Just a few months af­ter phar­ma gi­ant No­var­tis part­nered up with Sci­ence 37 on its vir­tu­al ap­proach to clin­i­cal tri­al work, Re­code re­ports that the would-be CRO dis­rup­tor is in talks with Soft­Bank ex­ecs on a $150 mil­lion in­vest­ment.

Noah Craft, Sci­ence 37 CEO

Soft­Bank, which pro­vid­ed Roivant chief Vivek Ra­maswamy with more than a bil­lion dol­lars to in­vest in biotech, ev­i­dent­ly has been drawn to Sci­ence 37’s promise that it can ef­fi­cient­ly and ef­fec­tive­ly re­cruit pa­tients for clin­i­cal tri­als with­out forc­ing them in­to a tri­al site. Us­ing new telemed­i­cine tech, they say they can ac­cu­mu­late clean datasets to show whether or not new drugs are work­ing — hop­ing to dis­rupt the big play­ers who now dom­i­nate the CRO world.

Quot­ing sources, Re­code notes that Sci­ence 37 is plan­ning to val­ue it­self at $300 mil­lion for this deal, up about $100 mil­lion since Lux Cap­i­tal and Google’s GV helped back the com­pa­ny a lit­tle more than a year ago. 

Soft­Bank’s big, $98 bil­lion Vi­sion Fund has made re­peat­ed for­ays in­to the world of drug de­vel­op­ment and tech­nol­o­gy. Aside from Roivant, the group par­tic­i­pat­ed in the mas­sive $500 mil­lion round to back George Scan­gos’ Vir, which is work­ing on an in­fec­tious dis­ease drug pipeline.

The CRO busi­ness has un­der­gone a decade of shak­ing out as pri­vate eq­ui­ty groups moved in to buy up the out­sourc­ing com­pa­nies and meld them in­to a set of large and ag­gres­sive glob­al play­ers, of­ten with big staffs. Shak­ing them up with a new tech ap­proach won’t come eas­i­ly in an R&D world where safe and de­pend­able are key watch­words in the high-risk world of drug de­vel­op­ment.

But Sci­ence 37 con­tin­ues to build up a head of steam to give it a try.

→ Weeks after winning EU approval to start marketing dapagliflozin as Forxiga, AstraZeneca has racked up another OK for a triplet combo involving the SGLT2 diabetes drug. Named Qtrilmet, the pill combines Forxiga with the DPP-4 inhibitor Onglyza (saxagliptin) and the bedrock drug metformin in a modified-release format. That 3-in-1 approach proved superior in reducing average blood glucose levels to a number of other dual combinations across 5 Phase III trials, including Forxiga plus metformin, Onglyza with metformin, or glimepiride with metformin.

As is custom, an EMA panel on Friday issued its weekly recommendations on marketing applications submitted by drug developers. This week, the agency backed the use of five new therapies — including two Novartis drugs — but issued no negative reviews.

Novartis’ S1P drug for relapsing forms of multiple sclerosis (MS) drug, Mayzent (known chemically as siponimod), which was approved by the FDA in March — has been given the nod by the EMA. The Swiss drugmaker already sells its other MS drug, Gilenya, in both regions.

The folks behind Atomwise’s spinout X-37 like to think in cosmological metaphors, and you can think of their AI drug development model as probes sent into space from a central station. That station just got $14.5 million in Series A funding from DCVC Bio, Alpha Intelligence Capital and Hemi Ventures to back those missions.

X-37 uses Atomwise’s AI platform to identify drug targets and – unlike the parent company, which largely sticks to computers  – bring those into a wet lab and preclinical testing.  In addition to AI professionals, it’s led in by part by drug developers from Velocity Pharmaceutical Development.

→ Abbott Laboratories has named a successor to CEO Miles White after he announced that he was stepping down in March after 21 years of service. Robert Ford, the company’s COO and president, will take the helm. Ford is known for his work in the $25 billion merger between St. Jude Medical into Abbott in January 2017. White will remain with the company as executive chairman of the board. 

→ After snapping up Novartis’ Swiss facility, Novartis Center of Excellence, in July, Lonza has announced that their CEO, Marc Funk, is hitting the exit for “personal reasons.” Funk has been the CEO of the company for less than a year — brought onto the company back in March. In the meantime, chairman Albert Baehny will serve as interim CEO. 

A month after posting positive top-line data from their first Phase III trial of the IL-17A/17F inhibitor bimekizumab, Belgium’s UCB says they’ve added more upbeat results from their second late-stage test in moderate-to-severe plaque psoriasis.

That leaves the company on track for regulatory submissions in the middle of next year, says CMO Iris Loew-Friedrich.
Their drug beat out a placebo on the co-primaries — a 90% improvement in PASI 90 (the Psoriasis Area and Severity Index) and Investigator Global Assessment (IGA) response of clear or almost clear (IGA 0/1) at week 16, compared to placebo. Investigators also boasted of hitting some key secondaries.
UCB is angling to enter an increasingly crowded market space.
In their first of 3 Phase III studies for bimekizumab, researchers touted top-line wins on statistically significant results on clearing plaque psoriasis, including a victory over J&J’s IL-23 contender Stelara on key endpoints. The drug targets both IL-17A and IL-17F, a modification on the IL-17A strategy laid out for Taltz (Eli Lilly) and Cosentyx (Novartis). And the new group also includes J&J’s Tremfya and AbbVie’s Skyrizi.

Social image: UCB