Bris­tol-My­ers part­ners with Park­er In­sti­tute, CRI on a next-gen twist on trans­la­tion­al R&D


Bris­tol-My­ers Squibb is team­ing up with the grow­ing vir­tu­al net­work of sci­en­tists at the Park­er In­sti­tute for Can­cer Im­munother­a­py to ex­pand its fo­cus on an al­ready thick pipeline of im­muno-on­col­o­gy pro­grams.

The 300-plus sci­en­tists who make up the Park­er In­sti­tute — the non­prof­it set up by Face­book mogul Sean Park­er — will now see their prover­bial tool­box grow as Bris­tol-My­ers kicks in on a three-way pact that al­so in­cludes the Can­cer Re­search In­sti­tute. And a top re­searcher at Park­er says that this is just the first of many such in­dus­try col­lab­o­ra­tions, as Park­er’s group looks to ramp up trans­la­tion­al work on a range of new can­cer drugs.

“This would be one of oth­er part­ner­ships we are plan­ning to do,” says Ramy Ibrahim, the vice pres­i­dent of clin­i­cal de­vel­op­ment at the in­sti­tute. The pur­pose, he says, is to “cre­ate a tool­box that our sci­en­tists can reach in­to and use in their tool­box,” which will in­clude nov­el ther­a­peu­tics that can be mixed and matched in ear­ly stage stud­ies aimed at iden­ti­fy­ing spe­cif­ic sub­pop­u­la­tions of pa­tients who could ben­e­fit from new com­bos.

The part­ners are keep­ing the fi­nan­cial de­tails of each of these new agree­ments un­der wraps, but Ibrahim tells me that com­pa­nies like Bris­tol-My­ers — which has in­vest­ed heav­i­ly in mak­ing it­self in­to a leader in the field with their check­point Op­di­vo — are asked to com­mit to $15 mil­lion to $20 mil­lion apiece to fund the work ahead.

For small­er biotechs who may be look­ing at new com­bi­na­tions for se­lect as­sets in the pipeline, there wouldn’t be any need for sim­i­lar fund­ing.

Bris­tol-My­ers is just get­ting start­ed in the part­ner­ship, Ibrahim adds, but there are al­ready talks un­der way about a po­ten­tial study that could go in­to the clin­ic. These three play­ers will re­main flex­i­ble on who’s fund­ing the work, he says, with com­mit­ments that could range any­where from 0% to 100%, de­pend­ing on the tri­al.

Park­er In­sti­tute wants to be clear that these arrange­ments are in­tend­ed to ac­cel­er­ate ear­ly re­search work and iden­ti­fy promis­ing new ap­proach­es. Any reg­is­tra­tion work would be up to the com­pa­nies, says Ibrahim, adding that to late-stage stud­ies could al­so lead to new part­ner­ship deals be­tween com­pa­nies.

The Park­er In­sti­tute, he says, will re­main out of com­mer­cial­iza­tion.

“Bris­tol-My­ers Squibb is ini­ti­at­ing this unique col­lab­o­ra­tion with a goal to ac­cel­er­at­ing the iden­ti­fi­ca­tion and de­vel­op­ment of new treat­ment op­tions for pa­tients who are fac­ing very se­ri­ous dis­ease,” said Fouad Namouni, head of on­col­o­gy de­vel­op­ment for Bris­tol-My­ers Squibb.

Robert Bradway (Photographer: Scott Eisen/Bloomberg via Getty Images)

UP­DAT­ED: Am­gen snaps up can­cer drug play­er Five Prime, adding PhI­II-ready FGFR2b drug in $2B M&A play

Amgen is making a long-awaited move on the M&A side, buying South San Francisco-based Five Prime $FPRX for close to $2 billion and adding a slate of new cancer drugs to the pipeline.

Amgen is paying $38 a share, putting the deal value at $1.9 billion. The stock closed at $21.26 last night, giving investors a 78% premium.

The jewel in the crown of this deal is bemarituzumab, which Amgen describes as a first-in-class, Phase III-ready anti-FGFR2b antibody. Amgen was drawn to the bargaining table by Five Prime’s mid-stage data on gastric cancer, satisfied by PFS and OS data helping to validate FGFR2b as a target. Amgen researchers will now expand on the R&D program in other epithelial cancers, including lung, breast, ovarian and other cancers.

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David Liu (Casey Atkins Photography courtesy Broad Institute)

David Liu has a new big idea: pro­teome edit­ing. It could one day shred tau, RAS and some of the worst dis­ease-caus­ing pro­teins

Before David Liu became famous for inventing new forms of gene editing, he was known around academia in part for a more obscure innovation: a Rube Goldberg-esque system that uses bacteria-infecting viruses to take one protein and turn it into another.

