Steve Chen, Cellis 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.

Im­ple­ment­ing re­silience in the clin­i­cal tri­al sup­ply chain

Since January 2020, the clinical trials ecosystem has quickly evolved to manage roadblocks impeding clinical trial integrity, and patient care and safety amid a global pandemic. Closed borders, reduced air traffic and delayed or canceled flights disrupted global distribution, revealing how flexible logistics and supply chains can secure the timely delivery of clinical drug products and therapies to sites and patients.

In fi­nal days at Mer­ck, Roger Perl­mut­ter bets big on a lit­tle-known Covid-19 treat­ment

Roger Perlmutter is spending his last days at Merck, well, spending.

Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

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Pascal Soriot (AP Images)

UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Michelle Longmire, Medable CEO (Jeff Rumans)

Med­able gets $91M for vir­tu­al clin­i­cal tri­als, bring­ing to­tal raise to $136M

As biotechs look to get clinical studies back on track amid the pandemic, Medable returned to the venture well for the second time this year, bagging a $91 million Series C to build out its virtual trial platform.

The software provider recently launched three new apps for decentralizing clinical trials, and saw a 500% revenue spike this year. And it isn’t alone. Back in August, Science 37 secured a $40 million round for its virtual trial tech, with support from Novartis, Sanofi Ventures and Amgen. Patients and researchers are taking a liking to the online approach, suggesting regulators could allow it to become a new normal even after the pandemic is over.

Feng Tian, Ambrx CEO (Ambrx)

Af­ter 5 qui­et years, a for­mer Scripps spin­out rais­es $200M and an­nounces plans to try again at an IPO

The first time San Diego biotech Ambrx tried to go public in 2014, they failed and the company’s board switched to a radically different strategy: They sold themselves for an undisclosed amount to a syndicate of Chinese investors and pharma companies.

Now, after 5 quiet years, that syndicate has raised a mountain of cash and indicated they’ll soon make another bid to go public.

Earlier this month, Ambrx raised $200 million in what they billed as a crossover round financed by Fidelity, BlackRock, Cormorant Asset Management, HBM Healthcare Investments, Invus, Adage Capital Partners and Suvretta Capital Management. It’s the largest amount they’ve ever raised and, according to Crunchbase figures, more than doubles the total amount of VC capital collected since their launch 17 years ago.

The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

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John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

UP­DAT­ED: Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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News brief­ing: Gilead part­ner Gala­pa­gos sells off CRO for $37M; Polyphor bags $3.3M from CF Foun­da­tion

Close Gilead ally Galapagos is selling off one of its contract research organizations to a Polish pharma company.

Galapagos has agreed to sell 100% of the outstanding shares in the CRO Fidelta to Selvita, in a deal worth roughly $37 million expected to close in the first week of January. The acquisition is expected to nearly double Selvita’s revenues, the company says, as well as expand its drug discovery efforts.

Gen­mab ax­es an ADC de­vel­op­ment pro­gram af­ter the da­ta fail to im­press

Genmab $GMAB has opted to ax one of its antibody-drug conjugates after watching it flop in the clinic.

The Danish biotech reported Tuesday that it decided to kill their program for enapotamab vedotin after the data gathered from expansion cohorts failed to measure up. According to the company:

While enapotamab vedotin has shown some evidence of clinical activity, this was not optimized by different dose schedules and/or predictive biomarkers. Accordingly, the data from the expansion cohorts did not meet Genmab’s stringent criteria for proof-of-concept.