Some of the pi­o­neers in on­colyt­ics drug de­vel­op­ment have gone back to the ven­ture well to fi­nance their lat­est play in the field. Replimune, which got start­ed in Ox­ford and is based in Woburn, MA, tanked up with $55 mil­lion in ven­ture cash. That mon­ey is be­ing used to po­si­tion the com­pa­ny for its first round of clin­i­cal work.

Howard Kauf­man, Replimune

Replimune is bring­ing in a rec­og­nized ex­pert in the im­muno-on­col­o­gy field as CMO along­side the round. The biotech re­cruit­ed Howard Kauf­man, who had been chief of the Di­vi­sion of Sur­gi­cal On­col­o­gy at the Rut­gers Robert Wood John­son Med­ical School and from 2014-2016 was pres­i­dent of the So­ci­ety for the Im­munother­a­py of Can­cer.

Replimune is one of sev­er­al up-and-com­ing biotechs that hope to do bet­ter than the first en­try in the field. The ap­proach us­es on­colyt­ic virus­es to specif­i­cal­ly in­fect can­cer cells and de­stroy them while flag­ging the im­mune sys­tem to send in the sen­tinels for a fol­lowup at­tack.

Robert Cof­fin

Com­pa­ny founder Robert Cof­fin was the CSO at BioVex when Am­gen scooped up the com­pa­ny and its lead drug, tal­imo­gene la­her­parepvec (T-VEC), now sold as Im­ly­g­ic. Philip Ast­ley-Sparke — a part­ner at For­bion — is the for­mer CEO at BioVex and is now ex­ec­u­tive chair­man at Replimune.

Ac­cord­ing to their web site, Am­gen has now paid off $675 mil­lion of the $1 bil­lion deal of­fered to snag that drug.

It’s no great sur­prise that For­bion was an ex­ist­ing in­vestor and came back for the B round, along with At­las Ven­ture and Omega Funds. Fore­site Cap­i­tal led the lat­est round with a group of new in­vestors in­clud­ing Bain Cap­i­tal Life Sci­ences, Red­mile Group, Cor­morant As­set Man­age­ment.

Brett Zbar from Fore­site Cap­i­tal will join Replimune’s board of di­rec­tors along with Kapil Dhin­gra, a Roche vet and well known can­cer ex­pert on sev­er­al biotech boards.

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.

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.

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.