OncXerna Therapeutics Announces Journal of Clinical Oncology Publication Featuring Phase 1b Data of Navicixizumab Plus Paclitaxel in Ovarian Cancer

Overall response rate (ORR) of 43% and median duration of response of 6 months seen with navicixizumab-paclitaxel combination in heavily pretreated platinum-resistant ovarian cancer patients

Xerna™ TME Panel shows enhanced response in biomarker positive (62%) vs. biomarker negative patients (25%)

Results support co-development of navicixizumab and Xerna TME Panel in ovarian cancer

Excerpt from the Press Release:

WALTHAM, Mass., April 21, 2022 (GLOBE NEWSWIRE) — OncXerna Therapeutics, Inc. (“OncXerna”), a precision medicine company using an innovative RNA-expression based biomarker platform to predict patient responses to its targeted oncology therapeutic candidates, today announced the peer-reviewed publication of results from a Phase 1b trial evaluating navicixizumab, an anti-DLL4/VEGF bispecific antibody, combined with paclitaxel, in patients with platinum-resistant ovarian cancer (PROC). The paper, entitled, “Phase Ib Study of Navicixizumab Plus Paclitaxel in Patients With Platinum-Resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancer,” was published in Journal of Clinical Oncology and can be found here.

Featured in the paper are efficacy and safety data from the trial as well as correlative biomarker results generated with OncXerna’s novel RNA gene expression-based diagnostic panel, the Xerna TME Panel. The Xerna TME Panel uses a machine learning-based algorithm to assign scores based on the interplay between angiogenic and immunogenic dominant biologies of the tumor microenvironment (TME). Given navicixizumab’s anti-angiogenic mechanism of action, patients with high Xerna TME Panel angiogenesis scores were classified as biomarker positive (B+), while those with low angiogenesis scores were classified as biomarker negative (B-).

“This prestigious publication highlights the encouraging, durable clinical activity of navicixizumab in a heavily pretreated platinum resistant ovarian cancer patient population where the treatment options are very limited,” said Kathleen Moore, M.D., Professor at The Stephenson Cancer Center, The University of Oklahoma. “In addition to seeing activity regardless of prior treatments, this study showed the potential of the Xerna TME panel to address the unmet need for a predictive biomarker for response to anti-angiogenic treatment.”

Key data and conclusions from the paper include:

• Navicixizumab plus paclitaxel showed promising and durable clinical activity in a heavily pretreated patient population regardless of prior treatment (median of four prior therapies)
  • Overall response rate (ORR) across all evaluable patients: 43% (19/44)
    • ORR in patients previously treated with bevacizumab (Avastin^®): 33% (10/30)
    • ORR in patients previously treated with a PARP inhibitor: 45% (9/20)
    • 11 of 19 patients with partial or complete response had progressive disease as best response to immediate prior therapy
  • Median duration of response: 6 months

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