Steve Chen, Cellics Therapeutics president and CMO (Cellics)

UC San Diego spin­out award­ed up to $15M for nanosponge de­signed to soak up sep­sis-caus­ing tox­ins

CARB-X, a glob­al part­ner­ship look­ing to spur the de­vel­op­ment of new an­tibac­te­r­i­al drugs, is award­ing Cellics Ther­a­peu­tics $3.94 mil­lion to do what pres­i­dent and CMO Steve Chen calls “look­ing at tra­di­tion­al drug de­vel­op­ment up­side down.”

In­stead of go­ing af­ter a tar­get di­rect­ly — in this case bac­te­r­i­al tox­ins and in­flam­ma­to­ry cy­tokines that cause sep­sis — Cellics re­searchers “flip it around” to ex­am­ine the host cells be­ing at­tacked. The UC San Diego spin­out then cre­ates what it calls “nanosponges” — nanopar­ti­cles cloaked in the frag­ments of macrophage cell mem­branes. Chen says the “sponges” are de­signed to trap the sep­sis-caus­ing en­do­tox­ins and cy­tokines on their cell mem­branes, neu­tral­iz­ing them.

The con­cept was pi­o­neered by UC San Diego na­no­engi­neer­ing pro­fes­sor Liang­fang Zhang, who found­ed Cellics in 2014. The San Diego-based biotech has sev­er­al macrophage and red blood cell nanosponges in the pipeline, in­clud­ing its lead can­di­date for MR­SA pneu­mo­nia. The CARB-X grant, though, is for Cellics’ macrophage can­di­date CTI-111, aimed at sep­sis caused by drug-re­sis­tant Gram-pos­i­tive and Gram-neg­a­tive bac­te­ria.

“Sep­sis in gen­er­al has been a very dif­fi­cult dis­ease to treat,” Chen said. The con­di­tion is caused by the body’s re­sponse to an in­fec­tion, and af­fects rough­ly 1.7 mil­lion adults in the US each year, ac­cord­ing to the CDC.

The CARB-X grant will be used to scale up pro­duc­tion of the nanosponges, and de­vel­op an an­i­mal mod­el for test­ing. Cellics is el­i­gi­ble for an­oth­er $11.05 mil­lion down the road, bring­ing the grant to­tal to $15 mil­lion if mile­stones are met. That amount would car­ry the can­di­date all the way through a Phase I study, Chen said.

Cellics plans on bring­ing the sep­sis can­di­date to the clin­ic in the next two years. It would be ad­min­is­tered by IV in com­bi­na­tion with an­tibi­otics and oth­er med­i­cines. The biotech’s MR­SA pneu­mo­nia can­di­date, CTI-005, should en­ter hu­man stud­ies next year, ac­cord­ing to Chen.

The CMO be­lieves the nanosponges could al­so be used for a range of oth­er ill­ness­es, from in­flam­ma­to­ry bow­el dis­ease to Covid-19. The con­cept is the same — in­stead of latch­ing on­to a host cell, the virus would latch on to a nanosponge and be­come neu­tral­ized. Chen said to imag­ine throw­ing a dart at a peb­ble: You aren’t very like­ly to hit it. But if the peb­ble is scat­tered in­to a bunch of tiny par­ti­cles (aka the nanosponges), the dart (the virus) is like­ly to hit one. The com­pa­ny may one day have an oral for­mu­la­tion, or even a top­i­cal one, he added lat­er.

Erin Duffy

Be­tween 2016 and 2022, CARB-X has pledged to pump up to $480 mil­lion in­to the de­vel­op­ment of new an­tibi­otics, vac­cines, rapid di­ag­nos­tics and oth­er prod­ucts. Big Phar­ma has re­treat­ed from the field, fraught with cheap gener­ics and poor fi­nan­cial re­turns. Back in Jan­u­ary, WHO di­rec­tor-gen­er­al Tedros Ad­hanom Ghe­breye­sus said the threat of an­timi­cro­bial re­sis­tance has nev­er been more im­me­di­ate.

“Sep­sis is a lead­ing cause of death around the world that is made worse by the lack of ef­fec­tive pre­ven­ta­tives and treat­ments for drug-re­sis­tant bac­te­r­i­al in­fec­tions. Ef­fec­tive treat­ments are ur­gent­ly need­ed,” CARB-X R&D chief Erin Duffy said in a state­ment.

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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