A Phase 1b Study of WU-NK-101 in Combination With Cetuximab for Advanced and/or Metastatic Colorectal Cancer (CRC) and Advanced and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

This study is a Phase 1b open-label study designed to characterize the safety, tolerability, and preliminary anti-tumor activity of WU-NK-101 in combination with cetuximab in patients with advanced and/or metastatic CRC (Cohort 1), and in patients with advanced and/or metastatic SCCHN (Cohort 2). The overall study will be comprised of two phases, a Dose Escalation Phase, and a Cohort Expansion Phase.

Start Date21 May 2024

Sponsor / Collaborator

Wugen, Inc.

NCT05470140 / Active, not recruitingPhase 1

A Phase 1 Study of WU-NK-101 in Patients With Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML)

This study is a Phase 1, open-label, dose escalation, and cohort expansion study designed to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary anti-leukemic activity of WU-NK-101 in R/R AML.

Start Date01 Jul 2023

Sponsor / Collaborator

Wugen, Inc.

100 Clinical Results associated with WU-NK-101

100 Translational Medicine associated with WU-NK-101

100 Patents (Medical) associated with WU-NK-101

News (Medical) associated with WU-NK-101

05 Dec 2024

·www.globenewswire.com

Wugen to Present Clinical Data at the 2024 ASH Annual Meeting Ahead of Pivotal Trial Launch of Off-the-Shelf, Allogeneic, CD7-Targeted CAR-T Cell Therapy WU-CART-007

