Phosplatin Therapeutics‘ investigational medication PT-112 showed promising efficacy and safety data in an early clinical trial of heavily-pretreated people with relapsed or refractory multiple myeloma. The findings were shared in a presentation, “A Phase I Dose Escalation Study of PT-112 in Patients with Relapsed or Refractory Multiple Myeloma,” at the 62nd American Society of Hematology (ASH)…
A couple of weeks after its approval, Orgovyx (relugolix) is now commercially available in the U.S. for adults with advanced prostate cancer through authorized specialty distributors, the therapy’s developer, Myovant Sciences, has announced. “Myovant has been focused on ensuring access to Orgovyx for men with advanced prostate cancer as quickly as possible following approval, and…
Lynparza (olaparib) has been approved in Japan as a maintenance treatment for women with advanced ovarian cancer who responded to a first-line chemotherapy regimen containing bevacizumab, AstraZeneca and Merck announced in a press release. The approval, for patients whose cancer is positive for homologous recombination deficiency (HRD), is based on data from the PAOLA-1 Phase 3 trial (NCT02477644),…
The Multiple Myeloma Research Foundation (MMRF) is partnering with Indapta Therapeutics to advance the biotechnology company’s investigational G-NK cell therapy into clinical trials for the treatment of multiple myeloma. The financial support for the therapy’s development is being given by the MMRF through an investment made via its venture philanthropy arm, the Myeloma Investment Fund.…
A breast cancer vaccine can now be tested in human trials after its investigational new drug application was accepted by the U.S. Food and Drug Administration (FDA). A Phase 1 clinical trial is expected to test the vaccine, developed by Anixa Biosciences and the Cleveland Clinic, for triple-negative breast cancer (TNBC). “We are pleased that…
BXCL501, BioXcel Therapeutics’ experimental therapy for the treatment of agitation associated with dementia, was found to be well-tolerated and able to rapidly and sustainably lower agitation in patients with different forms of dementia, including Alzheimer’s disease. These top-line findings from TRANQUILITY, BioXcel‘s Phase 1b/2 clinical trial (NCT04251910), are expected to support the therapy’s continued development…
Adding AIVITA Biomedical’s experimental and personalized cancer vaccine, AV-GBM-1, to post-surgery standard treatment slows disease progression in adults newly diagnosed with glioblastoma — the most aggressive type of brain cancer — according to two-year data from a Phase 2 clinical trial. “The improvement in glioblastoma patients who were treated with AV-GBM-1, compared to studies with…
Janssen and Legend Biotech are seeking U.S. approval for their investigational CAR T-cell therapy ciltacabtagene autoleucel — known as cilta-cel — to treat adults with relapsed or refractory (hard-to-treat) multiple myeloma. A rolling submission of the biologics license application (BLA) for cilta-cel has been started by Janssen with the U.S. Food and Drug Administration (FDA).…
The investigational therapy cavrotolimod (AST-008), in combination with the PD-1 inhibitor Keytruda (pembrolizumab), was safe and well-tolerated, and showed signs of efficacy in people with advanced solid tumors who failed prior PD-1 blockade therapy, according to the interim results of a Phase 1b/2 clinical trial. Based on these findings from the Phase 1b stage, the…
ARV-110, an investigational oral therapy that degrades the androgen receptor, has a favorable safety profile and showed promising anti-tumor activity in heavily pretreated men with metastatic castration-resistant prostate cancer (mCRPC), updated Phase 1 data suggests. The approach worked particularly well in a population with specific mutations in the androgen receptor, the researchers said. But it…
