An up­start im­munother­a­py biotech emerges from stealth mode with big love for Kendall Square

Daniel Passeri, Cue Bio­phar­ma

When Ron Sei­del and Rodol­fo “Rudy” Chap­ar­ro had to sit down and de­cide where to base their new biotech, the two in­ves­ti­ga­tors at Al­bert Ein­stein Col­lege of Med­i­cine in New York could have gone just about any­where in the US that they want­ed. Stay­ing in New York would have worked. One had fam­i­ly in Cal­i­for­nia to con­sid­er. But a year ago, they chose Cam­bridge, MA, and start­ed build­ing their team in a place on Kendall Square.

The com­pa­ny is Cue Bio­Phar­ma. Their mis­sion is to de­vel­op drugs that can com­mand and con­trol a se­lec­tive T cell re­sponse, ei­ther di­al­ing up or di­al­ing down a T cell at­tack. It’s one of the busiest tech cross­roads in biotech, and they chose one of the busiest hubs to pur­sue some am­bi­tious goals.

“We be­lieve that this is the epi­cen­ter of the biotech world,” says Sei­del. If you want to find the top tal­ent and push new tech­nol­o­gy at a rapid speed, he adds, Cam­bridge is the place to do it.

To­day, af­ter work­ing on their de­vel­op­ment plat­form for 5 years — with con­sid­er­able help from the NIH — Sei­del and Chap­ar­ro are step­ping out of stealth mode af­ter rais­ing $10 mil­lion in seed cash and $16.4 mil­lion in a re­cent round led by MDB Cap­i­tal Group. And a few months ago Daniel Passeri, the for­mer CEO at Curis, stepped in to helm the en­ter­prise, with plans to con­tin­ue to grow the team this year.

Like a lot of star­tups with a de­vel­op­ment plat­form and lots of work to do, Passeri is pur­su­ing ear­ly part­ner­ship talks with some key play­ers in the im­munother­a­peu­tic are­na, which has be­come quite a crowd.

Cue is build­ing a com­plex ther­a­peu­tic, mar­ry­ing a cos­tim­u­la­to­ry mol­e­cule with a T cell re­cep­tor-tar­get­ing pep­tide on an an­ti­body scaf­fold to or­ches­trate a spe­cif­ic T cell re­sponse. The pep­tide finds the T cells they need and the bi­o­log­ic de­liv­ers an en­gi­neered lig­and. And when you change the com­po­nents, you should be able to change the spe­cif­ic ef­fect.

To put it an­oth­er way, Passeri tells me, it’s like do­ing what you want to do with a CAR-T, but through a mol­e­cule rather than an ex vi­vo en­gi­neer­ing process. This is sec­ond-gen im­munother­a­peu­tic work, ide­al for check­point col­lab­o­ra­tions, and the CEO ex­pects to have the lead can­di­date for HPV se­lect­ed soon, with plans to go in­to the clin­ic in H1 2018.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

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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President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

UP­DAT­ED: White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

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.

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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Gilead bol­sters its case for block­buster hope­ful fil­go­tinib as FDA pon­ders its de­ci­sion

Before remdesivir soaked up the spotlight amid the coronavirus crisis, Gilead’s filgotinib was the star experimental drug tapped to rake in billions competing with other JAK inhibitors made by rivals including AbbVie and Eli Lilly.

Now, long term data on the drug — discovered by Gilead’s partners at Galapagos and posted as part of a virtual medical conference — have solidified the durability and safety of filgotinib in patients with rheumatoid arthritis, spanning data from three late-stage trials. An FDA decision on the drug is expected this year.

Covid-19 roundup: Mod­er­na read­ies to en­ter PhI­II in Ju­ly, As­traZeneca not far be­hind; EU ready to ne­go­ti­ate vac­cine ac­cess with $2.7B fund

Moderna may soon add another first to the Covid-19 vaccine race.

In March, the mRNA biotech was the first company to put a Covid-19 vaccine into humans. Next month, they may become the first company to put their vaccine into the large, late-stage trials that are needed to prove whether the vaccine is effective.

In an interview with JAMA editor Howard Bauchner, NIAID chief Anthony Fauci said that a 30,000-person, Phase III trial for Moderna’s vaccine could start in July. The news comes a week after Moderna began a Phase II study that will enroll several hundred people.

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New safe­ty da­ta ex­pose po­ten­tial weak­ness as Pfiz­er's abroc­i­tinib takes on Dupix­ent in eczema

Last September, when Pfizer celebrated positive data from a second Phase III study of abrocitinib, many watchers applauded the efficacy but were still waiting to see whether the JAK1 inhibitor is “safe enough to be a formidable competitor to Dupixent,” the clear leader in the atopic dermatitis field. The full slate of safety data are now out and, according to one analyst, the answer is: probably not.