PACT Phar­ma bags $75M for neoanti­gen TCR work, man­u­fac­tur­ing; Bay­er grabs ex­per­i­men­tal con­tra­cep­tive from Daré

→ With a new pres­i­dent and chief tech­ni­cal of­fi­cer in place, next-gen T cell ther­a­py play­er PACT Phar­ma has $75 mil­lion in fresh fi­nanc­ing to ex­pand the scope of its nascent clin­i­cal pro­grams and open its own man­u­fac­tur­ing fa­cil­i­ty in South San Fran­cis­co. By iso­lat­ing spe­cif­ic neoanti­gen re­cep­tors in pa­tients that ap­pear to be dri­ving an im­mune re­sponse, PACT promis­es to tack­le some of the tough­est sol­id tu­mors pre­vi­ous­ly im­pen­e­tra­ble to cell ther­a­pies. Vi­da Ven­tures, which has close ties to promi­nent cell ther­a­py biotechs such as Kite and Al­lo­gene, led the Se­ries C round. CTO Tim Moore, who jumped from Kite last Oc­to­ber, will su­per­vise ef­forts to au­to­mate some pro­duc­tion and an­a­lyt­ics process “to re­duce cy­cle time and man­u­fac­tur­ing costs.”

→ Large CRO Charles Riv­er is en­ter­ing a mul­ti-year drug dis­cov­ery col­lab­o­ra­tion with Take­da, fo­cus­ing on four ar­eas the Japan­ese drug­mak­er cham­pi­ons — on­col­o­gy, gas­troen­terol­o­gy, neu­ro­science and rare dis­ease. Un­der the deal, Charles Riv­er gets an undis­closed up­front fee from Take­da, and is el­i­gi­ble to re­ceive de­vel­op­ment pay­ments of up to $50 mil­lion per can­di­date as well as po­ten­tial com­mer­cial mile­stones of up to $120 mil­lion plus roy­al­ties on launched prod­ucts.

Bay­er has inked a li­cens­ing agree­ment with Daré Bio­science for com­mer­cial­iza­tion rights of an in­ves­ti­ga­tion­al hor­mone-free month­ly vagi­nal con­tra­cep­tive, Ovaprene, in the US. San Diego-based Daré will re­ceive an undis­closed up­front and $20 mil­lion if Bay­er de­cides to ex­er­cise its op­tion, plus mile­stones that add up to $310 mil­lion. The biotech ex­pects to launch a piv­otal study in the sec­ond half of 2020.

→ Af­ter tout­ing in­ter­im Phase II re­sults on its lead COPD drug last March, Verona Phar­ma has chalked up an­oth­er win in the next stage. The com­pa­ny re­port­ed pos­i­tive da­ta in the 4-week Phase IIb study eval­u­at­ing neb­u­lized en­sifen­trine (0.375 mg, 0.75 mg, 1.5 mg and 3.0 mg) or place­bo as an add-on treat­ment to tiotropi­um (Spiri­va Respi­mat), a long-act­ing an­ti-mus­carinic (“LAMA”) bron­chodila­tor mar­ket­ed by Boehringer In­gel­heim. The pri­ma­ry end­point was met at all dos­es, with sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in lung func­tion at week 4.

Al­lo­gene and Spring­Works Ther­a­peu­tics — two not­ed star­tups de­vel­op­ing port­fo­lios of drugs flow­ing from Pfiz­er are team­ing up to eval­u­ate Al­lo­gene’s BC­MA Al­lo­CAR T ther­a­py, AL­LO-715, in com­bi­na­tion with Spring­Works’ gam­ma sec­re­tase in­hibitor (GSI), nirogace­s­tat, in pa­tients with re­lapsed or re­frac­to­ry mul­ti­ple myelo­ma. Un­der the terms of agree­ment, Al­lo­gene will spon­sor and con­duct the Phase I study — which is ex­pect­ed to com­mence in the sec­ond half of 2020.

