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Welcome to another edition of “3 Things In Biotech You Should Learn Today,” a daily digest dedicated to helping you keep pace with the fast-moving world of pharmaceutical and biotechnology research.
Alexion lands favorable phase 3 PNH data
Company: Alexion (ALXN)
Disease: Paroxysmal nocturnal hemoglobinuria (PNH)
News: As part of its announced quarterly filing, ALXN provided top-line findings from their phase 3 switch study evaluating their C5 complement inhibitor ALXN1210. The study met its endpoint of noninferiority to Soliris treatment with respect to lactate dehydrogenase levels, as well as key secondary endpoints. In addition, there were no breakthrough bleeding episodes with ALXN1210 therapy.
Looking forward: These findings provide support for the ability to transition for eculizumab (Soliris) to ALXN1210. This builds well upon the data already generated in the disease, where patients who never received a complement factor inhibitor received ALXN1210, with favorable findings compared with eculizumab. The company guided that they anticipate moving toward regulatory filings later this year, and based on these findings it seems that the chances are good for this drug.
ADC Therapeutics throws in the towel in HER2-positive breast cancer
Company: ADC Therapeutics
Disease: HER2-positive breast cancer
News: ADC announced that they have terminated their phase 1 clinical trial evaluating the antibody drug conjugate ADCT-502 in HER2-positive breast cancer, due to safety and efficacy data not justifying further development of this agent. Comments from the chief medical officer suggested that the issue lay more with the safety: “PBD’s (pyrrolobenzodiazepine dimers) are extremely potent and have a well characterized safety profile that includes fluid retention and pulmonary edema. For most PBD ADCs this can be managed by selecting dosing regimens that are efficacious with manageable toxicities. However, during dose escalation in this trial we did not achieve the necessary efficacy at tolerated doses required for patient benefit.”
Looking forward: So this would seem to mark the end of the exploration of these “PBDs” in breast cancer. However, ADC remains committed to using this cytotoxin in hematologic malignancies, the most advanced developmental product being ADCT-301, which is being studied in a phase 1b study in Hodgkin and non-Hodgkin lymphoma. I’m not sure that this does, in fact, bode well for the rest of the ADC programs, but we’ll see.
AbbVie moves to finish out their latest interleukin program
Company: AbbVie (ABBV)
Disease: Plaque psoriasis
News: ABBV announced that they have completed submission of a licensing application to the FDA for their interleukin-23 (IL-23) antibody risankizumab for the treatment of patients with moderate to severe plaque psoriasis. The application was based on findings from four phase 3 studies, which included a total of over 2000 patients, and which demonstrated favorable efficacy compared with other interleukin antibodies like ustekinumab.
Looking forward: At this point, given the strength of the data, I don’t see why this application will not be accepted and eventually approved by the FDA. So this should continue to build on the strength of ABBV’s rheumatology portfolio. Not much to say about it other than that.
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