No­vo Nordisk to re­search oral obe­si­ty treat­ment; Dana-Far­ber taps in­to Har­bour Bio­Med's mice plat­form in mul­ti­year deal

No­vo Nordisk and Lu­men Bio­science have en­tered a re­search col­lab­o­ra­tion to ex­plore R&D and man­u­fac­tur­ing with­in obe­si­ty and oth­er meta­bol­ic dis­or­ders, the com­pa­nies an­nounced Wednes­day.

The col­lab­o­ra­tion builds off of re­search sur­round­ing an oral­ly de­liv­ered drug for the GI tract that can be man­u­fac­tured with more scal­a­bil­i­ty and af­ford­abil­i­ty than a typ­i­cal small-mol­e­cule drug. The ini­tial stages of re­search will last about a year, and the 2 com­pa­nies will de­vel­op mol­e­cules us­ing spir­uli­na, a type of cyanobac­te­ria.

“No­vo Nordisk is a world lead­ing meta­bol­ic dis­ease com­pa­ny, and we are thrilled that they share our en­thu­si­asm for new strate­gies for de­liv­er­ing oral bi­o­log­ics,” Lu­men’s CEO Bri­an Fin­row, said in a state­ment. “This col­lab­o­ra­tion brings the best of two worlds to­geth­er: Lu­men’s ex­per­tise in large-scale, af­ford­able man­u­fac­tur­ing of oral­ly de­liv­ered bi­o­log­ic drugs and No­vo Nordisk’s ex­per­tise in the clin­i­cal de­vel­op­ment and com­mer­cial­iza­tion of treat­ments for car­diometa­bol­ic dis­ease.”

Fi­nan­cial terms of the deal were not dis­closed. — Josh Sul­li­van

Dana-Far­ber taps in­to Har­bour Bio­Med’s mice plat­form in mul­ti­year deal

Har­bour Bio­Med has reached a mul­ti­year agree­ment with the Dana-Far­ber Can­cer In­sti­tute for the de­vel­op­ment of new CAR-T cell ther­a­pies and bis­pe­cif­ic an­ti­bod­ies in can­cer treat­ment, the com­pa­ny an­nounced Wednes­day.

The col­lab­o­ra­tion will com­bine Har­bour’s trans­genic mice plat­form with the ex­per­tise of Dana-Far­ber’s sci­en­tists in CAR-T cell de­vel­op­ment.

Har­bour used its mice plat­form and dis­cov­ered the an­ti­body 47D11 in 2019, which has since been li­censed out by Ab­b­Vie. In De­cem­ber, the com­pa­ny’s sci­en­tists said that the an­ti­body showed promise fight­ing Covid-19 and vari­ants of the virus.

The Har­bour mice pro­gram is based on two pro­pri­etary trans­genic mouse plat­forms that have the po­ten­tial for gen­er­at­ing bi and mul­ti-specifics, CAR-Ts or VH do­main de­liv­ered prod­ucts.

Er­ic Smith of the Dana-Far­ber Can­cer In­sti­tute said this in the press re­lease:

“We are de­light­ed to ini­ti­ate this col­lab­o­ra­tion with Har­bour Bio­Med. The com­ple­men­tary tech­nol­o­gy and ex­per­tise be­tween Har­bour and DF­CI will dra­mat­i­cal­ly short­en the in­ter­val from nov­el dis­cov­ery to de­vel­op­ing op­ti­mized an­ti­body and cel­lu­lar ther­a­pies for clin­i­cal trans­la­tion.” — Josh Sul­li­van

As it looks to boost ex­pan­sion in­to pet health, Elan­co ac­quires San Fran­cis­co-based pet ther­a­peu­tic com­pa­ny

Elan­co An­i­mal Health has an­nounced the ac­qui­si­tion of San Fran­cis­co-based Kin­dred Bio­sciences and with it, three “po­ten­tial block­busters in the de­vel­op­ment phase.”

All of Kin­dred­Bio’s out­stand­ing stock will be ac­quired at $9.25 a share, mak­ing the deal worth a to­tal of about $440 mil­lion. The com­pa­ny was found­ed in 2012, and brings three pro­grams that Elan­co calls po­ten­tial der­ma­tol­ogy block­busters that are ex­pect­ed to launch through 2025. Kin­dred­Bio al­so has a hand­ful of R&D pro­grams for chron­ic dis­or­ders and un­met needs, in­clud­ing ca­nine par­vovirus, a high­ly con­ta­gious virus that af­fects dogs’ gas­troin­testi­nal tract and spreads through con­t­a­m­i­nat­ed stool.

Elan­co be­lieves that the ac­qui­si­tion will add an­oth­er $100 mil­lion in rev­enue to its op­er­a­tions by 2025.

