Proven­tion Bio has some more pos­i­tive da­ta to add to its loom­ing BLA for a new treat­ment de­signed to de­lay the on­set of di­a­betes among pa­tients.

Their new tri­al da­ta for teplizum­ab boost­ed the av­er­age amount of time it takes for a pa­tient to be di­ag­nosed with type 1 di­a­betes to 5 years, adding a year to their ear­li­er num­ber com­pared to a steady 2 years for the place­bo arm.

Re­searchers added that they are track­ing clear ev­i­dence that the drug can sta­bi­lize and then re­verse de­te­ri­o­rat­ing C-pep­tide lev­els, “sug­gest­ing a de­lay in the de­struc­tion of be­ta cells and restora­tion of in­sulin pro­duc­tion by dys­func­tion­al be­ta cells. Im­por­tant­ly, even in those who ad­vanced to clin­i­cal-stage T1D, treat­ment with teplizum­ab re­sult­ed in a slow­er de­cline in C-pep­tide lev­els com­pared to place­bo.”

Pa­tients se­lect­ed for this study had de­clin­ing C-pep­tide lev­els when they en­rolled.

Jef­frey Blue­stone

That was all mu­sic to the ears of its back­ers, as Proven­tion’s shares $PRVB surged 9% on Mon­day.

Teplizum­ab is on a come­back trail, 10 years af­ter Eli Lil­ly wrapped a failed de­vel­op­ment pro­gram and washed its hands of the whole thing. The brain­child of long­time in­ves­ti­ga­tor Jef­frey Blue­stone, it’s thrived in the hands of Proven­tion, pick­ing up “break­through” sta­tus at the FDA as well as PRIME billing in Eu­rope.

The li­cens­ing ap­pli­ca­tion is set up for a 4th quar­ter fil­ing.

So­cial: Ash­leigh Palmer, Proven­tion Bio CEO (Third Pole via YouTube)

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.

Three years after first launching Calquence as a second generation BTK inhibitor, AstraZeneca continues to tout new data to compete with J&J and AbbVie’s first generation blockbuster Imbruvica.

The British pharma announced on Monday that Calquence passed a head-to-head Phase III study against Imbruvica in chronic lymphocytic leukemia, proving non-inferior — i.e. just as good — as the older drug. Although AstraZeneca did not break down any of the numbers, they said the drug proved superior on safety, triggering fewer cases of atrial fibrillation, an irregular heartbeat that can lead to stroke or heart failure.

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.