Eliot Forster, F-star Therapeutics CEO (F-star)

F-star's Eliot Forster maps a short­cut to Wall Street, bag­ging more cash to fu­el on­col­o­gy pipeline work

F-star Ther­a­peu­tics has found a short cut to Wall Street, work­ing out a re­verse deal with the strug­gling Spring Bank Phar­ma­ceu­ti­cals that of­fers new av­enues to land­ing more in­vestor cash.

Spring Bank’s stock plum­met­ed last De­cem­ber when the phar­ma en­coun­tered safe­ty prob­lems dur­ing a Phase IIb tri­al of its he­pati­tis B drug, ina­ri­givir so­prox­il, high­light­ed by a pa­tient death. It stopped ad­min­is­ter­ing dos­es when three pa­tients de­vel­oped “he­pa­to­cel­lu­lar dys­func­tion and an el­e­va­tion of ala­nine transam­i­nase (ALT) po­ten­tial­ly con­sis­tent with liv­er in­jury rather than im­mune flares,” and even­tu­al­ly scrapped the pro­gram al­to­geth­er while shift­ing fo­cus to an ear­ly-stage STING pro­gram.

The biotech’s tra­vails, though, are F-star’s op­por­tu­ni­ty. New F-star CEO Eliot Forster, a promi­nent UK biotech ex­ec who had run Im­muno­core for awhile, has been point­ing the com­pa­ny to its in-house on­col­o­gy R&D work af­ter his pre­de­ces­sor struck a string of im­pres­sive li­cens­ing deals.

Mar­tin Driscoll

“Our ob­jec­tive was to cre­ate a strate­gic com­bo that would yield a stronger com­pa­ny with the po­ten­tial to cre­ate med­i­cines for pa­tients with can­cer while in­creas­ing share­hold­er val­ue,” said Spring Bank CEO Mar­tin Driscoll in a call with an­a­lysts Thurs­day morn­ing.

Un­der the de­fin­i­tive share ex­change agree­ment, pend­ing stock­hold­er ap­proval, Spring Bank would ac­quire all of F-star’s out­stand­ing share cap­i­tal in re­turn for shares of Spring Bank. The com­bined com­pa­ny will op­er­ate as F-star Ther­a­peu­tics, Inc., with four main drugs in the pipeline and Forster at the helm. The com­pa­nies ex­pect to close the deal with $40 mil­lion in cash, with a con­cur­rent $25 mil­lion fi­nanc­ing deal to help.

Spring Bank stock­hold­ers would re­ceive con­tin­gent val­ue rights (CVRs) re­lat­ing the phar­ma’s STING ag­o­nist, SB 11285, which is cur­rent­ly is in a Phase I/II clin­i­cal tri­al.

“The first CVR rep­re­sents the right to re­ceive a po­ten­tial fu­ture cash pay­ment of at least $1.00 per share (on a pre-re­verse split ba­sis) if the com­bined com­pa­ny con­sum­mates one or more strate­gic trans­ac­tions for SB 11285 ag­gre­gat­ing at least ap­prox­i­mate­ly $18.0 mil­lion with­in a cer­tain pe­ri­od fol­low­ing the clos­ing. The sec­ond CVR gives Spring Bank stock­hold­ers the right to re­ceive 80% of the net pro­ceeds from a po­ten­tial de­vel­op­ment agree­ment and from one or more strate­gic trans­ac­tions re­lat­ed to the STING an­tag­o­nist re­search pro­gram that are con­sum­mat­ed with­in a cer­tain pe­ri­od fol­low­ing the clos­ing of the com­bi­na­tion,” Driscoll said in a pre­pared state­ment.

Here’s what’s in the pipeline, as list­ed by the new own­ers:

  • FS118, a LAG-3/PD-L1-tar­get­ing tetrava­lent bis­pe­cif­ic an­ti­body, cur­rent­ly in Phase I de­vel­op­ment
  • FS120, a Phase I-ready dual T cell ag­o­nist tetrava­lent bis­pe­cif­ic an­ti­body tar­get­ing OX40 and CD137
  • FS222, a con­di­tion­al ag­o­nist tar­get­ing CD137 and PD-L1 ex­pect­ed to en­ter first in hu­man tri­als in the first quar­ter of 2021
  • SB 11285, a nov­el IV-ad­min­is­tered STING ag­o­nist, cur­rent­ly in a Phase I/II clin­i­cal tri­al for the treat­ment of sol­id tu­mors

Cell and Gene Con­tract Man­u­fac­tur­ers Must Em­brace Dig­i­ti­za­tion

The Cell and Gene Industry is growing at a staggering 30% CAGR and is estimated to reach $14B by 20251. A number of cell, gene and stem cell therapy sponsors currently have novel drug substances and products and many rely on Contract Development Manufacturing Organizations (CDMO) to produce them with adherence to stringent regulatory cGMP conditions. Cell and gene manufacturing for both autologous (one to one) and allogenic (one to many) treatments face difficult issues such as: a complex supply chain, variability on patient and cellular level, cell expansion count and a tight scheduling of lot disposition process. This complexity affects quality, compliance and accountability in the entire vein-to-vein process for critically ill patients.

