Langer, Ciechanover god­fa­ther the lat­est AI up­start; Ipsen forges $446M AML de­vel­op­ment pact

There’s a new AI play­er jump­ing in­to the drug dis­cov­ery game. And they have some high-pow­ered sci­en­tif­ic ad­vi­sors in their cor­ner.

Tel Aviv-based Quris has built what it calls a “pa­tient-on-a-chip” AI plat­form that it’s tout­ing as a way to cir­cum­vent un­re­li­able an­i­mal test­ing with a more ef­fi­cient way to judge safe­ty and ef­fi­ca­cy. An­i­mal test­ing, par­tic­u­lar­ly in­volv­ing mice, has proven a no­to­ri­ous­ly un­re­li­able way to do pre­clin­i­cal test­ing — though it is well-es­tab­lished with reg­u­la­tors.

“Us­ing a break­through way to test drug can­di­dates on minia­tur­ized pa­tients on chips, Quris can demon­strate their safe­ty and ef­fi­ca­cy, or lack there­of, through pre­lim­i­nary chip-based clin­i­cal tri­als. This has nev­er been done be­fore, and Quris is chart­ing the path,” mar­vels No­bel Lau­re­ate Aaron Ciechanover, one of the up­start’s sci­ence guides.

Ciechanover is joined by the ubiq­ui­tous Bob Langer, the oft-quot­ed MIT pro­fes­sor — and bil­lion­aire Mod­er­na co-founder — who has some­how found the time to help god­fa­ther a mul­ti­tude of biotechs along the way.

The com­pa­ny gar­nered a $9 mil­lion seed round led by Ju­dith Richter and Ko­bi Richter, with par­tic­i­pa­tion from Moshe Yanai and strate­gic an­gel in­vestors.

There’s been con­sid­er­able boast­ing in the AI field in the last few years, which has tend­ed to be damp­ened by re­al­i­ty. — John Car­roll

Ipsen lands pre­clin­i­cal AML drug in $446M deal

Ipsen is beef­ing up the on­col­o­gy seg­ment of its pipeline with a new, $446 mil­lion deal with Ac­cent Ther­a­peu­tics.

The Paris-based play­er has signed off on a world­wide deal pack­age that gives it rights to Ac­cent’s pre-clin­i­cal stage MET­TL3 pro­gram for AML. The part­ners didn’t break out the up­front, but most of these pre­clin­i­cal deals are heav­i­ly back-end­ed with mile­stones.

“We are de­light­ed to part­ner with Ac­cent to progress the MET­TL3 pro­gram as we con­tin­ue our ex­pan­sion in­to hema­to­log­ic on­col­o­gy,” not­ed Ipsen ear­ly de­vel­op­ment chief Chris­telle Huguet. — John Car­roll

Centes­sa sub signs up for dis­cov­ery pact with Schrödinger

One of Centes­sa’s biotech subs has signed on with Schrödinger for a dis­cov­ery deal.

Orex­ia Ther­a­peu­tics is jump­ing on the com­pu­ta­tion­al com­pa­ny’s tech plat­form in search of ther­a­peu­tics that can hit the orex­in-2 re­cep­tor tar­get, a path­way that plays a key role in sleep dis­or­ders. This is the first time Schrödinger’s tech­nol­o­gy will be ap­plied in an orex­in ag­o­nist set­ting at scale.

Schrödinger gets an un­spec­i­fied up­front and a pack­age of mile­stones in the deal.

“While pre­vail­ing treat­ment ap­proach­es on­ly ad­dress the symp­toms as­so­ci­at­ed with nar­colep­sy type 1 (NT1), we be­lieve orex­in ag­o­nists of­fer a dis­rup­tive ap­proach, with the ca­pac­i­ty to ad­dress the un­der­ly­ing pathol­o­gy of the dis­or­der. Orex­ia’s uti­liza­tion of OX2R sta­bi­lized re­cep­tors pro­vides the foun­da­tion for R&D which could sig­nif­i­cant­ly ben­e­fit pa­tients with NT1. We look for­ward to part­ner­ing with Schrödinger to com­ple­ment the dis­cov­ery and de­vel­op­ment work we are con­duct­ing at Orex­ia,” said Saurabh Sa­ha, the CEO at Centes­sa. — John Car­roll

In­novent claims PhI­II win in EGFR-mu­tat­ed non­squa­mous NSCLC

In­novent is mak­ing noise Mon­day af­ter a Phase III study for its sin­til­imab pro­gram achieved the pri­ma­ry end­point. The biotech said the com­bi­na­tion of sin­til­imab and the an­ti-VEGF an­ti­body be­va­cizum­ab demon­strat­ed sig­nif­i­cant pro­gres­sion-free sur­vival im­prove­ment when al­so com­bined with chemother­a­py, com­pared to chemother­a­py alone.

In­novent en­rolled pa­tients with EGFR-mu­tat­ed non­squa­mous non-small cell lung can­cer that has pro­gressed af­ter treat­ment with an EGFR ty­ro­sine ki­nase in­hibitor. The biotech is al­so still wait­ing for da­ta look­ing at on­ly a sin­til­imab and chemo com­bo to ma­ture.

The study will con­tin­ue, as it did not reach the fu­til­i­ty stop­ping point, In­novent said. — Max Gel­man

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain drugs; 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.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,800+ biopharma pros reading Endpoints daily — and it's free.

Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,800+ biopharma pros reading Endpoints daily — and it's free.

Seagen interim CEO Roger Dansey and Daiichi Sankyo CEO Sunao Manabe

Paving the way for Mer­ck­'s buy­out, Seagen los­es ar­bi­tra­tion dis­pute with Dai­ichi over ADC tech

As Seagen awaits a final buyout offer from Merck that could be in the territory of $40 billion, Seagen revealed Friday afternoon that it lost an arbitration dispute with Daiichi Sankyo relating to the companies’ 2008 collaboration around the use of antibody-drug conjugate (ADC) technology.

But that loss likely won’t matter much when it comes to Merck’s deal.

After breaking off its pact with Daiichi in mid-2015, the two companies battled over “linker” tech — a chemical bridge between an ADC’s antibody component and the cytotoxic payload — that Seagen claims Daiichi would improve upon and implement in its current generation of ADCs.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,800+ biopharma pros reading Endpoints daily — and it's free.

House pass­es his­toric drug pric­ing re­forms, lin­ing up decades-in-the-mak­ing win for Biden and De­moc­rats

The US House of Representatives today voted along party lines (all Dems voted for it), 220-207 to pass new, wide-ranging legislation that will allow Medicare drug price negotiations for the first time ever, and cap seniors’ drug expenses to $2,000 per year and seniors’ insulin costs at $35 per month.

Setting up a major victory for President Joe Biden, representatives returned from their summer recess to pass the Inflation Reduction Act, even as many noted the bill would only modestly reduce inflation.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,800+ biopharma pros reading Endpoints daily — and it's free.

Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,800+ biopharma pros reading Endpoints daily — and it's free.

J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,800+ biopharma pros reading Endpoints daily — and it's free.