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.”

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data is messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data is exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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David Lockhart, ReCode Therapeutics CEO

Pfiz­er throws its weight be­hind LNP play­er eye­ing mR­NA treat­ments for CF, PCD

David Lockhart did not see the meteoric rise of messenger RNA and lipid nanoparticles coming.

Thanks to the worldwide fight against Covid-19, mRNA — the genetic code that can be engineered to turn the body into a mini protein factory — and LNPs, those tiny bubbles of fat carrying those instructions, have found their way into hundreds of millions of people. Within the biotech world, pioneers like Alnylam and Intellia have demonstrated just how versatile LNPs can be as a delivery vehicle for anything from siRNA to CRISPR/Cas9.

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Leen Kawas (L) has resigned as CEO of Athira and will be replaced by COO Mark Litton

Ex­clu­sive: Athi­ra CEO Leen Kawas re­signs af­ter in­ves­ti­ga­tion finds she ma­nip­u­lat­ed da­ta

Leen Kawas, CEO and founder of the Alzheimer’s upstart Athira Pharma, has resigned after an internal investigation found she altered images in her doctoral thesis and four other papers that were foundational to establishing the company.

Mark Litton, the company’s COO since June 2019 and a longtime biotech executive, has been named full-time CEO. Kawas, meanwhile, will no longer have ties to the company except for owning a few hundred thousand shares.

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Sen. Richard Durbin (D-IL, foreground) and Sen. Richard Blumenthal (D-CT) (Patrick Semansky/AP Images)

Sen­a­tors back FDA's plan to re­quire manda­to­ry pre­scriber ed­u­ca­tion for opi­oids

Three Senate Democrats are backing an FDA plan to require mandatory prescriber education for opioids as overdose deaths have risen sharply over the past decade, with almost 97,000 American opioid-related overdose deaths in the past year alone.

While acknowledging a decline in overall opioid analgesic dispensing in recent years, the FDA said it’s reconsidering the need for mandatory prescriber training through a REMS given the current situation with overdoses, and is seeking input on the aspects of the opioid crisis that mandatory training could potentially mitigate.

Suresh Katta, Saama CEO (via YouTube)

As AI con­tin­ues to en­tice Big Phar­ma, a Car­lyle-led drug­mak­er syn­di­cate shells out $430M for cloud com­put­ing play­er

The AI revolution permeating Big Pharma took a big financial step forward Wednesday, with VCs and major drugmakers coming together to acquire a cloud-focused company.

Led by the Carlyle Group, the investors will put up $430 million for a majority stake in Saama, a company that collects patient data to help speed along the drug development process. The investment arms of Pfizer, Merck, Amgen and McKesson all participated in the financing, in addition to other prominent life sciences VCs like Northpond.

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Raju Mohan, Ventyx Biosciences CEO

Ven­tyx sprints to Wall Street less than a year af­ter emerg­ing from stealth

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

It took seven months from exiting “quiet mode” for Ventyx Biosciences to land its very own stock ticker, raising $165 million in venture funds along the way.

Now, after pricing a massive $151.5 million IPO, the Encinitas, CA-based biotech is gunning for Phase II.

Ventyx priced close to 9.5 million shares at $16 apiece on Wednesday, the midpoint of its $15 to $17 range. CEO Raju Mohan filed the S-1 papers at the end of September, just over a week after unveiling a $114 million Series B round. He penciled in the standard figure of $100 million at first, likely knowing that in the last year, it’s been common for biotechs to raise much more than those initial estimates.

Bris­tol My­ers pledges to sell its Ac­celeron shares as ac­tivist in­vestors cir­cle Mer­ck­'s $11.5B buy­out — re­port

Just as Avoro Capital’s campaign to derail Merck’s proposed $11.5 billion buyout of Acceleron gains steam, Bristol Myers Squibb is leaning in with some hefty counterweight.

The pharma giant is planning to tender its Acceleron shares, Bloomberg reported, which add up to a sizable 11.5% stake. Based on the offer price, the sale would net Bristol Myers around $1.3 billion.

To complete its deal, Merck needs a majority of shareholders to agree to sell their shares.

Ep­i­darex, Sofinno­va dou­ble down on a par­al­lel take on 3rd-gen CAR-T — aim­ing straight at ovar­i­an can­cer

When John Maher treated the first head and neck cancer patient at Guy’s Hospital in London with his pan-ErbB CAR-T back in 2015, he was among a small club of researchers convinced they had an answer to the challenges that had kept those engineered T cells — wildly successful in hematological cancers — either too dangerous or out of reach for patients with solid tumors.

The field has blossomed since then, with a proliferation of technologies that promise to address any number of challenges identified as unique to solid tumors. And Maher himself has rethought his approach and come up with a new CAR-T platform to generate the next slate of candidates.