Bris­tol-My­ers beefs up big can­cer drug pipeline, buy­ing IFM drugs in $2.3B-plus deal

Gary Glick, cred­it: Uni­ver­si­ty of Michi­gan

At­las Ven­ture has an­oth­er block­buster biotech flip to boast about — while keep­ing an up­start in the port­fo­lio. And it’s a big one.

Just a lit­tle more than a year af­ter the At­las-in­cu­bat­ed IFM Ther­a­peu­tics achieved liftoff with a $27 mil­lion A round, with a co-lead in­vest­ment from Abing­worth, Bris­tol-My­ers Squibb has stepped in with a buy­out. Bris­tol-My­ers re­searchers are now carv­ing out the work the biotech has done on two pro­grams pro­mot­ing an in­nate im­mune re­sponse to can­cer, and spin­ning out the sig­nif­i­cant re­main­der in­to a new com­pa­ny al­so helmed by IFM co-founder Gary Glick.

To com­plete the deal, Bris­tol-My­ers is pay­ing a whop­ping $300 mil­lion up­front, with a lit­tle more than $1 bil­lion in mile­stones on each of the pre­clin­i­cal pro­grams. And there’s an un­spec­i­fied pay­ment due to se­cure an op­tion on one of its in­nate im­mune sys­tem pro­grams that al­so caught the bio­phar­ma’s eye as well as more biobucks for any oth­er drugs the are de­vel­oped out of the tech­nol­o­gy.

IFM was aimed at a prime tar­get when it jumped in­to view last sum­mer. The two lead can­cer projects look to use small mol­e­cules to ac­ti­vate NL­RP3 and STING, revving up in­nate im­mune re­spons­es that can play a com­ple­men­tary role with adap­tive im­mune ther­a­pies, like Bris­tol-My­ers’ big PD-1 drug Op­di­vo, which thwart a mech­a­nism can­cer cells use to evade an at­tack by im­mune sys­tem T cells. In­nate im­mu­ni­ty at­tacks as an im­me­di­ate guard — or first line of de­fense — against an in­vad­ing pathogen, and among oth­er things can re­cruit cells to the fight.

The biotech now will go on to con­cen­trate on the flip side of that coin: Rein­ing back in­nate im­mune at­tacks, tamp­ing down cy­tokine pro­duc­tion and re­duce chron­ic in­flam­ma­tion tied to au­to-in­flam­ma­to­ry con­di­tions like NASH, IBD and gout. And that work in­cludes NL­RP3 and some re­lat­ed mem­bers of the NLR fam­i­ly.

It’s that NL­RP3 an­tag­o­nist that Bris­tol-My­ers wants an op­tion on.

Thomas Lynch

Bris­tol-My­ers is pay­ing more than 10 times the A-round in cash for this com­pa­ny, which will not go un­no­ticed in At­las cir­cles to­day. At­las part­ner Jean-François Formela was chair­man of the com­pa­ny.

For Bris­tol-My­ers, which is look­ing to reignite its once-dom­i­nant check­point ef­fort, it rep­re­sents an­oth­er op­por­tu­ni­ty to steal a march against a slew of ri­vals all look­ing to sec­ond- and third-gen­er­a­tion tie-ups as they an­gle to keep and grow a ma­jor seg­ment of the mar­ket. Its busi­ness de­vel­op­ment group un­der Paul Bion­di has a cold and steady eye when it comes to tech deals, look­ing for ways to gain an ad­van­tage in core fields through this kind of ex­ter­nal ac­qui­si­tion.

“Tar­get­ing in­nate im­mu­ni­ty path­ways rep­re­sents a po­ten­tial­ly dif­fer­en­ti­at­ed ap­proach in im­muno-on­col­o­gy de­signed to ini­ti­ate and aug­ment im­mune re­spons­es that may help the body’s nat­ur­al de­fens­es bet­ter rec­og­nize and at­tack tu­mors,” said Thomas Lynch, ex­ec­u­tive vice pres­i­dent, chief sci­en­tif­ic of­fi­cer, Bris­tol-My­ers Squibb. “The ad­di­tion of STING and NL­RP3 ag­o­nist pro­grams broad­ens our abil­i­ty to in­ves­ti­gate ad­di­tion­al path­ways across the im­mune sys­tem and com­ple­ments our im­muno-on­col­o­gy port­fo­lio. We look for­ward to ad­vanc­ing the de­vel­op­ment of these im­por­tant pro­grams ini­ti­at­ed by Gary Glick, his lead­er­ship team and lead­ing aca­d­e­m­ic and in­dus­try ex­perts across im­munol­o­gy and on­col­o­gy.”

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to clinicaltrials.gov, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

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FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

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Brii Biosciences said it will stop manufacturing its Covid-19 antibody combination, sold in China, and is working to withdraw its emergency use authorization request in the US, which it started in October 2021.

The Beijing and North Carolina biotech commercially launched the treatment in China last July but is now axing the work and reverting resources to other “high-priority programs,” per a Friday update. The focus now is namely hepatitis B viral infection, postpartum depression and major depressive disorders.

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FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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Sijmen de Vries, Pharming CEO

FDA ap­proves Pharm­ing drug for ul­tra-rare im­mun­od­e­fi­cien­cy dis­ease

US regulators cleared an ultra-rare drug from Pharming Group, by way of Novartis, on Friday afternoon.

The Dutch biotech said the FDA greenlit leniolisib for an immunodeficiency disease known as activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome, or APDS. People 12 years and older can receive the oral drug, to be marketed as Joenja, beginning early next month, Pharming said, five days ahead of the decision deadline set by the FDA as part of a priority review.

Eu­ro­pean doc­tors di­al up dig­i­tal com­mu­ni­ca­tion with phar­mas, but still lean to­ward in-per­son med meet­ings, study finds

As in-person sales rep access declines in the big five European countries, a corresponding uptick in virtual rep access is happening. It’s not surprising, but it does run counter to pharma companies’ assessment – along with long-held sales rep sway in Europe – that in-person access hadn’t changed.

CMI Media Group and Medscape’s recent study reports that 75% of physicians in the EU5 countries of Spain, Germany, Italy, France and the UK already limit engagements with pharma sales reps, and 25% of those surveyed plan to decrease time with reps.

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