Ready to de­clare a de­fin­i­tive come­back in two months, Im­munomedics stops PhI­II ear­ly, re­cruits new CEO

More than a year ago, hit by a sur­prise com­plete re­sponse let­ter from the FDA, Im­munomedics bid its then-CEO, Michael Pehl, adieu and be­gan a 15-month quest to re­solve the man­u­fac­tur­ing is­sues cit­ed in the CRL and seek a new leader — all the while mov­ing for­ward with a Phase III study on its lead drug for metasta­t­ic triple-neg­a­tive breast can­cer.

Harout Se­mer­jian

To­day the biotech said their stars are fi­nal­ly align­ing. Not on­ly is No­var­tis On­col­o­gy vet Harout Se­mer­jian com­ing on board as CEO to steer what they be­lieve will be a smooth sail to a new PDU­FA date in June, Im­munomedics has al­so been in­formed that their late-stage tri­al can be stopped ear­ly due to “com­pelling ev­i­dence of ef­fi­ca­cy.”

The turn­around is not ex­act­ly com­plete but it’s enough to win in­vestors over, near­ly dou­bling its shares $IM­MU to $18.77.

The rec­om­men­da­tion by the da­ta safe­ty mon­i­tor­ing com­mit­tee means that Im­munomedics doesn’t need to wait un­til a cer­tain num­ber of pa­tients to progress be­fore they be­gin an­a­lyz­ing the da­ta.

The Phase III AS­CENT study was de­signed to eval­u­ate how its an­ti­body-drug con­ju­gate dubbed sac­i­tuzum­ab govite­can im­pacts pro­gres­sion-free sur­vival, over­all sur­vival and re­sponse rates com­pared to chemother­a­py.

Be­hzad Ag­haz­adeh

The plan is to sub­mit the re­vised sta­tis­ti­cal analy­sis plan to the FDA in a mat­ter of hours, ex­ec­u­tive chair­man Be­hzad Ag­haz­adeh told End­points News Mon­day morn­ing.

“More im­por­tant­ly, it’s not so much that we don’t have to wait any longer for pa­tients to progress, the in­de­pen­dent da­ta safe­ty mon­i­tor com­mit­tee is in­di­cat­ing to us that the tri­al was suc­cess­ful,” he said.

He cau­tious­ly added that the ex­perts on the com­mit­tee ap­pear to in­di­cate that in ad­di­tion to the pri­ma­ry end­point in PFS, they are al­so see­ing pos­i­tive trends on oth­er end­points.

Julie Gralow

Julie Gralow, a Fred Hutch re­searcher who chaired the DSMC, called the re­sults “re­mark­able” — a com­ment that in­spired Cowen’s Phil Nadeau to note “there is lit­tle ques­tion that sac­i­tuzum­ab will soon be­come stan­dard of care in the treat­ment of re­lapsed and re­frac­to­ry mTNBC.”

To be clear, none of that should fac­tor in­to the FDA’s on­go­ing re­view of sac­i­tuzum­ab govite­can. Ag­haz­adeh still ex­pects an ac­cel­er­at­ed ap­proval by June 2. Af­ter all, ac­cord­ing to the com­pa­ny, the on­ly is­sues stop­ping reg­u­la­tors from do­ing so the first time around had to do with man­u­fac­tur­ing and oth­er pro­ce­dur­al mat­ters dis­cov­ered dur­ing in­spec­tions. Scott Canute, a board mem­ber who was tapped as ex­ec­u­tive di­rec­tor up­on Pehl’s de­par­ture, has helped en­sure re­me­di­a­tion is in place to ad­dress those con­cerns.

On the oth­er hand, de­spite the short­ened time­line, a full ap­proval wouldn’t come un­til 6, 9, or even 12 months from now.

Im­munomedics has pre­vi­ous­ly pre­sent­ed Phase II da­ta sug­gest­ing a 33% re­sponse rate and a me­di­an du­ra­tion of re­sponse of 7.7 months.

“It is 2 or 3 times high­er based on what we would ex­pect in chemother­a­py,” Ag­haz­adeh, who al­so man­ages Avoro Cap­i­tal (for­mer­ly ven­Bio Se­lect Ad­vi­sor), said. “For the re­sponse rate, gen­er­al­ly we would ex­pect high sin­gle-dig­it, low dou­ble-dig­it re­spons­es. And we would ex­pect about 3 to 4 months of du­ra­tion for chemother­a­py.”

For Nadeau, it all bodes well for fur­ther clin­i­cal de­vel­op­ment of sac­i­tuzum­ab govite­can, with 2025 sales pegged at $1.2 bil­lion:

With sac­i­tuzum­ab pro­duc­ing sim­i­lar Ph. II da­ta in r/r ER+/HER2- mBC and mTNBC, we think the AS­CENT re­sults par­tial­ly de-risk sac­i­tuzum­ab’s de­vel­op­ment in r/r ER+/HER2- mBC. IM­MU ex­pects to com­plete en­roll­ment in the Ph. III TROP­iCS-02 study in ER+/HER2- BC this year with in­ter­im da­ta (ORR) to be re­leased not long af­ter the com­ple­tion of en­roll­ment.

The re­spon­si­b­li­ty to re­al­ize all that — start­ing with a po­ten­tial near-term launch — now falls on the shoul­der of Se­mer­jian.

Se­mer­jian moved days ago from his last job as chief com­mer­cial of­fi­cer of Ipsen in Lon­don and, in a sign of the times, “is sit­ting at home in so-called self quar­an­tine to en­sure that he is able to safe­ly come to the com­pa­ny site on [his of­fi­cial start date of] April 16,” Ag­haz­adeh said.

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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Amidst R&D reshuf­fle, Ver­tex ex­pands its pres­ence in Boston, aim­ing to be­come num­ber one

Vertex Pharmaceuticals has been one of the buzzier names in the bustling Boston biotech scene, but now the company is looking to vault to number one status — at least in terms of physical footprint.

At a ribbon cutting on Tuesday for its new Jeffrey Leiden Center for Cell and Genetic Therapies at the Boston Seaport, Vertex announced it would embark on a new project: The company will build a 344,000 square foot facility in the seaport to accommodate the company’s growing R&D needs, especially in its cell and gene therapies program.

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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.