Bris­tol-My­ers is scout­ing new com­pa­ny star­tups; Ab­b­Vie and Idera team up to eval­u­ate com­bi­na­tion for HN­SCC

Bris­tol-My­ers Squibb has looped in a new part­ner to help scout new com­pa­ny cre­ation op­por­tu­ni­ties. As a lim­it­ed part­ner of Bio­Mo­tiv, the phar­ma gi­ant will work with the drug de­vel­op­ment ac­cel­er­a­tor to fund trans­la­tion­al ven­tures “in dis­ease ar­eas where un­met med­ical needs re­main” — and get first dibs to buy the re­sult­ing star­tups up­on lead iden­ti­fi­ca­tion. The deal gives Bris­tol-My­ers ac­cess to Bio­Mo­tiv’s net­work of aca­d­e­m­ic in­sti­tu­tions and their cut­ting-edge, ear­ly-stage dis­cov­er­ies, said Bruce Car, in­ter­im head of dis­cov­ery re­search.

One of Bio­Mo­tiv’s port­fo­lio com­pa­nies, Dual Ther­a­peu­tics, pre­vi­ous­ly en­ticed Bris­tol-My­ers Squibb to an on­col­o­gy pact that came with $255 mil­lion in mile­stones. The tie-up ap­peared to have fiz­zled, but Bris­tol-My­ers has con­tin­ued to get on the ground floor of biotech when­ev­er it could, for ex­am­ple by spon­sor­ing Bi­o­Lab‘s start­up fa­cil­i­ties.

→ It’s an­oth­er deal for Ger­man phar­ma Boehringer In­gel­heim. Af­ter ink­ing a re­search pact with MD An­der­son ear­li­er last month to cre­ate a “Vir­tu­al Re­search and De­vel­op­ment Cen­ter,” the com­pa­ny and Lupin Lim­it­ed have en­tered in­to a part­ner­ship for Lupin’s MEK in­hibitor com­pound (LNP3794) to be used in com­bi­na­tion with Boehringer’s KRAS in­hibitor for pa­tients with gas­troin­testi­nal and lung can­cers har­bor­ing a broad range of onco­genic KRAS mu­ta­tions.

The com­pa­ny says that “Lupin will re­ceive an up­front pay­ment of $20 mil­lion and po­ten­tial ad­di­tion­al pay­ments for suc­cess­ful achieve­ment of de­fined clin­i­cal, reg­u­la­to­ry and com­mer­cial mile­stones for a to­tal deal val­ue of more than $700 mil­lion.  Ad­di­tion­al­ly, Lupin will be en­ti­tled to re­ceive dou­ble-dig­it roy­al­ties on the sales of the prod­uct.”

→ Af­ter Ab­b­Vie read the last rites to their fi­nal, failed Ro­va-T clin­i­cal tri­al last week, the com­pa­ny is now col­lab­o­rat­ing with Idera Phar­ma to test com­bi­na­tions of an OX40 ag­o­nist (AB­BV-368) and a TLR-9 ag­o­nist (tilso­tolimod) — hop­ing to stim­u­late the im­mune sys­tem re­sult­ing in an­ti-tu­mor re­spons­es — in a Phase Ib study in pa­tients with re­cur­rent or metasta­t­ic head and neck squa­mous cell car­ci­no­ma (HN­SCC)

The study will test three sep­a­rate treat­ment arms: AB­BV-368 plus tilso­tolimod; AB­BV-368 plus tilso­tolimod and chemother­a­py (nab-pa­cli­tax­el); and AB­BV-368 plus tilso­tolimod, nab-pa­cli­tax­el and PD-1 an­tag­o­nist (AB­BV-181).

→ Los An­ge­les-based Puma Ther­a­peu­tics‘ drug Ner­l­ynx has been grant­ed or­phan drug sta­tus by the FDA for the treat­ment of breast can­cer pa­tients with brain metas­tases.

