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Asset Brief

ALA-105

ALA·Arovella Therapeutics·Gastric and pancreatic cancer with CLDN18.2 (claudin 18.2) protein expression·Preclinical·[ TODO: fill in ]

Plain-language Brief

The trial in plain terms

The disease: Gastric (stomach) and pancreatic cancers are aggressive solid tumours with poor prognosis at advanced stages. A subset of these tumours overexpress claudin 18.2 (CLDN18.2), a tight-junction protein normally restricted to stomach lining cells. CLDN18.2 expression in tumour cells makes it a target for directed therapies. Both gastric and pancreatic cancers have limited treatment options once they progress past first-line chemotherapy.
What the asset is trying to do: ALA-105 is an allogeneic (donor-derived, not patient-specific) CAR cell therapy in which invariant natural killer T cells (iNKT cells) are engineered to express a chimeric antigen receptor (CAR) directed at CLDN18.2. iNKT cells are a distinct immune cell type that differs from conventional T cells used in most approved CAR therapies; the allogeneic approach means cells are manufactured in advance rather than collected from each patient. Arovella describes ALA-105 as the world's first iNKT cell therapy targeting CLDN18.2, and the programme was licensed from Sparx Group. Preclinical data were disclosed in an ASX announcement dated 31 March 2026.
What the trial is measuring, and why it matters: ALA-105 is currently in preclinical development; no clinical trial has been registered for this asset as of the data available. Preclinical studies typically measure tumour-cell killing activity in laboratory and animal models, as well as safety and persistence of the cell product. No clinical endpoints, trial design, or enrolment figures are available to report at this stage.
Efficacy benchmarks in this setting: For context on the CLDN18.2-positive gastric and pancreatic cancer setting, the anti-CLDN18.2 monoclonal antibody zolbetuximab combined with chemotherapy demonstrated a median progression-free survival of 10.61 months versus 8.67 months for chemotherapy alone in CLDN18.2-positive, HER2-negative gastric or gastro-oesophageal junction adenocarcinoma in the SPOTLIGHT trial (Shitara et al, Lancet 2023). Zolbetuximab received regulatory approval in multiple markets for this setting in 2024. No approved CAR-iNKT therapy for gastric or pancreatic cancer exists as a benchmark. Early-stage preclinical figures for ALA-105 are not statistically comparable to data from approved therapies in randomised trials.

Trial Design

Design summary

Phase: Preclinical
Design type: [ TODO: fill in ] — ALA-105 is preclinical; no clinical trial has been registered.
Primary endpoint: [ TODO: fill in ]
Key secondary endpoints: [ TODO: fill in ]
Enrolment target: [ TODO: fill in ]
Current enrolment status: Not yet in clinical development; preclinical stage as of June 2026 (per available announcements).
Sites: [ TODO: fill in ]
Expected readout window: [ TODO: fill in ] — No clinical trial registry entry or IND/CTN filing for ALA-105 has been identified in the input data.

Asset Track Record

Did ALA deliver against its own guidance?

Past catalysts on this ticker, reconciled against the announcement parse pipeline. Hover any row for the parsed outcome detail.

24 June 2026otherALA-101 (Phase 1 First-in-Human Trial of ALA-101) — First-In-Human Trialhit · positivesrc ASX ↗
6 May 2026otherArovella Appoints Acting CEOhitsrc ASX ↗
4 May 2026otherBoard Refresh and CEO Resignationhitsrc ASX ↗
31 Mar 2026data readoutCLDN18.2 CAR iNKT Cell Preclinical Data Updatehit · positivesrc ASX ↗
15 Mar 2026regulatory decisionALA-101 TGA — TGA Clears ALA-101 Trial Under CTN Schemehit · positivesrc ASX ↗

Class Catalyst Calendar

What's landed, what's next for ALA-105 and peers

ALA-105's own upcoming catalysts alongside class-defining historical readouts and upcoming primary completion dates in the same mechanism classes. Each event moves the broader thesis for ALA-105. Showing past 6 months and next 12 months · 5 later hidden.

