Lovisa Afzelius, Apriori Bio CEO

Flag­ship un­wraps new AI biotech that looks to pre­dict vari­ants be­fore they’re here

While Mod­er­na is test­ing Omi­cron-spe­cif­ic boost­ers for this fall, its in­vestor Flag­ship Pi­o­neer­ing is build­ing a biotech that says it us­es AI to pre­dict virus vari­ants pri­or to out­breaks.

Apri­ori Bio, de­rived from the Latin phrase a pri­ori that trans­lates to “from the pre­vi­ous,” emerged from stealth Mon­day with $50 mil­lion. The Cam­bridge, MA-based biotech was found­ed in 2020 in the midst of the Covid-19 pan­dem­ic, though Apri­ori CEO Lo­visa Afzelius says the biotech will tack­le mul­ti­ple “ul­tra-dy­nam­ic” virus­es out­side of SARS-CoV-2, in­clud­ing the flu virus and HIV.

“When we had looked back at nu­mer­ous years in the past, we saw that every sin­gle year there have been out­breaks that could have just as well led to a pan­dem­ic,” Afzelius, an As­traZeneca and Pfiz­er vet, said. “But yet, even though it was pre­dictable, we were so un­pre­pared.”

Apri­ori’s AI, which the biotech calls Oc­tavia, com­bines ex­per­i­men­tal bi­ol­o­gy with al­go­rithms. The biotech cre­ates li­braries of “mil­lions of syn­thet­ic vari­ants” of a giv­en virus and then tests how well each syn­thet­ic vari­ant binds to an­ti­bod­ies — both ther­a­peu­tic and post-in­fec­tion. The biotech feeds this ex­per­i­men­tal da­ta through its al­go­rithm, which can then tell the sci­en­tists how well cer­tain vari­ants bind to an­ti­bod­ies and how like­ly they are to es­cape vac­cines.

Then, the biotech can “run the en­gine in re­verse,” as Afzelius put it, and de­sign “vari­ant-proof vac­cines and an­ti­bod­ies” based on the AI da­ta.

Apri­ori’s ad­vi­so­ry board fea­tures a num­ber of ex-gov­ern­ment lead­ers, in­clud­ing for­mer FDA com­mis­sion­er Stephen Hahn; Welling­ton Sun, for­mer FDA vac­cine of­fi­cial and ex-leader of Mod­er­na’s vac­cine strat­e­gy; and An­drew We­ber, a for­mer as­sis­tant US sec­re­tary of de­fense un­der Pres­i­dent Barack Oba­ma.

Afzelius said the biotech was work­ing with both pri­vate and pub­lic en­ti­ties through­out the pan­dem­ic. When asked if the biotech has any plans to part­ner with Mod­er­na, which is cur­rent­ly build­ing a num­ber of vari­ant-based vac­cines, Afzelius gave a non-an­swer, re­it­er­at­ing that Apri­ori would be look­ing to part­ner with both pri­vate and pub­lic groups.

Apri­ori is not alone in us­ing AI for virus­es. BioN­Tech is col­lab­o­rat­ing with UK AI start­up In­staDeep to use AI for an ar­ray of biotech items, in­clud­ing drug dis­cov­ery, pro­tein en­gi­neer­ing, and man­u­fac­tur­ing.

“What it is we’re try­ing to do is move away from be­ing ex­treme­ly re­ac­tive and in­stead po­si­tion­ing our­selves to be proac­tive and un­der­stand where to go a pri­ori — be­fore a new vari­ant oc­curs,” Afzelius said. “We’ve been in the back seat through­out this pan­dem­ic, and we want to cre­ate a new op­por­tu­ni­ty to be in the dri­ver’s seat in­stead of be­ing dic­tat­ed by the virus.”

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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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.

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.

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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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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Bernhardt Zeiher, outgoing Astellas CMO (Astellas)

Q&A: Astel­las' re­tir­ing head of de­vel­op­ment re­flects on gene ther­a­py deaths

For anyone who’s been following discussions about the safety alarms surrounding the adeno-associated viruses (AAV) commonly used to deliver gene therapy, Astellas should be a familiar name.

The Japanese pharma — which bought out Audentes Therapeutics near the end of 2019 and later built a gene therapy unit around the acquisition — rocked the field when it reported three patient deaths in a trial testing AT132, the lead program from Audentes designed to treat a rare muscle disease called X-linked myotubular myopathy (XLMTM).

When the company restarted the trial, it adjusted the dose and instituted a battery of other measures to try to prevent the same thing from happening again. But tragically, the first patient to receive the new regimen died just weeks after administration. The therapy remains under clinical hold, and just weeks ago, Astellas flagged another safety-related hold for a separate gene therapy candidate. In the process of investigating the deaths, the company has also taken flak about the way it disclosed information.

Big questions remain — questions that can have big implications about the future of AAV gene therapies.

Bernhardt Zeiher did not imagine any of it when he first joined Astellas as the therapeutic area leader in inflammation, immunology and infectious diseases. But his ascent to chief medical officer and head of development coincided almost exactly with Astellas’ big move into gene therapy, putting him often in the driver’s seat to grapple with the setbacks.

As Zeiher prepares to retire next month after a 12-year tenure — leaving the unfinished tasks to his successor, a seasoned cancer drug developer — he chatted with Endpoints News, in part, to discuss the effort to understand what happened, lessons learned and the criticism along the way.

The transcript has been lightly edited for length and clarity.

Endpoints: I want to also ask you a bit about the gene therapy efforts you’ve been working on. Astellas has really been at the forefront of discovering the safety concerns associated with AAV gene therapy. What’s that been like for you?

Zeiher: Well, I have to admit, it’s been a bit of a roller coaster. We acquired Audentes. Huge amount of enthusiasm. What we saw with AT132 — that was the lead program in XLMTM — was just remarkable efficacy. I mean, kids who went from being on ventilators, not able to eat for themselves, sit up, do things like that, to off ventilators, walking, you know, really — one investigator called it this Lazarus-like effect. It was just really dramatic efficacy. And then to have the safety events that occurred. So they actually occurred within that first year of the acquisition. So we had the three patient deaths. Me and my organization became very, very much involved. In fact, Ed Conner, who had been the chief medical officer, he left after some of the deaths, but I stepped in as the kind of acting chief medical officer, we had another chief medical officer who was involved, and then we had a fourth death, and I became acting again for a period of time.

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