Back in May, in­vestor wor­ries cratered the com­pa­ny’s stock $PBYI when Q1 sales of the drug fell short of Wall Street es­ti­mates — with pa­tient dis­con­tin­u­a­tions run­ning high due to a poor tol­er­a­bil­i­ty pro­file, pre­dom­i­nate­ly re­lat­ing to di­ar­rhea. Ner­l­ynx was in-li­censed by Puma from Pfiz­er and was ap­proved by the FDA in Ju­ly 2017.

→ NICE has backed the NHS use of No­var­tis‘ gene ther­a­py Lux­tur­na for a rare, in­her­it­ed form of blind­ness in Eng­land and Wales. The one-off treat­ment, which was ap­proved in Eu­rope last No­vem­ber, has been sup­port­ed for use in chil­dren and adults who are liv­ing with vi­sion loss due to ge­net­ic mu­ta­tions in both copies of the RPE65 gene. No­var­tis bought the ex-US rights to the drug in 2018 for $170 mil­lion from Spark Ther­a­peu­tics.

→ The FDA has grant­ed re­gen­er­a­tive med­i­cine ad­vance ther­a­py (RMAT) des­ig­na­tion for Cam­bridge, Mass­a­chu­setts-based Ma­gen­ta Ther­a­peu­ticsMG­TA-456, a one-time cell ther­a­py for the treat­ment of mul­ti­ple in­her­it­ed meta­bol­ic dis­or­ders.

“The com­pa­ny is cur­rent­ly study­ing MG­TA-456 in a Phase II clin­i­cal tri­al in pa­tients old­er than 6 months of age with Hurler syn­drome, cere­bral adrenoleukody­s­tro­phy (cALD), metachro­mat­ic leukody­s­tro­phy (MLD) or globoid cell leukody­s­tro­phy (GLD) at four cen­ters of ex­cel­lence: Cincin­nati Chil­dren’s Hos­pi­tal, Duke Uni­ver­si­ty, Emory Uni­ver­si­ty and the Uni­ver­si­ty of Min­neso­ta.”

→ Re­genxbio has inked an op­tion and li­cense agree­ment for ex­clu­sive world­wide rights for Clear­side Bio­med­ical‘s SCS Mi­croin­jec­tor “for the de­liv­ery of RGX-314 to the supra­choroidal space to treat wet age-re­lat­ed mac­u­lar de­gen­er­a­tion (wet AMD), di­a­bet­ic retinopa­thy (DR) and oth­er con­di­tions for which an­ti-vas­cu­lar en­dothe­lial growth fac­tor (an­ti-VEGF) treat­ment is cur­rent­ly the stan­dard of care.”

The deal comes a lit­tle af­ter Clear­side Bio­med­ical an­nounced its pre­dic­tion that the FDA would re­ject its uveitis drug af­ter a re­quest for more da­ta.

Scott Gottlieb, AP Images

Scott Got­tlieb is once again join­ing a team that en­joyed good times at the FDA un­der his high-en­er­gy stint at the helm

Right after jumping on Michael Milken’s FasterCures board on Monday, the newly departed FDA commissioner is back today with news about another life sciences board post that gives him a ringside chair to cheer on a lead player in the real-world evidence movement — one with very close ties to the FDA.

Aetion is reporting this morning that Gottlieb is joining their board, a group that includes Mohamad Makhzoumi, a general partner at New Enterprise Associates, where Gottlieb returned after stepping out of his role at the FDA 2 years after he started.

Gottlieb — one of the best connected execs in biopharma — knows this company well. As head of FDA he championed the use of real-world evidence to help guide drug developers and the agency in gaining greater efficiencies, which helped set up Aetion as a high-profile player in the game.

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Deborah Dunsire. Lundbeck

UP­DAT­ED: Deb­o­rah Dun­sire is pay­ing $2B for a chance to leap di­rect­ly in­to a block­buster show­down with a few of the world's biggest phar­ma gi­ants

A year after taking the reins as CEO of Lundbeck, Deborah Dunsire is making a bold bid to beef up the Danish biotech’s portfolio of drugs in what will likely be a direct leap into an intense rivalry with a group of giants now carving up a growing market for new migraine drugs.

