Roche's Alzheimer's drug spurred bio­mark­er changes but no cog­ni­tive im­pact — pa­per; vTv out-li­cens­es for­mer lead pro­gram

More than a year ago, Roche and Eli Lil­ly were forced to con­tend with a Phase II/III fail­ure of their re­spec­tive Alzheimer’s drugs. But while Eli Lil­ly es­sen­tial­ly threw in the tow­els, Roche wasn’t ready to give up yet.

The Swiss drug­mak­er now has some bio­mark­er da­ta to spot­light as in­ves­ti­ga­tors con­tin­ue mon­i­tor­ing pa­tients in an open-la­bel ex­ten­sion study.

Dubbed DI­AN-TU, the study had been de­signed to see whether Roche’s gan­tenerum­ab and Lil­ly’s solanezum­ab could spur a cog­ni­tive ben­e­fit for a group of pa­tients who had a rare, in­her­it­ed form of Alzheimer’s that’d tied to ear­ly-on­set. In short, they didn’t: Both failed the pri­ma­ry end­point.

How­ev­er, in a new study pub­lished on Na­ture Med­i­cine, the in­ves­ti­ga­tors from the Wash­ing­ton Uni­ver­si­ty at St Louis not­ed that the two drugs didn’t per­form ex­act­ly the same way.

“The solanezum­ab-treat­ed group showed a greater cog­ni­tive de­cline on some mea­sures and did not show ben­e­fits on down­stream bio­mark­ers,” they wrote. “Gan­tenerum­ab sig­nif­i­cant­ly re­duced amy­loid plaques, cere­brospinal flu­id to­tal tau, and phos­pho-tau181 and at­ten­u­at­ed in­creas­es of neu­ro­fil­a­ment light chain.”

No­tably, both drugs were said to have en­gaged the be­ta-amy­loid tar­get — the ba­sis for the con­tro­ver­sial FDA ac­cel­er­at­ed ap­proval of Bio­gen’s Aduhelm.

Roche is run­ning two oth­er Phase III tri­als for gan­tenerum­ab in­volv­ing pa­tients with ear­ly spo­radic Alzheimer’s dis­ease. — Am­ber Tong

vTv out-li­cens­es for­mer lead Alzheimer’s pro­gram to Can­tex

Once herald­ing a drug can­di­date that flopped mul­ti­ple tests in Alzheimer’s dis­ease, vTv Ther­a­peu­tics has said au revoir to the pro­gram.

The small biotech an­nounced Tues­day that it has li­censed out the com­pound, azeli­ragon, to Can­tex Phar­ma­ceu­ti­cals. vTv is giv­ing Can­tex ex­clu­sive world­wide rights to de­vel­op and com­mer­cial­ize the can­di­date, ef­fec­tive­ly punt­ing on what was once their lead pro­gram.

But azeli­ragon pro­duced less than stel­lar re­sults in Alzheimer’s dis­ease about three years ago, a field that’s seen more than its fair share of clin­i­cal tri­al fail­ures. The pro­gram failed to make a mark and mild and mod­er­ate dis­ease, de­spite vTv’s ef­forts to high­light a po­ten­tial pos­i­tive in a sub­group of pa­tients with low­er max­i­mal plas­ma con­cen­tra­tions of azeli­ragon.

Fi­nan­cial terms of the deal weren’t dis­closed, but in a state­ment, Can­tex said it’s look­ing to ad­vance the RAGE an­tag­o­nist in can­cer. — Max Gel­man

Gy­ro­scope pairs up with Aus­tralian re­search cen­ter for gene ther­a­py cap­sids

Gy­ro­scope Ther­a­peu­tics is team­ing up with an Aus­tralian pe­di­atric re­search in­sti­tute in or­der to fur­ther de­vel­op gene ther­a­pies.

The Lon­don-based biotech will col­lab with Chil­dren’s Med­ical Re­search In­sti­tute to push for­ward R&D work in cap­sids for oc­u­lar gene ther­a­pies, the pair an­nounced Tues­day. A team of re­searchers from CM­RI and Gy­ro­scope will work to­geth­er in de­sign­ing and screen­ing cap­sid li­braries to iden­ti­fy new cap­sids for en­hanced de­liv­ery of such treat­ments. The CM­RI team is led by Leszek Lisows­ki.

