Gur­net Point-backed Boston Phar­ma­ceu­ti­cals su­per­charges pipeline with twin deals grab­bing top cast-offs from GSK, No­var­tis

The ex­ec­u­tive crew at Boston Phar­ma­ceu­ti­cals has been busy.

In one 48-hour stretch they com­plet­ed two big in-li­cens­ing deals with a pair of the world’s phar­ma gi­ants — No­var­tis and GSK — which will dou­ble the size of their clin­i­cal pipeline with 4 new ther­a­pies and a slate of late-pre­clin­i­cal ef­forts that should bring the to­tal num­ber of pro­grams in hu­man tri­als to a dozen by the end of next year.

In the process, they’ve been adding just slight­ly to the small team at the com­pa­ny, which was gift­ed with a $600 mil­lion bankroll by Gur­net Point Cap­i­tal, whose chief — ex-Sanofi CEO Chris Viehbach­er — stepped in as chair­man of the board.

Right now, the staff tal­ly is just un­der 30, says Rob Arm­strong, the Eli Lil­ly vet who runs the com­pa­ny. 

They’ve al­ready divvied up these new as­sets, which in­cludes some of the top pro­grams out of No­var­tis’ trans­la­tion­al med group NI­BR, which punt­ed its an­tibac­te­r­i­al and an­tivi­ral re­search pro­grams in Emeryville, CA. last Ju­ly. For GSK, the drugs in­clude a se­lec­tion from the 30 ther­a­pies that CEO Em­ma Walm­s­ley put on the auc­tion block as she cleaned house ahead of an R&D re­vamp.

There are no num­bers in this deal, though Arm­strong notes that No­var­tis end­ed up tak­ing some eq­ui­ty in a sub­sidiary built for the deal, along with an up­front and mile­stones and a roy­al­ty sched­ule. As for GSK, he’s just not say­ing — though typ­i­cal­ly Big Phar­ma doesn’t ask for a lot of cash for the drugs it casts off from time to time. In GSK’s case, they all but hand­ed off their gene ther­a­py work, look­ing on­ly for a con­tin­ued fi­nan­cial in­ter­est.

In this case Boston Phar­ma’s haul in­cludes:

  • GSK3352589, a small mol­e­cule RET in­hibitor ready for a Phase II tri­al in ir­ri­ta­ble bow­el syn­drome with di­ar­rhea.
  • GSK3008356, a DGAT 1 drug that is be­ing re­pur­posed from NASH to ac­ne.
  • GSK3183475, a BET BD2 “which as a top­i­cal for­mu­la­tion has ther­a­peu­tic po­ten­tial to treat vi­tili­go and/or pso­ri­a­sis and is Phase 1-ready. “

On the No­var­tis side they are gain­ing:

  • LYS228, which Boston Phar­ma­ceu­ti­cals be­lieves is a po­ten­tial best-in-class monobac­tam in Phase II clin­i­cal de­vel­op­ment that has “demon­strat­ed ac­tiv­i­ty against CRE with re­sis­tance caused by ser­ine be­ta-lac­ta­mases (SBLs) and/or met­al­lo be­ta-lac­ta­mases (MBLs).”
  • IID572, a nov­el be­ta-lac­ta­mase in­hibitor that may be used in com­bi­na­tion with LYS228 or oth­er be­ta-lac­tam an­tibi­otics to ex­pand their use against dif­fi­cult-to-treat in­fec­tions caused by a broad­er spec­trum of CRE.
  • MAK181, an oral, first-in-class LpxC in­hibitor for Pseudomonas in­fec­tions.

“This is part of a longterm strat­e­gy,” ven­tures a cau­tious Arm­strong, forged 3 years ago when they set out to build a pipeline with 20 drugs in it. “This is a very lean trans­la­tion­al med­i­cine plat­form.” 

Keep­ing the team small, while re­ly­ing on a sup­port­ing cast of out­side ex­perts to han­dle a lot of the load — was al­ways part of that game plan. With top ex­ecs com­ing out of com­pa­nies like Lil­ly and Sanofi, Boston Phar­ma­ceu­ti­cals likes the agili­ty of a small, ex­tra­or­di­nar­i­ly well fi­nanced com­pa­ny. And it doesn’t sound like they’re blow­ing any of the ex­cess on par­ties and danc­ing girls.

Al­so part of the game plan: They are cov­er­ing the wa­ter­front on dis­eases and drugs, se­lect­ing from a broad range to come up with the ther­a­pies they like. One um­brel­la team cov­ers every­thing — there’s on­ly one CMO at the com­pa­ny — and they’re steer­ing clear of busi­ness mod­els like Roivant, which is es­tab­lish­ing ful­ly staffed com­pa­nies un­der the guid­ance of the moth­er ship.

Long term, the group plans to start sell­ing off most of its as­sets ahead of Phase III, or in late-stage de­vel­op­ment if that makes sense.

Oth­ers can do the com­mer­cial work, once the biotech has plumbed the full val­ue of what’s there.

Im­age: Rob Arm­strong File Pho­to

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

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.

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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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.

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.

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.

Boston skyline (Shutterstock)

Boston, the Bay Area and San Diego dom­i­nate the life sci­ences re­al es­tate mar­ket. Where to next?

With strong competition for life sciences real estate in key clusters — greater Boston, San Francisco and San Diego — where will the industry look to expand next? That’s the question that real estate company JLL sought to answer in its latest report, released on Wednesday.

JLL scored US biotech hubs on a variety of criteria to come up with this year’s ranking, including talent, industry depth, innovation and lab real estate dynamics. Unsurprisingly, they found that last year’s top three clusters remain unchanged. JLL predicts that these core clusters will be “immovable” for the foreseeable future, comparing them to the Silicon Valley of biotech.

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Skin tu­mors in mice force Pro­tag­o­nist to halt lead pro­gram, crush­ing stock

Protagonist Therapeutics just can’t catch a break.

Six months after the Newark, CA-based biotech unveiled grand plans to launch its lead candidate for blood disorders into a Phase III trial, the FDA has slapped the program with a clinical hold. The halt — which applies to all trials involving the candidate, rusfertide — comes after skin tumors were discovered in mice treated with the drug, according to Protagonist.

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