Near­ly a year af­ter sur­prise re­jec­tion, Im­munomedics re­turns to FDA

As last Christ­mas ap­proached, an­a­lysts an­tic­i­pat­ed a po­ten­tial block­buster from Im­munomedics. In­stead, they got phar­ma coal: a CRL.

Now, near­ly a year af­ter the FDA first spurned Im­munomedics’ lead drug, the ADC biotech is re­turn­ing to plead their case again. They have re­sub­mit­ted their BLA, seek­ing ac­cel­er­at­ed ap­proval for sac­i­tuzum­ab govite­can for triple-neg­a­tive metasta­t­ic breast can­cer.

Im­munomedics said the FDA not­ed man­u­fac­tur­ing is­sues in their re­jec­tion. Soon af­ter, it emerged that the agency had pre­vi­ous­ly cit­ed them for a breach of da­ta in­tegri­ty in the months lead­ing up to their PDU­FA, al­though the pub­licly re­leased re­port is heav­i­ly redact­ed and it re­mains un­clear if the da­ta breach was di­rect­ly con­nect­ed to the FDA re­jec­tion.

Michael Pehl

The re­jec­tion trig­gered up­per-lev­el changes at a com­pa­ny that had gone decades with­out a drug ap­proval and bet big on this drug reach­ing mar­ket. CEO Michael Pehl left days af­ter the da­ta breach re­port be­came pub­lic in Feb­ru­ary. Pehl had joined in 2017 as part of a shake­up that saw ac­tivist in­vestors oust the hus­band-and-wife lead­er­ship team and nix a Seat­tle Ge­net­ics $300-mil­lion up­front, $1.7 bil­lion down-the-road deal they saw as un­der­valu­ing the as­set.

Pehl has not been of­fi­cial­ly re­placed, al­though the com­pa­ny named Scott Canute to lead a CRL re­sponse team and Be­hzad Ag­haz­adeh, the ven­Bio vet who led the ac­tivist takeover has stepped in to over­see strat­e­gy and busi­ness op­er­a­tions.

Im­munomedics told End­points News in an email that it met with the FDA in May and “val­i­dat­ed” a CRL re­sponse plan and gave a “suc­cess­ful up­date” in Sep­tem­ber.

“The FDA was very fa­vor­able to­wards our plan,” they said.

Un­like the EMA, the FDA does not re­veal the rea­sons for re­jec­tions. But the da­ta breach re­port, writ­ten af­ter an Au­gust in­spec­tion, was all but damn­ing. “There is no as­sur­ance that sam­ples and batch records form the [redact­ed] process val­i­da­tion and com­mer­cial batch­es man­u­fac­tured pri­or to Feb­ru­ary 2018 were not im­pact­ed by the da­ta in­tegri­ty breach,” agency in­spec­tors wrote. In a 13-point doc­u­ment, they list­ed poor retest­ing pro­ce­dures, back­dat­ing doc­u­ments, ma­nip­u­la­tion of biobur­den sam­ples, and fa­cil­i­ty de­sign flaws, among oth­er is­sues.

Im­munomedics said they ad­dressed the agency’s man­u­fac­tur­ing con­cerns pri­or to the FDA’s first de­ci­sion. Ex­pect­ing an ap­proval, they hired a sales force to mar­ket the drug and told End­points they had been in oth­er man­u­fac­tur­ing and post-mar­ket­ing dis­cus­sions.

“These mat­ters were re­solved dur­ing the re­view pe­ri­od last year,” the com­pa­ny wrote to End­points to­day of the da­ta con­cerns, “and we have fur­ther in­vest­ed sig­nif­i­cant re­sources this year to ac­cel­er­ate our qual­i­ty im­prove­ment plan, and plan for a suc­cess­ful po­ten­tial PAI as part of the re­sub­mis­sion.”

Sac­i­tuzum­ab govite­can, or IM­MU-132, is an an­ti­body drug con­ju­gate that is de­signed to de­liv­er a spe­cif­ic pay­load di­rect­ly to the tu­mor. In a Phase II clin­i­cal tri­al pub­lished in the New En­gal­nd Jour­nal of Med­i­cine, the drug had a 33.3% re­sponse rate and showed a me­di­an pro­gres­sion-free sur­vival of 5.5 months.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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Ken Frazier, AP Images

Why Mer­ck wait­ed, and what they now bring to the Covid-19 fight

Nicholas Kartsonis had been running clinical infectious disease research at Merck for almost 2 years when, in mid-January, he got a new assignment: searching the pharma giant’s vast libraries for something that could treat the novel coronavirus.

