The transat­lantic biotech ADC Ther­a­peu­tics is get­ting a speedy re­view for its an­ti-body drug con­ju­gate lon­cas­tux­imab tesirine (Lon­ca), de­vel­oped for re­lapsed or re­frac­to­ry dif­fuse large B-cell lym­phoma.

News briefing: ADC gets a speedy FDA review for their DLBCL therapy; Qiagen teams with the …Chris Mar­tin ADC

ADC $AD­CT said Fri­day morn­ing that the FDA put their drug on the fast lane, pro­vid­ing a pri­or­i­ty re­view for the drug with a May 21 PDU­FA date. The biotech won over reg­u­la­tors with Phase II da­ta that re­flect­ed an over­all re­sponse rate of 48.3% (70/145 pa­tients) and a com­plete re­sponse rate of 24.1%.

“The FDA’s ac­cep­tance of our BLA and grant­i­ng of pri­or­i­ty re­view for Lon­ca is a tremen­dous ac­com­plish­ment that brings ADC Ther­a­peu­tics one step clos­er to be­ing able to of­fer pa­tients with re­lapsed or re­frac­to­ry DL­B­CL a great­ly need­ed new treat­ment op­tion in 2021,” said ADC chief Chris Mar­tin. — John Car­roll

Qi­a­gen gets to work on a new di­ag­nos­tic for BioN­Tech

Qi­a­gen has signed up to work with mR­NA pi­o­neer BioN­Tech on a new di­ag­nos­tic that can be used to flag pa­tients with squa­mous cell car­ci­no­ma of the head and neck caused by in­fec­tions with hu­man pa­pil­lo­mavirus.

Their as­say will be de­signed to de­tect the pres­ence of HPV geno­types as­so­ci­at­ed with the biotech’s can­cer treat­ment BNT113. And then Qi­a­gen plans to ex­pand that to be­come a uni­ver­sal HPV com­pan­ion di­ag­nos­tic.

Ac­cord­ing to Qi­a­gen, head and neck squa­mous cell car­ci­no­ma is the sixth most com­mon can­cer, trig­ger­ing more than 650,000 cas­es and lead­ing to 330,000 deaths. Those num­bers are ex­pect­ed to dou­ble by 2035. — John Car­roll

An­ten­gene goes pub­lic in Hong Kong

An­ten­gene, the Hong Kong-based on­col­o­gy com­pa­ny long backed by Cel­gene, has gone pub­lic in an over­sub­scribed of­fer­ing worth rough­ly $340 mil­lion.

The com­pa­ny launched in 2017 with $21 mil­lion and a li­cens­ing deal with Cel­gene. They’ve since added oth­er as­sets from Karyopharm and As­traZeneca and raised an ad­di­tion­al $217 mil­lion in pri­vate fi­nanc­ing, in­clud­ing a $97 mil­lion Se­ries C ear­li­er this year.

The biotech now has dozens of pro­grams, but their fur­thest along as­set is the Karyopharm drug Se­linex­or. Ap­proved in the US, An­ten­gene is now test­ing it in Phase II for two blood can­cers and non-small cell lung can­cer. — Ja­son Mast

Ob­sid­i­an teams with MD An­der­son

MD An­der­son has been ratch­et­ing up its biotech part­ner­ships in re­cent months, par­tic­u­lar­ly around im­muno-on­col­o­gy.  Now they’re team­ing up with Ob­sid­i­an Ther­a­peu­tics.

The Michael Gilman-found­ed start­up has been qui­et since their $50 mil­lion launch back in 2017, but the com­pa­ny just added a new CSO as they work on their new spin to cell ther­a­py.

The idea is to be able to con­trol cell ther­a­pies such as CAR-T with oral drugs that will in­crease or de­crease the num­ber of ac­tive T cells in a pa­tient. The two en­ti­ties will team up on a tu­mor-in­fil­trat­ing lym­pho­cyte ther­a­py (TIL) that can be con­trolled with IL-15, with the goal of treat­ing sol­id tu­mors.

“TIL ther­a­py has emerged as a promis­ing op­tion for treat­ing pa­tients with sol­id tu­mors, though its wide­spread use to­day is lim­it­ed by safe­ty and ef­fi­ca­cy chal­lenges,” Rod­abe Amaria, as­so­ciate pro­fes­sor of Melanoma Med­ical On­col­o­gy at MD An­der­son, said in a state­ment. “We are pleased to work with Ob­sid­i­an to ad­vance their nov­el cy­toTIL pro­gram, which has the po­ten­tial to dri­ve more durable treat­ment re­spons­es and ex­pand TIL ther­a­py to a broad­er group of our pa­tients.”  — Ja­son Mast

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