NICE fails to en­dorse Roche's Tecen­triq for breast can­cer; Eli­cio clos­es fi­nanc­ing round with $33M

→ UK’s cost-ef­fec­tive­ness watch­dog NICE is not back­ing Roche‘s PD-L1 check­point in­hibitor Tecen­triq (known chem­i­cal­ly as ate­zolizum­ab), in an­oth­er blow to the Swiss drug­mak­er who re­vealed the drug wasn’t strong enough to score ap­proval in blad­der can­cer at the ES­MO con­fer­ence last week­end. NICE’s draft guid­ance, how­ev­er, per­tains to the im­munother­a­py’s use in ad­vanced breast can­cer in com­bi­na­tion with the chemother­a­py nab-pa­cli­tax­el.

“How­ev­er, there was no tri­al da­ta di­rect­ly com­par­ing ate­zolizum­ab plus nab-pa­cli­tax­el with oth­er treat­ments cur­rent­ly used at this stage – week­ly pa­cli­tax­el and do­c­etax­el -and the com­mit­tee felt that the com­pa­ny’s analy­sis in­di­rect­ly com­par­ing these treat­ments was un­re­li­able and lacked va­lid­i­ty,” NICE re­view­ers said.

→ Penn-al­lied Tmu­ni­ty — which is run by No­var­tis $NVS vet Us­man “Oz” Azam and bagged a $100 mil­lion mega-round last year — has part­nered with Chil­dren’s Hos­pi­tal of Philadel­phia to ad­vance a glyp­i­can 2 (GPC2) CAR-T ther­a­py for the treat­ment of neu­rob­las­toma (a rare can­cer that af­fects the de­vel­op­ing ner­vous sys­tem). “The ther­a­py al­so has ex­pan­sion po­ten­tial in medul­loblas­toma and small cell lung can­cer, among sev­er­al oth­er pe­di­atric and adult can­cers that ex­press an abun­dance of the GPC2 pro­tein on their cell sur­face.” Fi­nan­cial de­tails have not yet been dis­closed.

→ Dar­rell Irvine co-found­ed Eli­cio Ther­a­peu­tics — fo­cused on am­phiphile im­munother­a­pies — has closed its Se­ries B with $33 mil­lion. The com­pa­ny says that the fi­nanc­ing will ad­vance Eli­cio’s pipeline, in­clud­ing its am­phiphile mKRAS vac­cine, ELI-002 — which tar­gets sev­en KRAS mu­ta­tions that dri­ve 99% of all KRAS-dri­ven can­cers. In­vestors for the round in­clud­ed Clal Biotech­nol­o­gy In­dus­tries, Liv­zon Phar­ma­ceu­ti­cal Group and Efung Cap­i­tal.

Back in Au­gust at the Amer­i­can Vet­er­ans Na­tion­al Con­ven­tion, Don­ald Trump tout­ed the ben­e­fits of Spra­va­to for de­pres­sion, and or­dered the VA to get as much of the prod­uct as it could —  and sug­gest­ed its mak­er J&J $JNJ should of­fer it to vet­er­ans for free. To­day, J&J’s Janssen an­nounced the sub­mis­sion of an sN­DA to the FDA for a new in­di­ca­tion for Spra­va­to for the rapid re­duc­tion of de­pres­sive symp­toms in adult pa­tients with ma­jor de­pres­sive dis­or­der (MDD) who have ac­tive sui­ci­dal ideation with in­tent.

In June, Enan­ta Phar­ma­ceu­ti­cals $EN­TA put to­geth­er plans for a new RSV study in adult pa­tients af­ter post­ing pos­i­tive da­ta in a Phase IIa study test­ing its drug, EDP-938. Enan­ta plans to ini­ti­ate a Phase IIb clin­i­cal study of EDP-938 in adult out-pa­tients with RSV by the end of 2019.

Goldfinch Bio — fo­cused on de­vel­op­ing treat­ments and med­i­cines for kid­ney dis­eases — has inked a li­cense agree­ment with Take­da for world­wide rights to a pre­clin­i­cal, pe­riph­er­al­ly-re­strict­ed cannabi­noid re­cep­tor 1 (CB1) mon­o­clon­al an­ti­body. Fi­nan­cial terms have not yet been dis­closed. Goldfinch Bio plans to file an IND for the CB1 in­hibitor, re­named GFB-024, in the sec­ond half of 2020.

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.

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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.

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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.

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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.

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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.

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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.

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