Step Pharma CEO Andrew Parker

Step Phar­ma clos­es $41M round to take en­zyme tar­get­ing lead pro­gram in­to ear­ly-stage tri­al for T cell ma­lig­nan­cies

The search for bet­ter T and B cell ther­a­pies have ab­sorbed bil­lions in R&D funds from some of the biggest drug­mak­ers in the world. A French biotech thinks it could have a hy­per-fo­cused ap­proach to T and B cell ma­lig­nan­cies, and it’s tak­ing home a de­cent-sized check to race to the clin­ic.

Step Phar­ma has bagged $41.5 mil­lion in fund­ing to take its lead CTPS1 in­hibitor in­to clin­i­cal tri­als for T cell ma­lig­nan­cies by the first quar­ter of 2022, the French biotech said Wednes­day.

The com­pa­ny’s sci­ence was based on the work of French im­mu­nol­o­gist Alain Fis­ch­er, who iden­ti­fied a ge­net­ic con­nec­tion be­tween the CTP syn­thase 1 en­zyme and the in­abil­i­ty of nor­mal B and T cells to pro­lif­er­ate in pa­tients. The com­pa­ny was ini­tial­ly seed­ed in 2015, and cur­rent CEO An­drew Park­er stepped in about 18 months ago to help dri­ve the com­pa­ny in­to Phase I stud­ies. Step be­lieves its fo­cus on the CTPS1 en­zyme can of­fer a hy­per-tar­get­ed ap­proach to spur T cells and B cells to tar­get ag­gres­sive tu­mors.

“The ge­net­ics told us that if you block CTP syn­thase 1, you’ve got this very spe­cif­ic ef­fect on T and B cells,” Park­er said. “That’s what re­al­ly gives this a very tar­get­ed ap­proach to in­hib­it pro­lif­er­a­tion of B cells and T cells and spare oth­er cell types.”

The ini­tial Phase I, sched­uled to en­roll in the EU giv­en the com­pa­ny’s es­tab­lished pres­ence in France, will op­er­ate as a five-arm “bas­ket study,” Park­er said, with three arms fo­cus­ing on T cell hema­to­log­ic ma­lig­nan­cies and two arms fo­cus­ing on B cell con­di­tions. If any arm shows clin­i­cal promise, the biotech plans to ex­pand en­roll­ment up to 35 pa­tients in Phase II proof-of con­cept stud­ies.

In T cell lym­phomas, Step be­lieves a 35-pa­tients study in the Phase II set­ting could be enough for a break­through des­ig­na­tion and fast track, Park­er said. Mean­while, the B cell arms would like­ly re­quire Phase III stud­ies as they would ap­ply to third-line-or-lat­er pa­tients.

With the EU equiv­a­lent of an IND set for ear­ly 2022 — in the Jan­u­ary or Feb­ru­ary range, by Park­er’s count — Step is plan­ning to ex­pand its small team of five to around 10 as it en­ters the clin­ic.

The round was co-led by new in­vestors Hadean Ven­tures and Sun­stone Life Sci­ence Ven­tures, which joined ex­ist­ing in­vestors Kur­ma Part­ners, Pon­tif­ax and Bpifrance, which rein­vest­ed through its In­no­v­a­tive Bio­ther­a­pies and Rare Dis­eases fund and In­no­Bio 2 fund.

As part of the fi­nanc­ing, Ja­cob L. Moresco from Sun­stone Life Sci­ence Ven­tures and Wal­ter Stockinger from Hadean Ven­tures will join the board.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Who’s spend­ing and who’s cut­ting from Big Phar­ma’s $127B R&D bud­get? Here are the top 15 play­ers

A couple of the Big 15 biopharma companies in R&D hit the gas on research spending last year. Merck and Sanofi still have lots to prove in the pipeline, and they’re willing to gamble large sums to make a better future for themselves.

Doing nothing would be infinitely worse.

But collectively, the top players rang up a modest 2.4% increase in spending in 2022, which didn’t cover inflationary pressures. And that set the tone for an extraordinarily cautious year for the industry — even as it laid out about $127 billion to advance new drugs or up the ante on approved therapies.