ConferenceAACR Annual Meeting 2026· ChicagoApr 2026
ConferenceASCO Annual Meeting 2026· ChicagoMay 2026
Today
AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2
AstraZeneca

Trial design comparison

How ALA-105 reads against active peer trials

Same axes, same units. Discontinued and historical pivotal trials excluded; see Competitor Landscape below for the full set.

Trial	Sponsor	Class	Phase / Line	Design	Primary endpoint	Dosing	Key eligibility	n
ALA-105	Arovella Therapeutics	Allogeneic CLDN18.2 CAR-iNKT	Preclinical[ TODO: fill in ]	[ TODO: fill in ] — ALA-105 is preclinical; no clinical trial has been registered.	[ TODO: fill in ]	[ TODO: fill in ]	[ TODO: fill in ]	0
Clinical Efficacy and Safety of Paclitaxel Polymeric Micelles for Injection in the Treatment of Patients With Taxans-resistant Pancreatic Adenocarcinoma, Cholangiocarcinoma, Lung Cancer, Gastric Cancer, Esophageal Carcinoma, or Breast Cancer

Competitor Landscape

Competing programmes by mechanism and phase

Read-across commentary attached per trial. Phase ordering preserved within each group.

Allogeneic CLDN18.2 CAR-iNKTASX peers ›

4 activeexpand ›

SB
Study of JK08 in Patients with Unresectable Locally Advanced or Metastatic Cancer
PHASE1/PHASE2
Salubris Biotherapeutics Inc·Active, not recruiting·Primary completion 17 Oct 2025·NCT05620134
BB
Phase 1/2 Study of BHB810 in Advanced Gastric and GEJ Adenocarcinoma

Curated Commentary

Third-party coverage(none curated yet)

expand ›

External analyst notes, journalism, and industry commentary cited with attribution.

No third-party coverage curated for ALA-105 yet. Broker coverage of Arovella Therapeutics is thin; named analyst notes will appear here as they become available. For now, see the company's ASX announcements and the linked sponsor / class sources elsewhere on this page.

Asset Track Record

Did ALA deliver against its own guidance?

Past catalysts on this ticker, reconciled against the announcement parse pipeline. Hover any row for the parsed outcome detail.

24 June 2026otherALA-101 (Phase 1 First-in-Human Trial of ALA-101) — First-In-Human Trialhit · positivesrc ASX ↗
6 May 2026otherArovella Appoints Acting CEOhitsrc ASX ↗
4 May 2026otherBoard Refresh and CEO Resignationhitsrc ASX ↗
31 Mar 2026data readoutCLDN18.2 CAR iNKT Cell Preclinical Data Updatehit · positivesrc ASX ↗
15 Mar 2026regulatory decisionALA-101 TGA — TGA Clears ALA-101 Trial Under CTN Schemehit · positivesrc ASX ↗

Class Catalyst Calendar

What's landed, what's next for ALA-105 and peers

ConferenceAACR Annual Meeting 2026· ChicagoApr 2026
ConferenceASCO Annual Meeting 2026· ChicagoMay 2026
Today
AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2
AstraZeneca

Trial design comparison

How ALA-105 reads against active peer trials

Same axes, same units. Discontinued and historical pivotal trials excluded; see Competitor Landscape below for the full set.

Trial	Sponsor	Class	Phase / Line	Design	Primary endpoint	Dosing	Key eligibility	n
ALA-105	Arovella Therapeutics	Allogeneic CLDN18.2 CAR-iNKT	Preclinical[ TODO: fill in ]	[ TODO: fill in ] — ALA-105 is preclinical; no clinical trial has been registered.	[ TODO: fill in ]	[ TODO: fill in ]	[ TODO: fill in ]	0
Clinical Efficacy and Safety of Paclitaxel Polymeric Micelles for Injection in the Treatment of Patients With Taxans-resistant Pancreatic Adenocarcinoma, Cholangiocarcinoma, Lung Cancer, Gastric Cancer, Esophageal Carcinoma, or Breast Cancer

Competitor Landscape

Competing programmes by mechanism and phase

Read-across commentary attached per trial. Phase ordering preserved within each group.

