Jim Broderick

Jim Brod­er­ick reels in a $100M Se­ries B to ex­plore a 'new and big' an­gle of im­mune reg­u­la­tion

When Jim Brod­er­ick launched Mass­a­chu­setts-based Palleon Phar­ma­ceu­ti­cals in 2015, he had an of­fice in Cam­bridge’s Kendall Square, a bit of seed mon­ey, and a blank can­vas.

He set out to in­no­vate with­in a new space in im­munol­o­gy, and re­cruit­ed sci­en­tif­ic co-founders Car­olyn Bertozzi, a Stan­ford pro­fes­sor, and Paul Crock­er, a pro­fes­sor and the head of the cell sig­nal­ing and im­munol­o­gy di­vi­sion at the Uni­ver­si­ty of Dundee, Scot­land, to help him do it.

“When you start a new com­pa­ny in biotech, you need to be in some­thing that’s new and big, and you need to have the world’s best sci­en­tists be­hind you,” Brod­er­ick, who was the first en­tre­pre­neur-in-res­i­dence at GSK’s ven­ture arm SR One, told End­points News.

On Wednes­day, the five-year-old com­pa­ny an­nounced the com­ple­tion of a $100 mil­lion Se­ries B round to de­vel­op its pipeline of gly­co-im­munol­o­gy ther­a­pies. Its lead pro­gram in on­col­o­gy, an en­zy­mat­ic sialo­gly­can de­grad­er, is ex­pect­ed to hit the clin­ic next year.

“Gly­can-me­di­at­ed im­mune reg­u­la­tion presents an enor­mous op­por­tu­ni­ty for nov­el ther­a­peu­tics to treat a range of dis­eases char­ac­ter­ized by im­mune sys­tem dys­func­tion, in­clud­ing can­cer and in­flam­ma­to­ry dis­eases,” the CEO an­nounced in a state­ment. Be­fore Palleon, Brod­er­ick co-found­ed three oth­er biotechs, in­clud­ing Ra Phar­ma­ceu­ti­cals.

Ac­cord­ing to Brod­er­ick, it’s been known since 1959 that tu­mors have dif­fer­ent gly­can struc­tures on their sur­faces. “But no­body could fig­ure out what the gly­cans were do­ing,” he said.

The an­swer, he added, was hid­ing in plain sight. “But no­body could see it, be­cause we didn’t re­al­ly have the lens to view the im­mune sys­tem in this way that we now do.” The tu­mors, he said, use evolved gly­can struc­tures to hide from im­mune sys­tem at­tacks. And so Palleon is work­ing on us­ing cell sur­face sug­ar mol­e­cules to mod­u­late im­mune ac­tiv­i­ty.

In ad­di­tion to its EA­GLE plat­form, which us­es en­zy­mat­ic sialo­gly­can degra­da­tion to over­come in­tractable bi­o­log­i­cal re­dun­dan­cy and en­able a pan-im­mune an­ti-tu­mor re­sponse, the com­pa­ny al­so has its HY­DRA plat­form, which char­ac­ter­izes can­cer pa­tients by their tu­mor sur­face gly­can pro­file to iden­ti­fy which pa­tients are most like­ly to re­spond. Palleon says it’s de­vel­op­ing a “broad pipeline” of can­di­dates that tar­get in­di­vid­ual Siglecs and oth­er gly­can-sens­ing re­cep­tors, which may be use­ful against in­flam­ma­to­ry dis­eases like au­toim­mu­ni­ty and fi­bro­sis.

The Se­ries B, led by Ma­trix Cap­i­tal Man­ae­ment, will help push that pipeline to­ward the clin­ic, Brod­er­ick said. Re­turn­ing in­vestors SR One, Pfiz­er Ven­tures, Ver­tex Ven­tures HC, Take­da Ven­tures, and Ab­b­Vie Ven­tures, and new in­vestor Sur­vey­or Cap­i­tal al­so chipped in.

“It’s just a whole oth­er an­gle of im­mune reg­u­la­tion… You couldn’t see it be­fore… and now when you see it, there seems to be a lot of op­por­tu­ni­ty,” Brod­er­ick said.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Steve Harr (L) and Hans Bishop

One of the most am­bi­tious start­up teams in biotech just out­lined plans for a $400M IPO and a val­u­a­tion of about $4B

The executive team at Sana Biotechnology has sketched out more details about the full scope of its ambitions as the new unicorn to watch. They amended their S-1 today to include a price range of $20 to $23 a share — which puts them in reach of pulling in around $400 million on the high end with a market value starting right around $4 billion.

That’s not bad for a preclinical biotech with no drugs yet in human studies, but it squares with its ambitions to remake the cell therapy field with a slate of in-house platforms. The biotech raised $705 million — primarily from ARCH (44 million shares) and Flagship (34.2 million shares) — to get to this stage.

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Pfiz­er's big block­buster Xel­janz flunks its post-mar­ket­ing safe­ty study, re­new­ing harsh ques­tions for JAK class

When the FDA approved Pfizer’s JAK inhibitor Xeljanz for rheumatoid arthritis in 2012, they slapped on a black box warning for a laundry list of adverse events and required the New York drugmaker to run a long-term safety study.

That study has since become a consistent headache for Pfizer and their blockbuster molecule. Last year, Pfizer dropped the entire high dose cohort after an independent monitoring board found more patients died in that group than in the low dose arm or a control arm of patients who received one of two TNF inhibitors, Enbrel or Humira.

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Lil­ly at­tempts to re­vive an old idea for tack­ling pain, li­cens­ing PhI pro­gram from Japan’s Asahi Ka­sei Phar­ma

Eli Lilly is fronting some new cash in a space they’re quite familiar with.

The company is partnering with Japan’s Asahi Kasei Pharma on an experimental drug for chronic pain, acquiring the rights for the P2X7 receptor antagonist program dubbed AK1780. Lilly will shell out a pretty penny for the program, promising up to $410 million total should each milestone payment come to pass.

Asahi Kasei will receive an upfront sum of $20 million for the candidate. In addition, Lilly is on the hook for up to $210 million in development and regulatory milestones and another potential $180 million in sales milestones. Asahi Kasei can also obtain royalties ranging from the mid-single to low-double digits should an approved product come out of the deal.

Ther­mo Fish­er plat­form seeks to ex­pe­dite donor cell cul­ti­va­tion for al­lo­gene­ic cell ther­a­pies

One of the world’s leading CDMOs has launched a new technology it says will expedite a quickly-growing sect of biotech drug development: off-the-shelf, allogeneic cell therapies.

It’s been nearly a decade since the FDA approved the first use of the method that uses healthy donor cells to create a master cell bank, which is then used for specific therapies — a cord blood allogeneic treatment called Hemacord. In the years since, the use of allogeneic cells has taken off in research circles, most notably in the use of T cell therapies to target solid tumor cancers.

Top gene ther­a­py deals, M&A pacts in 2020 high­light an­oth­er big year in one of the hottest fields in bio­phar­ma

Chris Dokomajilar at DealForma has been crunching the numbers on gene therapy deals over the last 2 years and came away with a few key observations.

Both the upfront cash and deal totals last year backed off a bit from the record high hit in 2019, but the totals are still running well ahead of anything we’ve seen in the years prior to 2019/2020.
2020 R&D partnerships came in at 23 deals, with $1.1 billion in disclosed upfront cash and equity and more than $8.5 billion in total deal value. Looking at 2019-2020 M&A, Dokomajilar found: 9 Acquisitions, with over $11.1 billion in disclosed upfront cash and equity and more than $13.4 billion in total M&A value.

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Covid-19 roundup: EU and As­traZeneca trade blows over slow­downs; Un­usu­al unions pop up to test an­ti­bod­ies, vac­cines

After coming under fire for manufacturing delays last week, AstraZeneca’s feud with the European Union has spilled into the open.

The bloc accused the pharma giant on Wednesday of pulling out of a meeting to discuss cuts to its vaccine supplies, the AP reported. AstraZeneca denied the reports, saying it still planned on attending the discussion.

Early Wednesday, an EU Commission spokeswoman said that “the representative of AstraZeneca had announced this morning, had informed us this morning that their participation is not confirmed, is not happening.” But an AstraZeneca spokesperson later called the reports “not accurate.”

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Bob Nelsen (Michael Kovac/Getty Images)

ARCH an­nounces largest fund yet, rais­ing $1.85B to back men­tal health, cell and gene edit­ing ap­proach­es

Nearly a year ago, as the pandemic encroached and the stock market cratered, Flagship and ARCH Venture announced three mega-funds worth a combined $2.6 billion. They wanted, ARCH’s Bob Nelsen said, to restore confidence “that there was money out there and a lot of it” to invest in biotech.

Since then, the stock market has returned — almost frighteningly so — and Nelsen has kept raising and spending cash. On Thursday, he announced a new fund, worth $1.85 billion. It’s the largest pot yet for a VC famous for its deep pockets.

Janet Woodcock (AP Images)

Ad­vo­ca­cy groups don't want Janet Wood­cock to head the FDA, blast­ing ‘reg­u­la­to­ry fail­ures’ in opi­oid cri­sis

It turns out the controversies around Janet Woodcock’s regulatory legacy weren’t limited to Sarepta’s eteplirsen.

A coalition of advocacy groups dedicated to the opioid crisis urged Norris Cochran and Xavier Becerra — the acting and designated HHS secretary, respectively — to keep her reign as interim FDA chief a “very short transition.” During her lengthy tenure as CDER, they add, Woodcock presided over “one of the worst regulatory agency failures in U.S. history.”

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