Chiatai Tianqing Completes Enrollment of First Subject in Phase III Clinical Trial of New Class 1 Drug Garsorasib (D-1553)

Chiatai Tianqing is conducting the “Randomized, controlled, double-blind, dual-simulation, multicenter Phase III clinical study to evaluate D1553 versus docetaxel for the treatment of locally advanced or metastatic non-small cell lung cancer with KRAS G12C mutation-positive lung cancer that has failed previous standard therapy (D1553-III-01)” nationwide. Recently, the project has completed the enrollment and successful dosing of the first subject. Garsorasib is a novel targeted KRAS G12C mutation inhibitor, registered under the classification of chemical drug class 1, is the first self-developed KRAS G12C inhibitor in China that has entered the clinical trial stage, and is included in the breakthrough therapeutic varieties by the CDE. on December 29, 2023, the National Drug Administration (NMPA) has accepted Garsorasib’s New Drug Marketing Application for the treatment of locally advanced or metastatic non-small cell lung cancer with disease progression or intolerable disease after prior first-line systemic therapy and with the presence of a KRAS ...

• Source: drugdu
• 78
• May 10, 2024

International phase 3 clinical trial for new melanoma treatment recruits first patients

A phase 3 international trial evaluating a new personalised immunotherapy treatment for melanoma has recruited its first patients at University College London Hospitals (UCLH) NHS Foundation Trust. Results from the phase 2 study evaluating Moderna and Merck & Co’s – known as MSD outside the US and Canada – mRNA-based technology treatment were published in the Lancet. Currently the fifth most common type of cancer, melanoma is a serious form of skin cancer that is responsible for over 8,000 new cases every year. The condition is characterised by the uncontrolled growth of pigment-producing cells. The new trial, INTerpath-001, is evaluating mRNA-4157 (V940) in combination with Merck’s PD-1 inhibitor, Keytruda (pembrolizumab), versus Keytruda on its own – the current standard of care – as a risk-reducing treatment option for patients with resected, high-risk, stage 2b to 4 melanomas following surgical removal of the cancer, with primary outcomes of recurrence-free survival and ...

• Source: drugdu
• 108
• May 9, 2024

The BCR::ABL1 fusion gene plays a key role in the pathogenesis of several blood cancers, particularly chronic myeloid leukemia (CML). This gene results from a chromosomal translocation that causes constitutive activation of the ABL1 tyrosine kinase domain, triggering unchecked cell growth. Testing for the BCR::ABL1 fusion gene is crucial in managing leukemia, as it helps identify patients with Philadelphia chromosome-positive leukemia who might benefit from targeted therapies such as tyrosine kinase inhibitors (TKIs). While Sanger sequencing has been the standard method for this analysis, it has its limitations in sensitivity. Next-generation sequencing (NGS) offers a more comprehensive approach to detecting, quantifying, and analyzing the genetic alterations associated with leukemia, including minor BCR::ABL1 transcripts and mutations. NGS thus provides detailed insights into disease progression, treatment response, and potential resistance mutations, enabling personalized treatment plans. BioVendor MDx (Brno, Czech Republic) has introduced the first commercial NGS assay specifically for the BCR::ABL1 fusion ...

• Source: drugdu
• 72
• May 8, 2024

Henlius Dual HER2 Blockade Therapy Receives Phase 3 MRCT IND Approval from U.S. FDA

Shanghai, China, May 6, 2024-Shanghai Henlius Biotech, Inc. (2696.HK) announced that the investigational new drug application (IND) for phase 3 international multicenter clinical study of Henlius’ novel anti-HER2 mAb, HLX22, in combination with trastuzumab and chemotherapy for the first-line treatment of HER2-positive advanced gastric cancer has been approved by the United States Food and Drug Administration (FDA). As of now, no similar dual HER2 blockade therapy for the treatment of HER2-positive gastric cancer has received approval for commercialization globally. Until now, gastric/gastroesophageal junction (G/GEJ) cancer still constitutes a major global health problem. Globally, there were around 1 million cases in 2022. G/GEJ cancer generally carries a poor prognosis since it is often diagnosed at an advanced stage, with a 5-year relative survival rate of only 6%. The reported rates of HER2 positivity in patients with gastric cancer range from 12% to 23%, and the prognosis for patients with HER2-positive disease ...

• Source: drugdu
• 69
• May 8, 2024

Jacobio Pharma Announced its KRAS G12C inhibitor reached the primary endpoint

BEIJING and SHANGHAI and BOSTON, April 30, 2024 /PRNewswire/ — Jacobio Pharma (1167.HK) announced that the data from the Phase II registrational study of the KRAS G12C inhibitor glecirasib were offically reported at the April ASCO Plenary Series, which was held online. Prof. Yuankai Shi, chief physician of Cancer Hospital Chinese Academy of Medical Sciences, the lead principal investigator of this clinical trial, presented the data in the form of an online oral presentation (Abstract 468214). The efficacy data showed that among second-line non-small cell lung cancer patients receiving monotherapy treatment, the confirmed objective response rate (cORR) was 47.9% (56/117), including 4 patients achieved a complete response (CR) and 36 patients with tumor reduction exceeding 50%. Disease control rate (DCR) was 86.3%. The median progression-free survival (mPFS) was 8.2 months, and median overall survival (mOS) was 13.6 months. The median duration of response (mDoR) has not been reached:6-month and 12-month ...

