David Hering, Adagio interim CEO

Ada­gio press­es for­ward with their FDA pitch for Covid an­ti­body — de­spite Omi­cron flaws

Ada­gio, the Till­man Gern­gross biotech whose $750 mil­lion plan to build a pan-coro­n­avirus an­ti­body seem­ing­ly fell apart in the face of Omi­cron, is back again plead­ing its case.

The com­pa­ny re­leased da­ta from its piv­otal tri­als Wednes­day, an­nounc­ing that its an­ti­body ad­in­tre­vimab re­duced the risk of hos­pi­tal­iza­tion or death in par­tic­i­pants with mild to mod­er­ate Covid-19 by 66%, in­clud­ing a 77% re­duc­tion in pa­tients who were treat­ed with­in 3 days of symp­tom on­set.

The drug al­so worked as pre-ex­po­sure and post-ex­po­sure pro­phy­lax­is, re­duc­ing the risk of vol­un­teers de­vel­op­ing symp­to­matic Covid-19 by 71% and 75% re­spec­tive­ly.

The prob­lem is that near­ly all of the da­ta for the study were col­lect­ed pri­or to the ad­vent of Omi­cron, a vari­ant that Ada­gio’s own da­ta showed re­duced the po­ten­cy of their an­ti­body 300 times, forc­ing the com­pa­ny to pur­sue al­ter­na­tive strate­gies such as chang­ing dose and com­bi­na­tion treat­ments.

De­spite the set­backs, the biotech con­tin­ued to in­sist that the an­ti­body was al­ready so po­tent that it might have ef­fi­ca­cy against Omi­cron, even if it was re­duced. Lim­it­ed da­ta col­lect­ed in the tri­als at­test­ed to that. For ex­am­ple, pa­tients who re­ceived pro­phy­lac­tic ad­in­tre­vimab were still 47% less like­ly to de­vel­op symp­to­matic dis­ease with­in 77 days fol­low­ing the emer­gence of Omi­cron. (Ada­gio did not spec­i­fy when they be­gan the analy­sis or how wide­spread Omi­cron was at the time.)

But the US is no longer deal­ing sole­ly with Omi­cron. Omi­cron’s “sis­ter vari­ant,” BA.2, is now caus­ing a ma­jor­i­ty of new cas­es na­tion­wide, ac­cord­ing to CDC da­ta.

And Ada­gio’s drug has vir­tu­al­ly ze­ro ac­tiv­i­ty against BA.2, analy­ses from out­side labs have demon­strat­ed.

Nev­er­the­less, the com­pa­ny is go­ing to press its case at the FDA, with plans to sub­mit an ap­pli­ca­tion for emer­gency use au­tho­riza­tion in Q2. The com­pa­ny’s state­ment did not ad­dress the drug’s dra­mat­i­cal­ly re­duced ef­fi­ca­cy against BA.2.

Ada­gio al­so said it’s con­tin­u­ing with tri­als on a high­er dose of ad­in­tre­vimab while de­vel­op­ing new an­ti­bod­ies from its li­brary and at­tempt­ing to re-en­gi­neer ad­in­tre­vimab to have im­proved bind­ing against the new vari­ants.

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Ted Love, Global Blood Therapeutics CEO

Up­dat­ed: Pfiz­er scoops up Glob­al Blood Ther­a­peu­tics and its sick­le cell ther­a­pies for $5.4B

Pfizer is dropping $5.4 billion to acquire Global Blood Therapeutics.

Just ahead of the weekend, word got out that Pfizer was close to clinching a $5 billion buyout — albeit with other potential buyers still at the table. The pharma giant, flush with cash from Covid-19 vaccine sales, apparently got out on top.

The deal immediately swells Pfizer’s previously tiny sickle cell disease portfolio from just a Phase I program to one with an approved drug, Oxbryta, plus a whole pipeline that, if all approved, the company believes could make for a $3 billion franchise at peak.

