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.


Grow­ing ac­cep­tance of ac­cel­er­at­ed path­ways for nov­el treat­ments: but does reg­u­la­to­ry ap­proval lead to com­mer­cial suc­cess?

By Mwango Kashoki, MD, MPH, Vice President-Technical, and Richard Macaulay, Senior Director, of Parexel Regulatory & Access

In recent years, we’ve seen a significant uptake in the use of regulatory options by companies looking to accelerate the journey of life-saving drugs to market. In 2018, 73% of the novel drugs approved by the U.S. Federal Drug Administration (FDA) were designated under one or more expedited development program categories (Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval).ᶦ

Sanofi out­lines big API plans as coro­n­avirus out­break re­port­ed­ly threat­ens short­age of 150 drugs

As the world becomes increasingly dependant on Asia for the ingredients of its medicines, Sanofi sees business to be done in Europe.

The French drugmaker said it’s creating the world’s second largest active pharmaceutical ingredients (API) manufacturer by spinning out its six current sites into a standalone company: Brindisi (Italy), Frankfurt Chemistry (Germany), Haverhill (UK), St Aubin les Elbeuf (France), Újpest (Hungary) and Vertolaye (France). They have mapped out €1 billion in expected sales by 2022 and 3,100 employees for the new operations headquartered in France.

Bio­gen touts new ev­i­dence from the gene ther­a­py com­pa­ny it wa­gered $800M on

A year ago, Biogen made a big bet on a small gene therapy company. Now they have new evidence one of their therapies could work.

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Anthony Fauci (AP Images)

UP­DAT­ED: NIH-part­nered Mod­er­na ships off its PhI-ready coro­n­avirus vac­cine can­di­date to a sea of un­cer­tain­ty

Off it goes.

Moderna has shipped the first batch of its mRNA vaccine against SARS-CoV-2 from its manufacturing facility in Norwood, Massachusetts, to the National Institute of Allergy and Infectious Diseases in Bethesda, Maryland, for a pioneering Phase I study.

It’s a hectic race against time. In the 42 days since Moderna selected the sequence they would use to develop their vaccine — a record time, no less — the number of confirmed cases around the world has surged astronomically from a few dozen to over 80,000, per WHO and Johns Hopkins estimates.

The candidate that they came up with, mRNA-1273, encodes for a prefusion stabilized form of the spike protein, which gives the virus its crown shape and plays a key role in transmission. The Coalition for Epidemic Preparedness Innovations, the Oslo-based group better known as CEPI, funded the manufacture of this batch.

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In fi­nal re­port, ICER ap­pears to have a change of heart on new acute mi­graine ther­a­pies

ICER appears to have reversed course on the fresh crop of acute migraine therapies.

The cost-effectiveness watchdog in November issued a draft report suggesting that existing generic medicines are more effective and cheaper than Allergan’s December-approved CGRP ubrogepant, Biohaven rival molecule, rimegepant (which is under FDA review), and Lilly’s October-sanctioned lasmiditan, which binds to 5-HT1F receptors.

Bi­cy­cle Ther­a­peu­tics takes Roche's Genen­tech on an up to $2B im­muno-on­col­o­gy ride

Bicycle Therapeutics — which is developing a new class of chemically synthesized drugs designed to be pharmacologically as active as biologics, yet manufactured as small molecules —  has scored another big partner: Roche’s Genentech.

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When drug val­ue as­sess­ment meets re­al-world ev­i­dence: ICER en­lists Ae­tion in pric­ing eval­u­a­tion

In a union of two of the hottest trends in the US biopharma world, ICER is teaming up with a high-profile company to integrate real-world evidence in their assessment of treatment value.

The drug pricing watchdog — formally the Institute for Clinical and Economic Review — said it will utilize Aetion’s evidence platform in “select upcoming assessments” and their new 24-month re-evaluations of drugs granted accelerated approval by the FDA.

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First US Covid-19 tri­als set to get un­der­way in Ne­bras­ka and Wash­ing­ton, backed by NIH

The first US clinical trials on the novel coronavirus are scheduled to get underway next month at the University of Nebraska Medical Center, where American passengers were taken after being evacuated from the Diamond Princess cruise ship, and at the Kaiser Permanente Washington Health Research Institute. Both trials are sponsored by the NIH’s National Institute for Allergy and Infectious Diseases, which has led the US’s medical response to the outbreak.

Mallinck­rodt, once the na­tion’s largest oxy­codone pro­duc­er, an­nounces ten­ta­tive $1.6B set­tle­ment

Three years after it first paid out fines for its role in the US opioid abuse epidemic, Mallinckrodt has announced an agreement-in-principle that will see the company pay out $1.6 billion and place its generics unit in bankruptcy.

The tentative deal would settle hundreds of lawsuits from state and local governments over Mallinckrodt’s role in the epidemic, while also helping address the company’s increasingly mountainous debt. Although Purdue Pharma has drawn the bulk of both public and legal acrimony for opioid sales, documents made public earlier this year showed that Mallinckrodt subsidiary SpecGx, along with the generic subsidiaries of Teva and Endo Pharmaceuticals, accounted for the vast majority of the 76 billion opioid pills distributed from 2006 to 2012. Mallinckrodt was at the top of that list.