A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Zilovertamab (an ROR1 Antibody) Plus Ibrutinib Versus Ibrutinib Plus Placebo in Subjects With Relapsed or Refractory Mantle Cell Lymphoma

This is a Phase 3 study to investigate the safety and efficacy of the investigational drug, zilovertamab, when given in combination with ibrutinib in patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL).

Start Date01 Mar 2023

Sponsor / Collaborator

Oncternal Therapeutics, Inc.

[+1]

NCT05156905 / RecruitingPhase 1IIT

A Phase 1b Trial Investigating Docetaxel Combined With Cirmtuzumab in Patients With Metastatic Castration Resistant Prostate Cancer

The purpose of this study is to examine the safety and efficacy of cirmtuzumab in combination with standard of care docetaxel in patients with metastatic castration resistant prostate cancer. Docetaxel is a taxane chemotherapy which has been shown to prolong survival in men with castration resistant prostate cancer. Cirmtuzumab is a monoclonal antibody that targets the receptor called ROR1 of the non-canonical Wnt pathway and is suspected to contribute to prostate cancer growth and progression.

Start Date16 Jun 2022

Sponsor / Collaborator

University of California San Diego

NCT04501939 / Active, not recruitingPhase 2IIT

Cirmtuzumab Consolidation for Treatment of Patients With Detectable CLL on Venetoclax

Single center, open-label, phase 2 study to determine the efficacy of cirmtuzumab consolidation in patients with measurable disease on venetoclax.

Start Date06 Aug 2020

Sponsor / Collaborator

University of California San Diego

[+1]

100 Clinical Results associated with Zilovertamab

100 Translational Medicine associated with Zilovertamab

100 Patents (Medical) associated with Zilovertamab

Literatures (Medical) associated with Zilovertamab

01 Jun 2022·Leukemia

High expression level of ROR1 and ROR1-signaling associates with venetoclax resistance in chronic lymphocytic leukemia

Article

Author: Quijada-Álamo, Miguel ; Choi, Michael Y ; Ghia, Emanuela M ; Widhopf, George F ; Kipps, Thomas J ; Chu, Elvin ; Rassenti, Laura Z

Abstract:

Although the BH3-mimetic venetoclax is highly cytotoxic for chronic lymphocytic leukemia (CLL) cells, some patients with CLL fail to clear minimal residual disease (MRD). We examined the CLL cells of seven such patients (CLL1-7) and found each had high-level expression of ROR1. By examining the CLL cells from such patients prior to therapy at SC1 and then more than 1 year later (Sample Collection 2 (SC2)), when they had progressive increases in MRD despite continued venetoclax therapy, we found the levels of ROR1 expressed on CLL cells at SC2 were significantly higher than that on CLL cells collected at SC1. At SC2, we also observed upregulation of genes induced by Wnt5a-induced ROR1 signaling, including BCL2L1. Transduction of the CLL-cell-line MEC1 to express ROR1 enhanced expression of target genes induced by ROR1-signaling, increased expression of BCL-XL, and enhanced resistance to venetoclax, even in MEC1 made to express mutant forms of BCL2, which are associated with venetoclax resistance. Treatment of primary CLL cells with Wnt5a also increased their resistance to venetoclax, an effect that could be inhibited by the anti-ROR1 mAb (UC-961, zilovertamab). Collectively, these studies indicate that Wnt5a-induced ROR1-signaling can enhance resistance to venetoclax therapy.

17 Jun 2021·BloodQ1 · MEDICINE

ROR1 targeting with the antibody-drug conjugate VLS-101 is effective in Richter syndrome patient–derived xenograft mouse models

Q1 · MEDICINE

Article

Author: Allan, John N. ; Vaisitti, Tiziana ; Iannello, Andrea ; Braggio, Esteban ; Lannutti, Brian J. ; Di Napoli, Arianna ; Vitale, Nicoletta ; Lee, Thanh-Trang ; Deaglio, Silvia ; Miller, Langdon L. ; Chadburn, Amy ; Arruga, Francesca ; Furman, Richard R. ; Ko, Mira ; Jessen, Katti A.

Abstract:

