Roche is bring­ing back gan­tenerum­ab from the dead, tak­ing an­oth­er stab at Alzheimer’s PhI­II

Mar­lies Spro­ll, Mor­phoSys

Alzheimer’s drugs are ex­pen­sive to test and un­like­ly to suc­ceed, but they are al­so hard to kill.

More than two years af­ter gan­tenerum­ab failed de­ci­sive­ly in treat­ing ear­ly-stage Alzheimer’s, Roche is map­ping out an at­tempt­ed come­back through a new, piv­otal Phase III pro­gram that puts them back in­to the late-stage pipeline with their sec­ond ther­a­py.

In­ves­ti­ga­tors stub­born­ly vowed back at an in­ter­na­tion­al Alzheimer’s con­fer­ence in 2015 that if you amped up the dosage of the amy­loid be­ta an­ti­body it would be pos­si­ble to track a re­al treat­ment ef­fect for Alzheimer’s, im­prov­ing cog­ni­tion and func­tion. And now Roche part­ner Mor­phoSys, which con­tributed its plat­form tech in dis­cov­er­ing the drug, says the phar­ma gi­ant is go­ing for it — again.

The Ger­man biotech says that its con­tacts at Roche are plan­ning to launch two Phase III stud­ies in mild to pro­dro­mal pa­tients some­time lat­er in the year, stick­ing to a group of pa­tients who are just be­gin­ning to demon­strate symp­toms of the mem­o­ry-wast­ing ail­ment.

Roche nev­er gave up on gan­tenerum­ab. Roche neu­ro­science de­vel­op­ment chief Paulo Fon­toura tells me they’ve been us­ing two ex­tend­ed stud­ies to see if they can safe­ly use a much, much high­er dose need­ed to have an im­pact on the dis­ease with­out stir­ring up dan­ger­ous lev­els of ARIA-E, or brain swelling.

“We want­ed to find out if 4- or 5-fold (high­er dos­es) would be suc­cess­ful,” Fon­toura tells me, while con­trol­ling any cas­es of ARIA-E. And all in­di­ca­tions,he adds, is that they are on the right track.

Noth­ing has worked in Alzheimer’s R&D over the last 14 years, and gan­tenerum­ab looked like it would join a list of the most promi­nent drugs in the field to wash out of a big Phase III. But re­searchers have al­so been em­bold­ened by bet­ter di­ag­nos­tics to se­lect pa­tients as well as by the ear­ly da­ta from Bio­gen’s ad­u­canum­ab pro­gram which has shown glim­mers of ef­fi­ca­cy. Eli Lil­ly on­ly re­cent­ly wrapped its last piv­otal shot at solanezum­ab, its third straight fail­ure.

Mer­ck has al­so con­tributed to the drum­beat of fail­ures, re­cent­ly con­ced­ing de­feat in the most ad­vanced study of a BACE drug that tried to move up­stream in the dis­ease process, pre­vent­ing the pro­duc­tion of tox­ic lev­els of amy­loid be­ta. And Lund­beck flopped with its three Phase III stud­ies of their 5-HT6 an­tag­o­nist idalopir­dine, leav­ing Ax­o­vant as the last com­pa­ny to test that symp­to­matic ap­proach in a piv­otal study.

Why the ded­i­ca­tion? There are no drugs that can mod­i­fy the pro­gres­sion of Alzheimer’s and a big de­mand for any new symp­to­matic ther­a­pies that can slow the im­pact of the dis­ease, leav­ing the field wide open for a block­buster in­tro­duc­tion. And with every set­back, re­searchers in­sist that the same drugs could work un­der dif­fer­ent cir­cum­stances.

Now Roche will soon have two piv­otal pro­grams for Alzheimer’s back in the clin­ic, with gan­tenerum­ab run­ning along­side crenezum­ab.

“This is great news for Mor­phoSys. We are de­light­ed by the strong com­mit­ment to gan­tenerum­ab as a po­ten­tial new ther­a­py for Alzheimer’s dis­ease”, com­ment­ed Mar­lies Spro­ll, the chief sci­en­tif­ic of­fi­cer of Mor­phoSys AG. “The Hu­CAL-de­rived an­ti­body gan­tenerum­ab has prop­er­ties that we be­lieve make it a promis­ing can­di­date to treat Alzheimer’s dis­ease, and we look for­ward to learn­ing more about these new Phase III tri­als.”

