Ed­i­tas and Cel­gene sub Juno are tack­ling hottest im­munother­a­py cells

As the first CRISPR-edit­ed can­cer pa­tients watch their treat­ments un­fold, one of the first CRISPR com­pa­nies is re­jig­ging a ma­jor on­col­o­gy deal.

Ed­i­tas Med­i­cine is amend­ing its long-run­ning col­lab­o­ra­tion with Cel­gene and their sub­sidiary Juno Ther­a­peu­tics. The new deal will ex­pand the fo­cus of their work to cov­er a sub­set of im­mune cells that have be­come an in­creas­ing­ly hot tar­get for im­munother­a­py: gam­ma-delta cells.

The deal will make Ed­i­tas el­i­gi­ble for a $70 mil­lion pay­ment along with oth­er pos­si­ble mile­stones and roy­al­ties.

“It’s a sig­nif­i­cant ex­pan­sion” of the deal, Ed­i­tas CSO Char­lie Al­bright told End­points News. These cells are part of the im­mune sys­tem and have sig­nif­i­cant po­ten­tial to treat sol­id tu­mors.

Char­lie Al­bright

Since it be­gan in 2015, the Juno-Ed­i­tas col­lab­o­ra­tion has fo­cused large­ly on al­pha-be­ta cells, the ones out­fit­ted with the spe­cial re­cep­tors in cur­rent CAR-T treat­ments. Sci­en­tists at those com­pa­nies and else­where have most pub­licly tried to ap­ply CRISPR to im­prove CAR-T, which now work sole­ly through vi­ral gene trans­fer.

But they have al­so worked on ex­pand­ing the ap­proach to oth­er im­mune cell types in hopes of mak­ing the treat­ment more ef­fec­tive, more ac­ces­si­ble or — as is the case with some of the gam­ma delta re­search — ex­pand it in­to oth­er can­cer types, es­pe­cial­ly sol­id tu­mors.

Ed­i­tas has been slow­ly build­ing their gam­ma-delta base through­out the year, Al­bright said. In April, they signed an agree­ment with Blue­Rock, in part to ac­cess pluripo­tent stem cells they hope to make in­to en­gi­neered gam­ma-delta cells that can be de­liv­ered to a pa­tient. (Es­sen­tial­ly a form of off-the-shelf CAR–T).

Sev­er­al com­pa­nies are now pur­su­ing gam­ma-delta im­munother­a­pies, in­clud­ing Gam­maDelta Ther­a­peu­tics and its new spin­off Adap­tate and Re­gen­eron-backed Adicet Bio. They’re bet­ting chiefly on these cells’ abil­i­ty to pen­e­trate the sol­id tu­mors that have been so re­sis­tant to the first wave of CAR-T treat­ments.

Al­bright ar­gued, though, that for these tech­niques to work you need gene edit­ing. In­nate abil­i­ties in the cells have to be tuned up, he said. You have to in­crease cells’ per­sis­tence and en­hance their abil­i­ty to sur­vive in a tu­mors’ mi­cro-en­vi­ron­ment. Ide­al­ly, he said, you even give it new abil­i­ties, such as the pow­er to cat­alyze the body’s in­nate im­mune sys­tem.

“You can’t do that with vi­ral trans­duc­tion,” Al­bright said. “You need gene edit­ing.”

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

ProFound Therapeutics founding team

Flag­ship's lat­est biotech could turn some of the thou­sands of new pro­teins it dis­cov­ered in­to ther­a­pies — and it has $75M to start

Flagship Pioneering, the incubator of Moderna and dozens of other biotechs, says it has landed upon tens of thousands of previously undiscovered human proteins. The VC shop wants to potentially turn them into therapeutics.

Like other drug developers that have turned proteins into therapeutics (think insulin for diabetes), Flagship’s latest creation, ProFound Therapeutics, wants to tap into this new trove of proteins as part of its mission to treat indications ranging from rare diseases to cancer to immunological diseases.

Richard Silverman, Akava Therapeutics founder and Northwestern professor

This time around, Lyri­ca's in­ven­tor is de­vel­op­ing his North­west­ern dis­cov­er­ies at his own biotech

Richard Silverman was left in the dark for the last five years of clinical development of the drug he discovered. The Northwestern University professor found out about the first approval of Lyrica, in the last few days of 2004, like most other people: in the newspaper.

What became one of Pfizer’s top-selling meds, at $5 billion in 2017 global sales before losing patent protection in 2019, started slipping out of his hands when Northwestern licensed it out to Parke-Davis, one of two biotechs that showed interest in developing the drug in the pre-email days, when the university’s two-person tech transfer team had to ship out letters to garner industry appetite.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,700+ biopharma pros reading Endpoints daily — and it's free.