“Cap­sids are one of the most crit­i­cal com­po­nents of a gene ther­a­py, how­ev­er, there are some lim­i­ta­tions with the cap­sids avail­able to­day,” said Gy­ro­scope CSO Jane Hugh­es in a state­ment. “We are ex­cit­ed to col­lab­o­rate with as­so­ciate pro­fes­sor Lisows­ki and the team at CM­RI to en­gi­neer next-gen­er­a­tion cap­sids.” — Max Gel­man

LegoChem and Ik­su­da ex­pand agree­ment for ADC plat­form

Fol­low­ing the suc­cess of their first agree­ment, Ik­su­da Ther­a­peu­tics has reached a li­cense agree­ment with South Ko­rea-based LegoChem Bio­sciences to ex­pand its re­search, it an­nounced Tues­day.

The agree­ment will ex­plore ad­di­tion­al an­ti­body drug con­ju­gates. In April 2020, Ik­su­da li­censed three of its pro­grams us­ing the LCB’s ADC link­er/tox­in plat­form, and has been grant­ed the rights for three ad­di­tion­al tar­gets, bring­ing its to­tal num­ber of po­ten­tial pro­grams to six, the com­pa­ny said. Its pro­grams tar­get tu­mors that have lim­it­ed treat­ment op­tions and high treat­ment rates.

“Our part­ner­ship has val­i­dat­ed the su­pe­ri­or­i­ty of LCB’s ADC plat­form tech­nol­o­gy and the com­pet­i­tive po­ten­tial of IKS03 (for­mer­ly known as LCB73) as an in­no­v­a­tive ADC drug,” LegoChem CEO Yong-Zu Kim said in the press re­lease. “This val­i­da­tion has led to the ex­e­cu­tion of this ex­pand­ed li­cense agree­ment. We will con­tin­ue to co­op­er­ate close­ly with Ik­su­da to ac­cel­er­ate the ad­vance­ment of all LCB-re­lat­ed ADC can­di­dates in­to clin­ic.”

Ik­su­da re­cent­ly com­plet­ed a $47 mil­lion fi­nanc­ing round to help sup­port the ad­vance­ment of its lead ADC pro­grams. — Josh Sul­li­van

Adap­tive De­sign Meth­ods Of­fer Rapid, Seam­less Tran­si­tion Be­tween Study Phas­es in Rare Can­cer Tri­als

Rare cancers account for 22 percent of cancer diagnoses worldwide, yet there is no universally accepted definition for a “rare” cancer. Moreover, with the evolution of genomics and associated changes in categorizing tumors, some common cancers are now characterized into groups of rare cancers, each with a unique implication for patient management and therapy.

Adaptive designs, which allow for prospectively planned modifications to study design based on accumulating data from subjects in the trial, can be used to optimize rare oncology trials (see Figure 1). Adaptive design studies may include multiple cohorts and multiple tumor types. In addition, numerous adaptation methods may be used in a single trial and may facilitate a more rapid, seamless transition between study phases.

Matt Gline (L) and Pete Salzmann

UP­DAT­ED: Roivant bumps stake in Im­muno­vant with a $200M deal. But with M&A off the ta­ble, shares crater

Roivant has worked out a deal to pick up a chunk of stock in its majority-owned sub Immunovant $IMVT, but the stock buy falls far short of its much-discussed thoughts about buying out all of the 43% of shares it doesn’t already own.

Roivant, which recently inked a SPAC move to the market at a $7 billion-plus valuation, has forged a deal to boost its ownership in Immunovant by 6.3 points, ending with 63.8% of the biotech’s stock following a $200 million injection. That cash will bolster Immunovant’s cash reserves, giving it a $600 million war chest to fund a slate of late-stage studies for its big drug: the anti-FcRn antibody IMVT-1401.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 113,300+ biopharma pros reading Endpoints daily — and it's free.

Sanofi preps a multi­bil­lion-dol­lar buy­out of an mR­NA pi­o­neer af­ter falling be­hind in the race for a Covid-19 jab — re­port

It looks like Sanofi CEO Paul Hudson is dead serious about his intention to vault directly into contention for the future of mRNA vaccines.

A year after paying Translate Bio a whopping $425 million in an upfront and equity payment to help guide the pharma giant to the promised land of mRNA vaccines for Covid-19, Sanofi is reportedly ready to close the deal with a buyout.

