Roeland Nusse (Surrozen)

Sur­rozen re­loads with $50M for fi­nal dash to the clin­ic, shines some light on lead Wnt-mod­u­lat­ing can­di­dates

Two rounds to­talling $83 mil­lion have pro­pelled Sur­rozen through pre­clin­i­cal proof-of-con­cept, cul­mi­nat­ing in two an­ti­body can­di­dates mod­u­lat­ing the Wnt path­way for tis­sue re­gen­er­a­tion. Now, the South San Fran­cis­co biotech is top­ping up $50 mil­lion to com­plete the sprint to the clin­ic.

Craig Park­er

One of the two IND can­di­dates tar­gets liv­er dis­ease while the oth­er will be ini­tial­ly po­si­tioned for in­flam­ma­to­ry bow­el dis­ease. With the cash in­fu­sion, Sur­rozen can al­so pur­sue more dis­cov­ery projects in dif­fer­ent tis­sues and ar­eas.

“Our goal is to file IND ap­pli­ca­tions in 2021 and 2022,” CEO Craig Park­er said in a state­ment, 5 and 6 years af­ter the com­pa­ny first set out to catch and push a sec­ond wave of re­gen­er­a­tive med­i­cine.

Christo­pher Gar­cia

Christo­pher Gar­cia and Roe­land Nusse, two Stan­ford pro­fes­sors, pro­vid­ed some of the sci­en­tif­ic legs for the com­pa­ny. Aside from its role in can­cer, Wnt — a port­man­teau in­te­grat­ing Wing­less and Int-1 — sig­nal­ing is al­so key to the con­trol of cell de­vel­op­ment and re­gen­er­a­tion, but the in­sta­bil­i­ty means they are hard to man­u­fac­ture. As Nusse elu­ci­dat­ed cru­cial as­pects of Wnt bi­ol­o­gy, Gar­cia in­spired the idea to ac­ti­vate or en­hance re­sponse to en­doge­nous Wnts, through ei­ther bis­pe­cif­ic or an­ti­body-based mol­e­cules.

“While it has long been known that the Wnt sig­nal­ing path­way plays a cru­cial role in the main­te­nance and self-re­new­al of stem cells in a va­ri­ety of tis­sues, sci­en­tists had been un­able to over­come the tech­ni­cal chal­lenges in­her­ent in de­vel­op­ing a ther­a­peu­tic based on Wnt sig­nal­ing,” Nusse, the Vir­ginia and Daniel K. Lud­wig Pro­fes­sor of Can­cer Re­search and Pro­fes­sor of De­vel­op­men­tal Bi­ol­o­gy, said. “I am hope­ful that Sur­rozen’s ap­proach to mod­u­lat­ing the Wnt path­way, with the flex­i­bil­i­ty to ad­dress in­suf­fi­cient en­doge­nous Wnt or in­suf­fi­cient re­cep­tors, may some­day lead to ther­a­peu­tics that have the po­ten­tial to re­pair dam­aged tis­sue.”

Clau­dia Jan­da

Clau­dia Jan­da, a post­doc at Gar­cia’s lab who’s since moved on to the Princess Máx­i­ma Cen­ter for Pe­di­atric On­col­o­gy, re­mains a sci­en­tif­ic ad­vi­sor along­side Princess Máx­i­ma di­rec­tor Hans Clevers and Stan­ford’s Calvin Kuo.

Both tech plat­forms were rep­re­sent­ed in the lead nom­i­nat­ed can­di­dates.

Calvin Kuo

SZN-043 was de­signed on SWEETS, or Sur­rozen Wnt sig­nal en­hancers en­gi­neered for tis­sue speci­fici­ty. Through sta­bi­liz­ing the Friz­zled re­cep­tors that Wnt pro­teins sig­nal through, the com­pound was shown to stim­u­late he­pa­to­cyte pro­lif­er­a­tion in the liv­er and re­duce fi­bro­sis — some­thing that should be help­ful in con­di­tions like se­vere acute al­co­holic he­pati­tis or even cir­rho­sis.

The pos­si­bil­i­ties are al­most end­less, with Sur­rozen spelling out po­ten­tial ap­pli­ca­tions in NASH and de­com­pen­sat­ed liv­er dis­ease.

