Rene Russo (Credit: Alicia Petitti Photography)

Xilio Ther­a­peu­tics eyes the fast track to the clin­ic with $95M in in­vestor cash to test re­designed IL-2, CT­LA-4 meds

About three years af­ter join­ing the search for IL-2  and CT­LA-4 ther­a­pies with­out all those nasty side ef­fects, Xilio Ther­a­peu­tics has teed up $95 mil­lion to dri­ve its two lead can­di­dates in­to the clin­ic.

The Se­ries C round was led by Rock Springs Cap­i­tal, and should al­low the small Waltham, Mass­a­chu­setts-based biotech to file INDs for XTX101, its an­ti-CT­LA-4 an­ti­body, in Q2 and XTX202, its IL-2 ag­o­nist, in Q3.

Tim Clack­son

Xilio got its start in 2018 un­der the name Akre­via with $30 mil­lion in launch mon­ey from At­las and F-Prime. The 13-per­son shop was head­ed by sci­en­tist Tim Clack­son, whose last job was run­ning R&D at Ari­ad un­til Take­da bought it out. Clack­son is now pres­i­dent and CTO.

The big idea — based on tech­nol­o­gy in-li­censed from Thomas Jef­fer­son Uni­ver­si­ty and City of Hope — was to take a set of an­ti­bod­ies, cy­tokines and chemokines that are ei­ther too dan­ger­ous or plagued with tox­i­c­i­ty is­sues and re­design them.

Two years lat­er, with CEO Rene Rus­so at the helm, the com­pa­ny bagged a $100.5 mil­lion Se­ries B and re­brand­ed to Xilio. The name was in­spired by ex ni­hi­lo, a Latin term for cre­ation or big bang.

“We view how our mol­e­cules work as com­plete­ly off or dark when they’re cir­cu­lat­ing in the pe­riph­ery,” Rus­so told End­points News at the time, “and this cre­ation or big bang as ef­fi­ca­cy in the tu­mor specif­i­cal­ly.”

Xilio’s plat­form in­volves shield­ing the bind­ing ac­tiv­i­ty of mol­e­cules un­til they meet the pro­teas­es in the tu­mor. Then the block­ing mod­ules are re­moved, re­leas­ing the ther­a­py just where it’s need­ed.

The biotech joins sev­er­al oth­ers work­ing on a new-and-im­proved IL-2, in­clud­ing Alk­er­mes, which high­light­ed its first glimpse of ef­fi­ca­cy at vir­tu­al ES­MO 2020. Nek­tar, whose pro­gram with Bris­tol My­ers Squibb’s Op­di­vo hit a snag back in 2018, an­nounced ear­li­er this month that it’s en­ter­ing be­m­pe­galdesleukin in a Phase II/III tri­al with Keytru­da. Sanofi struck a deal with Mer­ck in Oc­to­ber to pair Keytru­da with a next-gen im­muno-on­col­o­gy can­di­date snagged in the Syn­thorx buy­out. And back in Ju­ly, Bright Peak Ther­a­peu­tics launched out of Ver­sant’s Ridge­line Ther­a­peu­tics Dis­cov­ery En­gine with its own mod­i­fied IL-2 mol­e­cule.

“In our view, agents like IL-2 and CT­LA-4 have tremen­dous ther­a­peu­tic po­ten­tial, but have been re­al­ly lim­it­ed by their tox­i­c­i­ty,” Rus­so said. “And our ap­proach re­al­ly aims to take ad­van­tage of what’s dif­fer­ent in­side the tu­mor mi­croen­vi­ron­ment, name­ly high ac­tiv­i­ty of MMPs, or ma­trix  met­al­lo­pro­teinas­es, and then uti­lize that to re­al­ly turn on the ac­tiv­i­ty and con­cen­trate it on­ly in the tu­mors.”

The team, which has since grown to 45 staffers, is al­so work­ing on IL-12 and IL-15 pro­grams. How­ev­er, it’s too soon to tell when those might be ready for IND sub­mis­sions.

When asked if an IPO is on the hori­zon, Rus­so said: “We will be think­ing care­ful­ly about that and what the right tim­ing will be for us to max­i­mize the de­vel­op­ment of these pro­grams and to fur­ther ad­vance the pipeline.”

BY­OD Best Prac­tices: How Mo­bile De­vice Strat­e­gy Leads to More Pa­tient-Cen­tric Clin­i­cal Tri­als

Some of the most time- and cost-consuming components of clinical research center on gathering, analyzing, and reporting data. To improve efficiency, many clinical trial sponsors have shifted to electronic clinical outcome assessments (eCOA), including electronic patient-reported outcome (ePRO) tools.

In most cases, patients enter data using apps installed on provisioned devices. At a time when 81% of Americans own a smartphone, why not use the device they rely on every day?

UP­DAT­ED: J&J paus­es vac­cine roll­out as feds probe rare cas­es of blood clots

The FDA and CDC have jointly decided to stop administering J&J’s Covid-19 vaccine after reviewing data involving six reported US cases of a rare and severe type of blood clot in individuals after receiving the vaccine.

