eltivutabart (TTX-030) / AbbVie, Trishula Therap - LARVOL DELTA

TTX-030-003: Phase 2 Study of TTX-030 and Chemotherapy With or Without Budigalimab for 1L mPDAC Patients (clinicaltrials.gov) - P2 | N=194 | Active, not recruiting | Sponsor: Trishula Therapeutics, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Metastases • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

Combination treatment with TTX-030, a first-in-class anti-CD39 antibody, in patients with advanced pancreatic cancer (ESMO 2024) - P1, P2 | "HLA-DQ is an HLA class II molecule expressed on APCs. Patients were enrolled May 2020 to Feb 2022 and treated with standard dosing of G/nP (d1, 8, 15) and either TTX-030 40mg/kg followed by 20mg/kg every two weeks (n = 31) or TTX-030 every 2 weeks and budigalimab (anti-PD1 Ab) 500mg every 4 weeks (n = 28). TTX-030 combinations show promising clinical activity in 1L PDAC with HLA-DQhigh having marked benefit. A randomized phase 2 study (NCT06119217) is underway to further evaluate TTX-030 combination treatment based on HLA-DQ status in metastatic PDAC."

Clinical • IO biomarker • Metastases • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • ENTPD1

Trishula Therapeutics Presents Positive Results from Phase 1 Trial of TTX-030 in First-Line Metastatic Pancreatic Cancer Patients (PRNewswire) - "'Prior evaluation of immune checkpoint treatment has demonstrated limited benefit in this patient population and new approaches are needed. These results are very encouraging, especially in the biomarker high patients and warrant further investigation of TTX-030 for patients with advanced pancreatic cancer,' said Zev Wainberg, MD, Professor of Medicine, UCLA."

Media quote

Trishula Therapeutics Presents Positive Results from Phase 1 Trial of TTX-030 in First-Line Metastatic Pancreatic Cancer Patients (PRNewswire) - P1 | N=185 | NCT04306900 | Sponsor: Trishula Therapeutics, Inc. | "Trishula Therapeutics, Inc...reported final results from a Phase 1 trial of TTX-030, a potential first-in-class, anti-CD39 antibody, in patients with first-line metastatic pancreatic cancer....'These findings have led to our currently enrolling global, randomized Phase 2 ELTIVATE study with results expected in 2026'....In the efficacy-evaluable population (n=57) consisting of 92% first-line metastatic and 8% locally advanced nonresecetable patients, the objective response rate (ORR) was 30%, with 3 complete responses; the median progression free survival (mPFS) was 7.5 months (95%CI 5.2, 9.4); and median overall survival was 19.1 months (9.8, NR)."

P1 data • P2 data • Gastrointestinal Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

TTX-030 in Combination With Immunotherapy and/or Chemotherapy in Subjects With Advanced Cancers (clinicaltrials.gov) - P1 | N=185 | Completed | Sponsor: Trishula Therapeutics, Inc. | Active, not recruiting ➔ Completed

Combination therapy • Metastases • Trial completion • Oncology • Solid Tumor

Phase 2 Study of TTX-030 and Chemotherapy With or Without Budigalimab for 1L mPDAC Patients (clinicaltrials.gov) - P2 | N=180 | Recruiting | Sponsor: Trishula Therapeutics, Inc. | Not yet recruiting ➔ Recruiting | Initiation date: Dec 2023 ➔ Mar 2024

Enrollment open • Metastases • Trial initiation date • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

Trishula Therapeutics Initiates Phase 2 Trial of TTX-030, an Anti-CD39 Antibody, in First Line Metastatic Pancreatic Cancer Patients (PRNewswire) - "Trishula Therapeutics, Inc...today announced the initiation of a randomized Phase 2 trial to evaluate the efficacy and safety of TTX-030, a potential first-in-class, anti-CD39 antibody. The trial will evaluate TTX-030 in combination with chemotherapy, with or without budigalimab (an investigational anti-PD-1 antibody), compared to chemotherapy alone, as first-line treatment for metastatic pancreatic ductal adenocarcinoma patients...The study is designed to enroll approximately 180 patients globally....Trishula will continue to develop TTX-030 in collaboration with AbbVie Inc. Per the terms of the collaboration agreement, at the conclusion of this Phase 2 study, AbbVie will have an exclusive option to license TTX-030 for further development."

