Rajeev Venkayya, Aerium Therapeutics CEO

In year 3 of the pan­dem­ic, a new Covid-19 biotech takes flight with an an­ti­body com­bo and Takeda's ex-vac­cines chief at the helm

Year three of the Covid-19 pan­dem­ic just be­gan, but this far in, Omega Funds thinks it’s not too late to launch a biotech to fight SARS-CoV-2 just as an­oth­er sub­vari­ant takes flight and cas­es rise in var­i­ous re­gions.

The pro­lif­ic biotech in­cu­ba­tor poached Take­da’s for­mer vac­cines leader Ra­jeev Venkayya and inked re­search agree­ments with Swiss uni­ver­si­ties to cre­ate Aeri­um Ther­a­peu­tics, named af­ter the Latin word for air­borne. With the cov­er now off, Aeri­um can put to work two mon­o­clon­al an­ti­bod­ies that it says have shown neu­tral­iza­tion against Omi­cron and its sub­vari­ants in pre­clin­i­cal test­ing that is yet to be peer re­viewed.

Af­ter a decade at Take­da, Venkayya told End­points News he want­ed a fresh start and “some­thing dif­fer­ent” when he was ap­proached by Omega’s Otel­lo Stam­pac­chia last No­vem­ber. Aeri­um’s goal to go af­ter not just Covid-19 but oth­er virus­es and po­ten­tial fu­ture pan­demics was al­so ap­peal­ing, es­pe­cial­ly from Venkayya’s van­tage point as a board mem­ber of the Coali­tion for Epi­dem­ic Pre­pared­ness In­no­va­tion.

Five months in, he’s as­sem­bled a team of al­most 20 peo­ple across Boston and Lau­sanne to quick­ly ramp up for a clin­i­cal tri­al this sum­mer to test the two mon­o­clon­al an­ti­bod­ies as a com­bi­na­tion pro­phy­lax­is treat­ment, the CEO said.

John Maraganore

Help­ing build out that team is board mem­ber John Maraganore, the for­mer found­ing CEO at Al­ny­lam, which axed its own Covid-19 an­tivi­ral last Au­gust, cit­ing “high­ly ef­fec­tive vac­cines and al­ter­na­tive treat­ment op­tions.” The RNAi biotech is al­so now su­ing and seek­ing mon­ey from Mod­er­na and Pfiz­er for their sup­posed use of its lipid nanopar­ti­cles in two of the world’s biggest Covid-19 vac­cine cash cows.

But Aeri­um is get­ting in­to the mon­o­clon­al race now be­cause it sees the need for Covid-19 treat­ments ex­tend­ing in­to the fu­ture giv­en the num­ber of im­muno­com­pro­mised pa­tients, as well as the wan­ing im­mu­ni­ty of vac­cines, Venkayya said.

“We do think that of­fer­ing those in­di­vid­u­als some­thing that can be giv­en over three to six months and give them the equiv­a­lent of vac­cine pro­tec­tion would be high im­pact,” Venkayya said of test­ing the an­ti­body com­bi­na­tion in im­muno­com­pro­mised pa­tients who “haven’t de­rived the ben­e­fit of the mirac­u­lous vac­cine ad­vance­ments.”

Aeri­um’s mon­o­clon­als came out of the labs of Giuseppe Pan­ta­leo at Cen­tre Hos­pi­tal­ier Uni­ver­si­taire Vau­dois and Di­di­er Trono at École Poly­tech­nique Fédérale de Lau­sanne. Omega teamed up with the sci­en­tif­ic founders to seed Aeri­um and has now led a se­ries A in the biotech. Venkayya de­clined to of­fer de­tails on how much is in the bank.

Aeri­um wants to work “as quick­ly as pos­si­ble” with the FDA and Eu­ro­pean reg­u­la­tors on get­ting “through clin­i­cal de­vel­op­ment on a very ex­pe­dit­ed time­frame, hope­ful­ly with­out an ef­fi­ca­cy study,” Venkayya said. Eli Lil­ly’s emer­gency au­tho­rized an­ti­body did not have phase III da­ta, he not­ed.

To help bankroll the test­ing, EUA fil­ing and in-li­cens­ing of an­tivi­rals for oth­er virus­es, Aeri­um will raise a se­ries B in the next two or three months, Venkayya said. He ex­pects the EUA mile­stone to hap­pen as ear­ly as this year.

The com­pa­ny is in dis­cus­sions with po­ten­tial large man­u­fac­tur­ers about scal­ing up pro­duc­tion, should the ther­a­py get green­lit, as well as Big Phar­mas about po­ten­tial co-de­vel­op­ment paths, he said.

Be­yond Covid-19, the start­up will go af­ter oth­er virus­es with “com­mer­cial po­ten­tial,” like in­fluen­za and Res­pi­ra­to­ry syn­cy­tial virus, Venkayya said. Big Phar­mas are in an RSV race, in­clud­ing Pfiz­er, Sanofi, Glax­o­SmithK­line, Mod­er­na and As­traZeneca.

Oth­er “more ne­glect­ed vi­ral dis­eases” could al­so be on the dock­et, Venkayya said, in­clud­ing those on the World Health Or­ga­ni­za­tion’s R&D blue­print. That work would be sup­port­ed by glob­al or­ga­ni­za­tions or gov­ern­ments, he said. Pri­or to Take­da, Venkayya was di­rec­tor of vac­cine de­liv­ery at the Bill & Melin­da Gates Foun­da­tion.

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.

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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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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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.”

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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Ab­b­Vie sur­veys emo­tion­al im­pact of chron­ic leukemia con­di­tion, finds 'roller coast­er' of emo­tions

Rare diseases often have more than just physical effects on patients — especially when it comes to chronic conditions. In the case of the rare slow-growing blood cancer chronic lymphocytic leukemia (CLL), AbbVie wanted to try to assess the mental and emotional toll on patients.

So it surveyed more than 300 CLL patients, caregivers and physicians. While each group differed in how they felt — caregivers overwhelmingly (81%) felt positive about their role, for instance — patients described a “roller coaster” of emotions traversing diagnosis to treatment to remission and even relapse for some.

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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