Park­er In­sti­tute, MD An­der­son and Seres de­vel­op­ing a mi­cro­bio­me/PD-1/L1 com­bo; CRISPR-Cas an­timi­cro­bial biotech Lo­cus rais­es $17M

→ Just days ago, MD An­der­son re­searcher Jen­nifer War­go and col­leagues pub­lished new re­search that showed how the gut mi­cro­bio­me played a big role in de­ter­min­ing whether or not a check­point ther­a­py could help save your life. This morn­ing, MD An­der­son and the sci­en­tif­ic net­work afi­ciona­dos at the Park­er In­sti­tute have put a deal to­geth­er to col­lab­o­rate with lead­ing mi­crio­bio­me biotech Seres on a pill. Seres’ $MCRB bac­te­ria pill is the pre­clin­i­cal SER-401. And the biotech land­ed a deal for MD An­der­son’s IP. The Park­er In­sti­tute will spon­sor a clin­i­cal tri­al to see if it works.

→ Re­search Tri­an­gle Park, NC-based Lo­cus Bio­sciences has round­ed up a $17 mil­lion A round to start mov­ing its an­timi­cro­bials in­to the clin­ic. The biotech is us­ing CRISPR-Cas tech to cre­ate a new ap­proach to coun­ter­at­tack­ing against drug-re­sis­tant su­per­bugs. AR­TIS Ven­tures led the round, with ad­di­tion­al fi­nanc­ing from Ten­cent Hold­ings Lim­it­ed, Ab­stract Ven­tures, and the North Car­oli­na Biotech­nol­o­gy Cen­ter.

→ The FDA has ap­proved a pill for schiz­o­phre­nia that in­cludes a dig­i­tal sen­sor that records that the pa­tient has tak­en the med­ica­tion, dis­patch­ing the in­for­ma­tion via a patch worn on the skin. The prod­uct is Ot­su­ka Phar­ma­ceu­ti­cal’s Abil­i­fy MyCite. The tech is there for an ob­vi­ous rea­son, with ap­pli­ca­tions in men­tal health for en­sur­ing com­pli­ance with dos­ing. By all ac­counts, these new dig­i­tal prod­ucts will be­come a rou­tine fea­ture in med­i­cine.

→ In an agree­ment that in­volved form­ing a new sub­sidiary, Itus Cor­po­ra­tion has se­cured an ex­clu­sive world­wide li­cense to The Wis­tar In­sti­tute’s CAR-T tech­nol­o­gy aimed at treat­ing sol­id tu­mors — ovar­i­an can­cer be­ing its first tar­get. Cer­tain­ty Ther­a­peu­tics is the name of the new com­pa­ny ma­jor­i­ty owned by the biotech $ITUS, a sis­ter to Itus’ can­cer de­tec­tion sub­sidiary Anixa Di­ag­nos­tics. While CAR-T has seen ex­cit­ing re­sults in B-cell can­cers, lit­tle progress on sol­id tu­mors has been made, CEO Amit Ku­mar said in a state­ment, and Itus is “ex­cit­ed to be at the fore­front of us­ing CAR-T tech­nol­o­gy against sol­id tu­mors,” in­clud­ing prostate, pan­cre­at­ic and oth­er can­cers.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA have vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Roche vaults to the front of the NL­RP3 clin­i­cal race, pay­ing $448M up­front to bag In­fla­zome

Roche is going all in on NLRP3.

The pharma giant is putting down $448 million (€380 million) upfront to snatch Novartis-backed Inflazome, which makes it a clinical player in the space overnight.

Dublin and Cambridge, UK-based Inflazome is the second NLRP3-focused biotech Roche has acquired in less than two years, and although no numbers were disclosed in the Jecure buyout, this is almost certainly a much larger deal.

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Sebastian Nijman (file photo)

Roche looks to ge­net­ic mod­i­fiers for new drug tar­gets, team­ing up with Dutch biotech in $375M deal

Roche is gambling on a new way of discovering drug targets and, ultimately, promising to infuse more than $375 million into a small biotech if all goes well.

A spinout of the Netherlands Cancer Institute and Oxford University, Scenic Biotech set out to pioneer a field that’s gaining some traction among top VCs in the US: to harness the natural protecting powers of genetic modifiers — specific genes that suppress a disease phenotype.

