2024 European Society of Medical Oncology (ESMO) Congress will take place from September 13-17 in Madrid, Spain. During the conference, Henlius will release multiple results on its first innovative product HANSIZHUANG (serplulimab) as well as its trastuzumab biosimilar approved in China, Europe and U.S., HANQUYOU. The results to be displayed include the smoking-related genomic mutation patterns in patients with small cell lung cancer treated in ASTRUM-005 study, a pivotal phase 3 clinical study of serplulimab for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC) led by Professor Ying Cheng from Jilin Cancer Hospital, and the exploratory biomarker analysis of ASTRUM-004 study, a pivotal phase 3 clinical study of serplulimab plus chemotherapy as first-line treatment for advanced squamous non-small-cell lung cancer (sqNSCLC) led by Professor Caicun Zhou from Shanghai East Hospital, School of Medicine, Tongji University. HANSIZHUANG (serplulimab) is a recombinant humanised anti-PD-1 monoclonal antibody(mAb)injection independently developed by Henlius, ...
Barrett’s esophagus is a condition where the lining of the esophagus changes due to chronic gastroesophageal reflux. Individuals with Barrett’s esophagus are at a slightly increased risk of developing esophageal cancer and require regular surveillance endoscopies. During these procedures, gastroenterologists collect numerous biopsies from the affected tissues. These samples are then cut into thin sections and placed on glass slides for examination under a microscope by pathologists. However, the tissue sections that pathologists view represent only about 1% or less of the actual biopsies and provide just a two-dimensional view, which can be misleading. Researchers are now conducting clinical studies of archived tissues from patients with the condition to develop computational 3D pathology methods for Barrett’s esophagus risk stratification. The research team at UW College of Engineering (Seattle, WA, USA) had previously invented 3D pathology methods to assess prostate cancer risk and shifted their focus on gastrointestinal applications of their ...
Chinese player Legend Biotech reached a new turning point last month when its Johnson & Johnson-partnered Carvykti became the first BCMA-targeted CAR-T cell therapy to be approved by the FDA for second-line treatment of multiple myeloma. From its original roots in China to its first FDA approval in 2022, the company has remained uniquely focused on CAR-T cells targeting the BCMA protein. Humble Beginnings and a Breakthrough Approval Back in 2014, a team of Chinese scientists began investigating cell therapies for cancer under the banner of the “Legend Project,” operating in what the company calls “a room the size of a freight elevator.” After making the decision to focus its research solely on chimeric antigen-receptor T-cells (CAR-T) targeting the BCMA protein in 2015, Legend began conducting its first clinical trials in 2016. The pioneering biotech landed its first major vote of confidence from the global life sciences community in 2017, ...
Chinese pharmaceutical industry insiders have warned that foreign takeovers may damage the sector and even threaten national security. Since December, five Chinese biotech drug makers have been sold to global pharmaceutical giants. Industry insiders have warned that this could have a negative impact, especially given the risk that the United States could extend its technology sanctions to essential medicines. John Cai, chairman of China Healthcare Innovation Platform Academy, a healthcare think tank in Shanghai, said: “When national conflicts occur and drugs are sanctioned as strategic products, it will affect the health of a country’s population. “Considering that China’s biopharmaceutical and broader healthcare industry are now facing international competition and restrictions, Beijing should act with a sense of urgency.” He also said that research and development was a long process and if innovative products were sold as soon as they were developed, it would be difficult for China to cultivate world-class ...
By Don Tracy, Associate Editor Regulatory action marks the first engineered cell therapy approved for a solid tumor cancer in the United States.The FDA has granted accelerated approval to Adaptimmune Therapeutics’ Tecelra (afamitresgene autoleucel), an engineered cell therapy that targets resectable or metastatic synovial sarcoma in adults who have undergone prior chemotherapy and are HLA-A*02 positive with MAGE-A4 antigen expression. The treatment, which was approved based on results from the SPEARHEAD-1 trial, marks the first engineered cell therapy for a solid tumor cancer to be approved in the United States, according to the company.1 “The approval of Tecelra is a momentous step in Adaptimmune’s journey to redefine the way cancer is treated and the culmination of a decade of groundbreaking R&D. I want to thank the patients, caregivers, investigators, and clinical teams as well as everyone at Adaptimmune and our partners who made possible this watershed moment for cell therapy ...
