Rene Russo (Alicia Petitti for Xilio)

Ex ni­hi­lo: Take­da leads $100M+ round to fund biotech's sneak at­tack on tu­mors, pro­pelling new IL-2, CT­LA-4 drugs to clin­ic

Since emerg­ing out of stealth in 2018 with $30 mil­lion in launch mon­ey from At­las and F-Prime, Akre­via has kept a rel­a­tive­ly low pro­file, ham­mer­ing away at its plat­form tech­nol­o­gy to de­sign im­munother­a­pies with all their po­ten­cy but lit­tle of their side ef­fects. With an of­fi­cial CEO in place for al­most a year — and now a new name — the biotech is ready to step up with an­oth­er $100.5 mil­lion to bring its two lead com­pounds in­to the clin­ic.

Tim Clack­son

Meet Xilio, a 35-strong team work­ing out of Waltham, MA. Where­as the orig­i­nal name had been de­rived from the Greek word for pre­ci­sion, Xilio draws in­spi­ra­tion from 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,” CEO Rene Rus­so told End­points News, “and this cre­ation or big bang as ef­fi­ca­cy in the tu­mor specif­i­cal­ly.”

Xilio’s pro­tein en­gi­neer­ing ap­proach­es shield the bind­ing ac­tiv­i­ty of mol­e­cules while they are trav­el­ling around the body, ex­plained Tim Clack­son, pres­i­dent and head of R&D. Once they meet the pro­teas­es in the tu­mor, the block­ing mod­ules are re­moved, re­leas­ing the ther­a­py just where it’s need­ed.

Un­der Clack­son, who ran the R&D shop at Ari­ad be­fore Take­da ac­quired it, the team went straight for IL-2 and CT­LA-4, two well-known tar­gets each with ap­proved ther­a­pies. Con­sid­er­ing the sig­nif­i­cant tox­i­c­i­ties as­so­ci­at­ed with the first-gen­er­a­tion treat­ments — Pro­leukin and Yer­voy both have black box warn­ings on their la­bels — many pa­tients can’t tol­er­ate the full dose. Xilio promis­es to change that with their re­com­bi­nant IL-2 and CT­LA-4 in­hibitor.

They are not the on­ly ones latch­ing on to IL-2, but Clack­son main­tains that theirs is a fun­da­men­tal­ly dif­fer­ent ap­proach to those tak­en by ri­vals such as Syn­thorx (now Sanofi), Ne­oleukin and Alk­er­mes — which have gen­er­al­ly fo­cused on bind­ing to spe­cif­ic re­cep­tors. The trou­bles Nek­tar has run in­to with its once-high-fly­ing NK­TR-214 af­ter Bris­tol-My­ers Squibb paid $1.85 bil­lion up­front to part­ner on it un­der­score the dif­fi­cul­ty of bal­anc­ing ef­fi­ca­cy and safe­ty.

Be­yond IL-2, Clack­son sees “clear un­tapped po­ten­tial” for cy­tokines as a class. Xilio has two pro­grams for tu­mor-se­lec­tive IL-12 and tu­mor-se­lec­tive IL-15 in the lead op­ti­miza­tion phase.

The Se­ries B, led by Take­da Ven­tures and fea­tur­ing SV Health In­vestors, MRL Ven­tures Fund (a ven­ture arm of Mer­ck), River­Vest Ven­ture Part­ners, Bay City Cap­i­tal, So­las­ta Ven­tures, M Ven­tures and Ipsen Ven­tures as well as the two orig­i­nal back­ers, gives them the fire­pow­er to steer the lead pro­grams to INDs by next year while mov­ing the oth­ers for­ward.

