James Porter, Nuvalent CEO

Nu­va­lent joins the IPO par­ty less than 6 months af­ter launch, while Icosavax kicks its 'soc­cer bal­l' VLPs to Nas­daq

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Less than six months af­ter emerg­ing from stealth, the Deer­field-backed biotech Nu­va­lent is al­ready prep­ping a jump to Nas­daq. And it’s a leap that could prove high­ly prof­itable for the blue chip firm.

Nu­va­lent filed its S-1 pa­per­work Wednes­day, pen­cil­ing in the $100 mil­lion raise es­ti­mate that’s be­come com­mon­place dur­ing the IPO boom of the last 15 or so months. The fi­nal fig­ure may end up high­er giv­en the biotech’s crossover raise in May hit the $135 mil­lion mark, but even if it falls short, it’s a rapid as­cent for Nu­va­lent af­ter its Jan­u­ary de­but.

It’s al­so a big win for Deer­field, which placed a big wa­ger on the com­pa­ny ear­li­er this year. Deer­field helped launch Nu­va­lent to the tune of a $50 mil­lion Se­ries A and cur­rent­ly owns more than 65% of shares.

Nu­va­lent got start­ed based on solv­ing a prob­lem that can some­times oc­cur in tar­get­ed can­cer ther­a­pies, where the tar­get is al­ways chang­ing. Even though new­er gen­er­a­tions of drugs can ap­pear to hit the tar­get, mu­ta­tions will usu­al­ly pop up that thwart the ther­a­pies from ac­com­plish­ing their mis­sions.

Matt Shair

Har­vard pro­fes­sor Matt Shair, founder and head sci­en­tif­ic ad­vi­sor of Nu­va­lent, be­lieves chem­istry can evolve fast enough to keep pace with the dis­eases, he told End­points News in Jan­u­ary. While in stealth, he pushed the biotech to uti­lize struc­ture-based drug de­sign to de­vel­op two com­pounds that tar­get the tu­mor dri­vers ROS1 and ALK for the clin­ic.

That ap­proach, Shair said, is com­ple­ment­ed with Nu­va­lent’s ef­forts to seek out physi­cian in­put for what kinds of prop­er­ties they want in a drug.

Both pro­grams have yet to reach their first in-hu­man stud­ies, but IPO funds are ex­pect­ed to help launch Phase I por­tions of planned Phase I/II stud­ies for each can­di­date and push them through to com­ple­tion. Some of the cash will al­so be ear­marked for pre­clin­i­cal pro­grams tar­get­ing ALK, IXDN and HER2 Ex­on 20 In­ser­tions.

In ad­di­tion to Deer­field, Bain Cap­i­tal al­so owns a sig­nif­i­cant chunk of the com­pa­ny, clock­ing in at 7.3%. Fi­deli­ty Man­age­ment has a 6.1% stake, while Shair him­self owns 6.5% of shares. CEO James Porter has tak­en home a mod­est 1%.

When Nu­va­lent goes pub­lic, it will trade un­der the tick­er $NU­VL.

Icosavax kicks its ‘soc­cer ball’ VLPs to Nas­daq

Icosavax al­so filed its S-1 pa­per­work Wednes­day with a $100 mil­lion place­hold­er fig­ure, aim­ing to kick its VLP plat­form to the pub­lic sec­tor.

Neil King

The tech­nol­o­gy comes out of Neil King’s lab at the Uni­ver­si­ty of Wash­ing­ton, where his team built on years-old re­search of how some vi­ral pro­teins could spon­ta­neous­ly as­sem­ble them­selves. Their work re­sult­ed in what’s es­sen­tial­ly a virus-like par­ti­cle shaped like a soc­cer ball — the “white” parts mak­ing up the struc­ture and the “black” spots rep­re­sent­ing the dis­played anti­gens, King told End­points in April.

It’s the same tech King is us­ing to de­vel­op a “su­per-sea­son­al” flu vac­cine with the NIH, though Icosavax is not in­volved in that re­search.

