Sim­ba Gill

With its lead “mon­o­clon­al mi­cro­bial” about to be test­ed for the first time on a hu­man, Evelo Bio­sciences be­lieves that this is the right time to float a $100 mil­lion IPO.

Launched with $85.4 mil­lion raised from the sale of stock to Flag­ship and a loan from Pa­cif­ic West­ern Bank, Evelo re­cent­ly added a $47.5 mil­lion Se­ries C to the cof­fers in Feb­ru­ary and then added $34 mil­lion more last month, ac­cord­ing to the S-1 fil­ing. Al­to­geth­er that tots up to $167 mil­lion. And as of the end of last year the Cam­bridge, MA-based biotech un­der the guid­ance of CEO Sim­ba Gill had burned through $56.4 mil­lion.

The sci­ence at Evelo fo­cused on the in­ter­sec­tion of the gut and body; specif­i­cal­ly how the gut op­er­ates in di­rect­ing the im­mune sys­tem. By de­sign­ing the right mi­cro­bial strains that op­er­ate in the gut, Evelo’s sci­en­tists be­lieve that they can up-reg­u­late the im­mune sys­tem to go af­ter, say, can­cer, or down-reg­u­late it to pre­vent in­flam­ma­to­ry dis­eases like pso­ri­a­sis or atopic der­mati­tis, rheuma­toid arthri­tis and Crohn’s dis­ease.

Noubar Afeyan

The biotech lists a to­tal of 10 pro­grams in its S-1 pipeline out­line, in­clud­ing col­orec­tal and re­nal cell car­ci­no­ma among its four can­cer tar­gets.

That kind of high-risk pre­clin­i­cal op­er­a­tion has been in and out of fa­vor in biotech. But with ven­ture cash pump­ing and the IPO win­dow open, Gill’s crew and Flag­ship back­ers, led by Noubar Afeyan, are bet­ting that they can sell it.

The S-1 isn’t com­plete, leav­ing its break­down of in­vestors emp­ty. But the com­pa­ny has been backed by Google’s GV, Cel­gene, Mayo Clin­ic and Alexan­dria Ven­ture.

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 That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled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.

US regulators cleared an ultra-rare drug from Pharming Group, by way of Novartis, on Friday afternoon.

The Dutch biotech said the FDA greenlit leniolisib for an immunodeficiency disease known as activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome, or APDS. People 12 years and older can receive the oral drug, to be marketed as Joenja, beginning early next month, Pharming said, five days ahead of the decision deadline set by the FDA as part of a priority review.

A California judge will allow a plaintiff in a state court case to introduce expert testimony connecting a potential carcinogen in former blockbuster medicine Zantac to cancer.

The order was handed down on Thursday from state judge Evelio Grillo, who is now allowing both parties to introduce expert testimony in an upcoming trial after what’s known as a Sargon hearing, where a judge determines the admissibility of expert witnesses and expert opinions.

A handful of CDMOs have made changes at the top over the past few weeks, including Genezen and Curia.

That also includes Australian CDMO BioCina, which announced last week that Mark Womack would be taking the helm. Womack previously served as chief business officer at AGC Biologics, CEO of Indian manufacturer Stelis Biopharma and most recently, CEO at CDMO KBI Biopharma and Selexis SA.

BioCina completed the takeover of a Pfizer manufacturing facility in Adelaide in 2021 and is now prepping for wider growth. Endpoints News sat down with Womack to discuss his new role, plans for the future, and how to compete in the wider CDMO market. This interview has been edited for brevity and clarity.