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Gilead re­leas­es an­oth­er round of murky remde­sivir re­sults

A month after the NIH declared the first trial on remdesivir in Covid-19 a success, Gilead is out with new results on their antiviral. But although the study met one of its primary endpoints, the data are likely to only add to a growing debate over how effective the drug actually is.

In a Phase III trial, patients given a 5-day dose of remdesivir were 65% more likely to show “clinical improvement” compared to an arm given standard-of-care. The trial, though, gave little indication for whether the drug had an impact on key endpoints such as survival or time-to-recovery. And in a surprising twist, a 10-day dosing arm of remdesivir didn’t lead to a statistically significant improvement over standard of care.

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Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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Ken Frazier, AP Images

Why Mer­ck wait­ed, and what they now bring to the Covid-19 fight

Nicholas Kartsonis had been running clinical infectious disease research at Merck for almost 2 years when, in mid-January, he got a new assignment: searching the pharma giant’s vast libraries for something that could treat the novel coronavirus.

The outbreak was barely two weeks old when Kartsonis and a few dozen others got to work, first in small teams and then in a larger task force that sucked in more and more parts of the sprawling company as Covid-19 infected more and more of the globe. By late February, the group began formally searching for vaccine and antiviral candidates to license. Still, while other companies jumped out to announce their programs and, eventually and sometimes controversially, early glimpses at human data, Merck remained silent. They made only a brief announcement about a data collection partnership in April and mentioned vaguely a vaccine and antiviral search in their April 28 earnings call.

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Mark Genovese (Stanford via Twitter)

Gilead woos fil­go­tinib clin­i­cal in­ves­ti­ga­tor from Stan­ford to lead the charge on NASH, in­flam­ma­to­ry dis­eases

With an FDA OK for the use of filgotinib in rheumatoid arthritis expected to drop any day now, Gilead has recruited a new leader from academia to lead its foray into inflammatory diseases.

Mark Genovese — a longtime Stanford professor and most recently the clinical chief in the division of immunology and rheumatology — was the principal investigator in FINCH 2, one of three studies that supported Gilead’s NDA filing. In his new role as SVP, inflammation, he will oversee the clinical development of the entire portfolio.

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Bris­tol My­ers Squib­b's just-launched MS drug Zeposia makes the cut in key ul­cer­a­tive col­i­tis tri­al

In March, Zeposia became the third oral S1P modulator to secure US approval for multiple sclerosis. Now, the drug has succeeded in a key ulcerative colitis study.

The immunomodulator, akin to others in its class, controls lymphocyte trafficking by limiting the white blood cells to the lymphatic system, in the lymph nodes, and thwarting their ability to jam up lymph nodes — precluding their ability to penetrate the bloodstream and the central nervous system.

Stephen Isaacs, Aduro president and CEO (Aduro)

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After a drumbeat of failure, setbacks and reorganizations over the last few years, Aduro CEO Stephen Isaacs is handing over his largely gutted-out shell of a public company to another biotech company and putting up some questionable assets in a going-out-of-business sale.

Isaacs —who forged a string of high-profile Big Pharma deals along the way — has wrapped a 13-year run at the biotech with one program for kidney disease going to the new owners at Chinook Therapeutics. A host of once-heralded assets like their STING agonist program partnered with Novartis (which dumped their work on ADU-S100 after looking over weak clinical results), the Lilly-allied cGAS-STING inhibitor program and the anti-CD27 program out-licensed to Merck will all be posted for auction under a strategic review process.

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Len Schleifer (left) and George Yancopoulos, Regeneron (Vimeo)

Eyes on he­mo­phil­ia prize, Re­gen­eron adds a $100M wa­ger on joint de­vel­op­ment cam­paign with In­tel­lia

When George Yancopoulos first signed up Intellia to be its CRISPR/Cas9 partner on gene editing projects 4 years ago, the upstart smartly ramped up its IPO at the same time. Today, Regeneron $REGN is coming back in, adding $100 million in an upfront fee and equity to significantly boot up a whole roster of new development projects.

And they’re highlighting some clinical hemophilia research plans in the process.

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Hill­house re­casts spot­light on Chi­na's biotech scene with $160M round for Shang­hai-based an­ti­body mak­er

Almost two years after first buying into Genor Biopharma’s pipeline of cancer and autoimmune therapies, Hillhouse Capital has led a $160 million cash injection to push the late-stage assets over the finish line while continuing to fund both internal R&D and dealmaking.

The Series B has landed right around the time Genor would have listed on the Hong Kong stock exchange, according to plans reported by Bloomberg late last year. Insiders had said that the company was looking to raise about $200 million.

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