From pro­tein degra­da­tion to 'toad ven­om': An­oth­er five biotechs will make the Nas­daq shuf­fle af­ter fil­ing SEC pa­per­work

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Fri­day proved to be an­oth­er busy day for biotech IPOs, with five more com­pa­nies fil­ing their S-1s and F-1s with the SEC ahead of ex­pect­ed jumps to Nas­daq.

Four biotechs pen­ciled in ini­tial es­ti­mates of $100 mil­lion rais­es: pro­tein-degra­da­tion play­er Monte Rosa, gene edit­ing biotech Graphite Bio, “toad ven­om”-fo­cused GH Re­search and mon­o­clon­al an­ti­body de­vel­op­er El­e­va­tion On­col­o­gy. The fifth com­pa­ny, reagents provider Al­pha Tekno­va, es­ti­mates at least $75 mil­lion with their raise.

The to­tal num­ber of biotechs to file or price their IPOs this year has now reached 65, ac­cord­ing to the End­points News tal­ly.

Al­so ear­ly on Mon­day, Janux Ther­a­peu­tics set its IPO terms for an es­ti­mat­ed $152 mil­lion raise by of­fer­ing 9.5 mil­lion shares in the $15 to $17 range. It’s ex­pect­ed to price by the end of this week, ac­cord­ing to Re­nais­sance Cap­i­tal.

Here’s a look at the lat­est biotechs do­ing the Nas­daq shuf­fle.

Al­most at the clin­ic, Monte Rosa preps its IPO

Since last Sep­tem­ber, Monte Rosa has pulled in two fundrais­ing rounds of $96 mil­lion and $95 mil­lion apiece. That mo­men­tum is lead­ing them to­ward the next step of be­com­ing a pub­lic com­pa­ny.

Their plat­form re­volves around de­vel­op­ing “mol­e­c­u­lar glues” that can re­pro­gram the ubiq­ui­tin lig­as­es cen­tral to pro­tein degra­da­tion, a field that’s been pro­duc­ing tons of buzz among in­vestors over the last cou­ple years. The re­sult­ing can­di­dates are dif­fer­ent from oth­er small mol­e­cule de­graders, such as PRO­TAC, that work more like in­hibitors.

Monte Rosa doesn’t have any clin­i­cal pro­grams just yet, but they’ve been plan­ning IND stud­ies for their lead can­di­date by the end of this month. The ex­per­i­men­tal drug will tar­get GSPT1, a reg­u­la­to­ry pro­tein im­pli­cat­ed in the syn­thet­ic lethal­i­ty of sol­id tu­mor cells.

With­in its S-1, Monte Rosa stayed silent over ex­act­ly how far it ex­pects to bring this pro­gram, on­ly di­vulging that some of the cash will be di­rect­ed to­ward it. The rest of the mon­ey will help fund fur­ther de­vel­op­ment of the plat­form and oth­er pre­clin­i­cal pro­grams.

Once it goes pub­lic, Monte Rosa plans to list un­der the tick­er $GLUE.

Ver­sant-backed Graphite pen­cils in a $100 mil­lion raise

Graphite came out of a part­ner­ship from Ver­sant and Stan­ford gene ther­a­py ex­perts, first get­ting things start­ed back in Sep­tem­ber 2020 with a $45 mil­lion round.

Matthew Por­teus

Now they’re ready to make the pub­lic leap less than a year lat­er, ex­pect­ing to launch their first clin­i­cal tri­al by the end of 2021 in sick­le cell dis­ease. The plat­form comes from Matthew Por­teus, an aca­d­e­m­ic founder of CRISPR Ther­a­peu­tics, who is work­ing along­side gene ther­a­py ex­pert Maria Grazia Ron­car­o­lo.

Draw­ing from re­search work led by Dan­ny De­v­er while a post­doc at Por­teus’ lab, Graphite’s big promise is to in­crease in­te­gra­tion ef­fi­cien­cy from less than 1% to greater than 50% “across di­verse ge­net­ic le­sions in a wide range of cell types.” The trio each serve as the co-aca­d­e­m­ic founders at Graphite.

Maria Grazia Ron­car­o­lo

The biotech has since built up its pipeline in­to three pro­grams, with can­di­dates for X-linked se­vere com­bined im­mune de­fi­cien­cy and Gauch­er dis­ease on top of the sick­le cell lead. All three are ex­pect­ed to be fun­neled cash with the IPO, and the two fol­low-up pro­grams are still in IND-en­abling stud­ies.

