Neil Kumar, BridgeBio CEO

A week af­ter dis­clos­ing lay­offs, Bridge­Bio nets a $90M up­front can­cer R&D pact with Bris­tol My­ers

Bridge­Bio has lo­cat­ed the bridge to green­er pas­tures, specif­i­cal­ly the lav­ish pur­ple of Bris­tol My­ers Squibb.

The two are col­lab­o­rat­ing in a deal giv­ing the re­or­ga­nized biotech an up­front pay­ment of $90 mil­lion, a cap­i­tal in­fu­sion that comes a week af­ter the Pa­lo Al­to, CA biotech dis­closed $23 to $25 mil­lion in re­struc­tur­ing-re­lat­ed costs. That move al­so in­clud­ed the out-li­cens­ing of six pro­grams, a round of lay­offs, con­sol­i­da­tion of fa­cil­i­ties and oth­er ac­tiv­i­ties in a ma­jor re-route.

A deal with BMS might get Bridge­Bio back on track af­ter a ma­jor Phase III set­back last year for aco­ramidis, a drug meant to slow the pro­gres­sion of the rare dis­ease TTR amy­loi­do­sis. The duo will work to­geth­er on BBP-398, an SHP2 in­hibitor, for var­i­ous on­col­o­gy pro­grams. The in­hibitor is thought to con­tribute to var­i­ous can­cers, be a source of re­sis­tance to tar­get­ed ther­a­pies and play a role in sup­press­ing im­mu­ni­ty to tu­mors.

The $90 mil­lion is just a small chunk of the over­all $905 mil­lion that Bridge­Bio can pull in from the part­ner­ship, should all mile­stones play out, and more in low- to mid-teens tiered roy­al­ties if the drug makes it to mar­ket. The two linked arms last sum­mer on the in­ves­ti­ga­tion­al can­cer treat­ment, with a non-ex­clu­sive, co-fund­ed clin­i­cal col­lab­o­ra­tion to pair up BBP-398 with BMS’ Op­di­vo in pa­tients with ad­vanced sol­id tu­mors with KRAS mu­ta­tions.

Bridge­Bio will con­tin­ue lead­ing those on­go­ing Phase I monother­a­py and com­bo treat­ment stud­ies. Fol­low­ing those tri­als, BMS will take over fi­nanc­ing for all oth­er de­vel­op­ment and com­mer­cial work, the com­pa­nies said Thurs­day. If Bridge­Bio wants high­er roy­al­ties, though, it could opt in to fund part of the de­vel­op­ment costs once reg­is­tra­tional stud­ies kick in­to gear.

Ru­pert Vessey

“We have seen the po­ten­tial role SHP2 in­hi­bi­tion could play in un­lock­ing pos­si­ble com­bi­na­tion ther­a­pies to treat pa­tients suf­fer­ing from a range of can­cers. We are hope­ful this col­lab­o­ra­tion with Bridge­Bio will help us max­i­mize the pos­si­bil­i­ties SHP2 in­hi­bi­tion with BBP-398 will hold for pa­tients,” said Ru­pert Vessey, BMS EVP of re­search and ear­ly de­vel­op­ment, in a press re­lease.

The drug was found­ed through a col­lab­o­ra­tion with the Uni­ver­si­ty of Texas MD An­der­son Can­cer Cen­ter. Lian­Bio and Bridge­Bio have teamed up on the drug, as well, for the treat­ment’s de­vel­op­ment and com­mer­cial­iza­tion in main­land Chi­na and oth­er re­gions of Asia. Those stud­ies re­volve around non-small cell lung can­cer and col­orec­tal and pan­cre­at­ic can­cer. The drug is al­so part of a com­bo test with Am­gen’s Lumakras for ad­vanced sol­id tu­mors with KRASG12C mu­ta­tions.

In ad­di­tion to the lay­offs and fa­cil­i­ty down­siz­ing an­nounced last week dur­ing earn­ings, Bridge­Bio said it wants to out-li­cense six pro­grams: two clin­i­cal-stage drugs, two pre­clin­i­cal AAV gene ther­a­pies and two oth­er pre-hu­man tri­al as­sets.

Bay­er sounds re­treat from a $670 mil­lion CAR-T pact in the wake of a pa­tient death

Two months after Atara Biotherapeutics hit the hold button on its lead CAR-T 2.0 therapy following a patient death, putting the company under the watchful eye of the FDA, its Big Pharma partners at Bayer are bowing out of a $670 million global alliance. And the move is forcing a revamp of Atara’s pipeline plans, even as research execs vow to continue work on the two drugs allied with Bayer 18 months ago, which delivered a $60 million cash upfront.