Hans Clevers

SZN-1326, mean­while, was born out of SWAP (Sur­rozen Wnt sig­nal ac­ti­vat­ing pro­teins). The mol­e­cule binds to Friz­zled re­cep­tors di­rect­ly and should stim­u­late re­gen­er­a­tion of in­testi­nal ep­ithe­lial cells. Re­searchers al­so not­ed an­ti-in­flam­ma­to­ry ef­fects in an­i­mal mod­els.

It is still a ways from hu­man da­ta. But old in­vestors are re­turn­ing to take that leap with Sur­rozen, in­clud­ing The Col­umn Group, Hart­ford Health­care Trust and Hori­zons Ven­tures. Eu­clid­i­an Cap­i­tal and three oth­er new be­liev­ers are jump­ing on board.

Regeneron CEO Leonard Schleifer speaks at a meeting with President Donald Trump, members of the Coronavirus Task Force, and pharmaceutical executives in the Cabinet Room of the White House (AP Photo/Andrew Harnik)

OWS shifts spot­light to drugs to fight Covid-19, hand­ing Re­gen­eron $450M to be­gin large scale man­u­fac­tur­ing in the US

The US government is on a spending spree. And after committing billions to vaccines defense operations are now doling out more of the big bucks through Operation Warp Speed to back a rapid flip of a drug into the market to stop Covid-19 from ravaging patients — possibly inside of 2 months.

The beneficiary this morning is Regeneron, the big biotech engaged in a frenzied race to develop an antibody cocktail called REGN-COV2 that just started a late-stage program to prove its worth in fighting the virus. BARDA and the Department of Defense are awarding Regeneron a $450 million contract to cover bulk delivery of the cocktail starting as early as late summer, with money added for fill/finish and storage activities.

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Daniel O'Day, Gilead CEO (Kevin Dietsch/UPI/Bloomberg via Getty Images)

A new study points to $6.5B in pub­lic sup­port build­ing the sci­en­tif­ic foun­da­tion of Gilead­'s remde­sivir. Should that be re­flect­ed in the price?

By drug R&D standards, Gilead’s move to repurpose remdesivir for Covid-19 and grab an emergency use authorization was a remarkably easy, low-cost layup that required modest efficacy and a clean safety profile from just a small group of patients.

The drug OK also arrived after Gilead had paid much of the freight on getting it positioned to move fast.

In a study by Fred Ledley, director of the Center for Integration of Science and Industry at Bentley University in Waltham, MA, researchers concluded that the NIH had invested only $46.5 million in the research devoted to the drug ahead of the pandemic, a small sum compared to the more than $1 billion Gilead expected to spend getting it out this year, all on top of what it had already cost in R&D expenses.

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UP­DAT­ED: Bio­gen shares spike as ex­ecs com­plete a de­layed pitch for their con­tro­ver­sial Alzheimer's drug — the next move be­longs to the FDA

Biogen is stepping out onto the high wire today, reporting that the team working on the controversial Alzheimer’s drug aducanumab has now completed their submission to the FDA. And they want the agency to bless it with a priority review that would cut the agency’s decision-making time to a mere 6 months.

The news drove a 10% spike in Biogen’s stock $BIIB ahead of the bell.

Part of that spike can be attributed to a relief rally. Biogen execs rattled backers and a host of analysts earlier in the year when they unexpectedly delayed their filing to the third quarter. That delay provoked all manner of speculation after CEO Michel Vounatsos and R&D chief Al Sandrock failed to persuade influential observers that the pandemic and other factors had slowed the timeline for filing. Actually making the pitch at least satisfies skeptics that the FDA was not likely pushing back as Biogen was pushing in. From the start, Biogen execs claimed that they were doing everything in cooperation with the FDA, saying that regulators had signaled their interest in reviewing the submission.

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Sin­gu­lar fo­cus on ROR1 earns Velos­Bio $137M to fund PhI ADC and oth­er pro­grams

Years after selling Acerta to AstraZeneca for $7 billion, largely on the promise of its BTK inhibitor, Dave Johnson has once again gathered hefty financial support behind a new cancer target.