Graphite plans to list un­der the tick­er $GRPH af­ter its de­but.

Toad-al­ly rad­i­cal: RA’s psy­che­del­ic wa­ger keeps on truck­ing

The psy­che­delics space con­tin­ues to see heavy in­vestor in­ter­est, and RA Cap­i­tal backed GH Re­search just two months ago with a nine-fig­ure round. GH is tak­ing its pro­grams pub­lic now, with a lead in­halant cen­tered around the sub­stance col­lo­qui­al­ly known as “toad ven­om.”

Though the drug’s sci­en­tif­ic name is a mouth­ful — 5-Methoxy-N, N-di­methyl­trypt­a­mine is the of­fi­cial name — it picked up the toad ven­om nick­name due to its pres­ence in a cer­tain toad species na­tive to the south­west­ern US and north­west­ern Mex­i­co. The psy­che­del­ic saw a rapid rise in recre­ation­al use in the mid-2010s, per a VICE News re­port, as in­di­vid­u­als at­tempt­ed to achieve the ‘ego death’ phe­nom­e­non.

GH is start­ing with treat­ment-re­sis­tant de­pres­sion and has two oth­er undis­closed in­di­ca­tions on tap. The DMT in­halant, dubbed GH001, is cur­rent­ly be­ing stud­ied in the Phase II por­tion of a Phase I/II clin­i­cal tri­al.

The Dublin-based biotech is al­so work­ing on an in­jectable for­mu­la­tion of the drug. GH’s IPO raise is ex­pect­ed to help de­vel­op both of these can­di­dates, with a Phase IIb study planned for GH001 and a Phase IIa tri­al to like­ly be set up for the oth­er can­di­date.

GH Re­search will list un­der the tick­er $GHRS once it goes pub­lic.

A for­mer Mer­ri­mack pro­gram gets a Nas­daq chance

El­e­va­tion On­col­o­gy has spent its time try­ing to re­vamp Mer­ri­mack’s high-pro­file serib­an­tum­ab pro­gram in­to some­thing that can treat sol­id tu­mors with the rare NRG1 ge­nom­ic fu­sion.

Af­ter flop­ping in NSCLC, serib­an­tum­ab was ac­quired by El­e­va­tion back in 2019 for up to $58 mil­lion. The drug can­di­date is a mon­o­clon­al an­ti­body that binds to HER3 and was one in a long string of clin­i­cal busts for Mer­ri­mack, ul­ti­mate­ly re­sult­ing in the biotech sell­ing sev­er­al as­sets and lay­ing off all its staff and ex­ec­u­tives.

El­e­va­tion launched in Ju­ly 2020 and quick­ly added a $65 mil­lion Se­ries B round to com­plete en­roll­ment in a Phase II study. Their S-1 was scant on de­tails over how far El­e­va­tion wants to take the pro­gram with its raise.

When it goes pub­lic, El­e­va­tion plans to list un­der the tick­er $ELEV.

Reagents provider Al­pha Tekno­va will make its pub­lic jump 

Al­pha Tekno­va has been around since 2000, but now it’s go­ing pub­lic on the backs of its reagents. The Hol­lis­ter, CA-based com­pa­ny says it has about 3,000 cus­tomers span­ning the en­tire life sci­ences mar­ket, in­clud­ing biotechs, larg­er phar­ma com­pa­nies and CROs.

Al­pha Tekno­va of­fers three prod­ucts: pre-poured me­dia plates for cell growth and cloning, liq­uid cell cul­ture me­dia and sup­ple­ments for cel­lu­lar ex­pan­sion, and mol­e­c­u­lar bi­ol­o­gy reagents for sam­ple ma­nip­u­la­tion, re­sus­pen­sion and pu­rifi­ca­tion.

Funds from the IPO will large­ly go to­ward up­ping man­u­fac­tur­ing and im­prov­ing ef­fi­cien­cy, though Al­pha Tekno­va said it couldn’t quan­ti­fy ex­act­ly how much. Once it goes pub­lic, the com­pa­ny plans to list un­der the tick­er $TKNO.

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

What lured Hal Bar­ron away?; Top FDA minds on ac­cel­er­at­ed ap­proval re­forms; ‘Dead wrong’ Aduhelm ad blitz; 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.

Nothing can really compete with Hal Barron’s departure from GlaxoSmithKline as the news of the week, but we do have plenty of original reporting and analysis from the Endpoints team in this edition. Enjoy and have a nice weekend.

