Fer­ring buys up PhI­II mi­cro­bio­me drug with ac­qui­si­tion of Re­bi­otix

A Min­neso­ta com­pa­ny work­ing on a drug that could be the na­tion’s first pill packed with mi­crobes has been snatched up by Swiss drug mak­er Fer­ring Phar­ma­ceu­ti­cals.

The start­up, called Re­bi­otix, was ac­quired in a deal that closed Wednes­day with undis­closed terms. The com­pa­ny is de­vel­op­ing a fe­cal mi­cro­bio­ta trans­plant dubbed RBX-2660 that’s cur­rent­ly in Phase III tri­als. It’s be­ing test­ed against an in­fec­tion caused by C dif­fi­cile, a bac­te­ria that can in­duce symp­toms rang­ing from di­ar­rhea to life-threat­en­ing in­flam­ma­tion of the colon. The in­fec­tion of­ten oc­curs in old­er pa­tients in hos­pi­tals or long-term care who hap­pen to be tak­ing an­tibi­otics for a long pe­ri­od of time. Iron­i­cal­ly, the stan­dard treat­ment for C diff is to take the pa­tient off the an­tibi­ot­ic that caused the in­fec­tion… and then put them on an­oth­er an­tibi­ot­ic.

Re­bi­otix’s RBX-2660 works quite dif­fer­ent­ly than an an­tibi­ot­ic. It re­pop­u­lates the gut mi­cro­bio­me, and the trans­plant­ed mi­crobes then go to war with C diff, pre­vent­ing it from grow­ing and forc­ing it out of the gut. The treat­ment could be a game-chang­er for pa­tients, which is why the FDA gave it fast track, break­through, and or­phan drug des­ig­na­tions.

Michel Pet­ti­grew

Fer­ring says it’s not pick­ing up Re­bi­otix just for one as­set. It thinks the start­up’s drug plat­form will de­liv­er long-term gains.

“The sci­en­tif­ic ad­vances Re­bi­otix has made add sig­nif­i­cant strate­gic val­ue to Fer­ring’s lead­er­ship in gas­troen­terol­o­gy,” Michel Pet­ti­grew, COO and pres­i­dent of the ex­ec­u­tive board at Fer­ring Phar­ma­ceu­ti­cals said in a state­ment. “Ther­a­pies tar­get­ed to­wards the mi­cro­bio­me have the po­ten­tial to trans­form health­care. To­geth­er, we have a unique op­por­tu­ni­ty to help peo­ple liv­ing with de­bil­i­tat­ing and life-threat­en­ing con­di­tions like Clostrid­i­um dif­fi­cile in­fec­tion.”

On top of its buy­out of Re­bi­otix, Fer­ring has been in­vest­ing in the mi­cro­bio­me space for years. It’s got a li­cense agree­ment with My­Bi­otics for its women’s health ther­a­peu­tics and a re­search deal with Metabo­Gen for a mi­cro­bio­me-based treat­ment for tra­hep­at­ic cholesta­sis of preg­nan­cy. The com­pa­ny al­so has part­ner­ships with re­search or­ga­ni­za­tions in mi­cro­bio­me are­na, in­clud­ing with the Karolin­s­ka In­sti­tutet and Sci­ence for Life Lab­o­ra­to­ry, and the Cen­tre for Trans­la­tion­al Mi­cro­bio­me Re­search, among oth­ers.

Im­age: Clostrid­i­um dif­fi­cile bac­te­ria, 3D il­lus­tra­tion. SHUT­TER­STOCK

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

FDA commissioner Stephen Hahn at the White House (AP Images)

Un­der fire, FDA to is­sue stricter guid­ance for Covid-19 vac­cine EUA this week — re­port

The FDA has been insisting for months that a Covid-19 vaccine had to be at least 50% effective – a measure of transparency meant to shore public trust in the agency and in a vaccine that had been brought forward at record speed and record political pressure. But now, with concerns of a Trump-driven authorization arriving before the election, the agency may be raising the bar.

The FDA is set to release new guidance that would raise safety and efficacy requirements for a vaccine EUA above earlier guidance and above the criteria used for convalescent plasma or hydroxychloroquine, The Washington Post reported. Experts say this significantly lowers the odds of an approval before the election on November 3, which Trump has promised despite vocal concerns from public health officials, and could help shore up public trust in the agency and any eventual vaccine.

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.

