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.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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So what hap­pened with No­var­tis' gene ther­a­py group? Here's your an­swer

Over the last couple of days it’s become clear that the gene therapy division at Novartis has quietly undergone a major reorganization. We learned on Monday that Dave Lennon, who had pursued a high-profile role as president of the unit with 1,500 people, had left the pharma giant to take over as CEO of a startup.

Like a lot of the majors, Novartis is an open highway for head hunters, or anyone looking to staff a startup. So that was news but not completely unexpected.

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Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Rafaèle Tordjman (Jeito Capital)

Con­ti­nu­ity and di­ver­si­ty: Rafaèle Tord­j­man's women-led VC firm tops out first fund at $630M

For a first-time fund, Jeito Capital talks a lot about continuity.

Rafaèle Tordjman had spotlighted that concept ever since she started building the firm in 2018, promising to go the extra mile(s) with biotech entrepreneurs while pushing them to reach patients faster.

Coincidentally, the lack of continuity was one of the sore spots listed in a report about the European healthcare sector published that same year by the European Investment Bank — whose fund is one of the LPs, alongside the American pension fund Teacher Retirement System of Texas and Singapore’s Temasek, to help Jeito close its first fund at $630 million (€534 million). As previously reported, Sanofi had chimed in €50 million, marking its first investment in a French life sciences fund.

When ef­fi­ca­cy is bor­der­line: FDA needs to get more con­sis­tent on close-call drug ap­provals, agency-fund­ed re­search finds

In the exceedingly rare instances in which clinical efficacy is the only barrier to a new drug’s approval, new FDA-funded research from FDA and Stanford found that the agency does not have a consistent standard for defining “substantial evidence” when flexible criteria are used for an approval.

The research comes as the FDA is at a crossroads with its expedited-review pathways. The accelerated approval pathway is under fire as the agency recently signed off on a controversial new Alzheimer’s drug, with little precedent to explain its decision. Meanwhile, top officials like Rick Pazdur have called for a major push to simplify and clarify all of the various expedited pathways, which have grown to be must-haves for sponsors of nearly every newly approved drug.

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Af­ter sell­ing to Genen­tech, the old Je­cure team is back at an RNA-fo­cused start­up — and more en­thu­si­as­tic than ever

When Genentech swooped in to buy NASH-focused Jecure Therapeutics back in 2018, a handful of the startup’s executives weren’t quite ready to disperse.

It had been just three years since Jecure launched with a preclinical portfolio of NLRP3 inhibitors — and the takeover came sooner than anyone, including CEO Jeff Stafford, had expected. So he got talking with James Veal and Gretchen Bain, two serial entrepreneurs in charge of Jecure’s R&D.

Lat­est news: It’s a no on uni­ver­sal boost­ers; Pa­tient death stuns gene ther­a­py field; In­side Tril­li­um’s $2.3B turn­around; and more

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