Data Support Start of First Pivotal Trial for an Off-the-Shelf, Allogeneic CD7-Targeted CAR-T Cell Therapy in Pediatric and Adult PatientsST. LOUIS and SAN DIEGO, Dec. 05, 2024 (GLOBE NEWSWIRE) -- Wugen, Inc., a clinical-stage U.S. biotechnology company developing allogeneic, off-the-shelf cell therapies for the treatment of hematological and solid tumor malignancies, today announced upcoming scientific presentations, including updates from the company’s Phase 1/2 study of WU-CART-007. Researchers will present Phase 1/2 updates and studies for its investigational cell therapies this week at the American Society of Hematology (ASH) Annual Meeting & Exposition, Dec. 7-10 in San Diego. Results from Phase 1/2 showed continued anti-leukemic activity and clinically manageable safety in adults and adolescents. WU-CART-007 is an investigational, potential first-in-class, allogeneic, anti-CD7 CAR-T cell therapy under evaluation for treatment of patients with relapsed or refractory (R/R) T cell acute lymphoblastic leukemia or T cell lymphoblastic lymphoma (T-ALL/LBL). Based on findings to date with WU-CART-007, including this week’s data, Wugen will initiate the first pivotal Phase 2 study for an off-the-shelf CD7-targeted CAR-T cell therapy. “Maturing evidence, including the Phase 1/2 study being presented, suggest WU-CART-007 has the potential to improve current standard of care for patients with these blood cancers. T-ALL/LBL are malignancies associated with high rates of relapse and mortality in patients, many of whom are young,” said Armin Ghobadi, M.D., professor of medicine and clinical director of Center for Gene and Cellular Immunotherapy (CGCI) at the Washington University School of Medicine in St. Louis. “At this year’s ASH meeting, we will present clinical data from adult and adolescent patients that support our soon to open pivotal trial for patients with relapsed or refractory T-ALL/LBL,” said Wugen Chief Medical Officer, Cherry Thomas, M.D. “We are looking forward to working with experienced investigators to provide meaningful clinical benefit to patients with limited treatment options.” The pivotal Phase 2 study is a single-arm trial evaluating the efficacy and safety of WU-CART-007 in patients with R/R T-ALL/LBL and T-ALL/LBL. The study will involve two groups: a R/R cohort and subsequently an exploratory minimal residual disease (MRD)-positive cohort. The trial will enroll pediatric and adult patients at oncology centers in the United States, Europe, Asia and Australia. Wugen Presentations at ASH 3450 WU-CART-007 (WT-7), an Allogeneic CAR T-Cell Targeting CD7 in Relapsed/Refractory (R/R) T-Cell Acute Lymphoblastic Leukemia/Lymphoma (T-ALL/LBL): Phase 2 Results Presenter: Armin Ghobadi, M.D., Washington University School of Medicine, St. Louis Presentation type: PosterTime/location: Sunday, Dec. 8, 6:00-8:00 p.m. PT; Halls G,HSession: 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Poster II 3461 WU-CART-007 (WT-7) Is an Effective Treatment for Adolescent Patients with Relapsed or Refractory (R/R) T-Cell Acute Lymphoblastic Leukemia/ Lymphoblastic Lymphoma (T-ALL/LBL) – Subgroup Analysis of WU-CART-007 1001 Presenter: Shannon L. Maude, M.D., Division of Oncology, Center for Childhood Cancer Research and Cancer Immunotherapy Program, Children's Hospital of Philadelphia, Philadelphia Presentation type: PosterTime/location: Sunday, Dec. 8, 6:00-8:00 p.m. PT; Halls G,HSession: 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Poster II Wugen researchers will also