“This high­ly com­ple­men­tary com­bi­na­tion is fo­cused in one of the most ex­cit­ing spaces in pet health, and one where we see a strate­gic im­per­a­tive to build a dif­fer­en­ti­at­ed com­pet­i­tive of­fer­ing,” Jeff Sim­mons, pres­i­dent and CEO of Elan­co, said in a press re­lease. “It fur­ther ac­cel­er­ates our mix shift in­to pet health and ad­vances our IPP strat­e­gy.”

Elan­co and Kin­dred­Bio’s ex­ist­ing re­la­tion­ship be­gan when Kin­dred li­censed out the rights of its late-stage ca­nine par­vovirus treat­ment. — Josh Sul­li­van

Ab­Sci ac­quires an­ti­body play­er To­tient

A for­mer­ly un­known play­er that burst on­to the scene with a Gink­go Bioworks deal last Sep­tem­ber has found a new home. The an­ti­body-fo­cused start­up To­tient out of the Vi­va Biotech in­cu­ba­tor was ac­quired by Ab­Sci, the com­pa­nies an­nounced late Tues­day.

Fi­nan­cial terms of the deal were not dis­closed.

To­tient emerged from stealth in Sep­tem­ber with the Gink­go part­ner­ship, in which they are try­ing to turn their al­ter­nate means of gen­er­at­ing virus-neu­tral­iz­ing an­ti­bod­ies in­to a treat­ment that could po­ten­tial­ly treat or tem­porar­i­ly pre­vent Covid-19 in­fec­tion. The biotech de­rives its an­ti­bod­ies from what is known as ter­tiary lym­phoid struc­tures, or ac­cu­mu­la­tions of im­mune cells that can form in places of height­ened in­flam­ma­tion.

In a state­ment Tues­day, To­tient said it had re­con­struct­ed more than 4,500 an­ti­bod­ies from over 50,000 pa­tients. By com­bin­ing these with Ab­Sci’s plat­form, the pair are go­ing af­ter a new set of undis­closed dis­eases.

“We look for­ward to scal­ing our tar­get dis­cov­ery ca­pa­bil­i­ties to com­pre­hen­sive­ly de-or­phan an­ti­bod­ies and val­i­date new op­por­tu­ni­ties for drug de­vel­op­ment,” To­tient CEO Deniz Kur­al said in a state­ment.

The buy­out comes less than three months af­ter Ab­Sci com­plet­ed a $125 mil­lion crossover round and fol­lows a sim­i­lar ac­qui­si­tion of the AI com­pa­ny De­n­ovi­um back in Jan­u­ary. — Max Gel­man

What Will it Take to Re­al­ize the Promise and Po­ten­tial of Im­mune Cell Ther­a­pies?

What does it take to get to the finish line with a new cancer therapy – fast? With approvals in place and hundreds of immune cell therapy candidates in the pipeline, the global industry is poised to create a fundamental shift in cancer treatments towards precision medicine. At the same time, unique challenges associated with cell and process complexity present manufacturing bottlenecks that delay speed to market and heighten cost of goods sold (COGS) — these hurdles must be overcome to make precision treatments an option for every cancer patient. This series of articles highlights some of the key manufacturing challenges associated with the production of cell-based cancer therapies as well as the solutions needed to transcend them. Automation, process knowledge, scalability, and assured supply of high-quality starting material and reagents are all critical to realizing the full potential of CAR-based therapies and sustaining the momentum achieved in recent years. The articles will highlight leading-edge technologies that incorporate these features to integrate across workflows, accelerate timelines and reduce COGS – along with how these approaches are enabling the biopharmaceutical industry to cross the finish line faster with new treatment options for patients in need.

The biggest ques­tions fac­ing gene ther­a­py, the XLMTM com­mu­ni­ty, and Astel­las af­ter fourth pa­tient death

After three patients died last year in an Astellas gene therapy trial, the company halted the study and began figuring out how to safely get the program back on track. They would, executives eventually explained, cut the dose by more than half and institute a battery of other measures to try to prevent the same thing from happening again.

Then tragically, Astellas announced this week that the first patient to receive the new regimen had died, just weeks after administration.

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Lat­est news: It’s a no on uni­ver­sal boost­ers; Pa­tient death stuns gene ther­a­py field; In­side Tril­li­um’s $2.3B turn­around; and more

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Next week is shaping up to be a busy one, as our editor-in-chief John Carroll and managing editor Kyle Blankenship lead back-to-back discussions with a great group of experts to discuss the weekend news and trends. John will be spending 30 minutes with Jake Van Naarden, the CEO of Lilly Oncology, and Kyle has a brilliant panel lined up: Harvard’s Cigall Kadoch, Susan Galbraith, the new head of cancer R&D at AstraZeneca, Roy Baynes at Merck, and James Christensen at Mirati. Don’t miss out on the action — sign up here.

