David Chang (Jeff Rumans for Endpoints News)

Al­lo­gene, Over­land plot speedy Asia play for off-the-shelf CAR-T with $117M joint ven­ture

David Chang got a good look at what it takes to bring CAR-T ther­a­py to Chi­na and Asia mar­kets when he and Arie Bellde­grun struck a deal with Fo­s­un Phar­ma to form a joint ven­ture around its pi­o­neer­ing lym­phoma treat­ment — which would come to be known as Yescar­ta — in 2017, just af­ter sub­mit­ting a BLA to the FDA.

With Al­lo­gene, the duo’s high pro­file start­up aimed at de­liv­er­ing off-the-shelf CAR-T, he’s do­ing the same.

“With cell ther­a­py, there is a con­tin­u­ous ef­fort to em­ploy the next gen­er­a­tion tech­nol­o­gy and re­fine what we’re do­ing,” Chang told End­points News, ex­plain­ing his reser­va­tions on a sim­ple out-li­cens­ing mod­el.

Hua Mu

Al­lo­gene’s part­ner of choice is Over­land Phar­ma­ceu­ti­cals, the well-heeled Hill­house start­up that en­tered the stage just days ago and al­ready un­veiled a sim­i­lar deal with ADC Ther­a­peu­tics. Over­land is pour­ing $117 mil­lion in­to Al­lo­gene Over­land Bio­pharm, $40 mil­lion in the form of an up­front to Al­lo­gene and the rest in­ject­ed straight in­to JV op­er­a­tions.

Con­trast that with the $20 mil­lion that Fo­s­un com­mit­ted to set up shop with Kite, and you can de­duce just how far the cell ther­a­py space in Chi­na has come.

Hua Mu, in­ter­im CEO and CMO of Over­land, would know. Dur­ing his stint at WuXi AppTec be­fore even­tu­al­ly land­ing a ven­ture part­ner role at Hill­house, he was in­volved in the dis­cus­sions with Juno that even­tu­al­ly gave birth to JW Ther­a­peu­tics — and de­spite the promis­ing clin­i­cal da­ta and clear need, both sides had ques­tions. Juno made it clear they wouldn’t want to get in un­less Chi­na start­ed reg­u­lat­ing CAR-T as a drug rather than med­ical tech­nol­o­gy; WuXi wasn’t en­tire­ly sure cell ther­a­py is a vi­able class of med­i­cine.

Af­ter a sweep­ing reg­u­la­to­ry re­form and a cou­ple of FDA ap­provals lat­er, the ques­tions have now changed. The lead pro­grams at Fo­s­un Kite and JW are both un­der re­view in Chi­na with OKs ex­pect­ed im­mi­nent­ly. It’s a mat­ter of who can get it and how fast.

“So there’s no doubt about cell ther­a­py as a vi­able new ther­a­py,” Mu said. “The ques­tion is how to make it bet­ter, how to make it more ap­plic­a­ble, how to make it more use­ful to ad­dress the un­met med­ical need.”

Ed Zhang

The promise of en­gi­neer­ing healthy donor cells to re­place the first-gen­er­a­tion, per­son­al­ized ap­proach ap­peared to of­fer the an­swer. Lin­ger­ing un­cer­tain­ty re­gard­ing cell ther­a­py im­por­ta­tion means it will take time to sort out how pre­cise­ly to get the drug ma­te­r­i­al to pa­tients, but the part­ners are al­so start­ing at an ear­li­er stage of de­vel­op­ment.

Since Al­lo­gene’s lead pro­gram in BC­MA has just gen­er­at­ed ini­tial Phase I da­ta, Chang still sees op­por­tu­ni­ties to in­clude come Chi­nese pa­tients in its piv­otal study down the line. Aside from that, it’s hand­ed over three oth­er cell ther­a­py con­structs tar­get­ing CD70, FLT3 and DLL3 to treat a num­ber of both hema­to­log­ic and sol­id tu­mors.

Over­land has al­so se­cured rights in Tai­wan, South Ko­rea and Sin­ga­pore, giv­ing the com­pa­ny plen­ty to work on while talk­ing to reg­u­la­tors and ex­plor­ing lo­cal man­u­fac­tur­ing in Chi­na.

Hill­house’s pres­ence in the re­gion, span­ning hos­pi­tal net­works, reg­u­la­to­ry tact, clin­i­cal ex­pe­ri­ence, CMC knowhow as well as sales and dis­tri­b­u­tion mus­cle, was a big part of why Over­land won over many oth­er bid­ders af­ter all.

For Over­land, the kind of in­dus­tri­al scale pro­duc­tion that al­lo­gene­ic cell ther­a­py en­ables — with each batch pro­duc­ing enough prod­ucts for 100 pa­tients and a turn­around time shrunk from weeks to days — fits well with the large, price-con­scious mar­ket that it’s try­ing to ad­dress.

“From cost of man­u­fac­tur­ing to ef­fi­cien­cy, I think al­lo­gene­ic brings a dif­fer­ent ball game,” said Ed Zhang, who’s dou­bling as chief busi­ness of­fi­cer and chief op­er­at­ing of­fi­cer.

And if every­thing goes well, it will be ball game plays out in Asia al­most in re­al-time as it does in the US and Eu­rope.

