#ES­MO17 ROUNDUP: Mer­ck’s da­ta on Keytru­da/chemo com­bo for lung can­cer takes ear­ly spot­light at ES­MO

MADRID — Mer­ck’s ab­stract $MRK on its big study of Keytru­da (pem­brolizum­ab) com­bined with chemo hit ear­ly at ES­MO, at­tract­ing con­sid­er­able at­ten­tion for the im­pres­sive pro­gres­sion-free sur­vival da­ta the phar­ma gi­ant post­ed as a front­line ther­a­py for non-small cell lung can­cer.

The scoop: The me­di­an PFS hit 19 months for the com­bo arm com­pared to 8.9 months for chemo alone. The 18-month over­all sur­vival rate was 70% with pem­bro + chemo and 56% with chemo. That was an easy win­ner at the FDA and the new mark to beat in the hottest com­pe­ti­tion in drug de­vel­op­ment.

Mer­ck’s suc­cess in lung can­cer has proven to be a game-chang­er in the ri­val­ry for PD-(L)1 check­point dom­i­nance with Bris­tol-My­ers Squibb, which is still work­ing at a come­back af­ter an ear­ly set­back on that front trig­gered a shake­up at the top of their R&D group.

Now that Mer­ck is the leader, though, they are al­so the pri­ma­ry tar­get not on­ly for Bris­tol-My­ers, but al­so As­traZeneca and oth­ers who are jock­ey­ing com­bo ther­a­pies with an eye for the lead po­si­tion. As­traZeneca was slammed re­cent­ly, though, when its com­bi­na­tion of Imfinzi (dur­vaum­ab) and treme­li­mum­ab failed at the first pri­ma­ry end­point on pro­gres­sion-free sur­vival, though re­searchers are stick­ing it out for over­all sur­vival re­sults in 2018.

More than half of pa­tients in the Keytru­da com­bi­na­tion arm re­spond­ed to treat­ment, says Mer­ck, com­pared to ap­prox­i­mate­ly one-third in the pem/car­bo arm.

“Lung can­cer is one of the most com­mon and dev­as­tat­ing can­cers, and these ad­di­tion­al da­ta con­firm that Keytru­da in com­bi­na­tion with peme­trexed and car­bo­platin has the po­ten­tial to have a mean­ing­ful im­pact in the lives of many of these pa­tients,” said Dr. Roger Dansey, se­nior vice pres­i­dent and ther­a­peu­tic area head, on­col­o­gy late-stage de­vel­op­ment, Mer­ck Re­search Lab­o­ra­to­ries.

Im­mune De­sign shows up at ES­MO with some en­cour­ag­ing, but ear­ly, com­bo da­ta

Im­mune De­sign $IMDZ got things start­ed at #ES­MO17 in Madrid with the first glimpse at some pos­i­tive pre­lim­i­nary da­ta to come out of its mid-stage com­bo us­ing its im­mune sys­tem ac­ti­va­tor CMB305 and Genen­tech’s check­point in­hibitor Tecen­triq (ate­zolizum­ab).

In a study that di­vid­ed 88 pa­tients with NY-ESO-1/pos­i­tive soft tis­sue sar­co­ma be­tween the com­bo and Tecen­triq alone, re­searchers teased out a few in­ter­im da­ta points that show some trends in their di­rec­tion.

Car­los Paya

With in­ter­im da­ta on 36 pa­tients, in­ves­ti­ga­tors high­light­ed a dis­ease con­trol rate of 61% for the com­bo — with one par­tial re­sponse — against 28% with no PRs.

Me­di­an PFS was 2.6 months vs 1.4 months and while sur­vival da­ta was not ma­ture enough to re­port at ES­MO there was al­so a dis­ease con­trol rate of 57% with 3 PRs (one un­con­firmed) ver­sus 38% in the full study group. Re­searchers al­so demon­strat­ed some key bio­mark­er da­ta, in­clud­ing far more tar­get­ed an­ti-NY-ESO-1 T cells and an­ti­bod­ies.

The ju­ry is still out ob­vi­ous­ly on just what kind of tan­gi­ble ben­e­fit pa­tients can ex­pect, but the biotech high­light­ed a trend to­ward im­proved over­all sur­vival. This kind of com­bo strat­e­gy to kick up an im­mune re­sponse with a check­point that dis­man­tles a front­line de­fense mech­a­nism for can­cer cells has gen­er­at­ed a lot of in­ter­est.

