René Russo, Xilio CEO (Alicia Petitti for Xilio)

Xilio Ther­a­peu­tics goes pub­lic as bio­phar­ma IPOs rum­ble for­ward in Q4

It’s been a busy fall on Wall Street — and this week, we’ve got an­oth­er biotech go­ing pub­lic af­ter Ven­tyx yes­ter­day.

Mass­a­chu­setts sol­id-tu­mor biotech Xilio Ther­a­peu­tics made its pub­lic de­but to­day, join­ing 149 oth­er biotechs that have gone pub­lic so far this year.

Back on Oc­to­ber 1st, Xilio filed its S-1 with the SEC to make its IPO de­but for $100 mil­lion — the next step in fi­nanc­ing af­ter com­plet­ing a $95 mil­lion Se­ries C back in Feb­ru­ary.

And yes­ter­day, the biotech an­nounced its pric­ing — of­fer­ing just over 7.3 mil­lion shares at $16 a share, for a to­tal raise of $117 mil­lion.

In ad­di­tion, Xilio has giv­en un­der­writ­ers 30 days to pur­chase up to an ad­di­tion­al 1.1 mil­lion shares of com­mon stock at the IPO price of $16 a share, mi­nus un­der­writ­ing dis­counts and com­mis­sions.

These shares have al­ready start­ed trad­ing, show­ing up on Nas­daq at $16 a share un­der the tick­er $XLO.

Be­tween all the Xilio di­rec­tors such as At­las Ven­ture part­ner David Grayzel, who will own more than 2 mil­lion shares, and Xilio CEO René Rus­so with over 407,000 shares, the 13 ex­ec­u­tives/di­rec­tors will own 22% of the com­pa­ny’s com­mon stock — more than 26 mil­lion shares. This in­cludes the 7.3 mil­lion in the IPO.

The biotech for­mer­ly known as Akre­via on­ly en­tered the clin­ic a month ago — with a Phase I/II study for their an­ti-CT­LA-4 mon­o­clon­al an­ti­body for ad­vanced sol­id tu­mors.

Most of the IPO funds will be di­rect­ed to­ward get­ting two pre­clin­i­cal can­di­dates in­to hu­man stud­ies — $20-25 mil­lion for an IL-12 and be­tween $30-35 mil­lion for an IL-2. And the com­pa­ny’s an­ti-CT­LA-4 an­ti­body will al­so see some cash — some­where be­tween $10 and $15 mil­lion, ac­cord­ing to an S-1 amend­ment.

The of­fer­ing will close on Tues­day, ac­cord­ing to a com­pa­ny state­ment. The trad­ing comes one week af­ter Xilio hired Tim­o­thy Hunt as the com­pa­ny’s chief cul­ture and cor­po­rate af­fairs of­fi­cer.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; and more

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Usama Malik

Ex-Im­munomedics CFO charged with in­sid­er trad­ing, faces up to 20 years in prison af­ter al­leged­ly tip­ping off girl­friend and rel­a­tives of a PhI­II suc­cess

The former CFO of Immunomedics, who helped steer the company to its $21 billion buyout by Gilead last year, has been charged with insider trading, the Department of Justice announced Thursday.

Usama Malik tipped off his then-girlfriend and four others that a Phase III study for Trodelvy would be stopped early four days before Immunomedics publicly announced the result in April 2020, DoJ alleged in its complaint. The individuals then purchased Immunomedics shares, selling them after the news broke and Immunomedics’ stock price doubled.

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Radek Spisek, Sotio CEO (Cellestia)

A qui­et Czech biotech bags $315M to dri­ve its blos­som­ing can­cer pipeline through the clin­ic

In the rather insular world of biotech, most innovation inevitably comes from a cluster of R&D hubs — Cambridge, San Francisco, etc. But sometimes success stories sprout from rocky soil, which is most certainly the case with Prague-based Sotio Biotech and its suddenly jam-packed pipeline of cancer drugs.

After years in quiet development, Sotio now has $315 million in new funds to play with from parent company PPF Group, an investment group founded in the Czech Republic, as the biotech looks to advance its growing pipeline through early- and mid-stage trials.

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In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

Ab­b­Vie tacks on a new warn­ing to Rin­voq la­bel as safe­ty frets crimp JAK class

The safety problems that continue to plague the JAK class as new data highlight some severe side effects are casting a large shadow over AbbVie’s Rinvoq.

As a result of a recent readout highlighting major adverse cardiac events (MACE), malignancy, mortality and thrombosis with Xeljanz a couple of months ago, AbbVie put out a notice late Friday afternoon that it is adding the new class risks to its label for their rival drug.

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Biospec­i­men M&A: Dis­cov­ery ac­quires Al­bert Li's he­pa­to­cyte project; PhI­II tri­al on Bay­er's Nube­qa reached pri­ma­ry end­point

Discovery Life Sciences has acquired what claims to be the Maryland-based host of the world’s largest hepatocyte inventory, known as IVAL, to help researchers select more effective and safer drug candidates in the future.

The combined companies will now serve a wider range of drug research and development scientists, according to Albert Li, who founded IVAL in 2004 and is set to join the Discovery leadership team as the CSO of pharmacology and toxicology.

Pfiz­er, Am­gen and Janssen seek fur­ther clar­i­ty on FDA's new ben­e­fit-risk guid­ance

Three top biopharma companies are seeking more details from the FDA on how the agency conducts its benefit-risk assessments for new drugs and biologics.

While Pfizer, Amgen and Janssen praised the agency for further spelling out its thinking on the subject in a new draft guidance, including a discussion of patient experience data as part of the assessment, the companies said the FDA could’ve included more specifics in the 20-page draft document.

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