Roche shares spike as PhI­II breast can­cer com­bo with Per­je­ta scores a suc­cess, Puma takes a beat­ing

San­dra Horn­ing

Roche scored a big win for its can­cer fran­chise to­day, re­port­ing that a key Phase III tri­al adding Per­je­ta to Her­ceptin and chemother­a­py out­per­formed the two old­er stan­dards alone in re­duc­ing the risk of death or re­lapse for ear­ly-stage breast can­cer pa­tients af­ter surgery. An­a­lysts crowed that the clin­i­cal vic­to­ry sig­nals a ma­jor ad­vance for Roche, like­ly adding bil­lions to its megablock­buster on­col­o­gy fran­chise.

Shares of Roche jumped as much as 7% on Thurs­day morn­ing, a rare spike for a Big Phar­ma like Roche.

Her­ceptin has played a huge role in com­bat­ing HER2-pos­i­tive breast can­cer. But Roche is now fac­ing gener­ic com­pe­ti­tion on that front that could se­ri­ous­ly erode sales. Adding Per­je­ta to their com­bo will make it a much tougher fran­chise to com­pete against.

Tim An­der­son, who ex­pects to see Per­je­ta world­wide sales dou­ble to more than $4 bil­lion in the next five years, wants to see the da­ta at AS­CO. “With­out full de­tails of the da­ta, how­ev­er, some de­gree of hand-wring­ing will like­ly con­tin­ue, in terms of just how big the clin­i­cal ben­e­fit is like­ly to be,” he added.

That mes­sage was not lost on in­vestors in Puma $PBYI. The biotech has been test­ing a com­bi­na­tion of ner­a­tinib and chemo against the stan­dard Her­ceptin matchup in breast can­cer. And while it has pro­duced pos­i­tive da­ta, ner­a­tinib is al­so linked close­ly with se­vere di­ar­rhea.

“Fol­low­ing this morn­ing’s…pos­i­tive top-line da­ta in APHIN­I­TY, bar­ring any un­like­ly and un­ex­pect­ed sur­pris­es when the full da­ta are pre­sent­ed (most like­ly at AS­CO), the com­mer­cial op­por­tu­ni­ty for ner­a­tinib in the ex­tend­ed ad­ju­vant set­ting should be con­sid­ered as elim­i­nat­ed,” not­ed RBC’s Simos Sime­oni­dis.

Puma’s shares tanked this morn­ing, plung­ing 23% in pre-mar­ket trad­ing.

The da­ta from Roche’s APHIN­I­TY study will have to wait for an up­com­ing con­fer­ence, but an­a­lysts say that they’re look­ing for a sev­er­al point im­prove­ment in the per­cent­age of women in this study whose breast can­cer did not re­turn with­in three years, beat­ing a stan­dard com­bo that al­ready has scored a very high suc­cess rate in stop­ping can­cer.

“These re­sults from the pos­i­tive APHIN­I­TY study rep­re­sent an im­por­tant ad­di­tion to the body of da­ta for Per­je­ta in the treat­ment of peo­ple with HER2-pos­i­tive ear­ly breast can­cer,” said San­dra Horn­ing, MD, chief med­ical of­fi­cer and head of Glob­al Prod­uct De­vel­op­ment. “We look for­ward to dis­cussing these ad­ju­vant re­sults with glob­al reg­u­la­to­ry au­thor­i­ties.”

Gunter von Minck­witz, MD, study co­or­di­na­tor from the Breast In­ter­na­tion­al Group and aca­d­e­m­ic study part­ners, added:

“APHIN­I­TY pro­vides yet an­oth­er ex­am­ple of the im­por­tance of in­dus­try-aca­d­e­m­ic col­lab­o­ra­tions and their val­ue in ad­vanc­ing can­cer care for peo­ple af­fect­ed by this chal­leng­ing dis­ease.”

Tesla and SpaceX founder Elon Musk gestures to the audience after being recognized by President Trump following the successful launch of a Falcon 9 rocket at the Kennedy Space Center. (via Getty Images)

Tes­la chief Elon Musk teams up with Covid-19 play­er Cure­Vac to build 'R­NA mi­cro­fac­to­ries'

Elon Musk has joined the global tech crusade now underway to revolutionize vaccine manufacturing — now aimed at delivering billions of doses of a new mRNA vaccine to fight Covid-19. And he’s cutting right to the front.

In a late-night tweet Wednesday, the Tesla chief announced:

Tesla, as a side project, is building RNA microfactories for CureVac & possibly others

That’s not a lot to go on. But the tweet comes a year after Tesla’s German division in Grohmann and CureVac filed a patent on a “bioreactor for RNA in vitro transcription, a method for RNA in vitro transcription, a module for transcribing DNA into RNA and an automated apparatus for RNA manufacturing.” CureVac, in the meantime, has discussed a variety of plans to build microfactories that can speed up the whole process for a global supply chain.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,700+ biopharma pros reading Endpoints daily — and it's free.

George Yancopoulos (Regeneron)

Re­gen­eron co-founder George Yan­copou­los of­fers a com­bat­ive de­fense of the po­lice at a high school com­mence­ment. It didn’t go well

Typically, the commencement speech at Yorktown Central School District in Westchester — like most high schools — is an opportunity to encourage students to face the future with confidence and hope. Regeneron president and co-founder George Yancopoulos, though, went a different route.

