Clinical Catch-Up: Seagen, Astellas, SOTIO & More

Clinical

Every week, there are dozens of clinical trial updates and announcements. Here’s a look at some of the more interesting news.

Seagen and Astellas Pharma announced positive topline results from the Phase Ib/II EV-103 trial (KEYNOTE-869) Cohort K of Padcev (enfortumab vedotin-ejfv) in combination with Merck’s anti-PD-1 checkpoint inhibitor Keytruda (pembrolizumab) as first-line treatment in patients with unresectable locally advanced or metastatic urothelial cancer who are ineligible to receive cisplatin-based chemotherapy. In patients receiving the combination, the data demonstrated a 64.5% confirmed objective response rate (ORR), the primary endpoint of Cohort K. The median duration of response (DOR) per the independent central review was not reached.

SOTIO Biotech announced it had dosed the first patient in its Phase II AURELIO-04 combination trial of SOT101 and Merck’s Keytruda in patients with selected advanced/refractory solid tumors. SOT101 is an anti-IL-15 superagonist. The first patient was dosed at the Masaryk Memorial Cancer Institute in Brno, Czech Republic.

Diffusion Pharmaceuticals plans to initiate a Phase II trial of trans sodium crocetinate (TSC) in newly diagnosed glioblastoma multiforme patients after reaching an agreement with the U.S. Food and Drug Administration on the study design. It will be designated Study 200-208. TSC is being evaluated to enhance oxygen diffusion to tissues with low oxygen levels (hypoxia), including hypoxic solid tumors.

InMed Pharmaceuticals provided an update on its Phase II trial of INM-755 for patients with epidermolysis bullosa. INM-775 is a cannabinol cream. Epidermolysis bullosa is a group of rare genetic skin diseases marked by fragile skin that can lead to extensive blistering and wounding, as well as mucous membranes in the GI tract and genitourinary and respiratory systems. Based on safety data from the first five adults in the Phase II trial, an independent Data Monitoring Committee gave the go-ahead to enroll adolescent patients with EB, defined as people 12 to 17 years of age.

Philogen SpA enrolled 214 patients in its Phase III European trial of Nidlegy in locally advanced melanoma. The trial will read when 95 events have occurred. The therapy is being tested via intratumoral injections as neoadjuvant therapy followed by standard-of-care treatment compared to standard-of-care alone, in melanoma with locally advanced, fully resectable metastatic disease, accessible to intralesional injection. Nidlegy is a combination of immunocytokines L19IL2 and L19TNF.

Acasti Pharma initiated its planned pharmacokinetic (PK) bridging study to evaluate the relative bioavailability of GTX-101 compared to the reference listed drug bupivacaine in 48 healthy patients. GTX-101 is a novel formulation of bupivacaine hydrochloride (HCl) for topical administration via a bio-adhesive, film-forming polymer for relief of pain associated with Postherpetic Neuralgia (PHN). PHN is a persistent and often debilitating nerve pain caused by nerve damage from shingles, resulting from a varicella zoster viral infection.

Celularity treated the first patient in its Phase I/IIa trial for CYNK-101. CYNK-101 is a novel allogeneic off-the-shelf human placental CD34+ stem cell-derived NK cell therapeutic candidate that is genetically engineered to express a high-affinity and cleavage-resistant CD16 variant to improve antibody-dependent cell-mediated cytotoxicity (ADCC). The therapy is being developed for advanced HER2-positive gastric and gastroesophageal junction (G/GEJ) cancers.

NewAmsterdam Pharma dosed the first patient in a pivotal Phase III trial of obicetrapib in adults with a history of heterozygous familial hypercholesterolemia (HeFH), whose LDL-C is not adequately controlled despite being on maximally tolerated lipid-modifying therapies. The drug is a next-generation oral, low-dose, once-a-day cholesteryl ester transfer protein (CETP) inhibitor. It is in development for patients with a high risk of cardiovascular disease with the highest-tolerated doses of statins, both as a monotherapy and in a fixed-dose combination with ezetimibe.

Ionis Pharmaceuticals announced positive topline results from its Phase IIb RE-THINC ESRD trial of fesomersen in end-stage renal disease (ESRD) patients on hemodialysis. Fesomersen hit the primary outcome measure of no increase in the incidence of major bleeding and clinically relevant non-major bleeding compared to placebo. Fesomersen is an investigational antisense drug engineered to decrease the production of Factor XI, a clotting factor produced in the liver that is a major component of the coagulation pathway.

ACM Biolabs dosed the first patient in a Phase I trial of a second-generation adjuvanted COVID-19 vaccine as part of Operation Nasal Vaccine. The vaccine is being evaluated as a booster, comparing intramuscular versus intranasal administration of various doses of antigen and adjuvant in healthy adult volunteers who have previously received three doses of approved COVID-19 vaccines.

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