Shares of Needham, Mass.-based Candel Therapeutics Inc. (NASDAQ:CADL) were trading at $11.16, up $6.55, or 142%, on results from a multicenter phase III trial with CAN-2409 viral immunotherapy in localized prostate cancer patients. The study met its primary endpoint by showing statistically significant improvement in disease-free survival in patients who received CAN-2409 plus prodrug (valacyclovir) combined with standard of care (SOC) compared to SOC alone. The 2-to-1 randomized, double-blind, placebo-controlled effort enrolled 745 subjects.

Atopic dermatitis efforts disappoint for Q32 Bio and Anaptysbio

Disappointing phase II readouts in atopic dermatitis studies sank shares of two companies Dec. 11. Q32 Bio Inc.’s bempikibart failed to best placebo on the primary endpoint of percent change from baseline to week 14 in the Eczema Area and Severity Index (EASI) score, sending the company’s stock (NASDAQ:QTTB) falling 68% in midmorning trading. The company, however, plans to continue evaluating the anti-IL-7Rα antibody in alopecia areata. Meanwhile, shares of Anaptysbio Inc. (NASDAQ:ANAB) were trading down 33% on news that its BTLA agonist, ANB-032, failed to meet any endpoints in the 201-patient Arise-AD trial.

Loud and clear: Sound Pharma has phase III success in Meniere’s

Sound Pharmaceuticals Inc.’s lead candidate, SPI-1005 (ebselen), has produced positive pivotal phase III study data in treating Meniere’s disease, an inner-ear disorder that can lead to vertigo and deafness. The oral capsule hit its co-primary endpoints in the study. The privately held company enrolled 221 adults in the randomized, double-blind, placebo-controlled clinical trial, administering 400-mg twice-daily doses of ebselen, a new chemical entity designed to reduce neuroinflammation in the center and peripheral nervous system. There are no U.S. FDA-approved therapies for Meniere’s disease.

Jury convicts biotech execs in fraud scheme

Nearly three years after being terminated as president and CEO of Cytodyn Inc., Nader Pourhassan was convicted Monday by a U.S. federal jury for his role in a securities fraud scheme to deceive investors about the Vancouver, Wash.-based company’s development of leronlimab. The jury also convicted Kazem Kazempour, the CEO of Amarex Clinical Research LLC, a contract research organization hired by Cytodyn, for his part in the scheme. “The defendants lied to investors and the public – including during the height of the COVID-19 pandemic – about a drug that purportedly treated HIV and COVID-19 in order to artificially inflate Cytodyn’s stock price,” said Principal Deputy Assistant Attorney General Nicole Argentieri, head of the U.S. Justice Department’s criminal division.

ASH 2024: Kura, Kyowa highlight positive combo data for ziftomenib

Kura Oncology, Inc. and Kyowa Kirin Co. Ltd.’s selective oral menin inhibitor ziftomenib showed encouraging data across multiple studies, the most encouraging of which were in combination with other standard of care therapies in patients with NPM1-mutant (NPM1-m) and KMT2A-rearranged (KMT2A-r) acute myeloid leukemia (AML). “These updated data overall continue to support ziftomenib’s best-in-class potential within the menin class,” Leerink Partners analyst Jonathan Chang said. Data, presented at the American Society of Hematology (ASH) annual meeting on Dec. 9., also validate ziftomenib's high combinability with standard-of-care agents that are being integrated into earlier lines of AML treatment.

Engineered T cells can serve as organ-specific delivery service

Researchers from the University of California San Francisco (UCSF) have successfully replicated the design of regulatory T cells, achieving local targeted immune suppression and protection from CAR T-cell cytotoxicity. Many of the treatments used so far in the context of inflammatory and autoimmune disorders lead to systemic immunosuppression. In this sense, limiting immunosuppression locally to targeted tissues may help overcome systemic toxicity. “An important question is how to target therapeutics efficiently and specifically,” Wendell Lim, director of the UCSF Cell Design Institute, told BioWorld.

Also in the news

AC Immune, Accent, Affimed, ALX Oncology, Arvinas, Ascendis, Atyr, Biomea Fusion, Cardiff Oncology, Celltrion, Cervomed, Chimerix, Cimeio, Clene, Convergent, Crispr, Daré, Eikonizo, EMD Serono, Er-Kim, Gen1e, Genesis, Grin, Iambic, Ichnos, Immix, Immune-Onc, Incendia, Keros, Krystal, Kyowa Kirin, Lava, Lyell, Maat, Maia, Nanobiotix, Neogap, Newamsterdam, Nurix, Olema, Orthogon, Pfizer, Poseida, Recursion, Regeneron, Relmada, Renaissthera, Rigel, Roche, Santhera, Scilex, Sellas, Sonnet, Sumitomo, Uniqure, Xaira