Five months af­ter a huge Phase III fail­ure trig­gered mass lay­offs at the com­pa­ny, Toca­gen will sign it­self out of ex­is­tence.

Paul Wag­n­er

The biotech, once fo­cused on brain can­cer, an­nounced it has signed a re­verse merg­er agree­ment with Forte Bio­sciences, a biotech tack­ling atopic der­mati­tis and oth­er in­flam­ma­to­ry skin dis­eases. Toca­gen’s stock shot up 85% on the news, al­though that on­ly trans­lat­ed to a 41-cent bump for a com­pa­ny that saw the last of its val­ue go poof in Sep­tem­ber. The new com­pa­ny will trade un­der the tick­er $FBRX.

Just two years ago, Toca­gen went pub­lic and raised $85 mil­lion on the promise of a two-part ther­a­py for glioblas­toma. Part 1 used a vec­tor to at­tack can­cer cells and de­liv­er the gene for an en­zyme and Part 2 was a pro­drug that con­verts in­to an an­ti-can­cer drug. It was an in­trigu­ing ap­proach to a dead­ly in­di­ca­tion that has evad­ed most pre­vi­ous at­tempts, but in Sep­tem­ber, in its biggest test, the two-part ther­a­py showed all but no signs of work­ing.

In fact, pa­tients on the con­trol arm lived a month longer on av­er­age than pa­tients on the drug arm, 12.2 vs 11.1. That com­put­ed to a haz­ard ra­tio of 1.06 and a p-val­ue of 0.62. The com­pa­ny’s stock dropped 81% on the an­nounce­ment, and a month lat­er they cut 65% of their work­force, leav­ing the San Diego-based biotech with just 30 em­ploy­ees.

There is lit­tle read­i­ly avail­able pub­lic in­for­ma­tion on Forte Bio­sciences – there is no ap­par­ent web­site – but they now have some high-pro­file back­ers. When the merg­er clos­es, an in­vestor syn­di­cate led by Al­ger, BVF Part­ners and Or­biMed will in­vest $14 mil­lion, the com­pa­ny said. They said that will bring their to­tal amount raised to $25 mil­lion. They were found­ed in 2017 and soon af­ter be­gan look­ing for an ini­tial $10.6 mil­lion fund­ing round, ac­cord­ing to an SEC doc­u­ment, and are led by Paul Wag­n­er, the for­mer chief busi­ness of­fi­cer at CAN­bridge Life Sci­ences.

The com­pa­ny said their lead as­set is FB-401, a top­i­cal drug for an in­flam­ma­to­ry skin dis­ease that showed “sig­nif­i­cant ef­fi­ca­cy” in a Phase I/II tri­al, the re­sults of which will be sub­mit­ted to a peer-re­viewed jour­nal in mid-2020. A Phase II on atopic der­mati­tis pa­tients is sched­uled to be­gin in mid-2020, with a read­out in mid-2021.

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.

Gilead is mounting its counterfeit drug lawsuit, naming two “kingpins” and a complex network of conspirators who allegedly sold imitation bottles of its HIV meds, some of which ended up in US pharmacies.

The pharma giant on Wednesday provided an update on what it called a “large-scale, sophisticated counterfeiting conspiracy,” accusing two new defendants of “leading and orchestrating” a scheme to sell hundreds of millions of dollars in illegitimate drugs posing as meds such as Biktarvy and Descovy.

The US government is all set to buy $10.7 million worth of Siga Technologies’ monkeypox oral antiviral, the company announced Thursday.

Of the total doses, $5.1 million worth of oral antivirals called Tpoxx (tecovirimat) will be delivered this year, with the US Department of Defense having the option of buying the rest at a later point.

The new contract follows an earlier one in which the government had purchased $7.4 million worth of Tpoxx from the company.

While it is not uncommon for a biotech to go down the route of having the product manufactured by a contract organization, one small biotech is looking to keep its card close to its chest.

Vor Biopharma has started manufacturing operations at an in-house facility at its HQ in Cambridge, MA after beginning construction last summer.

According to the biotech, the facility aims to develop Vor’s hematopoietic stem cells (eHSCs) and CAR-T therapies for patients with blood cancers. The site will initially manufacture a clinical supply of its candidate VCAR33allo to support its IND, which is slated to be submitted in the first half of next year. It also plans to transfer the production of VOR33 to the facility. Vor is getting to work quickly as engineering runs for VCAR33allo has started this week.