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.

Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen spot­lights a pair of painful pipeline set­backs as ad­u­canum­ab show­down looms at the FDA

Biogen has flagged a pair of setbacks in the pipeline, spotlighting the final failure for a one-time top MS prospect while scrapping a gene therapy for SMA after the IND was put on hold due to toxicity.

Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining. And the failures are being reported as Biogen was forced to cut its profit forecast for 2020 as a generic rival started to erode their big franchise drug.

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Stephen Hahn, FDA commissioner (AP Images)

As FDA sets the stage for the first Covid-19 vac­cine EUAs, some big play­ers are ask­ing for a tweak of the guide­lines

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee this Thursday, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input they’re looking for on EUAs, before they move on to the full BLA approval process.

All of this has already been spelled out to the developers. But the devil is in the details, and it’s clear from the first round of posted responses that some of the top players — including J&J and Pfizer — would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

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A new chap­ter in the de­cen­tral­ized clin­i­cal tri­al ap­proach

Despite the promised decentralized trial revolution, we haven’t yet moved the needle in a significant way, although we are seeing far bolder commitments to this as we continue to experience the pandemic restrictions for some time to come. The vision of grandeur is one thing, but operationalizing and execution are another and recognising that change, particularly mid-flight on studies, is worthy of thorough evaluation and consideration in order to achieve success. Here we will discuss one of the critical building blocks of a Decentralized and Remote Trial strategy: TeleConsent; more than paper under glass, it is a paradigm change and key digital enabler.

Pfizer CEO Albert Bourla (Drew Angerer/Getty Images)

Pfiz­er is on the verge of claim­ing a multi­bil­lion-dol­lar first-mover ad­van­tage with their Covid-19 vac­cine — an­a­lyst

From the beginning, Pfizer CEO Albert Bourla eschewed government funding for his Covid-19 vaccine work with BioNTech, willing to take all the $2 billion-plus risk of a lightning-fast development campaign in exchange for all the rewards that could fall its way with success. And now that the pharma giant has seized a solid lead in the race to the market, those rewards loom large.

SVB Leerink’s Geoff Porges has been running the numbers on Pfizer’s vaccine, the mRNA BNT162b2 program that the German biotech partnered on. And he sees a $3.5 billion peak in windfall revenue next year alone. Even after the pandemic is brought to heel, though, Porges sees a continuing blockbuster role for this vaccine as people around the world look to guard against a new, thoroughly endemic virus that will pose a permanent threat.

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Lit­tle Zosano takes an­oth­er beat­ing as the FDA slaps down their ap­pli­ca­tion for a mi­graine patch

Zosano $ZSAN has officially come up short in its bid to develop a migraine patch.

The FDA rejected the company’s application to repurpose the triptan zolmitriptan in a new delivery system as Qtrypta, Zosano said Wednesday morning, issuing a CRL for the microneedle patch. Regulators cited inconsistent exposure levels across multiple clinical trials as the main reason for the thumbs down.

Investors did not take too kindly to the news, with Zosano shares plunking down around 25%. The company is requesting a Type A meeting to “provide clarity on the next steps for the program,” CEO Steven Lo said in a statement.

Glax­o­SmithK­line's vac­cines group aims for a first as it kicks off PhI­II RSV stud­ies

One of GlaxoSmithKline’s big projects at its global vaccine R&D center in Rockville, MD is set to enter Phase III after passing early-stage tests with flying colors.

Eyeing the wide-open respiratory syncytial virus (RSV) space, GSK is pushing two different vaccine candidates: GSK3888550A is designed to confer protection to infants via maternal immunization, while GSK3844766A is meant for the elderly.

Pur­due Phar­ma signs guilty plea, preps $8B+ set­tle­ment on Oxy con­tro­ver­sy — re­port; Flag­ship brings in a comms chief

Purdue Pharma may soon be signing off on a guilty plea and an $8 million-plus settlement to wrap up its controversial role distributing OxyContin.

The AP has the breaking story this morning.

Purdue filed for bankruptcy last year, along with Insys and followed by Mallinckrodt, as it navigated its way through a blizzard of litigation surrounding Oxy, which triggered an epidemic of abuse around the country.

CEO Grace Colón (InCarda)

Look­ing to re­pur­pose an old drug to treat ir­reg­u­lar heart­beats, In­Car­da rais­es $30M in first Se­ries C close

A little less than two years after completing its $42 million Series B round, InCarda has returned to the venture well.

The San Francisco-based biotech announced the first portion of its Series C on Wednesday, pulling in $30 million in new funding. Most of the money will give enough runway for InCarda’s InRhythm program, an inhaled therapeutic aiming to treat sudden episodes of irregular heartbeats, through its Phase II trials and prepare it for Phase III.

UP­DAT­ED: CRISPR Ther­a­peu­tics gets a snap­shot of off-the-shelf CAR-T suc­cess in B-cell ma­lig­nan­cies — marred by the death of a pa­tient

Just days after scientific founder Emmanuelle Charpentier shared the Nobel prize for her work on CRISPR/Cas9, CRISPR Therapeutics $CRSP is showing off a snapshot of success in their early-stage study for an off-the-shelf CAR-T approach to CD19+ B cell malignancies — a snapshot marred by the death of a patient who had been given a high dose of the treatment.

Using their gene editing tech, researchers for CRISPR engineered cells from healthy donors into an attack vehicle aimed at cancer, something that has been achieved with great success using patients’ own cells — the autologous approach. But autologous CAR-T is hampered by the more complex vein-to-vein requirement that delays treatment, and now CRISPR Therapeutics along with other players like Allogene are determined to replace the pioneers with CAR-T 2.0.

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