present the following abstracts for the company’s investigational memory natural killer cell therapy, WU-NK-101: 916 W-NK1 Choreographs Innate and Adaptive Immune Responses to Provide a Robust and Durable Anti-AML Response Presenter: Tom Leedom, Wugen, Inc., St. Louis Presentation type: Oral Time/location: Monday, Dec. 9, 3:30 p.m. PT; Marriott Grand Ballroom 8-9, Marriott Marquis San Diego MarinaSession: 703. Cellular Immunotherapies other than CAR-T Cells: Basic and Translational: Enhancing NK Cell Therapeutics Hematology Disease Topics & Pathways: Research, Translational Research 2:45-4:15 p.m. PT 4257 WUN101-01: First in Human (FIH) Phase 1 Study of WU-NK-101 (W-NK1) in Patients with Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) Presenter: Amanda F. Cashen, M.D., Washington University School of Medicine, St. Louis Presentation type: PosterTime/location: Monday, Dec. 9, 6:00-8:00 p.m. PT; Halls G, HSession: 616. Acute Myeloid Leukemias: Investigational Drug and Cellular Therapies: Poster IIIHematology Disease Topics & Pathways: Research, Clinical trials, Translational Research, Clinical Research Investigator-initiated research 2066 Phase 1 Dose-Escalation and Dose-Expansion Study to Evaluate the Safety and Tolerability of Anti-CD7 Allogeneic CAR T-Cells (WU-CART-007) in Patients with CD7+ T-Cell Non-Hodgkin Lymphoma Presenter: Michael H. Kramer, M.D., Ph.D., Washington University School of Medicine, Saint Louis Presentation type: PosterTime/location: Sat., Dec. 7, 5:30-7:30 p.m. PT; Halls G, HSession: 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Poster I; About WU-CART-007 WU-CART-007 is an allogeneic, off-the-shelf, fratricide-resistant CD7-targeted CAR-T cell therapy engineered to overcome the technological challenges of harnessing CAR-T cells to treat CD7+ hematological malignancies. Wugen is deploying CRISPR/Cas9 gene editing technology to delete CD7 and the T cell receptor alpha constant (TRAC), preventing CAR-T cell fratricide and mitigating the risk of graft-versus-host-disease (GvHD). WU-CART-007 is manufactured using healthy donor-derived T cells to eliminate the risk of malignant cell contamination historically observed in the autologous CAR-T setting. WU-CART-007 is currently being evaluated in a global Phase 1/2 clinical trial for the treatment of relapsed or refractory (R/R) T cell acute lymphoblastic leukemia (T-ALL)/lymphoblastic lymphoma (LBL). More information on the Phase 1/2 trial is available on clinicaltrials.gov, identifier NCT# 04984356 and on the Phase 2 pivotal trial on clinicaltrials.gov, identifier NCT06514794. WU-CART-007 has received Regenerative Medicine Advanced Therapy (RMAT), Fast Track, Orphan Drug, and Rare Pediatric Disease designations from the U.S. Food and Drug Administration and Priority Medicines (PRIME) Scheme designation in the European Union for the treatment of relapsed/refractory (R/R) T cell acute lymphoblastic leukemia (T-ALL) and T cell lymphoblastic lymphoma (T-LBL). RMAT and PRIME designations provide increased agency support to expedite the development and review of promising therapies for patients in need. About Wugen Wugen, Inc. is a clinical-stage U.S. biotechnology company developing the next generation of off-the-shelf CAR-T and memory natural killer (NK) cell therapies for cancer. For more information, please visit www.wugen.com and follow Wugen’s LinkedIn page. Investor Contact:Mark LewisWugenMlewis@wugen.com314-501-1968 Media Contact:Christine FanelleScient PRchristine@scientpr.com215-595-5211

