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.

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 has 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.

#ES­MO20: Push­ing in­to front­line, Mer­ck and Bris­tol My­ers duke it out with new slate of GI can­cer da­ta

Having worked in parallel for years to move their respective PD-1 inhibitors up to the first-line treatment of gastrointestinal cancers, Merck and Bristol Myers Squibb finally have the data at ESMO for a showdown.

Comparing KEYNOTE-590 and CheckMate-649, of course, comes with the usual caveats. But a side-by-side look at the overall survival numbers also offer some perspective on a new frontier for the reigning checkpoint rivals, both of whom are claiming to have achieved a first.

Is­raeli biotech rais­es $57M to go where cur­rent BRAF in­hibitors can't, with back­ing from No­var­tis, SR One

For the blockbuster potential of Novartis’ Tafinlar and Pfizer’s Braftovi, all the BRAF inhibitors on the market so far only target V600 mutations — which accounts for roughly 50% of patients.

Israeli biotech Novellus now has $57 million to develop a drug that they say can help the other 50% who have everything else.

The Series C will fund a Phase II trial for PLX-8394, a “paradox breaker” that could block RAF without activating MAPK signaling. In a Phase I trial, a patient with a BRAF fusion saw their tumor go away after taking the drug, allowing Novellus to hit the ground running.

Jonathan Rigby, Immune Regulation group CEO

Im­mune Reg­u­la­tion, tak­ing two clin­i­cal pro­grams to 're­set' the im­mune sys­tem, nets $53M+ Se­ries B

A little under two years after a company rebranding, Immune Regulation is taking an even bigger step toward advancing its goals.

Formerly known as Peptinnovate, the British biotech announced a $53.4 million Series B early Monday morning, helping to further advance two clinical programs in rheumatoid arthritis and asthma. Though those are the two initial indications the company is focusing on, CEO Jonathan Rigby told Endpoints News he hopes the candidates can be applied to a broad swath of autoimmune disorders.

UP­DAT­ED: Two wild weeks for Grail end in $8B Il­lu­mi­na buy­out

Grail’s whirlwind two weeks have ended in the wealthy arms of its former founder and benefactors.

Illumina has shelled out $8 billion to reacquire the closely-watched liquid biopsy startup they spun out just 5 years ago and sold off much of its shares just 3 years ago. The deal comes nearly two weeks after the well-heeled startup filed for a potentially massive IPO — one that was disrupted just a week later when Bloomberg reported that Illumina was in talks to buy their former spinout for up to $8 billion.

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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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#ES­MO20: Bris­tol My­ers marks Op­di­vo's sec­ond ad­ju­vant win — eye­ing a stan­dard of care gap

Moving into earlier and earlier treatment lines, Bristol Myers Squibb is reporting that adjuvant treatment with Opdivo has doubled the time that esophageal or gastroesophageal junction cancer patients stay free of disease.

With the CheckMate-577 data at ESMO, CMO Samit Hirawat said, the company believes it can change the treatment paradigm.

While a quarter to 30% of patients typically achieve a complete response following chemoradiation therapy and surgery, the rest do not, said Ronan Kelly of Baylor University Medical Center. The recurrence rate is also high within the first year, Hirawat added.

Donald Trump, AP

Covid-19 roundup: Trump sug­gests Pfiz­er vac­cine could be first ap­proved; VBI Vac­cines inks de­vel­op­ment deal with Cana­da

President Donald Trump commented Monday morning that Pfizer’s Covid-19 vaccine candidate could be the first to win approval by regulators.

During an interview on a Fox News’ morning show, the president said Pfizer was doing “very well” when asked which candidate could be approved, according to a Reuters report. He added that J&J could follow up afterward, saying “they’ll probably be a little later.”

Clay Siegall (Life Science Washington via YouTube)

#ES­MO20: Seat­tle Ge­net­ics eyes 4th ap­proval with new da­ta in a crowd­ed field

Does Seattle Genetics have another approval on its hands?

The last 12 months, not so great for the world, has been great for Seattle Genetics. The company landed two separate FDA approvals, signed a $4.5 billion deal with Merck and watched antibody-drug conjugates — the technology they spent years developing to broad industry skepticism — emerge suddenly as one of the most popular approaches in oncology. And on Monday at ESMO, the company and their partners at Genmab unveiled the data behind the ADC it hopes will provide its next major FDA approval.