Trial status • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Phase 2 Study of TTX-030 and Chemotherapy With or Without Budigalimab for 1L mPDAC Patients (clinicaltrials.gov) - P2 | N=180 | Not yet recruiting | Sponsor: Trishula Therapeutics, Inc.

Metastases • New P2 trial • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

TTX-030 Single Agent and in Combination With Immunotherapy or Chemotherapy for Patients With Advanced Cancers (clinicaltrials.gov) - P1 | N=56 | Completed | Sponsor: Trishula Therapeutics, Inc. | Active, not recruiting ➔ Completed

Combination therapy • Metastases • Trial completion • Gastrointestinal Cancer • Hematological Malignancies • Lymphoma • Oncology • Pancreatic Cancer • Solid Tumor • ENTPD1

TTX-030 in Combination With Immunotherapy and/or Chemotherapy in Subjects With Advanced Cancers (clinicaltrials.gov) - P1 | N=185 | Active, not recruiting | Sponsor: Trishula Therapeutics, Inc. | Trial completion date: Dec 2022 ➔ Jun 2024

Combination therapy • Metastases • Trial completion date • Oncology • Solid Tumor

TTX-030 Single Agent and in Combination With Immunotherapy or Chemotherapy for Patients With Advanced Cancers (clinicaltrials.gov) - P1 | N=56 | Active, not recruiting | Sponsor: Trishula Therapeutics, Inc. | Trial completion date: Dec 2022 ➔ Dec 2023

Combination therapy • Metastases • Trial completion date • Gastrointestinal Cancer • Hematological Malignancies • Lymphoma • Oncology • Pancreatic Cancer • Solid Tumor • ENTPD1

Safety and efficacy of TTX-030, an anti-CD39 antibody, in combination with chemoimmunotherapy for the first line treatment of locally advanced or metastatic gastric/GEJ cancer (AACR 2022) - "The addition of nivolumab to chemotherapy has recently become the standard of care of 1st‑line (1L) treatment of locally advanced or metastatic (LA/M) gastric cancer but further improvements are needed. An expansion cohort of Study TTX‑030‑002 (ongoing, US and South Korea) is evaluating the safety and efficacy of the combination of TTX-030, budigalimab (anti-PD-1) and FOLFOX for the 1L treatment of patients (pts) with LA/M HER2− gastric/GEJ adenocarcinoma... Preliminary results indicate that the combination of TTX-030, budigalimab and FOLFOX exhibited promising efficacy as 1L treatment of LA/M gastric/GEJ cancer regardless of CPS status and has a manageable safety profile without evidence of excessive toxicities. To our knowledge, this represents the first report of an anti-CD39 antibody in combination with chemo-immunotherapy in gastric cancer. Updated clinical and biomarker data will be included in the final presentation."

Clinical • Combination therapy • IO biomarker • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • ENTPD1 • HER-2 • PD-L1

TTX-030 in Combination With Immunotherapy and/or Chemotherapy in Subjects With Advanced Cancers (clinicaltrials.gov) - P1 | N=185 | Active, not recruiting | Sponsor: Trishula Therapeutics, Inc. | Trial primary completion date: Sep 2022 ➔ Dec 2022

Combination therapy • Trial primary completion date • Oncology • Solid Tumor

"$SURF "pausing" development of SRF617 (anti-CD39 MAb), relevant for Tizona $ABBV (TTX-030), $IPH $AZN (IPH5201) & $GILD $RCUS (AB598)" (@JacobPlieth)

ENTPD1

A Quick Look at the 2022 AACR Annual Meeting (Oncology Nursing News) - "'TTX-030 in combination with budigalimab and modified FOLFOX6 for the treatment of patients with HER2-negative metastatic gastric cancer was well tolerated without excessive toxicities,' Zev A. Wainberg...said in a presentation of the findings."

Media quote

TTX-030 in Combination With Immunotherapy and/or Chemotherapy in Subjects With Advanced Cancers (clinicaltrials.gov) - P1 | N=185 | Active, not recruiting | Sponsor: Trishula Therapeutics, Inc. | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • Oncology • Solid Tumor

Opportunities for combination immunotherapies with TTX-030 (YouTube) - "Zev Wainberg, MD...postulates on potential opportunities for advances in combination immunotherapies following positive interim results on a novel CD39 inhibitor, TTX-030. This interview took place at the American Association for Cancer Research Annual Meeting 2022 in New Orleans, LA."

