Janssen Biotech, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, has entered into a worldwide collaboration and licensing agreement with Cellular Biomedicine Group (CBMG) for a pair of CAR T-cell therapy candidates. Under the terms of the agreement, Janssen will pay CBMG an upfront fee of $245m, with the Chinese biotech also eligible for certain milestone payments, as well as tiered royalties. In exchange, CBMG will grant Janssen a worldwide licence to develop and commercialise the CAR-T assets, except in Greater China, with the companies set to negotiate an option for the pharma to commercialise the products in the China territory. The investigational CAR-Ts have shown promising early-stage results in patients with relapsed/refractory non-Hodgkin’s lymphoma (NHL), the companies said, with the majority of patients in the studies having diffuse large B-cell lymphoma (DLBCL). DLBCL is the most common type of aggressive lymphoma, accounting for approximately one-third of ...
Acelyrin has raised $540 million in an initial public offering, the largest for a biotechnology startup since early 2021 and one of only a handful by young drugmakers this year. The company said Thursday it sold 30 million shares at $18 apiece, exceeding the projections it set earlier this week. It will start trading Friday on the Nasdaq under the ticker symbol “SLRN.” The pace of biotech IPOs has slowed considerably since 2021, when a record 104 startups flooded Wall Street, according to data compiled by BioPharma Dive. The following year, the number of new stock offerings fell by about 80%. Until this week, only five companies had priced a new offering in 2023, the sector’s slowest start in at least five years. The value of those offerings has also trended downwards. Prior to Acelyrin’s offering, nine of the last 15 biotech startups that went public raised $15 million or ...
Patent will allow the development of an industrial biomarker analysis kit which could be available worldwide. BioSenic – a company focusing on in autoimmune and inflammatory diseases – has announced that it has submitted a vital patent in relation to the use of its ATO platform. The patent is referred to as a ‘Diagnostic method for detecting the pathological correlates of chronic graft-versus-host disease (cGvHD) using particular cytokine or chemokine biomarkers’ and has duly been submitted to the European Patent Office desk for consideration. It also covers the use of a quantitative system of evaluating the impact of medications developed to change the course of cGvHD. Two years ago, BioSenic successfully concluded a national multi-location, single-arm phase 2 study in five university hospitals across France. During the trial, BioSenic treated 21 cGvHD patients with an intravenous formulation known as Arscimed. Subsequently, BioSenic published positive efficacy and safety results in the ...
The maker of the mpox vaccine is looking at ways to dramatically scale up its production capacity to prepare for a potential threat from smallpox. Bavarian Nordic CEO Paul Chaplin said the rapid spread of mpox last year was a wake-up call for the company, which is based in Denmark. “If it wasn’t mpox but it was smallpox, we are completely at the wrong scale,” Chaplin told CNBC in an interview. “We’re looking at ways we can dramatically change the way we manufacture to increase our scale,” he said. Mpox is in the same virus family as smallpox. Bavarian Nordic’s Jynneos vaccine is approved by the U.S. Food and Drug Administration to protect against both pathogens. Previously known as monkeypox, the World Health Organization changed the name to mpox last year to reduce stigma. Bavarian Nordic plans to simplify its production process so ...
Pfizer on Thursday gained U.S. approval of its newest pneumococcal conjugate vaccine for use in children and infants, helping it compete with a rival shot from Merck & Co. that won a similar OK last year. Pfizer’s vaccine, called Prevnar 20, is designed to protect against infection by 20 strains of the bacteria — seven more than the company’s prior Prevnar 13 version. It has been approved in adults since 2021. Last July, Merck won approval in children of its Vaxneuvance vaccine, which protects against 15 strains. Both companies could soon face more competition as the market has sparked interest from other drugmakers. While vaccines for the bacterial infection are widely available, thousands of cases still lead to hospitalization and death in the U.S. each year. In response, Pfizer, Merck and others have worked to develop new shots that offer better protection, particularly against strains that weren’t ...
