Francis Collins (Michael Reynolds/Pool via AP Images)

Sen­ate spend­ing bill slash­es funds for Biden's planned break­through drug ac­cel­er­a­tor at NIH

With the an­nounce­ment that Fran­cis Collins, the NIH’s long­time head, is leav­ing at the end of the year, a flashy new idea from Pres­i­dent Joe Biden to ac­cel­er­ate more can­cer, di­a­betes and Alzheimer’s drugs at the NIH ap­pears to have lost steam.

The Sen­ate Ap­pro­pri­a­tions Com­mit­tee on Mon­day un­veiled its pro­pos­al for the NIH’s spend­ing bill, which pro­pos­es just $2.4 bil­lion for this Biden project, to be known as the Ad­vanced Re­search Pro­jects Agency for Health or ARPA-H. Biden had ini­tial­ly re­quest­ed $6.5 bil­lion, and the House Ap­pro­pri­a­tions Com­mit­tee signed off on $3 bil­lion ear­li­er this sum­mer.

In ad­di­tion to the fund­ing snub, ARPA-H was al­so pulled from the rec­on­cil­i­a­tion bill, which is get­ting stripped as it tries to make it to the fin­ish line.

While the Sen­ate com­mit­tee called it Biden’s “bold and promis­ing pro­pos­al to ac­cel­er­ate the pace of break­throughs in med­i­cine us­ing the De­fense Ad­vanced Re­search Pro­jects Agency as a mod­el,” the drop in funds in the Sen­ate and drop from the rec­on­cil­i­a­tion bill may be par­tial­ly a re­sult of Collins’ de­par­ture. But not all have lost hope in ARPA-H as Rep. An­na Es­hoo (D-CA), chair of the En­er­gy & Com­merce health sub­com­mit­tee, in­tro­duced stand­alone leg­is­la­tion last week to cre­ate agency with $3 bil­lion an­nu­al­ly, and plen­ty of hir­ing au­ton­o­my.

Biden made clear in a state­ment ear­li­er this month that he’d asked Collins to stay at NIH “to help lay the ground­work for” ARPA-H.

“I was grate­ful he an­swered the call to serve even though it was ask­ing him to stay on the job longer than any­one in NIH his­to­ry,” Biden said.

Er­ic Lan­der

Biden will now look to an­oth­er of his sci­ence ad­vi­sors, Er­ic Lan­der, who co-au­thored with Collins a com­men­tary in Sci­ence last sum­mer on how ARPA-H will fo­cus on time-lim­it­ed projects with goals, bench­marks and ac­count­abil­i­ty, with an aim to pre­vent, treat, or cure a range of dis­eases, in­clud­ing can­cer, in­fec­tious dis­eases, Alzheimer’s dis­ease and oth­ers.

Ac­cord­ing to a White House fact sheet, ARPA-H in­vest­ments could go in­to var­i­ous re­search en­deav­ors, in­clud­ing can­cer vac­cine de­vel­op­ment, or even ways to make man­u­fac­tur­ing process­es for pa­tient-spe­cif­ic T cells cheap­er and eas­i­er.

Al­so in­clud­ed in that NIH fund­ing bill is the largest in­crease in bud­get au­thor­i­ty pro­vid­ed to the CDC in near­ly two decades, and a more than $200 mil­lion in­crease (to $823 mil­lion) in funds for BAR­DA to con­tin­ue in­vest­ing in late-stage med­ical coun­ter­mea­sures.

“The Com­mit­tee main­tains its com­mit­ment to find­ing a treat­ment and a cure for Alzheimer’s dis­ease, in­creas­ing fund­ing for re­search sup­port­ed by the Na­tion­al In­sti­tute on Ag­ing by $235 mil­lion,” the bill sum­ma­ry says.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Stéphane Bancel, Moderna CEO

'This is not go­ing to be good': Mod­er­na CEO Ban­cel warns of a 'ma­te­r­i­al drop' in vac­cine ef­fi­ca­cy as Omi­cron spreads

Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.

Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?

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Philip Dormitzer, new GSK global head of vaccines R&D

Glax­o­SmithK­line poach­es Pfiz­er's vi­ral vac­cines lead in rush to cap­i­tal­ize on fu­ture of mR­NA

GlaxoSmithKline has appointed Philip Dormitzer, formerly chief scientific officer of Pfizer’s viral vaccines unit, as its newest global head of vaccines R&D, looking to leverage one of the leading minds behind Pfizer and BioNTech’s RNA collaboration that led to Covid-19 jab Comirnaty, the British drug giant said Tuesday.