Bright and early European time Monday morning the company announced that it will pay up to about $2 billion to buy Alder, a little biotech that is far along the path in developing a quarterly IV formulation of a CGRP drug aimed at cutting back the number of crippling migraines patients experience each month. In a followup call, Dunsire also noted that the company will likely need 200 to 250 reps for this marketing task on both sides of the Atlantic. And analysts were quick to note that the dealmaking at Lundbeck isn’t done, with another $2 billion to $3 billion available for more deals to beef up the pipeline.

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Tower Bridge in London [Shutterstock]

#UK­BIO19: Join GSK’s Hal Bar­ron and a group of top biotech ex­ecs for our 2nd an­nu­al biotech sum­mit in Lon­don

Over the past 10 years I’ve made a point of getting to know the Golden Triangle and the special role the UK biopharma industry plays there in drug development. The concentration of world class research institutes, some of the most accomplished scientists I’ve ever seen at work and a rising tide of global investment cash leaves an impression that there’s much, much more to come as biotech hubs are birthed and nurtured.

San Diego cou­ple charged with steal­ing trade se­crets, open­ing Chi­nese biotech as DOJ crack­down con­tin­ues

A San Diego couple has been charged with stealing trade secrets from a US hospital and opening a business based off those secrets in China as the controversial industry-wide crackdown on alleged corporate espionage continues. On the same day, the Department of Justice announced they had arrested Beijing representative Zhongsan Liu for allegedly trying to obtain research visas for government recruiters.

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UP­DAT­ED: Bio­gen pulls the plug on prized IPF drug from $562M+ Stromedix buy­out

One of Biogen’s attempts to branch out has flopped as the biotech scraps a mid-stage program for idiopathic pulmonary fibrosis.

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Warts for the win: Aclar­is' lead drug clears piv­otal study

Aclaris Therapeutics has found a way to get rid of the warts and all.

The company — which earlier this month decided to focus on its arsenal of kinase inhibitors — on Monday unveiled positive data from a pivotal study testing its lead experimental drug for use in common warts.

The drug, A-101, was tested in a 502-patient study called THWART-2 — patients enrolled had one to six warts before qualifying for the trial. Patients either self-administered A-101 topical solution or a vehicle twice a week over a two-month period. A higher proportion of patients on the drug (a potent hydrogen peroxide topical solution) saw their warts disappear at day 60, versus the vehicle (p<0.0001) — meeting the main goal of the study.  Each secondary endpoint also emerged in favor of A-101, the company said.

Charles Nichols, LSU School of Medicine

Could psy­che­delics tack­le the obe­si­ty cri­sis? A long­time re­searcher in the field says his lat­est mouse study sug­gests po­ten­tial

Psychedelics have experienced a renaissance in recent years amid a torrent of preclinical and clinical research suggesting it might provide a path to treat mood disorders conventional remedies have only scraped at. Now a preclinical trial from a young biotech suggests at least one psychedelic compound has effects beyond the mind, and — if you believe the still very, very early hype — could provide the first single remedy for some of the main complications of obesity.

It’s fi­nal­ly over: Bio­gen, Ei­sai scrap big Alzheimer’s PhI­I­Is af­ter a pre­dictable BACE cat­a­stro­phe rais­es safe­ty fears

Months after analysts and investors called on Biogen and Eisai to scrap their BACE drug for Alzheimer’s and move on in the wake of a string of late-stage failures and rising safety fears, the partners have called it quits. And they said they were dropping the drug — elenbecestat — after the independent monitoring board raised concerns about…safety.

We don’t know exactly what researchers found in this latest catastrophe, but the companies noted in their release that investigators had determined that the drug was flunking the risk/benefit analysis.

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Ac­celeron drops a de­vel­op­ment pro­gram as #2 drug fails to spark func­tion­al ben­e­fits in pa­tients with a rare neu­ro­mus­cu­lar ail­ment

Acceleron is scrapping a muscular dystrophy development program underway for its number 2 drug in the pipeline after pouring over some failed mid-stage secondary data.

Gone is the ACE-083 project in patients with facioscapulohumeral muscular dystrophy. Their drug hit the primary endpoint on building muscle but flopped on key secondaries for functional improvements in patients, which execs felt was vital to the drug’s success.