Matrix Capital Management and Surveyor Capital are leading a $137 million round for VelosBio, which has recently begun a Phase I study for its lead antibody-drug conjugate targeted against ROR1. Johnson took up the CEO post in October 2018.

Alexander Vos, VarmX CEO

'Fun­da­men­tal­ly dif­fer­en­t' from Por­to­la, Dutch biotech lands €32M to steer an­ti-an­ti­co­ag­u­lant through the clin­ic

Portola may not have had much success proving the commercial value of an anti-anticoagulant, but that’s not stopping European investors from pouring $36.2 million (€32 million) into what they see as a superior approach put forth by a Dutch biotech.

VarmX’s blood thinner reversal agent stems from research done by founder and CSO Pieter Reitsma at Leiden University Medical Center. A modified recombinant form of factor X, VMX-C001 “has an insertion of 16 amino acids that replaces a stretch of 7 amino acids in the so-called serine protease domain” compared to the native coagulation factor, CEO Alexander Vos told Endpoints News.

FDA bars the door — for now — against Mer­ck’s star can­cer drug af­ter Roche beat them to the punch

Merck has been handed a rare setback at the FDA.

After filing for the accelerated approval of a combination of their star PD-1 drug Keytruda with Eisai’s Lenvima as a first-line treatment for unresectable hepatocellular carcinoma, the FDA nixed the move, handing out a CRL because Roche beat them to the punch on the same indication by a matter of weeks.

According to Merck:

Ahead of the Prescription Drug User Fee Act action dates of Merck’s and Eisai’s applications, another combination therapy was approved based on a randomized, controlled trial that demonstrated overall survival. Consequently, the CRL stated that Merck’s and Eisai’s applications do not provide evidence that Keytruda in combination with Lenvima represents a meaningful advantage over available therapies for the treatment of unresectable or metastatic HCC with no prior systemic therapy for advanced disease. Since the applications for KEYNOTE-524/Study 116 no longer meet the criteria for accelerated approval, both companies plan to work with the FDA to take appropriate next steps, which include conducting a well-controlled clinical trial that demonstrates substantial evidence of effectiveness and the clinical benefit of the combination.

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Covid-19 roundup: Mod­er­na sticks to Ju­ly for its Phase III as ru­mors swirl; Fol­low­ing US lead, EU buys up Covid-19 treat­ments

The Phase III might be delayed from its original early July goal, but Moderna says it will still kick off the pivotal study for what could ultimately be the first Covid-19 vaccine before the end of the month.

A day after Reuters reported that squabbling between the Cambridge biotech and government regulators had held up the trial by about two weeks, Moderna released a statement saying that they had completed enrollment of their 650-person Phase II trial and were on track to begin Phase III by the end of the month. The protocol for that study, which is meant to prove whether or not the vaccine can prevent people from becoming sick, has been finalized, they said.

GSK sets the stage for a toe-to-toe mar­ket show­down with Gilead­'s HIV cham­pi­on Tru­va­da

ViiV Healthcare and majority owner GlaxoSmithKline have cleared another important hurdle on a long-running quest to challenge Gilead’s dominance in preventative HIV treatments.

The final analysis of a new study shows the GSK subsidiary’s long-lasting injection, cabotegravir, proved 66% more effective in HIV prevention than Gilead’s breakthrough Truvada pill. And they now intend to carve away some of the blockbuster revenue that Gilead has enjoyed for years.

Stephen Hahn, AP

Trump and Navar­ro press again for hy­drox­y­chloro­quine. Can the FDA stay in­de­pen­dent?

Tuesday morning, economist and Trump advisor Peter Navarro walked onto the White House driveway and promptly brought a political cloud back onto the FDA.

Speaking to a White House pool reporter, Navarro said that four Detroit doctors were, based on a single disputed study, filing for the FDA to again issue an emergency authorization for hydroxychloroquine, the anti-malarial pill that President Trump hyped for months as a Covid-19 treatment over the objections of his own scientists. Then, while avoiding directly calling for the FDA to OK the drug, blasted the agency. He said its decision to pull an earlier authorization “was based on bad science” and “had a tremendously negative effect” on doctors and patients.

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