→ Back in No­vem­ber 2018, Eli Lil­ly showed their faith in NextCure by drop­ping $40 mil­lion in up­front and eq­ui­ty cash. Now, Lil­ly is ter­mi­nat­ing the deal, ef­fec­tive as of March 3, 2020.

→ For his lat­est com­pa­ny cre­ation, Vivek Ra­maswamy is look to serve the peo­ple who serve drug­mak­ers. Loka­vant’s stat­ed goal is to cen­tral­ize da­ta from over 1,000 tri­als “to pow­er a ma­chine learn­ing mod­el that an­tic­i­pates tri­al risk, pro­vides risk mit­i­ga­tion strate­gies, and pre­dicts the im­pact of mit­i­ga­tion strat­e­gy im­ple­men­ta­tion. Rhit Nam­bisan, head of dig­i­tal prod­uct at Roivant, will serve as pres­i­dent. The new com­pa­ny has al­so en­tered its first mul­ti-year en­ter­prise li­cense agree­ment with Parex­el, which re­cent­ly inked a re­al world ev­i­dence pact with an­oth­er Roivant sub­sidiary, Data­vant.

Nick Galakatos, Blackstone global head of life sciences

Nick Galakatos and the Black­stone team now have a record $4.6B to in­vest in bio­phar­ma, with a big fo­cus on push­ing com­pa­nies over the top

Nick Galakatos and his team at Blackstone Life Sciences have seen their biggest opportunities swell up in mostly established players who don’t have all the money they need to accomplish everything on the to-do list. And right now, with the industry booming, that’s a long list with some hefty needs.

The Blackstone team has neatly tied up the largest private fund ever raised in life sciences for making big dreams come true in biopharma. Late Thursday, Blackstone put out word that they had closed their highly anticipated fund with the projected $4.6 billion all in.

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Bio­gen shares spike as ex­ecs com­plete a de­layed pitch for their con­tro­ver­sial Alzheimer's drug — the next move be­longs to the FDA

Biogen is stepping out onto the high wire today, reporting that the team working on the controversial Alzheimer’s drug aducanumab has now completed their submission to the FDA. And they want the agency to bless it with a priority review that would cut the agency’s decision-making time to a mere 6 months.

The news drove a 10% spike in Biogen’s stock $BIIB ahead of the bell.

Part of that spike can be attributed to a relief rally. Biogen execs rattled backers and a host of analysts earlier in the year when they unexpectedly delayed their filing to the third quarter. That delay provoked all manner of speculation after CEO Michel Vounatsos and R&D chief Al Sandrock failed to persuade influential observers that the pandemic and other factors had slowed the timeline for filing. Actually making the pitch at least satisfies skeptics that the FDA was not likely pushing back as Biogen was pushing in. From the start, Biogen execs claimed that they were doing everything in cooperation with the FDA, saying that regulators had signaled their interest in reviewing the submission.

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Regeneron CEO Leonard Schleifer speaks at a meeting with President Donald Trump, members of the Coronavirus Task Force, and pharmaceutical executives in the Cabinet Room of the White House (AP Photo/Andrew Harnik)

OWS shifts spot­light to drugs to fight Covid-19, hand­ing Re­gen­eron $450M to be­gin large scale man­u­fac­tur­ing in the US

The US government is on a spending spree. And after committing billions to vaccines defense operations are now doling out more of the big bucks through Operation Warp Speed to back a rapid flip of a drug into the market to stop Covid-19 from ravaging patients — possibly inside of 2 months.

The beneficiary this morning is Regeneron, the big biotech engaged in a frenzied race to develop an antibody cocktail called REGN-COV2 that just started a late-stage program to prove its worth in fighting the virus. BARDA and the Department of Defense are awarding Regeneron a $450 million contract to cover bulk delivery of the cocktail starting as early as late summer, with money added for fill/finish and storage activities.

