Adrian Gottschalk, Foghorn CEO (Foghorn)

Foghorn hits Nas­daq in $120M de­but as the biotech IPO boom shows no sign of slow­ing

It’s been a record year for biotech IPOs, and the ex­ecs at Nas­daq would like noth­ing bet­ter than to see that mo­men­tum con­tin­ue in­to the first half of next year.

Since Jan­u­ary, 72 biotech and bio­phar­ma com­pa­nies have hit Wall Street, ac­cord­ing to Nas­daq head of health­care list­ings Jor­dan Saxe, to­geth­er rais­ing $13.2 bil­lion.

Jor­dan Saxe

The lat­est is Flag­ship’s Foghorn Ther­a­peu­tics, which priced its shares last night at $16 apiece, the mid­point of a $15 to $17 range. The Cam­bridge, MA-based biotech — which ini­tial­ly filed for a $100 mil­lion raise on Oct. 2 — is net­ting $120 mil­lion from a 7.5 mil­lion-share of­fer­ing. The pro­ceeds will go right in­to its gene traf­fic con­trol plat­form, in­clud­ing two lead pre­clin­i­cal on­col­o­gy can­di­dates.

Foghorn was found­ed in 2016 by Dana-Far­ber re­searcher Cigall Kadoch, and has since blown through $123 mil­lion, ac­cord­ing to its S-1/A fil­ing. When Bris­tol My­ers Squibb vet Carl De­ci­c­co joined as CSO in 2018, one of his first or­ders of busi­ness was pick­ing the pro­grams to prep for clin­i­cal tri­als, with a goal of hit­ting the clin­ic by 2020.

Cigall Kadoch

Foghorn is fo­cused on drug­ging tar­gets in the chro­matin reg­u­la­to­ry sys­tem — the sys­tem that con­trols the move­ment of mol­e­cules that turn genes “on” and “off,” ac­cord­ing to the com­pa­ny. An IND could be com­ing for its lead can­di­date, an al­losteric AT­Pase in­hibitor dubbed FHD-286, in AML and uveal melanoma lat­er this year, ac­cord­ing to the S-1/A. About $35 mil­lion from the IPO raise will sup­port that pro­gram.

An­oth­er $20 mil­lion is go­ing in­to the biotech’s hema­to­log­ic can­cer and sol­id tu­mors can­di­date, FHD-609, for which it ex­pects to sub­mit an IND in the first half of 2021.

Flag­ship owns 35.09% of Foghorn’s shares, ac­cord­ing to the S-1/A. Kadoch holds 11.09% of shares, and CEO Adri­an Gottschalk has a 2.56% slice of the pie.

Carl De­ci­c­co

Back in Ju­ly, Mer­ck inked a $425 mil­lion deal to es­sen­tial­ly li­cense one of the fac­tors Foghorn had just be­gun test­ing, buy­ing ex­clu­siv­i­ty on any po­ten­tial drugs that emerge to tar­get it. “I think this bi­ol­o­gy has been un­ex­plored and un­ex­ploit­ed as a drug, and I think the time is right,” Gottschalk said at the time.

This year’s biotech IPO tal­ly far sur­pass­es the 47 tracked last year by Brad Lon­car. Saxe told End­points News last month that a va­ri­ety of fac­tors, in­clud­ing the Covid-19 pan­dem­ic, have cre­at­ed the “per­fect storm” for an IPO boom. He and his team have been in talks with mul­ti­ple com­pa­nies prep­ping for an IPO at the end of this year or ear­ly next year, he said.

Round­ing out the year with 75 IPOs and just un­der $14 bil­lion in pro­ceeds would be a “fair es­ti­mate,” he said on Fri­day.

Adap­tive De­sign Meth­ods Of­fer Rapid, Seam­less Tran­si­tion Be­tween Study Phas­es in Rare Can­cer Tri­als

Rare cancers account for 22 percent of cancer diagnoses worldwide, yet there is no universally accepted definition for a “rare” cancer. Moreover, with the evolution of genomics and associated changes in categorizing tumors, some common cancers are now characterized into groups of rare cancers, each with a unique implication for patient management and therapy.

Adaptive designs, which allow for prospectively planned modifications to study design based on accumulating data from subjects in the trial, can be used to optimize rare oncology trials (see Figure 1). Adaptive design studies may include multiple cohorts and multiple tumor types. In addition, numerous adaptation methods may be used in a single trial and may facilitate a more rapid, seamless transition between study phases.

Matt Gline (L) and Pete Salzmann

UP­DAT­ED: Roivant bumps stake in Im­muno­vant with a $200M deal. But with M&A off the ta­ble, shares crater

Roivant has worked out a deal to pick up a chunk of stock in its majority-owned sub Immunovant $IMVT, but the stock buy falls far short of its much-discussed thoughts about buying out all of the 43% of shares it doesn’t already own.