Dormitzer had been with Pfizer for a little more than six years, joining up after a seven-year stint with Novartis, where he reached the role of US head of research and head of global virology for the company’s vaccines and diagnostics unit.

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In­tro­duc­ing End­points Stu­dio, a new way to ad­ver­tise with End­points-craft­ed brand­ing cam­paigns

Since our start in 2016, Endpoints has grown fast while executing our mission to cover biopharma’s most critical developments for industry pros worldwide. As readership has grown, our advertising business has too. Endpoints advertising partners support the mission and engage their desired audiences through announcements on our email and web platforms, brand recognition in our event coverage and sponsorships of Endpoints daily and weekly reports.

Lan Huang, BeyondSpring CEO

Months af­ter shock­ing in­vestors with lung can­cer win, Be­yond­Spring's lead drug hits road­block at the FDA

BeyondSpring shocked investors in early August after its once-marginal lead drug suddenly showed a lot of promise in a common form of lung cancer. With hopes high, the FDA has now slammed the door on that drug in another indication — does that spell bad news for BeyondSpring’s Cinderella story?

The FDA issued BeyondSpring a complete response letter for its plinabulin in combination with granulocyte colony-stimulating factor (G-CSF) for the prevention of chemotherapy-induced neutropenia, effectively shutting down the drug’s immediate chances at a marketing approval, the biotech said Wednesday.

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With on­ly burns to show in gene ther­a­py, Astel­las inks deal with AAV spe­cial­ist Dyno in push for a bet­ter cap­sid

On the hunt for a better AAV capsid for gene therapy, Eric Kelsic’s Dyno Therapeutics has set itself apart with its focus on machine learning to help speed discovery. Now, Japanese drugmaker Astellas — fresh off a slate of gene therapy burns — is taking a bet on Dyno as it looks to the future.

Astellas and Dyno will work together as part of an R&D pact to develop next-gen AAV vectors for gene therapy using Dyno’s CapsidMap platform directed at skeletal and cardiac muscle, the companies said Wednesday. Under the terms of the deal, Dyno will design AAV capsids for gene therapy, while Astellas will be responsible for conducting preclinical, clinical and commercialization activities for gene therapy product candidates using the capsids.

J&J and Sanofi's mul­ti­ple myelo­ma tit-for-tat con­tin­ues, as sub­cu­ta­neous Darza­lex wins com­bo ap­proval

J&J and Sanofi have gone back and forth in their multiple myeloma tug-of-war. Earlier this year, Sanofi notched an approval of Sarclisa in combination with Amgen’s Kyprolis to try to outflank the big conglomerate, but J&J is clapping back.

Wednesday afternoon, Amgen announced that the subcutaneous version of J&J’s blockbuster Darzalex is also now approved as a combo with Kyprolis and dexamethasone. The green light came through for adults with relapsed or refractory multiple myeloma who had progressed on one to three earlier lines of therapy.

As first Omi­cron case in US crops up, re­searchers won­der: which an­ti­bod­ies, vac­cines will hold up?

As Covid-19 drug and vaccine developers race to figure out which of their products might be hampered by the new variant, the CDC on Wednesday afternoon announced the first confirmed case of the Omicron variant (B.1.1.529) in the US, found in San Francisco.

The unidentified individual was a traveler who returned from South Africa on Nov. 22, 2021, was fully vaccinated, and had mild symptoms that the CDC described as improving. All close contacts have been contacted and have tested negative, the centers said.

Michael Handley, Statera Biopharma CEO

Stat­era Bio­phar­ma gets the OK to re­sume the study of a po­ten­tial stock­pile drug for lethal ra­di­a­tion ex­po­sure

Last summer, when Cytocom merged with Cleveland BioLabs to grab a spot on Nasdaq, it also inherited an intriguing rare disease program that was under clinical hold. With a new name and brand, the company says it’s ready to bring that program back to the forefront.

The FDA has lifted its clinical hold on entolimod, a toll-like receptor 5 (TLR5) agonist being developed for patients exposed to lethal amounts of radiation, the company — now called Statera Biopharma — announced on Wednesday.