Keytru­da gets ac­cel­er­at­ed OK in HER2-pos­i­tive gas­tric can­cer; Twin­Strand gets $50M to hunt for 'nee­dles in a haystack'

King Keytru­da keeps rack­ing up ap­provals, earn­ing a new ac­cel­er­at­ed OK from the FDA on Wednes­day.

Reg­u­la­tors hand­ed down the ap­proval for HER2-pos­i­tive gas­tric can­cer in the first-line set­ting, in com­bi­na­tion with trastuzum­ab, flu­o­ropy­rim­i­dine- and plat­inum-based chemo. It’s yet an­oth­er thumbs-up for one of the best-sell­ing drugs in the world.

Wednes­day’s OK came on the ba­sis of a 264-pa­tient study with in­di­vid­u­als who had not pre­vi­ous­ly re­ceived treat­ment for their dis­ease. Pa­tients were ran­dom­ized 1-to-1 to re­ceive Keytru­da or place­bo every three weeks in ad­di­tion to the chemother­a­py reg­i­men.

The drug arm reg­is­tered an over­all re­sponse rate of 74% com­pared to 52% tak­ing the con­trol, good for a p-val­ue of p<0.0001. Re­searchers al­so saw a me­di­an du­ra­tion of re­sponse of 10.6 months with Keytru­da ver­sus 9.5 months in the con­trol arm.

With the ap­proval, reg­u­la­tors gave pa­tients the op­tion of tak­ing 200 mg of Keytru­da every three weeks or 400 mg every six weeks. Both are rec­om­mend­ed for use by the FDA in oth­er in­di­ca­tions. The full in­di­ca­tion is for lo­cal­ly ad­vanced un­re­sectable or metasta­t­ic HER2-pos­i­tive gas­tric or gas­troe­sophageal junc­tion ade­no­car­ci­no­ma. — Max Gel­man

Twin­Strand gets $50M to hunt for ge­net­ic ‘nee­dles in a haystack’

A cou­ple months af­ter wran­gling a $16 mil­lion Se­ries A round, Twin­Strand Bio­sciences has re­turned to the ven­ture well, this time near­ly dou­bling its last raise to fund the de­vel­op­ment of tech­nol­o­gy used to find ge­net­ic “nee­dles in a haystack.”

Twin­Strand un­veiled a $50 mil­lion Se­ries B round on Thurs­day, led by Sec­tion 32, with par­tic­i­pa­tion from Soleus Cap­i­tal, Janus Hen­der­son In­vestors, Madrona Ven­ture Group, Ridge­back Cap­i­tal, Alexan­dria Ven­ture In­vest­ments and oth­ers.

Jesse Salk

The com­pa­ny’s DNA se­quenc­ing tech de­liv­ers “a new lev­el of sen­si­tiv­i­ty, clar­i­ty, and ac­cu­ra­cy to the ex­plo­ration of ge­nom­ic vari­a­tion,” Sec­tion 32’s Michael Pelli­ni said in a state­ment. Twin­Strand says it can iden­ti­fy ul­tra-low fre­quen­cy DNA mu­ta­tions with a res­o­lu­tion 10,000-fold greater than oth­er tools on the mar­ket.

“In ad­di­tion to the com­mer­cial launch of our first prod­ucts, and the build out of our clin­i­cal lab, 2020 marked an im­por­tant mile­stone in the val­i­da­tion of our ex­pand­ing in­tel­lec­tu­al prop­er­ty port­fo­lio as we closed a ma­jor deal in liq­uid biop­sy to kick off our out-li­cens­ing pro­gram,” CEO and CSO Jesse Salk said in a state­ment. — Nicole De­Feud­is 

Val­ne­va makes Nas­daq de­but two weeks af­ter launch­ing PhI­II Covid-19 vac­cine tri­al

The lat­est over­seas biotech de­vel­op­ing Covid-19 vac­cines has hit the Nas­daq in France-based Val­ne­va. The com­pa­ny raised $94 mil­lion and priced Thurs­day at $26.41, the mid­point of its pro­posed range.

Val­ne­va made news re­cent­ly when it an­nounced in late April that it would be giv­ing up vac­cine sup­ply dis­cus­sions with the EU and in­stead deal­ing with mem­ber states di­rect­ly. It had been wary of the trade ten­sions be­tween the UK and rest of the con­ti­nent since Brex­it, not­ing in its S-1 that ex­port re­stric­tions may af­fect its abil­i­ty to de­liv­er those shots promised to the UK.

Val­ne­va has com­mit­ments to de­liv­er 100 mil­lion vac­cines to Britain by 2022, with the UK own­ing ad­di­tion­al op­tions for an­oth­er 90 mil­lion in sup­ply be­tween 2023 and 2025.

In a Phase I/II tri­al, more than 90% of all study par­tic­i­pants de­vel­oped sig­nif­i­cant lev­els of an­ti­bod­ies to the SARS-CoV-2 virus spike pro­tein across all dose groups test­ed. They launched their Phase III tri­al on April 21, look­ing to en­roll 4,000 in a study pit­ting its own vac­cine head-to-head against the As­traZeneca/Ox­ford Uni­ver­si­ty shot. — Max Gel­man

In­side Track: Be­hind the Scenes of a Ma­jor Biotech SPAC

Dr. David Hung and Michelle Doig are no strangers to the SPAC phenomenon. As Founder and CEO of Nuvation Bio, a biotech company tackling some of the greatest unmet needs in oncology, Dr. Hung recently took the company public in one of this year’s biggest SPAC related deals. And as Partner at Omega Funds, Doig not only led and syndicated Nuvation Bio’s Series A, but is now also President of the newly formed, Omega-sponsored, Omega Alpha SPAC (Nasdaq: OMEG; oversubscribed $138m IPO priced January 6, 2021).