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.

Mi­rati’s drug sitra­va­tinib flops PhI­II in com­bo with Op­di­vo for cer­tain lung can­cer

Mirati Therapeutics’ path to a second drug approval will likely have to wait. The San Diego biotech company said Wednesday that its investigational lung cancer drug failed a Phase III trial testing it in combination with Bristol Myers Squibb’s Opdivo.

The drug, sitravatinib, and Opdivo weren’t better than the chemo drug docetaxel at keeping patients alive, Mirati said in a press release. The spectrum-selective kinase inhibitor missed the primary goal of overall survival in patients with second- or third-line advanced non-squamous, non-small cell lung cancer.

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End­points 20(+2) un­der 40, 2023; Bio­phar­ma's high­est-paid CEOs; N-of-1 CRISPR sto­ry goes on af­ter tragedy; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

We will be off Monday in observance of Memorial Day — and when we get back, it will be a straight march to ASCO, BIO and more. Enjoy the (long) weekend!

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Rich Horgan (R) with his late brother, Terry

Rich Hor­gan spear­head­ed a gene ther­a­py for his broth­er. The tri­al end­ed in tragedy, but the work con­tin­ues for more pa­tients

Rich Horgan’s quest to create a custom gene therapy for his brother, Terry, ended in tragedy. But Horgan doesn’t believe it’s the end of the story.

Terry, a 27-year-old patient with Duchenne muscular dystrophy, died last October just eight days after receiving the therapy in a clinical trial in which he was the only participant. The case raised questions about the safety of certain gene therapies and what would happen to other drug programs under a nonprofit that Horgan created, called Cure Rare Disease.

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Bio­phar­ma's 20 high­est-paid CEOs of 2022, each bring­ing in $20M+ pay­days

Even in a down year for much of the biopharma market, 20 CEOs brought in pay packages valued at more than $20 million, an Endpoints News analysis found.

Endpoints collected data on more than 350 CEO compensation packages, covering a wide range of pharma, biotech, and life sciences companies. All told, the 20 largest earners made over $725 million in 2022 — an average package of $36.4 million. Three brought in paydays over $50 million, and one CEO broke the $100 million mark.

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The 20(+2) un­der 40: Your guide to the next gen­er­a­tion of biotech lead­ers

This year’s list of 20 biotech leaders under the age of 40 includes a huge range of ambitions. Some of our honorees are planning to create the next big drug giant. Others are pushing the bounds of AI. One is working to revolutionize TB testing. All are compelling talents who are still young in age, but already far along in achievement.

And, as in years past, we went over. The 20 are actually 22 because of two double profiles that reflect how important teamwork is in the industry. As one of our honorees, Joe Illingworth of DJS Antibodies, told me in our interview, “It takes a village to raise a biotech.”

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Teresa Bitetti, Takeda's president of the global oncology business unit

Take­da wins pri­or­i­ty re­view for $400M col­orec­tal can­cer drug, li­censed from Hutchmed in Jan­u­ary

Takeda and Hutchmed scored a priority review Thursday afternoon for a colorectal cancer drug, the companies announced.

The experimental drug in question is fruquintinib, previously approved in China in 2018 to treat metastatic colorectal cancer. Takeda and Hutchmed are aiming to bring fruquintinib to the US and other countries outside China in the same indication, and the FDA set its decision date for Nov. 30 of this year.

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Athena Countouriotis, Avenzo Therapeutics CEO (website via Nasdaq)

Ex-Turn­ing Point ex­ecs plan to have their next bet, Aven­zo, on the Nas­daq next sum­mer

The crew at Turning Point Therapeutics is back together for a new biotech that wants to acquire early-stage oncology small molecules, including antibody drug conjugates, and potentially form partnerships with China-based drug developers for ex-China rights as it eyes a speedy leap onto the Nasdaq around this time next year, CEO Athena Countouriotis told Endpoints News.

After selling Turning Point to Bristol Myers Squibb, announced at the onset of last year’s ASCO confab, she and colleague Mohammad Hirmand founded Avenzo Therapeutics. The CEO and CMO already have approximately $200 million in seed and Series A financing from five big-name investors to evaluate which drugs to bring into its pipeline. That includes SR One, OrbiMed, Foresite Capital, Citadel’s Surveyor Capital and Lilly Asia Ventures. Bidding wars for assets have led Avenzo to miss out on some deals in recent months, but the biotech has three active term sheets and hopes to bring in its first asset in the third quarter, Countouriotis said in a Friday morning interview.

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David Ricks, Eli Lilly CEO (Carolyn Kaster/AP Images)

Lil­ly gears up trio of PhI­II tri­als for its oral GLP-1 amid No­vo Nordisk, Pfiz­er com­pe­ti­tion

As Novo Nordisk and Pfizer disclose some data on their oral weight loss drugs in Phase III and II, respectively, Eli Lilly is beefing up its stance in the obesity field with three late-stage clinical trials of its next-generation GLP-1 agonist orforglipron.

The moves, disclosed in updates to the federal clinical trials database this week, put the Indianapolis drugmaker ahead of Pfizer, whose science chief has said the company will “cherry-pick” which of its mid-stage candidates to take deeper into the clinic after data late this year or early next.

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