Tar­get­ing CD47? UCLA joins band­wag­on, with gel to stem tu­mors from resur­fac­ing

Hit­ting the “don’t eat me” CD47 re­cep­tor tar­get has gal­va­nized an army of drug de­vel­op­ers who want to make in­roads in the bur­geon­ing field of can­cer im­munother­a­py by off­set­ting im­muno­sup­pres­sion. But in an ef­fort to sub­vert side ef­fects that can be caused by the sys­temic ab­sorp­tion of such an­tag­o­nists, re­searchers are test­ing a gel that could be sprayed on pa­tients who have un­der­gone surgery to in­hib­it tu­mor re­cur­rence and metas­ta­sis.

A biodegrad­able fib­rin gel, which en­cap­su­lates cal­ci­um car­bon­ate nanopar­ti­cles pre-loaded with an an­ti-CD47 an­ti­body, was used by a team of re­searchers led by Zhen Gu, a pro­fes­sor of bio­engi­neer­ing at the UCLA Samueli School of En­gi­neer­ing. Fol­low­ing tu­mor re­sec­tion in mice with ad­vanced melanoma, the gel was sprayed on to the sur­gi­cal site to cur­tail the growth of tu­mor cells that lin­gered de­spite surgery. Half the mice in the study did not see their tu­mors re-emerge 60 days fol­low­ing treat­ment, da­ta showed.

Zhen Gu

Cal­ci­um car­bon­ate — the main com­po­nent of egg shells — was cho­sen due to its abil­i­ty to be grad­u­al­ly dis­solved in sur­gi­cal wound sites, which are slight­ly acidic, and be­cause it boosts macrophage ac­tiv­i­ty, said the study’s lead au­thor Qian Chen, a post­doc­tor­al re­searcher at UCLA.

A pletho­ra of drug de­vel­op­ers in­clud­ing Alexo Ther­a­peu­tics, Arch On­col­o­gy, Au­ri­gene, Blink Bio­med­ical, Cel­gene, Forty Sev­en, Novim­mune, OSE Im­munother­a­peu­tics, Sor­ren­to, Syn­thon Hold­ing and Tril­li­um Ther­a­peu­tics, are de­vel­op­ing CD47 an­tag­o­nists in the hope of scram­bling the “don’t eat me” sig­nal that can­cer cells are de­pen­dent on to evade macrophages.

Qian Chen

But the oc­cur­rence of ane­mia and throm­bo­cy­tope­nia caused by sys­temic ad­min­is­tra­tion of such an­tag­o­nists-in-de­vel­op­ment re­mains a con­cern, the UCLA team wrote in their peer re­viewed study pub­lished in Na­ture Nan­otech­nol­o­gy.

Many can­cer pa­tients un­der­go surgery to up­root tu­mors, but of­ten the can­cer re-emerges. This re­search sug­gests the im­munother­a­peu­tic fib­rin gel can “awak­en” the im­mune sys­tem by re-arm­ing macrophages at the sur­gi­cal site to chew up can­cer cells.

“We al­so learned that the gel could ac­ti­vate T cells in the im­mune sys­tem to get them to work to­geth­er as an­oth­er line of at­tack against lin­ger­ing can­cer cells,” Chen added in a state­ment.

The team of sci­en­tists in­tends to test this ap­proach in an­i­mal tri­als to de­ter­mine the ide­al mix of nanopar­ti­cles, op­ti­mal dos­ing and treat­ment fre­quen­cy, be­fore grad­u­at­ing to hu­man test­ing.


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.

Onno van de Stolpe, Galapagos CEO (Thierry Roge/Belga Mag/AFP via Getty Images)

Gala­pa­gos chops in­to their pipeline, drop­ping core fields and re­or­ga­niz­ing R&D as the BD team hunts for some­thing 'trans­for­ma­tive'

Just 5 months after Gilead gutted its rich partnership with Galapagos following a bitter setback at the FDA, the Belgian biotech is hunkering down and chopping the pipeline in an effort to conserve cash while their BD team pursues a mission to find a “transformative” deal for the company.

