Pi­lot project pro­vides a snap­shot of ef­fec­tive­ness of Pfiz­er’s PARP con­tender ta­la­zoparib

Jen­nifer Lit­ton, MD An­der­son Can­cer Cen­ter

You can ex­pect some no­table re­search up­dates on the slate of late-stage PARP in­hibitors at this week­end’s an­nu­al Eu­ro­pean So­ci­ety of Med­ical On­col­o­gy meet­ing. And an ear­ly teas­er on what’s to come at ES­MO should help whet every­one’s ap­petite for more.

Jen­nifer Lit­ton, the prin­ci­pal in­ves­ti­ga­tor in the Phase III ta­la­zoparib study and an in­ves­ti­ga­tor at MD An­der­son Can­cer Cen­ter, set up a small pi­lot study that used the PARP in­hibitor on a group of 13 breast can­cer pa­tients with BR­CA mu­ta­tions.

These pa­tients were giv­en the drug ahead of pre-sur­gi­cal chemo, and Lit­ton says her group tracked an av­er­age 78% tu­mor shrink­age among the women in the study. The full range ex­tend­ed from 30% to 98%.

“Ac­knowl­edg­ing that this is a small study, I can’t think of any sys­temic ther­a­py that gives re­sults this con­sis­tent­ly strong in on­ly two months,” Lit­ton said. A few weeks ago, Lit­ton start­ed an ex­ten­sion of the pi­lot, en­rolling the first 6 of 20 pa­tients who can shed fur­ther light on the drug’s use in treat­ing breast can­cer. And her group is us­ing back­ing from MD An­der­son’s Moon Shots pro­gram for the work, look­ing to quick­ly ad­vance new ther­a­pies for can­cer.

“If this study pro­duces sim­i­lar­ly strong re­sults, the next step would be to di­rect­ly com­pare ta­la­zoparib to chemother­a­py in the pre-sur­gi­cal, cu­ra­tive set­ting,” Lit­ton added, “We might be able to de­lay or re­place chemother­a­py if we can get sim­i­lar ef­fi­ca­cy with less tox­i­c­i­ty from treat­ment.”

That’s an in­trigu­ing piece of the puz­zle for Pfiz­er $PFE, which agreed to pay $14 bil­lion for Medi­va­tion to get its hands on Xtan­di as well as the late-stage PARP drug. These drugs work by block­ing a DNA re­pair path­way and there has been a con­sid­er­able amount of re­search demon­strat­ing their ef­fec­tive­ness as well as a rel­a­tive­ly good safe­ty pro­file.

The big show this week­end, though, will be re­served for Tesaro $TSRO and Clo­vis On­col­o­gy $CLVS, which both have close­ly-watched PARPs lin­ing up for po­ten­tial ap­provals. For Clo­vis, ru­ca­parib presents its first re­al op­por­tu­ni­ty to gain a cru­cial­ly im­por­tant FDA ap­proval. And Tesaro has been fu­el­ing high hopes with its own late-stage da­ta set. Share prices on both com­pa­nies have been soar­ing over the last few months.

We’ll keep you post­ed on the re­sults.

Image courtesy of The Janssen Pharmaceutical Companies of Johnson & Johnson.

Pro­tect­ing the glob­al phar­ma­ceu­ti­cal in­no­va­tion ecosys­tem – what’s at stake?

We are living in a new era of healthcare that is rapidly advancing progress impacting patient outcomes and experiences. We’ve seen a remarkable pace of transformational innovation, applied research, and advanced clinical development over the last decade.

Despite this tremendous progress, there is much more work to be done, and patients are counting on us – now more than ever – to continue that momentum. At the heart of our industry is a focus on developing and delivering medicines for some of the world’s most challenging diseases, including those that have few or no effective treatments today.

Eu­ro­pean Par­lia­ment calls mem­ber states to ac­tion on an­timi­cro­bial re­sis­tance

Members of the European Parliament have called on EU countries to develop national action plans against antimicrobial resistance (AMR), calling it a top-three priority health threat.

Parliament on Thursday announced recommendations for the fight against AMR, including national action plans that must be updated at least every two years, an EU-level database tracking AMR and antimicrobial use and increased partnership between the pharma industry, patient groups and academia.

