On November 14, 2018 Trillium Therapeutics Inc. (NASDAQ/TSX: TRIL), a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported financial and operating results for the nine months ended September 30, 2018 (Press release, Trillium Therapeutics, NOV 14, 2018, View Source [SID1234531305]).
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2018 Third Quarter Highlights:
Presented an update at the European Organisation for Research and Treatment of Cancer, Cutaneous Lymphoma Task Force (EORTC CLTF) meeting on the safety and efficacy of the ongoing multicenter, open-label phase 1 intratumoral trial of TTI-621 in 23 patients with relapsed/refractory mycosis fungoides/Sézary syndrome, 20 of whom only received induction therapy consisting of 1-6 injections over 2 weeks. Local delivery of TTI-621 was well tolerated, with no treatment-related > Grade 3 adverse events or dose-limiting toxicity observed. Reductions in CAILS scores, which measure local lesion responses, were observed in 89% of patients, with 44% exhibiting reductions of 50% or greater. These responses occurred rapidly within the 2-week induction period. Similar CAILS scores changes were seen in adjacent non-injected lesions, suggesting locoregional effects that were not confined to the site of injection. Evidence of a systemic effect was observed in 1 of 2 patients receiving continuation monotherapy beyond the 2-week induction therapy. In addition, data suggest a combination effect with pegylated IFN-alpha-2a.
Presented an update at the Discovery on Target conference on the safety and efficacy of the ongoing multicenter, open-label phase 1a/b intravenous trial of TTI-621 in patients with relapsed/refractory hematologic malignancies. Based on an expanded data set of 163 patients, weekly infusions of TTI-621 were shown to be well tolerated. Thrombocytopenia was the most frequent grade 3 or higher treatment-emergent adverse event, occurring in 20% of patients. Platelet reductions, however, were shown to be transient and pre-dose platelet levels remained steady during the course of the study. Notably, the reversible thrombocytopenia did not lead to an increased risk of bleeding and had no impact on drug delivery, nor was there a significant impact of TTI-621 on hemoglobin levels. Monotherapy efficacy was observed in patients with mycosis fungoides (19% ORR, n=21), peripheral T-cell lymphoma, or PTCL (25% ORR, n=12), and diffuse large B-cell lymphoma, or DLBCL (25% ORR, n=8), and in DLBCL patients when combined with rituximab (25% ORR, n=24). This clinical activity was observed in patients receiving relatively low doses of drug (0.2 mg/kg for monotherapy or 0.1 mg/kg in combination with rituximab). Dose intensification beyond 0.2 mg/kg is currently ongoing, and doses of 0.5 mg/kg have been well tolerated for up to 27 weeks.
"The growing body of data from the TTI-621 intratumoral trial in patients with CTCL continues to look encouraging, and we believe that there are several potential paths forward in this indication, and possibly in other accessible tumors," said Dr. Niclas Stiernholm, president and CEO of Trillium Therapeutics. "Additionally, data from over 160 patients in our intravenous trial indicate that systemically delivered TTI-621 has single-agent and combination activity at relatively low doses, and ongoing efforts to dose intensify appear encouraging. We believe that flexibility is the best way to address this new IO pathway, and having two development candidates in the clinic, and options of intravenous and intratumoral delivery, as monotherapy or in combination, gives Trillium the most comprehensive approach to targeting CD47."
Third Quarter 2018 Financial Results:
As of September 30, 2018, Trillium had cash and cash equivalents and marketable securities, and working capital, of $52.1 million and $41.8 million, respectively, compared to $81.8 million and $68.9 million, respectively, at December 31, 2017. The decrease in cash and cash equivalents and marketable securities was due mainly to cash used in operations of $30.8 million, net of an unrealized foreign exchange gain of $1.3 million. The decrease in working capital was due mainly to cash used in operations, increases to amounts receivable and prepaid expenses, and a decrease to accounts payable and accrued liabilities due to clinical trial payments.
Net loss for the nine months ended September 30, 2018 of $33.9 million was lower than the loss of $34.4 million for the nine months ended September 30, 2017. The net loss was lower mainly due to a net foreign currency gain of $1.5 million for the nine months ended September 30, 2018, compared to a net foreign currency loss of $4.9 million in the prior year period, and lower manufacturing costs, partially offset by higher clinical trial expenses and the expense relating to the amendment of the SIRPaFc license agreement.