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In Brief This Week: AstraZeneca, Genentech, Achilles, Bristol Myers Squibb, Roche, Anixa Biosciences

NEW YORK – AstraZeneca this week said that it will invest $1.5 billion to build a manufacturing facility in Singapore to produce antibody-drug conjugate cancer therapies. The facility will be AstraZeneca's first end-to-end ADC manufacturing site, in which all steps of the process will be conducted in one place at commercial scale. The company expects to begin construction by the end of 2024 and to complete it in 2029. 

Genentech on Tuesday said the US Food and Drug Administration granted breakthrough therapy designation to its mutant PI3Kα inhibitor inavolisib, which the company is developing in combination with fulvestrant as a treatment for patients with PIK3CA-mutated, hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer who have relapsed on or within 12 months of completing adjuvant endocrine therapy. 

Achilles Therapeutics and Arcturus Therapeutics said this week that they inked a research collaboration to develop second-generation personalized messenger RNA-based cancer vaccines. The firms will jointly develop personalized vaccines against patients' clonal neoantigens. Although the partnership is preclinical for now, both firms will jointly agree on any subsequent clinical development.  

Bristol Myers Squibb said this week that the US Food and Drug Administration has moved up the anticipated date for its decision on approving a subcutaneous formulation of BMS's immune checkpoint inhibitor Opdivo (nivolumab) co-formulated with Halozyme's recombinant human hyaluronidase (rHuPH20). Previously, the FDA had assigned a target prescription drug user-fee act (PDUFA) date of Feb. 28, 2025. Now, regulators say they will decide by Dec. 29, 2024. 

Roche this week announced that its Tina-quant lipoprotein Lp(a) RxDx test has received breakthrough device designation from the US Food and Drug Administration. The assay is intended to select patients with elevated Lp(a) and a history of atherosclerotic disease for treatment with an Lp(a) lowering drug. The test measures the number of Lp(a) molecules per liter in a person's blood and will run on selected Cobas instruments, Roche said in a statement. It was developed in collaboration with Amgen. 

Anixa Biosciences this week said it began treating the fifth patient in a Phase I study of its autologous CAR T-cell therapy for ovarian cancer. The first-in-human trial is enrolling patients with recurrent or progressing ovarian cancer who were unresponsive to at least two prior therapies. Anixa said the safety of the CAR T-cell therapy was confirmed in the first three patients enrolled in the trial, and now the trial is enrolling its second cohort to determine the maximum tolerated dose of T cells. The CAR T-cell therapy targets follicle-stimulating hormone receptor (FSHR), which is found only on ovarian cells. 

UK genomic data analysis firm Congenica said this week that it has been selected for the third phase of a contract under the Integrated and Standardized NGS Workflows for Personalized Therapy (Instand-NGS4P) project to develop standardized next-generation sequencing workflows in oncology. The project is funded in part by the European Union's Horizon 2020 program. Under the contract, Congenica will install and test its automated data analysis and reporting platform, which enables evidence-based interpretation of NGS data with a focus on actionable insights for fast treatment decisions, at various sites across Europe over the next 12 months. 

Oxford BioDynamics said this week that it has signed an agreement with the London Clinic, a private hospital in the UK, to provide patients at the clinic with access to OBD's EpiSwitch PSE (Prostate Screening) and EpiSwitch CiRT (Checkpoint inhibitor Response Test) blood tests. EpiSwitch PSE is a screening test for prostate cancer that has better accuracy than a standard PSA tests, according to the Oxford, UK-based firm. EpiSwitch CiRT identifies patients who will respond to immune checkpoint inhibitor therapy to support first-line treatment planning and to identify ICI candidates among patients where other options have been exhausted. 

The US Food and Drug Administration has granted Cartesian Therapeutics' Descartes-08 regenerative medicine advanced therapy designation, the Gaithersburg, Maryland-based biotech said this week. Descartes-08 is Cartesian's lead product candidate, an autologous mRNA CAR T-cell therapy being developed as a treatment for myasthenia gravis that is being tested in a Phase IIb study. The company previously received orphan drug designation from the FDA for Descartes-08 as a potential treatment for myasthenia gravis, as well. 

In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on Precision Medicine Online.