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.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

The End­points 11: They've got mad mon­ey and huge am­bi­tions. It's time to go big or go home

These days, selecting a group of private biotechs for the Endpoints 11 spotlight begins with a sprint to get ahead of IPOs and the M&A teams at Big Pharma. I’ve had a couple of faceplants earlier this year, watching some of the biotechs on my short list choose a quick leap onto Nasdaq or into the arms of a buyer.

Vividion, you would have been a great pick for the Endpoints 11. I’m sorry I missed you.

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Dave Lennon, former president of Novartis Gene Therapies

So what hap­pened with No­var­tis Gene Ther­a­pies? Here's your an­swer

Over the last couple of days it’s become clear that the gene therapy division at Novartis has quietly undergone a major reorganization. We learned on Monday that Dave Lennon, who had pursued a high-profile role as president of the unit with 1,500 people, had left the pharma giant to take over as CEO of a startup.

Like a lot of the majors, Novartis is an open highway for head hunters, or anyone looking to staff a startup. So that was news but not completely unexpected.

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Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

Jean Bennett (Brent N. Clarke/Invision/AP Images)

Lux­tur­na in­ven­tor Jean Ben­nett starts a new gene ther­a­py com­pa­ny to tack­le rare dis­eases left be­hind by phar­ma, VCs

A few years ago Jean Bennett found herself in a surprising place for a woman who invented the first gene therapy ever approved in the United States: No one, it seemed, wanted her work.

Bennett, who designed and co-developed Luxturna, approved in 2018 for a rare form of blindness, had kept building new gene therapies for eye diseases at her University of Pennsylvania lab. But although the results in animals looked promising, pharma companies and investors kept turning down the pedigreed ophthalmology professor.

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FDA au­tho­rizes Pfiz­er's vac­cine boost­er for se­niors, those at high risk for se­vere Covid-19

The Biden administration’s goal of kicking off its booster shot drive for the entire US population this week is not quite going as planned.

First, Pfizer applied for approval of a supplemental application for the booster shots, but since last Friday’s adcomm reviewing them, the plan has devolved into an EUA, which the FDA issued late Thursday evening.

The population that is now eligible for the booster, six months after receiving the first pair of Pfizer-BioNTech vaccines, also narrowed from what Pfizer applied for (everyone who’s eligible for the initial Pfizer shots) to just those who are 65 or older, or at high-risk of a Covid infection, including health care workers and others with occupational hazards.

Stéphane Bancel, AP Images

Fi­nal analy­sis of US-fund­ed Mod­er­na Covid vac­cine tri­al shows 98% ef­fi­ca­cy against se­vere dis­ease

A final look at the results of the placebo-controlled Moderna trial in the New England Journal of Medicine, published Thursday afternoon, shows how the vaccine continues to prevent Covid-19 and severe cases after more than five months following the second shot.

Of the more than 30,000 enrolled in the trial that ultimately led to the vaccine’s EUA, only two people in the vaccine group got a severe form of the disease, compared to 106 in the placebo group — leading to an efficacy of 98%.

Emma Walmsley, GlaxoSmithKline CEO (Credit: Fang Zhe/Xinhua/Alamy Live News)

The fire un­der Glax­o­SmithK­line's Em­ma Walm­s­ley grows as an­oth­er well-known ac­tivist in­vestor grabs its pitch­fork — re­port

Bluebell Capital Partners, a proxy brawler fresh off a campaign to oust global food giant Danone’s CEO and most of its board of directors, has bought a stake in UK drugmaker GlaxoSmithKline with its eyes trained directly on Emma Walmsley, the Financial Times reported Wednesday.

The London-based hedge fund joins another notorious activist firm in Paul Singer’s Elliott Management, which earlier this year called for a shakeup in leadership at GSK to handle what the company described as a wealth of riches across the drug giant’s portfolio hindered by limited vision from top staff.

FDA+ roundup: Bs­U­FA III ready for show­time, court tells FDA to re-work com­pound­ing plan, new guid­ance up­dates and more

The FDA has now spelled out what exactly will be included in the third iteration of Biosimilar User Fee Act (BsUFA) from 2023 through 2027, which similarly to the prescription drug deal, sets fees that industry has to pay for submitting applications, in exchange for firm timelines that the agency must meet.

This latest deal includes several sweeteners for the biosimilar industry, which has yet to make great strides in the US market, with shorter review timelines for safety labeling updates and updates to add or remove an indication that does not contain efficacy data.

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