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In Brief This Week: OnKure, Inovio, Syapse, Genetron Health

NEW YORK – Boulder, Colorado-based OnKure this week said that based on encouraging data from a Phase I trial of its investigational HDAC inhibitor OKI-179, it will launch a Phase Ib/II trial of the drug in combination with the MEK inhibitor binimetinib (Pfizer's Mektovi) in NRAS-mutant melanoma patients who haven't responded to checkpoint inhibitors. The Phase I trial showed OKI-179 was safe and generally well tolerated and that it had "robust target engagement" at doses of 120 mg and above in solid tumor models with RAS pathway mutations. Based on this, OnKure will start the Phase Ib/II study of the combination regimen in the first half of 2022. In the Phase Ib portion, the company will track the safety, pharmacokinetics, and pharmacodynamics of the regimen, as well as establish dosing for the Phase II portion, in which researchers will further explore therapeutic activity.

Pennsylvania-based Inovio said this week it has identified candidate biomarker signatures with partner Qiagen that can identify which women with human papillomavirus-associated cervical high-grade squamous intraepithelial lesions will respond to Inovio's DNA immunotherapy drug VGX-3100. Inovio and Qiagen expanded an existing partnership earlier this year and said they were developing a liquid biopsy CDx. The partners will select a final biomarker signature, which they hope will increase the probability of clinical response in biomarker-positive women with cervical HSIL. Inovio said it will provide an update on this biomarker development program next year.

The company also said that its REVEAL2 global Phase III trial of VGX-3100 in cervical HSIL is fully enrolled and top-line data will be reported in the second half of 2022. Furthermore, Inovio's partner in China, ApolloBio, has dosed the first participant in a Phase III study of VGX-3100 in cervical HSIL that's ongoing in that country. This trial, which will enroll up to 84 patients, has a similar design to REVEAL2.

Syapse said this week that it has inked an oncology real-world data partnership with Delaware healthcare system Bayhealth. Within the partnership, Bayhealth providers and researchers will have access to Syapse's de-identified databases of real-world clinical, molecular, treatment, and outcomes data, which they can use to help guide patients' cancer diagnosis and treatment. Bayhealth will also become a part of the Syapse Learning Health Network, through which providers can collaborate and learn about treatments that improve real-world outcomes in patients with clinically and molecularly similar cancers.

Genetron Health said this week that it has launched the "Lung Loves New Life" genetic testing campaign in collaboration with the China Primary Health Care Foundation. As the sole corporate donor, Genetron will provide free genetic testing services for 10,000 Chinese lung cancer patients using its eight-gene lung cancer assay, which in turn can help personalize their treatment. The China Primary Health Care Foundation noted that it hopes to improve patients' access to genetic tests that can improve lung cancer diagnosis and personalized treatment.

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 Oncology News.