Michael Corbo, Pfizer CDO of inflammation & immunology

UP­DAT­ED: Plan­ning ahead for crowd­ed ul­cer­a­tive col­i­tis mar­ket, Pfiz­er spells out PhI­II da­ta on $6.7B Are­na drug

Pfizer has laid out the detailed results behind its boast that etrasimod — the S1P receptor modulator at the center of its $6.7 billion buyout of Arena Pharma — is the winner of the class, potentially leapfrogging an earlier entrant from Bristol Myers Squibb.

Pivotal data from the ELEVATE program in ulcerative colitis — which consists of two Phase III trials, one lasting 52 weeks and the other just 12 weeks — illustrate an “encouraging balance of efficacy and safety,” according to Michael Corbo, chief development officer of inflammation & immunology at Pfizer. The company is presenting the results as a late breaker at Digestive Disease Week.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,700+ biopharma pros reading Endpoints daily — and it's free.

David Ricks, Eli Lilly CEO (David Paul Morris/Bloomberg via Getty Images)

Eli Lil­ly set to in­vest $2.1B in home state man­u­fac­tur­ing boost

Eli Lilly is looking to expand its footprint in its home Hoosier State by making a major investment in manufacturing.

The pharma is investing $2.1 billion in two new manufacturing sites at Indiana’s LEAP Lebanon Innovation and Research District in Boone County, northwest of Lilly’s headquarters in Indianapolis.

The two new facilities will expand Lilly’s manufacturing network for active ingredients and new therapeutic modalities, including genetic medicines, according to a press release.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,700+ biopharma pros reading Endpoints daily — and it's free.

Up­dat­ed: US sees spike in Paxlovid us­age as Mer­ck­'s mol­nupi­ravir and As­traZeneca's Evusheld are slow­er off the shelf

New data from HHS show that more than 162,000 courses of Pfizer’s Covid-19 antiviral Paxlovid were administered across the US over the past week, continuing a streak of increased usage of the pill, and signaling not only rising case numbers but more awareness of how to access it.

In comparison to this week, about 670,000 courses of the Pfizer pill have been administered across the first five months since Paxlovid has been on the US market, averaging about 33,000 courses administered per week in that time.

Almirall is tapping artificial intelligence on behalf of its sales force for insights and efficiencies. (via Shutterstock)

Almi­rall rolls out sales rep ar­ti­fi­cial in­tel­li­gence sys­tem, cut­ting pre-call prep and 'wind­shield time'

Dermatology specialty pharma Almirall is making its sales reps smarter. Not with extra training or educational courses, but instead with artificial intelligence tools.

It began a soft launch of a sales rep AI and machine learning platform it calls Polaris last August in one of its 7 US coverage regions. The platform from Aktana gathers information from across Almirall internal sources and external ones – such as claims and prescribing data – to generate insights for reps. Now, instead of spending hours prepping for a sales call, Polaris can generate details about a physician’s preferences, past behaviors and prescription habits for reps in minutes, said Almirall head of commercial operations Vincent Cerio.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,700+ biopharma pros reading Endpoints daily — and it's free.

Pfiz­er and CD­MOs ramp up Paxlovid man­u­fac­tur­ing with Kala­ma­zoo plant ex­pan­sion lead­ing the way

As the Covid-19 pandemic continues to evolve, pharma companies and manufacturers are exploring how to step up production on antivirals.

Pfizer is planning to expand its Kalamazoo-area facility to increase manufacturing capabilities for the oral Covid-19 antiviral Paxlovid, according to a report from Michigan-based news site MLive. The expansion of the facility, which serves as Pfizer’s largest manufacturing location, is expected to create hundreds of “high-skilled” STEM jobs, MLive reported. No details about the project’s cost and timeline have been released, but according to MLive, Pfizer will announce the details of the expansion at some point in early June.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,700+ biopharma pros reading Endpoints daily — and it's free.

FDA spells out the rules and re­stric­tions for states seek­ing to im­port drugs from Cana­da

The FDA is offering more of an explanation of the guardrails around its program that may soon allow states to import prescription drugs in some select circumstances from Canada, but only if such imports will result in significant cost reductions for consumers.

While the agency has yet to sign off on any of the 5 state plans in the works so far, and PhRMA’s suit to block the Trump-era rule allowing such imports is stalled, the new Q&A guidance spells out the various restrictions that states will have to abide by, potentially signaling that a state approval is coming.