At­tempt­ing to bounce back af­ter mid-stage flop, Novus piv­ots to im­munol­o­gy with CD40L-fo­cused ac­qui­si­tion of Anelix­is

Fol­low­ing a mid-stage fail­ure of its acute oti­tis me­dia can­di­date back in June that sent its shares deep in­to pen­ny stock ter­ri­to­ry, Novus Ther­a­peu­tics has found what it be­lieves to be a new, ex­cit­ing path for­ward in im­munol­o­gy.

The Irvine, CA-based com­pa­ny, orig­i­nal­ly called Tokai Phar­ma­ceu­ti­cals, an­nounced Mon­day af­ter­noon the ac­qui­si­tion of Anelix­is Ther­a­peu­tics — a biotech that was spun out of the ALS Ther­a­py De­vel­op­ment In­sti­tute in Boston in 2015 — as well as $108 mil­lion in pri­vate place­ment fund­ing led by BVF Part­ners. Anelix­is’ lead pro­gram AT-1501, an an­ti-CD40L an­ti­body, will be cen­tral to Novus’ new fo­cus, and the com­pa­ny is bring­ing along David-Alexan­dre Gros to steer the ship as new CEO.

David-Alexan­dre Gros

“The con­cept and dis­cus­sions were around not on­ly how to con­tin­ue to move this as­set for­ward in ALS, but al­so rec­og­niz­ing the broad­er po­ten­tial of the CD40 lig­and and be­gin­ning to think about how one could de­vel­op the as­set more broad­ly,” Gros, who joins the com­pa­ny af­ter co-found­ing Im­bria, told End­points News.

Novus’ new fund­ing will get AT-1501 through four Phase II tri­als in re­nal trans­plan­ta­tion, islet cell trans­plan­ta­tion, au­toim­mune nephri­tis and ALS. Sev­er­al oth­er in­vestors par­tic­i­pat­ed in the pri­vate place­ment, in­clud­ing Cor­morant As­set Man­age­ment, Ecor1, Lo­gos, Fi­deli­ty Man­age­ment and Re­search, Adage, Wood­line, Ridge­back Cap­i­tal, Janus Hen­der­son, and Sam­sara Bio­Cap­i­tal.

Join­ing Gros at Novus is Steven Per­rin, the founder and CEO of Anelix­is, who will work as the com­pa­ny’s new pres­i­dent and CSO. When Anelix­is was found­ed, the biotech spent its re­sources study­ing AT-1501’s ef­fect in the treat­ment of ALS, man­ag­ing to com­plete a Phase I tri­al eval­u­at­ing the com­pound’s safe­ty.

CD40 has a long his­to­ry of re­search, Per­rin said, and block­ing the path­way can in­duce pro­found ef­fects in the bi­ol­o­gy of both B cells and T cells, cre­at­ing po­ten­tial op­por­tu­ni­ties for drugs to treat a host of au­toim­mune dis­or­ders like mul­ti­ple scle­ro­sis, rheuma­toid arthri­tis and type 1 di­a­betes. But in ear­li­er ef­forts by com­pa­nies to cre­ate an­ti-CD40 drugs, sev­er­al in­stances of blood clots arose, putting ear­ly but ex­cit­ing clin­i­cal pro­grams on hold.

Promi­nent­ly, in 2018, a UCB and Bio­gen an­ti-CD40L pro­gram de­signed to treat lu­pus flopped in a Phase IIb tri­al. Lu­pus, how­ev­er, has been a chal­leng­ing in­di­ca­tion for years as the field has seen one FDA ap­proval in GSK’s Benlysta. As­traZeneca spin­out Viela Bio is al­so work­ing on an an­ti-CD40L in kid­ney trans­plant re­jec­tion, cur­rent­ly in a Phase II tri­al.

Steve Per­rin

Novus hopes to set it­self apart from the com­pe­ti­tion by fo­cus­ing on the CD40 lig­and, rather than the re­cep­tor, as part of an emerg­ing new gen­er­a­tion of trans­plant re­jec­tion ther­a­pies. The op­por­tu­ni­ty to join this pack is one of the main rea­sons why the pro­gram is be­ing ex­pand­ed from an ini­tial ALS tar­get in­to oth­er in­di­ca­tions, Per­rin said.

“The most im­por­tant part of the his­tor­i­cal da­ta is that to this day, block­ing CD40 lig­and sig­nal­ing is the most ef­fec­tive way to pre­vent trans­plant re­jec­tion in mul­ti­ple an­i­mal mod­els,” Per­rin said. “That’s why there’s been a long-term fo­cus on this path­way; it could re­al­ly be a trans­for­ma­tion­al way to treat au­toim­mune in­di­ca­tions and trans­plants.”

From Anelix­is’ busi­ness per­spec­tive, Per­rin and his team de­cid­ed to go against the tra­di­tion­al fundrais­ing — and even­tu­al IPO — route af­ter wrap­ping up the pro­gram’s Phase I at the end of 2019. Anelix­is want­ed to fur­ther AT-1501 de­vel­op­ment as the com­pa­ny was ex­cit­ed by their da­ta, but need­ed more than just cash. Novus’ ex­ist­ing in­fra­struc­ture, both from an ad­min­is­tra­tive and op­er­a­tional stand­point, made the pair­ing a suit­able match, Per­rin said.

Next up are the Phase II tri­als, af­ter which Novus will de­ter­mine fu­ture steps.

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.

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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President Donald Trump (via AP Images)

Signs of an 'Oc­to­ber Vac­cine Sur­prise' alarm ca­reer sci­en­tists

President Donald Trump, who seems intent on announcing a COVID-19 vaccine before Election Day, could legally authorize a vaccine over the objections of experts, officials at the FDA and even vaccine manufacturers, who have pledged not to release any vaccine unless it’s proved safe and effective.

In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Trump — who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA — will take matters into his own hands, running roughshod over the usual regulatory process.

#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.

Sebastian Nijman (file photo)

Roche looks to ge­net­ic mod­i­fiers for new drug tar­gets, team­ing up with Dutch biotech in $375M deal

Roche is gambling on a new way of discovering drug targets and, ultimately, promising to infuse more than $375 million into a small biotech if all goes well.

A spinout of the Netherlands Cancer Institute and Oxford University, Scenic Biotech set out to pioneer a field that’s gaining some traction among top VCs in the US: to harness the natural protecting powers of genetic modifiers — specific genes that suppress a disease phenotype.

Anthony Fauci (AP Images)

A press of­fi­cer at An­tho­ny Fau­ci’s NI­AID was un­masked as a hard-right Covid troll. He just re­tired to­day

William B Crews had been a public affairs specialist at the NIH’s National Institute of Allergy and Infectious Diseases.

That ended today when he informed the agency of his decision to retire, after he was identified as the managing editor at RedState, a prominent Trump loyalist website.

Crews’ RedState duties are performed under the alias streiff. While enjoying the benefits of pseudonymity, he disparaged and worked against NIAID with an incendiary level of rhetoric in the midst of a pandemic.

#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.”