Au­to­lus claims a CAR-T win at EHA; Ima­go touts two PhII tri­al wins for rare dis­ease drug

Pre­sen­ta­tions at the Eu­ro­pean Hema­tol­ogy As­so­ci­a­tion be­gan Fri­day, with Au­to­lus Ther­a­peu­tics re­veal­ing da­ta they say con­tin­ue to show the ben­e­fit of their CAR-T pro­gram.

The Au­to­lus pro­gram, known as 0be-cel, achieved a 100% com­plete re­mis­sion rate in a co­hort of in­do­lent B Cell Non-Hodgkin lym­phoma pa­tients, with all nine treat­ed pa­tients hit­ting the mark as of the May 17 cut­off. An­oth­er three pa­tients are still await­ing treat­ment, while a fourth en­rolled in­di­vid­ual died due to a Covid-19 in­fec­tion.

At a me­di­an fol­low-up of six months and rang­ing from four to 8.1 months, eight of nine pa­tients were dis­ease free at their last fol­low-up. One in­di­vid­ual re­lapsed at month 6 but was res­cued with ra­dio­ther­a­py. The Covid-19 pa­tient had achieved com­plete re­mis­sion, Au­to­lus says, at 5.6 months.

Ad­di­tion­al­ly, in an­oth­er co­hort for acute lym­phoblas­tic leukemia, 17 of 20 pa­tients saw MRD-neg­a­tive com­plete re­mis­sion af­ter one month. Fri­day’s news comes af­ter Au­to­lus chopped 20% of its staff in Jan­u­ary and set out to find a new part­ner for its CAR-T pro­gram. — Max Gel­man

Ima­go an­nounces re­sults from 2 PHII tri­als for bomedem­stat

Two Phase II stud­ies of bomedem­stat in pa­tients re­ceived pos­i­tive re­sults, Ima­go Bio­Sciences an­nounced Fri­day.

In a study in pa­tients with es­sen­tial throm­bo­cythemia, a rare dis­or­der in which the body pro­duces too many platelets, the da­ta showed that 83% of the 12 pa­tients dosed for more than six weeks showed a sig­nif­i­cant re­duc­tion of platelet counts. The drop hap­pened while pa­tients main­tained sta­ble he­mo­glo­bin lev­els, the com­pa­ny said.

Mean­while, the da­ta from a study in pa­tients with ad­vanced myelofi­bro­sis — a type of bone can­cer that dis­rupts the body’s nor­mal pro­duc­tion of blood cells — 94% of pa­tients showed a re­duc­tion of 50% or more in symp­toms. In 34 pa­tients eval­u­at­ed for mu­tant al­lele fre­quen­cies, the num­ber de­creased in 44% of pa­tients and re­mained the same in 47%, with no new mu­ta­tions in the 660 days that fol­lowed.

In the press re­lease, Ima­go CMO Wan-Jen Hong said:

These up­dat­ed clin­i­cal re­sults re­veal that bomedem­stat con­tin­ues to of­fer dis­tinct clin­i­cal ben­e­fits for pa­tients with ad­vanced MF, show­ing over­all im­prove­ment in to­tal symp­tom scores, spleen vol­umes and ane­mia. The study is now ful­ly en­rolled, so we look for­ward to shar­ing our cu­mu­la­tive da­ta as we con­tin­ue to ad­vance this in­ves­ti­ga­tion­al pro­gram for pa­tients who have few ther­a­peu­tic al­ter­na­tives.

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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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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As Covid-19 shifts the world's at­ten­tion to biotech, Noubar Afeyan's Flag­ship builds $3.4B fund to fu­el new in­ven­tions. Here's the plan

A little more than a year ago, Flagship Pioneering rolled out a monster fund with $1.1 billion in it to bankroll the platform companies they were creating inside their own labs. But it turns out, that was just the prelude to a much, much larger raise, as both current investors — who’ve been reaping the rewards of some booming biotech stocks — join in with new investors betting on more in the years to come.

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