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David Reese, Amgen R&D chief

UP­DAT­ED: In a fresh dis­ap­point­ment, Am­gen spot­lights a ma­jor safe­ty is­sue with KRAS com­bo

Amgen had hoped that its latest study matching its landmark KRAS G12C drug Lumakras with checkpoint inhibitors would open up its treatment horizons and expand its commercial potential. Instead, the combo spurred safety issues that blunted efficacy and forced the pharma giant to alter course on its treatment strategy, once again disappointing analysts who have been tracking the drug’s faltering sales and limited therapeutic reach.

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Uğur Şahin, BioNTech CEO (Kay Nietfeld/picture-alliance/dpa/AP Images)

De­spite falling Covid-19 sales, BioN­Tech main­tains '22 sales guid­ance

While Pfizer raked in almost $28 billion last quarter, its Covid-19 vaccine partner BioNTech reported a rise in total dose orders but a drop in sales.

The German biotech reported over $3.2 billion in revenue in Q2 on Monday, down from more than $6.7 billion in Q1, in part due to falling Covid sales. While management said last quarter that they anticipated a Covid sales drop — CEO Uğur Şahin said at the time that “the pandemic situation is still very much uncertain” — Q2 sales still missed consensus by 14%.

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FDA commissioner Rob Califf (Tom Williams/CQ Roll Call via AP Images)

With drug pric­ing al­most done, Con­gress looks to wrap up FDA user fee leg­is­la­tion

The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim.

FDA commissioner Rob Califf recently sent agency staff a memo explaining how, “Our latest estimates are that we have carryover for PDUFA [Prescription Drug User Fee Act], the user fee funding program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.”

Anna Protopapas, Mersana CEO

In $1.36B biobuck deal with GSK, Mer­sana touts 'biggest pre­clin­i­cal ADC deal ever'

Days after Enhertu reeled in another FDA nod, with the first-ever green light for HER2-low breast cancer, another antibody drug conjugate biotech claims it has secured the largest preclinical ADC pact to date for a single asset.

AstraZeneca and Daiichi Sankyo made waves with their nearly $7 billion collaboration back in spring 2019, but at that point, Enhertu was already nearing the FDA’s doors with clinical data. The latest ADC tie-up to enter the biopharma fray centers around a preclinical asset, Mersana Therapeutics’ XMT-2056.

Steve Paul, Karuna Therapeutics CEO (Third Rock)

Karuna's schiz­o­phre­nia drug pass­es a close­ly-watched PhI­II test, will head to FDA in mid-2023

An investigational pill that combines a former Eli Lilly CNS compound with an overactive bladder drug was better than placebo at reducing a scale of symptoms experienced by patients with schizophrenia in a Phase III trial.

Karuna Therapeutics’ drug passed the primary goal in EMERGENT-2, the Boston biotech said early Monday morning, alongside quarterly earnings. The study is the first of Karuna’s four Phase III clinical trials to read out in schizophrenia and will provide the backbone to the biotech’s first drug approval application, slated for mid-2023.

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Pascal Soriot, AstraZeneca CEO (David Zorrakino/Europa Press via AP Images)

As­traZeneca and Dai­ichi Sankyo sprint to mar­ket af­ter FDA clears En­her­tu in just two weeks

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, just two weeks after submitting a supplemental BLA. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.

GSK and IQVIA launch plat­form of US vac­ci­na­tion da­ta, show­ing drop in adult rates

Throughout the Covid-19 pandemic, the issue of vaccine uptake has been a point of contention, but a new platform from GSK and IQVIA is hoping to shed more light on vaccine data, via new transparency and general awareness.

The two companies have launched Vaccine Track, a platform intended to be used by public health officials, medical professionals and others to strengthen data transparency and display vaccination trends. According to the companies, the platform is intended to aid in increasing vaccine rates and will provide data on trends to assist public health efforts.

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