KUR-502 / Baylor College of Medicine, Texas Children’s Hospital, Athenex - LARVOL DELTA

CD19.CAR Allogeneic NKT for Patients With Relapsed or Refractory B-Cell Malignancies (ANCHOR) (clinicaltrials.gov) - P1 | N=13 | Active, not recruiting | Sponsor: Baylor College of Medicine | Trial primary completion date: Jun 2025 ➔ Jun 2026

Trial primary completion date • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Chronic Lymphocytic Leukemia • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma

CD19.CAR Allogeneic NKT for Patients With Relapsed or Refractory B-Cell Malignancies (ANCHOR) (clinicaltrials.gov) - P1 | N=13 | Active, not recruiting | Sponsor: Baylor College of Medicine | Trial completion date: Feb 2034 ➔ Feb 2035

Trial completion date • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Chronic Lymphocytic Leukemia • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma

CD19.CAR Allogeneic NKT for Patients With Relapsed or Refractory B-Cell Malignancies (ANCHOR) (clinicaltrials.gov) - P1 | N=13 | Active, not recruiting | Sponsor: Baylor College of Medicine | Recruiting ➔ Active, not recruiting | N=48 ➔ 13 | Trial completion date: Mar 2035 ➔ Feb 2034 | Trial primary completion date: Jan 2026 ➔ May 2025

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Chronic Lymphocytic Leukemia • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma

CD19.CAR Allogeneic NKT for Patients With Relapsed or Refractory B-Cell Malignancies (ANCHOR) (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Baylor College of Medicine | Trial primary completion date: Apr 2025 ➔ Jan 2026

Trial primary completion date • Chronic Lymphocytic Leukemia • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma

CD19.CAR Allogeneic NKT for Patients With Relapsed or Refractory B-Cell Malignancies (ANCHOR) (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Baylor College of Medicine | Trial primary completion date: Apr 2024 ➔ Apr 2025

Trial primary completion date • Chronic Lymphocytic Leukemia • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma

CD19.CAR Allogeneic NKT for Patients With Relapsed or Refractory B-Cell Malignancies (ANCHOR) (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Baylor College of Medicine | Trial primary completion date: Apr 2023 ➔ Apr 2024

Trial primary completion date • Chronic Lymphocytic Leukemia • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma • CD19

Athenex Provides Fourth Quarter and Full Year 2022 Financial Results and Business Update (GlobeNewswire) - "Recent FDA-imposed clinical hold of the KUR-501 Investigational New Drug Application (IND) following the death of a young heavily pretreated male patient with R/R HRNB treated at the fifth dose level of 300 million cells/m2 approximately three weeks after CAR-NKT cell therapy product administration....Anticipated Upcoming Milestones: Targeting Phase 1 GINAKIT2 study of KUR-501 reopening mid-2023, pending FDA potentially lifting clinical hold; Phase 1 GINAKIT2 dose escalation study safety and preliminary efficacy data update anticipated in 2H 2023....Next clinical trial data update from the ongoing ANCHOR and ANCHOR2 studies anticipated in 2H 2023....KUR-503: Allogeneic GPC3 CAR-NKT cell therapy for previously treated advanced GPC3-expressing hepatocellular carcinoma...IND application filing for the investigational treatment of adults with previously treated advanced GPC3-expressing hepatocellular carcinoma planned in 2024."

IND • P1 data • Trial suspension • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Gastrointestinal Cancer • Hematological Malignancies • Hepatocellular Cancer • Leukemia • Liver Cancer • Lymphoma • Neuroblastoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

Athenex Provides Third Quarter 2022 Financial Results and Business Update (GlobeNewswire) - "Key Anticipated Milestones - (i) KUR-501: Phase 1 GINAKIT2 study dose escalation, safety, and preliminary efficacy data update in 1H 2023; (ii) KUR-502: Next clinical trial data update from the ongoing ANCHOR study anticipated in 1H 2023."

P1 data • Acute Lymphocytic Leukemia • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Neuroblastoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma • Solid Tumor

ANCHOR2: Allogeneic NK T-Cells Expressing CD19 Specific CAR in B-Cell Malignancies (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Athenex, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Indolent Lymphoma • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD19

ANCHOR2: Allogeneic NK T-Cells Expressing CD19 Specific CAR in B-Cell Malignancies (clinicaltrials.gov) - P1 | N=36 | Not yet recruiting | Sponsor: Athenex, Inc.

