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In Brief This Week: Genprex, Veracyte, C2i Genomics, Arvinas, Pfizer, AstraZeneca, Sophia Genetics

NEW YORK – Genprex this week began treating EGFR-mutant non-small cell lung cancer patients in an expansion cohort of the Phase IIa Acclaim-1 trial of its immunogene therapy Reqorsa (quaratusugene ozeplasmid) in combination with AstraZeneca's EGFR inhibitor Tagrisso (osimertinib). The expansion portion of the trial will enroll 66 NSCLC patients harboring EGFR mutations, half of whom have progressed on single-agent Tagrisso and the other half having progressed on combination treatment with Tagrisso and chemotherapy. Initial results from the expansion cohort are expected in 2025, according to Genprex. 

Veracyte said this week that it has closed its previously announced acquisition of C2i Genomics, adding whole-genome minimal residual disease capabilities to its diagnostics platform. The firm purchased C2i for $70 million, paid for with 2.7 million Veracyte shares. It may pay an additional $25 million in Veracyte shares or cash based on milestones achieved over the next two years. Veracyte's first application of C2i's technology will be a muscle-invasive bladder cancer MRD test, to be followed by additional MRD tests in its focus indications. 

Arvinas and Pfizer this week said the US Food and Drug Administration granted fast-track designation to the estrogen receptor degrader vepdegestrant as a treatment for patients with estrogen receptor-positive, HER2-negative advanced or metastatic breast cancer who have previously received an endocrine-based therapy. The companies are studying vepdegestrant in the Phase III VERITAC-2 trial. Under fast-track designation, a sponsor can meet with the FDA more frequently to get advice on developing fast-track designated agents, submit data on a rolling basis, and apply for accelerated approval or priority review. 

AstraZeneca this week said it is building a facility in Rockville, Maryland, to produce cell therapies for cancer clinical trials and future commercial supply in the US. The company will invest $300 million in the facility and hire about 150 highly skilled workers to manufacture T-cell therapies. 

Sophia Genetics this week said it is expanding a 2022 program partnered with AstraZeneca to provide local testing for homologous recombination deficiency in Spain. The original agreement deployed HRD testing to five laboratories. Under the expanded agreement, HRD testing will be available to more laboratories with increased volume and speed of next-generation sequencing and tumor profiling. 

AgeCurve this week said it has secured a £250,000 ($315,200) investment from an undisclosed investor to further the development of its technology for assessing biological age. The company tracks human single cell somatic mutations to measure biological age at the level of genome instability with the goal of building tools that can be used to predict life expectancy as well as morbidity and mortality. 

Lucid Diagnostics this week said it has signed a contract with the World Trade Center Health Program to provide Lucid's EsoGuard Esophageal DNA test for esophageal precancer testing as a covered benefit for more than 120,000 first responders and other survivors who participate in the program for the monitoring and treatment of people affected by the 9/11 World Trade Center attack. EsoGuard tests are reimbursable at $2,475.81 each when prescribed by clinicians at the program's clinical centers of excellence. 

The Parkinson's Foundation said this week that Aligning Science Across Parkinson's (ASAP), under its Global Parkinson's Genetics Program (GP2), has awarded the foundation a grant of undisclosed size to expand its international genetics study. The study, named PD GENEration: Mapping the Future of Parkinson's Disease, provides genetic testing and counseling to patients with the disease. The new funding will allow the foundation to focus on patients who have been historically underrepresented in research through improved outreach to diverse communities in the US, Canada, and countries in Latin and South America. In addition, the foundation will move to whole-genome sequencing and share research data with the Accelerating Medicines Partnership Parkinson's Disease (AMP PD) portal, a public-private partnership of the National Institutes of Health, biopharmaceutical and life science companies, and nonprofit organizations. The PD GENEration study, launched in 2019, is expected to start expanding in the spring of 2024. 

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.