Eli Lilly CSO Dan Skovronsky (file photo)

#ES­MO20: Eli Lil­ly shows off the da­ta for its Verzenio suc­cess. Was it worth $18 bil­lion?

The press release alone, devoid of any number except for the size of the trial, added nearly $20 billion to Eli Lilly’s market cap back in June. Now investors and oncologists will get to see if the data live up to the hype.

On Sunday at ESMO, Eli Lilly announced the full results for its Phase III MonarchE trial of Verzenio, showing that across over 5,000 women who had had HR+, HER2- breast cancer, the drug reduced the odds of recurrence by 25%. That meant 7.8% of the patients on the drug arm saw their cancers return within 2 years, compared with 11.3% on the placebo arm.

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Greg Friberg (File photo)

#ES­MO20: Am­gen team nails down sol­id ear­ly ev­i­dence of AMG 510’s po­ten­tial for NSCLC, un­lock­ing the door to a wave of KRAS pro­grams

The first time I sat down with Amgen’s Greg Friberg to talk about the pharma giant’s KRAS G12C program for sotorasib (AMG 510) at ASCO a little more than a year ago, there was high excitement about the first glimpse of efficacy from their Phase I study, with 5 of 10 evaluable non-small cell lung cancer patients demonstrating a response to the drug.

After decades of failure targeting KRAS, sotorasib offered the first positive look at a new approach that promised to open a door to a whole new approach by targeting a particular mutation to a big target that had remained “undruggable” for decades.

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#ES­MO20: Out to beat Tagris­so, J&J touts 100% ORR for EGFR bis­pe­cif­ic/TKI com­bo — fu­el­ing a quick leap to PhI­II

J&J’s one-two punch on EGFR-mutant non-small cell lung cancer has turned up some promising — although decidedly early — results, fueling the idea that there’s yet room to one up on third-generation tyrosine kinase inhibitors.

Twenty out of 20 advanced NSCLC patients had a response after taking a combination of an in-house TKI dubbed lazertinib and amivantamab, a bispecific antibody targeting both EGFR and cMET engineered on partner Genmab’s platform, J&J reported at ESMO. All were treatment-naïve, and none has seen their cancer progress at a median follow-up of seven months.

Exelixis CEO Michael Morrissey (file photo)

#ES­MO20: Look out Mer­ck. Bris­tol My­ers and Ex­elix­is stake out their com­bo’s claim to best-in-class sta­tus for front­line kid­ney can­cer

Now that the PD-(L)1 checkpoints are deeply entrenched in the oncology market, it’s time to welcome a wave of combination therapies — beyond chemo — looking to extend their benefit to larger numbers of patients. Bristol Myers Squibb ($BMY} and Exelixis {EXEL} are close to the front of that line.

Today at ESMO the collaborators pulled the curtain back on some stellar data for their combination of Opdivo (the PD-1) and Cabometyx (the TKI), marking a significant advance for the blockbuster Bristol Myers franchise while offering a big leg up for the team at Exelixis.

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Donald Trump and White House chief of staff Mark Meadows, before boarding Marine One (Getty Images)

Pric­ing deal col­laps­es over Big Phar­ma's re­fusal to is­sue $100 'cash card­s' be­fore the elec­tion — re­port

Late in August, as negotiations on a pricing deal with President Trump reached a boiling point, PhRMA president Stephen Ubl sent an email update to the 34 biopharma chiefs that sit on his board. He wrote that if the industry did not agree to pay for a $100 “cash card” sent to seniors before November, White House chief of staff Mark Meadows was going to tell the news media Big Pharma was refusing to “share the savings” with the elderly — and that all of the blame for failed drug pricing negotiations would lie squarely on the industry.

Dan Skovronsky, Eli Lilly CSO

An­a­lysts are quick to pan Eli Lil­ly's puz­zling first cut of pos­i­tive clin­i­cal da­ta for its Covid-19 an­ti­body

Eli Lilly spotlighted a success for one of 3 doses of their closely-watched Covid-19 antibody drug Wednesday morning. But analysts quickly highlighted some obvious anomalies that could come back to haunt the pharma giant as it looks for an emergency use authorization to launch marketing efforts.

The pharma giant reported that LY-CoV555, developed in collaboration with AbCellera, significantly reduced the rate of hospitalization among patients who were treated with the antibody. The drug arm of the study had a 1.7% hospitalization rate, compared to 6% in the control group, marking a 72% drop in risk.

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