In the clin­i­cal waste­land of ag­gres­sive brain can­cers, Philly’s On­co­ceu­tics has churned out promis­ing da­ta with a Phase II can­di­date on the verge of an FDA fil­ing. Chimerix, look­ing to turn around its rep­u­ta­tion — and share price — has jumped on board, putting half-a-bil­lion-dol­lar hopes in On­co­ceu­tics’ drug.

Chimerix will ac­quire pri­vate biotech On­co­ceu­tics and lead can­di­date ONC-201, an oral small mol­e­cule dopamine re­cep­tor D2 an­tag­o­nist and ca­seinolyt­ic pro­tease ag­o­nist cur­rent­ly be­ing test­ed in a Phase II tri­al against re­cur­rent glioma, a form of brain can­cer with a par­tic­u­lar­ly poor prog­no­sis, the com­pa­nies said Fri­day.

On­co­ceu­tics ex­pects piv­otal da­ta on the ONC-201 pro­gram some time this year for glioma pa­tients with the H3 K27M mu­ta­tion, a con­di­tion that comes with a four-month over­all sur­vival prog­no­sis. Along­side ONC-201, On­co­ceu­tics will bring an­oth­er four on­col­o­gy pro­grams in­to the fold for Chimerix, which is ad­vanc­ing its own can­di­date, a gly­cosamino­gly­can com­pound de­rived from porcine he­parin dubbed DSTAT, through a Phase III tri­al in acute myeloid leukemia.

A win with ONC-201 could open a $500 mil­lion mar­ket op­por­tu­ni­ty in re­cur­rent glioma, Chimerix said.

As part of the deal, Chimerix will pay out $78 mil­lion to On­co­ceu­tics in­vestors — half in stock and half in cash — with a po­ten­tial $360 mil­lion in de­vel­op­ment, reg­u­la­to­ry and sales mile­stones down the road. In terms of the $39 mil­lion in cash on the ta­ble, Chimerix will pay out $25 mil­lion at clos­ing and the re­main­ing $14 mil­lion on the first an­niver­sary of clos­ing.

In ad­di­tion, share­hold­ers will be due 15% roy­al­ties on com­bined sales of ONC-201 and an­oth­er pro­gram, ONC206, of up to $750 mil­lion per year and 20% roy­al­ties above $750 mil­lion in an­nu­al rev­enue.

ONC-201 has earned the FDA’s fast track des­ig­na­tion based on da­ta from three tri­als show­ing promis­ing re­sponse rates. The drug’s Phase II study is test­ing the mol­e­cule in 50 pa­tients above the age of 2 who have re­ceived ra­di­a­tion at least 90 days pri­or to en­roll­ment and dis­played ev­i­dence of pro­gres­sive dis­ease, and cer­tain oth­er cri­te­ria, Chimerix said.

The re­sults from that study are planned for a Blind­ed In­de­pen­dent Cen­tral Re­view com­mit­tee’s analy­sis some­time this year, which could form the ba­sis for a reg­u­la­to­ry fil­ing down the road, Chimerix said. Re­sults from the first 30 pa­tients in that study were al­ready re­viewed in a sep­a­rate BI­CR held in No­vem­ber. So far, in over 350 pa­tients treat­ed, ONC-201 has shown a “gen­er­al­ly well tol­er­at­ed” safe­ty pro­file with most com­mon side ef­fects of nau­sea/vom­it­ing, fa­tigue and de­creased lym­pho­cytes.

Ac­quir­ing a promis­ing can­di­date in ag­gres­sive brain can­cers could help turn around the North Car­oli­na biotech with a sketchy past. In mid-2020, Chimerix laid off half its staff af­ter piv­ot­ing work on its oral an­tivi­ral brin­cid­o­fovir to small­pox fol­low­ing a string of clin­i­cal fail­ures. Now, that small­pox ap­pli­ca­tion for brin­cid­o­fovir is up for a PDU­FA date April 7 in what could be the biotech’s first ap­proval. Shares of Chimerix ($CM­RX) were trad­ing up 16% be­fore the bell Fri­day at $5.79.

More than five years after Corey Fishman and Michael Dunne dusted sulopenem off Pfizer’s shelves — the second castoff antibiotic they’ve brought out of the pharma giant — and founded Iterum Therapeutics around that single drug, they have lined up a quick shot at approval with priority review from the FDA.

The decision, six months from now, will mark a make-or-break moment for a struggling biotech that has just enough cash to keep the lights on until the third quarter.

Immunocore spent much of 2019 dealing with the fallout of the Neil Woodford scandal, as the former star investor’s fall crashed the biotech’s valuation out of unicorn range. Now it turns out that the company spent 2020 dealing with another internal scandal.

The longtime UK biotech darling disclosed in their IPO filing last week that they had fallen victim to an alleged kickback scheme involving one of their employees. After a whistleblower came forward, they said in their F-1, they spent the summer and spring investigating, finding fraud on the part of an employee and two outside vendors.

It’s not new for Lonza, the Swiss CDMO nearing its quasquicentennial anniversary, to be in the upper echelon of the biotech manufacturing industry.

But 2020 — as it was for many CDMOs — was a special year even by Lonza’s standards. The company inked a deal to produce 1 billion worldwide doses of Moderna’s Covid-19 vaccine and tapped pharma vet Pierre-Alain Ruffieux to lead its operations, moves which have allowed Lonza to make a myriad of other deals that will continue to ramp up its global production capacity.

Longtime Vertex CEO Jeffrey Leiden is taking on a new role.

Leiden has been appointed chairman of Tmunity’s board of directors, the company announced Monday. The move comes about a year and a half after Leiden announced he’d be stepping down from his position at Vertex.

Vertex saw immense growth under Leiden, leading the company from its exit out of hepatitis C, when cures were moving in, and into cystic fibrosis. The company’s cystic fibrosis triple combo therapy Trikafta is already its best-seller, reaching the distinction just six weeks after launch and recording the strongest first quarter of sales for any drug, per some estimates.