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2X Oncology Obtains Investigational New Drug Application for 2X-111 Glutathione Enhanced PEGylated Liposomal Doxorubicin

Cambridge, MA – June 8, 2017 — 2X Oncology, Inc. (“2X” or the “Company”), a precision medicine company developing targeted therapeutics to address significant unmet needs in women’s cancer, today announced that it has obtained the Investigational New Drug (IND) application for 2X-111 (doxorubicin hydrochloride and glutathione) from 2-BBB Medicines B.V., assuming all future development and ownership of the drug.

2X-111 is being developed as a new treatment option for women with brain metastases from breast cancer and for patients with recurrent glioblastoma multiforme (GBM), an orphan-designated condition.

George O. Elston, CEO of 2X Oncology, said, “Having this IND in place is an important step as we focus on initiating Phase 2 clinical trials of 2X-111 in GBM and brain metastases from breast cancer later this year.

“These studies will employ our proprietary DRP™ companion diagnostic to identify patients based on their unique tumor mRNA expression and treat those most likely to respond to and benefit from therapy,” Mr. Elston added.

“Patient selection based on the unique genetic properties of a tumor is an important new direction in the treatment of cancer, and we are pleased to have this capability for our programs and patients.”

The Drug Response Predictor (DRP™) technology utilizes messenger RNA (mRNA) from patient biopsies and uses proprietary analytics to create a unique fingerprint of relevant genes based on a tumor’s sensitivity, or resistance, to a compound. DRPs are specific for each product and have been validated in over 40 clinical studies.

“We expect data from these studies in 2018 which, if positive, can position this program for possible accelerated approval filings shortly thereafter,” Mr. Elston concluded.

Formerly known as 2B3-101, 2X-111 improves on commercially available PEGylated liposomal doxorubicin products with an additional glutathione coating that safely enhances drug delivery across the blood-brain barrier.  Doxorubicin is an anthracycline that inhibits the growth of many cancerous cell lines, including glioblastoma and breast cancer cell lines.  It is among the most widely used anti-cancer agents.

An abstract on the predictive ability of the DRP in treating advanced breast cancer with a similar anthracycline, epirubicin, was presented in a poster session at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting.

The abstract describes a retrospective-prospective blinded study which evaluated the ability of the DRP to predict the efficacy of epirubicin in a cohort of 135 metastatic breast cancer patients.  The DRP was significantly associated with progression free survival in this study.  The estimated median time to progression for a patient with a DRP value of 25% was 7 months, versus 13 months for a patient with a DRP value of 75%.

Mr. Elston will discuss 2X-111 and other 2X pipeline drugs at the Jefferies 2017 Global Healthcare Conference on June 9, 2017, at 10:00am EDT.  The presentation will be available as a live webcast and archived for post-listening on the Company’s website.

About Breast Cancer Brain Metastases

Breast cancer is the second most common common cause of brain metastases, with metastases occurring in 10–16 % of patients[1]. Patients who develop brain metastases tend to have poor prognosis with short overall survival.  Furthermore, brain metastases are a major cause of morbidity, associated with progressive neurologic deficits that result in a reduced quality of life.

About Glioblastoma Multiforme
Glioblastoma multiforme (GBM) is the most common class of malignant primary brain tumors and one of the most aggressive forms of cancer. This highly invasive and proliferative cancer resists standard chemotherapy and radiotherapy. Current therapeutic strategies for the treatment of GBM fail to demonstrate adequate efficacy and/or are generally palliative. Median overall survival is 12 to 14 months.

About 2X Oncology

2X Oncology Inc. is a clinical stage precision medicine company developing targeted therapeutics that leverage proprietary Drug Response Predictor (DRP™) technology to address significant unmet needs in women’s cancer.  The DRP™ generates a precision mRNA-based companion diagnostic for each compound, enabling the identification of patients that are most likely to respond and benefit from treatment.

The 2X pipeline includes product candidates with potential utility in the treatment of breast, ovarian, and endometrial cancers and primary and secondary brain tumors.  These programs have shown clinical efficacy and safety and are positioned to enter focused Phase 2 studies with data expected in 2018.

A Cambridge, MA based spin-out from Oncology Venture ApS, 2X works in close collaboration with Oncology Venture and leverages its Danish registry of over 1,100 cancer patients for initial clinical studies. Learn more at 2xoncology.com.

DRP™ is a trademark of Medical Prognosis Institute A/S.

[1] Leone JP and Leone BA. Breast cancer brain metastases: the last frontier. Exp Hem & Oncol. 2015;4:33. doi:10.1186/s40164-015-0028-8.