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Mer­ck wins le­gal bat­tle over in­sur­ance cov­er­age af­ter ran­somware at­tack

Merck has emerged victorious from a years-long legal battle with insurers over the coverage of more than a billion dollars in losses from the malware NotPetya, with a New Jersey Superior Court judge concluding that the responsibility is on insurers to clarify their policies around cyber attacks.

The pharma giant was one of several victims of a global cyber attack back in 2017 that also hit Danish shipping company Maersk, American food company Mondelēz, French construction giant Saint-Gobain and even the systems monitoring the Chernobyl nuclear power stations, Bloomberg reported back in 2019.

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Crit­ics push back on Alzheimer’s As­so­ci­a­tion ad blitz to get Medicare to change its Aduhelm rul­ing: 'Dead wrong'

The latest Alzheimer’s Association advertising campaign encourages people to fight.

Not against the disease or for more research or treatments, but against the Centers for Medicare and Medicaid Services. More specifically, CMS’ recent reimbursement decision to only pay for Biogen and Eisai’s controversial Alzheimer’s drug Aduhelm for patients in clinical trials.

With CMS’ preliminary decision now in a 30-day comment period, patient advocates’ goal is to convince CMS to reverse its decision with a marketing blitz and public pressure.

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Dan O'Day, Gilead CEO (Jim Watson/AFP via Getty Images)

Fail­ing to con­firm clin­i­cal ben­e­fit, Gilead pulls 2 ac­cel­er­at­ed ap­proval in­di­ca­tions for can­cer drug

Gilead recently decided to pull two indications for its cancer drug Zydelig — in relapsed follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic leukemia (SLL) — after failing to complete the confirmatory trials required as part of the accelerated approvals from 2014.

“As the treatment landscape for FL and SLL has evolved, enrollment into the confirmatory study has been an ongoing challenge,” Gilead said in a statement, noting it formally notified the FDA of its decision to voluntarily withdraw these indications.

Hal Barron, Endpoints UKBIO20 (Jeff Rumans)

'Al­tos was re­al­ly a once-in-a-life­time op­por­tu­ni­ty': Hal Bar­ron re­flects on his big move

By all accounts, Hal Barron had one of the best jobs in Big Pharma R&D. He made more than $11 million in 2020, once again reaping more than his boss, Emma Walmsley, who always championed him at every opportunity. And he oversaw a global R&D effort that struck a variety of big-dollar deals for oncology, neurodegeneration and more.

Sure, the critics never let up about what they saw as a rather uninspiring late-stage pipeline, where the rubber hits the road in the Big Pharma world’s hunt for the next big near-term blockbuster, but the in-house reviews were stellar. And Barron was firmly focused on bringing up the success rate in clinical trials, holding out for the big rewards of moving the dial from an average 10% success rate to 20%.

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Executive Director of the EMA Emer Cooke (AP Photo/Geert Vanden Wijngaert)

Eu­ro­pean Par­lia­ment signs off on strength­en­ing drug reg­u­la­tor's abil­i­ty to tack­le short­ages

The European Parliament on Thursday endorsed a plan to increase the powers of the European Medicines Agency, which will be better equipped to monitor and mitigate shortages of drugs and medical devices.

By a vote of 655 to 31, parliament signed off on a provisional agreement reached with the European Council from last October, in which the EMA will create two shortage steering groups (one for drugs, the other for devices), a new European Shortages Monitoring Platform to facilitate data collection and increase transparency, and on funding for the work of the steering groups, task force, working parties and expert panels that are to be established.

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FDA+ roundup: FDA's neu­ro­science deputy de­parts amid on­go­ing Aduhelm in­ves­ti­ga­tions; Califf on the ropes?

Amid increased scrutiny into the close ties between FDA and Biogen prior to the controversial accelerated approval of Aduhelm, the deputy director of the FDA’s office of neuroscience has called it quits after more than two decades at the agency.

Eric Bastings will now take over as VP of development strategy at Ionis Pharmaceuticals, the company said Wednesday, where he will provide senior clinical and regulatory leadership in support of Ionis’ pipeline.

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Sec­ondary patents prove to be key in biosim­i­lar block­ing strate­gies, re­searchers find

While the US biosimilars industry has generally been a disappointment since its inception, with FDA approving 33 biosimilars since 2015, just a fraction of those have immediately followed their approvals with launches. And more than a handful of biosimilars for two of the biggest blockbusters of all time — AbbVie’s Humira and Amgen’s Enbrel — remain approved by FDA but still have not launched because of legal settlements.