in late-stage testing that offered a new and distinct mechanism of action.
The two phase 3 studies – called EAGLE-2 and 3 – were stopped early by their data monitoring committees after an interim look at the data showed clear efficacy and safety for GSK’s drug.
The studies involved more than 3,000 female adults and adolescents with uncompleted UTIs and showed that a five-day oral course of gepotidacin was as effective as standard therapy nitrofurantoin at achieving combined clinical and microbiological responses to the infection at 28 days.
Another study called EAGLE-1 is comparing two oral doses of gepotidacin to a regimen based on an intramuscular injection of ceftriaxone and oral azithromycin in the treatment of urogenital gonorrhoea.
According to GSK’s head of development Chris Crisco, uncomplicated UTIs are the most common outpatient infection affecting over half of all women during their lifetime, with more than a quarter of them suffering recurrent infections. The number of UTIs caused by resistant pathogens is also on the rise, he said.
“The…recommendation to stop the EAGLE-2 and 3 trials early for efficacy provides GSK with the opportunity to engage regulatory authorities as we work together to bring a new class of antibiotics to patients.”
AMR is a growing problem and one that is already claiming around 1.2 million lives per year globally and is expected to grow to 10 million by 2050 unless new drugs and other measures become available to control infections.
There are real concerns that we could be entering a post-antibiotic era, where even minor infections can be enough to kill patients. GSK is one of the few remaining big pharma companies carrying out R&D on new antibiotics, after a mass exodus from the category in the last few decades.
The main problem has been that investment in antibiotic development isn’t attractive, because novel drugs tend to be used sparingly, reserved for patients with MDR infections, so developers can’t make a return on their spend.
The pharma industry has taken other steps, including pooling R&D dollars to help support biotechs working in this area, for example, via the AMR Action Fund, which backed projects at Adaptive Phage Therapeutics (APT) and Venatorx Pharmaceuticals earlier this year.
In addition, there have been efforts to change the commercial model for antimicrobials to make developing them less risky.
The UK Government has made a play to change that dynamic, launching ‘Netflix-style’ subscription payments for new antibiotics, getting access in return for a fixed annual fee, regardless of how much is used to treat patients. The first drugs were included in that scheme earlier this year.
https://pharmaphorum.com/news/gsk-preps-filing-for-novel-antibiotic-for-urinary-tract-infections/
Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a neurology-focused biopharmaceutical company, today announced the launch of its XEN1101 Phase 3 program with the initiation of the X-TOLE2 clinical trial, which will examine XEN1101 administered as an adjunctive treatment for adult patients with focal epilepsy.
