Overall Response Rate (ORR) of 43% and Median Duration of Response of 6 Months Observed with Navicixizumab and Paclitaxel in Patients With Heavily Pretreated Platinum-Resistant Ovarian Cancer
Xerna™ TME Panel shows better response in biomarker positive patients (62%) compared to biomarker negative patients (25%)
Results Support Co-Development of Navicixizumab and Xerna TME Panel in Ovarian Cancer
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 the responses of patients to its targeted oncology therapeutic candidates, today announced the peer-reviewed publication of the results of a Phase 1b trial evaluating navicixizumab, a bispecific anti-DLL4/VEGF antibody, combined with paclitaxel, in patients with platinum-resistant ovarian cancer (PROC). The article, titled “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.
The article presents the efficacy and safety data of the trial as well as the correlative results of the biomarkers generated with OncXerna’s new 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 the dominant angiogenic and immunogenic tumor microenvironment (TME) biology. Considering the anti-angiogenic mechanism of action of navicixizumab, patients with high Xerna TME Panel angiogenesis scores were classified as biomarker positive (B+), while those with low angiogenesis scores were classified as negative biomarkers (B-).
“This prestigious publication highlights the encouraging and durable clinical activity of navicixizumab in a population of patients with platinum-resistant, highly pretreated ovarian cancer, where treatment options are very limited,” said Kathleen Moore, MD, professor at the Stephenson Cancer Center at the University of Oklahoma. “In addition to seeing activity independent of prior treatments, this study demonstrated the potential of the Xerna TME panel to address the unmet need for a predictive biomarker for response to anti-angiogenic therapy.”
Key data and findings from the article include:
- Navicixizumab plus paclitaxel showed promising and durable clinical activity in a heavily treatment-experienced patient population, regardless of prior treatment (median of four prior treatments)
- Overall response rate (ORR) for 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 a partial or complete response had progressive disease as the best response to immediate prior therapy
- Median duration of response: 6 months
- Overall response rate (ORR) for all evaluable patients: 43% (19/44)
- The B+ classification showed an enrichment of patients with a tumor response
- ORR in B+ vs B- patients: 62% (8/13) vs. 25% (5/20)
- Better progressive disease response in B+ vs B- patients: 0% (0/13) vs. 30% (6/20)
- Median progression-free survival in B+ vs B- patients: 9.2 months vs. 3.9 months
- The safety profile of navicixizumab plus paclitaxel was consistent with known toxicities, with no new safety signals or unexpected safety findings. The monitoring and management plan for hypertension and pulmonary hypertension was effective in reducing the risk of severe toxicity and showed recovery upon discontinuation of treatment. No grade 3 pulmonary hypertension or grade 4 hypertension was reported. Treatment-related adverse events led to treatment discontinuation in 9% (4/44) of patients.
Laura Benjamin, Ph.D., Chief Executive Officer of OncXerna Therapeutics, said, “We are thrilled with both the strength of our data and the external validation that comes from publishing it in such a high-impact journal. Biomarkers to improve the selection of patients most likely to respond to treatment and to prevent those least likely to receive ineffective treatment at an advanced stage are an important unmet need for cancer patients. This study provides proof of principle for the further development of navicixizumab, a drug designed to combat anti-VEGF and chemotherapeutic resistance, as well as the potential of the Xerna TME panel to provide a predictive biomarker for anti-angiogenic therapy. To confirm this result, the Xerna TME panel will be used to stratify patients enrolled in a planned Phase 3 study. »
OncXerna’s planned Phase 3 study, REVELARE, is designed as a randomized, open-label study evaluating navicixizumab ± paclitaxel versus paclitaxel monotherapy in treatment-experienced PROC patients stratified by Xerna TME Panel biomarker status. Additional information about this planned trial can be found using the ClinicalTrials.gov identifier NCT05043402.
About the phase 1b trial
The Phase 1b trial was an open-label, non-randomized, dose-escalation, expansion study of the safety, tolerability, and efficacy of navicixizumab plus paclitaxel in patients with prostate cancer. platinum-resistant ovary. The trial enrolled patients who had previously received Avastin (bevacizumab) and/or more than two prior lines of treatment. Patients were treated with navicixizumab once every two weeks with weekly paclitaxel. The primary endpoint of the trial was the incidence of dose-limiting toxicities. Secondary endpoints included response rate assessed by RECIST 1.1 criteria and progression-free survival. For more information, see ClinicalTrials.gov ID: NCT03030287.
Navicixizumab is an anti-DLL4/VEGF bispecific antibody that demonstrated antitumor activity in patients previously treated with Avastin® (bevacizumab) in a Phase 1b clinical trial. The United States Food and Drug Administration has granted Fast Track Designation to navicixizumab for the treatment of high-grade cancer of the ovary, primary peritoneum, or fallopian tubes in patients who have previously received Avastin and/or or more than 2 previous lines of treatment. Navicixizumab is an investigational agent that has not been approved and has not been shown to be safe or effective for any use, including for the treatment of advanced ovarian cancer.
About the Xerna TME Panel
The Xerna TME panel uses proprietary RNA-based gene expression data and a machine learning-based algorithm to classify patients based on the interplay between the dominant angiogenic and immunogenic tumor microenvironment (TME) biology. The Xerna TME Panel is an investigational test that has not been approved and has not been demonstrated to be safe or effective for any use.
About OncXerna Therapeutics
OncXerna Therapeutics is a clinical-stage oncology company developing novel monoclonal antibodies to treat solid tumors. In combination with its innovative precision medicine platform, the Xerna TME Panel, OncXerna leverages artificial intelligence technologies and RNA expression-based biomarkers to match a specific patient’s tumor with the most best suited to treat this tumour. By integrating our new Xerna TME platform with our deep clinical development expertise, we believe we can accelerate the development, approval and commercialization of drug candidates and bring meaningful new treatments to patients as soon as possible. Our current clinical pipeline includes the Company’s lead product candidate, navicixizumab, which is a bispecific antibody that targets both VEGF and DLL4 to treat solid tumors and is currently entering a Phase 3 study for the treatment of cancer. advanced ovary. Another product candidate, bavituximab, is an investigational antibody designed to reverse immune suppression by inhibiting phosphatidylserine (PS) signaling and is currently in Phase 2 clinical trials to treat a specific subset of patients. patients with advanced gastric cancer to improve their response to anti-PD-1 treatment. Navicixizumab and bavituximab are investigational agents that have not been approved and have not been shown to be safe or effective for any use. For more information, please visit oncxerna.comor follow us on LinkedIn and Twitter.
Investor and media contact:
Ashley R. Robinson
LifeSci Partners, LLC