Just a few months af­ter its last in­ter­im read­out, Sutro Bio­phar­ma $STRO is shar­ing more Phase I da­ta in a small, sin­gle-arm tri­al for its ovar­i­an can­cer pro­gram.

The San Fran­cis­co-based biotech an­nounced Thurs­day af­ter­noon that pa­tients with heavy pre­vi­ous treat­ment con­tin­ued to see im­prove­ments as they re­mained on the drug, with one in­di­vid­ual achiev­ing a com­plete re­sponse af­ter more than a year. With the new da­ta in hand, Sutro plans to be­gin a dose-ex­pan­sion co­hort in Jan­u­ary, which could be fol­lowed by an ac­cel­er­at­ed ap­proval ap­pli­ca­tion in the sec­ond half of 2021.

In­vestors greet­ed the news hap­pi­ly, send­ing shares up about 22% af­ter Thurs­day’s clos­ing bell.

Sutro’s ex­per­i­men­tal drug in ques­tion, called STRO-002, is a fo­late re­cep­tor al­pha (Fol­Rα) tar­get­ing an­ti­body-drug con­ju­gate. The can­di­date was be­ing stud­ied as a monother­a­py in 34 ovar­i­an can­cer pa­tients who col­lec­tive­ly un­der­went a me­di­an of 6 pre­vi­ous ther­a­pies, and of those, 31 met the cri­te­ria to be eval­u­at­ed at the Oct. 30 da­ta cut­off.

Though re­searchers had looked at 33 pa­tients in their last in­ter­im look on Aug. 30, the over­all re­sponse rate and num­ber of pa­tients reg­is­ter­ing a re­sponse in­creased. As of the newest Oc­to­ber read­out, 10 of 31 in­di­vid­u­als achieved at least a par­tial re­sponse, in­clud­ing one whose can­cer dis­ap­peared en­tire­ly. The pro­gram al­so saw 23 of 31 pa­tients achieve dis­ease con­trol af­ter 12 weeks, and 18 of 31 af­ter 16 weeks.

Pa­tients re­mained on the treat­ment for a me­di­an of 19 weeks, and on the read­out date 10 were still tak­ing the treat­ment.

In terms of safe­ty, Sutro said the ther­a­py con­tin­ued to be well-tol­er­at­ed, with 86% of treat­ment-re­lat­ed side ef­fects clock­ing in at Grade 1 or 2. Stifel’s Kon­stan­ti­nos Apri­lakis not­ed there was one ad­di­tion­al case of Grade 3 neu­ropa­thy, but saw the safe­ty pro­file as “high­ly con­sis­tent” with the Au­gust up­date.

The con­sen­sus among Apri­lakis and oth­er an­a­lysts sings the prais­es of the con­tin­ued ef­fi­ca­cy of the da­ta, es­pe­cial­ly giv­en the sheer amount of treat­ments pa­tients had un­der­gone in the past. Apri­lakis said the com­plete re­sponse was “a re­mark­able achieve­ment” while Cowen’s Boris Peak­er wrote the da­ta “ex­ceed­ed in­vestor ex­pec­ta­tions.”

Wed­bush’s David Nieren­garten al­so chimed in, say­ing Thurs­day’s an­nounce­ment bodes well for fu­ture stud­ies.

“Im­por­tant­ly, re­spons­es ap­pear to deep­en with time,” he wrote to in­vestors. “Giv­en the ear­li­er in­ter­ven­tion with STRO-002, we ex­pect STRO to achieve an even more com­pelling ef­fi­ca­cy pro­file than ob­served in the es­ca­la­tion por­tion of the study.”

Mov­ing for­ward, Sutro is plan­ning the dose-es­ca­la­tion co­hort to be­gin in Jan­u­ary with a da­ta read­out ex­pect­ed some­time in the first half of next year. If all goes ac­cord­ing to plan, Apri­lakis ex­pects a de­ci­sion on whether to file for ac­cel­er­at­ed ap­proval be­fore 2021 is out.

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.

New research shows how generic drug companies can successfully market a limited number of approved indications for a brand name drug, prior to coming to market for all of the indications. But several recent court decisions have created a layer of uncertainty around these so-called “skinny” labels.

While courts have generally allowed generic manufacturers to use their statutorily permitted skinny-label approvals, last summer, a federal circuit court found that Teva Pharmaceuticals was liable for inducing prescribers and patients to infringe GlaxoSmithKline’s patents through advertising and marketing practices that suggested Teva’s generic, with its skinny label, could be employed for the patented uses.