On May 30, 2018 Symphogen, a private clinical late-stage antibody oncology focused biopharmaceutical company with a novel and differentiated antibody mixture pipeline, reported that it has enrolled the first patients into two separate Phase 1 clinical trials with two new investigational antibody therapies discovered from its immuno-oncology (I-O) activities with Shire targeting LAG3 (Sym022) and TIM3 (Sym023) (Press release, Symphogen, MAY 30, 2018, View Source [SID1234527007]).
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These are the second and third clinical programs to have been initiated under the I-O activities, the first being a Phase 1 trial of Sym021, an anti-PD1 antibody discovered by Symphogen, for solid tumors or lymphomas. All three I-O programs result from Symphogen’s antibody discovery and development activities under a strategic agreement with Shire plc established in 2016.
The Phase 1 clinical trials for each of these investigational therapies are open-label, dose-escalation studies designed to evaluate the preliminary safety and tolerability of the monotherapies in patients with locally advanced/unresectable or metastatic solid tumors or lymphomas that are refractory to available therapy or for which no standard therapy is available (Sym021: NCT03311412; Sym022: NCT03489369; Sym023: NCT03489343). Data is expected to be available in early 2019.
Commenting on the announcement, Chief Executive Officer of Symphogen, Martin Olin, said:
"We are excited about these important additions to our clinical pipeline. Our ability to advance three important immune checkpoint inhibitors into clinical development within a short period of time further validates the quality and the productivity of our antibody platform to rapidly generate unique antibody therapeutics that may enable new and improved treatment options for cancer patients. We now have seven product candidates in clinical development targeting important unmet medical needs demonstrating the potential significant value of our antibody platform. Our agreement with Shire provides the opportunity to bring next generation immunotherapies to patients for the treatment of cancer that could potentially be used in combination."
About the I-O programs
Symphogen’s research and development activities in the I-O area are focused on employing its antibody discovery and screening methodology against a number of targets demonstrated to be involved in cancer development and progression via negative regulation of the immune system, such as immune checkpoints found on immune cells. PD1, LAG3 and TIM3 are immune checkpoints playing important roles in regulating immune responses, including the body’s immune response to tumor cells (NEJM 2015; 2006-17, NEJM 2015; 372, 2509-20 and Nat Rev Drug Discovery 14; 561-584; 2015).
Sym021 is a novel, high affinity, chicken-derived, humanized antibody against PD1 with promising anti-cancer potential demonstrated in mouse tumor models. Sym022 is a novel antibody against LAG3, which shows enhanced anti-cancer activity in combination with anti-PD1 antibody therapy. Sym023 is an anti-TIM3 antibody with a novel mode of action.
Preclinical data for Sym021, Sym022 and Sym023 were presented at the recent American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2018 (Sym021: Abstract #3822; Sym022: Abstract #5626; Sym023: Abstract #5629).