Robert Bazemore (Epizyme)

UP­DAT­ED: Robert Baze­more inks one last deal for Epizyme — adding Chi­na to Tazverik's glob­al blue­print — be­fore head­ing out from CEO of­fice

Among the ear­ly pi­o­neers of Chi­na biotech, Hutchmed (then Chi-Med) stood out for a rea­son: It large­ly stayed out of in-li­cens­ing drugs from West­ern drug­mak­ers, choos­ing in­stead to hun­ker down on de­vel­op­ing its own com­pounds — notch­ing big part­ners in As­traZeneca and Eli Lil­ly for savoli­tinib and fruquin­tinib, both on the mar­ket now, along the way.

As its peers be­gin herald­ing in-house dis­cov­ery to com­ple­ment the ex­ter­nal­ly-sourced parts of the pipeline, though, Hutchmed is once again go­ing in the op­po­site di­rec­tion.

Hutchmed is team­ing up with Epizyme — which will be un­der­go­ing some changes at the top — to de­vel­op Tazverik, the US biotech’s methyl­trans­ferase in­hibitor of EZH2, pay­ing $25 mil­lion up­front to take the lead for de­vel­op­ment and com­mer­cial­iza­tion in Chi­na.

Ap­proved in the US for cer­tain sub­types of ep­ithe­lioid sar­co­ma and fol­lic­u­lar lym­phoma, Tazverik works through an epi­ge­net­ic mech­a­nism — con­trol­ling the ex­pres­sion of cer­tain genes — and was de­signed for niche, un­reached cor­ners of the vast can­cer space. Hutchmed and Epizyme are eye­ing as many as eight po­ten­tial in­di­ca­tions in Chi­na; if they all go well, de­vel­op­ment and reg­u­la­to­ry mile­stones will add up to $110 mil­lion.

An­oth­er $175 mil­lion is re­served for sales mile­stones.

Epizyme CEO Robert Baze­more called Hutchmed an “ide­al part­ner” to de­vise and ex­e­cute new clin­i­cal tri­als in Chi­na that will then feed in­to its big­ger plans.

“Through this col­lab­o­ra­tion we an­tic­i­pate Tazverik to be­come the first EZH2 in­hibitor brought to mar­ket in Greater Chi­na,” he said in a state­ment, “and we be­lieve the in­volve­ment of Hutchmed in the glob­al de­vel­op­ment of Tazverik can al­low for a more rapid, re­source-ef­fi­cient, and ge­o­graph­i­cal­ly in­clu­sive de­vel­op­ment plan for the U.S. con­fir­ma­to­ry EZH-302 tri­al of Tazverik in sec­ond line fol­lic­u­lar lym­phoma (2L FL) in com­bi­na­tion with Revlim­id plus rit­ux­imab (‘R²’).”

He won’t be the one over­see­ing that plan, though. Hours af­ter an­nounc­ing the deal, Epizyme re­vealed that Baze­more is step­ping down. Af­ter steer­ing Tazverik to two US ap­provals, com­plet­ing the next five-year growth strat­e­gy and now en­gi­neer­ing a ma­jor deal, he be­lieves it’s time for Grant Bogle, a board di­rec­tor and for­mer ex­ec of Tesaro, to take the lead at an in­creas­ing­ly com­mer­cial­ly ori­ent­ed com­pa­ny while Baze­more can “redi­rect his time and en­er­gy to­ward oth­er ar­eas of his life that have be­come a pri­or­i­ty for him, per­son­al­ly.”

Mean­while, Chris­t­ian Hogg, Hutchmed’s chief ex­ec­u­tive, point­ed to the po­ten­tial for com­bi­na­tion ther­a­py with the can­cer drugs in its port­fo­lio.

Hutchmed’s pric­ing strat­e­gy for Tazverik will al­so serve as an in­ter­est­ing in­di­ca­tor of Chi­na’s open­ness to ex­pen­sive rare dis­ease drugs — con­sid­er­ing its price tag of $186,000. Drug­mak­ers typ­i­cal­ly have to dis­count their way in­to the Na­tion­al Re­im­burse­ment Drug List, bet­ting that they could earn more by tap­ping a much larg­er vol­ume.

Ed­i­tor’s Note: This sto­ry has been up­dat­ed to re­flect Robert Baze­more’s up­com­ing de­par­ture.

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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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.

Dave Lennon, former president of Novartis Gene Therapies

Zol­gens­ma patent spat brews be­tween No­var­tis and Re­genxbio as top No­var­tis gene ther­a­py ex­ec de­parts

Regenxbio, a small licensor of gene therapy viral vectors spun out from the University of Pennsylvania, is now finding itself in the middle of some major league patent fights.

In addition to a patent suit with Sarepta Therapeutics from last September, Novartis, is now trying to push its smaller partner out of the way. The Swiss biopharma licensed Regenxbio’s AAV9 vector for its $2.1 million spinal muscular atrophy therapy Zolgensma.

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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.