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Mi­rati's KRAS drug looks like the fa­vorite in colon can­cer with new da­ta, putting the pres­sure square on Am­gen

With Amgen already providing proof-of-concept for KRAS inhibitors with its sotorasib, Mirati Therapeutics is piecing together a follow-up effort in lung cancer with data it thinks are superior. But in colon cancer, where solo sotorasib has turned in a dud, Mirati may now have a strong case for superiority.

Mirati’s adagrasib, dosed solo or in combination with chemotherapy cetuximab, showed response rates grater than sotorasib solo  and as part of combination study in a similar patient population also revealed this week at #ESMO21. Mirati’s data were presented as part of a cohort update from the Phase II KRYSTAL-1 study testing adagrasib in a range of solid tumors harboring the KRAS-G12C mutation.

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President Biden and Pfizer CEO Albert Bourla (Patrick Semansky/AP Images)

Chaot­ic ad­comm sees Pfiz­er/BioN­Tech boost­ers re­ject­ed for gen­er­al pop­u­la­tion, but rec­om­mend­ed for old­er and high-risk pop­u­la­tions

With just days before President Joe Biden’s Covid-19 booster rollout is set to go into effect, an FDA advisory committee appeared on the verge of not recommending boosters for anyone in the US before a last-minute change of wording laid the groundwork for older adults to have access to a third dose.

The FDA’s adcomm on Vaccines and Related Biological Products (VRBPAC) roundly rejected Pfizer/BioNTech booster shots for all individuals older than 16 by a 16-2 vote Friday afternoon. Soon after, however, the agency posed committee members a new question limiting booster use to the 65-and-older population and individuals at high risk of disease due to occupational exposure or comorbidities.

The best of the rest: High­lights from the be­low-the-fold pre­sen­ta­tions at #ES­MO21

This year’s ESMO Congress has had a major focus on Big Pharma drugs — most notably candidates from Merck and AstraZeneca — but there have also been updates from smaller biotechs with data looking to challenge the big-name drugmakers.

Today, we’re highlighting some of the data releases that flew under the radar at #ESMO21 — whether from early-stage drugs looking to make a mark or older stalwarts with interesting follow-up data.

As­traZeneca, Dai­ichi Sanky­o's ADC En­her­tu blows away Roche's Kad­cy­la in sec­ond-line ad­vanced breast can­cer

AstraZeneca and Japanese drugmaker Daiichi Sankyo think they’ve struck gold with their next-gen ADC drug Enhertu, which has shown some striking data in late-stage breast cancer trials and early solid tumor tests. Getting into earlier patients is now the goal, starting with Enhertu’s complete walkover of a Roche drug in second-line breast cancer revealed Saturday.

Enhertu cut the risk of disease progression or death by a whopping 72% (p=<0.0001) compared with Roche’s ADC Kadcyla in second-line unresectable and/or metastatic HER2-positive breast cancer patients who had previously undergone treatment with a Herceptin-chemo combo, according to interim data from the Phase III DESTINY-Breast03 head-to-head study presented at this weekend’s #ESMO21.

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Merck Research Laboratories CMO Roy Baynes

Mer­ck­'s Keytru­da un­corks full da­ta on lat­est ad­ju­vant win — this time in melanoma — adding bricks to ear­ly can­cer wall

In recent months, the battle for PD-(L)1 dominance has spilled over into early cancer with Merck’s Keytruda and Bristol Myers Squibb’s Opdivo all alone on the front lines. Keytruda now has another shell in its bandolier, and it could spell a quick approval.

Keytruda cut the risk of relapse or death by 35% over placebo (p=0.00658) in high-risk, stage 2 melanoma patients who had previously undergone surgery to remove their tumors, according to full data from the Phase III KEYNOTE-716 presented Saturday at #ESMO21.

Mer­ck flesh­es out Keytru­da win in first-line cer­vi­cal can­cer, adding more fire­pow­er to its ear­ly can­cer push

Merck has worked hard to bring its I/O blockbuster Keytruda into earlier and earlier lines of therapy, and now the wonder drug appears poised to make a quick entry into early advanced cervical cancer.

A combination of Keytruda and chemotherapy with or without Roche’s Avastin cut the risk of death by 33% over chemo with or without Avastin (p=<0.001) in first-line patients with persistent, recurrent or metastatic cervical cancer, according to full data from the Phase III KEYNOTE-826 study presented Saturday at #ESMO21.