The filgotinib disaster didn’t warrant a mention as Galapagos laid out its Darwinian restructuring plans. Forced to make choices, the company is ditching its IPF molecule ’1205, while moving ahead with a Phase II IPF study for its chitinase inhibitor ’4617.

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Stéphane Bancel, Getty

Mod­er­na CEO brush­es off US sup­port for IP waiv­er, eyes more than $19B in Covid-19 vac­cine sales in 2021

Moderna is definitively more concerned with keeping pace with Pfizer in the race to vaccinate the world against Covid-19 than it is with Wednesday’s decision from the Biden administration to back an intellectual property waiver that aims to increase vaccine supplies worldwide.

In its first quarter earnings call on Thursday, Moderna CEO Stéphane Bancel shrugged off any suggestion that the newly US-backed intellectual property waiver would impact his company’s vaccine or bottom line. Still, the company’s stock price fell by about 9% in early morning trading.

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'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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Ad­comm splits slight­ly in fa­vor of FDA ap­prov­ing Chemo­Cen­tryx’s rare dis­ease drug

The FDA’s Arthritis Advisory Committee on Thursday voted 10 for and 8 against the approval of ChemoCentryx’s $CCXI investigational drug avacopan as a treatment for adults with a rare and serious disease known as anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis.

The vote on whether the FDA should approve the drug was preceded by a split vote of 9 to 9 on whether the efficacy data support approval, and 10 to 8 that the safety profile of avacopan is adequate enough to support approval.

Brent Saunders (Richard Drew, AP Images)

OcuWho? Star deal­mak­er turned aes­thet­ics czar Brent Saun­ders flips back in­to biotech. But who’s he team­ing up with now?

Brent Saunders went on a tear of headline-blazing deals building Allergan, merging and rearranging a variety of big companies into one before an M&A pact with Pfizer blew up and sent him on a bout of biotech drug deals. That didn’t work so well, so under pressure, he got his buyout at AbbVie — which needed a big franchise like Botox. And it was no big surprise to see him riding the SPAC wave into a recent $1 billion-plus deal that left him in the executive chairman’s seat at an aesthetics outfit — now redubbed The Beauty Health Company — holding a big chunk of the equity.

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Drug pric­ing watch­dog joins the cho­rus of crit­ics on Bio­gen's ad­u­canum­ab: What about charg­ing $2,560 per year?

As if Biogen’s aducanumab isn’t controversial enough, the researchers at drug pricing watchdog ICER have drawn up the contours of a new debate: If the therapy does get approved for Alzheimer’s by June, what price should it command?

Their answer: At most $8,290 per year — and perhaps as little as $2,560.

Even at the top of the range, the proposed price is a fraction of the $50,000 that Wall Street has reportedly come to expect (although RBC analyst Brian Abrahams puts the consensus figure at $11.5K). With critics, including experts on the FDA’s advisory committee, making their fierce opposition to aducanumab’s approval loud and clear, the pricing pressure adds one extra wrinkle Biogen CEO Michel Vounatsos doesn’t need as he orders full-steam preparation for a launch.

Biden ad­min­is­tra­tion backs a po­lar­iz­ing pro­pos­al to waive IP for all Covid-19 vac­cines

In a surprise U-turn, the Biden administration said Wednesday that it will support a proposal at the World Trade Organization to temporarily waive intellectual property protections on Covid-19 vaccines.

The proposal, backed by South Africa and India at the WTO, seeks to help developing countries with limited vaccine supplies. The US and Europe historically opposed the proposal, saying IP should be protected because it incentivizes new drug and vaccine development.

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Nick Leschly at Endpoints' JPM20 Breakfast Panel (Jeff Rumans for Endpoints News)

2sev­en­ty: Nick Leschly brings a trio of top ex­ecs with him on top-speed flight from the blue­bird nest

After serving more than a decade as bluebird bio’s chief bluebird, Nick Leschly is switching it up.

At some point this year, Leschly will officially become the CEO of 2seventy — the new company that will house bluebird’s oncology business while Andrew Obenshain, the current president for severe genetic diseases, will take over as CEO to oversee the rare disease pipeline remaining at bluebird.

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