Vas Narasimhan (AP Images)

UP­DAT­ED: Still held down by clin­i­cal hold, No­var­tis' Zol­gens­ma falls fur­ther be­hind Bio­gen and Roche as FDA asks for a new piv­otal study

Last October, the FDA slowed down Novartis’ quest to extend its gene therapy to older spinal muscular atrophy patients by slapping a partial hold on intrathecal administration. Almost a year later, the hold is still there, and regulators are adding another hurdle required for regulatory submission: a new pivotal confirmatory study.

The new requirement — which departs significantly from Novartis’ prior expectations — will likely stretch the path to registration beyond 2021, when analysts were expecting a BLA submission. That could mean more time for Biogen to reap Spinraza revenues and Roche to ramp up sales of Evrysdi in the absence of a rival.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,400+ biopharma pros reading Endpoints daily — and it's free.

Scoop: ARCH’s Bob Nelsen is back­ing an mR­NA up­start that promis­es to up­end the en­tire man­u­fac­tur­ing side of the glob­al busi­ness

For the past 2 years, serial entrepreneur Igor Khandros relied on a small network of friends and close insiders to supply the first millions he needed to fund a secretive project to master a new approach to manufacturing mRNA therapies.

Right now, he says, he has a working “GMP-in-a-box” prototype for a new company he’s building — after launching 3 public companies — which plans to spread this contained, precise manufacturing tech around the world with a set of partners. He’s raised $60 million, recruited some prominent experts. And not coincidentally, he’s going semi-public with this just as a small group of pioneers appears to be on the threshold of ushering in the world’s first mRNA vaccines to fight a worldwide pandemic.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Isaac Veinbergs, Libra CEO

With $29M in Se­ries A, Boehringer-backed Li­bra looks to tack­le neu­rode­gen­er­a­tion through cel­lu­lar clean­ing

Can the natural process by which cells clean out toxic proteins be harnessed to create potential treatments for neurodegenerative disorders?

That’s the question Libra Therapeutics will be trying to answer, as the new biotech officially launched Wednesday morning with $29 million in Series A financing. The company has three preclinical programs at the ready, with its lead candidate targeting ALS and frontotemporal dementia. But CEO Isaac Veinbergs said he hopes to develop therapies for a wide range of diseases, including Parkinson’s, Alzheimer’s and Huntington’s.

Patrick Enright, Longitude co-founder (Longitude)

As its biotechs hit the pan­dem­ic ex­it, Lon­gi­tude rais­es $585M for new neu­ro, can­cer, ag­ing and or­phan-fo­cused fund

The years have been kind to Longitude Capital. This year, too.

A 2006 spinout of Pequot Capital, its founders started their new firm just four years before the parent company would go under amid insider trading allegations. Their first life sciences fund raised $325 million amid the financial crisis, they added a second for $385 million and then in, 2016, a third for $525 million. In the last few months, the pandemic biotech IPO boom netted several high-value exits from those funds, as Checkmate, Vaxcyte, Inozyme and Poseida all went public.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,400+ biopharma pros reading Endpoints daily — and it's free.

Gene Wang, Immetas co-founder and CEO (file photo)

Im­metas Ther­a­peu­tics nabs $11M Se­ries A to nar­row their bis­pe­cif­ic work tar­get­ing in­flam­ma­tion in age-re­lat­ed dis­eases

How does a biotech celebrate its two-year anniversary? For Immetas Therapeutics, it’s with an $11 million Series A round and a game plan to fight age-related disease.

Co-founders Gene Wang and David Sinclair came together years ago around the idea that inflammation is the ultimate process driving age-related illnesses, including cancer. The duo launched Immetas in 2018 and packed the staff with industry experts. Wang, who says he’s always had an entrepreneurial spirit, has held lead roles at Novartis, GSK, Bristol Myers Squibb and Merck. He’s worked on blockbuster drugs like Humira, Gardasil, Varubi and Zolinza. And now, he’s channeling that spirit as CEO.

Samit Hirawat (Bristol Myers Squibb)

Af­ter bruis­ing re­jec­tion, blue­bird and Bris­tol My­ers Squibb land ide-cel pri­or­i­ty re­view. But will it mat­ter for the CVR?

With the clock all but up, the FDA accepted and handed priority review to Bristol Myers Squibb and bluebird bio’s BCMA CAR-T, keeping a narrow window open for Celgene investors to still cash in on the $9 CVR from the $63 billion Celgene merger.

The acceptance comes five months after the two companies weres slammed with a surprise refuse-to-file that threatened to foreclose the CVR entirely. Today’s acceptance sets the FDA decision date for March 27, 2021 – or precisely 4 days before the CVR deadline of March 31. Given the breakthrough designation and strong pivotal data — 81.5% response rate, 35.2% complete response rate — priority review was largely expected.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,400+ biopharma pros reading Endpoints daily — and it's free.