ONC-002

Combining REQORSA® Immunogene Therapy with Tarceva (erlotinib)

Phase 1 portion completed; Phase 2 portion no longer enrolling due to our change of focus to conduct Acclaim-1

A Phase 1/2 clinical trial evaluated REQORSA® in combination with Tarceva® in stage IIIB/IV lung cancer patients without an activating EGFR mutation and in patients with an activating EGFR mutation whose cancer has progressed on Tarceva therapy.  Patients without the EGFR mutation represent the vast majority of lung cancer patients. However, such patients generally are not candidates for Tarceva therapy.

In the Phase 2 trial combining REQORSA with Tarceva, subjects received REQORSA in combination with Tarceva every 21 days until the occurrence of progressive disease (PD), unacceptable toxicity, withdrawal of consent, or study treatment discontinuation for other reasons, whichever occurred first. We believe that the results from the Phase 2 trial are encouraging. Out of 10 patients, 9 had received 2 or more cycles and were therefore evaluable for response. Four patients had tumor regression. The median duration of response was three months. The disease control rate (CR+PR+SD > 8weeks) was 78%, which substantially exceeds the 7% response rate (with no CRs) and 58% disease control rate reported for the LUX-Lung 1 trial, a clinical trial of Gilotrif (afatinib) in a comparable group of patients.

One patient in the Phase 2 combination trial had a Complete Response, or CR, under the Response Evaluation Criteria in Solid Tumors, or RECIST. This patient, a 58-year-old female, upon enrollment in the study had metastatic NSCLC status following 6 cycles of pemetrexed and carboplatin and 2 cycles of maintenance pemetrexed with cancer progression. The patient’s tumor has EGFR exon 18 and 20 missense mutations, which are not sensitive to Tarceva.

We are no longer enrolling the Phase 2 portion of the Phase 1/2 Combination Tarceva Trial due to receipt of our FDA Fast Track Designation for the combination of REQORSA with Tagrisso and our change of focus to conduct Acclaim-1, which uses REQORSA combined with Tagrisso.

To learn more about scientific evidence and studies supporting REQORSA and the TUSC2 gene, please refer to our TUSC2 Bibliography page.

Tarceva® is a registered trademark of Astellas and the Roche Group of companies.

Tagrisso® is a registered trademark of AstraZeneca.