New P1 trial • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Indolent Lymphoma • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD19

Athenex Provides Second Quarter 2022 Financial Results and Business Update (GlobeNewswire) - "Key Anticipated Milestones: Oral Paclitaxel: Phase 2 data from I-SPY 2 trial evaluating Oral Paclitaxel in combination with dostarlimab in neoadjuvant breast cancer expected in 2H 2022. Regulatory interactions with UK MHRA for Oral Paclitaxel in advanced breast cancer in UK remain on track with responses to questions expected later this quarter. KUR-501: autologous GD2 CAR-NKT cell therapy for relapsed/refractory high-risk neuroblastoma...Next data update from the ongoing GINAKIT2 study expected in 2023. KUR-502: allogeneic CD19 CAR-NKT cell therapy for relapsed/refractory B-cell malignancies. Ongoing multicenter expansion of Phase 1 dose escalation ANCHOR study. Next clinical trial data update from the ongoing ANCHOR study anticipated in 4Q 2022 or 1Q 2023. KUR-503: IND filing for KUR-503 in GPC3-expressing hepatocellular carcinoma planned in 2023."

European regulatory • IND • P1 data • P2 data • Breast Cancer • Diffuse Large B Cell Lymphoma • Gastrointestinal Cancer • Hematological Malignancies • Hepatocellular Cancer • Neuroblastoma • Oncology

Athenex Presents Interim Data from Phase 1 ANCHOR Study of KUR-502 (Allogeneic CD19 CAR-NKT Cells) in Relapsed or Refractory Lymphoma and Leukemia at the 2022 Transplantation & Cellular (“Tandem”) Meetings of ASTCT and CIBMTR (GlobeNewswire) - P1 | N=48 | ANCHOR (NCT03774654) | "Interim analysis provides response data from 7 evaluable patients including two additional patients, one with non-Hodgkin lymphoma (NHL) and one with acute lymphoblastic leukemia (ALL). Six-month CR rate of 29%, including 1 ongoing CR at 34 weeks in heavily pretreated patients. Encouraging response rates at low doses: 57% overall response rate (ORR), 71% disease control rate (DCR). Two responses observed in patients who failed previous autologous CAR-T therapy. Allogeneic CD19 CAR-NKT cells well tolerated with 3 cases of grade 1 cytokine release syndrome (CRS), no immune effector cell-associated neurotoxicity syndrome (ICANS) and no graft versus host disease (GvHD). Early responses at low doses suggest promise of “off-the-shelf” cancer immunotherapy platform."

P1 data • Acute Lymphocytic Leukemia • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology

Athenex Provides Fourth Quarter and Full Year 2021 Financial Results and Provides Business Update (GlobeNewswire) - "Key Anticipated Milestones: Update on ANCHOR data previously presented at ASH in 2021 at ASTCT on April 23-26, 2022; Update from KUR-501, our autologous program in pediatric neuroblastoma at the American Society of Gene & Cell Therapy (ASGCT) annual meeting on May 16-19, 2022; Expand CD19 CAR-NKT ANCHOR study to a multi-center study under the newly allowed IND; Potential regulatory update from MHRA for Oral Paclitaxel in metastatic breast cancer (mBC) in UK."

Clinical • Clinical data • European regulatory • P1 data • Trial status • Breast Cancer • Neuroblastoma • Oncology

Athenex to Host a KOL Webinar Today on CAR-NKT Cell Approach to Cancer and Latest Data at the 63rd ASH Annual Meeting (GlobeNewswire) - P1, N=48; ANCHOR (NCT03774654); "NKT cells were isolated from the leukapheresis product of one HLA-unmatched healthy individual, transduced with the CAR, expanded ex vivo for 14 days (99.8% NKT purity), and cryopreserved. Patients received 107 (DL 1) or 3×107 (DL 2) CAR-NKT cells per square meter of body surface area following lymphodepleting conditioning with cyclophosphamide/fludarabine. Adverse events were evaluated per NCI criteria. When accessible, patients underwent core biopsies of an involved site at 2-5 weeks post-infusion. Response to therapy was assessed at 4 weeks per Lugano Criteria (for NHL) or NCCN guidelines (for ALL)."

