Amazon (Nasdaq:AMZN) and the Fred Hutchinson Cancer Research Center are working together on a Phase 1 FDA-approved clinical study that will investigate a personalized neo-antigen peptide vaccine for melanoma and certain types of breast cancer. According to a listing on clinicaltrials.gov, the study aims to recruit 20 participants. Amazon will offer scientific and machine learning capabilities…
AstraZeneca and Daiichi Sankyo win new breakthrough therapy designation for Enhertu
The HER2-directed antibody-drug conjugate Enhertu (trastuzumab deruxtecan) has won its fifth breakthrough therapy designation from the FDA. Enhertu was developed jointly by AstraZeneca (LON:AZN) and Daiichi Sankyo (OTCMKTS: DSNKY). The latest designation relates to treating adults with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-negative) breast cancer. Of the five breakthrough therapy designations for the drug,…
AstraZeneca’s and Merck’s Lynparza wins new breast cancer approval from FDA
The poly(ADP-ribose) polymerase inhibitor Lynparza (olaparib) has become the first FDA-approved medicine targeting BRCA mutations in early breast cancer. The drug was developed by AstraZeneca (NSDQ:AZN) and Merck & Co. (NYSE:MRK), which is known as MSD outside of the U.S. Lynparza is already approved for a number of other indications. FDA approved the drug to…
Tukysa effective against HER2-positive breast cancer
Tukysa from Seagen won FDA approval for HER2-positive breast cancer in conjunction with chemotherapy (trastuzumab and capecitabine) to treat advanced unresectable or metastatic HER2-positive breast cancer. The indication covers patients with brain metastases who previously received anti-HER2-based therapies for metastatic cancer.
Piqray remains a novel treatment option for patients metastatic breast cancer
Piqray from Novartis is FDA indicated to treat hormone receptor (HR)- positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer. The FDA indication requires the use of an FDA-approved test following progression on or after an endocrine-based regimen.
4D Path and University of Leeds extend partnership to validate oncology platform
The precision oncology company 4D Path has committed to partnering with the U.K.-based University of Leeds at least until 2027. The two entities are already collaborators, having worked together on three completed breast cancer clinical trials. In particular, researchers at the University of Leeds have used 4D Path’s Q-plasia OncoReader Breast software to analyze data from more…
FDA OKs clinical trial for ‘paradigm-shifting’ breast cancer vaccine
The FDA has OK’d human clinical trials for Anixa Biosciences (NASDAQ: ANIX) and Cleveland Clinic’s novel breast cancer vaccine that immunizes against the alpha-lactalbumin protein. Within the mammary gland, the alpha-lactalbumin protein is involved in lactose synthase production, which, in turn, is required to make lactose and milk. Typically expressed later in pregnancy and during lactation,…