Roivant, which recently inked a SPAC move to the market at a $7 billion-plus valuation, has forged a deal to boost its ownership in Immunovant by 6.3 points, ending with 63.8% of the biotech’s stock following a $200 million injection. That cash will bolster Immunovant’s cash reserves, giving it a $600 million war chest to fund a slate of late-stage studies for its big drug: the anti-FcRn antibody IMVT-1401.

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Sanofi preps a multi­bil­lion-dol­lar buy­out of an mR­NA pi­o­neer af­ter falling be­hind in the race for a Covid-19 jab — re­port

It looks like Sanofi CEO Paul Hudson is dead serious about his intention to vault directly into contention for the future of mRNA vaccines.

A year after paying Translate Bio a whopping $425 million in an upfront and equity payment to help guide the pharma giant to the promised land of mRNA vaccines for Covid-19, Sanofi is reportedly ready to close the deal with a buyout.

Translate’s stock $TBIO soared 78% after the market closed Monday. A spokesperson for Sanofi declined to comment on the report, telling Endpoints News that the company doesn’t comment on market rumors.

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Anthony Sun, Zentalis and Zentera CEO (Zentalis)

With clin­i­cal tri­als lined up for Zen­tal­is drugs, Chi­na's Zen­tera sets its sights on more deal­mak­ing and an IPO

As Zentalis geared up for an AACR presentation of early data on its WEE1 inhibitor earlier this year, its Chinese joint venture Zentera wasn’t idle, either.

Zentera, which has headquarters in Shanghai, had already nabbed clearance to start clinical trials in China for three of the parent company’s drugs. In May — just a month after Zentalis touted three “exceptional responses” out of 55 patients for their shared lead drug, ZN-c3 — it got a fourth CTA approval.

Thomas Soloway, T-knife CEO

What hap­pens when you give a mouse a hu­man self-anti­gen? In­vestors bet $110M to find out

T-knife Therapeutics launched last August on a mission to isolate T cell receptors not from human donors, but from mice. Now, with a new CEO and a candidate bound for the clinic, the Versant-backed company is reloading with a fresh $110 million.

“What we are trying to do for the field of TCR therapy and solid tumor therapy is very analogous to what the murine platforms have done in antibody development,” CEO Thomas Soloway told Endpoints News. 

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UP­DAT­ED: Watch out Glax­o­SmithK­line: As­traZeneca's once-failed lu­pus drug is now ap­proved

Capping a roller coaster journey, AstraZeneca has steered its lupus drug anifrolumab across the finish line.

Saphnelo, as the antibody will be marketed, is the only treatment that’s been approved for systemic lupus erythematosus since GlaxoSmithKline’s Benlysta clinched an OK in 2011. The British drugmaker notes it’s also the first to target the type I interferon receptor.

Mirroring the population that the drug was tested on in late-stage trials, regulators sanctioned it for patients with moderate to severe cases who are already receiving standard therapy — setting up a launch planned for the end of August, according to Ruud Dobber, who’s in charge of AstraZeneca’s biopharmaceuticals business unit.

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Not all mR­NA vac­cines are cre­at­ed equal. Does it mat­ter?; Neu­ro is back; Pri­vate M&A af­fair; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

As part of our broader and deeper drive, Endpoints has been pairing webinars with our special reports to cover more angles on a given topic. In conjunction with Max Gelman’s neuroscience feature, Kyle Blankenship moderated an insightful panel to discuss where the field is headed. You can register to watch it on demand here.

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Bris­tol My­ers pulls lym­phoma in­di­ca­tion for Is­to­dax af­ter con­fir­ma­to­ry tri­al falls flat

Amid an industrywide review of cancer drugs with accelerated approval, Bristol Myers Squibb had to make the tough call last month to yank an approval for leading I/O drug Opdivo after flopping a confirmatory study. Now, a second Bristol Myers drug is on the chopping block.

Bristol Myers has pulled aging HDAC inhibitor Istodax’s indication in peripheral T cell lymphoma after a Phase III confirmatory study for the drug flopped on its progression-free survival endpoint, the drugmaker said Monday.

Rick Pazdur (via AACR)

FDA's on­col­o­gy head Rick Paz­dur de­fends the ac­cel­er­at­ed ap­proval path­way, claim­ing it is 'un­der at­tack'

The FDA is sounding the alarm over its accelerated approval pathway as backlash continues over the recent nod in favor of Biogen’s Alzheimer’s drug Aduhelm, and an ODAC meeting on six such approvals that could potentially be pulled from the market — two of which already have.

“Do you think accelerated approval is under attack? I do,” Rick Pazdur, head of FDA’s Oncology Center of Excellence, said at a Friends of Cancer Research webinar on Thursday.

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