Agomab Therapeutics has received the US Food and Drug Administration (FDA)’s fast track designation for AGMB-129 to treat fibrostenosing Crohn’s disease (FSCD). Designed to inhibit ALK5 in the gastrointestinal (GI) tract, AGMB-129 is an oral, small molecule GI-restricted ALK5 (TGF-βRI) inhibitor currently in clinical development. The single and multiple-dose AGMB-129 was well-tolerated at all doses in a Phase I study in healthy participants. The company has also announced the commencement of the STENOVA Phase IIa clinical study to assess AGMB-129 for patients with symptomatic FSCD. This global, placebo-controlled, multi-centre, double-blind study will assess 36 patients with symptomatic FSCD at investigational sites in Europe, Canada and the US. Subjects will be randomised to receive one of two doses of AGMB-129 or a placebo for a period of 12 weeks. Tolerability and safety of AGMB-129 in FSCD patients are the primary endpoints of the trial. The pharmacokinetics and target engagement at the ...
The Novo Nordisk Foundation has announced that it has committed up to €127m in funding to develop and manufacture a new cell therapy facility, Cellerator, in Denmark, to help fight chronic diseases. The new Novo Nordisk Foundation, Cellerator, will be used for the final development steps of animal research and upscaling new cell therapies for testing in humans. This will help to accelerate treatments for people with diseases including chronic heart failure, Parkinson’s disease, kidney disease, type 1 diabetes and several forms of cancer. Cell therapies work by transplanting living cells into patients to treat diseases. It’s estimated that one in three adults suffers from multiple chronic conditions. In the US alone, it’s been calculated that out of 58 million deaths in 2005, chronic disease was responsible for 35 million. The funding follows a report prepared for the European Federation of Pharmaceutical Industries and Associations, which came to the conclusion ...
Kezar Life Sciences and Everest Medicines have signed a partnership and licence agreement for the development and commercialisation of zetomipzomib for lupus nephritis (LN) in select territories. The territories covered under the agreement include Greater China, South Korea and South East Asia. As per the deal terms, Kezar is eligible to receive up to $132.5m in initial upfront and milestone payments contingent on meeting development, regulatory and commercialisation goals in the future. Kezar will also receive tiered royalty payments on net product sales from Everest. Everest will obtain sole rights for developing and marketing zetomipzomib in regions such as Greater China, Indonesia, Malaysia, the Philippines, Singapore, South Korea, Thailand and Vietnam. Everest will also collaborate with Kezar for the Phase IIb PALIZADE clinical trial of zetomipzomib, an immunoproteasome inhibitor of Kezar, in active LN patients in Greater China, South Korea and South East Asia. In the licensed territories, Everest will ...
It’s been about 10 months since FDA inspectors rebuked a production plant in India that made popular platinum-based chemotherapies, kicking off a chain reaction of drug shortages that continues to jeopardize cancer care in the U.S.While the White House recently announced that overseas importations and other efforts have increased U.S. supplies of carboplatin and cisplatin, not all clinics are able to access the drugs, according to the American Society of Clinical Oncology’s (ASCO’s) chief medical officer Julie Gralow, M.D. Even as supplies recover around the country, a “certain set” of cancer clinics are still unable to get their hands on the medicines, Gralow said in an interview. The disparity in availability reflects the disproportionate impact the shortage has had on patients based on factors such as location or socioeconomic status, Gralow added. It’s often smaller sites that can’t secure the drugs. While bigger hospitals may have them, those sites often ...
Danish biotech Acesion Pharma has raised €45m in an oversubscribed Series B financing round. The money will go towards funding the clinical development of the company’s atrial fibrillation therapy, AP31969. The investors that took part in the Series B financing round include Canaan, Alpha Wave, Global BioAccess Fund and Novo Holdings. AP31969 is an oral SK ion channel inhibitor that is being developed as a maintenance treatment to prevent the recurrence of atrial fibrillation. In March, Acesion announced that more than 50% of the participants in the Phase II AP31969 trial (NCT04571385) reported atrial fibrillation conversion to normal sinus rhythm within 90 minutes of infusion start, compared to zero participants in the placebo group. Atrial fibrillation is the most common form of arrhythmia or abnormal heart rhythm in which the top chambers of the heart (the atria) quiver or twitch, which is known as fibrillation. The US Centers for Disease ...