“We be­lieve the greater clin­i­cal ben­e­fit and more ro­bust im­mune re­sponse shown in the com­bi­na­tion study arm sup­ports the hy­poth­e­sis that the com­bi­na­tion of an ap­pro­pri­ate­ly-de­signed, next-gen­er­a­tion can­cer vac­cine such as CMB305 with a check­point in­hibitor is im­por­tant to pro­duce clin­i­cal ben­e­fit in a cold tu­mor such as STS, where check­point in­hibitors oth­er­wise may have lim­it­ed ef­fi­ca­cy,” said Im­mune De­sign CEO Car­los Paya. “In ad­di­tion, we are pleased to ob­serve the trend to­wards longer over­all sur­vival in pa­tients with an in­duced an­ti-NY-ESO-1 im­mune re­sponse, fur­ther sup­port­ing the pos­i­tive CMB305 monother­a­py da­ta we pre­sent­ed at AS­CO in June.”

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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UP­DAT­ED: Leg­end fetch­es $424 mil­lion, emerges as biggest win­ner yet in pan­dem­ic IPO boom as shares soar

Amid a flurry of splashy pandemic IPOs, a J&J-partnered Chinese biotech has emerged with one of the largest public raises in biotech history.

Legend Biotech, the Nanjing-based CAR-T developer, has raised $424 million on NASDAQ. The biotech had originally filed for a still-hefty $350 million, based on a range of $18-$20, but managed to fetch $23 per share, allowing them to well-eclipse the massive raises from companies like Allogene, Juno, Galapagos, though they’ll still fall a few dollars short of Moderna’s record-setting $600 million raise from 2018.

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As it hap­pened: A bid­ding war for an an­tibi­ot­ic mak­er in a mar­ket that has rav­aged its peers

In a bewildering twist to the long-suffering market for antibiotics — there has actually been a bidding war for an antibiotic company: Tetraphase.

It all started back in March, when the maker of Xerava (an FDA approved therapy for complicated intra-abdominal infections) said it had received an offer from AcelRx for an all-stock deal valued at $14.4 million.

The offer was well-timed. Xerava was approved in 2018, four years after Tetraphase posted its first batch of pivotal trial data, and sales were nowhere near where they needed to be in order for the company to keep its head above water.

Drug man­u­fac­tur­ing gi­ant Lon­za taps Roche/phar­ma ‘rein­ven­tion’ vet as its new CEO

Lonza chairman Albert Baehny took his time headhunting a new CEO for the company, making it absolutely clear he wanted a Big Pharma or biotech CEO with a good long track record in the business for the top spot. In the end, he went with the gold standard, turning to Roche’s ranks to recruit Pierre-Alain Ruffieux for the job.

Ruffieux, a member of the pharma leadership team at Roche, spent close to 5 years at the company. But like a small army of manufacturing execs, he gained much of his experience at the other Big Pharma in Basel, remaining at Novartis for 12 years before expanding his horizons.

Covid-19 roundup: Ab­b­Vie jumps in­to Covid-19 an­ti­body hunt; As­traZeneca shoots for 2B dos­es of Ox­ford vac­cine — with $750M from CEPI, Gavi

Another Big Pharma is entering the Covid-19 antibody hunt.

AbbVie has announced a collaboration with the Netherlands’ Utrecht University and Erasmus Medical Center and the Chinese-Dutch biotech Harbour Biomed to develop a neutralizing antibody that can treat Covid-19. The antibody, called 47D11, was discovered by AbbVie’s three partners, and AbbVie will support early preclinical work, while preparing for later preclinical and clinical development. Researchers described the antibody in Nature Communications last month.

Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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Bris­tol My­ers is clean­ing up the post-Cel­gene merg­er pipeline, and they’re sweep­ing out an ex­per­i­men­tal check­point in the process

Back during the lead up to the $74 billion buyout of Celgene, the big biotech’s leadership did a little housecleaning with a major pact it had forged with Jounce. Out went the $2.6 billion deal and a collaboration on ICOS and PD-1.

Celgene, though, also added a $530 million deal — $50 million up front — to get the worldwide rights to JTX-8064, a drug that targets the LILRB2 receptor on macrophages.

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Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.