Cel­lec­tis re­cruits ex-Servi­er re­search chief De­pil; Are­na inks $224M deal on new drugs; JLABS heads to Shang­hai; As­traZeneca vet takes Goldfinch helm

→ French CAR-T de­vel­op­er Cel­lec­tis has re­cruit­ed Stéphane De­pil, the for­mer R&D chief of Servi­er, to lead the com­pa­ny’s clin­i­cal de­vel­op­ment. De­pil will serve as se­nior vice pres­i­dent of R&D and chief med­ical of­fi­cer. The new ap­point­ment brings De­pil back to the in­dus­try af­ter a break while he di­rect­ed the can­cer im­munother­a­py pro­gram at the Léon Bérard Can­cer Cen­ter in Ly­on, France. But back when he was at Servi­er, he over­saw 20 can­cer pro­grams, sev­er­al of which were in clin­i­cal tri­als. Cel­lec­tis hopes to ben­e­fit from De­pil’s track record in the field to move its CAR-T as­sets in­to the clin­ic af­ter a rough start in­volv­ing a pa­tient death. “Stéphane De­pil’s deep med­ical, aca­d­e­m­ic, and clin­i­cal reg­u­la­to­ry on­col­o­gy ex­pe­ri­ence – specif­i­cal­ly in R&D for all phas­es with­in the phar­ma­ceu­ti­cal, biotech­nol­o­gy, and clin­i­cal re­search spaces – will be in­valu­able as he leads Cel­lec­tis’ strat­e­gy and pro­motes aware­ness of the break­through work that we are do­ing as a leader and in­no­va­tor in the gene-edit­ing field,” said An­dré Chouli­ka, Cel­lec­tis’ CEO, in a state­ment. “His strate­gic al­liance-build­ing, col­lab­o­ra­tion skills, un­der­stand­ing of the glob­al en­vi­ron­ment with on­co­log­i­cal clin­i­cal re­search, and first­hand ex­pe­ri­ence run­ning a phar­ma com­pa­ny all add a great de­gree of abil­i­ty and depth to our lead­er­ship team.”

→ Are­na Phar­ma­ceu­ti­cals, the San Diego drug mak­er best known for its di­et pill Belviq, has inked a deal worth up to $224M with Ever­est Med­i­cines to de­vel­op and com­mer­cial­ize its two new pipeline drugs in main­land Chi­na, Tai­wan, Hong Kong, Macau, and South Ko­rea. The two drugs, ra­linepag and es­trasi­mod, are a far cry from Are­na’s ear­ly work in obe­si­ty drugs. Ra­linepag is a Phase III-ready oral, se­lec­tive prosta­cy­clin re­cep­tor ag­o­nist for the treat­ment of pul­monary ar­te­r­i­al hy­per­ten­sion. The drug’s Phase II da­ta got Are­na’s in­vestors pret­ty jazzed ear­li­er this year. The drug is de­signed to be more po­tent and ef­fec­tive than Acte­lion’s Up­travi. Then there’s etrasi­mod, a Phase II oral S1P re­cep­tor mod­u­la­tor be­ing eval­u­at­ed for mul­ti­ple au­toim­mune dis­eases, in­clud­ing ul­cer­a­tive col­i­tis, a form of in­flam­ma­to­ry bow­el dis­ease. Ear­li­er this year, Amit Mun­shi said the drug was safer and po­ten­tial­ly more ef­fi­ca­cious than Ozan­i­mod, the drug de­vel­oped by San Diego’s Re­cep­tos (pur­chased by Cel­gene for $7.2 bil­lion). In the new deal with Ever­est, a com­pa­ny backed by $50M from Chi­na’s C-Bridge Cap­i­tal, Are­na gets $12M in an up­front pay­ment and is el­i­gi­ble to re­ceive up to $212M in mile­stones, along with roy­al­ties.

