Craig Gibbs, Asher Bio CEO (Asher)

Ash­er Bio­ther­a­peu­tics joins search for a bet­ter IL-2 sans the tox­i­c­i­ties

Can IL-2 ther­a­pies — which can be pow­er­ful against can­cer but in­fa­mous for their tox­ic side ef­fects — be made in­her­ent­ly more spe­cif­ic? For Ash­er Bio­ther­a­peu­tics, that’s the $55 mil­lion ques­tion.

Ivana Djuret­ic and Andy Ye­ung left their jobs in can­cer im­munol­o­gy and pro­tein en­gi­neer­ing at Pfiz­er in 2019 to start Ash­er with the idea that they could im­prove the ef­fi­ca­cy of im­munother­a­pies. More specif­i­cal­ly, they want­ed to know if re­strict­ing the ac­tiv­i­ty of a cy­tokine to on­ly the cells that mat­ter would coun­ter­in­tu­itive­ly re­sult in bet­ter ther­a­peu­tics.

They de­cid­ed to start with IL-2, what Djuret­ic called “one of the most ex­cit­ing chal­lenges to­day.” And that work, she said, led them to an “aha mo­ment.”

Ivana Djuret­ic

“We sort of re­al­ized that we could … mod­u­late spe­cif­ic im­mune cell sub­sets in many con­texts, not on­ly IL-2, not on­ly CD8,” through a process called cis-tar­get­ing, Djuret­ic said. Cis-tar­get­ing is an en­gi­neer­ing ap­proach that works by re­quir­ing the si­mul­ta­ne­ous en­gage­ment of two re­cep­tors on the same im­mune cell for ac­ti­va­tion.

Djuret­ic and Ye­ung ran in­to Third Rock at an ear­ly 2020 meet­ing in Boston, and the rest is his­to­ry. Wash­ing­ton Uni­ver­si­ty pro­fes­sor Robert Schreiber and Nether­lands Can­cer In­sti­tute top sci­en­tist Ton Schu­mach­er, who were in­volved with Third Rock, hopped on board as co-founders. And on Tues­day morn­ing, the com­pa­ny un­veiled a $55 mil­lion Se­ries A to take its lead on­col­o­gy pro­gram, AB248, to the clin­ic next year.

Andy Ye­ung

“So a lot of peo­ple are try­ing to tar­get IL-2 spa­tial­ly to the site of the tu­mor, but it’s an in­her­ent­ly non­spe­cif­ic mol­e­cule. So we think there’s on­ly a lim­it­ed amount of speci­fici­ty we can get out of that,” CEO Craig Gibbs said. “What we’re try­ing to do is make IL-2 in­her­ent­ly spe­cif­ic, so it on­ly binds CD8+ T cells, which is the ones that we want, and not to T regs which are go­ing to be im­muno­sup­pres­sive, and not to NK cells which just cause tox­i­c­i­ty, and not to en­dothe­lial cells which cause vas­cu­lar leak.”

Gibbs left his job as CBO at Forty Sev­en to join Ash­er last sum­mer, af­ter the for­mer was bought by Gilead for near­ly $5 bil­lion. That Sep­tem­ber, he was “grat­i­fied” by some “re­al­ly stel­lar” da­ta from Schreiber’s lab. In vit­ro and mon­key stud­ies have shown a “much larg­er ex­pan­sion” of CD8 cells, with­out the ac­ti­va­tion of reg­u­la­to­ry T cells or NK cells, he said.

In ad­di­tion to on­col­o­gy, the Ash­er team be­lieves the plat­form could have ap­pli­ca­tions in au­toim­mu­ni­ty and in­fec­tious dis­ease.

The Se­ries A was led by Third Rock with par­tic­i­pa­tion from Box­er Cap­i­tal of Tavi­s­tock Group, In­vus, Y Com­bi­na­tor and MBC Bi­o­labs.

Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Vas Narasimhan (Photographer: Jason Alden/Bloomberg via Getty Images)

No­var­tis de­tails plans to axe 8,000 staffers as Narasimhan be­gins sec­ond phase of a glob­al re­org

We now know the number of jobs coming under the axe at Novartis, and it isn’t small.

