VXM-01

AstraZeneca's oral SERD to face FDA adcomNewron's schizophrenia trial stalls in USGilead gets priority review for once-a-day HIV pillOSR locks in $815M deal for oral immunotherapyAstraZeneca's oral SERD to face FDA adcomTwo cancer drugs from AstraZeneca will be scrutinised by the FDA's Oncologic Drugs Advisory Committee (ODAC) on Thursday: oral selective oestrogen receptor degrader (SERD) camizestrant and AKT inhibitor Truqap (capivasertib).The UK pharma is seeking approval of camizestrant in combination with a CDK4/6 inhibitor to treat adults with HR-positive, HER2-negative, locally advanced or metastatic breast cancer. At question is the company's novel strategy of switching patients to the oral SERD prior to radiographic progression based on the appearance of ESR1 mutations in circulating tumour DNA (see – Spotlight On: Key takeaways from AstraZeneca's first quarter earnings call).Data from the SERENA-6 trial, presented at last year's American Society of Clinical Oncology (ASCO) meeting, demonstrated that patients who switched to camizestrant had a 56% reduction in the risk of disease progression or death (see – Physician Views Results: ASCO reveal of AstraZeneca's camizestrant data draws strong oncologist support). Despite the positive findings, briefing documents released ahead of the meeting show the FDA has its doubts, with the agency arguing that "evidence is lacking to show that switching treatment at detection of ESR1m rather than at radiographic progression is beneficial to patients."For Truqap, AstraZeneca is seeking to expand its label to include adults with metastatic, PTEN-deficient, hormone-sensitive prostate cancer, when given in combination with abiraterone. The drug is already approved to treat HR-positive, HER2-negative, locally advanced or metastatic breast cancer.-Elizabeth EatonNewron's schizophrenia trial stalls in USThe FDA paused enrollment of new patients in Newron Pharmaceuticals' Phase III ENIGMA-TRS 2 study of evenamide, which is being evaluated in patients with treatment-resistant schizophrenia.The hold follows the company's report of a sudden death involving a trial participant at a site outside the US, which investigators determined was unrelated to the study drug.The company said an independent international safety monitoring board reviewed the case and recommended that both ENIGMA-TRS studies continue as designed. While US enrollment in ENIGMA-TRS 2 is on hold, the global ENIGMA-TRS 1 trial remains ongoing across 21 countries, with more than 400 patients already recruited.Additional ENIGMA-TRS 2 sites outside the US are progressing following approvals in countries including Argentina and India. Earlier this year, the company secured up to €38 million to help fund the ENIGMA-TRS programme.-Anna BratulicGilead gets priority review for once-a-day HIV pillThe FDA on Wednesday agreed to review Gilead Science's application for a single-tablet combination of bictegravir/lenacapavir (BIC/LEN) to treat HIV in adults who are virologically suppressed under priority review, granting it a PDUFA date of August 27, 2026.The once-daily treatment includes integrase strand transfer inhibitor bictegravir, which anchors Gilead's top selling HIV drug Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide), as well as the active ingredient of Yeztugo (lenacapavir), the drugmaker's twice-yearly HIV pre-exposure prophylaxis (PrEP) shot. The submission for BIC/LEN features data from the Phase III ARTISTRY-1 and ARTISTRY-2 trials. In the former, 0.8% of study participants who switched from a complex multi-tablet regimen to the experimental once-daily pill had viral loads rebound to 50 copies/mL or higher at week 48, compared to 1.1% who continued their current treatment plan. The second study involved participants taking Biktarvy; 1.3% of those who switched to BIC/LEN had viral loads at or above 50 copies/mL at week 48, versus 1% for those who stayed on Biktarvy.-Elizabeth EatonOSR locks in $815M deal for oral immunotherapyOSR Holdings finalised a global exclusive licensing agreement with its largest shareholder, BCM Europe, worth up to $815 million in milestone payments to advance VXM01, a Phase III-ready oral, live-attenuated bacterial vaccine engineered to express VEGFR2.The programme has demonstrated "encouraging clinical activity and immune activation" in glioblastoma and pancreatic cancer studies, OSR said. The deal, which builds on the previously disclosed binding term sheet, grants BCM Europe rights to develop, manufacture, commercialise and potentially sublicense the asset.BCM Europe has pledged its entire OSR shareholding — roughly 29.7% — "as collateral for the performance of milestone payment obligations of up to $815 million." The agreement also includes OSR's acquisition of full VXM01 intellectual property from its Vaximm subsidiary for $30 million and a provision allowing OSR to receive 100% of downstream royalties after BCM Europe recovers its investment and preferred return.-Anna Bratulic