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Op­ti­miz­ing Cell and Gene Ther­a­py De­vel­op­ment and Pro­duc­tion: How Tech­nol­o­gy Providers Like Corn­ing Life Sci­ences are Spurring In­no­va­tion

Remarkable advances in cell and gene therapy over the last decade offer unprecedented therapeutic promise and bring new hope for many patients facing diseases once thought incurable. However, for cell and gene therapies to reach their full potential, researchers, manufacturers, life science companies, and academics will need to work together to solve the significant challenges facing the industry.

Amid mon­key­pox fears, biotechs spring to ac­tion; Mod­er­na’s CFO trou­ble; Cuts, cuts every­where; Craft­ing the right pro­teins; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

It’s always a bittersweet moment saying goodbye, but as Josh Sullivan goes off to new adventures we are grateful for the way he’s built up the Endpoints Manufacturing section — which the rest of the team will now carry forward. If you’re not already, this may be a good time to sign up for your weekly dose of drug manufacturing news. Thank you for reading and wish you a restful weekend.

Sanofi and Re­gen­eron clear the fin­ish line in an in­flam­ma­to­ry esoph­a­gus dis­ease, leav­ing Take­da in the dust

With atopic dermatitis rivals breathing down Dupixent’s neck, Sanofi and Regeneron on Friday secured a first win in new territory in what Sanofi’s head of immunology and inflammation Naimish Patel called the fastest approval he’s ever seen.

The FDA approved Dupixent on Friday to treat patients 12 years and older with eosinophilic esophagitis (EoE), an inflammatory condition that causes swelling and scarring of the esophagus. The approval came just a couple months after regulators granted Dupixent priority review, and months ahead of its PDUFA date on Aug. 3.

Fu­ji­film con­tin­ues its biotech build­ing spree with new fa­cil­i­ty in Chi­na

A Japanese conglomerate is making a big play in China with the opening of a new facility, as it continues to expand.

Fujifilm Irvine Scientific has opened its new Innovation and Collaboration Center in Suzhou New District, China, an area in Jiangsu province specifically designated for technological and industrial development.

According to Fujifilm, the 12,000-square-foot site will be responsible for the company’s cell culture media optimization, analysis and design services. Cell culture media itself often requires customization of formulas and protocols to achieve the desired quantity and quality of therapeutic desired. Fujifilm Irvine Scientific is offering these services from its headquarters in California and Japan to its customers globally, as well as in China now.

Try­ing to shake up the Parkin­son's par­a­digm, Ab­b­Vie sub­mits NDA for con­tin­u­ous, 24-hour in­fu­sion ther­a­py

AbbVie is approaching the FDA with a new therapy to potentially treat Parkinson’s disease, using prodrugs of two medications commonly used for the condition.

The Big Pharma submitted its NDA for ABBV-951, a solution of levodopa and carbidopa prodrugs being evaluated in advanced Parkinson’s patients who don’t respond well to oral therapy, AbbVie announced Friday morning. Researchers are hoping a positive Phase III study that reads out in late October will help move things along quickly at the agency.

Siddhartha Mukherjee (Brian Ach/Getty Images for The New Yorker)

All Blue's $733M bid to ac­quire Zymeworks turns hos­tile as board bat­tles back — af­ter a biotech celebri­ty jumps in

Yesterday, the team at All Blue Capital — bent on the takeover of a badly battered Zymeworks — brought in celebrated oncologist, Pulitzer prize-winning writer and biotech exec Siddhartha Mukherjee to add some glitz to their proposed board. But they’re still not winning over any converts.

This morning, Zymeworks’ board officially turned this acquisition offer into a hostile showdown, rejecting the unsolicited offer and marshaling its forces to prevent a buyout at $10.50 per share.

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Rob Etherington, Clene CEO

Mary­land of­fers loan to Clene de­spite ALS tri­al bumps

Even after Utah-based Clene failed to hit its primary endpoints for its ALS drug last year, the state of Maryland is putting its money at least behind Clene’s manufacturing facility.

The Maryland Board of Public Works has finalized a $3 million, 60-month loan facility with Clene Nanomedicine. The loan was provided by the state’s Neighborhood BusinessWorks program within the Maryland Department of Housing and Community Development.

Armon Sharei, SQZ founder and CEO

SQZ's out­side-the-box man­u­fac­tur­ing method slash­es pro­duc­tion time in ear­ly in study

At ASCO 2021 in June of last year, SQZ Biotech showcased a glimpse of its unorthodox cell therapy manufacturing tech. And on Wednesday, the Watertown, MA, company announced that its first-generation system showed comparable or better performance than a conventional clean-room-based manufacturing process.

The study was non-clinical. Clinical trials are expected by the first half of 2023.

SQZ’s device opens up a temporary window by cell-squeezing to deliver cargoes into cells. Its average processing time was less than six hours per batch, which is more than half the time than conventional methods. The company is planning to use the technology in its first red blood cell derived program for celiac disease. That IND is set to be submitted in the first half of 2023, the company said.