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.

Ryan Watts, Denali CEO

Bio­gen hands De­nali $1B-plus in cash, $1B-plus in mile­stones to part­ner on late-stage Parkin­son’s drug

Biogen is handing over more than a billion dollars cash to partner with the up-and-coming neurosciences crew at Denali on a new therapy for Parkinson’s. And the big biotech is ready to pile on more than a billion dollars more in milestones — if the alliance is a success.

For Biogen $BIIB, the move on Denali’s small molecule inhibitors of LRRK2 puts them in line to collaborate on a late-stage program for DNL151, which is scheduled to start next year.

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Ab­b­Vie aban­dons a pi­o­neer­ing CRISPR R&D al­liance with Ed­i­tas as Brent Saun­der­s' deal is cast out

A little more than 3 years ago Allergan paid $90 million in a cash upfront to partner with gene editing player Editas on a CRISPR alliance focused on the eye. The lead program centered on LCA10, a rare, inherited retinal degenerative disease that appears in childhood and leads to blindness.

Allergan then went to AbbVie $ABBV in a buyout, and the pharma giant has no interest in moving forward on the gene editing front. The company punted it all back to Editas Thursday, with the biotech $EDIT noting in a statement after the market closed Thursday that it is regaining all rights for its ocular medicines, including EDIT-101.

President Trump speaks with members of the media before boarding Marine One (AP Images)

'Oc­to­ber is com­ing,' and every­one still wants to know if a Covid-19 vac­cine will be whisked through the FDA ahead of the elec­tion

Right on the heels of a lengthy assurance from FDA commissioner Stephen Hahn that the agency will not rush through a quick approval for a Covid-19 vaccine, the President of the United States has some thoughts on timing he’d like to share.

In an exchange with Fox News’ Geraldo Rivera on Thursday, President Trump allowed that a vaccine could be ready to roll “sooner than the end of the year, could be much sooner.”

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Yvonne Greenstreet, incoming Alnylam president (Alnylam)

Al­ny­lam pres­i­dent Bar­ry Greene leaves af­ter 17 years, hand­ing po­si­tion over to Yvonne Green­street as biotech looks to­ward prof­itabil­i­ty

After 17 years helping Alnylam steer control of buzzy but unproven science they promised could change medicine, president Barry Greene is leaving the RNAi biotech just as that technology is beginning to hit prime time.

Leaving to “pursue outside interests in the biopharmaceutical industry,” the longtime executive will hand over the reins on October 1 to current COO Yvonne Greenstreet. Greenstreet, a former Pfizer and GlaxoSmithKline executive, inherits the high-profile spot at a company that’s proven its tech can work in rare diseases but now faces the daunting task of turning a couple successes and a new mountain of cash into drugs that are broadly applicable and, crucially, profitable.

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Covid-19 roundup: 34 AGs call for ‘march-in’ rights on remde­sivir; Hahn pleads with pub­lic to trust FDA's vac­cine re­view

A bipartisan group of 34 attorneys general have asked the federal government to bypass Gilead’s patent rights on remdesivir and begin scaling and distributing the Covid-19 antiviral, or to allow the states to do it themselves.

In a letter to HHS secretary Alex Azar, the AGs expressed frustrations over the $3,250 price tag Gilead placed on the the drug, citing the federal funding that went into its developments. And they noted the sustained difficulties hospitals have faced in getting supplies from either the California biotech or their contract manufacturer AmerisourceBergen.

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Douglas Fambrough, Dicerna CEO (Boehringer Ingelheim via YouTube)

Roche-backed Dicer­na push­es in­to the pack rac­ing to­ward the block­buster hep B goal line, armed with PhI da­ta

Dicerna has lined up a set of proof-of-concept data from a small cohort of hepatitis B patients in a match-up against some heavyweight rivals which got out in front of this race. And right in the front row you’ll find a team from Roche, which paid $200 million in cash and offered another $1.5 billion in milestones to partner with Dicerna $DRNA on their RNAi program for hep B.

Right now it’s looking competitive, with lots of big challenges ahead.

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UP­DAT­ED: No­vavax her­alds the lat­est pos­i­tive snap­shot of ear­ly-stage Covid-19 vac­cine — so why did its stock briefly crater?

High-flying Novavax $NVAX became the latest of the Covid-19 vaccine players to stake out a positive set of biomarker data from its early-stage look at its vaccine in humans.

Their adjuvanted Covid-19 vaccine was “well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera,” the company noted. According to the biotech:

All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease. Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional.

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Jan Hatzius (Photographer: Christopher Goodney/Bloomberg via Getty Images)

When will it end? Gold­man econ­o­mist gives late-stage vac­cines a good shot at tar­get­ing 'large shares' of the US by mid-2021 — but the down­side is daunt­ing

It took decades for hepatitis B research to deliver a slate of late-stage candidates capable of reining the disease in.

With Covid-19, the same timeline has devoured all of 5 months. And the outcome will influence the lives of billions of people and a multitrillion-dollar world economy.

Count the economists at Goldman Sachs as optimistic that at least one of these leading vaccines will stay on this furiously accelerated pace and get over the regulatory goal line before the end of this year, with a shot at several more near-term OKs. That in turn should lead to the production of billions of doses of vaccines that can create herd immunity in the US by the middle of next year, with Europe following a few months later.

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J&J gets a fresh OK for es­ke­t­a­mine, but is it re­al­ly the game-chang­er for de­pres­sion Trump keeps tweet­ing about?

Backed by an enthusiastic set of tweets from President Trump and a landmark OK for depression, J&J scooped up a new approval from the FDA for Spravato today. But this latest advance will likely bring fresh scrutiny to a drug that’s spurred some serious questions about the data, as well as the price.

First, the approval.

Regulators stamped their OK on the use of Spravato — developed as esketamine, a nasal spray version of the party drug Special K or ketamine — for patients suffering from major depressive disorder with acute suicidal ideation or behavior.

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