Toca­gen is cir­cling the drain, fol­low­ing the crush­ing late-stage fail­ure of its ex­per­i­men­tal brain can­cer ther­a­py last month. On Thurs­day, the San Diego-based com­pa­ny slashed its work­force by 65%.

Its two-part ther­a­py was be­ing test­ed in pa­tients with re­cur­rent high-grade glioma un­der­go­ing re­sec­tion in the To­ca 5 study. On av­er­age, pa­tients on the Toca­gen reg­i­men ac­tu­al­ly did not live as long as those giv­en stan­dard treat­ment (11.1 months me­di­an com­pared to 12.2 months). In ad­di­tion, the com­pa­ny’s ther­a­py hit a haz­ard ra­tio of 1.06, re­flect­ing an in­creased risk to pa­tients, along with an un­sa­vory p-val­ue of 0.6154.

Toca­gen’s tech­nol­o­gy em­ploys retro­vi­ral repli­cat­ing vec­tors, or RRVs, which are en­gi­neered to se­lec­tive­ly de­liv­er ther­a­peu­tic genes in­to can­cer cells. The ex­per­i­men­tal brain can­cer ther­a­py in ques­tion com­bines an RRV, called To­ca 511, with an in­ves­ti­ga­tion­al small mol­e­cule, To­ca FC.

To­ca 511 is de­signed to iso­late can­cer cells and de­liv­er a gene for the en­zyme, cy­to­sine deam­i­nase (CD). On­ly in­fect­ed can­cer cells are meant to car­ry and spawn CD. When To­ca FC en­coun­ters CD, it is tai­lored to trans­form in­to the an­ti-can­cer drug 5-FU, and in turn to an­nex the tu­mor.

Fol­low­ing the lay­offs, Toca­gen — which made its pub­lic de­but in 2017 — is left with 30 em­ploy­ees. They will fo­cus on the Phase II/III tri­al of To­ca 511-To­ca FC in new­ly-di­ag­nosed glioblas­toma (HGG) pa­tients — as well as an ear­ly-stage study in blad­der can­cer.

“Giv­en the To­ca 5 miss on both pri­ma­ry and sec­ondary end­points (re­lat­ing to over­all sur­vival and dura­bil­i­ty of re­sponse, re­spec­tive­ly), we main­tain low ex­pec­ta­tions (0% POS) for the To­ca 511 & To­ca FC reg­i­men in HGG in the ab­sence of new in­for­ma­tion,” Chardan an­a­lysts wrote in a note on Thurs­day.

The com­pa­ny plans to present the com­plet­ed analy­sis of the To­ca 5 tri­al at the 2019 So­ci­ety for Neu­ro-On­col­o­gy an­nu­al meet­ing in No­vem­ber, it said.

Brain can­cer is no­to­ri­ous­ly hard to treat and re­mains the dead­liest of can­cers, de­spite decades of re­search. Tu­mors are of­ten lo­cat­ed be­yond the reach of even the most con­sum­mate neu­ro­sur­geon, and pro­tect­ed by the blood-brain bar­ri­er, there­by thwart­ing ex­po­sure to sys­temic chemother­a­py. In ad­di­tion, the par­tic­u­lar de­vel­op­men­tal, ge­net­ic, and mi­cro-en­vi­ron­men­tal ecosys­tem in the brain ren­ders tu­mors re­sis­tant to tra­di­tion­al weapons in the on­col­o­gist’s ar­ma­men­tar­i­um.

In its sec­ond quar­ter re­port — pub­lished in Au­gust — Toca­gen in­di­cat­ed it had cash, cash equiv­a­lents and mar­ketable se­cu­ri­ties of $68.3 mil­lion, as of June 30. Shares of the drug de­vel­op­er $TO­CA have been lan­guish­ing in pen­ny stock ter­ri­to­ry since its piv­otal fail­ure dis­clo­sure in Sep­tem­ber.

So­cial im­age: Shut­ter­stock

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.

A handful of CDMOs have made changes at the top over the past few weeks, including Genezen and Curia.

That also includes Australian CDMO BioCina, which announced last week that Mark Womack would be taking the helm. Womack previously served as chief business officer at AGC Biologics, CEO of Indian manufacturer Stelis Biopharma and most recently, CEO at CDMO KBI Biopharma and Selexis SA.

BioCina completed the takeover of a Pfizer manufacturing facility in Adelaide in 2021 and is now prepping for wider growth. Endpoints News sat down with Womack to discuss his new role, plans for the future, and how to compete in the wider CDMO market. This interview has been edited for brevity and clarity.