Less than a month af­ter of­fer­ing a glimpse at ear­ly clin­i­cal da­ta for its lead can­cer im­munother­a­py at vir­tu­al ES­MO, Sen­sei Bio­ther­a­peu­tics has reeled in $28.5 mil­lion to wade deep­er in­to Phase II.

The Mary­land-based biotech, for­mer­ly known as Panacea, is look­ing to ex­pand Phase II tri­als for SNS-301, an en­gi­neered in­ac­ti­vat­ed bac­te­rio­phage de­signed to “awak­en” the im­mune sys­tem. “Right now we’re re­al­ly fo­cused on adding ad­di­tion­al Phase II clin­i­cal and trans­la­tion­al da­ta to sup­port SNS-301,” CEO John Celebi said.

The round, which the com­pa­ny is call­ing a Se­ries AA, fol­lows sev­er­al seed rounds, Celebi said. It was led by Cam­bri­an Bio­phar­ma and H&S Ven­tures, and will fund the Phase II de­vel­op­ment of SNS-301. It will al­so help ready the biotech’s ear­li­er can­di­dates for IND ap­pli­ca­tions, which could come some­time in the next 12 to 18 months. That in­cludes SNS-401, a po­ten­tial vac­cine cock­tail against Merkel cell car­ci­no­ma, and SNS-VISTA, an an­ti­body-based ther­a­peu­tic.

Last sum­mer, Sen­sei joined forces with As­traZeneca to test SNS-301 in com­bi­na­tion with Imfinzi in two Phase II tri­als across mul­ti­ple sol­id tu­mors. And at ES­MO, the biotech read out ear­ly da­ta from a Phase I/II study of the can­di­date and Mer­ck’s Keytru­da for ad­vanced head and neck can­cer. One of 9 pa­tients eval­u­at­ed at the time had a par­tial re­sponse, with a tu­mor re­duc­tion of 43%, ac­cord­ing to the com­pa­ny.

“The ap­proval of pem­brolizum­ab is an ex­cit­ing event for pa­tients, but clear­ly there’s a lot of room for im­prove­ment,” Celebi said, cit­ing a Keynote-012 study which showed Mer­ck’s drug achieved an 18% over­all re­sponse in pa­tients with metasta­t­ic squa­mous cell car­ci­no­ma of the head and neck.

CMO Marie-Louise Fjaell­skog not­ed in a state­ment:

To date, we have ob­served promis­ing clin­i­cal ac­tiv­i­ty that is cor­re­lat­ed with im­mune re­sponse for SNS-301, in­clud­ing a par­tial re­sponse in a pa­tient with PD-L1-neg­a­tive dis­ease. This ini­tial da­ta from 9 pa­tients pro­vides us with the ra­tio­nale to con­tin­ue ex­plor­ing its safe­ty and ef­fi­ca­cy in 1^st and 2^nd line SC­CHN pa­tients.

Fu­ture Ven­tures, Chris­t­ian Anger­may­er’s Ape­iron In­vest­ment Group, and Pre­sight Ven­tures al­so chipped in to the round.

“With ex­pe­ri­enced man­age­ment and sci­en­tif­ic teams, Sen­sei is well po­si­tioned to be­come a leader in next gen­er­a­tion of im­mune-on­col­o­gy ther­a­peu­tics,” Cam­bri­an Bio­phar­ma CEO James Pey­er said in a state­ment.

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.”