Im­age: Colleen Cut­cliffe WHOLE BIO­ME

The boom in mi­cro­bio­me ther­a­peu­tics has el­e­vat­ed the “good” gut bac­te­ria from pro­bi­otics to drug sta­tus, spurring some up­starts backed by promi­nent ven­ture in­vestors to take their ther­a­pies on the high­ly reg­u­lat­ed jour­ney to­ward an FDA ap­proval. But Whole Bio­me wants to go a sep­a­rate di­rec­tion by oc­cu­py­ing the mid­dle ground with what it’s call­ing “med­ical pro­bi­otics.”

“This is ba­si­cal­ly a prod­uct that has phar­ma­ceu­ti­cal grade ef­fi­ca­cy, clin­i­cal ef­fi­ca­cy, but it has es­sen­tial­ly got the safe­ty of a pro­bi­ot­ic,” CEO Colleen Cut­cliffe tells me as the com­pa­ny emerges from stealth mode with $35 mil­lion in Se­ries B cash.

Jim Bullard Whole Bio­me

Cut­cliffe, a vet­er­an of Elan Phar­ma­ceu­ti­cals, was work­ing at the DNA se­quenc­ing com­pa­ny Pa­cif­ic Bio­sciences when she met her co-founders, Jim Bullard and John Eid. Com­bin­ing their bio­chem­istry, bio­sta­tis­tics and physics back­ground, the trio built a plat­form that com­pares deep se­quenc­ing da­ta from dif­fer­ent pop­u­la­tions, ar­riv­ing at meta­bol­ic maps that sug­gest ex­act­ly which mi­crobes are miss­ing in pa­tients with cer­tain dis­eases.

Se­quoia Cap­i­tal was an ear­ly sup­port­er of the 6-year-old ven­ture, chip­ping in­to the cur­rent round with True Ven­tures, Khosla Ven­tures, Mayo Foun­da­tion, AME Cloud Ven­tures and oth­ers. Roelof Botha is join­ing the board.

John Eid Whole Bio­me

Whole Bio­me plans to com­mer­cial­ize its first off-the-shelf prod­uct, for type 2 di­a­betes, ear­ly next year. Da­ta from sev­er­al re­cent — though un­pub­lished — place­bo-con­trolled clin­i­cal tri­als show that their treat­ment achieved re­duc­tion in A1C and glu­cose spikes on top of the stan­dard met­formin reg­i­men, Cut­cliffe says.

The the­o­ry is that peo­ple with type 2 di­a­betes lack the mi­crobes that are en­tire­ly re­spon­si­ble for me­tab­o­liz­ing fiber, which then trig­gers GLP1 re­sponse for reg­u­lat­ing glu­cose and in­sulin. WBF-011, which Whole Bio­me in­tends to mar­ket as a med­ical food, is de­signed to put ex­act­ly those mi­crobes back.

With 40 staffers and its own man­u­fac­tur­ing op­er­a­tions at its San Fran­cis­co base, the com­pa­ny is al­so ex­plor­ing oth­er prod­ucts for ir­ri­ta­ble bow­el syn­drome and a third, undis­closed in­di­ca­tion.

Indian-based generics manufacturer Aurobindo Pharma has been in the crosshairs of the FDA for several years now, but the company is also attracting attention from regulators within the subcontinent.

According to the Indian business news site Business Standard, a warning letter was sent to the company from the Securities Exchange Board of India, or SEBI.

The letter is related to disclosures made by the company on an ongoing FDA audit of the company’s Unit-1 API facility in Hyderabad, India as well as observations made by the US regulator between 2019 and 2022.

While Massachusetts-based Charles River Laboratories has been on an acquisition spree, they are not against planting their flag. The latest move by the company sees them crossing the pond to establish a manufacturing site in the UK.

The company on Tuesday opened its cell and gene therapy manufacturing center at Bruntwood SciTech’s Alderley Park in Cheshire, United Kingdom. The expansion follows Charles River’s acquisition of Cognate BioServices and Cobra Biologics in 2021 for $875 million. Cognate is a plasmid DNA, viral vector and cell therapy CDMO.

Following some backlash from the American College of Cardiology and patients, Bristol Myers Squibb and Pfizer lowered the price of their blockbuster blood thinner Eliquis, thus ensuring that CVS Caremark would cover the drug after 6 months of it being off the major PBM’s formulary.

“Because we secured lower net costs for patients from negotiations with the drug manufacturer, Eliquis will be added back to our template formularies for the commercial segment effective July 1, 2022, and patient choices will be expanded,” CVS Health said in an emailed statement. “Anti-coagulant therapies are among the non-specialty products where we are seeing the fastest cost increases from drug manufacturers and we will continue to push back on unwarranted price increases.”