The biotech’s bi­va­lent vac­cine pro­gram, which will soak up most of the IPO cash, is go­ing af­ter res­pi­ra­to­ry syn­cy­tial virus and hu­man metap­neu­movirus. Icosavax’s plan is to start with the RSV “soc­cer ball” and then lay­er the hM­PV vac­cine on top of it as the new funds will help com­plete a Phase IIb study for the pro­gram.

Adam Simp­son

It’s not yet clear when the da­ta from this can­di­date will be ready, how­ev­er, as it’s not ex­pect­ed to be­gin a Phase I study un­til the sec­ond half of 2022. Oth­er IPO funds will be di­rect­ed to­ward the biotech’s Covid-19 vac­cine, with Icosavax look­ing to wrap up a Phase I/II tri­al thanks to the in­com­ing wind­fall.

Five dif­fer­ent firms hold stakes in Icosavax that range be­tween 10.8% and 13% — RA Cap­i­tal Man­age­ment, Qim­ing, Adams Street Part­ners, Aven­tis and Nan­oDi­men­sion. Chair Tadata­ka Ya­ma­da owns 4.8%, CEO Adam Simp­son has a 3.1% stake and CSO Doug Holtz­man clocks in at 1.2%.

When Icosavax goes pub­lic, it will trade un­der the tick­er $ICVX.

What Will it Take to Re­al­ize the Promise and Po­ten­tial of Im­mune Cell Ther­a­pies?

What does it take to get to the finish line with a new cancer therapy – fast? With approvals in place and hundreds of immune cell therapy candidates in the pipeline, the global industry is poised to create a fundamental shift in cancer treatments towards precision medicine. At the same time, unique challenges associated with cell and process complexity present manufacturing bottlenecks that delay speed to market and heighten cost of goods sold (COGS) — these hurdles must be overcome to make precision treatments an option for every cancer patient. This series of articles highlights some of the key manufacturing challenges associated with the production of cell-based cancer therapies as well as the solutions needed to transcend them. Automation, process knowledge, scalability, and assured supply of high-quality starting material and reagents are all critical to realizing the full potential of CAR-based therapies and sustaining the momentum achieved in recent years. The articles will highlight leading-edge technologies that incorporate these features to integrate across workflows, accelerate timelines and reduce COGS – along with how these approaches are enabling the biopharmaceutical industry to cross the finish line faster with new treatment options for patients in need.

The biggest ques­tions fac­ing gene ther­a­py, the XLMTM com­mu­ni­ty, and Astel­las af­ter fourth pa­tient death

After three patients died last year in an Astellas gene therapy trial, the company halted the study and began figuring out how to safely get the program back on track. They would, executives eventually explained, cut the dose by more than half and institute a battery of other measures to try to prevent the same thing from happening again.

Then tragically, Astellas announced this week that the first patient to receive the new regimen had died, just weeks after administration.

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Lat­est news: It’s a no on uni­ver­sal boost­ers; Pa­tient death stuns gene ther­a­py field; In­side Tril­li­um’s $2.3B turn­around; 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.

Next week is shaping up to be a busy one, as our editor-in-chief John Carroll and managing editor Kyle Blankenship lead back-to-back discussions with a great group of experts to discuss the weekend news and trends. John will be spending 30 minutes with Jake Van Naarden, the CEO of Lilly Oncology, and Kyle has a brilliant panel lined up: Harvard’s Cigall Kadoch, Susan Galbraith, the new head of cancer R&D at AstraZeneca, Roy Baynes at Merck, and James Christensen at Mirati. Don’t miss out on the action — sign up here.

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Mi­rati's KRAS drug looks like the fa­vorite in colon can­cer with new da­ta, putting the pres­sure square on Am­gen

With Amgen already providing proof-of-concept for KRAS inhibitors with its sotorasib, Mirati Therapeutics is piecing together a follow-up effort in lung cancer with data it thinks are superior. But in colon cancer, where solo sotorasib has turned in a dud, Mirati may now have a strong case for superiority.

