Jun­shi, Co­herus gun for ma­jor PD-(L)1 mar­ket with PhI­II NSCLC re­sults

As a slate of made-in-Chi­na check­point in­hibitors ar­rive on the scene, Chi­na-based drug­mak­ers have shown time and again that they’re not con­tent with just the Chi­nese mar­ket or nich­es of the Amer­i­can mar­ket. Rather, they are more than ea­ger to fol­low the sprawl­ing roadmap that lead­ers like Mer­ck and Bris­tol My­ers Squibb have of­fered — and dive right in­to large can­cer in­di­ca­tions.

For the lat­est ex­am­ple, look no fur­ther than Shang­hai Jun­shi — the first biotech to steer a home­grown PD-(L)1 to­ward ap­proval from Chi­na’s NM­PA.

Jun­shi tout­ed pos­i­tive re­sults from a Phase III lung can­cer tri­al late Wednes­day, as tori­pal­imab (Tuoyi in Chi­na) beat place­bo as a first-line treat­ment when com­bined with chemother­a­py. Among 465 ad­vanced non-small cell lung can­cer pa­tients who have nev­er re­ceived ther­a­py (both squa­mous and non­squa­mous), in­ves­ti­ga­tors ob­served a “sig­nif­i­cant im­prove­ment in pro­gres­sion-free sur­vival at the in­ter­im analy­sis.”

To­geth­er with part­ners at Co­herus, Jun­shi said it plans to meet with the FDA — where it’s al­ready racked up break­through des­ig­na­tions for two dif­fer­ent types of na­sopha­ryn­geal car­ci­no­ma. Co­herus wa­gered $150 mil­lion cash for US rights to the drug.

Af­ter years of spec­u­la­tion from an­a­lysts and com­men­ta­tors that the new wave of PD-(L)1 in­hibitors from Chi­na will com­modi­tize the class, there’s lit­tle sign that prices in the US will come down any time soon. But that doesn’t mean Chi­nese biotechs aren’t gear­ing up to mount at­tacks on all fronts — just a few days ago, Eli Lil­ly-part­nered In­novent un­veiled a fresh da­ta set for gas­tric or gas­troe­sophageal junc­tion ade­no­car­ci­no­ma.

In Tuoyi’s NSCLC tri­al, Jun­shi said the haz­ard ra­tio was 0.58 (p=0.0001), with me­di­an PFS of 8.3 months ver­sus 5.6 months for those on place­bo.

At the one-year cut­off, the rates of pa­tients who lived with­out their dis­ease pro­gress­ing were 32.6% and 13.1% for the tori­pal­imab and place­bo arms, re­spec­tive­ly.

NSCLC, through all lines of treat­ment, has long been con­sid­ered a huge­ly need­ed, multi­bil­lion-dol­lar op­por­tu­ni­ty.

“With an ex­cel­lent clin­i­cal pro­file be­ing es­tab­lished across mul­ti­ple tu­mor types, we ex­pect to pur­sue reg­is­tra­tion for tori­pal­imab for a broad ar­ray of in­di­ca­tions in Chi­na, the Unit­ed States and oth­er mar­kets,” said Jun­shi CMO Pa­tri­cia Kee­gan.

Jun­shi has lined up piv­otal stud­ies across esophageal, lung, liv­er, breast, kid­ney, blad­der, stom­ach and skin can­cers.

So­cial im­age: Li Ning, Jun­shi CEO

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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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.

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.