OncoSec Slashes Headcount by Almost Half, Goes All-In on Lead Candidate
Cancer immunotherapy biotech OncoSec Medical Inc. will lay off around 45% of its workforce to focus its resources on the development of its lead asset, TAVO-EP (tavokinogene telseplasmid), the company announced Tuesday.
The pipeline prioritization move will help OncoSec minimize operating expenses. Employees that will remain with the company will prioritize the pipeline activities of TAVO-EP in melanoma, working toward an upcoming data milestone of the KEYNOTE-695 trial. Downsizing will also extend the company’s cash runway.
Initial readout for objective response rate (ORR) as assessed by the investigator, a KEYNOTE-695 secondary endpoint, is expected later this year. Top-line data for ORR determined by blinded independent central review (BICR) will come out early next year.
In a statement, company CEO Robert H. Arch, Ph.D. said that after a review of OncoSec’s technology and pipeline, he deemed it best to restructure the company’s operations and refocus its plans, allowing OncoSec to accelerate the clinical development and assessment of TAVO-EP.
The company will provide a more thorough financial summary, including details about the implications of its restructuring, later in October via a Form 10-K.
With more than 150 patients enrolled, KEYNOTE-695 is a non-comparative, open-label and single-arm study of TAVO-EP with intravenous Keytruda (pembrolizumab). The intervention is being tested against locally advanced or metastatic melanoma, with a primary endpoint of ORR by BICR.
AVO-EP is a plasmid that encodes for IL-12, which is delivered directly into the tumor through electroporation. Once inside, TAVO-EP induces the expression of pro-inflammatory cytokine IL-12 in the tumor’s direct vicinity, which in turn can recruit the immune system to attack the cancer cells.
Through this mode of action, TAVO-EP has been postulated to enhance the effects of anti-PD-1 drugs, and could even convert non-responders to responders.
From Launch to Layoffs
In 2018, OncoSec launched a Phase II clinical trial called KEYNOTE-890, which assessed TAVO-EP in combination with Merck’s blockbuster anti-PD-1 drug Keytruda for the treatment of late-stage and triple-negative breast cancer.
Two years later, in June 2020, based on positive data, tumor regression and clinical response to the active intervention, OncoSec expanded KEYNOTE-890, adding another cohort of patients with metastatic triple-negative breast cancer. The TAVO-EP/Keytruda combo was tested as a first-line treatment in these patients.
In July 2021, OncoSec inked a deal with Merck for a pivotal and global Phase III study dubbed Keynote-C87. The trial is meant to evaluate TAVO-EP plus Keytruda in metastatic melanoma patients refractory to immune checkpoint therapy, with standard chemotherapy as the reference. Findings from KEYNOTE-C87 are meant to support accelerated FDA approval.
Aside from Keytruda, OncoSec also launched another Phase II study of TAVO-EP in 2020, assessing its efficacy as a neoadjuvant intervention for melanoma in combination with BMS’s anti-PD-1 checkpoint inhibitor Opdivo (nivolumab). The trial included only patients with operable, locally or regionally advanced malignancies and was designed to see if TAVO-EP could boost Opdivo’s published anti-tumor response.