Tocagen said it is eliminating about two-thirds of its staff—approximately 50 employees—nearly a month after the company acknowledged the failure of its lead candidate, the combination of Toca 511 (vocimagene amiretrorepvec) and Toca FC, in a Phase III trial in patients with recurrent high grade glioma (HGG) undergoing resection.
Tocagen said it would restructure its staff and operations, retaining approximately 30 people—compared with the 79 full-time employees it reported as of December 31, 2018, according to its Form 10-K annual report for last year, filed February 27. Form 10-K annual report
“We have an extraordinary team at Tocagen, which makes this an extremely difficult decision, and we are deeply grateful for the contributions that all of our employees have made to the advancement of our founding vision that No One Should Die Of Cancer,” Tocagen CEO Marty Duvall said yesterday in a statement.
Of the 79 employees Tocagen reported in its annual filing, 63 employees were engaged in R&D and the remainder, in “finance and general management activities including accounting, contracts, human resources, information technology, investor relations, marketing and business development.”
Duvall said the restructuring would extend Tocagen’s cash position, allowing the company to move forward.
“Our immediate priorities are to complete the analysis of the Toca 5 trial data, present the results thereof at the upcoming Society for Neuro-Oncology [24th] Annual Meeting [and Education Day, set for November 20-24 in Phoenix], and interact with the regulatory agencies to determine potential next steps for Toca 511 & Toca FC in recurrent high grade glioma,” Duvall added.
In a regulatory filing yesterday, Tocagen estimated it will incur a one-time personnel-related restructuring charges of approximately $1 million for employee severance and other related termination benefits, with the severance payments expected to be paid in full by year’s end.
Toca 511/Toca FC is a two-part cancer immunotherapy. Toca 511 is an injectable retroviral replicating vector (RRV) that encodes a prodrug activator enzyme, cytosine deaminase (CD). Toca FC is an oral extended-release formulation of the prodrug 5-fluorocytosine (5-FC), which is converted into 5-fluorouracil (5-FU), when it encounters CD.
“Up and Coming”
The combination was among “25 Up and Coming Gene Therapies of 2019” highlighted in a GEN A-List published on May 20. The list included “up-and-coming” gene-therapy candidates that have reached Phase III and/or registrational trials as of the first quarter of 2019, based on figures from the Alliance for Regenerative Medicine (ARM), as well as ClinicalTrials.gov and/or company announcements.
On September 12, Tocagen acknowledged the failure of Toca 511 and Toca FC in Toca 511 & Toca FC in the Phase III portion of the Toca 5 trial (NCT02414165). The combination immunotherapy missed the primary endpoint of overall survival compared to standard of care treatment (11.1 months median compared to 12.2 months). All secondary endpoints showed no meaningful difference between the arms of the trial, the company added.
Toca 511 and Toca FC remain under study in a Phase II/III trial for patients newly diagnosed with glioblastoma, sponsored by the NCI and conducted by NRG Oncology (NCT04105374), and a Phase I trial in patients with non-muscle invasive bladder cancer, with a cohort expansion planned at the recommended Phase II dose (NCT04089163). However, both trials are not yet recruiting patients, according to ClinicalTrials.gov.
In addition to Toca 511 and Toca FC, Tocagen’s pipeline includes the Phase II candidate NRG-BN006, being developed in collaboration with NRG Oncology for newly diagnosed glioblastoma; Toca 6 for advanced solid tumors (CRC, pancreatic, sarcoma & lung); Toca 8 for recurrent high grade non-muscle invasive bladder cancer; and several discovery-phase oncology gene therapies.