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Jeff Bluestone (R), Sonoma Biotherapeutics CEO

Jef­frey Blue­stone brings his start­up haul to $400M+, join­ing forces with Re­gen­eron on cell ther­a­pies

These days, when Jeffrey Bluestone gets together with his contemporaries in science, the conversation often turns to retirement plans.

But a little more than three years ago, Bluestone reached a momentous turning point in his career, exiting a prestigious post at UCSF, where he had spent decades in the scientific pursuit of new therapies. And it had nothing to do with retirement anytime in the near future.

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Covant acting CEO Matt Maisak (L) and CSO Iván Cornella

With Boehringer In­gel­heim’s help, Roivant churns out an­oth­er Vant to go up against En­deav­or, Im­pact founders

Roivant Sciences has added another branch to its family tree, unveiling Covant Therapeutics with a $10 million upfront commitment from Boehringer Ingelheim to turn up the heat in cancer.

The Boston-based drug discovery startup will jointly create a new small molecule immunotherapy with the private German pharma giant. The deal, made public Tuesday morning, includes up to $471 million in future payments and tiered royalties, should the product make it to market.

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Richard Murray, Jounce Therapeutics CEO

Jounce nix­es Redx of­fer as I/O biotech in­stead goes with Con­cen­tra Bio­sciences’ takeover bid

A minority shareholder has won out in the Jounce Therapeutics takeover battle, with the once-ambitious immunotherapy biotech now choosing to be acquired by Kevin Tang’s Concentra Biosciences rather than follow through with an already-announced deal that would have brought the UK’s Redx onto Nasdaq.

Via its new merger partner, Jounce is expected to get $1.85 per share from Concentra, which was formed by Tang Capital Partners, the owner of about 10% of Jounce shares. Two weeks ago, Concentra laid out a $1.80 per share proposal plus more for the ability to swoop up 80% of proceeds from licenses of legacy programs out of Jounce’s pipeline.

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Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Van­da wins court case against FDA over dis­clo­sure of CRL de­tails for sleep drug

DC District Court Judge Christopher Cooper today granted Vanda Pharma’s request to require the FDA to disclose more info on the complete response letter for its sleep disorder drug Hetlioz.

The melatonin receptor agonist is approved by the FDA to treat non-24-hour sleep-wake disorder, a circadian rhythm disorder. But in 2018 Vanda filed a supplemental application to market Hetlioz as a treatment for jet lag, which the FDA rejected in August 2019, with few details on what Vanda needed to correct course, according to the company.

Sally Susman, Pfizer EVP and chief corporate affairs officer

Q&A: Pfiz­er cor­po­rate com­mu­ni­ca­tions chief Sal­ly Sus­man dis­cuss­es book craft­ed in pan­dem­ic and per­son­al lessons

From the political arena to the finance and beauty industries to pharmaceuticals, Pfizer’s Sally Susman has broken barriers, stereotypes and conventions. And now the chief communicator is “Breaking Through,” the title of her first book about effective and innovative communications launching today. The full official title is “Breaking Through: Communicating to Open Minds, Move Hearts, and Change the World.”

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Max Colao, OncoVerity CEO

Tiny mul­ti­omics biotech se­cures for­mer J&J drug, new ex­ecs and new fi­nanc­ing

A new spinout from Belgium’s argenx seeks to give new life to a candidate once in-licensed to J&J.

OncoVerity announced Monday afternoon that it had in-licensed cusatuzumab from argenx. The biotech also appointed two new C-suite executives and secured a $30 million Series A round.

CEO Max Colao joins OncoVerity after working as Aurinia’s commercial chief, and stints at Alexion and Amgen. New CMO Clay Smith has been associate chief of the University of Colorado’s hematology division.

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Kevin Lee, Bicycle Therapeutics CEO

No­var­tis rides with Bi­cy­cle for new pact on tar­get­ed ra­dio­ther­a­pies

Novartis has inked a three-year deal with Bicycle Therapeutics to develop new targeted radiotherapies for cancer.

Novartis will pay Bicycle $50 million upfront, with downstream milestones adding up to a potential $1.7 billion. In exchange, Bicycle will use its virus-based platform to discover new bicyclic peptides, which it calls bicycles, that would be used for radiotherapies. Those bicycles would act as a homing beacon for radioactive isotopes, delivering them to cancer cells to kill the cells while limiting radiation to healthy tissue.

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