Mission Bio and Onconova Therapeutics Partner to Advance Precision Oncology Clinical Trials Employing Single-Cell Genomics

The alliance will leverage Mission Bio’s Tapestri Platform to investigate Onconova’s novel cancer therapy rigosertib, through clinical trials

SOUTH SAN FRANCISCO, Calif. and NEWTOWN, Pa. (August 12, 2019) Mission Bio, the pioneer in targeted single-cell DNA analysis and precision genomics, and Onconova Therapeutics (NASDAQ: ONTX), a Phase 3-stage biopharmaceutical company discovering and developing novel products to treat cancer, with a focus on myelodysplastic syndromes (MDS), today announced that they have formed a collaboration to utilize the Mission Bio Tapestri Platform for targeted single-cell DNA analysis to study Onconova’s novel cancer therapy, rigosertib, through clinical trials.

With the growing complexity of clinical trials, precision biomarkers are needed to reduce the time and costs associated with the drug development cycle. Broad-based sequencing technologies lack the sensitivity to identify the earlier initial single cell events that contain the driver mutations that initiate the oncologic disease. With Mission Bio’s Tapestri Platform, researchers can detect rare cancer subclones and co-occurring cancer mutations at the single-cell level, offering a precise way to measure therapy response and disease progression. Supporting the pharma and biopharma industries through clinical trials and commercialization continues to be a focus for Mission Bio.

Ras proteins control cell proliferation, and mutation of this protein can lead to cancer in affected individuals. Ras is mutated in over 30 percent of patients with cancer, making it one of the most sought-after targets. Onconova is developing rigosertib, a first-in-class, small molecule Ras mimetic, to target this mutation. Rigosertib blocks the activation of Ras effector proteins, thus modulating the Ras pathway. Onconova’s goal is to fully enroll INSPIRE, its phase 3 clinical trial studying rigosertib in higher-risk MDS patients who fail the current standard of care, by year-end.

“Through single-cell genomics, we can identify mutations with far better resolution than that of traditional sequencing methods. This allows a view into each patient’s disease at a level never before achieved,” explained Darrin Crisitello, CCO of Mission Bio. “The Tapestri Platform can identify subclones to help monitor a patient’s response to research drugs in clinical trials, supporting the advancement of rigosertib to the clinic.”

“Rigosertib has the potential to be the first new higher-risk MDS treatment in more than 15 years, for a condition affecting an estimated 59,000 patients with low and higher-risk MDS in the United States alone,” said Dr. Steve Fruchtman, CEO of Onconova. “In adding the Tapestri Platform to our research and development program, we are including the opportunity to study single cell clones in MDS and determine the sequence of genetic events and the influence of rigosertib on these events along with clinical outcomes. These studies have the potential to make a meaningful difference in the lives of patients in need.”

About Mission Bio
Mission Bio delivers targeted solutions for high impact applications with the Tapestri Platform. The Tapestri Platform is the industry’s first single-cell DNA sequencing platform, enabling precise detection of heterogeneity in disease progression and treatment response. Application areas include blood cancers, solid tumors, and genome editing validation. The platform includes an instrument, consumables and software, which plug seamlessly into existing NGS workflows. LabCorp’s Covance Drug Development business will be the first global contract research organization to offer services on the Mission Bio Tapestri Platform, supporting biopharmaceutical customers in their need for faster, more precise clinical trials.

The company’s Tapestri Platform was also honored as a Top 10 Innovation of 2018 by The Scientist, as well as utilized by researchers at MD Anderson Cancer Center (MDACC) for the largest single-cell study completed to date. With Mission Bio, researchers have a highly sensitive, targeted, and customizable solution to move precision medicine forward.

To learn more about Mission Bio and how it’s moving precision medicine forward, visit www.missionbio.com.

About Onconova Therapeutics, Inc.
Onconova Therapeutics, Inc. is a Phase 3-stage biopharmaceutical company focused on discovering and developing novel small molecule drug candidates to treat cancer, with a focus on Myelodysplastic Syndromes (MDS). Using a proprietary chemistry platform, Onconova has created a pipeline of targeted agents designed to work against specific cellular pathways that are important in cancer cells. Onconova has three product candidates in the clinical stage and several pre-clinical programs. Advanced clinical trials with the Company’s lead compound, rigosertib, are aimed at what the Company believes are unmet medical needs of patients with MDS. For more information, please visit http://www.onconova.com.

About Rigosertib
Rigosertib, Onconova’s lead candidate, is a proprietary Phase 3 small molecule. A key publication demonstrated rigosertib’s ability to block cellular signaling by targeting RAS effector pathways (Divakar, S.K., et al., 2016: “A Small Molecule RAS-Mimetic Disrupts RAS Association with Effector Proteins to Block Signaling.” Cell 165, 643). Onconova is currently in the clinic with oral and IV rigosertib, including single agent IV rigosertib in second-line higher-risk MDS patients (pivotal Phase 3 INSPIRE trial) and oral rigosertib plus azacitidine in first-line higher-risk MDS patients (Phase 2). Patents covering oral and injectable rigosertib have been issued in the US and are expected to provide coverage until at least 2037.

About IV Rigosertib
The intravenous form of rigosertib has been studied in Phase 1, 2, and 3 clinical trials involving more than 1000 patients, and is currently being evaluated in a randomized Phase 3 international INSPIRE trial for patients with higher-risk MDS (HR-MDS), after failure of hypomethylating agent, or HMA, therapy.

Media Contacts:
Kathryn Ryan
VSC for Mission Bio
missionbio@vscconsulting.com
(631) 255-5281

Avi Oler
Onconova Therapeutics, Inc.
267-759-3680
ir@onconova.us
http://www.onconova.com/contact