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.

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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Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

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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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.

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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Sanofi, GSK tout 72% Omi­cron ef­fi­ca­cy in PhI­II tri­al of next-gen, bi­va­lent shot — with an eye to year-end roll­out

Sometimes, being late can give you an advantage.

That’s what Sanofi and GSK are trying to say as the Big Pharma partners report positive results from a late-stage trial of their next-gen bivalent Covid-19 vaccine, which was designed to protect against both the original strain of the SARS-CoV-2 virus and the Beta variant. Specifically, against Omicron, they note, the vaccine delivered 72% efficacy in all adults and 93.2% in those previously infected.

Matt Kapusta, uniQure CEO

In trou­bled Hunt­ing­ton’s space, uniQure’s gene ther­a­py shows ear­ly promise

In randomized clinical trial data from a small number of patients, Dutch biotech uniQure shared that its gene therapy for Huntington’s disease seems to reduce the amount of the mutant protein responsible for the disease over the course of a year.

In seven patients with early-stage Huntington’s — four who got the treatment and three who got a placebo — mutant huntingtin protein levels in the cerebrospinal fluid decreased by an average of just over 50% in patients who got the gene therapy compared to around a 17% drop in patients who got the placebo after a year.

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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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