Selecta released an 8-K after market today which disclosed that one of the patients in the SEL-403 trial died from a Grade 5 Serious Adverse Event related to pneumonitis (lung inflammation). This was deemed to be probably related to SVP-Rapamycin and possibly related to the patient’s pleural mesothelioma condition.
Pleural mesothelioma originates in the lining of the lungs, the pleura. The average life expectancy for most patients with mesothelioma in this location ranges from 4 to 18 months. This specific patient had received previous therapies, including two courses of radiation therapy and three different immune checkpoint inhibitors. They were very sick.
In addition, a Serious Adverse Event (pericardial effusion) was seen in one of the other three patients dosed in the SEL-403 clinical trial. Pericardial effusion can be a side effect of immunotoxin therapies targeting mesothelin. There are currently no patients active in the SEL-403 clinical trial nor are new patients being enrolled at this time.
SEL-403 Trial Was For Advanced Mesothelioma Patients
The objective of this Phase 1 trial (read study design here) was to learn how safe and tolerable LMB-100 plus SEL-110 is in people with advanced mesothelioma.
The study was enrolling patients with malignant pleural or peritoneal mesothelioma (read more here).
Pleural mesothelioma, as mentioned above, originates in the lining of the lungs, the pleura. The average life expectancy for most patients with mesothelioma in this location ranges from 4 to 18 months
Peritoneal mesothelioma also originates in the lining of the lungs, but the peritoneum. This has a higher life expectancy (avg of 12 months), though having surgery paired with chemo called HIPEC can improve prognosis to ~7 years.
No Impact on SEL-212 Gout Trial
News of this death has no impact on Selecta’s Phase 2 trial in gout, which will readout next week (October 23,2018 @ ACR). In this gout Phase 2 trial to date, over 150 patients have received multiple (up to 5) doses of SEL-212 and no cases of pneumonitis have been reported.
Bottom line: This was obviously not good news for Selecta, but it should not be overestimated. The death was in a patient population that is considered to be very sick - advanced mesothelioma. Selecta’s lead candidate in chronic gout (SEL-212) has been dosed in more than 150 patients with no significant adverse events. We are still confident that the data on October 23 will show Selecta’s candidate is superior to commercial competitor Krystexxa. We recently released a note (here) where we valued the company at more than $18/share. In this $18/share figure we assumed the value of its other pipeline candidates (including SEL-403) was $0.
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