Ar­gos’ PhI­II for its per­son­al­ized can­cer vac­cine im­plodes dur­ing an in­ter­im analy­sis

Ar­gos CEO Jeff Abbey

Ar­gos Ther­a­peu­tics’ $ARGS Phase III study of its per­son­al­ized can­cer vac­cine ro­ca­pulden­cel-T has end­ed in dis­as­ter. Its in­de­pen­dent mon­i­tor­ing com­mit­tee con­clud­ed in an in­ter­im analy­sis that the late-stage tri­al for metasta­t­ic re­nal cell car­ci­no­ma was head­ed to a near cer­tain fail­ure, call­ing for an end to the study.

Ar­gos treat­ment is de­signed to cap­ture the anti­gens spe­cif­ic to a pa­tients’ tu­mor cells, ramp­ing up an im­mune re­sponse to wipe out those can­cer cells. In­ves­ti­ga­tors com­bined their drug with Su­tent (suni­tinib) and com­pared it to stan­dard of care.

The set­back marks back to back fail­ures of new can­cer vac­cines, a trou­bled field that’s seen re­peat­ed fail­ures in re­cent years. These per­son­al­ized vac­cines were seen as a bet­ter way to go af­ter can­cer, but Ar­gos will be fac­ing some bit­ter ques­tions over the util­i­ty of its plat­form tech­nol­o­gy now.

The biotech’s shares im­plod­ed with the study, plung­ing 74% in a mat­ter of min­utes.

Ar­gos faced con­sid­er­able skep­ti­cism in ear­ly 2015 when it took the same ap­proach to train pa­tients’ T cells to at­tack HIV and failed. Their Phase IIb tri­al failed to sig­nif­i­cant­ly re­duce vi­ral load in chron­i­cal­ly af­flict­ed pa­tients.

In­ves­ti­ga­tors re­cruit­ed 462 pa­tients for the study.

Ar­gos has known ear­li­er set­backs as well.

“We are ex­treme­ly dis­ap­point­ed with these re­sults, which in­clud­ed sev­en­ty-five per­cent of the tar­get­ed events need­ed to per­mit the pri­ma­ry analy­sis and as­sess­ment of over­all sur­vival in the study,” said Ar­gos CEO Jeff Abbey in a state­ment. “We sin­cere­ly ap­pre­ci­ate the pa­tients and in­ves­ti­ga­tors who have par­tic­i­pat­ed in the ADAPT Phase 3 tri­al, and re­main con­vinced in the abil­i­ty of pre­ci­sion im­munother­a­py to im­prove the lives of pa­tients.”

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As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

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UP­DAT­ED: Pfiz­er hits the brakes on their piv­otal tri­al for a BC­MA/CD3 bis­pe­cif­ic on safe­ty con­cerns while FDA road­block is hold­ing up Duchenne MD PhI­II

Pfizer’s ambitious plan to take a Phase II study of its BCMA CD3-targeted bispecific antibody elranatamab (PF-06863135) and run it through to an accelerated approval has derailed.

The pharma giant said in a release this morning that they have halted enrollment for their MagnetisMM-3 study after researchers tracked three cases of peripheral neuropathy in the ongoing Phase I. They are now sharing info with the FDA as they explore the red safety flag.

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Stéphane Bancel at the Endpoints #JPM20 breakfast panel in San Francisco, January 2020 (Photo: Jeff Rumans, Endpoints News)

Mod­er­na says Covid-19 vac­cine boost­er in­creased im­mune re­sponse against vari­ants of con­cern

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Volunteers given a booster shot about six to eight months after receiving their second dose saw increased antibody levels against SARS-CoV-2 and two variants of concern: B.1.351, which was first identified in South Africa, and P.1, first identified in Brazil, the company said on Wednesday.

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CN Bio said the scope of the research performed by the FDA’s Center for Drug Evaluation and Research has expanded to include the exploration of the company’s lung-on-a-chip system to help with the agency’s evaluation of inhaled drugs, in addition to the agency’s work on its liver model.

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In quest to meet user fee goals, FDA’s per­for­mance con­tin­ues down­ward trend

A recent update to the FDA’s running tally of how it’s meeting its user fee-related performance goals during the pandemic shows an agency that is not out of the woods yet.

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Cynthia Butitta (L) and Joe Jimenez

Is that an­oth­er IPO in the mak­ing? Ex-No­var­tis CEO Joe Jimenez and a lead Kite play­er take up new posts at an off-the-shelf ri­val to 2 pi­o­neer­ing drugs

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Joe Wiley, Amryt CEO

A biotech with a yen for pricey rare dis­ease drugs — and bar­gain base­ment shop­ping — adopts an­oth­er or­phan in lat­est M&A pact

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Ngozi Okonjo-Iweala, Director general of WTO (AP Photo/Keystone/Alessandro Della Bella)

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