Since 2011, Liu’s lab has used the system, called PACE, to dream up fantastical new proteins: DNA base editors far more powerful than the original; more versatile forms of the gene editor Cas9; insecticides that kill insecticide-resistant bugs; enzymes that slide synthetic amino acids into living organisms. But they struggled throughout to master one of the most common and powerful proteins in the biological world: proteases, a set of Swiss army knife enzymes that cut, cleave or shred other proteins in everything from viruses to humans.

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The 2021 top 100 bio­phar­ma in­vestors: As the pan­dem­ic hit and IPOs boomed, VCs swung in­to ac­tion like nev­er be­fore

The global pandemic may have roiled economies, killed hundreds of thousands and throttled entire industries, but the only effect it had on biopharma venture investing was to help turbocharge the field to giddy new heights.

Below you’ll find the new top 100 venture investors in the industry, ranked by the number of deals they were publicly involved in, as tracked by DealForma chief Chris Dokomajilar. The numbers master then calculated the estimated amount of money they put into each deal — divvying up the cash by the number of players — to indicate how they managed their syndicates.

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Eli Lil­ly claims a TKO in its long-run­ning ti­tle fight with No­vo Nordisk for the block­buster di­a­betes mar­ket — but there’s a hitch

Eli Lilly isn’t just gunning for a better diabetes drug in tirzepatide. They want to cut ahead of Novo Nordisk’s blockbuster rival Ozempic (semaglutide) on the obesity front as well. But a newly-claimed win in a head-to-head Phase III showdown over reducing A1C while shedding pounds — complete with clear evidence of superiority over the approved rival — could prove a tough sell right now.

Let’s start with the latest data from Lilly.

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Hal Barron, Endpoints UKBIO19

GSK, Vir's hopes for a Covid-19 an­ti­body fall flat in NIH 'mas­ter pro­to­col' with no ben­e­fit in hos­pi­tal­ized pa­tients

GlaxoSmithKline and Vir Biotechnology were hopeful that one of their partnered antibodies would carve out a win after getting the invite to a major NIH study in hospitalized Covid-19 patients. But just like Eli Lilly, the pair’s drug couldn’t hit the mark, and now they’ll be left to take a hard look at the game plan.

The NIH has shut down enrollment for GSK and Vir’s antibody VIR-7831 in its late-stage ACTIV-3 trial after the drug showed negligible effect in achieving sustained recovery in hospitalized Covid-19 patients, the partners said Wednesday.

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As Brain­Storm con­tin­ues to tout ‘clear sig­nal’ on ALS drug, the FDA of­fers a rare pub­lic slap­down on the da­ta

A little more than a week after BrainStorm acknowledged that regulators at the FDA had informed them that the biotech needed more data before it could expect to gain an approval for its ALS treatment NurOwn — while still touting a “clear signal” of efficacy and not ruling out an application — the agency has decided to clarify the record in a most unusual statement.

The FDA statement amounts to a straight slapdown, offering a different set of efficacy numbers from the company’s public presentation last November and ruling out any chance of statistical significance.

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Eli Lil­ly claims suc­cess in a new JAK in­di­ca­tion: hair loss

Over the last decade, drugmakers have proven JAK inhibitors can treat a smattering of immune-related diseases ranging from rheumatoid arthritis to Covid-19. Now Eli Lilly has pulled out a new one.

Lilly and its biotech partner Incyte announced Wednesday that their JAK inhibitor baricitinib effectively regrew patients’ hair in a Phase III trial for alopecia areata, an autoimmune condition that can cause sudden, severe and patchy hair loss. Lilly didn’t break down the results from the 546-patient trial, but the primary endpoint was improvement on a standard score for alopecia symptoms.

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Cedric Francois, Apellis CEO (Apellis)

Apel­lis joins the grow­ing num­ber of bio­phar­mas scrap­ping a failed Covid-19 pro­gram af­ter an ear­ly flop

The global pandemic set off a frenzy of R&D activity as biotechs around the world scrambled to see if they could come up with a new medication or vaccine to help fight back. But even as the mRNA standouts are highlighting the market El Dorado open to successful teams, the failures are starting to pile up.

Thursday afternoon it was Apellis’ $APLS turn to deep-six a new drug.

The biotech reports that their C3 therapy APL-9 had failed to move the needle on mortality when combined with standard of care, as compared to SOC alone.

Norbert Bischofberger (Kronos)

Kro­nos seals pact with reg­u­la­tors to hunt AML with pre­vi­ous­ly off-lim­its bio­mark­er end­point

As head of R&D at Gilead, Norbert Bischofberger shelved the SYK inhibitor entospletinib after it proved to need too lengthy a development cycle to win approval. The FDA heard those concerns and will now give entospletinib, once again under Bischofberger’s watchful eye at Kronos, a faster shot on goal.

Kronos has reached an agreement with the FDA to conduct a Phase III trial with a unique primary endpoint, the company announced Thursday, one that it hopes will accelerate entospletinib’s path forward in a certain type of acute myeloid leukemia. The endpoint is measurable residual disease (MRD) negativity, which Kronos says can paint a clearer picture when it comes to the study’s complete response rate.