Drug dis­cov­ery and de­vel­op­ment play­er Evotec en­tered an­oth­er li­cens­ing deal with Big Phar­ma — this time with J&J’s Janssen.

The com­pa­nies put out word that they en­tered in­to a strate­gic col­lab­o­ra­tion and li­cense agree­ment with each oth­er that fo­cus­es on tar­get­ed im­mune-based can­cer ther­a­pies, to be com­mer­cial­ized by Janssen.

Ac­cord­ing to a state­ment, the col­lab­o­ra­tion will hinge on Evotec’s in­te­grat­ed drug dis­cov­ery and man­u­fac­tur­ing ca­pa­bil­i­ties. Dur­ing the pre-clin­i­cal R&D phase, the com­pa­nies will col­lab­o­rate close­ly — and then Janssen will take on full re­spon­si­bil­i­ty for both clin­i­cal de­vel­op­ment and com­mer­cial­iza­tion.

That said, Evotec gets an undis­closed pay­ment up­front and is en­ti­tled to both re­search and com­mer­cial mile­stones worth more than $350 mil­lion, plus tiered roy­al­ties.

It’s not Evotec’s first al­liance with Big Phar­ma, as Evotec had a deal with Bris­tol My­ers Squibb for a neu­rode­gen­er­a­tion can­di­date. Bris­tol My­ers ex­er­cised its op­tion in 2021, pay­ing Evotec $20 mil­lion and tak­ing on any fur­ther de­vel­op­ment.

Genelux nabs $15 mil­lion IPO af­ter ini­ti­at­ing PhI­II

A small on­col­o­gy biotech sold 2.5 mil­lion shares at $6 apiece to kick off its time in the pub­lic mar­ket.

The qui­et, San Diego-based biotech found­ed in 2001 has been de­vel­op­ing on­colyt­ic vi­ral im­munother­a­pies. Its lead can­di­date, called Olvi-Vec and a mod­i­fied strain of the vac­cinia virus, met a pre-es­tab­lished end­point in a Phase II tri­al for pa­tients with plat­inum-re­sis­tant/re­frac­to­ry ovar­i­an can­cer.

Now, the biotech has start­ed up a Phase III tri­al. A state­ment said that the tri­al of­fi­cial­ly launched in the sec­ond quar­ter of 2022, and be­gan en­roll­ment in Q3.

The com­pa­ny will be trad­ing un­der the tick­er $GN­LX.

Cy­tomX trig­gers $5M mile­stone pay­ment from Astel­las

Cy­tomX Ther­a­peu­tics has a new up­date on its pre­vi­ous deal with Astel­las.

The com­pa­ny put out word that it reached a mile­stone for a clin­i­cal can­di­date, which nets Cy­tomX $5 mil­lion from Astel­las. The two are still col­lab­o­rat­ing on ad­di­tion­al mol­e­cules that Cy­tomX can get more mile­stones from.

This col­lab­o­ra­tion is cen­tered around T cell bis­pecifics, which got kicked off back in 2020 thanks to Astel­las start­ing things off with $80 mil­lion up­front. The deal at the time al­so al­lowed for $1.6 bil­lion in mile­stones for a num­ber of tar­gets — and gave Cy­tomX the op­tion to co-fund part of the clin­i­cal de­vel­op­ment for sev­er­al pro­grams in ex­change for prof­it-share or co-com­mer­cial­iza­tion.

San Francisco-based biotech 89bio announced on Friday that it expects to rake in $275 million on a stock offering. The raise comes after 89bio announced on Tuesday results of a Phase II study showing that its drug was better than placebo at lessening fibrosis without worsening nonalcoholic steatohepatitis, or NASH.

To run a Phase III study, 89bio CEO Rohan Palekar told Endpoints News that the biotech “would need to raise additional capital.” 89bio offered over 16 million shares of its common stock at $16.25 per share, and expects the offering closes on March 28.

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.