Eric Halioua (PDC*line Pharma via Andrew Lloyd & Associates)

French-Bel­gian biotech banks €20M to break ground in blood-splat­tered field of ther­a­peu­tic can­cer vac­cines

About a decade ago, the ill-fat­ed ther­a­peu­tic can­cer vac­cine — Provenge — was ap­proved, even­tu­al­ly bank­rupt­ing its de­vel­op­er Den­dreon. Since then, a num­ber of drug­mak­ers have seen sim­i­lar ef­forts splut­ter and fiz­zle, al­though the emer­gence of im­munother­a­pies — check­point in­hibitors and CAR-T drugs — of­fered a glim­mer of hope in re­sus­ci­tat­ing the field. Bank­ing on that promise is PDC*line Phar­ma, which se­cured a €20 mil­lion in­jec­tion on Wednes­day.

Spun out of the French Blood Bank, the Bel­gian-French biotech is de­vel­op­ing off-the-shelf can­cer vac­cines that are based on a ther­a­peu­tic cell line of plas­ma­cy­toid den­drit­ic cells, which are some­times re­ferred to as the Swiss army knife of im­mune cells due to their di­verse range of func­tion. PDC*line Phar­ma’s tech­nol­o­gy is be­ing de­vel­oped to be syn­er­gis­tic with check­point in­hibitors.

Sci­en­tists ini­tial­ly hoped that tur­bocharg­ing the im­mune sys­tem to bat­tle can­cer cells would be enough to shrink tu­mors. But that didn’t quite oc­cur since can­cer cells pos­sess the abil­i­ty to put ‘brakes’ on that im­mune as­sault.

In the case of Provenge, da­ta showed the prod­uct helped prostate can­cer pa­tients live longer — but there was no ev­i­dence of tu­mor shrink­age or can­cer cell death. Still, Wall Street tagged it with block­buster ex­pec­ta­tions. But its adop­tion was re­strict­ed by its com­plex au­tol­o­gous ther­a­peu­tic ad­min­is­tra­tion, high price tag and chang­ing treat­ment land­scape. Since then, a num­ber of oth­er ther­a­peu­tic can­cer vac­cine mak­ers have crashed and burned — in­clud­ing Ar­gos Ther­a­peu­tics and Bavar­i­an Nordic.

A few years ago, the emer­gence of check­point in­hibitors — which are en­gi­neered to un­leash the im­mune sys­tem — emerged as the per­fect part­ner in crime for the ther­a­peu­tic can­cer vac­cine. That is what PDC*line Phar­ma hopes its vac­cine will ac­com­plish.

Its lead prod­uct is cur­rent­ly in a Phase I/II study in pa­tients with the most com­mon form of lung can­cer. En­roll­ment is ex­pect­ed to be com­plet­ed by 2022, chief Er­ic Halioua told End­points News.

Provenge’s com­pli­cat­ed au­tol­o­gous ad­min­is­tra­tion, cost of goods, batch-to-batch vari­abil­i­ty and un­der­whelm­ing ef­fi­ca­cy all con­tributed to its tepid sales, Halioua sug­gest­ed, in­di­cat­ing that PDC*line Phar­ma’s plan to in­cor­po­rate a check­point in­hibitor in­to the equa­tion would like­ly be ben­e­fi­cial.

“You need a good vac­cine to ac­ti­vate (the) im­mune sys­tem, and you need some­thing to break the de­fense mech­a­nisms of the tu­mor. And all the first gen­er­a­tions of vac­cines were not in these sit­u­a­tions. ”

Al­though the com­pa­ny is ini­tial­ly test­ing its off-the-shelf vac­cine as a monother­a­py, even­tu­al­ly a check­point in­hibitor will be added to the mix.

But cau­tion is war­rant­ed: Ef­forts to com­bine ther­a­peu­tic can­cer vac­cines and check­point in­hibitors have al­so met with fail­ure. Last month, French biotech Trans­gene aban­doned its ther­a­peu­tic lung can­cer vac­cine af­ter mid-stage da­ta showed that when test­ed along­side Bris­tol-My­ers’ Op­di­vo, the com­bi­na­tion did not sig­nif­i­cant­ly shrink tu­mors.

Al­to­geth­er PDC*line Phar­ma — which re­cent­ly signed a €108 mil­lion li­cens­ing deal (plus roy­al­ties) for its lung can­cer vac­cine in South Ko­rea and oth­er Asian re­gions — has raised more than €30 mil­lion since its in­cep­tion in 2014.

In this lat­est round of Se­ries B fund­ing, PDC*line Phar­ma lured five new in­vestors: Ko­re­an In­vest­ment Part­ners, as well as two South Ko­re­an funds — Shin­han-Cog­ni­tive Start-up Fund and UTC 2019 BIOVEN­TURE­FUND — in ad­di­tion to two Bel­gian funds, SRIW (The Re­gion­al In­vest­ment Com­pa­ny of Wal­lo­nia) and Sam­brin­vest (the in­vest­ment fund of Charleroi).