Mirati’s adagrasib, dosed solo or in combination with chemotherapy cetuximab, showed response rates grater than sotorasib solo  and as part of combination study in a similar patient population also revealed this week at #ESMO21. Mirati’s data were presented as part of a cohort update from the Phase II KRYSTAL-1 study testing adagrasib in a range of solid tumors harboring the KRAS-G12C mutation.

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President Biden and Pfizer CEO Albert Bourla (Patrick Semansky/AP Images)

Chaot­ic ad­comm sees Pfiz­er/BioN­Tech boost­ers re­ject­ed for gen­er­al pop­u­la­tion, but rec­om­mend­ed for old­er and high-risk pop­u­la­tions

With just days before President Joe Biden’s Covid-19 booster rollout is set to go into effect, an FDA advisory committee appeared on the verge of not recommending boosters for anyone in the US before a last-minute change of wording laid the groundwork for older adults to have access to a third dose.

The FDA’s adcomm on Vaccines and Related Biological Products (VRBPAC) roundly rejected Pfizer/BioNTech booster shots for all individuals older than 16 by a 16-2 vote Friday afternoon. Soon after, however, the agency posed committee members a new question limiting booster use to the 65-and-older population and individuals at high risk of disease due to occupational exposure or comorbidities.

The best of the rest: High­lights from the be­low-the-fold pre­sen­ta­tions at #ES­MO21

This year’s ESMO Congress has had a major focus on Big Pharma drugs — most notably candidates from Merck and AstraZeneca — but there have also been updates from smaller biotechs with data looking to challenge the big-name drugmakers.

Today, we’re highlighting some of the data releases that flew under the radar at #ESMO21 — whether from early-stage drugs looking to make a mark or older stalwarts with interesting follow-up data.

As­traZeneca, Dai­ichi Sanky­o's ADC En­her­tu blows away Roche's Kad­cy­la in sec­ond-line ad­vanced breast can­cer

AstraZeneca and Japanese drugmaker Daiichi Sankyo think they’ve struck gold with their next-gen ADC drug Enhertu, which has shown some striking data in late-stage breast cancer trials and early solid tumor tests. Getting into earlier patients is now the goal, starting with Enhertu’s complete walkover of a Roche drug in second-line breast cancer revealed Saturday.

Enhertu cut the risk of disease progression or death by a whopping 72% (p=<0.0001) compared with Roche’s ADC Kadcyla in second-line unresectable and/or metastatic HER2-positive breast cancer patients who had previously undergone treatment with a Herceptin-chemo combo, according to interim data from the Phase III DESTINY-Breast03 head-to-head study presented at this weekend’s #ESMO21.

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Merck Research Laboratories CMO Roy Baynes

Mer­ck­'s Keytru­da un­corks full da­ta on lat­est ad­ju­vant win — this time in melanoma — adding bricks to ear­ly can­cer wall

In recent months, the battle for PD-(L)1 dominance has spilled over into early cancer with Merck’s Keytruda and Bristol Myers Squibb’s Opdivo all alone on the front lines. Keytruda now has another shell in its bandolier, and it could spell a quick approval.

Keytruda cut the risk of relapse or death by 35% over placebo (p=0.00658) in high-risk, stage 2 melanoma patients who had previously undergone surgery to remove their tumors, according to full data from the Phase III KEYNOTE-716 presented Saturday at #ESMO21.

Mer­ck flesh­es out Keytru­da win in first-line cer­vi­cal can­cer, adding more fire­pow­er to its ear­ly can­cer push

Merck has worked hard to bring its I/O blockbuster Keytruda into earlier and earlier lines of therapy, and now the wonder drug appears poised to make a quick entry into early advanced cervical cancer.

A combination of Keytruda and chemotherapy with or without Roche’s Avastin cut the risk of death by 33% over chemo with or without Avastin (p=<0.001) in first-line patients with persistent, recurrent or metastatic cervical cancer, according to full data from the Phase III KEYNOTE-826 study presented Saturday at #ESMO21.