Allogeneic CLDN18.2 CAR-iNKTASX peers ›

4 activeexpand ›

SB
Study of JK08 in Patients with Unresectable Locally Advanced or Metastatic Cancer
PHASE1/PHASE2
Salubris Biotherapeutics Inc·Active, not recruiting·Primary completion 17 Oct 2025·NCT05620134
BB
Phase 1/2 Study of BHB810 in Advanced Gastric and GEJ Adenocarcinoma

ALA-105n = 0

Arovella Therapeutics·Allogeneic CLDN18.2 CAR-iNKT·Preclinical·[ TODO: fill in ]

Design: [ TODO: fill in ] — ALA-105 is preclinical; no clinical trial has been registered.
Primary endpoint: [ TODO: fill in ]
Dosing: [ TODO: fill in ]
Eligibility: [ TODO: fill in ]

Clinical Efficacy and Safety of Paclitaxel Polymeric Micelles for Injection in the Treatment of Patients With Taxans-resistant Pancreatic Adenocarcinoma, Cholangiocarcinoma, Lung Cancer, Gastric Cancer, Esophageal Carcinoma, or Breast Cancern = —

Liu Huang·Drug Delivery Device·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Vaccine (Ad5.F35-hGCC-PADRE) for the Treatment of Gastrointestinal Adenocarcinoman = —

Thomas Jefferson University·Cancer vaccine·Phase 2

Design: —
Primary endpoint: —
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Eligibility: —

AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2n = —

AstraZeneca·Monoclonal antibody·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Phase II Clinical Study Evaluating SSGJ-706 in Combination Therapy for Advanced Gastrointestinal Cancersn = —

Shenyang Sunshine Pharmaceutical Co., LTD.·Other·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Phase 2 Study of Zanidatamab in Patients With HER2-expressing Tumorsn = —

Jazz Pharmaceuticals·Monoclonal antibody·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumorsn = —

AstraZeneca·Antibody-drug conjugate·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Study of HER3-DXd in Subjects With Locally Advanced or Metastatic Solid Tumorsn = —

Daiichi Sankyo·Antibody-drug conjugate·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Study To Evaluate The Efficacy And Safety Of Ifinatamab Deruxtecan (I-DXd) In Subjects With Recurrent Or Metastatic Solid Tumors (IDeate-PanTumor02)n = —

Daiichi Sankyo·Antibody-drug conjugate·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Dostarlimab for Locally Advanced or Metastatic Cancer (Non-colorectal/Non-endometrial) With Tumor dMMR/MSIn = —

UNICANCER·Monoclonal antibody·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Adoptive Transfer of Tumor Infiltrating Lymphocytes for Advanced Solid Cancersn = —

Udai Kammula·Tumor Infiltrating Lymphocyte·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CT041 Autologous CAR T-cell Injectionn = —

CARsgen Therapeutics Co., Ltd.·Autologous Claudin18.2 CAR-T·PHASE1/PHASE2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Study of CBX-12 in Subjects With Advanced or Metastatic Refractory Solid Tumorsn = —

Cybrexa Therapeutics·Monoclonal antibody·PHASE1/PHASE2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Claudin18.2 CAR-T (CT041) in Patients With Gastric, Pancreatic Cancer, or Other Specified Digestive Cancersn = —

CARsgen Therapeutics Co., Ltd.·Autologous Claudin18.2 CAR-T·PHASE1/PHASE2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

