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Lytix Biopharma

Biotek
#764

1051P - Intratumoral injection of LTX-315 in combination with pembrolizumab in patients with advanced melanoma refractory to prior PD-1/PD-L1 therapy: Interim results from the ATLAS-IT-05 trial

Presentation Number

1051P

Speakers

  • Stephane Dalle (Pierre Benite, France)

Onsite Poster display date

Monday, 23 October 2023

Background

LTX-315 is an oncolytic peptide of non-viral origin that is in clinical development for the treatment of solid tumors. We investigated whether treatment with LTX-315 in combination with pembrolizumab is safe and efficacious.

Methods

This open-label, single-arm phase II trial includes patients with stage IIIB-stage IVm1b (without liver metastases) metastatic melanoma, who have progressed on or after after PD-1/PD-L1 inhibitor therapy. In Part A, patients receive intratumoral LTX-315 injections (5 mg per injection and up to 40 mg total) on up to 7 treatment days over 5 weeks and pembrolizumab (200 mg i.v.) on Days 1 and 22. In Part B, pembrolizumab (400 mg i.v.) is given every 6 weeks starting at Day 43 until maximum 24 months. The primary objective is antitumor activity assessed by the investigators using RECIST v1.1 criteria. Secondary objectives include safety data.

Results

At the cutoff date of 24 April 2023, 14 of 20 planned patients have been enrolled and treated: 13 patients with metastatic melanoma and 1 patient with advanced acinic cell carcinoma (included under an earlier protocol version). Mean age of enrolled patients was 64 years and 50% had received 2 or more prior systemic anti-cancer therapies. Preliminary antitumor activity was evaluable in 7 patients who had ≥1 post-baseline scan available at the cutoff date. The Overall Response Rate was 14% with 1 patient with partial response. Disease Control Rate was 43%. All 14 enrolled patients had received ≥1 LTX-315 injection and ≥1 pembrolizumab infusion and were included in the interim Safety Population. Treatment-emergent adverse events (TEAEs) were reported in 11 patients (79%). The most common (≥10%) TEAEs related to LTX-315 were mild to moderate injection site pain (50%) and asthenia (14%). There was no increase in immune-related adverse events.

Conclusions

Intratumoral LTX-315 administration in combination with pembrolizumab appears to be well tolerated and showed preliminary efficacy in patients with advanced melanoma. Updated efficacy and safety data will be presented at the conference.

Clinical trial identification

NCT04796194.

3 Likes
#765

Lytix Biopharma’s abstract with preliminary interim Phase II data from the ATLAS-IT-05 study is published

#766

De rakk det før børsåpning med et skrik :grin:

#767

Hva sammenligner vi med her? Er det bra, so-so eller dårlig? :smiley:

#768

Hadde det vært en eneste PR til, så hadde ORR vært kjempebra. Nå er det vel so-so. Med det lave antallet pasienter sier dette tallet mao så og si ingen ting, mener jeg.

1 Like
#769

Ja det virker nesten litt snålt nå at de ønsker å gå ut med data når de kun viser til 7 av 20 pasienter i studiet og marginene er så små.

#770

Noen som har en link til presentasjonen
/dataene på esmo? Finner den ikke . :see_no_evil:

#771

https://cslide.ctimeetingtech.com/esmo2023/attendee/confcal_2/presentation/list?q=Lytix

1051P - Intratumoral injection of LTX-315 in combination with pembrolizumab in patients with advanced melanoma refractory to prior PD-1/PD-L1 therapy: Interim results from the ATLAS-IT-05 trial

Presentation Number

1051P

Speakers

  • Stephane Dalle (Pierre Benite, France)

Onsite Poster display date

Monday, 23 October 2023

Background

LTX-315 is an oncolytic peptide of non-viral origin that is in clinical development for the treatment of solid tumors. We investigated whether treatment with LTX-315 in combination with pembrolizumab is safe and efficacious.

