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.

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Vlad Coric, Biohaven CEO

Vlad Coric charts course for new Bio­haven with neu­ro­science push and Big Phar­ma vets on board

What’s Biohaven without its CGRP portfolio? That’s what CEO Vlad Coric is tasked with deciding as he maps out the new Biohaven post-Pfizer takeover.

Pfizer officially scooped up Biohaven’s CGRP assets on Monday, including blockbuster migraine drug Nurtec and the investigational zavegepant, for $11.6 billion. As a result, Coric spun the broader pipeline into an independent company on Tuesday — with the same R&D team behind Nurtec but about 1,000 fewer staffers and a renewed focus on neuroscience and rare disease.

Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

Fa­ther starts lab af­ter in­tel­lec­tu­al prop­er­ty is­sues stymie rare dis­ease drug de­vel­op­ment

Under bright lab lights, Casey McPherson holds his 6-year-old daughter, Rose. His free hand directs Rose’s gaze toward a computer screen with potential clues in treating her one-of-a kind genetic condition.

Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

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Dave Marek, Myovant CEO

My­ovant board balks as ma­jor­i­ty own­er Sum­it­o­mo swoops in with a $2.5B deal to buy them out

Three years after Sumitomo scooped up Roivant’s 46% stake in the publicly traded Myovant $MYOV as part of a 5-company, $3 billion deal, they’re coming back for the whole thing.

But these other investors at Myovant want more than what the Japanese pharma company is currently offering to pay at this stage.

Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

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In AstraZeneca's latest campaign, wild eosinophils called Phils personify the acting up often seen in uncontrolled asthma

As­traZeneca de­buts an­noy­ing pur­ple ‘Phil’ crea­tures, per­son­i­fied asth­ma eosinophils ‘be­hav­ing bad­ly’

There are some odd-looking purple creatures lurking around the halls of AstraZenca lately. The “Phil” character cutouts are purple, personified eosinophils with big buggy eyes and wide mouths, and they’re a part of AZ’s newest awareness effort to help people understand eosinophilic asthma.

The “Asthma Behaving Badly” characters aren’t only on the walls at AZ to show the new campaign to employees, however. The “Phils” are also showing up online on the campaign website, and in digital and social ads and posts on Facebook and Instagram.

Christophe Bourdon, Leo Pharma CEO

Leo Phar­ma looks 'be­yond the skin' in atopic der­mati­tis aware­ness cam­paign

As Leo Pharma aims to take on heavyweight champ Dupixent in atopic dermatitis, the company is launching “AD Days Around the World,” an awareness campaign documenting real patient stories across Europe.

The project, unveiled on Monday, spotlights four patients: Marjolaine, Laura, Julia and África from France, Italy, Germany and Spain, respectively, in short video clips on the challenges of living with AD, the most common form of eczema.

Marc Dunoyer, Alexion CEO (AstraZeneca via YouTube)

Up­dat­ed: As­traZeneca nabs a small rare dis­ease gene ther­a­py play­er for 667% pre­mi­um

AstraZeneca is kicking off the fourth quarter with a little M&A Monday for a gene editing player recently overcoming a second clinical hold to its only program in human studies.

The Big Pharma and its subsidiary Alexion are buying out little LogicBio for $2.07 per share. That’s good for a massive 667% premium over its Friday closing price, when it headed into the weekend at 27 cents and just weeks after Nasdaq said LogicBio would have to delist, which has been put on hold as the biotech requests a hearing. It’s one of two biotech deals to commence October, alongside the news of Incyte buying a vitiligo-focused biotech.

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Ying Huang, Legend CEO

Lentivi­ral vec­tor ramp-up: J&J and Leg­end to in­vest $500M in New Jer­sey man­u­fac­tur­ing to sup­port Carvyk­ti

In response to a question on manufacturing scale at Legend Biotech’s R&D day yesterday, the company’s top exec said its partnership with Johnson & Johnson will be doubling its investment in its New Jersey manufacturing center and will be investing a total of $500 million.

With an eye on their BCMA-directed CAR-T therapy Carvykti (cilta-cel), approved in February as a fifth-line treatment for multiple myeloma, Legend CEO Ying Huang said that the ramp-up in production and the decision to manufacture its own lentiviral vectors — currently in shortage worldwide — means they won’t have to deal with that shortage.

Kite Phar­ma gets FDA to sign off on new Cal­i­for­nia-based vec­tor man­u­fac­tur­ing fa­cil­i­ty

Kite Pharma just got FDA approval to kick off operations at a new manufacturing campus.

The cancer-focused, CAR-T cell therapy player made the announcement Monday, saying that the federal regulatory agency gave the green light to Kite’s 100,000 square-foot, retroviral vector manufacturing facility in Oceanside, CA.

Kite’s global head of technical operations Chris McDonald tells Endpoints News that the facility has been in the works for about four years, after Kite teamed up with its parent company Gilead. Gilead acquired Kite Pharma for just shy of $12 billion in 2017.