As tislelizum­ab gains trac­tion in Chi­na, BeiGene pulls the cur­tain on NSCLC da­ta sup­port­ing the PD-1 drug

In a world now brim­ming with check­point in­hibitors, com­pa­nies of­ten strug­gle to make a mark giv­en a raft of ther­a­pies have al­ready cap­tured a con­sid­er­able por­tion of the vast on­col­o­gy mar­ket.

BeiGene’s tislelizum­ab was the fourth PD(L)-1 in­hibitor to se­cure ap­proval in Chi­na — and as it works on ex­pand­ing its share the com­pa­ny has put out de­tailed da­ta on the use of the drug in cer­tain pa­tients with lung can­cer.

On­ly last month did BeiGene un­veil that tislelizum­ab in com­bi­na­tion with stan­dard chemother­a­py fared bet­ter than chemo alone as the first line of de­fense in pa­tients with ad­vanced squa­mous non-small cell lung can­cer (NSCLC). On Fri­day, as part of the key can­cer con­fer­ence Amer­i­can So­ci­ety of Clin­i­cal On­col­o­gy (AS­CO), the Chi­na-based drug­mak­er dis­closed the num­bers.

The 360-pa­tient tri­al, which test­ed the check­point in­hibitor with two dif­fer­ent chemo reg­i­mens against chemo alone, showed that the me­di­an time dur­ing which pa­tients did not see dis­ease pro­gres­sion in the tislelizum­ab com­bo groups was 7.6 months ver­sus 5.5 months for chemo alone.

Ob­jec­tive re­sponse rates were al­so “mean­ing­ful­ly high­er” — be­tween 73% and 75% in the tislelizum­ab groups, ver­sus 50% in the chemo alone arm. In ad­di­tion, treat­ment with the BeiGene drug al­so rough­ly dou­bled the me­di­an du­ra­tion of re­sponse com­pared to chemother­a­py alone: 8.2 months and 8.6 months for the two tislelizum­ab groups, ver­sus 4.2 months for the chemo arm.

Tislelizum­ab was first ap­proved in Chi­na in late 2019 for clas­si­cal Hodgkin’s lym­phoma and then lat­er for metasta­t­ic urothe­lial car­ci­no­ma pa­tients. The drug marked a key mile­stone in the coun­try — the first in­stance of a for­eign part­ner pro­duc­ing a mar­ket­ed drug un­der a re­formed con­tract man­u­fac­tur­ing reg­u­la­to­ry sys­tem. BeiGene’s part­ner in this case is Ger­many’s Boehringer In­gel­heim, which is sup­ply­ing the PD-1 an­ti­body for com­mer­cial use us­ing a Shang­hai fa­cil­i­ty.

The ap­proval of tislelizum­ab in late 2019 was rough­ly a year af­ter the first ap­proval by Jun­shi for Tuoyi. In­novent’s Tyvyt and Mer­ck’s flag­ship Keytru­da were ush­ered in af­ter.

Tislelizum­ab, de­spite the crowd­ed land­scape, has had an en­cour­ag­ing launch. In the first quar­ter of 2020, the drug gen­er­at­ed about $52 mil­lion in sales, best­ing con­sen­sus ex­pec­ta­tions of $47 mil­lion, SVB Leerink’s An­drew Berens wrote in a note ear­li­er this month. He lift­ed his mar­ket share ex­pec­ta­tions for tislelizum­ab in Chi­na, vault­ing his in peak sales ex­pec­ta­tions to $768 mil­lion, up from $461 mil­lion pre­vi­ous­ly.

Da­ta from the non-squa­mous NSCLC pa­tient piv­otal study have al­ready been dis­closed, and the Chi­nese reg­u­la­tor is cur­rent­ly re­view­ing an ap­pli­ca­tion to mar­ket the drug in NSCLC pa­tients. Mean­while, in 2020 or ear­ly 2021, the com­pa­ny ex­pects to re­veal topline re­sults from a glob­al late-stage tri­al com­par­ing tislelizum­ab ver­sus do­c­etax­el in sec­ond and third-line NSCLC pa­tients as well as da­ta from the Phase 3 tri­al com­par­ing tislelizum­ab ver­sus chemother­a­py in sec­ond-line ad­vanced esophageal squa­mous-cell car­ci­no­ma pa­tients.

Mean­while, akin to pret­ty much every oth­er check­point in­hibitor mak­er, BeiGene is ex­plor­ing the use of its of­fer­ing in com­bi­na­tion with oth­er treat­ments. On­ly days ago, it said it would be test­ing two of part­ner Chi-Med’s drug can­di­dates, su­r­u­fa­tinib and fruquin­tinib, in com­bi­na­tion with tislelizum­ab, for the treat­ment of var­i­ous sol­id tu­mor can­cers, in the US, Eu­rope, Chi­na and Aus­tralia.