Cell TherapyImmunotherapyFast TrackPhase 2ASH

12 Nov 2024

·www.globenewswire.com

Wugen to Initiate a Pivotal Trial for Its Investigational, Off-the-Shelf, Allogeneic, CD7-Targeted CAR-T Cell Therapy, WU-CART-007, in Patients with Relapsed or Refractory T Cell Acute Lymphoblastic Leukemia or T Cell Lymphoblastic Lymphoma

-- First Pivotal Trial for an Off-the-Shelf, Allogeneic CD7-Targeted CAR-T Cell Therapy to Begin in First Quarter 2025-- The Global Study Will Evaluate WU-CART-007 in Pediatric and Adult Patients ST. LOUIS, Mo. and SAN DIEGO, Nov. 12, 2024 (GLOBE NEWSWIRE) -- Wugen, Inc., a clinical-stage U.S. biotechnology company developing allogeneic, off-the-shelf cell therapies for the treatment of hematological and solid tumor malignancies, today announced it will initiate a pivotal Phase 2 study in the first quarter of 2025 for the company’s potential first-in-class, investigational, anti-CD7 CAR-T cell therapy, WU-CART-007, in patients with relapsed or refractory (R/R) T cell acute lymphoblastic leukemia or T cell lymphoblastic lymphoma (T-ALL/LBL). “T-ALL/LBL is an aggressive cancer with a significant need for new therapies given that many patients will progress on standard of care,” said Kumar Srinivasan, Ph.D., Wugen president and chief executive officer. “Wugen is well positioned for this critical stage of research and development for WU-CART-007. Recently, we generated positive Phase 1/2 results; received significant new regulatory designations – RMAT and PRIME – to expedite our clinical development path in the United States and Europe; and deepened our cell therapy expertise with Cherry T. Thomas, M.D. joining our team as chief medical officer.” The pivotal Phase 2 study is a single-arm trial evaluating the efficacy and safety of WU-CART-007 in patients with R/R T-ALL/LBL and T-ALL/LBL. The study will evaluate the efficacy of WU-CART-007 in two groups: an R/R cohort and an exploratory minimum residual disease (MRD)-positive cohort. The trial will enroll pediatric and adult patients at oncology centers in the United States, Europe, Asia and Australia. “With a 20-year void of new medicines to treat patients with relapsed or refractory T-ALL/LBL, many of whom are young, we believe off-the-shelf allogeneic CD7-targeted CAR-T cell therapies may offer hope and innovation,” said Dr. Thomas, Wugen’s chief medical officer. “Wugen’s progress in advancing WU-CART-007 also includes a robust, scalable and efficient commercial manufacturing process, developed with our partners to create a CD7-targeted therapy for off-the-shelf use,” said Matt Cooper, Ph.D., Wugen’s co-founder and chief scientific officer, who invented WU-CART-007 as a researcher at Washington University in St. Louis, MO. Wugen previously announced positive results from a Phase 1/2 cohort expansion study showing clinically manageable safety and evidence of anti-leukemic activity (overall response rate of 91%) in heavily pre-treated patients with R/R T-ALL/LBL. Researchers will present a data update at the American Society of Hematology Annual Meeting (ASH) 2024, Dec. 7-10 in San Diego. Follow Wugen’s LinkedIn page to see abstracts to be presented at ASH 2024 for WU-CART-007 and for WU-NK-101, Wugen’s investigational off-the-shelf memory natural killer cell therapy. About WU-CART-007 WU-CART-007 is an allogeneic, off-the-shelf, fratricide-resistant CD7-targeted CAR-T cell therapy engineered to overcome the technological challenges of harnessing CAR-T cells to treat CD7+ hematological malignancies. Wugen is deploying CRISPR/Cas9 gene editing technology to delete CD7 and the T cell receptor alpha constant (TRAC), preventing CAR-T cell fratricide and mitigating the risk of graft-versus-host-disease (GvHD). WU-CART-007 is manufactured using healthy donor-derived T cells to eliminate the risk of malignant cell contamination historically observed in the autologous CAR-T setting. WU-CART-007 is currently being evaluated in a global Phase 1/2 clinical trial for the treatment of relapsed or refractory (R/R) T cell acute lymphoblastic leukemia (T-ALL)/lymphoblastic lymphoma (LBL). More information on the Phase 1/2 trial is available on clinicaltrials.gov, identifier NCT# 04984356 and on the Phase 2 pivotal trial on clinicaltrials.gov, identifier NCT06514794. WU-CART-007 has received Regenerative Medicine Advanced Therapy (RMAT), Fast Track, Orphan Drug, and Rare Pediatric Disease designations from the U.S. Food and Drug Administration and Priority Medicines (PRIME) Scheme designation in the European Union for the treatment of relapsed/refractory (R/R) T cell acute lymphoblastic leukemia (T-ALL) and T cell lymphoblastic lymphoma (T-LBL). RMAT and PRIME designations provide increased agency support to expedite the development and review of promising therapies for patients in need. About Wugen Wugen, Inc. is a clinical-stage U.S. biotechnology company developing the next generation of off-the-shelf CAR-T and memory natural killer (NK) cell therapies for cancer. For more information, please visit www.wugen.com and follow Wugen’s LinkedIn page. Investor Contact:Mark LewisWugenMlewis@wugen.com314-501-1968 Media Contact:Christine FanelleScient PRchristine@scientpr.com215-595-5211

