Im­munomedics lays out its case for an ac­cel­er­at­ed OK of IM­MU-132 in triple-neg­a­tive breast can­cer

Aditya Bar­dia, Mass­a­chu­setts Gen­er­al Hos­pi­tal Can­cer Cen­ter

A lit­tle over a month af­ter Seat­tle Ge­net­ics $SGEN snapped up the glob­al rights to Im­munomedics lead can­cer drug IM­MU-132 (sac­i­tuzum­ab govite­can) in a $2 bil­lion deal, in­clud­ing $300 mil­lion in cash, the Mor­ris Plains, NJ-based biotech de­tailed the da­ta they plan to hus­tle to the FDA from its pos­i­tive mid-stage study for triple-neg­a­tive breast can­cer.

While the study was a fair­ly small, sin­gle-arm probe of ef­fi­ca­cy and safe­ty, the two part­ners are plan­ning the short­est route pos­si­ble to see if they can get an ac­cel­er­at­ed ap­proval while the ther­a­py nav­i­gates a Phase III piv­otal study.

In­ves­ti­ga­tors in the study tracked a me­di­an over­all sur­vival rate of 16.6 months and a pro­gres­sion-free sur­vival time of six months for the drug, which has the FDA’s break­through ther­a­py des­ig­na­tion for TNBC. Al­so, 30% of the 69 heav­i­ly pre­treat­ed pa­tients in the sin­gle-arm study achieved an ob­jec­tive re­sponse — two com­plete and 19 par­tial.

“These re­sults are very en­cour­ag­ing giv­en the im­pres­sive clin­i­cal ac­tiv­i­ty seen in a re­frac­to­ry set­ting, dura­bil­i­ty of re­spons­es, and the safe­ty pro­file,” not­ed lead au­thor Aditya Bar­dia, MD, MPH, at­tend­ing physi­cian at Mass­a­chu­setts Gen­er­al Hos­pi­tal Can­cer Cen­ter. “The av­er­age PFS is about 3.5 months for stan­dard agents, in­clud­ing cis­platin, capecitabine, nab-pa­cli­tax­el, and eribu­lin, as re­port­ed in ear­li­er metasta­t­ic TNBC tri­als.”

Three out of four of the pa­tients in the study who had pre­vi­ous­ly been treat­ed with a check­point — and failed — al­so achieved a par­tial re­sponse, a snap­shot of pos­si­ble com­bo po­ten­tial the biotech plans to fol­low up on.

These da­ta were laid out in the Jour­nal of Clin­i­cal On­col­o­gy. And Im­munomedics stock bumped up on the re­port, which fol­lows ear­li­er re­ports of the drug’s ef­fi­ca­cy.

The drug is an an­ti­body-drug con­ju­gate, or armed an­ti­body, de­signed for pre­cise de­liv­ery of SN-38, the ac­tive metabo­lite of irinote­can. As such, it fits com­fort­ably in Seat­tle Ge­net­ics sphere.

The drug didn’t kill any­one, but it’s not with­out safe­ty is­sues. Thir­ty-nine per­cent of the pa­tients suf­fered from neu­trope­nia, with 7% ex­pe­ri­enc­ing febrile neu­trope­nia and 13% af­flict­ed by se­vere di­ar­rhea.

Re­marked Im­munomedics CEO Cyn­thia L. Sul­li­van:

“We are work­ing dili­gent­ly with the FDA to make this valu­able prod­uct can­di­date avail­able to this group of pa­tients as soon as pos­si­ble. Blind­ed, in­de­pen­dent ra­di­o­log­i­cal as­sess­ments are on­go­ing, and so far show a high con­cor­dance with lo­cal to­mog­ra­phy find­ings.”

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

The End­points 11: They've got mad mon­ey and huge am­bi­tions. It's time to go big or go home

These days, selecting a group of private biotechs for the Endpoints 11 spotlight begins with a sprint to get ahead of IPOs and the M&A teams at Big Pharma. I’ve had a couple of faceplants earlier this year, watching some of the biotechs on my short list choose a quick leap onto Nasdaq or into the arms of a buyer.

