Tar­get­ing the tricky PI3K path­way in can­cer, MEI gets $75M to push pro­gram through reg­is­tra­tion study

MEI Phar­ma $MEIP, a small pub­lic com­pa­ny in San Diego, has raised $75 mil­lion in a pri­vate sale of stock to push for­ward its PI3K in­hibitor — a class of drugs with a mixed his­to­ry — to treat a com­mon non-Hodgkin lym­phoma.

The com­pa­ny ac­quired the pro­gram back in 2013 from San Fran­cis­co-based Path­way Ther­a­peu­tics, and has brought the oral drug to clin­i­cal proof-of-con­cept tri­als in both fol­lic­u­lar lym­phoma and in­do­lent lym­phoma and dif­fuse large B-cell lym­phoma.

Daniel Gold

MEI’s pres­i­dent and CEO Daniel Gold said the new funds will get its PI3K in­hibitor (called ME-401) in­to a reg­is­tra­tion study.

The PI3K field — once a hot prospect in R&D — has lost a bit of its al­lure in re­cent years. The path­way is one of the most fre­quent­ly dys­reg­u­lat­ed path­ways in can­cer, and there­fore more than 40 com­pounds tar­get­ing the path­way have been test­ed in clin­i­cal tri­als in­volv­ing pa­tients with a range of dif­fer­ent can­cers. The clin­i­cal de­vel­op­ment of many of these agents, how­ev­er, has stymied be­fore reach­ing late-stage tri­als. Plus, the an­ti­tu­mor ac­tiv­i­ty ob­served thus far has been lim­it­ed, and some tox­i­c­i­ties were found to be pro­hib­i­tive.

Not to men­tion, Gilead’s Zy­delig got slapped with a black box warn­ing for dan­ger­ous side ef­fects, and the rest of the field is still quite ear­ly in de­vel­op­ment.

Still, the FDA has ap­proved some PI3K’s that have en­joyed suc­cess. Just last fall, Bay­er’s Aliqopa (co­pan­lis­ib) got the FDA OK, set­ting it­self up as a po­ten­tial ri­val to Im­bru­vi­ca. In ad­di­tion, Ve­rastem, a com­pa­ny near Boston, has filed for ap­proval of Ab­b­Vie’s castoff du­velis­ib, tack­ling chron­ic lym­pho­cyt­ic leukemia, small lym­pho­cyt­ic lym­phoma, and fol­lic­u­lar lym­phoma.

MEI Phar­ma — along with sev­er­al oth­ers — doesn’t ap­pear to be cowed by chal­lenges in the space.

“With this fi­nanc­ing in­volv­ing lead­ing health­care in­vest­ment firms, we are well fund­ed to progress a ro­bust port­fo­lio of po­ten­tial first-in-class and best-in-class on­col­o­gy drugs,” Gold said in a state­ment. “With the start of a planned reg­is­tra­tion study of ME-401, we an­tic­i­pate hav­ing two pro­grams in piv­otal tri­als by the end of 2018.”

The com­pa­ny’s pri­vate place­ment was led by Vi­vo Cap­i­tal and CAM Cap­i­tal. Oth­er par­tic­i­pants in­clud­ed New En­ter­prise As­so­ci­ates, Per­cep­tive Ad­vi­sors, The Biotech­nol­o­gy Val­ue Fund, Box­er Cap­i­tal of Tavi­s­tock Group, and Amzak Health, as well as oth­er new and ex­ist­ing in­vestors.

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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UP­DAT­ED: 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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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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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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Atul Deshpande, Harbour BioMed chief strategy officer & head, US operations (Harbour BioMed)

An­oth­er biotech IPO set-up? Multi­na­tion­al biotech leaps from round to round, scoop­ing up cash at a blis­ter­ing pace

A short four months after announcing a $75 million haul in Series B+ fundraising, the multinational biotech Harbour BioMed pulled in another round of investments and eclipsed the nine-digit mark in the process.

Harbour completed its Series C financing, the company announced Thursday morning, raising $102.8 million and bringing its total investment sum to over $300 million since its founding in late 2016. The biotech plans to use the money to transition early-stage candidates from the discovery phase, fund candidates already in the clinic, and prep late-stage candidates for commercialization.

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An­oth­er four biotechs scratch out the first num­ber and ask for more as IPO boom con­tin­ues

Four more biotechs are raising their offers in an already record year for biotech IPOs.

Softbank-backed Relay Therapeutics scratched out its original $200 million filing and proposed a $250 million raise that would make them a $1.5 billion company. CAR-T developer Poseida Therapeutics bumped itself up $74 million to $224 million. Off-the-shelf cell therapy startup Nkarta upped from $150 million to $215 million — and then priced even higher, at $252 million. France’s Inventiva did its own modest reset, raising its bar from $102 million to $108 million.

Top biotech an­a­lyst projects a gloomy out­look for Pfiz­er's JAK port­fo­lio

Many in the pharma world are hoping — better yet, expecting — JAK inhibitors to provide one of the next big boons for the industry. Few have invested as heavily in this area as Pfizer, which boasts a portfolio including Xeljanz and at least five mid-to-late stage candidates in the pipeline.

But a top Wall Street analyst is pumping the brakes on just how much good fortune is in store for the Big Pharma.