Phase III read­outs spell dis­as­ter for Genen­tech’s lead IBD drug

Roche had big plans for etrolizumab. Eyeing a hyper-competitive IBD and Crohn’s market where they have not historically been a player, the company rolled out 8 different Phase III trials, testing the antibody for two different uses across a range of different patient groups.

On Monday, Roche released results for 4 of those studies, and they mark a decided setback for both the Swiss pharma and their biotech sub Genentech, potentially spelling an end to a drug they put over half-a-decade and millions of dollars behind.

Warren Huff, Reata CEO

Rea­ta sug­gests Friedre­ich's atax­ia pro­gram could be de­layed, send­ing stock plung­ing

Reata Pharmaceuticals $RETA made waves last October when its drug omaveloxolone produced positive trial results in treating a rare neurological disorder, but the candidate’s path forward became much murkier Monday.

In a report of quarterly earnings, the biotech divulged that the FDA is considering delaying omaveloxolone’s NDA pending completion of a second trial. That could push back approval by at least a year given that the target population, individuals with Friedreich’s ataxia, is limited and progression of the hard-to-treat illness is notoriously slow. The Covid-19 pandemic would also hinder Reata’s ability to complete an additional trial.

Brian Stuglik, Verastem CEO

The du­velis­ib hot pota­to is tossed to a new own­er as Ve­rastem looks to re­or­ga­nize around the pipeline

When Infinity put up duvelisib for a no-money-down instant deal, the biotech was looking for a quick exit from a clinical disaster. AbbVie had walked away from their alliance after looking at how the data stacked up in a crowded field.

And while it was approvable, it wasn’t looking pretty to anyone who thought in commercial terms.

One Big Pharma’s trash, though, was seen as a biotech treasure as a deeply troubled Verastem stepped up to grab the PI3K-delta/gamma — promising to run it across the goal lines at the FDA. And they did just that, only with little to show for it.

DFC CEO Adam Boehler and Kodak CEO Jim Continenza (Kodak)

Covid-19 roundup: Cure­Vac beefs up its uni­corn IPO dreams as bil­lion­aire own­er takes this Covid-19 mR­NA play­er on a forced march to Nas­daq; Ko­dak's $765M deal is put on hold

When CureVac initially jotted down $100 million for its IPO raise a couple of weeks ago, it seemed small. The German mRNA player, after all, had jumped into a Covid-19 race that swelled the sails of Moderna and BioNTech by tens of billions. And after raising $640 million in a slate of deals, $100 million in a hot market like this seemed like a pittance in the bigger scheme of things.

Today, we got a look at a figure that probably comes closer to the game-changing number the top execs probably have in mind. Selling 15.3 million shares at the high end of their $14 to $16 range would net a $243 million bounty. Majority owner Dietmar Hopp is putting in another €100 million, bringing the total to around $350 million. And what are the chances they want to do even better than that?

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Eric Shaff (Seres)

UP­DAT­ED: Af­ter a 4-year so­journ, strug­gling mi­cro­bio­me pi­o­neer Seres claims a break­out PhI­II come­back. And shares re­spond in fren­zied spike

Almost exactly 4 years ago, Seres Therapeutics $MCRB experienced one of those soul-crunching failures that can raise big questions about a biotech’s future. Out front in their pursuit of a gut punch to C. difficile infection (CDI), the Phase II test was a flat failure, and investors wiped out a billion dollars of equity value that never returned in the years that followed.

Seres, though, pressed ahead, changing out CEOs a year ago — bidding Merck vet Roger Pomerantz farewell from the C suite — and pushing through a Phase III, hoping that amping up the dosage would make the key difference. And this morning, they unveiled a claim that they had aced the Phase III and positioned themselves for a run at a landmark FDA OK.

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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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Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen scores a pri­or­i­ty re­view for its Alzheimer's drug ad­u­canum­ab, mov­ing one gi­ant leap for­ward in its con­tro­ver­sial quest

Biogen scored a big win at the FDA today as regulators accepted their application for the controversial Alzheimer’s drug aducanumab and gave it a priority review.

The PDUFA date is March 7, 2021.

Significantly, Biogen says it did not use its priority review voucher to win special treatment at the FDA. The agency handed that out gratis.

That’s the ideal scenario Biogen was looking for as disappointed analysts wondered aloud about the delayed application earlier in the year.

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Vi­da Ven­tures co-leads Dyne's $115M megaround for next-gen oli­go ther­a­pies aimed square­ly at mus­cles

Dyne Therapeutics started out last April with a modest $50 million to mine targeted muscle disease therapies from its in-house conjugate technology. The biotech has now convinced more investors that it’s got gems on its hands, closing $115 million in fresh financing to push its next-gen oligonucleotide drugs into the clinic.

Vida Ventures and Surveyor Capital led the round, joined by a group of other new backers including Wellington Management Company, Logos Capital and Franklin Templeton.