Im­munomedics must en­dure an­oth­er de­lay as FDA re­jects can­cer drug cit­ing man­u­fac­tur­ing is­sues

We all like to root for the un­der­dog. Fol­low­ing an arid spell stretch­ing over three decades that in 2017 led to the ouster of Im­munomedics founder/CSO and his CEO wife, the com­pa­ny (and an­a­lysts) were hope­ful the drug de­vel­op­er would fi­nal­ly win its first FDA nod for its treat­ment for a dif­fi­cult-to-treat form of breast can­cer. The man­age­ment shake­up, at the be­hest of an ac­tivist share­hold­er cam­paign, had re­ju­ve­nat­ed the com­pa­ny’s for­tunes by at­tract­ing in­vest­ment and ramp­ing up the drug’s de­vel­op­ment. But the FDA on Thurs­day hand­ed the biotech a re­jec­tion cit­ing man­u­fac­tur­ing is­sues, adding yet an­oth­er de­lay to the reg­u­la­to­ry time­line.

The New Jer­sey-based com­pa­ny’s shares plum­met­ed about 33.5% in ear­ly Fri­day trad­ing.

The drug — called IM­MU-132 or sac­i­tuzum­ab govite­can — is an an­ti­body drug con­ju­gate (ADC) or an armed an­ti­body which is de­signed to de­liv­er a spe­cif­ic pay­load of a chemother­a­py di­rect­ly to a tu­mor, to re­duce the tox­i­c­i­ty as­so­ci­at­ed with the con­ven­tion­al ad­min­is­tra­tion of chemother­a­py. The FDA grant­ed the drug pri­or­i­ty re­view on the ba­sis of da­ta from an on­go­ing sin­gle-arm Phase II study in pa­tients with metasta­t­ic triple-neg­a­tive breast can­cer (mTNBC) who have un­der­gone pri­or ther­a­py. Sac­i­tuzum­ab govite­can, which is al­so be­ing test­ed in a con­fir­ma­to­ry Phase III study in mTNBC pa­tients, was ex­pect­ed to win ac­cel­er­at­ed ap­proval on Jan­u­ary 18. An­a­lysts had sug­gest­ed avail­able mid-stage drug da­ta in­di­cat­ed it was a sig­nif­i­cant im­prove­ment over stan­dard-of-care and had as­signed it peak sales ex­pec­ta­tions of $1 bil­lion and more.

Michael Pehl

In its last up­date in De­cem­ber, Im­munomedics re­port­ed da­ta from the 108-pa­tient mid-stage study — as as­sessed by in­de­pen­dent re­view — demon­strat­ed the drug in­duced par­tial or com­plete tu­mor shrink­age in 34% of pa­tients, with a me­di­an du­ra­tion of re­sponse of about 9 months.

To be sure, the com­pa­ny was not ex­pect­ing the re­jec­tion. It hired a sales force back in No­vem­ber in an­tic­i­pa­tion of the Jan­u­ary ap­proval and told an­a­lysts in De­cem­ber that man­u­fac­tur­ing is­sues the US health reg­u­la­tor had flagged in Au­gust had been since ad­dressed.

In a De­cem­ber 20 note, Jef­feries an­a­lysts said that while man­u­fac­tur­ing is­sues could be a source of con­cern, they re­mained “con­fi­dent in ‘132 as the com­pa­ny be­lieves all is­sues have been re­solved and it has in­vest­ed heav­i­ly in the com­mer­cial in­fra­struc­ture pri­or to ap­proval. Ad­di­tion­al­ly, we would high­light that IM­MU has se­cured an agree­ment with Sam­sung Bi­o­log­ics as a sec­ondary man­u­fac­tur­er…pro­vid­ing risk mit­i­ga­tion if is­sues can­not be re­solved at cur­rent site.”

On Thurs­day, Im­munomedics un­der­scored the sac­i­tuzum­ab govite­can re­jec­tion had noth­ing to do with the drug’s clin­i­cal da­ta.

“The is­sues re­lat­ed to ap­prov­abil­i­ty in the CRL were ex­clu­sive­ly fo­cused on Chem­istry, Man­u­fac­tur­ing and Con­trol mat­ters and no new clin­i­cal or pre­clin­i­cal da­ta need to be gen­er­at­ed,” Im­munomedics chief Michael Pehl said in a state­ment, adding that the com­pa­ny in­tend­ed to re­quest a meet­ing with the FDA to bet­ter un­der­stand the agency’s re­quire­ments.

But with no light at the end of the gov­ern­ment shut­down tun­nel, who knows how long that will take.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

#ES­MO20: Push­ing in­to front­line, Mer­ck and Bris­tol My­ers duke it out with new slate of GI can­cer da­ta

Having worked in parallel for years to move their respective PD-1 inhibitors up to the first-line treatment of gastrointestinal cancers, Merck and Bristol Myers Squibb finally have the data at ESMO for a showdown.