P1 data • Hematological Malignancies • Lymphoma • Oncology

Athenex to Host Key Opinion Leader Webinar on CAR-NKT Approach to Cancer (GlobeNewswire) - "Dr. Ramos will discuss the interim data from the ongoing ANCHOR study evaluating KUR-502 in relapsed or refractory lymphoma and leukemia. These data will also be featured in a poster presentation at the American Society of Hematology (ASH) Annual Meeting and Exposition, being held from December 11th to December 14th."

P1 data • Hematological Malignancies • Leukemia • Lymphoma • Oncology

Athenex Presents Interim Data from ANCHOR Study of KUR-502 (Allogeneic CD19 CAR-NKT Cells) in Relapsed or Refractory Lymphoma and Leukemia at 63rd ASH Annual Meeting and Exposition (GlobeNewswire) - "Athenex, Inc...announced today data from the ANCHOR Phase 1 study of KUR-502 to be highlighted in a poster presentation at the 63rd American Society of Hematology (ASH) Annual Meeting and Exposition, being held from December 11th to December 14th, 2021. The data demonstrates that allogeneic CD19 CAR-NKT cells are well-tolerated and can mediate objective responses in B-cell relapsed/refractory non-Hodgkin lymphoma (NHL) and acute lymphoblastic leukemia (ALL) patients even at the low doses tested."

P1 data • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology

Athenex Provides Third Quarter 2021 Corporate and Financial Update (GlobeNewswire) - "Key Anticipated Milestones: ANCHOR Phase 1 poster presentation at 2021 ASH in December; Results from the I-SPY 2 trial of oral paclitaxel plus anti PD-1 expected in 2022; Almirall to continue phased roll-out of Klisyri in other European countries in ."

P1 data • P1/2 data

Athenex Provides Second Quarter 2021 Corporate and Financial Update (GlobeNewswire) - “Plan to discuss the design of a new clinical study for oral paclitaxel in metastatic breast cancer with the FDA in Q4 2021; Abstract on the ANCHOR Phase 1 study submitted to ASH 2021; Phase 1 trial to evaluate TCRT-ESO-A2 (high-affinity TCR-T targeting NY-ESO-1 solid tumors) to initiate enrollment in 3Q 2021; Results from the I-SPY 2 trial of oral paclitaxel plus anti PD-1 expected in 2022.”

FDA event • Launch Europe • New P1 trial • P2 data • Acute Lymphocytic Leukemia • Breast Cancer • Chronic Lymphocytic Leukemia • Hematological Malignancies • Oncology

Kuur Therapeutics Announces Interim Clinical Data Supporting CAR-NKT Cell Therapy Platform (Businesswire) - P1, N=48; ANCHOR (NCT03774654); "In the ANCHOR study, of the two evaluable lymphoma patients treated to date at the starting DL of 1x107 cells/m2, one patient has experienced a CR and the other a PR. The patient with a CR was initially observed to be in PR four weeks after infusion but subsequently converted to a CR without additional therapy....The patient with a PR had previously failed autologous CAR-T cell therapy. KUR-502 has so far demonstrated a promising safety profile with no CRS, no ICANS, and no evidence of graft versus host disease (GvHD)."

Cytokine release syndrome • P1 data • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma

Kuur Therapeutics Announces First Patients Dosed with Allogeneic CAR-NKT Cell Therapy (Businesswire) - “Kuur Therapeutics…announced the treatment of the first patients in its ANCHOR phase 1 study of KUR-502, an allogeneic CAR-NKT therapy…The ANCHOR (NCT03774654) study is a phase 1, first-in-human, dose escalation evaluation of KUR-502 in adults with R/R CD19 positive malignancies, including B cell lymphomas, acute lymphoblastic leukemia (ALL) and chronic lymphocytic leukemia (CLL).”

Trial status • Acute Lymphocytic Leukemia • Chronic Lymphocytic Leukemia • Hematological Malignancies • Lymphoma • Oncology