In a fiery speech, the outspoken billionaire defended the police against the “prejudice and bias against law enforcement” that has erupted around the country in street protests from coast to coast. And for many who attended the commencement, Yancopoulos struck the wrong note at the wrong time, especially when he combatively challenged someone for interrupting his speech with a honk for “another act of cowardness.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,700+ biopharma pros reading Endpoints daily — and it's free.

Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)

Elias Zer­houni dis­cuss­es ‘am­a­teur hour’ in DC, the de­struc­tion of in­fec­tious dis­ease R&D and how we need to prep for the next time

Elias Zerhouni favors blunt talk, and in a recent discussion with NPR, the ex-Sanofi R&D and ex-NIH chief had some tough points to make regarding the pandemic response.

Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

It was basically amateur hour. There is no central concept of operations for preparedness, for pandemics, period. This administration doesn’t want to or has no concept of what it takes to protect the American people and the world because it is codependent. You can’t close your borders and say, “OK, we’re going to be safe.” You’re not going to be able to do that in this world. So it’s a lack of vision, basically just a lack of understanding, of what it takes to protect the American people.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,700+ biopharma pros reading Endpoints daily — and it's free.

Pfiz­er shares surge on pos­i­tive im­pact of their mR­NA Covid-19 vac­cine — part­nered with BioN­Tech — in an ear­ly-stage study

Pfizer and their partners at the mRNA specialist BioNTech have published the first glimpse of biomarker data from an early-stage study spotlighting the “robust immunogenicity” triggered by their Covid-19 vaccine, which is one of the leaders in the race to vanquish the global pandemic.

Researchers selected 45 healthy volunteers 18-55 years of age for the study. They were randomized to receive 2 doses, separated by 21 days, of 10 µg, 30 µg, or 100 µg of BNT162b1, “a lipid nanoparticle-formulated, nucleoside-modified, mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein RBD.” Their responses were compared against the effect of a natural, presumably protective defense offered by a regular infection.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,700+ biopharma pros reading Endpoints daily — and it's free.

Sec­ond death trig­gers hold on Astel­las' $3B gene ther­a­py biotech's lead pro­gram, rais­ing fresh con­cerns about AAV

Seven months after Astellas shelled out $3 billion to acquire the gene therapy player Audentes, the biotech company’s lead program has been put on hold following the death of 2 patients taking a high dose of their treatment. And there was another serious adverse event recorded in the study as well, with a total of 3 “older” patients in the study affected.

The incidents are derailing plans to file for a near-term approval, which had been expected right about now.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,700+ biopharma pros reading Endpoints daily — and it's free.

An ex­pe­ri­enced biotech is stitched to­geth­er from transpa­cif­ic parts, with 265 staffers and a fo­cus on ‘new bi­ol­o­gy’

Over the past few years, different teams at a pair of US-based biotechs and in labs in Japan have labored to piece together a group of cancer drug programs, sharing a single corporate umbrella with research colleagues in Japan. But now their far-flung operations have been knit together into a single unit, creating a pipeline with 10 cancer drug development programs — going from early-stage right into Phase III — and a host of discovery projects managed by a collective staff of some 265 people.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,700+ biopharma pros reading Endpoints daily — and it's free.

Joseph Kim, Inovio CEO (Andrew Harnik, AP Images)

Pos­i­tive Covid-19 vac­cine da­ta? New mouse study? OWS in­clu­sion? Yep, but some­how, the usu­al tid­bits from In­ovio back­fire

You don’t go more than 40 years in biotech without ever getting a product to market unless you can learn the art of writing a promotional press release. And Inovio captures the prize in baiting the hook.

Tuesday morning Inovio, which has been struggling to get its Covid-19 vaccine lined up for mass manufacturing, put out a release that touched on virtually every hot button in pandemic PR.

There was, first and foremost, an interim snapshot of efficacy from their Phase I program for INO-4800.

Jan van de Winkel, Genmab CEO

Seat­tle Ge­net­ics, Gen­mab turn on TV for a high­light reel in cer­vi­cal can­cer — but a ri­val biotech promis­es a bet­ter show

Seattle Genetics $SGEN and their partners at Genmab $GMAB polished up some positive Phase II numbers for their antibody drug conjugate tisotumab vedotin — you can call it TV — for recurrent cervical cancer. And while they mapped out a shortcut to a potential quick approval, the big challenge for this team is being presented by a rival biotech which muscled its way into the spotlight for the same indication a year ago.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,700+ biopharma pros reading Endpoints daily — and it's free.

Randy Schatzman, Bolt CEO (Bolt Biotherapeutics)

Bolt Bio­ther­a­peu­tics nabs $93.5M to push Provenge in­ven­tor's new idea deep­er in the clin­ic

A cancer-fighting concept from the inventor of the first cancer vaccine is nearing prime time, and its biotech developer has received a significant new infusion of cash to get it there.

Bolt Biotherapeutics announced a $93.5 million Series C round led by Sofinnova Investments and joined by more than 9 others, including Pfizer Ventures and RA Capital Management. That money will go toward pushing the San Francisco biotech’s platform of innate immune-boosting warheads through its first trial on metastatic solid tumors and into several more.