It’s a boom time in the cell and gene therapy market, with manufacturers making moves to secure a larger piece of the pie. Wednesday, two CDMOs revealed acquisitions that will bolster their production capabilities and increase their global presence. Korean manufacturer SK pharmteco has taken a controlling stake in the Philadelphia-based Center for Breakthrough Medicines (CBM) for an undisclosed sum. Meanwhile, England’s Oxford Biomedica said it is in talks with Institut Mérieux to buy out its subsidiary, ABL Europe, for 15 million euros ($16 million). SK’s move comes after it invested $350 million in CBM in January of last year. As part of the agreement, SK had an option to increase its stake, which it exercised, becoming its largest stockholder. CBM was established in 2019 at a former GSK site. The prior funding allowed CBM to begin building end-to-end manufacturing capabilities. SK boasted that the site will be the world’s ...
By Connor Lynch Pictured: FDA sign in its headquarters/iStock, Grandbrothers Taysha Gene Therapies has decided to drop its lead experimental AAV-based gene therapy candidate after the FDA reiterated calls for the company to put the treatment through a randomized, double-blind placebo-controlled trial. The Dallas-based company announced on Tuesday that it would no longer be developing its TSHA-120 treatment for giant axonal neuropathy (GAN) based on the FDA’s Type C meeting feedback regarding the therapy’s potential pathway. “FDA continues to recommend a randomized, double-blind, placebo-controlled trial as the optimal path to demonstrate efficacy in TSHA-120,” the company said in a statement. Taysha noted in the announcement that the FDA “provided a potential path for a single-arm trial with an external control group matched with to-be treated patients by multiple prognostic factors and recommended longer term follow up to account for potential bias.” CEO Sean Nolan said in a statement that the ...
First Wave BioPharma has acquired Sanofi’s capeserod with plans to repurpose it as a gastrointestinal (GI) disease therapy. Following the news, First Wave’s stock skyrocketed by over 80% in pre-market trading. The US-based company has a market cap of $3.112m. The agreement includes a $500,000 upfront payment, with developmental and commercial milestone payments of up to $46m and $235m, respectively. Additionally, Sanofi would have the right of first refusal on any capeserod sublicensing agreement and would be entitled to a percentage of any licensing payments. Sanofi also reserves the first refusal right to reacquire capeserod during development. Capeserod is a selective partial agonist of the serotonin type 4 (5-HT4) receptor. In the GI tract, these receptors perform various functions, including gastric emptying, decreasing oesophageal reflux, and promoting intestinal peristalsis. Sanofi had previously evaluated capeserod in Alzheimer’s disease and urinary incontinence but had since terminated the drug development. However, Fist Wave ...
CancerVAX has announced the development of a universal chimeric antigen receptor (CAR) T-cell platform in partnership with a research team from the University of California, Los Angeles (UCLA). The company plans to adapt the nanoparticle technology developed by the UCLA team, which is currently being used for a universal cancer vaccine project to target T cells. The nanoparticle technology is inspired by the lipid nanoparticle and messenger RNA (mRNA) technology used to develop Covid-19 vaccines. Conventional CAR-T therapies rely on gene editing performed in the laboratory to transform the allogeneic T cells to induce CAR protein expression before reinfusion of these calls back into the patient. The universal CAR-T cell therapy would use injectable smart nanoparticles, which would be loaded with genetic information for specific cancer cell targeting. These nanoparticles would attach to the patient’s T cells and reprogram them to target specific cancer cells. CancerVAX has reported that preliminary ...
University of Pennsylvania spinout BlueWhale Bio has surfaced on a mission to smash bottlenecks in cell and gene therapy manufacturing.The new company uncloaked Thursday with news it has raised $18 million in seed financing. The funding round was led by the ventures arm of Danaher Corporation with contributions from the likes of Novalis LifeSciences and Marshall Wace as well. Concerned that demand for cell therapy products is outstripping supply, BlueWhale aims to develop a technology platform and product portfolio that could bring the benefits of cell therapy to more patients “faster and at lower costs,” the company said in a press release. BlueWhale will be based in Philadelphia and led by CEO Peter Keller. The company’s scientific team is spearheaded by immunotherapy pioneers Carl June, M.D., the Richard W. Vague professor in immunotherapy at Penn’s Perelman School of Medicine, and James Riley, Ph.D., a professor of microbiology at Penn. “With ...
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