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.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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Jay Bradner (Jeff Rumans for Endpoints News)

Div­ing deep­er in­to in­her­it­ed reti­nal dis­or­ders, No­var­tis gob­bles up an­oth­er bite-sized op­to­ge­net­ics biotech

Right about a year ago, a Novartis team led by Jay Bradner and Cynthia Grosskreutz at NIBR swooped in to scoop up a Cambridge, MA-based opthalmology gene therapy company called Vedere. Their focus was on a rather narrow market niche: inherited retinal dystrophies that include a wide range of genetic retinal disorders marked by the loss of photoreceptor cells and progressive vision loss.

But that was just the first deal that whet their appetite.

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Volker Wagner (L) and Jeff Legos

As Bay­er, No­var­tis stack up their ra­dio­phar­ma­ceu­ti­cal da­ta at #ES­MO21, a key de­bate takes shape

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

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Rafaèle Tordjman (Jeito Capital)

Con­ti­nu­ity and di­ver­si­ty: Rafaèle Tord­j­man's women-led VC firm tops out first fund at $630M

For a first-time fund, Jeito Capital talks a lot about continuity.

Rafaèle Tordjman had spotlighted that concept ever since she started building the firm in 2018, promising to go the extra mile(s) with biotech entrepreneurs while pushing them to reach patients faster.

Coincidentally, the lack of continuity was one of the sore spots listed in a report about the European healthcare sector published that same year by the European Investment Bank — whose fund is one of the LPs, alongside the American pension fund Teacher Retirement System of Texas and Singapore’s Temasek, to help Jeito close its first fund at $630 million (€534 million). As previously reported, Sanofi had chimed in €50 million, marking its first investment in a French life sciences fund.

Mi­rati tri­umphs again in KRAS-mu­tat­ed lung can­cer with a close­ly watched FDA fil­ing now in the cards

After a busy weekend at #ESMO21, which included a big readout for its KRAS drug adagrasib in colon cancer, Mirati Therapeutics is ready to keep the pressure on competitor Amgen with lung cancer data that will undergird an upcoming filing.

In topline results from a Phase II cohort of its KRYSTAL-1 study, adagrasib posted a response rate of 43% in second-line-or-later patients with metastatic non-small cell lung cancer containing a KRAS-G12C mutation, Mirati said Monday.

FDA hands ac­cel­er­at­ed nod to Seagen, Gen­mab's so­lo ADC in cer­vi­cal can­cer, but com­bo stud­ies look even more promis­ing

Biopharma’s resident antibody-drug conjugate expert Seagen has scored a clutch of oncology approvals in recent years, finding gold in what are known as “third-gen” ADCs. Now, another of their partnered conjugates is ready for prime time.

The FDA on Monday handed an accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv, or “TV”) in second-line patients with recurrent or metastatic cervical cancer who previously progressed after chemotherapy rather than PD-(L)1 systemic therapy, the companies said in a release.

Mi­rati's KRAS drug looks like the ear­ly fa­vorite in colon can­cer with new da­ta, putting the pres­sure square on Am­gen

With Amgen already providing proof-of-concept for KRAS inhibitors with its sotorasib, Mirati Therapeutics is piecing together a follow-up effort in lung cancer with data it thinks are superior. But in colon cancer, where solo sotorasib has turned in a dud, Mirati may now have a strong case for superiority.

Mirati’s adagrasib, dosed solo or in combination with chemotherapy cetuximab, showed numerically higher response rates than sotorasib solo and as part of a combination study in a similar patient population also revealed this week at #ESMO21. Mirati’s data were presented as part of a cohort update from the Phase II KRYSTAL-1 study testing adagrasib in a range of solid tumors harboring the KRAS-G12C mutation.

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