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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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https://ir.candeltx.com/news-releases/news-release-details/candel-therapeutics-announces-positive-final-survival-data

Candel ned 16% så langt i dag, trolig på disse dataene. Merkelig. Eller er det noe jeg ikke forstår?

Edit: Sur børsdag på US børser uansett da.

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https://ir.candeltx.com/news-releases/news-release-details/candel-therapeutics-reports-prolonged-overall-survival-phase-2/

Er guida at oppdatert OS-data på NSCLC skal være på bordet innen Q1 2025.

Lenka er til press release fra mai 2024. Da var mOS 20,6 måneder for CAN-2409 + valacyclovir vs. kontroll (SoC chemo) på 11,6 mnd.

Oppdatert OS-data i pancreatic cancer fase II kom for litt siden og sendte CADL ned rundt 20% Dataene så egentlig overbevisende ut, men det var veldig få pasienter (13 stk totalt).

NSCLC-studien CADL skal komme oppdatert OS data på nå innen slutten av mars, er visst snakk om 90 pasienter (halvparten i eksperimentell, halvparten i kontroll).

Så om den gode OS’en holder seg eller forbedres (og safety ser ikke ut til å være en issue med CAN-2409), så er det ihvertfall vanskeligere å argumentere med.

Skal bli spennende å se kursreaksjon.

Holder NSCLC seg på samme nivå, så finnes det altså (allerede) 3 indikasjoner (solid tumors) hvor CAN-2409 har demonstrert effekt (prostate, pancreatic, og NSCLC)

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CEO Paul Peter Tak kommenter pancreatic-trial’en.

Sier de ønsker å kjøre en større trial nå.

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https://x.com/paulpetertak/status/1867187961059479601

CEO kommenterer dataene fra CAN-2409 i prostata.

Vel verdt å følge ham på X, ser det ut som.

https://x.com/paulpetertak/status/1902282904887079347

https://ir.candeltx.com/news-releases/news-release-details/candel-therapeutics-and-idea-pharma-announce-strategic

"NEEDHAM, Mass., March 20, 2025 (GLOBE NEWSWIRE) – Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, together with IDEA Pharma, a Division of SAI MedPartners (IDEA), a pioneering biopharmaceutical strategy consultancy, today announced a strategic commercial partnership. Under this agreement, IDEA will provide strategic commercial input throughout the development and commercialization process for Candel’s lead asset, CAN-2409.

This partnership comes at a pivotal time for Candel following positive phase 3 data for CAN-2409 in intermediate-to-high risk, localized prostate cancer, which showed a statistically significant improvement in disease-free survival with 30% decrease in disease recurrence and a statistically significant increase in pathological complete response rate in the 2-year post-treatment biopsies (80.4% in the CAN-2409 arm versus 63.6% observed in the placebo arm).

The IDEA team will help guide Candel’s commercial strategy development and support the Company’s commercial projects related to CAN-2409. Through this partnership, Candel will gain access to a dedicated team of experts with extensive experience in oncology commercialization and go-to-market strategy optimization."

CADL ned 7-8% fra åpning i dag på denne. Som vel oversatt fra “marked” til “norsk” betyr:

Sjansene for en BP buyout er litt lavere enn hva de var i går.

På den andre siden: Gjør CADL dette alene, så vil de jo sitte igjen med mer. Det bare tar lenger tid.

https://www.globenewswire.com/news-release/2025/03/26/3050122/0/en/Candel-Therapeutics-Reports-Both-Prolonged-Median-Overall-Survival-and-Long-Tail-of-Survival-in-Phase-2a-Clinical-Trial-of-CAN-2409-in-Advanced-Non-Small-Cell-Lung-Cancer-NSCLC-Pat.html

“The extension of survival in patients with non-squamous disease is notable even when compared to data that have been reported for other investigational products, such as antibody-drug conjugates, for this patient population,” said W. Garrett Nichols, MD, CMO of Candel. “CAN-2409, in addition to continued ICI treatment, may prolong survival beyond that offered by docetaxel chemotherapy, and has the potential to be better tolerated.”

Ganske fine tall her for OS i NSCLC også. Helt koko at CADL faller på dette, egentlig. Bortsett fra potensiell “sell the news” pga usikker makroframtid? Det sier vel mest om hvordan markedet i USA er for tiden (les: tenderer i retning uinvesterbart, ihvertfall for denne typen aksjer).

Uansett: Nå skjer det lite på avlesningsfronten, frem til Q4 her. Da kommer det [trolig] “overall survival data in patients with recurrent high-grade glioma (rHGG) from ongoing phase 1b trial evaluating multiple doses of CAN-3110.”

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