Methods

This open-label, single-arm phase II trial includes patients with stage IIIB-stage IVm1b (without liver metastases) metastatic melanoma, who have progressed on or after after PD-1/PD-L1 inhibitor therapy. In Part A, patients receive intratumoral LTX-315 injections (5 mg per injection and up to 40 mg total) on up to 7 treatment days over 5 weeks and pembrolizumab (200 mg i.v.) on Days 1 and 22. In Part B, pembrolizumab (400 mg i.v.) is given every 6 weeks starting at Day 43 until maximum 24 months. The primary objective is antitumor activity assessed by the investigators using RECIST v1.1 criteria. Secondary objectives include safety data.

Results

At the cutoff date of 24 April 2023, 14 of 20 planned patients have been enrolled and treated: 13 patients with metastatic melanoma and 1 patient with advanced acinic cell carcinoma (included under an earlier protocol version). Mean age of enrolled patients was 64 years and 50% had received 2 or more prior systemic anti-cancer therapies. Preliminary antitumor activity was evaluable in 7 patients who had ≥1 post-baseline scan available at the cutoff date. The Overall Response Rate was 14% with 1 patient with partial response. Disease Control Rate was 43%. All 14 enrolled patients had received ≥1 LTX-315 injection and ≥1 pembrolizumab infusion and were included in the interim Safety Population. Treatment-emergent adverse events (TEAEs) were reported in 11 patients (79%). The most common (≥10%) TEAEs related to LTX-315 were mild to moderate injection site pain (50%) and asthenia (14%). There was no increase in immune-related adverse events.

Conclusions

Intratumoral LTX-315 administration in combination with pembrolizumab appears to be well tolerated and showed preliminary efficacy in patients with advanced melanoma. Updated efficacy and safety data will be presented at the conference.

#772

Starter med:

Slutter med:

Så på Mandag kommer det mer modne data.

3 Likes
#773

Lytix Biopharma granted up to NOK14.3m (US$1.3m) of public non-dilutive funding from ’SkatteFUNN’

10 Likes
#774

Voldsomt hvordan noen presser kursen ned, selv på en dag der selskapet kan motta inntil 14,3 mill nok. Kan det kun forklares med NM sitt salgspress eller tenker dere at det kan forklares i andre forhold?

#775

Noen med tilgang på oppdatert aksjonærliste? Noe endring på top20 listen?

#776

Siden det er så stille i denne nå som solen skinner på Ultimovacs :sun_with_face:

Her er abstraktet fra forrige uke.

image
image991×1407 411 KB

2 Likes
#777

Undret på det selv. Og selv om jeg må innrømme at Biotec-firmaer ikke akkurat er i favorittskiktet (typisk ufattelige kostnader og en haug med emisjoner) mitt, så syntes jeg 14.3 mill i subsidier (!!) kombinert med nedgang i kurs gjorde det verdt å ta et lodd. Problemstillingen er selvfølgelig at det er lett å komme inn (tror jeg handlet halvparten av omsetningen) og trangere å komme ut så lenge det omsettes omtrent for så mye som en pølsekiosk (i den grad de ennå eksisterer) selger for i løpet av en dag eller fire. Jaja, den som lever får se! :grinning: :beer:

1 Like
#778

Lytix Biopharma to host webcast after release of preliminary data from ATLAS-IT-05

4 Likes
#779

Dette er altså oppkjøringen til en nært forestående emi, for de som ikke fikk med seg wake-up callen. Det er dessverre lite å gjøre med det.

Men: de vil jo legge frem enda mer oppdaterte tall og her kan det da komme enda bedre nyheter enn de allerede har rapportert.

Likevel: ha i mente at vi alltid snakker om “high risk/high reward” og aldri bare high reward i biotek. Og tidligere styreleder (Gert Munthe/North Murray) har solgt seg kraftig ned de siste mnd.

Så her, som alltid, er det lurt å aldri satse mer enn du er OK med å tape.

2 Likes
#780

Hvor mange aksjer har han igjen ?
Har du oversikt på top20?

#781

1,1 mill.

Insider gir deg topp20

#782

Nedsalg fra ca 3 mill aksjer, så han har lempet ut ca 1.8 mill aksjer de siste mnd.

#783

Takk for svaret :blush: