Al­lied with Genen­tech and Pfiz­er on dis­cov­ery deals, pro­tein degra­da­tion crew at Arv­inas looks for $100M IPO ahead of PhI start

The next wave of biotech IPOs is start­ing to swell to­day as the pro­tein degra­da­tion crew at Arv­inas jumps in with a $100 mil­lion of­fer­ing. And once again we’re see­ing a dis­cov­ery com­pa­ny go­ing ear­ly — with their first Phase I pro­gram still out ahead.

Arv­inas gained a con­sid­er­able amount of at­ten­tion for two deals with Genen­tech and Pfiz­er, which we now know came with a rel­a­tive­ly small up­front and big back end num­bers.

John Hous­ton

The big Roche sub­sidiary stepped up first in 2015, then re­jigged their deal in 2017. Genen­tech can tap up to 10 tar­gets in the dis­cov­ery al­liance, which was worth $11 mil­lion to get start­ed and an­oth­er $34.5 mil­lion pay­day to ex­tend last year. And there’s $156 mil­lion in col­lec­tive mile­stones for each tar­get — should it go all the way in­to the mar­ket.

Pfiz­er is in for less. The phar­ma gi­ant hand­ed over $28 mil­lion to get start­ed and com­mit­ted up to $775 mil­lion in de­vel­op­ment and com­mer­cial mile­stones for the pack­age. That an­swers one of the unan­swered ques­tions from Arv­inas’ days as a pri­vate start­up.

Pro­tein degra­da­tion has be­come a hot field in on­col­o­gy, as new com­pa­nies look to do bet­ter than the orig­i­nal set of ther­a­pies that have hit the mar­ket. In Arv­inas’ case, CEO John Hous­ton has been go­ing af­ter prostate can­cer and breast can­cer, with their first Phase I for the lead prostate can­cer ther­a­py lin­ing up for a start in ear­ly 2019.

Craig Crews

Arv­inas is by no means play­ing so­lo in the sec­ond-gen pro­tein degra­da­tion field. Ri­vals to the pro­tein degra­da­tion ti­tle in­clude C4 Ther­a­peu­tics — out of Jay Brad­ner’s lab at Dana Far­ber be­fore he took the helm at NI­BR — and the start­up Kymera. And not sur­pris­ing­ly, Brad­ner — who now runs NI­BR — re­cent­ly forged a close re­la­tion­ship with UC San Fran­cis­co on pro­tein degra­da­tion as well.

They’re look­ing to use an E3 lig­ase to dis­patch tar­get pro­teins through the cell’s nat­ur­al “garbage dis­pos­al” called the ubiq­ui­tin-pro­tea­some sys­tem, knock­ing them en­tire­ly out of the pic­ture and do­ing a much bet­ter job than what you get from mere pro­tein in­hi­bi­tion.

5AM and Canaan have the biggest stakes in the com­pa­ny, at 18.5% each. Craig Crews, who pro­vid­ed the sci­en­tif­ic in­sights from his Yale lab, has 8.9% while RA Cap­i­tal is in for 8%, Or­biMed has 6% and Nex­tech V On­col­o­gy is down for 5%. CEO Hous­ton has a 4.5% batch of stock.

Op­ti­miz­ing Cell and Gene Ther­a­py De­vel­op­ment and Pro­duc­tion: How Tech­nol­o­gy Providers Like Corn­ing Life Sci­ences are Spurring In­no­va­tion

Remarkable advances in cell and gene therapy over the last decade offer unprecedented therapeutic promise and bring new hope for many patients facing diseases once thought incurable. However, for cell and gene therapies to reach their full potential, researchers, manufacturers, life science companies, and academics will need to work together to solve the significant challenges facing the industry.

David Baker working with a student on their protein design (Jason Mast)

Sci­en­tists are fi­nal­ly learn­ing how to de­sign pro­teins from scratch. Drug de­vel­op­ment may nev­er be the same

SEATTLE — It’s a cloudy Thursday afternoon in mid-July and David Baker is reclining into the futon in his corner office at the University of Washington, arms splayed out like a daytime talk show host as he coaches another one of his postdocs through the slings and arrows of scientific celebrity.

“Be jealous of your time,” he says, before plotting ways of sneaking her out of Zooms. “It’s this horrible cost to science that you’re tied up in some stupid meeting.”

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Pre­sent­ing a live End­points News event: Man­ag­ing a biotech in tur­bu­lent times

Biotech is one of the smartest, best educated industries on the planet. PhDs abound. We’ve had a long enough track record to see a new generation of savvy, experienced execs coming together to run startups.

And in these times, they are being tested as never before.

Biotech is going through quite a rough patch right now. For 2 years, practically anyone with a decent resume and some half-baked ideas on biotech could start a company and get it funded. The pandemic made it easy in many ways to pull off an IPO, with traditional road shows shut down in exchange for a series of quick Zoom meetings. Generalist investors flocked as the numbers raised soared into the stratosphere.

Clay Siegall (Photo by Dimitrios Kambouris/Getty Images for Gabrielle's Angel Foundation)

UP­DAT­ED: Clay Sie­gall re­signs from Seagen amid in­ves­ti­ga­tion in­to do­mes­tic vi­o­lence claims

A week after Seagen revealed that longtime CEO Clay Siegall was on leave due to an allegation of domestic violence, he has resigned.

Since that shocking revelation, more details about the claims have emerged into the public eye. As Endpoints News reported, Siegall was arrested on April 23. A police report about that night and a subsequent temporary restraining order described a pattern of abusive behavior against his wife and a physical altercation that left her with multiple bruises. Siegall denied the claims.

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Patty Murray, D-WA (Graeme Sloan/Sipa USA)(Sipa via AP Images)

Sen­ate user fee reau­tho­riza­tion bill omits ac­cel­er­at­ed ap­proval re­forms, shows wide gaps with House ver­sion

The Senate health committee on Tuesday released its first version of the bill to reauthorize all the different FDA user fees. But unlike the House version, there are only a few controversial items in the Senate’s version, which does not address either accelerated approval reforms or clinical trial diversity (as the House did).

While it’s still relatively early in the process of finalizing this legislation (the ultimate statutory deadline is the end of September), the House and Senate, at least initially, appear to be starting off in different corners on what should be included.

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Warren Buffett, Berkshire Hathaway CEO

Berk­shire Hath­away pulls out of Ab­b­Vie, Bris­tol My­ers Squibb in­vest­ments

It looks like Warren Buffett is sticking to ice cream and railroads for the moment.

The billionaire CEO of Berkshire Hathaway backed out of two major holdings in the pharma industry, Forexlive first reported, including a $410 million investment in AbbVie and a $324.4 million stake in Bristol Myers Squibb.

The move comes after Berkshire abandoned its Teva shares just last quarter, Bloomberg reported.

Long-ex­pect­ed UK lay­offs im­mi­nent for No­var­tis fol­low­ing sale

Nearly a year ago, more than 200 workers at Novartis’ Grimsby, UK, facility were able to hang on to their jobs after the pharma closed a Switzerland site as a part of its workforce restructuring plan. Now, it looks like those employees’ time is up, as the site has been sold, Grimsby Telegraph reported today.

The manufacturing site has been sold to Humber Industrials, a subsidiary of International Process Plants. None of the current staff members will be working with the new owners, however.

FDA lob­bies Con­gress over rare dis­ease court rul­ing with wide im­pli­ca­tions

Usually reserved for making decisions on drug applications or enforcing what Congress stipulates, the FDA is now dipping its toe into the wild world of congressional politics as it attempts to fix a major court decision that could have a chilling effect on rare disease R&D.

The case in question from last October saw a US appeals court overturn a prior FDA court win, saying that the agency never should’ve approved a rare disease drug because a previously approved but more expensive drug with the same active ingredient has orphan drug exclusivity barring such an approval.

Peter Marks (Greg Nash/Pool via AP)

Even FDA's Pe­ter Marks is wor­ried about the com­mer­cial vi­a­bil­i­ty of gene and cell ther­a­pies

When bluebird bio’s gene therapy to treat beta thalassemia won European approval in 2019, the nearly $2 million per patient price tag for the potential cure seemed like a surmountable hurdle.

Fast forward two years later, and bluebird has withdrawn Zynteglo, the beta thal drug, along with the rest of its gene therapy portfolio from Europe, which the company said is generally unwilling to pay a fair price for the treatment.