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Candel Therapeutics (NASDAQ: CADL)

Starter en tråd om Candel Therapeutics (NASDAQ: CANDL)
https://www.candeltx.com/

Smallcap Biotech selskap som står foran store og viktige triggere nå i Q4 2024. Fast Track i tre indikasjoner og Orphan Drug i en indikasjon. Apscopal effekt. Har Jim Allison ombord som rådgiver. Nylig kommet med fase 2 data i bukspyttkjertelkreft og Ikke småcellet lungekreft.

Selskapet omtaler seg selv som:

“Candel is a clinical stage biopharmaceutical company focused on developing off-the-shelf multimodal biological immunotherapies that elicit an individualized, systemic anti-tumor immune response to help patients fight cancer. Candel has established two clinical stage multimodal biological immunotherapy platforms based on novel, genetically modified adenovirus and herpes simplex virus (HSV) gene constructs, respectively”

April i år steg kursen ~600% på oppdaterte Interim data fra deres randomiserte fase 2 studie i Bukspyttkjertelkreft. Da meldte de:
“…median overall survival of 28.8 months after experimental treatment with CAN-2409 versus only 12.5 months in control group in borderline resectable pancreatic ductal adenorcarcinoma (PDAC)”
LINK

Mai i år publiserte de følgende fra fase 2 studien i Ikke småcellet lungekreft:
“Median overall survival of 20.6 months was observed following two administrations of CAN-2409 + valacyclovir in NSCLC patients with progressive disease despite immune checkpoint inhibitor therapy compared to published results of median overall survival of 11.6 months observed with standard of care docetaxel-based chemotherapy in a similar patient population”

Dette ble også til en poster på ASCO 2024 (LINK)

Etter data for bukspyttkjertelkreft har kursen falt en del tilbake og data for Ikke småcellet lungekreft påvirket ikke kursen positivt. Men data ser i utgangspunktet ok ut.

Men rosinen i pølsa er kommende data nå i Q4 fra den randomiserte fase 3 studien i prostata kreft (NCT01436968) med 711 pasienter og studie start helt tilbake i 2011. Kommer i tillegg også data fra en fase 2 studie i prostata kreft (Active Surveillance).

Merk at selskapet har kort runway (Q1-25), så her må det kapital inn på en eller annen måte relativt snart.

Link til selskapspresentasjon:

Disclaimer: Har ingen aksjer i selskapet.

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Og der kom data for begge disse studiene.
Kurs ligger nå på +135% pre-market.

https://ir.candeltx.com/news-releases/news-release-details/candel-therapeutics-announces-can-2409-achieved-primary-endpoint

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https://ir.candeltx.com/news-releases/news-release-details/candel-therapeutics-provides-corporate-update-and-highlights

Bullet points fra lenket oppdatering. Hva skjer i 2025 for CADL:

  • On track to report updated overall survival data for CAN-2409 from phase 2a clinical trials in pancreatic ductal adenocarcinoma (PDAC) and non-small cell lung cancer (NSCLC), expected in Q1 2025

  • Preparations for Biologics License Application (BLA) for CAN-2409 in prostate cancer underway, with submission expected in Q4 2026

  • The Company intends to present phase 3 clinical trial data from CAN-2409 in prostate cancer at upcoming scientific conferences

  • On track to report overall survival data in patients with recurrent high-grade glioma (rHGG) from ongoing phase 1b trial evaluating multiple doses of CAN-3110, expected in Q4 2025

  • The Company expects that its cash and cash equivalents of approximately $103M (unaudited) as of December 31, 2024, will be sufficient to fund its current operating plan into Q1 of 2027

Stusser litt over guidet BLA submission for CAN-2409 så seint som q4 2026. Mener selskapet kanskje q4 2025? Dette er jo under overskriften “Key value drivers for 2025”…

Disclaimer: Jeg eier aksjer

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