Daily Brief Health Care: Paradigm Biopharmaceuticals, Oryzon Genomics, OSE Immuno, SIGA Technologies and more

Paradigm has announced the completion of patient recruitment for stage one (dose selection) of its pivotal Phase III trial, PARA_OA_002, a multi-centre (US/Australia/UK/EU/Canada), two-stage, adaptive, randomised, double-blind, placebo-controlled study to assess injectable pentosan polysulfate (iPPS) in patients with knee osteoarthritis (kOA) pain. Paradigm has efficiently recruited participants for the trial through various initiatives, such as through its partnership with NFL Alumni Health. Management expects stage one to be complete in Q3 CY23, and for stage two to commence with the most effective dose later in H2 CY23. The selected dose will also be used in the initiation of the separate confirmatory Phase III trial in H2 CY23. These events represent key milestones for Paradigm, in our view.

Oryzon has announced positive aggregate safety data for vafidemstat, which is being evaluated in the ongoing PORTICO trial as a potential treatment for borderline personality disorder (BPD). The independent data monitoring committee (DMC) has reviewed the safety data from the first 167 patients treated in the trial and reported no cases of treatment-related serious adverse events (AEs) or deaths. The DMC has therefore recommended that PORTCIO proceeds without modification until patient enrolment is completed (expected n=188), which is anticipated to be in Q323. We view this as an encouraging update for the clinical development of vafidemstat and believe that the announcement of top-line data, expected in Q124, may represent the next most significant catalyst for the PORTICO trial and for Oryzon’s central nervous system (CNS) portfolio.

OSE Immunotherapeutics has announced that Tedopi, the company’s lead cancer vaccine candidate, has been granted a new patent by the United States Patent and Trademark Office. The patent provides further protection of Tedopi as a potential second-line treatment in non-small cell lung cancer (NSCLC) patients post PD-1/PD-L1 immune checkpoint inhibitor (ICI) failure. We note that Tedopi is already being developed for HLA-A2+ patients with advanced or metastatic NSCLC. OSE is preparing for a follow-on Phase III confirmatory and potentially pivotal trial by end-FY23 or early FY24, and the additional patent protection represents a key milestone in the clinical development of Tedopi, in our view. Additionally, we note that the company already has similar patent approval in Japan, with multiple patent applications pending in other international markets.

Ahead of its H123 results and an anticipated period of increased business activity in the second half of the year, we present a preview of SIGA Technologies, which continues to have strong fundamentals (despite the bearish macro environment) with several potential inflection points on the horizon. The nearest catalysts, in our opinion, are the upcoming TPOXX deliveries to the US strategic national stockpile (which we expect in Q3/Q423) and data readouts from the post-exposure prophylactic (PEP) label expansion trials, anticipated in Q323, positive results from which could materially expand SIGA’s addressable market. With a strong balance sheet and potential incremental income generation for shareholders (via dividends and buybacks), we believe that SIGA has a resilient business case in the biotech space.