The pharma giant is confirming a report from Swiss newspaper Tages-Anzeiger that it is chopping 8,000 jobs out of its 108,000 global staffers. A large segment will hit right at company headquarters in Basel, as CEO Vas Narasimhan axes some 1,400 of a little more than 11,000  jobs in Switzerland.

The first phase of the work is almost done, the company says in a statement to Endpoints News. Now it’s on to phase two. In the statement, Novartis says:

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Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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(AP Photo/Gemunu Amarasinghe)

Some phar­ma com­pa­nies promise to cov­er abor­tion-re­lat­ed trav­el costs — while oth­ers won't go that far yet

As the US Department of Health and Human Services promises to support the millions of women who would now need to cross state lines to receive a legal abortion, a handful of pharma companies have said they will pick up employees’ travel expenses.

GSK, Sanofi, Johnson & Johnson, BeiGene, Alnylam and Gilead have all committed to covering abortion-related travel expenses just four days after the Supreme Court overturned Roe v. Wade and revoked women’s constitutional right to an abortion.

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Aurobindo Pharma co-founders P. V. Ram Prasad Reddy (L) and K. Nityananda Reddy

Au­robindo Phar­ma re­ceives warn­ing let­ter from In­di­a's SEC fol­low­ing more FDA ques­tion marks

Indian-based generics manufacturer Aurobindo Pharma has been in the crosshairs of the FDA for several years now, but the company is also attracting attention from regulators within the subcontinent.

According to the Indian business news site Business Standard, a warning letter was sent to the company from the Securities Exchange Board of India, or SEBI.

The letter is related to disclosures made by the company on an ongoing FDA audit of the company’s Unit-1 API facility in Hyderabad, India as well as observations made by the US regulator between 2019 and 2022.

New Charles River Laboratories High Quality (HQ) Plasmid DNA Centre of Excellence at Bruntwood SciTech’s Alderley Park in Cheshire, United Kingdom. (Charles River)

Charles Riv­er Lab­o­ra­to­ries to start cell and gene ther­a­py man­u­fac­tur­ing at UK site in Sep­tem­ber

While Massachusetts-based Charles River Laboratories has been on an acquisition spree, they are not against planting their flag. The latest move by the company sees them crossing the pond to establish a manufacturing site in the UK.

The company on Tuesday opened its cell and gene therapy manufacturing center at Bruntwood SciTech’s Alderley Park in Cheshire, United Kingdom. The expansion follows Charles River’s acquisition of Cognate BioServices and Cobra Biologics in 2021 for $875 million. Cognate is a plasmid DNA, viral vector and cell therapy CDMO.

Bristol Myers Squibb (Alamy)

CVS re­sumes cov­er­age of block­buster blood thin­ner af­ter price drop fol­lows Jan­u­ary ex­clu­sion

Following some backlash from the American College of Cardiology and patients, Bristol Myers Squibb and Pfizer lowered the price of their blockbuster blood thinner Eliquis, thus ensuring that CVS Caremark would cover the drug after 6 months of it being off the major PBM’s formulary.

“Because we secured lower net costs for patients from negotiations with the drug manufacturer, Eliquis will be added back to our template formularies for the commercial segment effective July 1, 2022, and patient choices will be expanded,” CVS Health said in an emailed statement. “Anti-coagulant therapies are among the non-specialty products where we are seeing the fastest cost increases from drug manufacturers and we will continue to push back on unwarranted price increases.”

#Can­nes­Lions2022: Con­sumer health ex­ecs call on agen­cies to in­volve pa­tients in cre­ative process

CANNES — When Tamara Rogers joined GSK back in 2018, “science was king and R&D were the gods.” Now the global chief marketing officer of consumer healthcare wants to make room for another supreme being: the consumer.

As health and wellness becomes more relevant to consumers amid the pandemic, four health-focused executives called on marketers to involve patients in their creative process in a panel discussion at the Cannes Lions advertising creativity festival.

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