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.

The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; 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.

With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Ei­sai cut­ting 91 jobs af­ter out-li­cense deal; Mer­ck touts first-line Keytru­da re­sults in en­dome­tri­al can­cer

Eisai will eliminate 91 after it out-licensed a seizure drug.

An Eisai spokesperson told Endpoints News that the change-up is tied to Fycompa, a seizure treatment that Florida rare disease biotech Catalyst Pharmaceuticals agreed to pay $160 million to Eisai in exchange for commercial rights back in December. The job cuts were originally flagged in a New Jersey state WARN notice.

The spokesperson said that Catalyst indicated interest in retaining up to 40 employees who work on Fycompa. Those who qualify will have an opportunity to interview with Catalyst.

Raymond Stevens, Structure Therapeutics CEO

Be­hind Fri­day's $161M IPO: A star sci­en­tist, GPCR drug dis­cov­ery and a plan to chal­lenge phar­ma in di­a­betes

What does it take to pull off a $161 million biotech IPO these days?

In Structure Therapeutics’ case, it means having a star scientist co-founder paired with the computational drug discovery company Schrödinger, $198 million in private funding from blue-chip investors, almost six years of research work on G protein-coupled receptors and a slate of oral, small-molecule drugs, with an eye on the huge and growing diabetes and weight-loss market.

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Af­ter 13 years, Ramy Mah­moud steps in­to CEO seat at Opti­nose; Ru­pert Vessey set to ex­it Bris­tol My­ers in Ju­ly

After 13 years as president and COO at Optinose, Ramy Mahmoud has stepped into a new role as its CEO. He is taking the place of Peter Miller, who stepped down earlier this week, though Miller is still staying with the company as a consultant.

In 2010, the two business partners joined Optinose to take it in a new direction, transforming it from a delivery platform to product company. They previously worked together at Johnson & Johnson, when Miller was president at Janssen and Mahmoud headed medical affairs. Miller said after he learned about Optinose, “I did what I always do, which is find people smarter than me to talk with about the idea. And the first person I called was Ramy … and I said, ‘Hey, Ramy, what do you think of this technology?’”

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Ma­gen­ta halts stem cell work and may sell it­self fol­low­ing pa­tient death, clin­i­cal hold

Magenta Therapeutics said it is halting work on its stem cell transplant drug pipeline and may sell itself, a week after the company reported the death of a patient in an early stage trial of its antibody-drug conjugate.

The Cambridge, MA-based company said it will conduct a “review of strategic alternatives,” and that could include an “acquisition, merger, business combination, or other transaction.”

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Te­va drops out of in­dus­try trade group PhRMA

Following in AbbVie’s footsteps, Teva confirmed on Friday that it’s dropping out of the industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA).

Teva didn’t give a reason for its decision to leave, saying only in a statement to Endpoints News that it annually reviews “effectiveness and value of engagements, consultants and memberships to ensure our investments are properly seated.”

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Sanofi CFO Jean-Baptiste de Chatillon (L) and CEO Paul Hudson (Romuald Meigneux/Sipa via AP Images)

Sanofi sees downtick in flu sales as it preps for launch of RSV an­ti­body

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.