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Welcome to another edition of "3 Things In Biotech," a daily digest dedicated to helping you keep pace with the fast-moving world of pharmaceutical and biotechnology research.
Pfizer looking to the end game for the world's 4th PARP inhibitor
Disease: Breast cancer
News: PFE announced that the FDA has accepted its new drug application for its PARP inhibitor talazoparib in the treatment of BRCA-mutated advanced breast cancer. The agency granted the application priority review status, bringing the action date to sometime in December. BMRN also received a $20 million milestone payment from PFE relating to a deal it made with Medivation, the company PFE bought to acquire this PARP inhibitor.
Looking forward: Finally, PFE's inhibitor has been billed as a potential best in class, given its peerless ability to trap the PARP-DNA complex, which experts think may lead to enhanced clinical activity. To date, we have not really seen that bear out, as talazoparib has yielded good, not amazing, data in BRCA-mutant diseases. However, now that this agent is being considered for FDA approval, we may finally get to see the range of indications open up, and PFE is likely going to be able to capitalize on a growing but competitive market.
Endocyte looks to complete its VISION
Company: Endocyte, Inc. (ECYT)
Disease: Castration-resistant prostate cancer
News: ECYT announced that it has enrolled the first patient into its phase 3 VISION study. This open-label, randomized trial is assessing the addition of its radiolabeled prostate-specific membrane antigen to standard therapy for PSMA-positive, previously treated metastatic castration-resistant prostate cancer. The study will enroll 750 patients in total, with the primary endpoint being overall survival.
Looking forward: This is an interesting trial, building on a successful phase 2 study and cooperation with the FDA, which agreed to the primary endpoint being assessed. To date, although PSMA has been an attractive target for prostate cancer therapy, no drugs have yet emerged that can take advantage of it. By targeting tumor cells with radioligand therapy, it is possible that ECYT will be able to achieve tumor control, similar to how Bayer (OTCPK:BAYZF) does with its Radium drug Xofigo, and how Novartis (NVS) is attacking neuroendocrine tumors with Lutathera.
Lilly gives a big dose of positive data in ulcerative colitis
Company: Eli Lilly (LLY)
Disease: Ulcerative colitis
News: LLY presented data from a phase 2 study comparing different doses of its investigational anti-IL-23 drug mirikizumab in patients with moderate-to-sever ulcerative colitis. The drug yielded significantly improved clinical remission rates at 12 weeks compared with placebo, in addition to improving several key secondary endpoints like clinical response rate and endoscopic healing rate. The treatment was well tolerated, with similar frequencies of key adverse events between the placebo and treatment arms.
Looking forward: These efficacy findings compare well with other anti-inflammatory drugs like tofacitinib in this disease setting. Unlike tofacitinib, however, mirikizumab is not associated with a risk for serious infection. It's no surprise that LLY is looking to initiate a phase 3 trial as soon as possible. Of course, it's likely to encounter competition sooner rather than later, with drugs like Stelara and risankizumab also being explored in this disease.
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