Xiaolin Zhang, Dizal CEO

#ES­MO22: Dizal touts win in niche NSCLC pop­u­la­tion cor­nered by Take­da, J&J

As­traZeneca spin­out Dizal said its can­cer drug cleared the pri­ma­ry goal in a Phase II tri­al of pa­tients with EGFR ex­on 20 in­ser­tion mu­ta­tions, for which Take­da and J&J have ap­proved meds, and oth­ers like Cul­li­nan On­col­o­gy and Blue­print Med­i­cines are at­tempt­ing to treat.

Send­ing out the da­ta in the ear­ly hours of this year’s Eu­ro­pean So­ci­ety for Med­ical On­col­o­gy meet­ing in Paris, Dizal said 59.8% of pa­tients evalu­able as of the end of Ju­ly had a con­firmed ob­jec­tive re­sponse. The study, con­duct­ed in Chi­na, test­ed the break­through-des­ig­nat­ed sun­voz­er­tinib in plat­inum-pre­treat­ed non-small cell lung can­cer pa­tients who have EGFR ex­on 20 in­ser­tion mu­ta­tions.

That pop­u­la­tion, about 2% to 3% of pa­tients with NSCLC, has two ap­proved drugs: Take­da’s Exkiv­i­ty and John­son & John­son’s Ry­bre­vant. The FDA green­lit both in 2021.

Shang­hai-based Dizal said 58 of 97 pa­tients (59.8%) in the 300 mg co­hort had a con­firmed ob­jec­tive re­sponse, as de­ter­mined by the blind­ed in­de­pen­dent cen­tral re­view team. Out of 31 pa­tients who had base­line brain metas­ta­sis, 15 of them (48.4%) had a con­firmed ob­jec­tive re­sponse.

The WU-KONG6 tri­al, which Dizal is billing as a piv­otal study, had 277 pa­tients evalu­able for safe­ty, with di­ar­rhea and rash be­ing the most com­mon treat­ment-re­lat­ed ad­verse events, the biotech said. The ad­verse ef­fects were “mild in na­ture and re­versible,” the com­pa­ny said.

Dizal of­fered no oth­er da­ta from the study in its short press re­lease Tues­day.

The biotech, launched as a joint ven­ture be­tween As­traZeneca and a Chi­na-owned pri­vate eq­ui­ty shop in 2017, had pre­vi­ous­ly at­tempt­ed to test the drug in pa­tients with non-Hodgkin’s B cell lym­phoma, but that tri­al was sus­pend­ed due to “clin­i­cal de­vel­op­ment strat­e­gy ad­just­ment, non-safe­ty rea­son,” ac­cord­ing to an up­date to the US fed­er­al clin­i­cal tri­als data­base.

With break­through tags both in the US and Chi­na, Dizal said the drug is in “glob­al piv­otal stud­ies” for first-line and be­yond the treat­ment of the niche NSCLC pop­u­la­tion, with tri­als in Chi­na, the US, EU, Aus­tralia, South Ko­rea and else­where.

“The im­por­tance of ad­vanc­ing re­search on NSCLC with EGFR ex­on20ins mu­ta­tion — a com­pli­cat­ed and dev­as­tat­ing dis­ease — can­not be over­stat­ed, as avail­able treat­ment op­tions pro­vide lim­it­ed ben­e­fit, es­pe­cial­ly to those who de­vel­op brain metas­ta­sis,” CEO Xi­aolin Zhang said in a state­ment.

Dizal’s da­ta drop fol­lows that of Cul­li­nan at this year’s AS­CO, where the biotech showed that its oral ty­ro­sine ki­nase in­hibitor led to me­di­an pro­gres­sion-free sur­vival of about 12 months in a Phase I/IIa study. The tri­al of CLN-081 al­so showed that 28 of 73 over­all pa­tients had a con­firmed par­tial re­sponse. An­oth­er 42 had sta­ble dis­ease and 3 had pro­gres­sive dis­ease, Cul­li­nan re­port­ed at the US on­col­o­gy con­fab in Chica­go in June.

Al­so in the EGFR 20 field is Blue­print Med­i­cines, which en­tered the clin­ic with a drug, BLU-451, tar­get­ing the mu­ta­tions in March thanks to its ac­qui­si­tion of Lengo Ther­a­peu­tics in late 2021.

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.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,400+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,400+ biopharma pros reading Endpoints daily — and it's free.

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.

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.

Rob Etherington, Clene CEO

Star­tup's gold nanocrys­tal ALS drug flops a PhII tri­al, a re­minder of the dis­ease's ob­sta­cles de­spite Amy­lyx OK

Despite the FDA approving an ALS drug for the first time in five years last week, the disease continues to fluster researchers, and another biotech is feeling the pain of a mid-stage failure.

Clene Nanomedicine reported early Monday that its ALS program, which uses gold nanocrystals to try to catalyze intracellular reactions, did not achieve its Phase II primary or secondary endpoints. And in a press release, the company noted for the first time that it’s speaking with “potential strategic partners” about the program — language that typically indicates a biotech is preparing to sell off an asset.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,400+ biopharma pros reading Endpoints daily — and it's free.

Mar­ket­ingRx roundup: No­var­tis re­cruits NFL coach for Leqvio cam­paign; Pfiz­er pro­motes ‘Sci­ence’ merch on so­cial me­dia

Novartis is turning to a winning coach to talk about Leqvio and the struggles of high cholesterol — including his own. Bruce Arians, the retired NFL head coach of the Arizona Cardinals and Super Bowl-winning Tampa Bay Buccaneers, is partnering with the pharma for its “Coaching Cholesterol” digital, social and public relations effort.

In the campaign, Arians talks about the potential for “great comebacks” in football and heart health. Once nicknamed a “quarterback whisperer,” he is now retired from fulltime coaching (although still a front-office consultant for Tampa Bay), and did a round of media interviews for Novartis, including one with People and Forbes.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,400+ biopharma pros reading Endpoints daily — and it's free.

Amy West, Novo Nordisk head of US digital innovation and transformation (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: No­vo Nordisk dig­i­tal in­no­va­tion chief Amy West dis­cuss­es phar­ma pain points and a health­care 'easy but­ton’

Amy West joined Novo Nordisk more than a decade ago to oversee marketing strategies and campaigns for its US diabetes portfolio. However, her career path shifted into digital, and she hasn’t looked back. West went from leading Novo’s first digital health strategy in the US to now heading up digital innovation and transformation.

She’s currently leading the charge at Novo Nordisk to not only go beyond the pill with digital marketing and health tech, but also test, pilot and develop groundbreaking new strategies needed in today’s consumerized healthcare world.

Endpoints Premium

Premium subscription required

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

Astel­las, Pan­th­er­na add or­gan to mR­NA tie-up; Rock­et launch­es sale of six fig­ures worth of stock

Astellas and Pantherna have expanded their November 2021 pact surrounding the latter’s mRNA platform to include a new target organ, the duo announced Tuesday morning, though they did not specify what that target is.

German biotech Pantherna is home to two platform technologies — one that designs mRNAs for non-vaccine therapies and another that designs LNPs. Astellas and Pantherna’s deal appears to mainly revolve around the first platform, which Astellas said it is using to research direct reprogramming, or turning cells from one kind into another without an intermediate stem cell phase.