Comparing KEYNOTE-590 and CheckMate-649, of course, comes with the usual caveats. But a side-by-side look at the overall survival numbers also offer some perspective on a new frontier for the reigning checkpoint rivals, both of whom are claiming to have achieved a first.

President Donald Trump (via AP Images)

Signs of an 'Oc­to­ber Vac­cine Sur­prise' alarm ca­reer sci­en­tists

President Donald Trump, who seems intent on announcing a COVID-19 vaccine before Election Day, could legally authorize a vaccine over the objections of experts, officials at the FDA and even vaccine manufacturers, who have pledged not to release any vaccine unless it’s proved safe and effective.

In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Trump — who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA — will take matters into his own hands, running roughshod over the usual regulatory process.

#ES­MO20: Bris­tol My­ers marks Op­di­vo's sec­ond ad­ju­vant win — eye­ing a stan­dard of care gap

Moving into earlier and earlier treatment lines, Bristol Myers Squibb is reporting that adjuvant treatment with Opdivo has doubled the time that esophageal or gastroesophageal junction cancer patients stay free of disease.

With the CheckMate-577 data at ESMO, CMO Samit Hirawat said, the company believes it can change the treatment paradigm.

While a quarter to 30% of patients typically achieve a complete response following chemoradiation therapy and surgery, the rest do not, said Ronan Kelly of Baylor University Medical Center. The recurrence rate is also high within the first year, Hirawat added.

Clay Siegall (Life Science Washington via YouTube)

#ES­MO20: Seat­tle Ge­net­ics eyes 4th ap­proval with new da­ta in a crowd­ed field

Does Seattle Genetics have another approval on its hands?

The last 12 months, not so great for the world, has been great for Seattle Genetics. The company landed two separate FDA approvals, signed a $4.5 billion deal with Merck and watched antibody-drug conjugates — the technology they spent years developing to broad industry skepticism — emerge suddenly as one of the most popular approaches in oncology. And on Monday at ESMO, the company and their partners at Genmab unveiled the data behind the ADC it hopes will provide its next major FDA approval.

Jonathan Rigby, Immune Regulation group CEO

Im­mune Reg­u­la­tion, tak­ing two clin­i­cal pro­grams to 're­set' the im­mune sys­tem, nets $53M+ Se­ries B

A little under two years after a company rebranding, Immune Regulation is taking an even bigger step toward advancing its goals.

Formerly known as Peptinnovate, the British biotech announced a $53.4 million Series B early Monday morning, helping to further advance two clinical programs in rheumatoid arthritis and asthma. Though those are the two initial indications the company is focusing on, CEO Jonathan Rigby told Endpoints News he hopes the candidates can be applied to a broad swath of autoimmune disorders.

Eli Lilly CSO Dan Skovronsky (file photo)

UP­DAT­ED: #ES­MO20: Eli Lil­ly shows off the da­ta for its Verzenio suc­cess. Was it worth $18 bil­lion?

The press release alone, devoid of any number except for the size of the trial, added nearly $20 billion to Eli Lilly’s market cap back in June. Now investors and oncologists will get to see if the data live up to the hype.

On Sunday at ESMO, Eli Lilly announced the full results for its Phase III MonarchE trial of Verzenio, showing that across over 5,000 women who had had HR+, HER2- breast cancer, the drug reduced the odds of recurrence by 25%. That meant 7.8% of the patients on the drug arm saw their cancers return within 2 years, compared with 11.3% on the placebo arm.

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Greg Friberg (File photo)

#ES­MO20: Am­gen team nails down sol­id ear­ly ev­i­dence of AMG 510’s po­ten­tial for NSCLC, un­lock­ing the door to a wave of KRAS pro­grams

The first time I sat down with Amgen’s Greg Friberg to talk about the pharma giant’s KRAS G12C program for sotorasib (AMG 510) at ASCO a little more than a year ago, there was high excitement about the first glimpse of efficacy from their Phase I study, with 5 of 10 evaluable non-small cell lung cancer patients demonstrating a response to the drug.

After decades of failure targeting KRAS, sotorasib offered the first positive look at a new approach that promised to open a door to a whole new approach by targeting a particular mutation to a big target that had remained “undruggable” for decades.

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#ES­MO20: Out to beat Tagris­so, J&J touts 100% ORR for EGFR bis­pe­cif­ic/TKI com­bo — fu­el­ing a quick leap to PhI­II

J&J’s one-two punch on EGFR-mutant non-small cell lung cancer has turned up some promising — although decidedly early — results, fueling the idea that there’s yet room to one up on third-generation tyrosine kinase inhibitors.

Twenty out of 20 advanced NSCLC patients had a response after taking a combination of an in-house TKI dubbed lazertinib and amivantamab, a bispecific antibody targeting both EGFR and cMET engineered on partner Genmab’s platform, J&J reported at ESMO. All were treatment-naïve, and none has seen their cancer progress at a median follow-up of seven months.