Laurent Fischer, Adverum CEO

Ad­verum lays off 38% of staff as it en­ters new tri­al for oc­u­lar gene ther­a­py af­ter last year's safe­ty woes

Ad­verum is mov­ing for­ward with its eye dis­ease gene ther­a­py that caused headaches in April 2021, but is do­ing so with few­er staff on board.

The biotech is lay­ing off 78 em­ploy­ees, or about 38% of its work­force, in or­der to con­serve cash and keep the lights on in­to 2025, ac­cord­ing to an SEC fil­ing.

Ad­verum CMO Richard Beck­man

The Red­wood City, CA, biotech said Wednes­day it has amend­ed the IND for a Phase II study of its gene ther­a­py in wet age-re­lat­ed mac­u­lar de­gen­er­a­tion (AMD). The tri­al of AD­VM-022 will kick off this quar­ter, CMO Richard Beck­man said in a state­ment.

Ad­verum’s stock $AD­VM rose near­ly 9% af­ter the open­ing bell Thurs­day. The re­struc­tur­ing will elim­i­nate about $15.3 mil­lion an­nu­al­ly in “di­rect la­bor cost,” ac­cord­ing to the biotech’s SEC fil­ing.

Now dubbed ixobero­gene soropar­vovec (Ixo-vec), an ear­li­er tri­al of the gene ther­a­py led to a loss of vi­sion in one pa­tient’s treat­ed eye last year. That pa­tient had di­a­bet­ic mac­u­lar ede­ma and re­ceived a high­er dose of the gene ther­a­py.

The safe­ty is­sues from the high dose end­ed up af­fect­ing five of 12 pa­tients with di­a­bet­ic mac­u­lar ede­ma in that Phase II tri­al, the com­pa­ny said last Ju­ly. It is now mov­ing for­ward with a low­er dose and is on­ly test­ing the gene ther­a­py in pa­tients with wet AMD in the Phase II LU­NA tri­al.

“We de­signed the LU­NA tri­al af­ter a thor­ough re­view of da­ta gen­er­at­ed in all 55 study par­tic­i­pants treat­ed to date with a sin­gle in­jec­tion of AD­VM-022, some of whom have now demon­strat­ed con­tin­u­ous and sta­ble afliber­cept ex­pres­sion for over three years. We have deep­ened our un­der­stand­ing of ade­no-as­so­ci­at­ed virus (AAV) me­di­at­ed oc­u­lar gene ther­a­py, in­clud­ing the in­flam­ma­to­ry re­sponse to AAV, and this is in­form­ing our strat­e­gy to mit­i­gate im­muno­genic­i­ty,” Beck­man, the med­ical chief, said in a state­ment.

CEO Lau­rent Fis­ch­er said the com­pa­ny has worked on its man­u­fac­tur­ing strat­e­gy to have a “scal­able ap­proach de­signed to pro­vide an am­ple sup­ply of Ixo-vec to sup­port our clin­i­cal de­vel­op­ment pro­gram through bi­o­log­ics li­cense ap­pli­ca­tion fil­ing.”

With the lay­offs and re­fined fo­cus on AD­VM-022, Ad­verum has enough cash to fund it­self be­yond one-year topline re­sults from the 72-pa­tient LU­NA tri­al, Fis­ch­er said in a state­ment. The biotech had $271.1 mil­lion in cash as of March 31.

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In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance Chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

Pharma brands are trying to figure out new ways to better reach patients and doctors, but also measure results. (Credit: Shutterstock)

Do phar­ma TV and so­cial ads work? Phar­ma mar­ket­ing agen­cies adopt­ing new tech so­lu­tions to find out

It’s a timeworn advertising question — is my ad campaign working? In pharma, that can be an especially difficult question to answer in part because of privacy regulations, but also because the brands spend a lot of money on TV commercials where viewers can’t directly click on an ad.

Healthcare marketing services companies like Lasso and CMI Media Group are trying to change that with new measurement methods and partnerships that aim to get closer to patients’ and physicians’ actions.

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Corey McCann, Pear Therapeutics CEO

Pear Ther­a­peu­tics touts Q2 growth while scal­ing back full-year goals and chop­ping 9% of staff

Pear Therapeutics set some ambitious goals back in March, predicting a five-fold boost in revenue and a surge in new prescriptions for its digital therapeutics. Now the company is scaling back those estimates and chopping 9% of its workforce — an all-too-common occurrence in biotech lately.

CEO Corey McCann unveiled Pear’s Q2 numbers on Thursday, touting a 20% quarter-over-quarter revenue growth totaling $3.3 million. That’s more than double what the company made in Q2 2021, and McCann thinks the team could see a nearly four-fold jump in revenue this year, falling in the range of $14 million to $16 million.

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Seagen interim CEO Roger Dansey and Daiichi Sankyo CEO Sunao Manabe

Paving the way for Mer­ck­'s buy­out, Seagen los­es ar­bi­tra­tion dis­pute with Dai­ichi over ADC tech

As Seagen awaits a final buyout offer from Merck that could be in the territory of $40 billion, Seagen revealed Friday afternoon that it lost an arbitration dispute with Daiichi Sankyo relating to the companies’ 2008 collaboration around the use of antibody-drug conjugate (ADC) technology.

But that loss likely won’t matter much when it comes to Merck’s deal.

After breaking off its pact with Daiichi in mid-2015, the two companies battled over “linker” tech — a chemical bridge between an ADC’s antibody component and the cytotoxic payload — that Seagen claims Daiichi would improve upon and implement in its current generation of ADCs.

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Benjamin Oakes, Scribe Therapeutics CEO

CEO of Doud­na spin­out: With­in five years, genome ed­i­tors will have a 're­al­ly big im­pact' on pa­tients' lives

“CRISPR-by-design” is the idea behind Scribe Therapeutics, a company spun out from Jennifer Doudna’s Nobel-winning lab that’s competing in a closely-tracked field of genome editor companies just starting to make their way to the clinic.

After nabbing $100 million last March for its Series B funding round, Scribe is taking a different tack from some of its competitors, crafting a new enzyme isolated from bacteria called CasX, which has now been tweaked extensively and may be targeted to a range of genome-related diseases, offering a plethora of therapeutic options.

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