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.”

The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

Onno van de Stolpe, Galapagos CEO (Thierry Roge/Belga Mag/AFP via Getty Images)

Gala­pa­gos chops in­to their pipeline, drop­ping core fields and re­or­ga­niz­ing R&D as the BD team hunts for some­thing 'trans­for­ma­tive'

Just 5 months after Gilead gutted its rich partnership with Galapagos following a bitter setback at the FDA, the Belgian biotech is hunkering down and chopping the pipeline in an effort to conserve cash while their BD team pursues a mission to find a “transformative” deal for the company.

The filgotinib disaster didn’t warrant a mention as Galapagos laid out its Darwinian restructuring plans. Forced to make choices, the company is ditching its IPF molecule ’1205, while moving ahead with a Phase II IPF study for its chitinase inhibitor ’4617.

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Stéphane Bancel, Getty

Mod­er­na CEO brush­es off US sup­port for IP waiv­er, eyes more than $19B in Covid-19 vac­cine sales in 2021

Moderna is definitively more concerned with keeping pace with Pfizer in the race to vaccinate the world against Covid-19 than it is with Wednesday’s decision from the Biden administration to back an intellectual property waiver that aims to increase vaccine supplies worldwide.

In its first quarter earnings call on Thursday, Moderna CEO Stéphane Bancel shrugged off any suggestion that the newly US-backed intellectual property waiver would impact his company’s vaccine or bottom line. Still, the company’s stock price fell by about 9% in early morning trading.

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'Chang­ing the whole game of drug dis­cov­ery': Leg­endary R&D vet Roger Perl­mut­ter leaps back in­to work as a biotech CEO

Roger Perlmutter needs no introduction to anyone remotely involved in biopharma. As the R&D chief first at Amgen and then Merck, he’s built a stellar reputation and a prolific career steering new drugs toward the market for everything from cancer to infectious diseases.

But for years, he’s also held a less known title: science partner at The Column Group, where he’s regularly consulted about the various ideas the VCs had for new startups.

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Ad­comm splits slight­ly in fa­vor of FDA ap­prov­ing Chemo­Cen­tryx’s rare dis­ease drug

The FDA’s Arthritis Advisory Committee on Thursday voted 10 for and 8 against the approval of ChemoCentryx’s $CCXI investigational drug avacopan as a treatment for adults with a rare and serious disease known as anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis.

The vote on whether the FDA should approve the drug was preceded by a split vote of 9 to 9 on whether the efficacy data support approval, and 10 to 8 that the safety profile of avacopan is adequate enough to support approval.

Drug pric­ing watch­dog joins the cho­rus of crit­ics on Bio­gen's ad­u­canum­ab: What about charg­ing $2,560 per year?

As if Biogen’s aducanumab isn’t controversial enough, the researchers at drug pricing watchdog ICER have drawn up the contours of a new debate: If the therapy does get approved for Alzheimer’s by June, what price should it command?

Their answer: At most $8,290 per year — and perhaps as little as $2,560.

Even at the top of the range, the proposed price is a fraction of the $50,000 that Wall Street has reportedly come to expect (although RBC analyst Brian Abrahams puts the consensus figure at $11.5K). With critics, including experts on the FDA’s advisory committee, making their fierce opposition to aducanumab’s approval loud and clear, the pricing pressure adds one extra wrinkle Biogen CEO Michel Vounatsos doesn’t need as he orders full-steam preparation for a launch.

Biden ad­min­is­tra­tion backs a po­lar­iz­ing pro­pos­al to waive IP for all Covid-19 vac­cines

In a surprise U-turn, the Biden administration said Wednesday that it will support a proposal at the World Trade Organization to temporarily waive intellectual property protections on Covid-19 vaccines.

The proposal, backed by South Africa and India at the WTO, seeks to help developing countries with limited vaccine supplies. The US and Europe historically opposed the proposal, saying IP should be protected because it incentivizes new drug and vaccine development.

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FDA ex­tends re­search agree­ment with MIT-li­censed or­gan-on-chip sys­tems

The FDA on Wednesday extended its four-year agreement with CN Bio, a developer of single- and multi-organ-on-chip systems used for drug discovery, for another three years.

CN Bio said the scope of the research performed by the FDA’s Center for Drug Evaluation and Research has expanded to include the exploration of the company’s lung-on-a-chip system to help with the agency’s evaluation of inhaled drugs, in addition to the agency’s work on its liver model.

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In quest to meet user fee goals, FDA’s per­for­mance con­tin­ues down­ward trend

A recent update to the FDA’s running tally of how it’s meeting its user fee-related performance goals during the pandemic shows an agency that is not out of the woods yet.

The latest numbers reveal that for a second straight quarter in 2021, the FDA has met its user fee goal dates for 93% of original new drug applications, which compares with 94% and 98% for the previous two quarters in 2020, respectively.

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