SRF388 clinical program advancing well; updated clinical data expected in the first half of 2023
First patient dosed in a Phase 1/2 study evaluating SRF114, a potential best-in-class anti-CCR8 antibody, in patients with advanced solid tumors
Cash runway guidance extended into the third quarter of 2024
“Our teams have done an outstanding job advancing SRF388 and SRF114, and we are pleased with the progress of both clinical programs,” said
Fourth Quarter and Subsequent Corporate Highlights
- In the fourth quarter of 2022, Surface announced encouraging new SRF388 monotherapy data in non-small cell lung cancer (NSCLC) with two confirmed partial responses, as well as a third patient with adenocarcinoma who experienced durable disease stabilization, ongoing for more than 56 weeks. All three of these patients had previous treatment with chemotherapy and with anti-PD-(L)1 agents. Based on these results, Surface opened the second stage of the Simon’s 2-stage monotherapy trial which is expected to enroll 40 patients with NSCLC in total. In addition, Surface initiated a single-arm Phase 2 study evaluating SRF388 in combination with pembrolizumab in patients with NSCLC who have progressed after 1-3 prior lines of therapy, including chemotherapy and anti-PD-(L)1 agents. The study is anticipated to enroll up to 40 patients with NSCLC.
January 2023, Surface announced the first patient had been dosed in a Phase 1/2 study evaluating SRF114 as a monotherapy in patients with advanced solid tumors. SRF114 is a potential best-in-class, fully human, afucosylated anti-CCR8 antibody that has demonstrated highly specific binding properties exclusively to human CCR8 in preclinical studies.
- Following a strategic portfolio review, Surface announced the decision to pause the internal clinical development of SRF617, a novel antibody targeting CD39, and pursue potential business development opportunities for the program. As a result of the reprioritization, the company conducted a corresponding workforce reduction and implemented cost reduction efforts, which extended cash runway.
- Surface presented non-clinical SRF388 and SRF114 data at the
Society for Immunotherapy of Cancer(SITC) 2022 Annual Meeting in Boston. A poster presentation detailed the immune-suppressive communication, co-localization, and upregulation between IL-27 and PD-L1 expression within the tumor microenvironment, supporting clinical studies evaluating SRF388. Additionally, Surface presented SRF114 preclinical data that demonstrated the antibody’s ability to selectively deplete tumor Treg cells, resulting in dose-dependent activation of immune cells, and a potential mechanism to inhibit tumor growth independent of checkpoint inhibition.
October 2022, Cell Reports published findings from a preclinical collaboration study between Surface and VIB detailing the structural basis of IL-27 receptor activation and signaling by the IL-27 cytokine. The study further elucidated SRF388 binding properties to IL-27 to prevent interaction with the IL-27 receptor, inhibiting the cytokine’s signaling activity and providing structural evidence for SRF388’s potent antagonistic properties.
Selected Anticipated Near-term Corporate Milestones
- In the first half of 2023, Surface expects to present updated clinical data from the ongoing Phase 2 trials investigating SRF388 in liver and lung cancer.
- Initial safety and efficacy data from the ongoing SRF114 Phase 1/2 clinical study are anticipated in 2024.
Research and development (R&D) expenses were
General and administrative (G&A) expenses were
For the fourth quarter ended
Based upon its current operating plan and recent cost savings initiatives, Surface now projects it has cash runway into the third quarter of 2024.
SRF388 is a fully human anti-IL-27 antibody designed to inhibit the activity of this immunosuppressive cytokine.
SRF114 is a fully human, afucosylated anti-CCR8 antibody designed to preferentially deplete CCR8+ Treg cells within the tumor microenvironment. In preclinical studies,
Cautionary Note Regarding Forward-Looking Statements
Certain statements set forth in this press release constitute “forward-looking” statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements can be identified by terms such as “believes,” “expects,” “plans,” “potential,” “would” or similar expressions, and the negative of those terms. These forward-looking statements are based on Surface Oncology’s management’s current beliefs and assumptions about future events and on information currently available to management.
Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Surface Oncology’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks include, but are not limited to, risks and uncertainties related to Surface Oncology’s ability to successfully develop SRF388, SRF114 and its other product candidates through current and future milestones or regulatory filings on the anticipated timeline, if at all, the therapeutic potential of Surface Oncology’s product candidates, the risk that results from preclinical studies or early clinical trials may not be representative of larger clinical trials, the risk that Surface Oncology’s product candidates, including SRF388, SRF617 and SRF114, will not be successfully developed or commercialized either by
Selected Financial Information
(In thousands, except share and per share amounts)
|Three Months Ended
||Twelve Months Ended
|Statement of Operations Items||2022||2021||2022||2021|
|Research and development||15,288||16,323||67,003||53,572|
|General and administrative||5,896||7,205||24,866||25,128|
|Total operating expenses||21,184||23,528||91,869||78,700|
|Loss from operations||(21,184||)||(23,374||)||(61,869||)||(76,013||)|
|Interest and other expense, net||(149||)||(676||)||(1,717||)||(2,472||)|
|Net loss per share - basic and diluted||$||(0.35||)||$||(0.52||)||$||(1.14||)||$||(1.77||)|
|Weighted average common shares outstanding - basic and diluted||60,562,603||46,419,124||55,761,386||44,243,317|
|Selected Balance Sheet Items:|
|Cash, cash equivalents and marketable securities||$||124,823||$||154,149|
|Accounts payable and accrued expenses||10,470||14,639|
|Total stockholders’ equity||93,403||118,900|
Source: Surface Oncology, Inc.