The new in­vestors joined ex­ist­ing in­vestors SF­PI-FPIM, the Bel­gian Fed­er­al Hold­ing and In­vest­ment Com­pa­ny, Noshaq Group, the Fi­nan­cière Spin-off Lux­em­bour­geoise/IN­VEST­SUD Group, among oth­er undis­closed names.

'Chang­ing the whole game of drug dis­cov­ery': Leg­endary R&D vet Roger Perl­mut­ter leaps back in­to work as a biotech CEO

Roger Perlmutter needs no introduction to anyone remotely involved in biopharma. As the R&D chief first at Amgen and then Merck, he’s built a stellar reputation and a prolific career steering new drugs toward the market for everything from cancer to infectious diseases.

But for years, he’s also held a less known title: science partner at The Column Group, where he’s regularly consulted about the various ideas the VCs had for new startups.

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The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

UP­DAT­ED: Pfiz­er hits the brakes on their piv­otal tri­al for a BC­MA/CD3 bis­pe­cif­ic on safe­ty con­cerns while FDA road­block is hold­ing up Duchenne MD PhI­II

Pfizer’s ambitious plan to take a Phase II study of its BCMA CD3-targeted bispecific antibody elranatamab (PF-06863135) and run it through to an accelerated approval has derailed.

The pharma giant said in a release this morning that they have halted enrollment for their MagnetisMM-3 study after researchers tracked three cases of peripheral neuropathy in the ongoing Phase I. They are now sharing info with the FDA as they explore the red safety flag.

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Matt Gline (L) and Vivek Ramaswamy

Vivek Ra­maswamy and Matt Gline swoop in­to Nas­daq on the wings of Jim Mom­tazee's SPAC with a $7B-plus Roivant de­but ready to do some deals

Seven years after founding Roivant Sciences as an upstart contender in the world of biotech creation, Vivek Ramaswamy and his recently anointed CEO Matt Gline are gliding into Nasdaq on the gilded wings of a cash-heavy SPAC.

In a carefully crafted SPAC pact aimed at wedding new investors at Montes Archimedes Acquisition Corp. with a syndicate of investors coming back to re-up for the next round of company building, they’ve assembled a fresh $611 million in financing for Roivant — $411 million held in trust from the investors in MAAC with a fresh $200 million from the syndicate.

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FDA ex­tends re­search agree­ment with MIT-li­censed or­gan-on-chip sys­tems

The FDA on Wednesday extended its four-year agreement with CN Bio, a developer of single- and multi-organ-on-chip systems used for drug discovery, for another three years.

CN Bio said the scope of the research performed by the FDA’s Center for Drug Evaluation and Research has expanded to include the exploration of the company’s lung-on-a-chip system to help with the agency’s evaluation of inhaled drugs, in addition to the agency’s work on its liver model.

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In quest to meet user fee goals, FDA’s per­for­mance con­tin­ues down­ward trend

A recent update to the FDA’s running tally of how it’s meeting its user fee-related performance goals during the pandemic shows an agency that is not out of the woods yet.

The latest numbers reveal that for a second straight quarter in 2021, the FDA has met its user fee goal dates for 93% of original new drug applications, which compares with 94% and 98% for the previous two quarters in 2020, respectively.

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Kelli Luginbuhl and Ashutosh Chilkoti

Start­up sets out to tack­le the gene ther­a­py man­u­fac­tur­ing cri­sis

After Kelli Luginbuhl finished her PhD, her advisor, Duke bioengineer and PhaseBio co-founder Ashutosh Chilkoti, sat her down and asked if she wanted to launch and then run a company. Chilkoti had a once-obscure technology he and the venture capitalist Joe McMahon thought could form the basis of his second company and finally pay huge dividends. Luginbuhl knew the tech from years in his lab and was already looking for biotech jobs. It all added up.

June Lee, Esker CEO

Vik Ba­ja­j's start­up in­cu­ba­tor at Fore­site un­cloaks an im­munol­o­gy play­er with a lead TYK2 in­hibitor in tow

Looking at a healthcare system made more unequal by Covid-19, Foresite Capital managing director Vik Bajaj recently launched an expansive plan to launch five innovative startups to address unmet need. Just weeks after the first of those biotechs emerged from stealth, a second has now uncloaked, and it’s got immunology in its sights.

Esker Therapeutics launched Wednesday with a $70 million Series A to pursue precision immunology targets backed by Foresite Labs’ analytics engine kickstarted by Bajaj’s team, the biotech said. Foresite footed the entire round for Esker as it continues to develop its pipeline and advance its lead compound.

Josh Bilenker, Endpoints JPM 2020

Josh Bilenker and Jeff En­gel­man bun­dle a moth­er lode of cash for their stealthy start­up, at­tract­ing a who's who of biotech in­vestors

Josh Bilenker and Jeff Engelman won’t be worrying about money for their stealthy startup anytime soon.

Late last week the pair filed a Form D for their new biotech Treeline Biosciences outlining a $212 million raise for their new company — which Bilenker founded around the time he ejected from his top position at Eli Lilly’s oncology group.

Their plan is to top out the raise at $220 million, but with Bilenker’s list of marquee investors on board for his latest creation, that won’t be much of a stretch.

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