CEO John Celebi (Sensei)

Sen­sei Bio­ther­a­peu­tics rakes in $28.5M to give can­cer im­munother­a­pies a push

Less than a month af­ter of­fer­ing a glimpse at ear­ly clin­i­cal da­ta for its lead can­cer im­munother­a­py at vir­tu­al ES­MO, Sen­sei Bio­ther­a­peu­tics has reeled in $28.5 mil­lion to wade deep­er in­to Phase II.

The Mary­land-based biotech, for­mer­ly known as Panacea, is look­ing to ex­pand Phase II tri­als for SNS-301, an en­gi­neered in­ac­ti­vat­ed bac­te­rio­phage de­signed to “awak­en” the im­mune sys­tem. “Right now we’re re­al­ly fo­cused on adding ad­di­tion­al Phase II clin­i­cal and trans­la­tion­al da­ta to sup­port SNS-301,” CEO John Celebi said.

The round, which the com­pa­ny is call­ing a Se­ries AA, fol­lows sev­er­al seed rounds, Celebi said. It was led by Cam­bri­an Bio­phar­ma and H&S Ven­tures, and will fund the Phase II de­vel­op­ment of SNS-301. It will al­so help ready the biotech’s ear­li­er can­di­dates for IND ap­pli­ca­tions, which could come some­time in the next 12 to 18 months. That in­cludes SNS-401, a po­ten­tial vac­cine cock­tail against Merkel cell car­ci­no­ma, and SNS-VISTA, an an­ti­body-based ther­a­peu­tic.

Last sum­mer, Sen­sei joined forces with As­traZeneca to test SNS-301 in com­bi­na­tion with Imfinzi in two Phase II tri­als across mul­ti­ple sol­id tu­mors. And at ES­MO, the biotech read out ear­ly da­ta from a Phase I/II study of the can­di­date and Mer­ck’s Keytru­da for ad­vanced head and neck can­cer. One of 9 pa­tients eval­u­at­ed at the time had a par­tial re­sponse, with a tu­mor re­duc­tion of 43%, ac­cord­ing to the com­pa­ny.

“The ap­proval of pem­brolizum­ab is an ex­cit­ing event for pa­tients, but clear­ly there’s a lot of room for im­prove­ment,” Celebi said, cit­ing a Keynote-012 study which showed Mer­ck’s drug achieved an 18% over­all re­sponse in pa­tients with metasta­t­ic squa­mous cell car­ci­no­ma of the head and neck.

CMO Marie-Louise Fjaell­skog not­ed in a state­ment:

To date, we have ob­served promis­ing clin­i­cal ac­tiv­i­ty that is cor­re­lat­ed with im­mune re­sponse for SNS-301, in­clud­ing a par­tial re­sponse in a pa­tient with PD-L1-neg­a­tive dis­ease. This ini­tial da­ta from 9 pa­tients pro­vides us with the ra­tio­nale to con­tin­ue ex­plor­ing its safe­ty and ef­fi­ca­cy in 1st and 2nd line SC­CHN pa­tients.

Fu­ture Ven­tures, Chris­t­ian Anger­may­er’s Ape­iron In­vest­ment Group, and Pre­sight Ven­tures al­so chipped in to the round.

“With ex­pe­ri­enced man­age­ment and sci­en­tif­ic teams, Sen­sei is well po­si­tioned to be­come a leader in next gen­er­a­tion of im­mune-on­col­o­gy ther­a­peu­tics,” Cam­bri­an Bio­phar­ma CEO James Pey­er said in a state­ment.

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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