16 Jun Oncologie Announces Key Updates and Planned Activities for its Clinical Programs and RNA-based Biomarker Platform
Press Release | June 16, 2020 | Source: Oncologie
- Phase 2 Trial with Bavituximab in Patients with Gastric Cancer on Track to Report Preliminary Results During the Second Half of 2020
- Phase 1b Trial with Navicixizumab in Patients with Ovarian Cancer Recently Presented at the Society for Gynecological Oncology Annual Meeting
- Later this Year, Results from Oncologie’s Analysis Using its RNA-based Tumor Microenvironment Biomarker Platform Will Inform Future Trials of Bavituximab and Navicixizumab
Waltham, MA, June 16, 2020 – Oncologie, Inc., a precision medicine company using an innovative, RNA-based biomarker platform to develop next-generation oncology therapeutics, today announced updates to its clinical programs and planned activities during the remainder of 2020.
“Oncologie made significant progress during the first half of 2020, despite the complexities of COVID-19, and we remain on track to report updates to our clinical programs during the remainder of this year,” said Laura E. Benjamin, Ph.D., President and Chief Executive Officer at Oncologie. “Importantly, our analysis of samples from our ongoing clinical programs using our RNA-based biomarker platform continues. We are excited to incorporate these results expected later this year to define our clinical strategy for bavituximab and navicixizumab to potentially improve upon the encouraging results demonstrated so far with these programs. With the recent closing of the second tranche of our Series B financing, we are well-positioned to advance these clinical programs and our biomarker platform to develop next-generation oncology therapeutics using precision-based approaches.”
Clinical Updates with Bavituximab and Navicixizumab:
Bavituximab, a chimeric monoclonal antibody that targets phosphatidylserine, demonstrated clinical activity in a review of a subset of non-small cell lung cancer (NSCLC) patients who were given a PD-1 inhibitor following bavituximab treatment, leading to the hypothesis that a treatment combination of bavituximab and a PD-1 inhibitor could generate similar activity in a clinical trial. The ongoing Phase 2 trial is intended to further evaluate the safety, tolerability, and antitumor activity of bavituximab plus pembrolizumab in patients with advanced gastric or gastroesophageal junction cancer. In addition, Oncologie plans to explore the ability of its biomarker platform to select patients for future clinical development. Oncologie plans to present data from this Phase 2 trial, including biomarker results, in the second half of 2020 at an upcoming medical conference.
Oncologie’s next clinical-stage program, navicixizumab, is a bispecific antibody designed to inhibit both Delta-like ligand 4 (DLL4) in the Notch cancer stem cell pathway as well as vascular endothelial growth factor (VEGF). Interim data from a Phase 1b dose escalation and expansion trial of navicixizumab plus paclitaxel in 44 platinum-resistant ovarian cancer patients who had failed more than two prior therapies and/or received prior bevacizumab were presented virtually at the 2020 Society of Gynecologic Oncology (SGO) Annual Meeting in May 2020. Preliminary results from the trial demonstrated an overall response rate (ORR) of 43% in heavily pretreated patients. Treatment with navicixizumab and paclitaxel demonstrated an ORR of 64% and 33% in bevacizumab-naïve, and bevacizumab pre-treated patients, respectively. Treatment-related adverse events were manageable and included hypertension (58%), headache (29%), fatigue (26%) and pulmonary hypertension (18%). Using its biomarker platform, Oncologie is analyzing patient tissue samples from all navicixizumab trials with results expected later this year to inform future clinical development with this program.
Successfully Closed Second Tranche of Series B Financing
Oncologie recently closed the second tranche of its previously announced $80 million Series B financing. The second tranche includes new investor CR-CP Life Science Fund as well as full participation from the existing syndicate including Pivotal BioVenture Partners, Nan Fung Life Sciences, Panacea Venture and Korea Investment Partners.
Bavituximab is an investigational chimeric monoclonal antibody that targets the activity of phosphatidylserine (PS). Bavituximab is believed to reverse PS-mediated immunosuppression by blocking the engagement of PS with its receptors, as well as by sending an alternate immune activating signal. PS-targeting antibodies have been shown to shift the functions of immune cells in tumors, resulting in multiple signs of immune activation and anti-tumor immune responses. This mechanism may play an important role in allowing other cancer therapies to more effectively attack tumors by reversing the immunosuppression that limits the impact of those treatments. Importantly, bavituximab has also demonstrated a manageable safety and tolerability profile in previous clinical trials conducted to date, which may allow it to be combined effectively with other agents.
Navicixizumab is an anti-DLL4/VEGF bispecific antibody designed to inhibit both Delta-like ligand 4 (“DLL4”) in the Notch cancer stem cell pathway as well as vascular endothelial growth factor (“VEGF”) and thereby induce potent anti-tumor responses while mitigating certain angiogenic-related toxicities. In preclinical studies, navicixizumab demonstrated robust in vivo anti-tumor activity across a range of solid tumor xenografts, including colon, ovarian, lung and pancreatic cancers, among others. In a Phase 1a study with single-agent navicixizumab, 19 of 66 patients with various types of refractory solid tumors had tumor shrinkage following treatment with navicixizumab. Notably, 3 of the 12 (25%) ovarian cancer patients treated in the trial achieved an unconfirmed partial response with single-agent navicixizumab therapy. The FDA granted Fast Track designation to navicixizumab for the treatment of high-grade ovarian, primary peritoneal or fallopian tube cancer in patients who have received at least three prior therapies and/or prior treatment with bevacizumab.
About Oncologie’s Biomarker Platform
Predictive biomarkers historically worked on single-driver mutations yet only approximately 10% of cancer patients have known driver mutations with available targeted therapies. Using its proprietary biomarker platform, Oncologie is advancing a new paradigm of precision oncology with an RNA-based approach to identify the dominant biology in the tumor microenvironment. This could improve clinical outcomes by matching patients to therapies with a mechanism of action that targets that specific biology and expand precision medicine to those therapies whose potential remains unrealized. Oncologie is further optimizing the biomarker platform’s tumor microenvironment panel through multiple research collaborations, including a collaboration with Moffitt Cancer Center.
About Oncologie, Inc.
Oncologie, Inc. is a next generation, precision medicine oncology company. Oncologie leverages its unique biomarker platform to develop targeted therapies that are matched to individual tumors based on RNA profiles that describe the biology of the cancer. The current pipeline is focused on novel mechanisms to modulate tumor immune biology and tumor angiogenesis. Oncologie, Inc., based in Waltham, Massachusetts, and Oncologie Shanghai Co., Ltd., based in Shanghai, China, are subsidiaries of Oncologie, Ltd., and are working with global partners to acquire and further develop innovative drugs for cancer patients around the world. For more information on Oncologie, Inc., please visit www.oncologie.com.
Heather Savelle or Ryan Baker