Vividion, you would have been a great pick for the Endpoints 11. I’m sorry I missed you.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Dave Lennon, former president of Novartis Gene Therapies

So what hap­pened with No­var­tis Gene Ther­a­pies? Here's your an­swer

Over the last couple of days it’s become clear that the gene therapy division at Novartis has quietly undergone a major reorganization. We learned on Monday that Dave Lennon, who had pursued a high-profile role as president of the unit with 1,500 people, had left the pharma giant to take over as CEO of a startup.

Like a lot of the majors, Novartis is an open highway for head hunters, or anyone looking to staff a startup. So that was news but not completely unexpected.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

Emma Walmsley, GlaxoSmithKline CEO (Credit: Fang Zhe/Xinhua/Alamy Live News)

The fire un­der Glax­o­SmithK­line's Em­ma Walm­s­ley grows as an­oth­er well-known ac­tivist in­vestor grabs its pitch­fork — re­port

Bluebell Capital Partners, a proxy brawler fresh off a campaign to oust global food giant Danone’s CEO and most of its board of directors, has bought a stake in UK drugmaker GlaxoSmithKline with its eyes trained directly on Emma Walmsley, the Financial Times reported Wednesday.

The London-based hedge fund joins another notorious activist firm in Paul Singer’s Elliott Management, which earlier this year called for a shakeup in leadership at GSK to handle what the company described as a wealth of riches across the drug giant’s portfolio hindered by limited vision from top staff.

FDA au­tho­rizes Pfiz­er's vac­cine boost­er for se­niors, those at high risk for se­vere Covid-19

The Biden administration’s goal of kicking off its booster shot drive for the entire US population this week is not quite going as planned.

First, Pfizer applied for approval of a supplemental application for the booster shots, but since last Friday’s adcomm reviewing them, the plan has devolved into an EUA, which the FDA issued late Thursday evening.

The population that is now eligible for the booster, six months after receiving the first pair of Pfizer-BioNTech vaccines, also narrowed from what Pfizer applied for (everyone who’s eligible for the initial Pfizer shots) to just those who are 65 or older, or at high-risk of a Covid infection, including health care workers and others with occupational hazards.

Stéphane Bancel, AP Images

Fi­nal analy­sis of US-fund­ed Mod­er­na Covid vac­cine tri­al shows 98% ef­fi­ca­cy against se­vere dis­ease

A final look at the results of the placebo-controlled Moderna trial in the New England Journal of Medicine, published Thursday afternoon, shows how the vaccine continues to prevent Covid-19 and severe cases after more than five months following the second shot.

Of the more than 30,000 enrolled in the trial that ultimately led to the vaccine’s EUA, only two people in the vaccine group got a severe form of the disease, compared to 106 in the placebo group — leading to an efficacy of 98%.

FDA+ roundup: Bs­U­FA III ready for show­time, court tells FDA to re-work com­pound­ing plan, new guid­ance up­dates and more

The FDA has now spelled out what exactly will be included in the third iteration of Biosimilar User Fee Act (BsUFA) from 2023 through 2027, which similarly to the prescription drug deal, sets fees that industry has to pay for submitting applications, in exchange for firm timelines that the agency must meet.

This latest deal includes several sweeteners for the biosimilar industry, which has yet to make great strides in the US market, with shorter review timelines for safety labeling updates and updates to add or remove an indication that does not contain efficacy data.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Jean Bennett (Brent N. Clarke/Invision/AP Images)

Lux­tur­na in­ven­tor Jean Ben­nett starts a new gene ther­a­py com­pa­ny to tack­le rare dis­eases left be­hind by phar­ma, VCs

A few years ago Jean Bennett found herself in a surprising place for a woman who invented the first gene therapy ever approved in the United States: No one, it seemed, wanted her work.

Bennett, who designed and co-developed Luxturna, approved in 2018 for a rare form of blindness, had kept building new gene therapies for eye diseases at her University of Pennsylvania lab. But although the results in animals looked promising, pharma companies and investors kept turning down the pedigreed ophthalmology professor.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 118,000+ biopharma pros reading Endpoints daily — and it's free.