NEW YORK – Olema Oncology said this week that it has increased the targeted number of metastatic estrogen receptor positive breast cancer patients in its Phase I/II trial of palazestrant and Novartis' Kisqali (ribociclib) to 60. Under the terms of an initial collaboration with Novartis, Olema and Novartis were targeting a 30-patient enrollment. By adding an additional 30, Olema believes it can generate a big enough clinical dataset to support a first-line pivotal clinical trial for the drug combination.
Eckert & Ziegler this week said it will supply PharmaLogic with actinium-225 for labeling radiopharmaceuticals for R&D and commercial use. The agreement will allow PharmaLogic to move forward its radiopharmaceutical programs and enable patient access to therapies.
Kazia Therapeutics this week said it is voluntarily withdrawing from the Australian Securities Exchange because the costs, administrative burden, and commercial disadvantages of remaining on the exchange outweigh any benefits. Kazia is developing the PI3K/AKT/mTOR pathway inhibitor paxalisib for treating solid tumor brain metastases harboring PI3K pathway mutations. The Sidney, Australia-based firm's shares will continue to trade on the Nasdaq as American Depository Shares. The company has set up a voluntary ADS conversion facility for shareholders. Kazia shareholders are not required to approve delisting on the ASX, which the firm expects to be complete by Nov. 14.
Myriad Genetics this week established a new long-term agreement with UnitedHealthcare. The agreement includes pricing for MyRisk, MyChoice CDx, BRACAnalysis CDx, Foresight, Prequel, GeneSight, and Prolaris, among others. The new agreement runs from Jan. 1, 2024, through Dec. 31, 2027. Additional terms of the deal were not disclosed.
Biocartis of Mechelen, Belgium, said this week that it has expanded its collaboration with Apis Assay Technologies, a UK-based molecular diagnostics company, to include the commercialization of the Apis ESR1 Mutations Kit, a qualitative qPCR test, through Biocartis' global commercial network. Biocartis will distribute the kit, with an initial focus on Europe. Earlier this year, the two companies had announced a partnership to develop and commercialize the Apis Breast Cancer Subtyping assay on Biocartis' Idylla platform.
Utica, New York-based Masonic Medical Research Institute this week announced a project led by Nathan Tucker, an assistant professor of biomedical research and translational medicine at the research center, has received a $3.9 million grant from the National Institute of Health's National Heart, Lung, and Blood Institute to study genetic factors linked with cardiac arrythmia risk. During the five-year study, investigators will aim to identify genes that contribute to cardiac arrythmia, which they say could underpin development of new therapeutics.
Coeptis Therapeutics this week said it expanded a licensing agreement with the University of Pittsburgh to add the SNAP-CAR NK platform, a technology for making targeted natural killer cells. The company previously licensed the university's SNAP-CAR T-Cell platform, which is designed to target multiple antigens at the same time, potentially treating a range of hematologic and solid tumors, including HER2-expressing cancers.
AstraZeneca said this week that the Scottish Medicines Consortium (SMC) has accepted AstraZeneca and Merck's Lynparza (olaparib) for use as adjuvant treatment, either as a monotherapy or combined with endocrine therapy, for patients with germline BRCA1/2 mutated, HER2-negative, high-risk early-stage breast cancer within the NHS Scotland. The SMC conducts its own cost-effectiveness analyses of drugs separate from the UK's National Institute for Health and Care Excellence, which in April recommended Lynparza's use in this patient population in England.
Knight Therapeutics said this week that its Brazilian subsidiary United Medical has submitted an application to Brazilian regulators seeking approval for Pemazyre (pemigatinib) for previously treated locally advanced or metastatic cholangiocarcinoma patients whose cancers harbor FGFR2 fusions or rearrangements. Knight has a supply-and-distribution agreement in place with Pemazyre developer Incyte under which Knight is responsible for marketing the drug in Latin America.
Korea-based cancer molecular diagnostics company Gencurix announced this week that it has obtained regulatory approval in Australia for its Droplex POLE Mutation Test targeting endometrial cancer mutations. The test uses Droplet Digital PCR to detect abnormalities in the DNA polymerase epsilon (POLE) gene, potentially reducing unnecessary treatments and improving prognosis and treatment outcomes for patients with endometrial cancer. Gencurix has applied for the inclusion of other Droplex companion diagnostic tests in the Australian Register of Therapeutic Goods and plans to leverage the recent approval to expand into other countries which are members of the Medical Device Single Audit Program (MDSAP).
Anixa Biosciences this week said that the first cohort of ovarian cancer patients has completed treatment with its follicle-stimulating hormone receptor-targeted CAR T-cell therapy in a trial underway with Moffitt Cancer Center. A review of the data from three patients indicated it is safe to escalate the dose of the cell therapy, and investigators will immediately begin enrolling patients into a second cohort, in which they will receive triple the dose of the first cohort. The goal of the study is to evaluate the safety of the therapy and determine a maximum-tolerated dose.
In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared in Precision Medicine Online.