• Source: drugdu
• 85
• May 6, 2024

Research Shows Generative AI In The EHR Can Work Well, But Only With Human Oversight

As the burden of documentation and various other administrative duties has increased, physician burnout has reached historical levels. In response, EHR vendors are embedding generative AI tools to aid physicians by drafting their responses to patient messages. However, there is a lot that we don’t yet know about these tools’ accuracy and effectiveness. Researchers at Mass General Brigham recently conducted research to learn more about how these generative AI solutions are performing. They published a study last week in The Lancet Digital Health showing that these AI tools can be effective at reducing physicians’ workloads and improving patient education — but also that these tools have limitations that require human oversight. For the study, the researchers used OpenAI’s GPT-4 large language model to produce 100 different hypothetical questions from patients with cancer. The researchers had GPT-4 answer these questions, as well as six radiation oncologists who responded manually. Then, the ...

• Source: drugdu
• 100
• May 6, 2024

Novartis Set to Acquire Mariana Oncology to Enhance Radioligand Therapy Pipeline

Don Tracy, Associate Editor Deal includes a number of radioligand therapies targeting solid tumors, such as breast, prostate, and lung cancers. Novartis announced that it has acquired Mariana Oncology, a biotech specializing in developing radioligand therapies (RLTs) for cancer treatment. According to the company, the acquisition is expected to enhance Novartis’ existing RLT pipeline and add major research capabilities. These programs target breast, prostate, and lung cancers, and features a leading developmental candidate, MC-339, for small cell lung cancer. As per terms of the agreement, Novartis is expected to make an upfront payment of $1 billion, with further potential payments of up to $750 million upon the completion of pre-specified milestones.1 “The acquisition of Mariana Oncology reflects our commitment to radioligand therapy as one of our company’s key technology platforms and strengthens our leadership in this field,” said Fiona Marshall, president, biomedical research, Novartis, in a press release. “We are ...

• Source: drugdu
• 114
• May 6, 2024

AstraZeneca’s Lynparza to dominate PARP inhibitors market with $4 bn in sales by 2027

In 2014, the FDA approved the first (adenosine diphosphate-ribose) polymerase (PARP) inhibitor AstraZeneca/Merck’s Lynparza (olaparib) for use in breast cancer gene (BRCA)-mutated metastatic ovarian cancer patients who have received three or more prior lines of chemotherapy. Since then, the PARP inhibitors market has made significant strides, but Lynparza maintains its dominance with projected global sales of $4 billion by 2027, according to an analyst consensus forecast by GlobalData. GlobalData’s analyst consensus reveals that high sales projections underscore Lynparza’s role in treating multiple cancer types, including ovarian, pancreatic, prostate, and human epidermal growth factor receptor 2 (HER2)-negative breast cancer. Expected revenues in these indications will reach over 68 per cent of the global PARP inhibitors market by 2027. GlaxoSmithKline’s (GSK) Zejula (niraparib) holds the second position with over $1.6 billion in sales and 28 per cent of the market share. Most of Lynparza’s sales come from ovarian and HER2-negative breast cancer treatment. Biswajit Podder, ...

• Source: https://www.expresspharma.in/astrazenecas-lynparza-to-dominate-parp-inhibitors-market-with-4-bn-in-sales-by-2027-globaldata/
• 158
• May 4, 2024

Six Biopharma Companies to Watch at MedCity INVEST Pitch Perfect Contest

The MedCity INVEST conference is scheduled for May 21-22 at the Ritz Carlton hotel in Chicago, The companies will offer a window into some of the promising treatments under development such as different types of cancers to muscular dystrophy. Space is limited so register today! By Stephanie Baum Biopharma companies are responsible for some of the most transformative, life-changing technologies in medicine from gene therapy to immunotherapy. At the MedCity INVEST conference scheduled for May 21-22 at the Ritz Carlton hotel in Chicago, six biopharma companies will give attendees a window into some of the promising treatments under development. MedCity News Senior Biopharma Reporter Frank Vinluan will moderate the biopharma track of the startup contest Pitch Perfect. One judge confirmed for the track is Meredith Wilkerson, an investment principal with Plains Ventures who serves as the primary subject matter expert for evaluating life sciences and biotech investment opportunities. Wilkerson will also ...

• Source: drugdu
• 94
• May 2, 2024

KCL study reveals particles in cows’ milk effective for oral delivery of RNA drugs

In a new study, researchers from King’s College London (KCL) have revealed that tiny particles present in cows’ milk could offer a new and effective method for the oral delivery of ribonucleic acid (RNA) drugs. Published in the Journal of Nanobiotechnology, the tiny particles known as extracellular vesicles (EV) could help protect and deliver RNA drugs following oral administration. RNA therapies are a powerful class of drugs based on nucleic acids that offer a way to target previously untreatable diseases on a molecular level. Despite successful administration via injection, there has been no successful way to deliver them orally, as the drugs are destroyed by the harsh conditions of the gut. Researchers extracted EVs from cows’ milk and loaded them with RNA molecules to treat inflammatory bowel disease (IBD). EVs are nanoscale transporters that carry biological molecules in a protective coat throughout the body, controlling and regulating the access of ...

• Source: drugdu
• 102
• May 1, 2024