Jayson Pun­wani, part­ner at Take­da Ven­tures, is join­ing the board along­side Mike Ross of SV Health In­vestors, Pe­ter Dudek of MRL Ven­tures Fund and Nan­cy Hong of River­Vest Ven­ture Part­ners.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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Cy­to­ki­net­ics’ ALS drug fails PhI­II, leav­ing the biotech with a sin­gle late-stage prospect

Cytokinetics’ candidate for the muscle disease amyotrophic lateral sclerosis, or ALS, failed a Phase III trial, the Bay Area biotech announced Friday morning.

At a second interim analysis of the trial, an independent review committee recommended that Cytokinetics discontinue its COURAGE-ALS trial for reldesemtiv, as it “found no evidence of effect” compared to placebo on the primary or key secondary endpoints.

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CHMP gives thumbs-up for We­govy use in ado­les­cents, along with nine new drug rec­om­men­da­tions

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended nine drugs for approval this week while also giving thumbs up for six expanded indications, including Novo Nordisk’s approved obesity medication Wegovy for younger people. Wegovy is already approved as an obesity treatment in the EU for adults, and the new indication would allow prescriptions for adolescents aged 12 and older.

Green­Light re­ceives buy­out of­fer; Apol­lomics com­pletes SPAC merg­er

RNA biotech GreenLight Biosciences has been handed an offer for potential acquisition.

GreenLight said in a release that it has received a non-binding “indication of interest” from Fall Line Endurance Fund to acquire GreenLight’s capital stock for $0.60 per share in cash. The release said any potential agreement between the two parties would depend on certain conditions.

Through a special committee, the biotech will evaluate the offer but added there’s no certainty a deal will go forward. GreenLight will also not make any more announcements until a deal comes through or “otherwise determines” a statement is necessary.

TScan Therapeutics' departing CEO David Southwell and CSO/COO Gavin MacBeath

TCR up­start an­nounces CEO ex­it, with CSO now act­ing re­place­ment

A public T cell biotech’s chief executive has decided to leave the company.

TScan Therapeutics said Friday morning that CEO David Southwell stepped down earlier this week, leaving both his chief executive and board member roles. Filling in is Gavin MacBeath, the company’s CSO and COO. He became the acting CEO on Tuesday, and will continue to remain CSO and COO, TScan’s announcement read.

Sar­to­rius to ac­quire French man­u­fac­tur­er for $2.6B+ in cell and gene ther­a­py play

The German life science group Sartorius will be picking up French contract manufacturer Polyplus for the price of €2.4 billion, or $2.6 billion.

On Friday, Sartorius announced the acquisition through its French subgroup, Sartorius Stedim Biotech, which will be acquiring Polyplus from private investors ARCHIMED and WP GG Holdings IV. Polyplus has 270 employees and produces materials and components that go into making viral vectors that are used in cell and gene therapies. This includes DNA/RNA reagents as well as plasmid DNA. Polyplus has locations in France, Belgium, China and the US.

Austin biotech Mol­e­c­u­lar Tem­plates lays off more than 100 staffers as pipeline nar­rows

Molecular Templates is ridding itself of a Phase I HER2 asset and fine-tuning its pipeline to focus on three programs and a preclinical Bristol Myers Squibb collaboration. With the narrowed scope on its so-called engineered toxin bodies, the Austin, TX biotech is laying off about half of its staff.

That’s a little more than 100 employees, per an SEC filing. Molecular’s layoffs, approved by its board Wednesday, add to the dozens of pullbacks in the industry in the first three months of 2023.

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Sen­ate Fi­nance Com­mit­tee lobs more bi­par­ti­san pres­sure on­to PBMs

Congress is honing in on how it wants to overhaul the rules of the road for pharmacy benefit managers, with a Senate Finance Committee hearing Thursday serving as the latest example of the Hill’s readiness to make changes to how pharma middlemen operate.

While pledging to ensure patients and pharmacies “don’t get a raw deal,” Finance Committee Chair Ron Wyden (D-OR) laid out the beginning of what looks like a major bipartisan effort — moves the PBM industry is likely to challenge vigorously.

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