TAS102 in Combination With NAL-IRI in Advanced GI Cancersn = —

Emory University·Small Molecule Other·PHASE1/PHASE2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Study of JK08 in Patients with Unresectable Locally Advanced or Metastatic Cancern = —

Salubris Biotherapeutics Inc·Allogeneic CLDN18.2 CAR-iNKT·PHASE1/PHASE2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Phase I/IIa Trial of HMBD-001 in Advanced HER3 Positive Solid Tumoursn = —

Cancer Research UK·Monoclonal antibody·PHASE1/PHASE2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumorsn = —

Chongqing Precision Biotech Co., Ltd·Tcr Engineered T Cell·PHASE1/PHASE2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Study to Evaluate TROP2 ADC LCB84 Single Agent and in Combination With an Anti-PD-1 Ab in Advanced Solid Tumorsn = —

LigaChem Biosciences, Inc.·Antibody-drug conjugate·PHASE1/PHASE2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Biomarker-Guided Dual-Target CAR-T Cells for Advanced Solid Tumorsn = —

Beijing Biotech·Bispecific Other·PHASE1/PHASE2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Study of SNS-101 (Anti VISTA) Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumorsn = —

Sensei Biotherapeutics, Inc.·Monoclonal antibody·PHASE1/PHASE2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patientsn = —

National Cancer Institute (NCI)·Tcr Engineered T Cell·PHASE1/PHASE2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Spevatamig (PT886) as Monotherapy or in Combination With Chemo and/or ICI, for the Treatment of Patients With Advanced Gastric, Gastroesophageal Junction, Pancreatic Ductal or Biliary Tract Carcinomas (the TWINPEAK Study)n = —

Phanes Therapeutics·Monoclonal antibody·PHASE1/PHASE2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Study of Anti-CEACAM5 ADC M9140 in Participants With Advanced Solid Tumors (PROCEADE PanTumor)n = —

EMD Serono Research & Development Institute, Inc.·Antibody-drug conjugate·PHASE1/PHASE2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With Advanced Solid Tumorsn = —

Bristol-Myers Squibb·Bispecific Other·PHASE1/PHASE2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Dose Escalation and Dose Expansion Study of MDX2001 in Patients With Advanced Solid Tumorsn = —

ModeX Therapeutics, An OPKO Health Company·Bispecific Other·PHASE1/PHASE2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Phase 1/2 Study of BHB810 in Advanced Gastric and GEJ Adenocarcinoman = —

BigHat Biosciences, Inc.·Allogeneic CLDN18.2 CAR-iNKT·PHASE1/PHASE2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

EBNK-001 Allogeneic NK Cells With Low-Dose IL-15 ± Pembrolizumab in Advanced Solid Tumorsn = —

Essen Biotech·Nk Cell Therapy·PHASE1/PHASE2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

GAIA-102 Intraperitoneal Administration in Patients With Advanced Gastrointestinal Cancer of Microsatellite Stable With Malignant Ascitesn = —

Kyushu University·Allogeneic CLDN18.2 CAR-iNKT·PHASE1/PHASE2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Study of ASP546C in Adults With Gastroesophageal Cancer, Pancreatic Cancer or Other Solid Tumorsn = —

Astellas Pharma Global Development, Inc.·Other·PHASE1/PHASE2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Triplex Checkpoint Inhibitors Therapy for Advanced Solid Tumorsn = —

Second Affiliated Hospital of Guangzhou Medical University·Small Molecule Other·PHASE1/PHASE2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Phase I/II Trial of UCB4594 in Participants With Advanced Cancern = —

Cancer Research UK·Allogeneic CLDN18.2 CAR-iNKT·PHASE1/PHASE2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Clinical Safty and Efficacy Study of Infusion of iNKT Cells and CD8+T Cells in Patients With Advanced Solid Tumorn = —

Shanghai Public Health Clinical Center·Allogeneic Cell Therapy Other·PHASE1/PHASE2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —