A quiver of ar­rows for im­mune dis­or­ders: Pan­dion scores $80M in fresh fund­ing

Sci­en­tists be­gan with mak­ing re­com­bi­nant ver­sions of nat­u­ral­ly-oc­cur­ring hu­man pro­teins, then grad­u­at­ed to mon­o­clon­al an­ti­bod­ies. Now, rather than repli­cat­ing moi­eties with­in the body, re­searchers are mod­i­fy­ing these mol­e­cules to have pre­cise bi­ol­o­gy in a func­tion­al man­ner.

This tech­nol­o­gy, re­ferred to as bis­pe­cif­ic an­ti­bod­ies, is al­ready be­ing em­ployed to fight can­cer. In ear­ly 2018, Pan­dion Ther­a­peu­tics was born to re­verse-en­gi­neer the sci­ence in­to the realm of au­toim­mune and in­flam­ma­to­ry dis­or­ders.

Rahul Kakkar

Mon­o­clon­al an­ti­bod­ies are de­signed to in­hib­it a path­way, but Pan­dion is tak­ing a mol­e­cule that the body cre­ates, and en­gi­neer­ing it for the bi­ol­o­gy that we want, said com­pa­ny chief Rahul Kakkar in an in­ter­view.

As the com­pa­ny shep­herds its lead ther­a­py in­to pa­tients, on Wednes­day it raised a meaty $80 mil­lion in a fresh round of fi­nanc­ing.

Pan­dion, which counts Astel­las as a part­ner, has cre­at­ed com­po­nents that can be mixed and matched to cre­ate mol­e­cules that have both the bi­o­log­ic and the chem­i­cal ther­a­peu­tic prop­er­ties that we want, Kakkar ex­plained.

“The way I like to think about it is our mol­e­cules rep­re­sent ar­rows, with­in a quiver of ar­rows that rep­re­sents our pipeline,” he said. “So each of these ar­rows has an ar­row­head. The ar­row­head is an en­gi­neered vari­ant of some­thing our bod­ies nat­u­ral­ly use to con­trol the im­mune sys­tem.”

The ar­row­head in the com­pa­ny’s lead pro­gram — PT101 — is a mu­tat­ed vari­ant of in­ter­leukin two. Nat­u­ral­ly, the body us­es IL-2 to ex­pand reg­u­la­to­ry T cells and to en­hance con­ven­tion­al pro-in­flam­ma­to­ry T cells. Pan­dion’s IL-2 two has been en­gi­neered to be high­ly spe­cif­ic for reg­u­la­to­ry T cells, but to have no ef­fect on the oth­er cells. The ther­a­py is cur­rent­ly be­ing eval­u­at­ed in healthy vol­un­teers — and if all goes well, come 2021, the com­pound will be test­ed in ul­cer­a­tive col­i­tis pa­tients.

The ar­row­head is in charge of the bi­ol­o­gy, but the tail gives the ar­row­head phar­ma­cother­a­peu­tic prop­er­ties that we want. “So we can mar­ry an FC fu­sion, for in­stance, which gives half-life ex­ten­sion, so then that ar­row­head re­sides with­in the sys­temic cir­cu­la­tion, has sys­temic im­mune-mod­u­la­to­ry prop­er­ties and be­haves like an in­jectable bi­o­log­ic,” Kakkar said.

The next junc­ture, which Pan­dion has un­der de­vel­op­ment, is cre­at­ing a bi­func­tion­al or bis­pe­cif­ic, so the tail end ac­tu­al­ly has a func­tion, rather than just half-life ex­ten­sion.

“That tail…is de­signed as a teth­er or a dock, where it binds the ar­row­head with­in an or­gan of in­ter­est so we can, there­fore, guide the ar­row­head in­to spe­cif­ic or­gan sys­tems,” Kakkar said. “So, for in­stance, we can guide it in­to the be­ta cells of the pan­creas, which is where our col­lab­o­ra­tion with Astel­las fo­cus­es.”

The word Pan­dion is the genus name for the os­prey (or a sea hawk), a brown-and-white bird of prey. Spread­ing its wings, it swoops down to wa­ter sur­faces to seize un­sus­pect­ing fish us­ing its talons. “The im­age of a very pre­cise hit with wing­spread ba­si­cal­ly looks like an an­ti­body bind­ing to a very spe­cif­ic lo­cal­iza­tion in ge­og­ra­phy and so that’s ex­act­ly what our mol­e­cules do par­tic­u­lar­ly in the bis­pe­cif­ic for­mat,” said Kakkar.

The Se­ries B was led by Ac­cess Biotech­nol­o­gy, Box­er Cap­i­tal, RA Cap­i­tal and Or­biMed and in­clud­ed the par­tic­i­pa­tion of Po­laris Part­ners, Ver­sant Ven­tures, Roche Ven­ture Fund, SR One, JDRF T1D Fund and BioIn­no­va­tion Cap­i­tal. The Boston-based start­up raised $58 mil­lion in Jan­u­ary 2018.

De­spite the dis­rup­tions faced by the on­go­ing coro­n­avirus pan­dem­ic, since the biotech in­dus­try is con­sid­ered es­sen­tial in Boston, the com­pa­ny con­tin­ues to work on its com­pounds, al­though all non-lab per­son­nel are work­ing re­mote­ly.

“Frankly speak­ing, the need of pa­tients suf­fer­ing from au­toim­mune dis­ease con­tin­ues and so as long as that need is there, we con­tin­ue to be fo­cused on ex­e­cut­ing on our goals,” Kakkar said.

That be­ing said, work­ing from home is hard­ly a walk in the park. ” I think we’re all sup­port­ing each oth­er as best we can, but I think it’s a chal­lenge for every­one.”

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The FDA is keeping the good news coming for Alzheimer’s drug developers. And Eli Lilly is taking them up on it.

Amid continued controversy around whether Biogen’s new flagship drug, Aduhelm, should have been approved at all — and swelling, heated debates surrounding its $56,000 price tag — the agency had no issue handing them and their Japanese partner Eisai a breakthrough therapy designation for a second anti-amyloid beta antibody, lecanemab, late Wednesday.

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James Peyer, Cambrian

Can a cell ther­a­py treat mus­cu­lar dy­s­tro­phy? A Ger­man bil­lion­aire's an­ti-ag­ing start­up is try­ing to find out

Gene therapy companies have faced huge hurdles trying to deliver healthy genes into muscular dystrophy patients’ muscle cells, so here’s an idea: Why don’t we just replace the muscle cells themselves?

Over the last two years, Vita Therapeutics has been exploring that possibility, building on early stem cell work from Johns Hopkins professor Peter Andersen. And on Tuesday they announced a $32 million Series A to begin to move their first therapy into the clinic, where they hope it will help rebuild muscle in patients with a type of dystrophy that afflicts the arms and legs.

From left: Rajul Jain, Stefan Vitorovic, Arjun Goyal, Arie Belldegrun, Jean-Philippe (JP) Kouakou-Zebouah, Helen Kim

Arie Bellde­grun's Vi­da Ven­tures goes back to the well with $825M mega­fund and its eyes set on more in­no­v­a­tive meds

Among the list of bright names in biopharma, few shine brighter than Kite founder and serial entrepreneur Arie Belldegrun, who has rattled off a remarkable run of success in recent years. Now, a Belldegrun investment team is locking up a massive third fund to keep chasing the cutting edge in therapeutics.

Vida Ventures closed its third investment fund at a whopping $825 million — its largest yet — as the ever-expanding VC firm hits 30 companies in its portfolio developing new routes to hard-to-treat diseases, the company said Thursday.

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Hervé Hoppenot, Incyte CEO (Jeff Rumans)

ODAC echoes FDA con­cern over In­cyte PD-1, as Paz­dur sig­nals broad­er shift for ac­cel­er­at­ed ap­proval

After the FDA lambasted their PD-1 ahead of an adcomm earlier this week, Incyte ran into new trouble Thursday as ODAC panelists voted against an accelerated OK by a wide margin.

Members of the Oncologic Drugs Advisory Committee recommended with a 13-4 vote to defer a regulatory decision on Incyte’s retifanlimab until after more data can be collected from a placebo-controlled trial. The PD-1 therapy is due for a PDUFA date in late July after receiving priority review earlier this year.

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In a lengthy review document and a pair of memos from top officials, the FDA released on Tuesday night its most detailed argument yet for approving Biogen’s intensely controversial Alzheimer’s drug aducanumab.

The documents amount to an agency attempt to quench the firestorm their decision kindled, as outside advisors members resigned and experts warned that an unproven drug now could stretch Medicare’s budget to a breaking point. Ultimately, the documents show how CDER director Patrizia Cavazzoni and Office of New Drugs director Peter Stein both concurred with FDA neuroscience head Billy Dunn on the accelerated approval while the staff at FDA’s Office of Biostatistics did not think an approval was warranted.

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Karen Flynn, Catalent

Q&A: When the pan­dem­ic struck, Catal­en­t's CCO had just joined the team

Karen Flynn came aboard Catalent’s team just in time.

The company was going through a surge of changes, and she had been brought over from her role as CCO of West Pharmaceutical Services to serve in the same capacity for the New Jersey-based CDMO. Then a few months later, the pandemic was in full-force.

Since then, Catalent’s been in hyper-expansion mode. In early May, it acquired Promethera’s Hepatic Cell Therapy Support SA subsidiary and its 32,40-square-foot facility in Gosselies, Belgium. Prior to that, the company acquired Belgian CDMO Delphi Genetics, wrapped up the expansion of an already-existing site in Madison, WI and added an ultra-low temperature freezer partner in Sterling. As Emergent has botched millions of doses of AstraZeneca’s vaccine, the company has swooped in to move that production to its Maryland plant as well.

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Richard Pazdur (vis AACR)

FDA en­cour­ages in­clud­ing in­cur­able can­cer pa­tients in tri­als, re­gard­less of pri­or ther­a­pies

The FDA on Thursday called to include those with incurable cancers (when there is no potential for cure or for prolonged/near normal survival) in appropriate clinical trials, regardless of whether they have received existing alternative treatments.

Historically, many cancer clinical trials have required that participating patients previously received multiple therapies, according to Richard Pazdur, director of the FDA’s Oncology Center of Excellence.

On heels of Aduhelm ap­proval, Bris­tol My­ers jumps back in­to Alzheimer's race

Bristol Myers Squibb last put major resources behind an Alzheimer’s drug nearly a decade ago, when their own attempt at targeting amyloid flamed out in mid-stage studies. They invented another molecule, a Tau-targeted antibody, but jettisoned it to Biogen in 2017 as they dropped out of neuroscience altogether.

But on Thursday, the New York pharma announced they were getting back in the game. Bristol Myers exercised an $80 million option to bring a tau-targeted antibody from Prothena into a Phase I study. The opt-in, which Bristol Myers triggered ahead of analyst expectations, opens the door for another $1.7 billion in milestones down the road.

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