Translate’s stock $TBIO soared 78% after the market closed Monday. A spokesperson for Sanofi declined to comment on the report, telling Endpoints News that the company doesn’t comment on market rumors.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 113,300+ biopharma pros reading Endpoints daily — and it's free.

FTC pulls re­main­ing case against Ab­b­Vie; New EU clin­i­cal tri­als sys­tem com­ing in 2022; Abing­worth bets big on CymaBay

The Federal Trade Commission on Friday withdrew its remaining case against AbbVie after the Supreme Court declined to review a lower court’s ruling.

The punt by SCOTUS means that while the Illinois pharma company illegally blocked patients’ access to lower-cost alternatives to its testosterone drug AndroGel, the FTC will no longer be able to return about $500 million directly to AndroGel consumers.

UP­DAT­ED: Watch out Glax­o­SmithK­line: As­traZeneca's once-failed lu­pus drug is now ap­proved

Capping a roller coaster journey, AstraZeneca has steered its lupus drug anifrolumab across the finish line.

Saphnelo, as the antibody will be marketed, is the only treatment that’s been approved for systemic lupus erythematosus since GlaxoSmithKline’s Benlysta clinched an OK in 2011. The British drugmaker notes it’s also the first to target the type I interferon receptor.

Mirroring the population that the drug was tested on in late-stage trials, regulators sanctioned it for patients with moderate to severe cases who are already receiving standard therapy — setting up a launch planned for the end of August, according to Ruud Dobber, who’s in charge of AstraZeneca’s biopharmaceuticals business unit.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 113,300+ biopharma pros reading Endpoints daily — and it's free.

Not all mR­NA vac­cines are cre­at­ed equal. Does it mat­ter?; Neu­ro is back; Pri­vate M&A af­fair; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

As part of our broader and deeper drive, Endpoints has been pairing webinars with our special reports to cover more angles on a given topic. In conjunction with Max Gelman’s neuroscience feature, Kyle Blankenship moderated an insightful panel to discuss where the field is headed. You can register to watch it on demand here.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 113,300+ biopharma pros reading Endpoints daily — and it's free.

Bris­tol My­ers pulls lym­phoma in­di­ca­tion for Is­to­dax af­ter con­fir­ma­to­ry tri­al falls flat

Amid an industrywide review of cancer drugs with accelerated approval, Bristol Myers Squibb had to make the tough call last month to yank an approval for leading I/O drug Opdivo after flopping a confirmatory study. Now, a second Bristol Myers drug is on the chopping block.

Bristol Myers has pulled aging HDAC inhibitor Istodax’s indication in peripheral T cell lymphoma after a Phase III confirmatory study for the drug flopped on its progression-free survival endpoint, the drugmaker said Monday.

Rick Pazdur (via AACR)

FDA's on­col­o­gy head Rick Paz­dur de­fends the ac­cel­er­at­ed ap­proval path­way, claim­ing it is 'un­der at­tack'

The FDA is sounding the alarm over its accelerated approval pathway as backlash continues over the recent nod in favor of Biogen’s Alzheimer’s drug Aduhelm, and an ODAC meeting on six such approvals that could potentially be pulled from the market — two of which already have.

“Do you think accelerated approval is under attack? I do,” Rick Pazdur, head of FDA’s Oncology Center of Excellence, said at a Friends of Cancer Research webinar on Thursday.

Endpoints Premium

Premium subscription required

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

Alan Hirzel, Abcam

Drug sup­pli­er Ab­cam brings a long­time col­lab­o­ra­tor in house as part of $340M buy­out pact

BioVision has supplied Abcam with research tools since 1999, and now the two are making it official as part of a merger unveiled Monday.

Abcam will buyout BioVision as part of a $340 million acquisition deal to bring aboard the supplier’s biochemical and cell-based assays for biological research, as well as recombinant proteins, antibodies and enzymes.

The deal will give Abcam control of BioVision’s portfolio and allow for both the expansion of research existing areas of focus such as oncology, neuroscience and epigenetics and preparation to expand into new products. As a part of the deal, Abcam will develop and supply products and services to NKY, the previous owner of BioVision and receive support for ongoing development and commercialization of in vitro diagnostic products.