John Oyler, BeiGene CEO (Endpoints News, PharmCube)

BeiGene dives in on nat­ur­al killer cells with dis­cov­ery pact for small biotech's stem cell-based plat­form

Chi­na’s BeiGene has been busy on the on­col­o­gy front in re­cent years, look­ing to keep up with the pack with one late-stage PD-1 on the way to a fil­ing and a slate of small deals flesh­ing out the pipeline. Now, with its eyes on the hori­zon, the drug­mak­er has snared an ear­ly-stage pact for a clutch of next-gen cell ther­a­pies.

BeiGene will shell out $45 mil­lion in cash and an undis­closed amount in fu­ture biobucks and roy­al­ties for up to four of Shore­line Bio­sciences’ in­duced pluripo­tent stem cell-based nat­ur­al killer ther­a­pies for can­cer, the part­ners said Wednes­day.

The mul­ti-year pact will ini­tial­ly tar­get four po­ten­tial ther­a­pies with the op­tion to ex­pand in fu­ture years, the com­pa­nies said. BeiGene will lead glob­al clin­i­cal de­vel­op­ment with Shore­line pick­ing up com­mer­cial-scale man­u­fac­tur­ing du­ties. In re­turn for its in­vest­ment, BeiGene will hold glob­al com­mer­cial rights to any ap­proved ther­a­py with Shore­line re­serv­ing the op­tion for US and Cana­di­an rights for two of those tar­gets.

BeiGene al­so re­served the op­tion to buy up an eq­ui­ty stake in Shore­line in the biotech’s next fi­nanc­ing round, the com­pa­ny said.

“We are ex­cit­ed to col­lab­o­rate with Shore­line as BeiGene looks to ex­pand our pipeline of trans­for­ma­tive med­i­cines from small mol­e­cule and an­ti­body ther­a­peu­tics to off-the-shelf cell ther­a­pies, a com­pelling area of re­search that has been pri­mar­i­ly out of reach for many of the world’s pa­tients,” CEO John Oyler said in a state­ment.

Shore­line spe­cial­izes in off-the-shelf ad­vanced can­cer im­munother­a­pies, in­clud­ing iP­SC NK cells and macrophages for var­i­ous tu­mors. Where the San Diego-based com­pa­ny hopes to set it­self apart in that rapid­ly grow­ing field is in man­u­fac­tur­ing, where it main­tains a “strate­gic man­u­fac­tur­ing re­la­tion­ship” with UC San Diego’s Ad­vanced Cell Ther­a­py Lab­o­ra­to­ry. The biotech is backed by a slew of big-name in­vestors, head­lined by Gilead’s Kite and Box­er Cap­i­tal.

The push in­to next-gen cell ther­a­pies comes as Chi­na’s BeiGene looks to rein­vent it­self around on­col­o­gy R&D, most no­tably in its on­go­ing race to bring its own PD-1 check­point in­hibitor tislelizum­ab to mar­ket. That drug was out-li­censed to No­var­tis in Feb­ru­ary, bring­ing a Big Phar­ma part­ner on board amid late-stage read­outs.

In May, the part­ners read out topline re­sults show­ing the drug met its pri­ma­ry end­point of pro­gres­sion-free sur­vival in first-line re­cur­rent or metasta­t­ic na­sopha­ryn­geal can­cer as a com­bi­na­tion with chemo. The drug topped chemother­a­py alone at a sta­tis­ti­cal­ly sig­nif­i­cant rate, BeiGene said, po­ten­tial­ly set­ting up a Chi­nese ap­proval in the in­di­ca­tion.

Mean­while, de­spite its stat­ed in­tent to ex­pand be­yond an­ti­bod­ies, BeiGene has looked to grow in that space as well. In Feb­ru­ary, the com­pa­ny signed off on a $120 mil­lion-plus deal with Boston Im­mune Tech­nolo­gies and Ther­a­peu­tics to de­vel­op and com­mer­cial­ize their tu­mor necro­sis fac­tor re­cep­tor 2 (TN­FR2) an­tag­o­nist an­ti­bod­ies in Asia (ex­clud­ing Japan), Aus­tralia and New Zealand. That move was all part of BeiGene’s play to take more shots on goal to build its on­col­o­gy brand, SVP of ex­ter­nal in­no­va­tions Lu­song Luo told End­points News at the time.

“The com­mon de­nom­i­na­tor is we are try­ing to bring ex­ter­nal in­no­va­tions in, and al­so bring our in­no­va­tions out to oth­er ge­o­graph­i­cal re­gions,” Luo said.

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).

Janet Woodcock, acting FDA commissioner (Al Drago/Bloomberg via Getty Images)

New Alzheimer's drug ap­proval fall­out: Pub­lic Cit­i­zen seeks re­moval of FDA's Wood­cock, Cavaz­zoni and Dunn

As Capitol Hill begins to wake up to the financial and scientific mess behind the FDA’s approval of Biogen’s new controversial Alzheimer’s drug Aduhelm, nonprofit watchdog Public Citizen is now calling for the top three FDA officials who are responsible to be removed from their positions.

In a letter to HHS Secretary Xavier Becerra on Wednesday, the group highlighted the “litany of flaws” in the FDA’s approval of the new drug, including the “unprecedented, inappropriately close” collaboration between the FDA and Biogen in the analysis of key trial data, basing approval on an unvalidated surrogate endpoint, not following the advice of its expert advisory committee (3 members of which have since resigned), and the wide label that the agency granted.

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Aus­tralian spin­out eyes the clin­ic with a pro­phy­lac­tic nasal spray for Covid-19

Whether patients are immunocompromised or just don’t like needles, one fledgling Australian biotech says it has an alternative to Covid-19 vaccines that doesn’t involve a jab in the arm — and on Tuesday, it pulled in a fresh round of funding to take it into the clinic.

ENA Respiratory, which spun out of ENA Therapeutics last year, has pulled in nearly $24.7 million (AU $30 million) to advance its nasal spray for respiratory viral infections, the company said Tuesday.

Someit Sidhu, JATT

An­oth­er life sci­ences SPAC has popped up from a small biotech CEO with the help of Take­da, No­var­tis vet­er­ans

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

The SPAC train has slowed down since the extraordinarily high levels from late 2020 into early this year, but Tuesday saw the filing of a new blank-check company targeting the life sciences industry.

Jatt Acquisition submitted its SEC paperwork Tuesday, penciling in an estimated raise of $120 million as it sets its sights on a reverse merger partner. The SPAC is run by Someit Sidhu, a co-founder of Pathios Therapeutics, as well as CEO of Akaza Bioscience and Izana Bioscience. Sidhu will control about 97% of the blank-check company’s shares, per the S-1.

In a first, Re­gen­eron's an­ti­body cock­tail re­duces deaths for a sub­group of hos­pi­tal­ized Covid-19 pa­tients

Scientists have come up with the first evidence that Regeneron’s antibody cocktail, which has so far only been authorized for the outpatient setting, may reduce deaths of hospitalized Covid-19 patients — albeit only a subset.

The combination of casirivimab and imdevimab is the subject of the latest data cut from RECOVERY, the large-scale UK-based trial testing a variety of potential treatments. In total, 9,785 patients hospitalized with Covid-19 were enrolled in this arm of the study and were randomly assigned to receive either usual care plus the intravenous combo or usual care alone.

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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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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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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