Amid string of splashy pan­dem­ic IPOs, ADC re­turns for its mil­lions

Six months af­ter with­draw­ing their bid for a mas­sive IPO, ADC Ther­a­peu­tics is back with a more con­ser­v­a­tive num­ber: $100 mil­lion.

The Swiss biotech had swung from huge fund­ing round to huge fund­ing round be­fore, with its lead pro­gram near­ing a reg­u­la­to­ry sub­mis­sion. It filed for a $200 mil­lion IPO in Sep­tem­ber. They ev­i­dent­ly found few tak­ers, though, as they with­drew the bid with­in two weeks of pric­ing.

Now, though, the glob­al pan­dem­ic has drained mon­ey out of much of the stock mar­ket and fun­neled it in­to drug­mak­ers. Biotech IPO af­ter biotech IPO has land­ed with a splash. Zen­tal­is, a small and ob­scure can­cer biotech that pri­vate­ly raised a small frac­tion of what ADC has raised, man­aged a sur­pris­ing $165 mil­lion to open the month. ORIC Ther­a­peu­tics filed for a $75 mil­lion of­fer­ing and emerged less than a week lat­er with $120 mil­lion.

That should make it a ripe mar­ket for ADC, a com­pa­ny that, led by As­traZeneca vet­er­an Chris Mar­tin and Wyeth vet­er­an Jay Fein­gold, al­ready raised over $530 mil­lion on the pri­vate mar­ket since its 2011 found­ing and is clos­er to an FDA ap­proval than any of the oth­er pan­dem­ic era biotech IPOs. ADC has yet to price its new of­fer­ing, but the Sep­tem­ber at­tempt would’ve val­ued the com­pa­ny at $1.8 bil­lion.

ADC stands for an­ti­body-drug con­ju­gate, the old con­struct for build­ing tar­get­ed can­cer ther­a­pies that has gained steam again in re­cent years. The idea is to at­tach a cell-killing chem­i­cal — chemother­a­py — in­to an an­ti­body that guides the chem­i­cal di­rect­ly to the tu­mor, as op­posed to dif­fus­ing the chem­i­cal through­out the body like in tra­di­tion­al chemother­a­py. Three such drugs have been ap­proved in the last few years: two from Seat­tle Ge­net­ics and, last week, one from Im­munomedics.

ADC’s plat­form tries to im­prove on the orig­i­nal prin­ci­ple by us­ing a class of chem­i­cals called pyrroloben­zo­di­azepines in­stead of tra­di­tion­al chemother­a­py. Orig­i­nal­ly de­vel­oped in Strep­to­myces bac­te­ria, these chem­i­cals bond to spe­cif­ic grooves of DNA in­side the tu­mor, pre­vent­ing the can­cer cells from di­vid­ing and even­tu­al­ly killing them.

The com­pa­ny’s lead drug is AD­CT-402, or lon­cas­tux­imab tesirine, which they are test­ing in re­lapsed or re­frac­to­ry dif­fuse large B-cell lym­phoma. An ear­ly 52-pa­tient read­out from their 145-pa­tient piv­otal tri­al in De­cem­ber showed a 46.2% re­sponse rate and a 19.2% com­plete re­sponse rate. They are aim­ing for a BLA sub­mis­sion by the third quar­ter of 2020.

The com­pa­ny has re­port­ed promis­ing re­sults on a sec­ond can­di­date, AD­CT-301 or cami­dan­lum­ab tesirine, in Hodgkin’s lym­phoma, with a re­sponse rate of 86.5% at dos­ing in a Phase II tri­al of fifth-line pa­tients. This month, though, the FDA placed a par­tial clin­i­cal hold on the tri­al af­ter two pa­tients were di­ag­nosed with Guil­lain-Bar­ré syn­drome, a rapid mus­cle weak­ness caused by the im­mune sys­tem at­tack­ing its own tis­sue. A par­tial hold had been placed on a Phase I tri­al in 2017 for the same rea­son.

So­cial im­age: Chris Mar­tin, ADC Ther­a­peu­tics CEO via YouTube

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Dave Marek, Myovant CEO

My­ovant board balks as ma­jor­i­ty own­er Sum­it­o­mo swoops in with a $2.5B deal to buy them out

Three years after Sumitomo scooped up Roivant’s 46% stake in the publicly traded Myovant $MYOV as part of a 5-company, $3 billion deal, they’re coming back for the whole thing.

But these other investors at Myovant want more than what the Japanese pharma company is currently offering to pay at this stage.

Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

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Justin Klee (L) and Joshua Cohen, Amylyx co-CEOs (Cody O'Loughlin/The New York Times; courtesy Amylyx)

Ad­vo­cates, ex­perts cry foul over Amy­lyx's new ALS drug, cit­ing is­sues with price, PhI­II com­mit­ment

Not 24 hours after earning the first ALS drug approval in five years, Amylyx Pharmaceuticals’ Relyvrio is already drawing scrutiny. And it’s coming from multiple fronts.

In an investor call Friday morning, Amylyx revealed that it would charge about $158,000 per year, a price point that immediately drew backlash from ALS advocates and some outside observers. The cost reveal had been highly anticipated in the immediate hours after Thursday evening’s approval, though Amylyx only teased Relyvrio would cost less than previously approved drugs.

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Albert Bourla, Pfizer CEO (Gian Ehrenzeller/Keystone via AP)

Can a smart­phone app de­tect Covid? Pfiz­er throws down $116M to find out

What can a cough say about a patient’s illness? Quite a bit, according to ResApp Health — and Pfizer’s listening.

The pharma giant is shelling out about $116 million ($179 million AUD) to scoop up the University of Queensland spinout and its smartphone technology that promises to diagnose Covid and other respiratory illnesses based on cough and breathing sounds, the university announced last week.

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Big Phar­ma heavy­weights seek tweaks to FDA's clin­i­cal out­come as­sess­ment guid­ance

Pfizer, GSK, Janssen, Regeneron, Boehringer Ingelheim and at least a half dozen other companies are calling on the FDA to provide significantly more clarity in its draft guidance from this summer on clinical outcome assessments, which are a type of patient experience.

The draft is the third in a series of four patient-focused drug development guidance documents that the FDA had to create as part of the 21st Century Cures Act, and they describe how stakeholders (patients, caregivers, researchers, medical product developers and others) can collect and submit patient experience data and other relevant information for medical product development and regulatory decision-making.

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Rob Etherington, Clene CEO

Star­tup's gold nanocrys­tal ALS drug flops a PhII tri­al, a re­minder of the dis­ease's ob­sta­cles de­spite Amy­lyx OK

Despite the FDA approving an ALS drug for the first time in five years last week, the disease continues to fluster researchers, and another biotech is feeling the pain of a mid-stage failure.

Clene Nanomedicine reported early Monday that its ALS program, which uses gold nanocrystals to try to catalyze intracellular reactions, did not achieve its Phase II primary or secondary endpoints. And in a press release, the company noted for the first time that it’s speaking with “potential strategic partners” about the program — language that typically indicates a biotech is preparing to sell off an asset.

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Marc Dunoyer, Alexion CEO (AstraZeneca via YouTube)

Up­dat­ed: As­traZeneca nabs a small rare dis­ease gene ther­a­py play­er for 667% pre­mi­um

AstraZeneca is kicking off the fourth quarter with a little M&A Monday for a gene editing player recently overcoming a second clinical hold to its only program in human studies.

The Big Pharma and its subsidiary Alexion are buying out little LogicBio for $2.07 per share. That’s good for a massive 667% premium over its Friday closing price, when it headed into the weekend at 27 cents and just weeks after Nasdaq said LogicBio would have to delist, which has been put on hold as the biotech requests a hearing. It’s one of two biotech deals to commence October, alongside the news of Incyte buying a vitiligo-focused biotech.

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Land­mark Amy­lyx OK spurs de­bate; Some... pos­i­tive? Alzheimer's da­ta; Can­cer tri­al bot­tle­neck; Sanofi's CRISPR bet; 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.

After brief stops in Paris and Boston, John Carroll and the Endpoints crew are staying on the road in October with their return for a live/streaming EUBIO22 in London. The hybrid event fireside chats and panels on mRNA, oncology and the crazy public market. We hope you can join him there.

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An­oth­er warn­ing let­ter for Lupin as FDA iden­ti­fies de­fi­cien­cies at In­dia-based site

With few new details of what needs fixing, Lupin disclosed last week that the FDA recently sent a warning letter to its Tarapur, India-based site.

After an inspection from March 22 to April 4, Lupin disclosed in an April stock filing that it received a Form 483 with four observations, but it didn’t offer any details on the observations.

Similar to comments made in April, the company said last week it does not believe the FDA slap will disrupt its drug supplies or the existing revenues from operations of this facility.

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