Disease detectives with the US Centers for Disease Control and Prevention are investigating a cluster of rare and serious brain abscesses in kids in and around Las Vegas, Nevada, and doctors from other parts of the country say they may be seeing a rise in cases, too. In 2022, the number of brain abscesses in kids tripled in Nevada, rising from an average of four to five a year to 18. “In my 20 years’ experience, I’ve never seen anything like it,” said Dr. Taryn Bragg, an associate professor at the University of Utah who treated the cases. Pediatric neurosurgeons like Bragg are rare. She is the only one for the entire state of Nevada, and because she treated all the cases, she was the first to notice the pattern and to alert local public health officials. “After March of 2022, there was just a ...
By LabMedica International staff writers Bladder cancer is often fatal, and survival rates have not improved in the past 30 years. Although immunotherapy has revolutionized bladder cancer treatment, it has significant limitations, as most patients do not respond to the therapy. Checkpoint immunotherapy drugs, which enable the body’s immune system to recognize tumors, are effective for only about 20% of bladder cancers. However, it is unclear which patients will benefit and why these drugs are not more effective for all patients. In a breakthrough that could enhance bladder cancer patients’ survival, researchers have now developed a biomarker signature test to predict which tumors will be responsive to immunotherapy. In the new study, scientists at Northwestern Medicine (Chicago, IL, USA), along with multiple international collaborators, identified three types of tumors that could respond to immunotherapy and two that could not. By employing a combination of gene expression profiling, mutations, and spatial ...
Swedish biotech company Hansa Biopharma has entered a research and development collaboration with Genethon. The partnership will assess the efficacy and safety of imlifidase, Hansa Biopharma’s antibody cleaving enzyme, in a clinical trial. Imlifidase will be developed as a pre-treatment for patients with Crigler-Najjar syndrome and pre-existing neutralising antibodies (NAbs) to adeno-associated virus serotype 8 (AAV8), before administering GNT-0003, Genethon’s gene therapy product candidate. The company stated that patients with circulating NAbs will be excluded from the clinical trial of potentially curative gene therapies as well as from access to approved gene therapies. Hansa Biopharma president and CEO Søren Tulstrup said: “Genethon is a pioneer at the cutting-edge of research and development of gene therapies for rare diseases and we are thrilled to be collaborating with them. “This research collaboration further validates Hansa’s commitment in gene therapy and underscores the important role that our antibody-cleaving ...
Delilah AlvaradoAssociate Editor A general view of the Pfizer Headquarters sign on November 10, 2020 in Tadworth, England. Dan Kitwood via Getty Images Dive Brief: Pfizer on Thursday gained U.S. approval of its newest pneumococcal conjugate vaccine for use in children and infants, helping it compete with a rival shot from Merck & Co. that won a similar OK last year. Pfizer’s vaccine, called Prevnar 20, is designed to protect against infection by 20 strains of the bacteria — seven more than the company’s prior Prevnar 13 version. It has been approved in adults since 2021. Last July, Merck won approval in children of its Vaxneuvance vaccine, which protects against 15 strains. Both companies could soon face more competition as the market has sparked interest from other drugmakers. Dive Insight: While vaccines for the bacterial infection are widely available, thousands of cases still lead to hospitalization and death in the ...
By Michael Greenwood, M.Sc.Reviewed by Danielle Ellis, B.Sc. Doggybone DNA ™ (dbDNA) is a technology developed by biotech company Touchlight, which is a form of linear plasmid with applications in genetic engineering and therapeutics. Plasmids are small circular double-stranded DNA molecules naturally generated by bacterial cells, some eukaryotes, and archaea and separate from chromosomal DNA. Plasmids can self-replicate by using host enzymes, and each carries at least one gene, most of which are beneficial to the host. The gene(s) carried by the plasmid may then be incorporated into the genome for expression. For example, a plasmid may encode a gene that produces a protein with antiphage functionality, allowing viral resistance to be incorporated into the bacterial chromosome. Plasmids are transferred between bacterial cells via pili; thus, beneficial genes carried by plasmids can be disseminated and incorporated into the chromosomal DNA of neighboring cells. Owing to the natural function of plasmids, they can be ...
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