Recent financing news includes several companies raising money to advance their research to the clinic. Here’s a look back at funding rounds from companies such as Outpace Bio, GRO Biosciences, and Confo Therapeutics. By Frank VinluanOne challenge for developing drugs for autoimmune diseases is that biologic therapies can spark an immune response against them. Immunology and inflammation research is coming up with new approaches to reduce the risk of such responses. That science is progressing in the hands of new companies raising fresh rounds of capital. Inflammation and immunology figures prominently in recent funding news, which includes several companies approaching the clinic with novel biologic drugs. Here’s a recap of recent biotech financings, grouped according to therapeutic area: Immunology & Inflammation —Abiologics unveiled an artificial intelligence-driven platform technology for designing novel biologic drugs based on non-standard amino acids. The startup, which has been incubating within Flagship Pioneering for the past ...
Otsuka Pharmaceutical is acquiring Jnana Therapeutics, whose lead drug is a potential treatment for the rare metabolic disorder phenylketonuria (PKU). Jnana’s drug could provide an alternative to two FDA-approved PKU medicines from BioMarin Pharmaceutical. By Frank VinluanOtsuka Pharmaceutical is broadening its scope in rare disease, striking a deal to acquire Jnana Therapeutics and its lead drug candidate, a small molecule on track for pivotal testing in a metabolic disorder with few treatments. Per deal terms announced Thursday, Otsuka is paying $800 million up front to buy Boston-based Jnana. The Japanese pharma company could shell out up to $325 million more if the lead drug candidate of privately held Jnana achieves development and regulatory milestones. Jnana’s lead program, JNT-517, is in development for phenylketonuria (PKU), an inherited disorder that leads to deficiency of an enzyme needed to break down phenylalanine, an amino acid found in certain foods. Buildup of phenylalanine in ...
Oxford-based cell therapy company Adaptimmune Therapeutics has received accelerated approval from the US Food and Drug Administration (FDA) for Tecelra (afamitresgene autoleucel) for treatment of synovial sarcoma. Tecelra is the first engineered cell therapy for solid tumours approved in the US, and represents the first therapy option against synovial sarcoma in more than a decade. It is indicated to treat adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, and whose tumours express the MAGE-A4 antigen. Additionally, the tumours need to have a certain HLA type— HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive. The approval was granted based on results from the Phase II SPEARHEAD-1 trial (NCT04044768). Amongst 44 patients with synovial sarcoma, the overall response rate (ORR) to treatment was 43% with a median duration of response of six months (95% CI: 4.6, not reached). Continued approval remains subject to verification of clinical benefit in further trials. ...
Vir Biotechnology has signed a licensing agreement with Sanofi for three clinical-stage masked T-cell engagers (TCE) for cancer treatment. The US-based company has also started strategic restructuring, which includes a workforce reduction of approximately 25% and the discontinuation of its influenza and Covid-19 programmes. Vir will also phase out its T cell-based viral vector platform. The company expects to save approximately $50m each from staff cuts and pipeline reprioritisation, which will be reinvested into the Sanofi-licensed programmes. Vir reported $1.43bn in cash reserves at the end of Q2. The Sanofi-licensed TCE candidates include SAR446309, a dual inhibitor of HER2 and CD3; SAR446329, a dual-masked PSMA and CD3 TCE; and SAR446368, a dual-masked EGFR and CD3 TCE. The TCE candidates were developed using the protease-cleavable masking platform, which Sanofi acquired from Amunix Pharmaceuticals. Both SAR446309 and SAR446329 are being evaluated in Phase I trials in patients with metastatic treatment-resistant HER2-positive tumours ...
Otsuka Pharmaceutical is looking to acquire US-based Jnana Therapeutics in a deal worth up to approximately $1.1bn. The Japanese company will pay Jnana’s shareholders $800m through its US subsidiary, Otsuka America. Jnana will also be in line to receive up to $325m in milestone-based payments. The deal is expected to close in Q3 this year. Otsuka plans for Jnana to operate as its subsidiary following the acquisition. To achieve this, it plans to merge Jnana with a special purpose company, established under Otsuka America, with the Jnana remaining as the surviving company. Jnana’s lead asset is JNT-517 being developed to treat phenylketonuria (PKU), a rare inherited metabolic disorder that causes an amino acid called phenylalanine to build up in the body. JNT-517 inhibits SLC6A19 or solute carrier family 6 member 19, a transmembrane protein that regulates phenylalanine absorption and reuptake in the small intestine and kidney. In June, Jnana reported ...
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