Interview • Video

TTX-030, Budigalimab, and FOLFOX Combination Therapy in Advanced or Metastatic Gastric/GEJ Cancer (YouTube) - "Zev Wainberg, MD...discusses promising preliminary results from an ongoing Phase I trial evaluating TTX-030 (a first-in-class anti-CD39 antibody) in combination with budigalimab (an investigational anti-PD-1 antibody) and FOLFOX for the first-line treatment of patients with locally advanced/metastatic HER2-negative gastric or gastroesophageal junction cancer...This interview took place at the American Association for Cancer Research Annual Meeting 2022 in New Orleans, LA."

Interview • Video

TTX-030 Single Agent and in Combination With Immunotherapy or Chemotherapy for Patients With Advanced Cancers (clinicaltrials.gov) - P1 | N=56 | Active, not recruiting | Sponsor: Trishula Therapeutics, Inc. | Trial completion date: Mar 2022 ➔ Dec 2022 | Trial primary completion date: Mar 2022 ➔ Nov 2022

Combination therapy • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hematological Malignancies • Lymphoma • Oncology • Pancreatic Cancer • Solid Tumor • ENTPD1

"Dr Wainberg from #UCLA presenting the results from the TTX-030 CD39 in GE cancers #AACR2022" (@DavidHongMD)

Oncology • ENTPD1

Trishula Therapeutics Announces Promising Early Phase 1b Data of TTX-030, an Anti-CD39 Antibody, in Combination with Chemoimmunotherapy as First-Line Treatment for Locally Advanced or Metastatic Gastric Cancer/GEJ Cancer (PRNewswire) - P1b | N=185 | NCT04306900 | Sponsor: Trishula Therapeutics, Inc. | "Study results were presented in an oral presentation at the American Association for Cancer Research (AACR) Annual Meeting....Among 40 efficacy-evaluable patients, 21 patients (25 patients including unconfirmed) achieved best overall response of partial response or better including 4 CRs: ORR=52.5% (62,5% including unconfirmed), and disease-control rate = 92.5%. Thirty-seven (37) of the efficacy-evaluable patients had known PD-L1 Combined Positive Score (CPS); response rates in patients with CPS ≥1 were 65% (77% including unconfirmed)."

P1 data • Gastric Cancer • Gastroesophageal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Trishula Therapeutics Announces Oral Presentation on TTX-030 Anti-CD39 Antibody at American Association for Cancer Research (AACR) Annual Meeting (PRNewswire) - "Trishula Therapeutics...announced preliminary results from an ongoing Phase 1 trial evaluating TTX-030 in combination with chemoimmunotherapy for the first-line treatment of patients with locally advanced or metastatic HER2- gastric or gastroesophageal junction (GEJ) cancer will be highlighted in an oral presentation at the American Association for Cancer Research (AACR) Annual Meeting 2022 taking place in New Orleans, LA, April 8-13, 2022."

P1 data • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology

TTX-030 Single Agent and in Combination With Immunotherapy or Chemotherapy for Patients With Advanced Cancers (clinicaltrials.gov) - P1 | N=56 | Active, not recruiting | Sponsor: Trishula Therapeutics, Inc. | Recruiting ➔ Active, not recruiting | N=100 ➔ 56

Combination therapy • Enrollment change • Enrollment closed • Gastrointestinal Cancer • Hematological Malignancies • Lymphoma • Oncology • Pancreatic Cancer • Solid Tumor • ENTPD1

TTX-030: Early proof of concept data from P1/1b trial (NCT03884556) for solid tumors in 2022 (AbbVie, 40th Annual J.P. Morgan Healthcare Conference (Virtual Meeting))

P1 data • Oncology • Solid Tumor

TTX-030: Early proof of concept data from P1/1b trial (NCT03884556) for solid tumors in 2022 (AbbVie, 40th Annual J.P. Morgan Healthcare Conference (Virtual Meeting))

P1 data • Oncology • Solid Tumor