Nirsevimab

AstraZeneca on Tuesday lifted its earnings outlook for the full year, boosted by strong sales growth across its portfolio. However, investor and analyst attention will be firmly focused on the company's performance in China amid ongoing investigations into the conduct of one of its executives.Leon Wang, head of the pharma's operations in China, is said to be cooperating with a probe by authorities in the country, although details are scarce. The investigation reportedly comes after Chinese police recently detained five current and former AstraZeneca employees over allegations of medical insurance fraud, illegal drug importation and personal information breaches. On Tuesday, AstraZeneca CEO Pascal Soriot said "we take the matters in China very seriously. If requested we will fully cooperate with the authorities."With China looming large, US get investmentAstraZeneca said Tuesday it will invest $3.5 billion on expanding its research and manufacturing footprint in the US by the end of 2026. The figure includes $2 billion of new investment that will create over 1000 jobs, with Soriot noting that the move "reflects the attractiveness of the business environment" in the country.The US continues to represent AstraZeneca's largest market, with third-quarter revenue in the country rising 23% to $6 billion — twice the value of European sales, which were up 22% to $2.9 billion — while growth in China was 15% to $1.7 billion. The company's overall sales in the quarter jumped 18% to $13.6 billion, driven by products including Tagrisso (+14%, $1.7 billion), Enhertu (+50%, $510 million) and Beyfortus (+73%, $238 million). Profit in the three-month period grew 4% to $1.4 billion.For the full year, AstraZeneca expects both sales and core earrings per share to increase by a high teens percentage, up from a prior estimate of a mid teens percentage rise.Dato-DXd change of tack AstraZeneca and partner Daiichi Sankyo have withdrawn a US filing seeking approval of the TROP2-directed antibody-drug conjugate datopotamab deruxtecan (dato-DXd) for patients with advanced or metastatic non-squamous non–small-cell lung cancer (NSCLC). The companies have instead submitted a new application for the treatment of adults with locally advanced or metastatic EGFR NSCLC who have received prior systemic therapies, including an EGFR-directed therapy.The initial filing was based on the Phase III TROPION-Lung01 trial, while the new submission includes data from the study, but is mainly based on the mid-stage TROPION-Lung05 trial. New results from a pooled analysis of patients with previously treated EGFR-mutated NSCLC in the two studies trials will be featured in a late-breaking presentation at the upcoming European Society for Medical Oncology (ESMO) Asia congress."The results…showed an especially pronounced benefit for patients with an EGFR mutation which informed our discussions with the FDA and the decision to seek accelerated approval of datopotamab deruxtecan in this patient population," remarked Susan Galbraith, EVP of oncology R&D at AstraZeneca.Bloomberg Intelligence analyst John Murphy suggested that the move "could drive further cuts to long-term sales estimates for this potential blockbuster drug," while Jefferies' Peter Welford said the withdrawal and re-submission of the FDA application was "a setback but not entirely unanticipated."KOMET rockets to study winThe Phase III KOMET study of Koselugo (selumetinib) in adults with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN) met its primary endpoint. In the trial, the oral, selective MEK inhibitor demonstrated a statistically significant and clinically meaningful objective response rate (ORR) versus placebo.Koselugo — which is partnered with Merck & Co. — is currently approved for the treatment of certain paediatric patients with NF1 who have symptomatic, inoperable PN. AstraZeneca noted that the top-line KOMET results support expanding use of the drug into adults, with the data set to be shared with regulatory authorities.

