Russia’s Enteromix Cancer Vaccine Achieves Complete Success in Preclinical Trials
Summary:
Russia has unveiled Enteromix, an mRNA-based cancer vaccine that achieved complete tumour suppression in preclinical trials. Designed as a personalised therapy, Enteromix initially targets colorectal cancer and is being explored for aggressive cancers like glioblastoma and melanoma. The vaccine showed strong safety and tumour reduction in animal models, and Phase I human trials are now planned. While the results are promising, experts caution that clinical studies are needed to confirm effectiveness in patients.
FDA Rejects Ultra-Rare Disease Therapy from Saol Therapeutics
Summary:
The FDA has issued a Complete Response Letter rejecting Saol Therapeutics’ application for SL1009, an oral therapy for pyruvate dehydrogenase complex deficiency (PDCD) – a fatal mitochondrial disorder affecting fewer than 1,000 U.S. patients. Saol said the agency cited unspecified “specific observations” that could take years and significant funding to resolve. SL1009 had orphan drug, rare pediatric disease, and priority review designations, but no approved treatments currently exist for PDCD. Patient advocacy groups expressed deep disappointment, urging regulatory flexibility for rare diseases.
Pfizer/BioNTech Booster Shows Strong Protection Against New COVID Strains
Summary:
Pfizer and BioNTech reported that their updated COVID-19 booster generated a four-fold rise in neutralizing antibodies against current coronavirus variants in late-stage testing, with no new safety issues observed. The data, now submitted to the FDA, supports the recently approved shot for adults – particularly seniors and those with underlying conditions. The results come amid shifting U.S. vaccine policies and debates over access, as federal eligibility for COVID boosters has narrowed under new leadership.
Orexin Drugs Show Strong Results for Narcolepsy
Summary:
At the World Sleep Congress, Takeda, Alkermes, and Eisai reported promising late-stage data for their experimental orexin-2 agonists, a new class of treatments for narcolepsy. Takeda’s drug oveporexton significantly increased wakefulness and reduced cataplexy events, while Alkermes and Eisai reported similar improvements with their candidates in mid- and early-stage trials. Takeda plans to seek regulatory approval by March, signaling a potential breakthrough for patients needing more effective therapies.
FDA Issues Draft Guidance to Accelerate Non-Opioid Pain Treatments
Summary:
The FDA has released draft recommendations aimed at spurring development of non-opioid therapies for chronic pain. The guidance outlines trial design expectations, encourages broad indications that cover multiple pain conditions, and supports testing drugs that could reduce or replace opioid use. While expedited pathways may be available, the agency cautioned that pain’s subjective nature makes accelerated approval challenging. The move, mandated by the SUPPORT Act, seeks to give physicians more alternatives as the opioid crisis persists and follows recent progress such as Vertex’s approval of the non-opioid pain drug Journavx.