The outbreak was barely two weeks old when Kartsonis and a few dozen others got to work, first in small teams and then in a larger task force that sucked in more and more parts of the sprawling company as Covid-19 infected more and more of the globe. By late February, the group began formally searching for vaccine and antiviral candidates to license. Still, while other companies jumped out to announce their programs and, eventually and sometimes controversially, early glimpses at human data, Merck remained silent. They made only a brief announcement about a data collection partnership in April and mentioned vaguely a vaccine and antiviral search in their April 28 earnings call.

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Gilead re­leas­es an­oth­er round of murky remde­sivir re­sults

A month after the NIH declared the first trial on remdesivir in Covid-19 a success, Gilead is out with new results on their antiviral. But although the study met one of its primary endpoints, the data are likely to only add to a growing debate over how effective the drug actually is.

In a Phase III trial, patients given a 5-day dose of remdesivir were 65% more likely to show “clinical improvement” compared to an arm given standard-of-care. The trial, though, gave little indication for whether the drug had an impact on key endpoints such as survival or time-to-recovery. And in a surprising twist, a 10-day dosing arm of remdesivir didn’t lead to a statistically significant improvement over standard of care.

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Len Schleifer (left) and George Yancopoulos, Regeneron (Vimeo)

Eyes on he­mo­phil­ia prize, Re­gen­eron adds a $100M wa­ger on joint de­vel­op­ment cam­paign with In­tel­lia

When George Yancopoulos first signed up Intellia to be its CRISPR/Cas9 partner on gene editing projects 4 years ago, the upstart smartly ramped up its IPO at the same time. Today, Regeneron $REGN is coming back in, adding $100 million in an upfront fee and equity to significantly boot up a whole roster of new development projects.

And they’re highlighting some clinical hemophilia research plans in the process.

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Mark Genovese (Stanford via Twitter)

Gilead woos fil­go­tinib clin­i­cal in­ves­ti­ga­tor from Stan­ford to lead the charge on NASH, in­flam­ma­to­ry dis­eases

With an FDA OK for the use of filgotinib in rheumatoid arthritis expected to drop any day now, Gilead has recruited a new leader from academia to lead its foray into inflammatory diseases.

Mark Genovese — a longtime Stanford professor and most recently the clinical chief in the division of immunology and rheumatology — was the principal investigator in FINCH 2, one of three studies that supported Gilead’s NDA filing. In his new role as SVP, inflammation, he will oversee the clinical development of the entire portfolio.

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Bris­tol My­ers Squib­b's just-launched MS drug Zeposia makes the cut in key ul­cer­a­tive col­i­tis tri­al

In March, Zeposia became the third oral S1P modulator to secure US approval for multiple sclerosis. Now, the drug has succeeded in a key ulcerative colitis study.

The immunomodulator, akin to others in its class, controls lymphocyte trafficking by limiting the white blood cells to the lymphatic system, in the lymph nodes, and thwarting their ability to jam up lymph nodes — precluding their ability to penetrate the bloodstream and the central nervous system.

Stephen Isaacs, Aduro president and CEO (Aduro)

Once a high fly­er, a stag­ger­ing Aduro is auc­tion­ing off most of the pipeline as CEO Stephen Isaacs hands off the shell to new own­ers

After a drumbeat of failure, setbacks and reorganizations over the last few years, Aduro CEO Stephen Isaacs is handing over his largely gutted-out shell of a public company to another biotech company and putting up some questionable assets in a going-out-of-business sale.

Isaacs —who forged a string of high-profile Big Pharma deals along the way — has wrapped a 13-year run at the biotech with one program for kidney disease going to the new owners at Chinook Therapeutics. A host of once-heralded assets like their STING agonist program partnered with Novartis (which dumped their work on ADU-S100 after looking over weak clinical results), the Lilly-allied cGAS-STING inhibitor program and the anti-CD27 program out-licensed to Merck will all be posted for auction under a strategic review process.

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Hill­house re­casts spot­light on Chi­na's biotech scene with $160M round for Shang­hai-based an­ti­body mak­er

Almost two years after first buying into Genor Biopharma’s pipeline of cancer and autoimmune therapies, Hillhouse Capital has led a $160 million cash injection to push the late-stage assets over the finish line while continuing to fund both internal R&D and dealmaking.

The Series B has landed right around the time Genor would have listed on the Hong Kong stock exchange, according to plans reported by Bloomberg late last year. Insiders had said that the company was looking to raise about $200 million.

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