On a mission to grow in oncology, GSK has more positive data to report in endometrial cancer. This time, the company is touting results for its PD-1 inhibitor Jemperli and PARP inhibitor Zejula, which could become a threat to a rival therapy at AstraZeneca. Adding Jemperli and Zejula to chemotherapy significantly extended the time before tumor progression or death in patients with primary advanced or recurrent endometrial cancer that’s mismatch repair proficient or microsatellite stable (pMMR/MSS), GSK said Monday. The results came from the second part of the phase 3 RUBY trial. The trial also showed that the Jemperli-Zejula-chemo regimen was better at delaying disease worsening than chemo alone in the overall population, regardless of genetic stability. But GSK appears to think that the combo has more value in the pMMR/MSS subgroup. Patients with pMMR/MSS endometrial cancer have few treatment options, Hesham Abdullah, GSK’s head of oncology R&D, said in ...
ROCKVILLE, U.S. and SUZHOU, China, Dec 18, 2023,— Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, metabolic, autoimmune, ophthalmology and other major diseases, announces that results of a Phase 2 clinical trial of mazdutide (Innovent R&D code: IBI362), a glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR) dual agonist, in Chinese patients with overweight or obesity were published in Nature Communications. Professor Linong Ji, the leading principal investigator of the study, Peking University People’s Hospital, stated, “As a chronic disease with complex underlying causes, obesity is one of the leading risk factors of type 2 diabetes, fatty liver, cardiovascular and cerebrovascular diseases, joint diseases, sleep apnea in addition to cancers. Obesity requires increased public awareness of long-term treatment and management with effective and science-backed approaches. China has the largest obese population; however, no safe and efficacious ...
Since Merck secured approval for kidney cancer pill and blockbuster hopeful Welireg (belzutifan) in August of 2021, sales have grown slowly but surely. With a second FDA nod on Thursday for a much larger patient population, the company can anticipate a more pronounced upswing in revenue from the hypoxia-inducible factor-2 alpha (HIF-2a) inhibitor. The U.S. regulator has given a thumbs up for Welireg to treat relapsed or refractory renal cell carcinoma (RCC) for adult patients who have not responded to a PD-1 or PD-L1 inhibitor and who have also been treated with a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TK1). Welireg becomes the first drug in its class for patients with advanced RCC and the first novel-class treatment in the indication since 2015, Merck noted. The nod comes on top of its original approval to treat the rare von Hippel-Lindau disease, a hereditary condition that causes tumor growth in ...
On December 16th, during the 18th Asia-Pacific Symposium on Hypertension, the National Launching Meeting of Sacubitril Valsartan Sodium Tablets (trade name: Yixintan®), which is exclusively commercialized by Fosun Pharmaceuticals and researched, developed and manufactured by Nanjing Fangshenghe Pharmaceuticals, was held grandly in Shanghai. The approved indications of Yixintan® (sacubitril valsartan sodium tablets) are for use in adult patients with chronic heart failure (NYHA class II-IV, LVEF ≤ 40%) with reduced ejection fraction, to reduce the risk of cardiovascular death and hospitalization for heart failure; and for the treatment of essential hypertension. The product is a first-line drug for the treatment of heart failure and hypertension with an innovative crystalline form with independent intellectual property rights. After the launching ceremony, a press conference on the national launching of Yixintan® was held, in which experts appeared and answered questions from the media about the current situation of cardiovascular prevention and treatment, the ...
For a long time, visible signs of tumor growth on scans were the benchmark for initiating cancer treatment. However, the emergence of precision oncology tools, including circulating tumor DNA sequencing, is changing this approach. These advancements allow for earlier cancer detection and adaptation of treatment strategies to combat mutations that cause resistance to current therapies. They also offer the potential for less toxic alternatives to chemotherapy. New research led by a clinical scientist at UC Davis Health (Sacramento, CA, USA) highlights the benefits of using blood tests to search for cancer DNA. This method can speed up cancer detection and inform the use of targeted treatments. Cancer DNA circulating in a patient’s blood can be identified from a simple blood draw. This DNA is then sequenced to determine its genetic structure, helping to classify the cancer based on the findings in the blood sample. Unlike traditional tissue biopsies, which are ...
