Say good­bye to Toca­gen, strug­gling brain can­cer biotech to re­verse merge with Forte Bio­sciences

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.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Dave Lennon, former president of Novartis Gene Therapies

Zol­gens­ma patent spat brews be­tween No­var­tis and Re­genxbio as top No­var­tis gene ther­a­py ex­ec de­parts

Regenxbio, a small licensor of gene therapy viral vectors spun out from the University of Pennsylvania, is now finding itself in the middle of some major league patent fights.

In addition to a patent suit with Sarepta Therapeutics from last September, Novartis, is now trying to push its smaller partner out of the way. The Swiss biopharma licensed Regenxbio’s AAV9 vector for its $2.1 million spinal muscular atrophy therapy Zolgensma.

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Ex­elix­is pulls a sur­prise win in thy­roid can­cer just days ahead of fi­nal Cabome­tyx read­out

Exelixis added a thyroid cancer indication to its super-seller Cabometyx’s label on Friday — months before the FDA was expected to make a decision, and days before the company was set to unveil the final data at #ESMO21.

At a median follow-up of 10.1 months, differentiated thyroid cancer patients treated with Cabometyx (cabozantinib) lived a median of 11 months without their disease worsening, compared to just 1.9 months for patients given a placebo, Exelixis said on Monday.

Volker Wagner (L) and Jeff Legos

As Bay­er, No­var­tis stack up their ra­dio­phar­ma­ceu­ti­cal da­ta at #ES­MO21, a key de­bate takes shape

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

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Rafaèle Tordjman (Jeito Capital)

Con­ti­nu­ity and di­ver­si­ty: Rafaèle Tord­j­man's women-led VC firm tops out first fund at $630M

For a first-time fund, Jeito Capital talks a lot about continuity.

Rafaèle Tordjman had spotlighted that concept ever since she started building the firm in 2018, promising to go the extra mile(s) with biotech entrepreneurs while pushing them to reach patients faster.

Coincidentally, the lack of continuity was one of the sore spots listed in a report about the European healthcare sector published that same year by the European Investment Bank — whose fund is one of the LPs, alongside the American pension fund Teacher Retirement System of Texas and Singapore’s Temasek, to help Jeito close its first fund at $630 million (€534 million). As previously reported, Sanofi had chimed in €50 million, marking its first investment in a French life sciences fund.

Mi­rati tri­umphs again in KRAS-mu­tat­ed lung can­cer with a close­ly watched FDA fil­ing now in the cards

After a busy weekend at #ESMO21, which included a big readout for its KRAS drug adagrasib in colon cancer, Mirati Therapeutics is ready to keep the pressure on competitor Amgen with lung cancer data that will undergird an upcoming filing.

In topline results from a Phase II cohort of its KRYSTAL-1 study, adagrasib posted a response rate of 43% in second-line-or-later patients with metastatic non-small cell lung cancer containing a KRAS-G12C mutation, Mirati said Monday.

Den­mark's Gubra to col­lab­o­rate with Bay­er on pep­tides; Sam­sung and Bio­gen re­ceive FDA ap­proval for Lu­cen­tis biosim­i­lar

Danish biotech Gubra announced a research collaboration and license agreement with Bayer to develop peptide therapeutics to treat cardiorenal diseases. The collaboration will utilize Gubra’s peptide drug discovery platform to identify potential candidates.

This is not the first time Gubra has partnered with a company on peptide therapeutics — they partnered with Boehringer Ingelheim back in 2017 to create peptide therapeutics to treat obesity.