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Andrey Zarur, GreenLight Biosciences CEO

Green­Light Bio­sciences se­cures merg­er as it looks to go pri­vate

GreenLight Bioscience, the developer and manufacturer of RNA vaccines and therapeutics, is set to be acquired.

The company announced earlier this week that it would be acquired by a group of buyers led by Fall Line Capital in a cash deal valuing GreenLight at around $45.5 million. According to a release, Fall Line and the group agreed to acquire all of the shares of the company for $0.30 per share. The deal is expected to close sometime in the third quarter of this year.

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Roche plans to di­vest from lega­cy Genen­tech man­u­fac­tur­ing fa­cil­i­ty in Cal­i­for­nia

Roche is planning to make some changes to its subsidiary’s manufacturing network in California.

The Swiss pharma announced Wednesday that it plans to divest from Genentech’s manufacturing facility in Vacaville, CA, around 58 miles northeast of San Francisco. According to a statement from Roche, the move is part of a “broader strategy” to bring its manufacturing capabilities in line with its future pipeline. Roche is starting the process of finding a buyer for the site but has not named any candidates yet.

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FDA lifts hold on Mol­e­c­u­lar Tem­plates’ mul­ti­ple myelo­ma tri­al af­ter less than two months

The FDA has lifted a partial clinical hold on Molecular Templates’ early-stage trial for a multiple myeloma drug, the biotech company announced Thursday morning.

Regulators had put the trial on partial hold in early April, pausing patient enrollment, following two adverse heart-related events in patients who received the highest dose of Molecular Templates’ treatment MT-0169 last year. One patient had asymptomatic grade 2 myocarditis, or heart muscle inflammation, while the other had a grade 3 cardiomyopathy. Both recovered within two months.

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Roger Perlmutter, Eikon Therapeutics CEO

Roger Perl­mut­ter builds Eikon's pipeline with deal-mak­ing flur­ry, rais­ing $106M more

Eikon Therapeutics announced three business development deals on Thursday, effectively dropping in a pipeline of cancer drugs alongside more than $100 million in fresh funding.

The Hayward, CA-based company has become one of biotech’s richest startups since its 2019 founding, having raised nearly $775 million. It’s developing a massive, automated research approach built around Nobel Prize-winning microscope science to peer inside cells and watch proteins in action. After its Series B last year, PitchBook reported a $3.02 billion valuation. And while CEO Roger Perlmutter declined to comment on that figure, he said its first tranche of nearly $106 million in Series C funding is a “meaningful step-up to our Series B valuation.”

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Peter van de Sande, Synaffix CEO

Lon­za shells out $107M cash to snap up Synaf­fix and its ADC plat­form

After lining up a string of partnerships over the years, Dutch antibody-drug conjugate specialist Synaffix has found a new home: Lonza, the contract development and manufacturing giant.

Lonza is paying about $107 million (€100 million) in cash to acquire Synaffix, with up to $64 million (€60 million) in “additional performance-based consideration” on the table. Synaffix’s ADC tech platform will now become part of Lonza’s offering for biopharma clients, lending its bioconjugate technologies to not just ADCs but also targeted gene therapy, immune cell engagers and other applications.

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Who's con­fi­dent­ly in­vest­ing in biotech star­tups dur­ing these tense days? We've got some an­swers

We’ve got a changeup to our event schedule in Boston next week, where we’ll be doing a mix of live/streaming events at our base at The Seaport Hotel as part of a two-day lineup of webinars, virtual firesides and a cocktail hour Q&A with a veteran of the biotech financing scene.

The 9:30-10:30 am ET live slot on Tuesday, June 6, will now feature a panel conversation on the current state of affairs for VC investing in biotech, focusing on what startups are getting cash — and how. Alaa Halawa, head of US ventures at Mubadala, is confirmed, along with Brian Goodman at MPM and Geoff von Maltzahn, a general partner at Moderna-buoyed Flagship. I have a couple of other invites out and will let you know how that plays out.

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As­traZeneca gives up on late-stage IL-23 drug due to tri­al de­lays, com­pet­i­tive land­scape

AstraZeneca is shelving an IL-23 antibody that’s been through a winding journey around pharma — including stops at Amgen and Allergan — and putting an end to Phase II and III trials testing the drug for inflammatory bowel disease.

“The decision to discontinue brazikumab’s IBD development follows a recent review of brazikumab’s development timeline and the context of a competitive landscape that has continued to evolve,” a press release reads.

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