Pharmaceutical Executive Editorial Staff Bristol Myers Squibb will pay $800 million upfront to SystImmune for the rights to codevelop and sell a potentially first-in-class bispecific antibody-drug conjugate that has shown promise treating non-small cell lung cancer and breast cancer. Bristol Myers Squibb (BMS) has reached an agreement with SystImmune for the rights to codevelop and sell a potentially first-in-class EGFRxHER3 bispecific antibody-drug conjugate (ADC) in a deal that could exceed $8 billion. As part of the agreement, BMS will pay $800 million upfront to SystImmune and up to $500 million in contingent near-term payments.1 Should certain developmental, regulatory, and sales performance milestones be achieved, SystImmune would be eligible for additional payments that would bring the total for the agreement to approximately $8.4 billion.1 “Our collaboration with SystImmune allows us to strengthen our leadership in oncology and is consistent with our strategy to diversify beyond immuno-oncology to transform patient care,” said ...
Effective monitoring of cancer cells is crucial for physicians in guiding treatment and managing the disease, potentially reducing cancer-related mortality. Non-invasive diagnostic platforms that measure the electrical properties of cancer cells show promise for early detection of drug resistance and metastasis in cancer. Earlier studies have found that the type of cancer and its drug resistance status can be understood from cellular permittivity and conductivity data. As a result, there is a growing need for analytical methods that can quickly measure these electrical properties of cells. Electrorotation (ROT) is one method that can capture these cellular properties by analyzing permittivity and conductivity based on how a cell moves in an electric field. This method characterizes cell types and states by profiling their frequency-dependent rotational movement under a modulated electric field. However, traditional ROT methods have limitations, primarily the cumbersome process of capturing, measuring, and replacing cells, which reduces the throughput ...
December 11, 2023—SystImmune, a clinical-stage biopharmaceutical company, and Bristol Myers Squibb (NYSE: BMY) today announced an exclusive license and collaboration agreement for SystImmune’s BL-B01D1, a potentially first-in-class EGFRxHER3 bispecific antibody-drug conjugate (ADC). Under the terms of the agreement, the companies will jointly develop and commercialize BL-B01D1 in the United States. Through its affiliates, SystImmune will be solely responsible for development, commercialization, and manufacturing in Mainland China and will be responsible for manufacturing certain drug supplies for use outside of Mainland China. Bristol Myers Squibb will assume sole responsibility for development and commercialization in the rest of the world. BL-B01D1, a bispecific topoisomerase inhibitor-based ADC which targets both epidermal growth factor receptor and human epidermal growth factor receptor 3 (EGFRxHER3), is currently being evaluated in a global multi-center Phase 1 study (BL-B01D1-LUNG101) for safety and efficacy in individuals with metastatic or unresectable non-small cell lung cancer (NSCLC). Data from earlier clinical ...
Pharmaceutical Executive Editorial Staff Phase III trial to investigate novel individualized neoantigen therapy V940 (mRNA-4157) in combination with Keytruda (pembrolizumab) as an adjuvant treatment for patients with completely resected Stage II, IIIA, or IIIB non-small cell lung cancer. Image credit: Axel Kock | stock.adobe.com Merck and Moderna, Inc., have announced plans to launch the pivotal Phase III INTerpath-002 (NCT06077760) clinical trial of the novel individualized neoantigen therapy V940 (mRNA-4157) in combination with Keytruda (pembrolizumab) as an adjuvant treatment for patients with completely resected Stage II, IIIA, or IIIB non-small cell lung cancer (NSCLC). V940 is comprised of synthetic mRNA coding for up to 34 neoantigens that are designed and produced based on the unique mutational signature of a patient’s tumor. After administration of the drug, the algorithmically derived and RNA-encoded neoantigen sequences are endogenously translated and undergo natural cellular antigen processing and presentation. “As lung cancer is the leading cause ...
If you can’t beat them, join them. After Bristol Myers Squibb’s Opdivo topped Seagen’s classical Hodgkin lymphoma (cHL) therapy Adcetris in a head-to-head trial, Seagen has trotted out new datasets suggesting the two drugs—a PD-1 inhibitor and an antibody-drug conjugate—hold potential when paired together as part of a combination. In a midstage study, all patients with early-stage cHL who received a combination of Adcetris, Opdivo and the chemotherapy regimen AD (doxorubicin and dacarbazine) were alive without disease progression after one year of treatment. The analysis came from 150 patients enrolled in part C of the phase 2 SGN35-027 trial and was shared at the 65th American Society of Hematology annual meeting. The data look promising, but cHL is known to be relatively easy to treat. In an interview, Megan O’Meara, M.D., Seagen’s head of clinical development, acknowledged that people want to see longer-term data—and ultimately a survival benefit—in frontline cHL. ...
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