Kleanthis Xanthopoulos, Shoreline CEO

Fresh off Kite and BeiGene deals, Shore­line ups the ante with a hefty crossover. But the biotech in­sists it's in no rush

Though it may seem like Shore­line Bio­sciences is rapid­ly gain­ing mo­men­tum with a flur­ry of deals — and, now, a new fund­ing round — Klean­this Xan­thopou­los doesn’t feel he’s in a rush.

The biotech’s chief ex­ec­u­tive put the bow on a $140 mil­lion Se­ries B on Tues­day, as Shore­line con­tin­ues a streak of wheel­ing and deal­ing that’s seen it part­ner with Gilead’s Kite and BeiGene these last few months. And de­spite the new raise tech­ni­cal­ly be­ing a crossover round with Al­ly Bridge Group lead­ing the way, Xan­thopou­los is tak­ing his time in prep­ping a pub­lic of­fer­ing.

“It’s on­ly smart for us to be ready for an IPO, but we have so much cap­i­tal we can pick the right tim­ing,” Xan­thopou­los told End­points News. “Prac­ti­cal­ly, we’re go­ing to be ready to be­come a pub­lic com­pa­ny. When the time comes, we’ll be set, but it’s good to have that lux­u­ry.”

Dri­ving all the in­ter­est are Shore­line’s off-the-shelf can­cer ther­a­pies, in­clud­ing a par­tic­u­lar fo­cus on iP­SC NK cells and macrophages for var­i­ous tu­mors. Part­nered with Dan Kauf­man’s lab out of UC-San Diego, Shore­line has built a war chest of $300 mil­lion to ad­vance such treat­ments, build out its man­u­fac­tur­ing ca­pa­bil­i­ties and sign its high-pro­file col­lab­o­ra­tions.

Man­u­fac­tur­ing specif­i­cal­ly has a spe­cial place in Shore­line’s plans, as Xan­thopou­los even­tu­al­ly hopes the com­pa­ny will be able to cre­ate NK cell ther­a­pies that will be used in the com­mu­ni­ty set­ting. It’s a pitch that’s dri­ven sig­nif­i­cant in­vest­ment to­ward the field as a whole, with com­pa­nies like Arti­va gain­ing back­ing from blue-chip in­vestors and Mer­ck.

But Shore­line’s fo­cus on pluripo­tent stem cells — com­pared to Arti­va’s donor cell ap­proach — gives it a key dif­fer­en­ti­at­ing fac­tor, Xan­thopou­los said. The two have very dif­fer­ent man­u­fac­tur­ing process­es and the CEO be­lieves iP­SC NK cells will prove safer and more cost-ef­fec­tive in the long run.

“We in­cor­po­rat­ed AI, au­toma­tion to com­plete­ly re­think how we’re go­ing to cre­ate the man­u­fac­tur­ing,” he said. “We’ve re­cruit­ed peo­ple from the elec­tron­ic chip man­u­fac­tur­ing in­dus­try to see how it worked there. A large por­tion of the raise is ear­marked to build that fa­cil­i­ty.”

The com­pa­ny is now sit­ting on 10 pipeline pro­grams large­ly aimed at a va­ri­ety of hema­to­log­i­cal and sol­id tu­mors. Xan­thopou­los said there are nine can­di­dates in­volv­ing NK cells, in­clud­ing two in house, three from the Kite part­ner­ship and four be­ing co-de­vel­oped with BeiGene. The last is Shore­line’s in-house macrophage pro­gram, which is slight­ly be­hind the rest, the CEO said.

Xan­thopou­los likes to think of it as not just Shore­line’s pipeline, how­ev­er, but the pipelines of three dif­fer­ent com­pa­nies com­ing to­geth­er. Mov­ing for­ward, Shore­line is get­ting ready to send its first IND for the lead in-house NK cell ther­a­py by the end of 2022, with plans to sub­mit “one or two” INDs every year af­ter that, Xan­thopou­los said.

And once that’s ac­com­plished, maybe the IPO will come. But Xan­thopou­los isn’t count­ing his cell ther­a­pies be­fore they come home to roost.

“We want to see [our ther­a­pies] as broad­ly avail­able as an­ti­bod­ies,” he said. “It should be that sim­ple giv­en how safe the NK cells have proven to be in the clin­ic.”

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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David Loew (Ipsen)

Ipsen snags an ap­proved can­cer drug in $247M M&A deal as an­oth­er bat­tered biotech sells cheap

You can add Paris-based Ipsen to the list of discount buyers patrolling the penny stock pack for a cheap M&A deal.

The French biotech, which has had plenty of its own problems to grapple with, has swooped in to buy Epizyme $EPZM for $247 million in cash and a CVR with milestones attached to it. Epizyme shareholders, who had to suffer through a painfully soft launch of their EZH2a inhibitor cancer drug Tazverik, will get $1.45 per share along with a $1 CVR tied to achieving $250 million in sales from the drug over four consecutive quarters as well as an OK for second-line follicular lymphoma by 1 Jan. 2028.

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AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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Yong Dai, Frontera Therapeutics CEO

Scoop: Lit­tle-known Or­biMed-backed biotech clos­es $160M round to start gene ther­a­py tri­al

Frontera Therapeutics, a China and US biotech, has closed a $160 million Series B and received regulatory clearance to test its first gene therapy stateside, Endpoints News has learned.

Led by the largest shareholder, OrbiMed, the biotech has secured $195 million total since its September 2019 founding, according to an email reviewed by Endpoints. The lead AAV gene therapy program is for an undisclosed rare eye disease, according to the source.

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Spanish Prime Minister Pédro Sanchez and European Commission President Ursula von der Leyen (AP Photo/Geert Vanden Wijngaert)

EU to launch vac­cine de­vel­op­ment and man­u­fac­tur­ing part­ner­ship with Latin Amer­i­can and Caribbean coun­tries

While European companies, including BioNTech, are focused on increasing vaccine access to African countries by setting up vaccine manufacturing facilities, the European Union is looking westward to Latin America and the Caribbean.

Speaking at a press conference with Spanish Prime Minister Pédro Sanchez, EU Commission president Ursula von der Leyen said that the EU is launching a new initiative for vaccines and medicines manufacturing in Latin America, to get drugs to Latin America and the Caribbean faster.

DEM BioPharma CEO David Donabedian (L) and executive chair Jan Skvarka

Long­wood sets an­oth­er 'don't eat me' biotech in­to gear with help of for­mer Tril­li­um CEO Jan Skvar­ka

Jonathan Weissman and team are out with a cancer-fighting biotech riding the appetite for those so-called “don’t eat me” and “eat me” signals.

The scientific co-founder — alongside fellow Whitehead Institute colleague Kipp Weiskopf and Stanford biologist Michael Bassik — has launched DEM BioPharma with incubator Longwood Fund and a crop of other investors.

In all, the nascent, 10-employee biotech has $70 million to bankroll hematology- and solid tumor-based programs, including a lead asset that could enter human trials in two to three years, CEO David Donabedian told Endpoints News.

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GSK says its drug for chron­ic hep B could ‘lead to a func­tion­al cure’ — but will it be alone or in com­bi­na­tion?

GSK, newly branded and soon-to-be demerged, shared interim results from its Phase II trial on its chronic hepatitis B treatment, one that it says has the “potential to lead to a functional cure.”

At a presentation at the EASL International Liver Congress, GSK shared that in around 450 patients who received its hep B drug bepirovirsen for 24 weeks, just under 30% had hepatitis B surface antigen and viral DNA levels that were too low to detect.

De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.