Barry Greene, Sage CEO

UP­DAT­ED: Sage's sec­ond chance at de­pres­sion hits the PhI­II pri­ma­ry, but ques­tions re­main over dura­bil­i­ty, side ef­fects

Looking to make a comeback after a big Phase III flop, Sage Therapeutics revealed data they believe could change the entire depression treatment landscape, given the vast array of failures in the field. But some results are spooking investors, sending Sage $SAGE shares down early Tuesday.

First, the primary: Sage and Biogen reported Phase III data for once-daily zuranolone Tuesday morning, saying the experimental drug hit its primary endpoint by spurring a statistically significant change from baseline in the 17-item Hamilton Rating Scale for Depression total score. After 15 days, patients in the drug arm saw an average change of -14.1 points, compared to -12.3 on placebo.

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Harith Rajagopalan (Fractyl)

Af­ter a decade in the Type 2 di­a­betes game, Fractyl Lab­o­ra­to­ries recharges with a fresh $100M and a new name

Harith Rajagopalan compared the way Type 2 diabetes is managed to sticking your fingers in a dam that’s leaking from a number of places.

You can take drugs to lower your blood sugar, cholesterol, or blood pressure, but you’re not addressing what he says is the core issue — the metabolic abnormality that causes the disease.

“We’re so busy plugging the holes in the dam, we don’t have time to see that the whole infrastructure is at risk,” he said. “That infrastructure is a full-body systemic metabolic abnormality called metabolic syndrome, that we’re ignoring while we’re so busy trying to treat all of the individual symptoms of the condition.”

Bio­gen sig­nals a big PhI­II fail­ure as the lead gene ther­a­py in their $800M Night­star buy­out goes down in flames

That $800 million buyout of Nightstar has turned into a bust for Biogen as the lead therapy in the deal failed a pivotal study, signaling a severe setback for the biotech’s ambitions in gene therapies.

The big biotech put out the word after the market closed on Monday that the gene therapy they picked up in the deal for a degenerative blindness called choroideremia failed the Phase III study, just a month after their #2 drug in the deal also flopped in a mid-stage study.

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Hal Barron, GSK R&D chief (Endpoints News)

Hal Bar­ron gam­bles $625M cash on high-wire TIG­IT act, throw­ing Glax­o­SmithK­line in­to heat­ed race and com­plet­ing next-gen I/O trin­i­ty

Count Hal Barron and GlaxoSmithKline in for the TIGIT fight.

The stakes are as high as the risks: While a growing pack of Big Pharma rivals is lending credence to the hypothesis that TIGIT will be the next big immune checkpoint and cancer drug target, the first clinical trials have shown response rates that can be described as modest at best. But Barron’s bet is on the whole “axis” that the receptor sits on, with an eye on testing its new anti-TIGIT antibody not just in combo with PD-1 but also in triplets.

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Michel Sade­lain puts his name and new cell en­gi­neer­ing tech be­hind 'ag­nos­tic' CAR-T start­up chas­ing epi­ge­net­ic anti­gens

It felt natural for Alain Maiore and Sebastian Amigorena to bring in Michel Sadelain as a co-founder of Mnemo Therapeutics. A CAR-T pioneer, Sadelain had been involved as an advisor since the early days — enthusiastic about Amigorena’s work in a genetic knockout that could enhance T cell memory and a new class of potential targets he’s discovered — and could introduce some well-known technologies to the toolbox. So they got the initial cash from Sofinnova Partners to plant roots in Paris and New York in early 2019; within a few months, they began to see more clearly just what the antigen discovery platform might unlock.

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Is­rael's VBL Ther­a­peu­tics hit with CMC de­lays in ovar­i­an can­cer study; No­vo Hold­ings buys out di­ag­nos­tics play­er BBI

VBL Therapeutics has hit a roadblock in its Phase III study for platinum-resistant ovarian cancer.

Batches of the VB-111 compound being evaluated in the study are still being reviewed by the FDA’s CMC group, the company announced Tuesday, with regulators trying to compare VB-111 manufacturing between different sites. As a result, supply will be limited and VBL is pausing enrollment of the 400-patient study until the batches can be cleared.

Lynn Fitch, Mississippi Attorney General (Rogelio V. Solis/AP Images)

Mis­sis­sip­pi sues Eli Lil­ly, Sanofi and No­vo over in­sulin prices as in­ter­change­able biosim­i­lars may ar­rive soon

Mississippi Attorney General Lynn Fitch last week sued the top three insulin manufacturers, which collectively cover almost the entire US insulin market, alleging that they’ve colluded to raise their prices in lockstep, and in some cases by more than 1,000% for drugs that are decades old.

“Because of Manufacturer Defendants’ collusive price increases, nearly a century after the discovery of insulin, diabetes medications have become unaffordable for many diabetics,” the lawsuit says.

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Andrew Hopkins, Exscientia CEO

Ex­sci­en­tia spends Soft­Bank's cash in bid to edge out AI ri­vals

Exscientia is sprinting to win the great AI biotech race.

The UK company, having long labored on small discovery deals with large pharmas, raised up to $525 million in a Series D led by the infamous Japanese conglomerate SoftBank in April and followed it up less than a month later with a Bristol Myers Squibb deal that paid $50 million cash and $1.2 billion in milestones.

Now, the Oxford spinout is splurging on a shiny new tool. On Monday they announced they purchased the three-year-old molecule-screening biotech Allcyte, a longtime collaborator, for $60.6 million in cash and stock.

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