Cell TherapyOrphan DrugFast TrackASHPhase 2

12 Nov 2024

·wugen.com

About us Company Leadership Board of Directors Scientific Advisory Board Investors Science Science Memory NK Platform CAR-T Platform Pipeline News Scientific Publications Press Releases Articles Patients Clinical Trials Expanded Access Policy Career Opportunities Contact us Company Leadership Board of Directors Scientific Advisory Board Investors Science Memory NK Platform CAR-T Platform Pipeline Scientific Publications Press Releases Articles Clinical Trials Expanded Access Policy About us Company Leadership Board of Directors Scientific Advisory Board Investors Science Science Memory NK Platform CAR-T Platform Pipeline News Scientific Publications Press Releases Articles Patients Clinical Trials Expanded Access Policy Career Opportunities Contact us Company Leadership Board of Directors Scientific Advisory Board Investors Science Memory NK Platform CAR-T Platform Pipeline Scientific Publications Press Releases Articles Clinical Trials Expanded Access Policy — First Pivotal Trial for an Off-the-Shelf, Allogeneic CD7-Targeted CAR-T Cell Therapy to Begin in First Quarter 2025 — — The Global Study Will Evaluate WU-CART-007 in Pediatric and Adult Patients — ST. LOUIS, MO and SAN DIEGO, CA, Nov. 12, 2024 – Wugen, Inc., a clinical-stage U.S. biotechnology company developing allogeneic, off-the-shelf cell therapies for the treatment of hematological and solid tumor malignancies, today announced it will initiate a pivotal Phase 2 study in the first quarter of 2025 for the company’s potential first-in-class, investigational, anti-CD7 CAR-T cell therapy, WU-CART-007, in patients with relapsed or refractory (R/R) T cell acute lymphoblastic leukemia or T cell lymphoblastic lymphoma (T-ALL/LBL). “T-ALL/LBL is an aggressive cancer with a significant need for new therapies given that many patients will progress on standard of care,” said Kumar Srinivasan, Ph.D., Wugen president and chief executive officer. “Wugen is well positioned for this critical stage of research and development for WU-CART-007. Recently, we generated positive Phase 1/2 results; received significant new regulatory designations – RMAT and PRIME – to expedite our clinical development path in the United States and Europe; and deepened our cell therapy expertise with Cherry T. Thomas, M.D. joining our team as chief medical officer.” The pivotal Phase 2 study is a single-arm trial evaluating the efficacy and safety of WU-CART-007 in patients with R/R T-ALL/LBL and T-ALL/LBL. The study will evaluate the efficacy of WU-CART-007 in two groups: a R/R cohort and an exploratory minimum residual disease (MRD)-positive cohort. The trial will enroll pediatric and adult patients at oncology centers in the United States, Europe, Asia and Australia. “With a 20-year void of new medicines to treat patients with relapsed or refractory T-ALL/LBL, many of whom are young, we believe off-the-shelf allogeneic CD7-targeted CAR-T cell therapies may offer hope and innovation,” said Dr. Thomas, Wugen’s chief medical officer. “Wugen’s progress in advancing WU-CART-007 also includes a robust, scalable and efficient commercial manufacturing process, developed with our partners to create a CD7-targeted therapy for off-the-shelf use,” said Matt Cooper, Ph.D., Wugen’s co-founder and chief scientific officer, who invented WU-CART-007 as a researcher at Washington University in St. Louis, MO. Wugen previously announced positive results from a Phase 1/2 cohort expansion study showing clinically manageable safety and evidence of anti-leukemic activity (overall response rate of 91%) in heavily pre-treated patients with R/R T-ALL/LBL. Researchers will present a data update at the American Society of Hematology Annual Meeting (ASH) 2024, Dec. 7-10 in San Diego. Follow Wugen’s LinkedIn page to see abstracts to be presented at ASH 2024 for WU-CART-007 and for WU-NK-101, Wugen’s investigational off-the-shelf memory natural killer cell therapy. About WU-CART-007 WU-CART-007 is an allogeneic, off-the-shelf, fratricide-resistant CD7-targeted CAR-T cell therapy engineered to overcome the technological challenges of harnessing CAR-T cells to treat CD7+ hematological malignancies. Wugen is deploying CRISPR/Cas9 gene editing technology to delete CD7 and the T cell receptor alpha constant (TRAC), preventing CAR-T cell fratricide and mitigating the risk of graft-versus-host-disease (GvHD). WU-CART-007 is manufactured using healthy donor-derived T cells to eliminate the risk of malignant cell contamination historically observed in the autologous CAR-T setting. WU-CART-007 is currently being evaluated in a global Phase 1/2 clinical trial for the treatment of relapsed or refractory (R/R) T cell acute lymphoblastic leukemia (T-ALL)/lymphoblastic lymphoma (LBL). More information on the Phase 1/2 trial is available on clinicaltrials.gov, identifier NCT# 04984356 and on the Phase 2 pivotal trial on clinicaltrials.gov, identifier NCT06514794. WU-CART-007 has received Regenerative Medicine Advanced Therapy (RMAT), Fast Track, Orphan Drug, and Rare Pediatric Disease designations from the U.S. Food and Drug Administration and Priority Medicines (PRIME) Scheme designation in the European Union for the treatment of relapsed/refractory (R/R) T cell acute lymphoblastic leukemia (T-ALL) and T cell lymphoblastic lymphoma (T-LBL). RMAT and PRIME designations provide increased agency support to expedite the development and review of promising therapies for patients in need. About Wugen Wugen, Inc. is a clinical-stage U.S. biotechnology company developing the next generation of off-the-shelf CAR-T and memory natural killer (NK) cell therapies for cancer. For more information, please visit www.wugen.com and follow Wugen’s LinkedIn page. Investor Contact: Mark Lewis Wugen Mlewis@wugen.com 314-501-1968 Media Contact: Christine Fanelle Scient PR christine@scientpr.com 215-595-5211 4260 Forest Park Ave Suite 100 St. Louis, MO 63108 (636) 385-5306 9880 Campus Point Dr Suite 430 San Diego, CA 92121 Copyright © 2024 Wugen. All Rights Reserved. Privacy Notice a COGNEO design

Cell TherapyFast TrackPhase 2ASHOrphan Drug

100 Deals associated with WU-NK-101

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic Colorectal Carcinoma	Phase 1	US	Wugen, Inc.	21 May 2024
Squamous cell carcinoma of head and neck metastatic	Phase 1	US	Wugen, Inc.	21 May 2024
Acute Myeloid Leukemia	Phase 1	US	Wugen, Inc.	01 Jul 2023
Acute Myeloid Leukemia	Phase 1	AU	Wugen, Inc.	01 Jul 2023
Solid tumor	Preclinical	CN	Alpha Biopharma (Jiangsu) Co., Ltd.	29 Mar 2024
Melanoma	Preclinical	US	Wugen, Inc.	-

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


SITC2021	Not Applicable	Neoplasms	-	WU-NK-101	acpnoigrqi(wheoxyhwmp) = The cells maintain durable expression of CD25 after expansion awziajdygh (ejfvnfcmbg ) View more	Positive	10 Nov 2021

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