Kling-Select is a uniquely promising approach to identifying novel targets and therapeutic antibodies from human and animal sources Kling-Evolve enables highly rapid selection of effective neutralizing antibodies against viral escape variants AMSTERDAM, Oct. 31, 2024 /PRNewswire/ -- Kling Biotherapeutics ("Kling" or "the Company"), a biotech company developing antibody-based drugs for cancer and infectious diseases, today announces that it will be presenting findings on its proprietary primary B-cell selection and evolution platform technologies, Kling-Select and Kling-Evolve at the Annual Protein & Antibody Engineering Summit (PEGS) Europe, held in Barcelona, Spain from 5-7 November 2024. Poster one entitled ' Highly efficient capture of circulating and tissue-infiltrating B cell repertoires from multiple species: Kling-Select,' describes advances in Kling-Select, a proprietary B-cell immortalization platform developed to efficiently capture and screen B cells demonstrating its promise as an approach to the identification of both valuable new targets and therapeutic antibodies. Kling-Select is applied for the immortalization of B cells derived from human and animal sources such as camelid, rabbit, mouse, and non-human primates. The poster also highlights advances in the optimization of the fully integrated workflow allowing the discovery of functional monoclonal antibodies from primary B cells in as little as three weeks. Poster two entitled ' Kling-Evolve as a tool for rapid response to emerging variants and pandemic preparedness: directed evolution of variant-specific antibody from immortalized B cells,' details the Kling-Evolve platform which enables the rapid ex vivo maturation of immortalized human B cells to identify neutralizing antibodies against escape variants. Kling-Evolve poses the potential for rapid development of countermeasures to combat and pre-emptively address evolving viruses amidst emerging pandemic threats. Michael Koslowski, Chief Executive Officer at Kling Biotherapeutics, said: "Our technology is a powerful platform which is clinically validated, having been used to discover the fully human Respiratory Syncytial Virus (RSV) neutralizing antibody nirsevimab (Beyfortus™ – AstraZeneca / Sanofi). By using an 'effective antibody first' discovery approach, Kling's platform technologies enable the discovery of relevant, completely novel antigen targets applicable to cancer as well as infectious diseases. Kling is well poised to develop next-generation antibody-based therapeutics to bring new, highly targeted treatments to cancer patients and address rising global concerns of the speed of response to emerging pandemic threats." Details of the poster presentations are as follows: Poster Title: Highly efficient capture of circulating and tissue-infiltrating B cell repertoires from multiple species: Kling-Select Presenter: Casper Marsman, Senior Scientist – B Cell Platform Lead, Kling Biotherapeutics Presentation Number: A073 Poster Title: Kling-Evolve as a tool for rapid response to emerging variants and pandemic preparedness: directed evolution of variant-specific antibody from immortalized B cells Presenter: Alessandra Villa, Director of Discovery Platforms, Kling Biotherapeutics Presentation Number: A074 Posters will be displayed in the Exhibit Hall at the following dates and times: Tuesday, 5 November from 10:30 – 19:35 CET Wednesday, 6 November from 10:30 -17:15 CET Thursday, 7 November from 10:00 – 13:55 CET About Kling Biotherapeutics Kling Biotherapeutics is a privately held biotech company focused on discovery and development of novel targets and therapeutics. The Company is headquartered in Amsterdam, the Netherlands with a fully owned IP portfolio that covers its proprietary platform technologies Kling-Select and Kling-Evolve for the simultaneous discovery of novel targets and identification of fully human antibodies directly from patient-derived B cells. Kling-Select relies on a fully-owned and clinically validated B cell immortalization and screening technology to identify novel therapeutic targets and antibody binders from patients with exceptional clinical responses. This technology has successfully identified novel neutralizing antibodies for various infectious diseases such as RSV (nirsevimab/Beyfortus), Covid, and Influenza. More recently, Kling-Select has been applied to peripheral and tumor-infiltrating B cells derived from cancer patients and produced a portfolio of novel and selective target-antibody pairs. The unbiased nature of this discovery platform allows identification of novel targets and unique epitopes inaccessible to traditional target discovery approaches. Kling-Evolve enables the ex vivo affinity maturation of B cell clones against targets of interest. This powerful technology can be used for the rapid evolution of neutralizing antibodies against emerging viral variants or for affinity and selectivity improvement of oncology assets. Kling Biotherapeutics is progressing a unique pipeline of oncology and infectious disease programs with KBA1412, a first-in-class CD9 antibody, being explored in blood cancers. About PEGS PEGS Europe is the largest protein & antibody engineering event in Europe which has been described as "the best biologics technology meeting in Europe." New this year, event has expanded to include coverage of AI/ML, Mult specific antibodies, antibody-drug conjugates, and an entire stream devoted to Oncology. SOURCE Kling Biotherapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED