Gonorrhea, a sexually transmitted bacterial infection that affects more than 80 million people worldwide every year, has become resistant to almost all known antibiotics. That makes it notoriously difficult to treat, but left untreated, an infection could lead to serious or even fatal complications. It also increases a person’s risk of contracting HIV. A new study suggests artificial intelligence (AI) may help identify a vaccine’s key ingredients. This week in mBio, an international collaboration between academic and commercial researchers reported the identification of 2 promising antigens as candidates for a gonorrhea vaccine. The researchers used an AI model called Efficacy Discriminative Educated Network, or EDEN, to identify the protective proteins. They also used EDEN to generate scores that accurately predicted how well antigen combinations would reduce pathogenic bacterial populations of Neisseria gonorrhoeae, the microbe that causes gonorrhea. “To the best of our knowledge, this correlation has not been shown before,” ...
Shorla Oncology has acquired the oncology and autoimmune drug Jylamvo (methotrexate) from Therakind, for commercialisation in the US market. Jylamvo was approved by the US Food and Drug Administration (FDA) approval in November 2022, to treat adults with acute lymphoblastic leukaemia, mycosis fungoides, relapsed or refractory non-Hodgkin lymphoma, rheumatoid arthritis and severe psoriasis. Shorla is headquartered in Ireland and has operations in the US. The company had raised $35m earlier this month to advance its oncology pipeline. Jylamvo is an oral solution, making the treatment accessible to patients who may struggle taking tablets or other dosage forms. Commercialisation is set to begin immediately in the US. Chief Technical Officer and founder of Shorla Oncology Orlaith Ryan said: “This acquisition will provide a much-needed treatment to patients in need. It brings a crucial oral treatment to a larger patient population who suffer from cancer and other debilitating illnesses.” In March, Shorla ...
Two AstraZeneca studies have highlighted the continued significant and disproportionate burdens of COVID-19 on immunocompromised (IC) individuals.Covering almost 30 million individuals, the INFORM and EPOCH real-world studies showed that IC individuals have a higher rate of severe outcomes from COVID-19 compared to the general population. Including around 12 million participants aged 12 years and older in England, the INFORM study aimed to assess clinical outcomes and utilisation of healthcare resources in relation to COVID-19.The EPOCH study conducted an extensive insurance claims database of around 17 million people, providing real-world data on COVID-19 risks and outcomes in IC and non-IC populations within the US.The data revealed that 22% of all COVID-19 hospitalisations consisted of IC individuals, along with 28% of ICU admissions and 25% of deaths in England. People who are IC have a weakened immune system and are more susceptible to illness with COVID-19 or could be sick for a ...
The US Food and Drug Administration (FDA) has approved UCB’s inflammatory disease drug to treat moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.The decision makes Bimzelx (bimekizumab-bkzx) the first and only approved psoriasis treatment designed to selectively inhibit IL-17A and IL-17F, two key cytokines driving inflammatory processes. More than 7.5 million adults in the US are affected by some form of psoriasis, a chronic inflammatory condition caused by dysfunction of the immune system, which results in skin cells reproducing at a faster rate than normal.Up to 90% of patients with psoriasis have plaque psoriasis, characterised by dry, raised, red skin lesions (plaques) covered with silvery scales. The plaques may be itchy or painful and can occur anywhere on the body, including the scalp, elbows, knees and lower back. As well as its physical manifestations, psychological impact has been increasingly recognised as a significant part of ...
Up until this point, immune checkpoint inhibitors have been allowed to treat early-stage non-small cell lung cancer (NSCLC) either before or after surgery. Thanks to a new FDA approval, a continuous immunotherapy regimen for use on both sides of surgery is now available for certain patients. The approval, for Merck’s Keytruda, clears the PD-1 inhibitor to be used both as part of a neoadjuvant regimen before surgery and as an adjuvant therapy after surgery in patients with resectable NSCLC. Patients also take chemotherapy during presurgical treatment. In a coveted win for Merck, Keytruda’s updated label (PDF) already includes data showing that, compared with neoadjuvant chemo alone, the addition of perioperative Keytruda significantly cut the risk of death by 28% in the Keynote-671 study. Patients who took neoadjuvant chemo alone lived a median 52.4 months, while the median result for the Keytruda arm wasn’t reached by the time of the analysis, ...
Bristol Myers Squibb’s (BMS) Opdivo (nivolumab) has been approved by the US Food and Drug Administration (FDA) as an adjuvant treatment for adults and adolescents aged 12 years and older with completely resected stage 2B or 2C melanoma. The decision makes Opdivo, which is already approved in the US for use in certain melanoma patients, the only PD-1 inhibitor indicated as an adjuvant treatment for eligible patients with stages 2B, 2C and 3, as well as stage 4 completely resected melanoma. The incidence of melanoma, a type of skin cancer that develops when pigment-producing cells located in the skin grow uncontrollably, has been rising steadily over the past few decades, with more than 97,000 new cases expected to be diagnosed in the US overall this year. Melanomas can be mostly treatable when caught in the very early stages, but survival rates can decrease as the disease progresses. “Within five years ...
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) confirmed a positive recommendation for Merck’s Keytruda (pembrolizumab) as part of a first-line treatment for advanced gastric and gastroesophageal junction cancer (GEJ). Keytruda, an anti-programmed death receptor-1 (PD-1) therapy, would be used in conjunction with fluoropyrimidine- and platinum-containing chemotherapy in adults whose tumours express PD-L1 with a combined positive score (CPS) ≥1. The intravenously administered drug is designed to improve the immune system’s anti-tumour response by inhibiting the binding of PD-1 to its ligands PD-L1 and PD-L2, thereby activating tumor-fighting T-cells. Keytruda is also being studied as a treatment for hepatobiliary, oesophageal, pancreatic, and colorectal cancers. The EU CHMP’s positive recommendation was based on results from the Phase III KEYNOTE-859 (NCT03675737) study, a randomised, double-blind clinical trial evaluating the efficacy of Keytruda plus chemotherapy as a first-line treatment for human epidermal growth factor receptor-2 (HER2) negative, unresectable or ...
Almirall and EpimAb Biotherapeutics have announced a bispecific antibody partnership worth up to $210m. The agreement will give dermatology-focused Almirall a licence to utilise EpimAb’s Fabs-In-Tandem Immunoglobulin (FIT-Ig) platform to generate, develop and commercialise bispecific antibodies. Almirall will have exclusive global rights for any resulting products and, in exchange, EpimAb is eligible to receive milestone payments totalling up to $210m plus royalties on net sales. Karl Ziegelbauer, executive vice president, research and development, and chief scientific officer of Almirall, said the agreement was “an important step” towards the company’s ambition to develop new biologics in the dermatology field. EpimAb’s FIT-Ig platform generates bispecific antibodies using only the basic structural parts of monoclonal antibodies without adding any complex changes. The company has so far focused the technology within the oncology space and currently has five clinical-stage assets being evaluated for indications including non-small cell lung cancer (NSCLC), gastrointestinal cancer and multiple ...
New raw vaccine materials that could make vaccines more accessible, sustainable, and ethical have been discovered. Adjuvants are vaccine ingredients that boost a person’s immune response to a vaccine, providing greater protection against disease. One of the most prevalent adjuvant materials used in vaccines is squalene, which is typically sourced from shark livers. Researchers at the University of Nottingham collaborated with the Access to Advanced Health Institute (AAHI) to identify synthetic alternatives to squalene that ensure sustainable, reliable, and ethical sourcing of adjuvant raw materials for vaccines moving forward. New synthetic adjuvant materials were developed from commercially available methacrylate monomers, ensuring that a reliable supply of the material is continually available. The combination of these adjuvant materials are scalable through catalytic chain transfer polymerization, a process that allows high levels of control over the molecular weight of the product polymer. Controlling the molecular weight is key to the use of ...
Almirall has signed a licensing agreement with EpimAb Biotherapeutics to utilise the latter’s Fabs-In-Tandem Immunoglobulin (FIT-Ig) platform to develop up to three bispecific antibody targets. EpimAb is eligible for up to $210m (¥1.53bn) in milestone-based payments and net sale royalties. Almirall will hold exclusive global commercialisation rights over the therapies developed during the course of the partnership, based on a 12 October press release. EpimAb’s FIT-Ig platform rearranges the DNA sequences of two monoclonal antibodies to generate bispecific antibodies. “While we have made significant progress in utilizing our platform technology to develop a differentiated portfolio of bispecific antibodies in oncology, the potential of our platform in other areas such as immunology remains untapped,” said EpimAb’s CEOChengbin Wu in the press release. “We believe Almirall is the partner of choice for this endeavour and look forward to exploring the use of our novel bispecific platform to offer additional treatment options for ...
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