On March 28, 2019 Unum Therapeutics Inc. (NASDAQ: UMRX), a clinical-stage biopharmaceutical company focused on the development of cellular immunotherapies to treat cancer based on its novel T cell technology platforms, reported financial results and provided a corporate update for the full year ended December 31, 2018, and recent activities (Press release, Unum Therapeutics, MAR 28, 2019, View Sourcenews-releases/news-release-details/unum-therapeutics-reports-fourth-quarter-and-full-year-2018" target="_blank" title="View Sourcenews-releases/news-release-details/unum-therapeutics-reports-fourth-quarter-and-full-year-2018" rel="nofollow">View Source [SID1234534736]).
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"2018 was an important year for Unum as we brought the company public and continued to innovate in cell therapy with the advancement of our ACTR platform and the development of our new BOXR platform," said Chuck Wilson, President and CEO of Unum. "We have demonstrated proof of concept with the ACTR approach and see a clear path to further evaluating differentiated, potentially best-in-class product candidates designed to address continued patient needs. We are building out our solid tumor pipeline and have initiated our first solid tumor clinical trial, ATTCK-34-01, and selected BOXR1030 as our first product candidate from the BOXR platform. In 2019, we look forward to reporting data from all of our ongoing trials that will help determine next steps for our efforts in non-Hodgkin lymphoma, multiple myeloma, and solid tumors."
Recent Highlights
Continuing Dose Escalation in ATTCK-20-03 Phase I Trial: At the 2018 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December, Unum presented preliminary results from the first two dose levels of its ongoing Phase 1 study of ACTR707 in combination with rituximab in patients with relapsed/refractory CD20+ B cell non-Hodgkin lymphoma (r/r NHL). These data demonstrated that three of the six patients treated at Dose Level 1 (25 MM ACTR+ T cells) and one of three patients treated at Dose Level 2 (40 MM ACTR+ T cells) achieved a complete response. Enrollment and dose-limiting toxicity (DLT) assessments at Dose Level 3 (55 MM ACTR+ T cells) have since been completed, and enrollment at Dose Level 4 (80 MM ACTR+ T cells) has initiated. Through the first three cohorts, no DLTs and no severe adverse events of cytokine release syndrome (CRS) or neurologic events have been observed. Following completion of the dose escalation phase of the trial, Unum plans to initiate a cohort expansion at the preliminary recommended Phase 2 dose of ACTR707 in the second half of 2019.
Completed Enrollment of ATTCK-20-2 Phase I Trial: Following the decision in 2018 to prioritize ACTR707 for future development in r/r NHL, Unum has completed enrollment in the ATTCK-20-2 study, a Phase I clinical trial evaluating safety and anti-lymphoma activity of ACTR087 in combination with rituximab in patients with r/r NHL. Unum plans to report data on all enrolled patients from ATTCK-20-2 at the end of 2019. These data will inform other ACTR programs, specifically ATTCK-17-01, a Phase I trial of ACTR087 in combination with SEA-BCMA.
Continuing Dose Escalation with ATTCK-17-01 Phase I Trial: At the 2018 ASH (Free ASH Whitepaper) Annual Meeting in December, Unum presented data from the initial cohorts of the ongoing Phase 1 ATTCK-17-01 study, testing ACTR087 in combination with SEA-BCMA (an investigational monoclonal antibody targeting B cell maturation antigen, or BCMA) in patients with relapsed/refractory multiple myeloma (r/r MM). In the first three cohorts, no DLTs and no severe adverse events of CRS or neurologic events were observed. Having cleared cohorts with very low levels of SEA-BCMA antibody administered, dose escalation is continuing now at doses of SEA-BCMA that may be expected to have pharmacological activity based upon preclinical studies. Enrollment at Dose Level 4 (30 MM ACTR+ T cells and 2.0 mg/kg SEA-BCMA) is ongoing. In subsequent dose cohorts, the dose of both ACTR087 and SEA-BCMA will be explored. Unum expects to continue to enroll and dose patients through the dose escalation phase of the trial and to report data from multiple dose cohorts in the second half of 2019.
Initiated ATTCK-34-01 Phase I Trial in Solid Tumors: Unum announced that it has initiated ATTCK-34-01, a Phase 1, multicenter, single-arm, open-label dose escalation study evaluating ACTR T cells in combination with trastuzumab for the treatment of patients with HER2+ advanced cancers. This is Unum’s first ACTR T cell study in solid tumors. The primary study objectives are to assess the safety and tolerability of the combination, and to define dose recommendations for further development. Additional objectives include assessment of anti-tumor activity, ACTR T cell persistence, and trastuzumab pharmacokinetics. Unum plans to report initial clinical data from the ongoing dose escalation at the end of 2019.
Initiated Preclinical Development of the First Product Candidate from the BOXR Platform: In November 2018, Unum announced its new Bolt-On Chimeric Receptor technology platform (BOXR), which improves T cell functionality by countering immunosuppression in solid tumor cancers. Unum presented preclinical data at the 2018 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) meeting demonstrating the ability to significantly improve the activity of both ACTR- and CAR-targeted engineered T cells in immunosuppressive solid tumors. Unum has subsequently nominated BOXR1030 as the first product candidate from this platform and has initiated IND-enabling preclinical studies and plans to present additional information regarding BOXR1030 in the second half of 2019. BOXR1030 consists of a T cell co-expressing a glypican-3 (GPC3)-directed CAR and an undisclosed metabolism-enhancing bolt-on transgene. GPC3 is a well-known oncofetal antigen selectively expressed in a variety of tumor types including certain liver and lung cancers.
Fourth Quarter 2018 Financial Results
Collaboration Revenue: Collaboration revenue recognized during the fourth quarter ended December 31, 2018 was $3.8 million, compared to $2.1 million in the same period of 2017. The increase reflects the recognition of a portion of the $25.0 million upfront payment received from Seattle Genetics under Unum’s collaboration agreement as well as reimbursements of research and development costs attributed to the ATTCK-17-01 study.
R&D Expenses: Research and development expenses were $10.8 million for the fourth quarter ended December 31, 2018, compared to $7.6 million for the same period of 2017. The increase reflects higher clinical trial costs for the active Phase I clinical trials, as well as increased personnel-related costs, materials and facility-related costs related to scaling manufacturing processes, and increased consultant costs to support these activities.
G&A Expenses: General and administrative expenses for the fourth quarter ended December 31, 2018, were $2.0 million, compared to $1.4 million for the same period of 2017. The increase is primarily due to expenses around operating as a public company and higher personnel related costs.
Net Loss: Net loss attributable to common stockholders was $8.6 million, or $0.29 per share, for the fourth quarter ended December 31, 2018, and $6.7 million, or $0.66 per share, for the same period of 2017.
Cash, Cash Equivalents and Marketable Securities: As of December 31, 2018, Unum had cash, cash equivalents, and marketable securities of $78.6 million. Total cash burn for 2018, net of IPO related costs, was $36.3 million. Today, Unum updated its cash runway and now anticipates that its existing cash, cash equivalents, and marketable securities will fund operating expenses and capital expenditure requirements into early 2021.
Investor Call and Webcast Information
Unum will host a live conference call and webcast today, March 28, 2019, at 8:00 a.m. ET, to discuss these financial results and company updates. To access the call, please dial 866-300-3411 (domestic) or 636-812-6658 (international) and refer to conference ID number 8169027. A webcast will be available at View Source at least 10 minutes before the event begins. The archived webcast will be available at the same location approximately two hours after the event and will be archived for 90 days.