John­son & John­son is launch­ing a JLABS in Shang­hai — the first lo­ca­tion out­side of North Amer­i­ca — af­ter reach­ing agree­ments with the Shang­hai Mu­nic­i­pal Gov­ern­ment, Pudong New Area Gov­ern­ment and Shang­hai Phar­ma En­gine Com­pa­ny. Sched­uled to open in Q2 2019, the fa­cil­i­ty in Zhangjiang Hi-Tech Park will span 4,400 sq. me­ter (47,000+ sq. ft.) and can host up to 50 life sci­ence and health care star­tups. “Chi­na, and Shang­hai specif­i­cal­ly, have be­come a glob­al hotspot for health­care in­no­va­tion,” said Vladimir Makat­saria, John­son & John­son Chi­na Group chair­man, in a state­ment. J&J is cur­rent­ly ac­cept­ing ap­pli­ca­tions from biotech, phar­ma­ceu­ti­cal, med­ical de­vice, con­sumer and dig­i­tal health com­pa­nies to this site as well as its eight oth­er JLABS lo­ca­tions.

→ In­dus­try vet An­tho­ny John­son is tak­ing the helm at Goldfinch Bio, a Cam­bridge, MA-based biotech look­ing to de­vel­op new drugs for ge­net­i­cal­ly de­fined kid­ney dis­eases. Goldfinch launched a year ago with $55 mil­lion in Third Rock mon­ey. John­son is the lat­est in a long line of Big Phar­ma R&D ex­ecs mak­ing a move to a start­up, leav­ing his post as head of ear­ly clin­i­cal de­vel­op­ment for the In­no­v­a­tive Med­i­cines and Ear­ly De­vel­op­ment Biotech Unit. His bio in­cludes 25 pos­i­tive proof-of-con­cept stud­ies. In ad­di­tion, Michael Brox­son is join­ing Goldfinch as chief busi­ness and op­er­at­ing of­fi­cer.

Shire $SH­PG has struck a col­lab­o­ra­tion deal with Rani Ther­a­peu­tics that gives the rare dis­ease gi­ant ex­clu­sive rights to re­search, eval­u­ate and pur­sue a world­wide li­cense for the oral de­liv­ery of fac­tor VI­II to pa­tients with he­mo­phil­ia A. This in­vest­ment, the terms of which were not dis­closed, comes just a few weeks af­ter ri­val Roche’s Hem­li­bra nabbed an FDA ap­proval, some­thing that an­a­lysts said could help shrink Shire’s share of the he­mo­phil­ia mar­ket from 49% to 29%. The Rani Pill tech­nol­o­gy brings a nov­el in­testi­nal de­liv­ery ap­proach to the treat­ment of he­mo­phil­ia, which is dom­i­nat­ed by in­jecta­bles, though the com­pa­ny is al­so do­ing work on rheuma­toid arthri­tis, can­cer and Crohn’s dis­ease. As part of the pact, Shire has al­so made an eq­ui­ty in­vest­ment in­to Rani Ther­a­peu­tics.

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.

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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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.

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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Den­mark's Gubra to col­lab­o­rate with Bay­er on pep­tides; Sam­sung and Bio­gen re­ceive FDA ap­proval for Lu­cen­tis biosim­i­lar

Danish biotech Gubra announced a research collaboration and license agreement with Bayer to develop peptide therapeutics to treat cardiorenal diseases. The collaboration will utilize Gubra’s peptide drug discovery platform to identify potential candidates.

This is not the first time Gubra has partnered with a company on peptide therapeutics — they partnered with Boehringer Ingelheim back in 2017 to create peptide therapeutics to treat obesity.

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.

Ex­elix­is pulls a sur­prise win in thy­roid can­cer just days ahead of fi­nal Cabome­tyx read­out

Exelixis added a thyroid cancer indication to its super-seller Cabometyx’s label on Friday — months before the FDA was expected to make a decision, and days before the company was set to unveil the final data at #ESMO21.

At a median follow-up of 10.1 months, differentiated thyroid cancer patients treated with Cabometyx (cabozantinib) lived a median of 11 months without their disease worsening, compared to just 1.9 months for patients given a placebo, Exelixis said on Monday.