Less than a month af­ter achiev­ing break­through ther­a­py des­ig­na­tion in melanoma, IO Biotech has se­cured an over­sub­scribed Se­ries B that will help them get their im­mune-mod­u­lat­ing IDO and PD-L1 can­cer vac­cines through a late-stage tri­al.

The Copen­hagen-based com­pa­ny net­ted €127 mil­lion ($154.5 mil­lion) in the round, it re­vealed Wednes­day morn­ing, rais­ing the stakes for its T cell ac­ti­vat­ing ther­a­pies. It’s the biggest fundraise for the biotech since its found­ing in con­junc­tion with No­vo Seeds in 2014, when it pulled in an amount more than 11 times high­er than its Se­ries A about four years ago.

No­vo Seeds man­ag­ing part­ner Søren Møller ac­knowl­edged the com­pa­ny’s quick rise, not­ing an “in­flec­tion point” af­ter IO launched a Phase II study in non-small cell lung can­cer in May 2019 and last month’s BTD. Møller does not sit on IO’s board.

In un­re­sectable or metasta­t­ic melanoma, where IO re­ceived the BTD, the biotech com­bines two of its pro­grams along with Mer­ck’s Op­di­vo. IO’s can­di­dates, IO102 and IO103, work to di­rect T cells against IDO and PD-L1, re­spec­tive­ly, and are spe­cif­ic to­ward their tar­gets.

IDO and PD-1 com­bi­na­tion ap­proach­es have proved a trou­bling ground in the past, as In­cyte’s ef­fort to match its epaca­do­stat can­di­date with Keytru­da in melanoma fell flat in April 2018. A few weeks lat­er, NewLink Ge­net­ics scrapped a Phase III tri­al for its own IDO pro­gram and end­ed up re­verse-merg­ing with Lu­mos in Oc­to­ber 2019 af­ter shares cratered to $1.59 af­ter hov­er­ing over $50.

But IO Biotech is tak­ing a slight­ly dif­fer­ent ap­proach, de­riv­ing pep­tides from IDO and PD-L1 in their ex­per­i­men­tal drugs. Møller notes the ul­ti­mate goal is to ac­ti­vate the body’s im­mune re­sponse in­to elim­i­nat­ing the tu­mor mi­croen­vi­ron­ments.

The da­ta that trig­gered De­cem­ber’s BTD in melanoma came last Sep­tem­ber and en­gi­neered much of the ex­cite­ment sur­round­ing Wednes­day’s raise. In an open-la­bel Phase II tri­al with 30 pa­tients, IO’s com­bo of IO102, IO103 and Op­di­vo showed an over­all re­sponse rate of 79% with 45% of pa­tients achiev­ing a com­plete re­sponse in the first-line set­ting. IO has yet to reach an over­all sur­vival point for the study, Møller said.

Pa­tients were treat­ed with Op­di­vo every oth­er week for as long as there was a clin­i­cal ben­e­fit or no side ef­fects. IO102 and IO103 were giv­en from the start of Op­di­vo ad­min­is­tra­tion and every oth­er week for the first six treat­ments. Af­ter that, the vac­cines were giv­en every fourth week up for up to a year.

With the da­ta, BTD and fund­ing now in hand, the next step is launch­ing the Phase III tri­al in melanoma. Møller ex­pects that to be­gin lat­er this year or in ear­ly 2022, with da­ta read­outs com­ing rough­ly two-and-a-half to three years af­ter­ward. IO’s NSCLC pro­gram, which com­bines IO102 with Keytru­da, should have da­ta some­time in the first half of this year.

Wednes­day’s round was led by HBM Health­care In­vest­ments, and oth­er new in­vestors join­ing the round in­clud­ed Vi­vo Cap­i­tal, Kur­ma Part­ners, Avoro Cap­i­tal, RA Cap­i­tal Man­age­ment, Sam­sara Bio­cap­i­tal, Id­in­vest Part­ners, PFM Health Sci­ences, Soleus Cap­i­tal, Eir Ven­tures and Ser­ra­do Cap­i­tal. In ad­di­tion to No­vo Seeds, ex­ist­ing in­vestors Lund­beck­fonden Emerge and Sun­stone Life Sci­ence Ven­tures al­so par­tic­i­pat­ed.

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

German pharma giant Bayer will be looking to make a significant investment into one of its US plants that produces over-the-counter drugs.

Bayer announced that it will spend $43.6 million to expand its facility in Myerstown, PA, a small town east of Harrisburg. Bayer plans to increase the site by 70,000 square feet and will have room for the installation of eight packaging lines and an area to install rooftop solar panels. The project is expected to be completed by 2025 and will add around 50 to 75 jobs.

As the global biologics market is expected to hit nearly the half-trillion-dollar mark this year, new JAMA research points to the importance of timely biosimilar entry, particularly as fewer biosimilars are entering the US than in Europe, and as monthly treatment costs for biosimilars were “substantially higher” in the US compared with Germany and Switzerland.

Among the three countries, biosimilar market share at launch was highest in Germany, but increased at the fastest rate in the US, the authors from the University of Zurich’s Institute of Law wrote in JAMA Network Open today.

The European Medicines Agency said Friday that it’s pulling from all European markets pholcodine-containing medicines, which are an opioid used in adults and children for the treatment of dry cough and in combo with other drugs as a treatment for cold and flu.

The decision to pull the medicines comes as the EMA points to the results from the recent ALPHO study, which show that use of pholcodine during the 12 months preceding anesthesia is linked to a risk of an anaphylactic reaction related to the neuromuscular blocking agents (NMBAs) used (with an adjusted OR of 4.2, and a 95% confidence interval of 2.5 to 6.9).