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Gilead boasts of pos­i­tive remde­sivir da­ta on mor­tal­i­ty — but their analy­sis pro­vokes the skep­tics

Gilead is surging again off data that suggest its antiviral remdesivir might improve survival.

The new data come from an analysis Gilead conducted comparing the death rate and recovery time of patients in one of its remdesivir trials to a group of 800 patients “with similar baseline characteristics and disease severity” who received only standard-of-care around the same time. The result, they said, suggested that patients who received remdesivir had a 62% better chance at surviving than those who did not.

Hal Barron, GSK

Win or lose on the mar­ket­ing OK, the FDA just gunned down GSK’s bright hopes for their BC­MA ther­a­py

The FDA’s ODAC — the Oncologic Drugs Advisory Committee — has a well-known bias in favor of adding new cancer drugs to the market, even if efficacy is at best marginal and serious safety issues demand careful management.

Doctors want as many arrows in their quiver as they can get. And when patients are dying after failing multiple drugs, why not give it a go one more time?

GlaxoSmithKline, though, is about to test out how their new BCMA antibody drug conjugate belantamab mafodotin can do after being mauled in an in-house FDA review, ahead of the Tuesday expert panel discussion. Even if the agency goes ahead with an expected green light, this drug will likely be constrained to a small niche — icing any plans they may have for making waves in oncology anytime soon.

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Covid-19 roundup: BioN­Tech go­ing head-to-head with Mod­er­na as PhI­II mR­NA launch looms; Tri­al on Shin­zo Abe’s once-fa­vorite an­tivi­ral is in­con­clu­sive

It’s a race to the Phase III finish line now for the 2 leading mRNA vaccines in the pipeline for Covid-19.

BioNTech chief Ugur Sahin told the Wall Street Journal that his company will start Phase III testing of their vaccine later this month, setting them up to lateral the data to regulators before the end of this year.

That puts them essentially on the exact same schedule as Moderna is dedicated to. The Massachusetts rival to BioNTech also expects to launch Phase III this month. Lots of rumors have circulated about delays and conflict among the scientists advancing the Moderna jab, but the biotech has consistently stuck to its plan to start a late-stage pivotal this month.

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Andrew Kruegel, Kures president and co-founder (Columbia Tech Ventures via Vimeo)

Af­ter psilo­cy­bin and ke­t­a­mine, a new biotech comes along de­vel­op­ing a drug Scott Got­tlieb fought

Andrew Kruegel was six years into his chemistry work at Columbia University, when, one day in August 2016, he learned he might have only 30 days before the government made him destroy his research.

Kruegel had been studying kratom, a leaf long used in Southeast Asia as a stimulant or for pain. It had opioid-like properties, he found, but seemed to offer pain relief without the addictive potential or respiratory side effects of traditional opioids — a riddle that might help illuminate how human opioid receptors work.

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The home run count: The $100M+ mega-round boom in biotech in­spired a $7.3B feed­ing fren­zy — so far this year

Over the last 6 months there’s been a blizzard of money piling up drifts of the green stuff through the biotech landscape. And the forecast calls for more cash windfalls ahead.

Even as a global pandemic has killed more than half a million people, blighted economies and divided nations over the proper response, it’s also helped ignite an unprecedented burst of big-time investing. And not just in Covid-19 deals, as we’ve looked at before.

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Nello Mainolfi (Kymera via YouTube)

Out to re­vive R&D, a resur­gent Sanofi pays $150M cash to part­ner up with a pi­o­neer­ing pro­tein degra­da­tion play­er

Frank Nestle was appointed Sanofi’s global head of immunology and inflammation research therapeutic area just days before dupilumab, the blockbuster-to-be IL-4 antibody, would be accepted for priority review. After four years of consolidating immunology expertise from multiple corners of the Sanofi family and recruiting new talents to build the discovery engine, he’s set eyes on a Phase I-ready program that he believes can grow into a Dupixent-sized franchise.