Tonix snaps up assets from Healion Bio; Mesoblast gives its BLA another shot

02 Feb 2023
endpts.com
Fast Track
New Jersey-based Tonix Pharmaceuticals is adding several assets to its portfolio in its latest move. The biotech announced Thursday it has acquired all assets belonging to Healion Bio. However, financial details were not disclosed. Healion’s assets include some small-molecule antiviral candidates. Tonix has labeled one of its pickups as TNX-3900, previously known as HB-121, a cathepsin protease inhibitorcathepsin protease inhibitor meant to work against SARS-CoV-2. While the antiviral candidate is currently being tested to counter to SARS-CoV-2, Tonix said in its release that it believes that it has other antiviral capabilities. However, the details of what TNX-3900 will be going after were not immediately available. “We are excited to develop Healion’s drug programs that include TNX-3900, which is a class of drugs with potential broad-spectrum anti-viral activity, either as monotherapies or in combination with other antivirals. Broad-spectrum antiviral agents have the potential to reduce viral load and allow the adaptive immune system to alert the other arms of the immune system to mount a protective response,” said Seth Lederman, Tonix’s CEO in a release . Tonix certainly needs a lift, as the biotech spent a good portion of 2022 hovering above or within the penny stock zone. The news today has driven its stock price $TNXP up 4%. In 2020, the FDA handed the Australian biotech Mesoblast a CRL for remestemcel-L, a treatment meant for children with steroid-refractory acute graft-versus-host disease (SR-aGVHD), with the FDA finding issue with the trial design. But now Mesoblast is heading back to the FDA. Mesoblast said in its announcement that the resubmission has new information that the FDA required in the 2020 CRL. In October of last year, Mesoblast stated that it was going forward on resubmission and eventually got a Fast Track designation for the candidate. The new resubmission will have a review period of up to six months. The resubmission includes new long-term survival data of the pediatric patients and information showing the treatment’s effect through four years. Mesoblast also included new data on remestemcel-L’s benefit in high-risk patients and a new analysis of the potency, among other pieces of data. “There is an urgent need for a therapy that improves the dismal survival outcome in children with SR-aGVHD. Our team has worked tirelessly over the past two years to provide a comprehensive response to the FDA. We are grateful for the agency’s active dialogue and constructive feedback that will ensure a high bar is met in terms of product consistency and predictability of clinical outcomes,” Mesoblast CEO Silviu Itescu said in a release .
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