With $58M in hand, the start­up team at Pan­dion sets their sights on a next-gen ap­proach to im­munol­o­gy

An­tho­ny Coyle start­ed Pfiz­er’s Cen­ters for Ther­a­peu­tic In­no­va­tion with an eye to chang­ing the way the phar­ma gi­ant went about the busi­ness of drug dis­cov­ery. And then af­ter leav­ing last sum­mer and join­ing the great mi­gra­tion out of Big Phar­ma, he switched in­to a new role as biotech CEO — where he gets to take a more hands-on role in that strug­gle.

Coyle is at the helm of a new start­up called Pan­dion Ther­a­peu­tics, one of the lat­est ar­rivals in the bustling Cam­bridge, MA hub, where Po­laris seed­ed a group of about 12 re­searchers who have been look­ing to take some of the many lessons learned from im­muno-on­col­o­gy and then re­verse en­gi­neer­ing the tech­nol­o­gy for an­ti-in­flam­ma­to­ry or au­toim­mune drugs.

Jo Viney

“There have been tremen­dous ad­vances in un­der­stand­ing how the im­mune sys­tem in­ter­plays with the tu­mor,” Coyle tells me. And Pan­dion’s ob­jec­tives, in­spired in part by co-founder and im­munol­o­gy ex­pert David Sachs, “res­onat­ed with (chief sci­en­tist) Jo Viney and my­self.”

Viney was pre­vi­ous­ly se­nior vice pres­i­dent of drug dis­cov­ery and VP of im­munol­o­gy re­search for Bio­gen, and had ear­li­er worked at Am­gen.

“It will be fas­ci­nat­ing if we can shift the par­a­digm on de­vel­op­ing new drugs,” says the CEO.

The big idea here is that the com­pa­ny be­lieves it can cre­ate a set of bis­pe­cif­ic an­ti­bod­ies that will al­low for tar­get­ed, lo­cal­ized mod­u­la­tion of the im­mune sys­tem, with one arm of the bis­pe­cif­ic bind­ing to mol­e­cules ex­pressed at the site of in­flam­ma­tion.

That kind of work has ap­pli­ca­tions for in­flam­ma­to­ry bow­el dis­ease as well as au­toim­mune dis­eases of the liv­er, to start with.

Alan Crane

Po­laris en­tre­pre­neur­ship part­ner Alan Crane helped arrange the seed mon­ey and gath­ered the syn­di­cate to­geth­er for to­day’s an­nounce­ment of the $58 mil­lion launch round. Po­laris is in the co-lead po­si­tion with Ver­sant Ven­tures and Roche Ven­ture Fund. Glax­o­SmithK­line’s SR One and BioIn­no­va­tion Cap­i­tal al­so chipped in on the round.

The mon­ey should be enough to get be­yond the first 2 or 3 years of the start­up phase, says Coyle, with enough cash to move pro­grams out of the pre­clin­i­cal stage and in­to the clin­ic. And he wouldn’t be sur­prised to see the first part­ner­ship come to­geth­er this year, as the team dou­bles up in size.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Lat­est on ul­tra-rare dis­ease ap­proval; Pos­i­tive, if mixed, signs for Bio­gen's ALS drug; Clay Sie­gall finds a new job; and more

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FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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Steven James, Pionyr Immunotherapeutics CEO

Gilead pass­es on ful­ly ac­quir­ing Pi­o­nyr, as eyes now turn to Tizona, a fel­low sum­mer 2020 buy­out op­tion

Gilead and Pionyr Immunotherapeutics, a biotech trying to follow up on the first generation of checkpoint inhibitors, have “mutually agreed” on a rewrite to their 2020 terms, with Gilead deciding not to buy out the company.

The California biopharma waived its option to acquire the remaining 50.1% of Pionyr, which would have triggered a $315 million upfront payment and up to $1.15 billion down the road. Had Gilead waited to decide, the drugmaker would have had a potential payment to make in the near term under their agreement, a spokesperson said in an email to Endpoints News.

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Sijmen de Vries, Pharming CEO

FDA ap­proves Pharm­ing drug for ul­tra-rare im­mun­od­e­fi­cien­cy dis­ease

US regulators cleared an ultra-rare drug from Pharming Group, by way of Novartis, on Friday afternoon.

The Dutch biotech said the FDA greenlit leniolisib for an immunodeficiency disease known as activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome, or APDS. People 12 years and older can receive the oral drug, to be marketed as Joenja, beginning early next month, Pharming said, five days ahead of the decision deadline set by the FDA as part of a priority review.

Eu­ro­pean doc­tors di­al up dig­i­tal com­mu­ni­ca­tion with phar­mas, but still lean to­ward in-per­son med meet­ings, study finds

As in-person sales rep access declines in the big five European countries, a corresponding uptick in virtual rep access is happening. It’s not surprising, but it does run counter to pharma companies’ assessment – along with long-held sales rep sway in Europe – that in-person access hadn’t changed.

CMI Media Group and Medscape’s recent study reports that 75% of physicians in the EU5 countries of Spain, Germany, Italy, France and the UK already limit engagements with pharma sales reps, and 25% of those surveyed plan to decrease time with reps.

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Judge al­lows ex­pert tes­ti­mo­ny in GSK tri­al al­leg­ing Zan­tac link to can­cer

A California judge will allow a plaintiff in a state court case to introduce expert testimony connecting a potential carcinogen in former blockbuster medicine Zantac to cancer.

The order was handed down on Thursday from state judge Evelio Grillo, who is now allowing both parties to introduce expert testimony in an upcoming trial after what’s known as a Sargon hearing, where a judge determines the admissibility of expert witnesses and expert opinions.