CDC will convene a meeting of its Advisory Committee on Immunization Practices on Wednesday to further review these cases and assess their potential significance. “FDA will review that analysis as it also investigates these cases. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research and Anne Schuchat, Principal Deputy Director of the CDC, said in a joint statement Tuesday morning.

Pankaj Bhargava, MPM executive partner

Pankaj Bhar­ga­va was a cen­tral fig­ure in the group fash­ion­ing Gilead’s on­col­o­gy strat­e­gy. Now he’s jumped to the VC side and the next-gen tech game

Over the past 3 years, Pankaj Bhargava played a key role at Gilead as therapeutics area head of oncology, which put him in the dead center of one of the busiest pipeline makeovers in the industry.

“When I joined (the big biotech), there was a clear realization that Gilead had missed the first boat with immuno-oncology,” he tells me. “We hadn’t gone into the PD-1s, the checkpoints, etc. They had just bought Kite and the question was how do we get into oncology.”

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Fifth Cir­cuit sides with FTC in ma­jor pay-for-de­lay set­tle­ment case

The US Court of Appeals for the Fifth Circuit on Tuesday upheld the Federal Trade Commission’s ruling that generic drugmaker Impax Laboratories should be charged with antitrust violations for accepting payments worth about $100 million to delay the entry of a generic opioid for more than two years.

The court’s opinion upheld the FTC’s anticompetitive findings on the deal between Impax (now owned by Amneal Pharmaceuticals) and Endo Pharmaceuticals, under which Endo committed to not market an authorized generic, which increased Impax’s projected profits by $24.5 million. Endo agreed to pay Impax credits for the shrunken market that Impax would inherit if, as expected, Endo made a successful hop to a reformulated Opana ER.

Opin­ion: Biden needs to step up and nom­i­nate an FDA com­mis­sion­er

Enough with the waiting. President Joe Biden needs to embrace the FDA during this pandemic and kickstart the Senate confirmation process for the next permanent commissioner.

And this needs to happen quickly. There are plenty of qualified candidates for the role outside of acting commissioner Janet Woodcock and Josh Sharfstein. Biden needs to move fast not because the biopharma world struggles with even the perception of FDA uncertainty (it does), but because thousands of FDA employees have been dealing with four years of political smears while putting in overtime to review thousands of Covid-19 drug and vaccine trials, and to authorize three safe vaccines in record time.

Patrizia Cavazzoni, new CDER director

Pa­trizia Cavaz­zoni named per­ma­nent di­rec­tor of CDER, adding to ques­tions around where Wood­cock will end up

Patrizia Cavazzoni on Monday became the permanent director of the FDA’s Center for Drug Evaluation and Research, which puts to rest the idea that Janet Woodcock, Cavazzoni’s predecessor, might return to lead CDER if she isn’t made permanent commissioner.

Woodcock, who’s currently serving as acting commissioner and principal medical advisor to the commissioner, a position she was detailed to last year, may not make the move to permanent commissioner because of lingering questions from Senate Democrats. She previously served as director of CDER since 1994. Cavazzoni took over as acting director of CDER when Woodcock moved over to Operation Warp Speed to run the therapeutics side of the Trump-era program.

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Janet Woodcock, acting FDA commissioner (AP Images)

FDA dis­pens­es with in-per­son re­quire­ment for abor­tion pill ac­cess dur­ing the pan­dem­ic

Women seeking the abortion pill mifepristone during the pandemic will be able to order it through the mail and will no longer have to go into a clinic in person, acting FDA commissioner Janet Woodcock wrote Monday in response to a series of concerns from the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine.

Mifepristone is a drug that can end a pregnancy that is less than 10 weeks along, and has created a whirlwind of political and legal questions related to this in-person requirement.

Tim Lu, Senti Bio CEO (MIT)

Tim Lu’s gene-cir­cuit star Sen­ti signs up for a $645M dis­cov­ery al­liance with Roche sub Spark

Three months after bringing in Bayer and a group of new investors in his first mega-round, Senti Bio chief Tim Lu now has the first high-profile Big Pharma alliance to help burnish his prospects for a cutting-edge breakthrough in gene therapies.

Spark Therapeutics — which Roche acquired as its base camp in gene therapy development — has turned to Senti in a collaboration aimed at using its synthetic gene circuit tech in new programs aimed at the CNS, eye and liver.

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Tony Coles, Cerevel

Bain dou­bles down on Tony Coles’ quest to get a late-stage Parkin­son’s drug through to mar­ket

Cerevel Therapeutics had a charmed start to its life with the backing of financial giant Bain Capital and a clutch of former Pfizer assets to work with. Now, extending its relationship with Bain, Cerevel has snagged another big check to race its Parkinson’s disease candidate through late-stage studies and on to market.

Bain and NovaQuest will drop $125 million in non-dilutive funding to drive Cerevel’s Phase III program for Parkinson’s drug tavapadon, with up to $531 million in future milestones at stake, the biotech said Tuesday.

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