So­cial: Ma Luyao via Wiki­me­dia

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

PhII Alzheimer's fail­ure deals new blow to Roche, AC Im­mune — but the tau hy­poth­e­sis is far from dead

The leading anti-tau antibody has failed its first Phase II testing, casting a shadow on a popular target (just trailing amyloid beta) for Alzheimer’s disease.

Roche and AC Immune are quick to acknowledge disappointment in the topline readout, which suggested that semorinemab did not reduce cognitive decline among patients with early Alzheimer’s disease, who are either just starting to have symptoms or have mild manifestations.

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FDA commissioner Stephen Hahn at the White House (AP Images)

Un­der fire, FDA to is­sue stricter guid­ance for Covid-19 vac­cine EUA this week — re­port

The FDA has been insisting for months that a Covid-19 vaccine had to be at least 50% effective – a measure of transparency meant to shore public trust in the agency and in a vaccine that had been brought forward at record speed and record political pressure. But now, with concerns of a Trump-driven authorization arriving before the election, the agency may be raising the bar.

The FDA is set to release new guidance that would raise safety and efficacy requirements for a vaccine EUA above earlier guidance and above the criteria used for convalescent plasma or hydroxychloroquine, The Washington Post reported. Experts say this significantly lowers the odds of an approval before the election on November 3, which Trump has promised despite vocal concerns from public health officials, and could help shore up public trust in the agency and any eventual vaccine.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

News brief­ing: PureTech plans Nas­daq de­but with sec­ondary list­ing; GoodRx prices $725M IPO

London Stock Exchange-listed PureTech Health announced Wednesday that it’s looking to extend to Nasdaq. But due to its “strong cash position,” the biotech says it isn’t issuing any new shares in the potential secondary listing.

The company’s shares closed at £256.50 Tuesday on the London Stock Exchange. Its candidate LYT-100 is currently in Phase I development for various indications, including lymphatic flow disorders and fibrotic and inflammatory disorders. PureTech is expecting a Phase Ib readout in lymphatic flow disorders later this year, and is also planning to launch a Phase II study for the drug to treat respiratory conditions experienced after Covid-19.

Rep. Andy Harris (R-MD) (Tasos Katopodis/Pool via AP Images)

The mi­cro-cap that tapped a mask-skep­tic con­gress­man for their Covid DSMB is ap­ply­ing for an EUA. Their ev­i­dence? 21 pa­tients

NeuroRx, the tiny biotech that came under fire last week after Politico reported they selected a congressman and two other acquaintances of the CEO to supervise their Covid-19 drug trial, announced today that they will ask the FDA to authorize their drug based on the results of just 21 patients.

Such an application would test the agency’s standards of evidence for an EUA, which have already come under scrutiny after controversial authorizations for convalescent plasma and hydroxychloroquine. The only other company to discuss their intention to file for an EUA, Eli Lilly, did so after results came back from a randomized control study testing their antibody in over 450 patients.

Covid-19 roundup: J&J be­gins piv­otal Phase III tri­al for vac­cine; Con­tro­ver­sial hu­man chal­lenge tri­als to be­gin in Lon­don — re­port

Johnson & Johnson announced it’s beginning a pivotal Phase III trial for its Covid-19 candidate, JNJ-78436735 — the first single-dose vaccine in this stage.

The Phase III trial, dubbed ENSEMBLE, will enroll 60,000 patients worldwide, making it the largest Phase III study of a Covid-19 vaccine to date. J&J said the candidate achieved positive interim results in a Phase I/IIa study, which will be published “imminently.” There’s a possibility that the first batches will be ready for potential emergency use in early 2021, according to the biotech.

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Vas Narasimhan (AP Images)

UP­DAT­ED: Still held down by clin­i­cal hold, No­var­tis' Zol­gens­ma falls fur­ther be­hind Bio­gen and Roche as FDA asks for a new piv­otal study

Last October, the FDA slowed down Novartis’ quest to extend its gene therapy to older spinal muscular atrophy patients by slapping a partial hold on intrathecal administration. Almost a year later, the hold is still there, and regulators are adding another hurdle required for regulatory submission: a new pivotal confirmatory study.

The new requirement — which departs significantly from Novartis’ prior expectations — will likely stretch the path to registration beyond 2021, when analysts were expecting a BLA submission. That could mean more time for Biogen to reap Spinraza revenues and Roche to ramp up sales of Evrysdi in the absence of a rival.

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Patrick Enright, Longitude co-founder (Longitude)

As its biotechs hit the pan­dem­ic ex­it, Lon­gi­tude rais­es $585M for new neu­ro, can­cer, ag­ing and or­phan-fo­cused fund

The years have been kind to Longitude Capital. This year, too.

A 2006 spinout of Pequot Capital, its founders started their new firm just four years before the parent company would go under amid insider trading allegations. Their first life sciences fund raised $325 million amid the financial crisis, they added a second for $385 million and then in, 2016, a third for $525 million. In the last few months, the pandemic biotech IPO boom netted several high-value exits from those funds, as Checkmate, Vaxcyte, Inozyme and Poseida all went public.

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