Richter syndrome (RS) represents the transformation of chronic lymphocytic leukemia (CLL), typically to an aggressive lymphoma. Treatment options for RS are limited and the disease is often fatal. Receptor tyrosine kinase–like orphan receptor 1 (ROR1) is expressed on CLL cells and other cancers but not on healthy adult tissues, making it an attractive, tumor-specific therapeutic target. VLS-101 is being developed as an antibody-drug conjugate (ADC) for therapy of ROR1-expressing (ROR1+) cancers. VLS-101 comprises UC-961 (a humanized immunoglobulin G1 monoclonal antibody that binds an extracellular epitope of human ROR1), a maleimidocaproyl-valine-citrulline-para-aminobenzoate linker, and the antimicrotubule cytotoxin monomethyl auristatin E (MMAE). VLS-101 binding to ROR1 results in rapid cellular internalization and delivery of MMAE to induce tumor cell death. We studied 4 RS patient-derived xenografts (RS-PDXs) with varying levels of ROR1 expression (11%, 32%, 85%, and 99% of cells). VLS-101 showed no efficacy in the lowest-expressing RS-PDX but induced complete remissions in those with higher levels of ROR1 expression. Responses were maintained during the posttherapy period, particularly after higher VLS-101 doses. In systemic ROR1+ RS-PDXs, VLS-101 dramatically decreased tumor burden in all RS-colonized tissues and significantly prolonged survival. Animals showed no adverse effects or weight loss. Our results confirm ROR1 as a target in RS and demonstrate the therapeutic potential of using an ADC directed toward ROR1 for the treatment of hematological cancers. A phase 1 clinical trial of VLS-101 (NCT03833180) is ongoing in patients with RS and other hematological malignancies.

01 Jun 2021·LeukemiaQ1 · MEDICINE

Wnt5a enhances proliferation of chronic lymphocytic leukemia and ERK1/2 phosphorylation via a ROR1/DOCK2-dependent mechanism

Q1 · MEDICINE

Article

Author: Kipps, Thomas J ; Ghia, Emanuela M ; Hasan, Md Kamrul ; Widhopf, George F ; Rassenti, Laura Z

Abstract:

Patients with chronic lymphocytic leukemia (CLL) have high plasma-levels of Wnt5a, which can induce phosphorylation of ERK1/2 and enhance CLL-cell proliferation. Such effects could be inhibited by treatment with an ERK1/2 inhibitor, ERK1/2-specific siRNA, or cirmtuzumab, an anti-ROR1 mAb. The CLL-derived line, MEC1, expresses Wnt5a, but not ROR1. MEC1 cells transfected to express ROR1 (MEC1-ROR1) had higher levels of phosphorylated ERK1/2 than parental MEC1, or MEC1 transfected with ROR1ΔPRD, a truncated ROR1 lacking the cytoplasmic proline-rich domain (PRD), or ROR1P808A a mutant ROR1 with a P→A substitution at 808, which is required for complexing with the Rac-specific-guanine-nucleotide-exchange factor DOCK2 upon stimulation with Wnt5a. We silenced DOCK2 with siRNA and found this repressed the capacity of Wnt5a to induce ERK1/2 phosphorylation in MEC1-ROR1 or CLL cells. CLL cells that expressed ROR1 had higher levels of phosphorylated ERK1/2 or DOCK2 than CLL cells lacking ROR1. Although we found ibrutinib could inhibit the phosphorylation of ERK1/2 and DOCK2 induced by B-cell-receptor ligation, we found that this drug was unable to inhibit Wnt5a-induced, ROR1-dependent phosphorylation of ERK1/2 or DOCK2. This study demonstrates that Wnt5a can induce activation of ERK1/2 and enhance CLL-cell proliferation via a ROR1/DOCK2-dependent pathway independent of BTK.

News (Medical) associated with Zilovertamab

30 May 2024

·www.globenewswire.com

Oncternal Announces Enrollment Completed and Dosing Initiated for Fifth Dose Cohort of Phase 1/2 Study of ONCT-534 for the Treatment of R/R Metastatic Castration-Resistant Prostate Cancer

SAN DIEGO, May 30, 2024 (GLOBE NEWSWIRE) -- Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, today announced that enrollment has been completed and dosing initiated for the fifth dose cohort of its Phase 1/2 study of ONCT-534 for the treatment of patients with metastatic castration-resistant prostate cancer who are relapsed or refractory to approved androgen receptor pathway inhibitors (ARPI). Patients in the fifth cohort are receiving ONCT-534, the company’s dual-action androgen receptor inhibitor (DAARI), at a dose of 600 mg taken orally once each day. The decision to proceed to this higher dose level was made by the study’s Safety Review Committee (SRC) after reviewing data from the fourth dose level of 300 mg ONCT-534 daily. An initial update on ONCT-534 safety and efficacy based on prostate-specific antigen (PSA) levels from this study is expected in the third quarter of 2024 and will include data from this 600 mg dose cohort. “We are encouraged by the rapid enrollment in the dose escalation portion of our Phase 1/2 study with ONCT-534. The drug has been well tolerated, with no dose limiting toxicities observed to date. We continue to open new sites and patient demand continues to be strong,” said Salim Yazji M.D., Chief Medical Officer at Oncternal Therapeutics. “We are looking forward to sharing initial safety and efficacy data soon, which will include a larger, more robust set of clinical and biomarker results, as well as longer follow-up from the initial dosing cohorts.” About Study ONCT-534-101Study ONCT-534-101 is a Phase 1/2, single-arm, open-label, multi-center study to evaluate the safety and tolerability, pharmacokinetics, and preliminary anti-tumor activity of ONCT-534 in patients with mCRPC who have relapsed or are refractory to approved ARPIs including enzalutamide, abiraterone, apalutamide, and darolutamide. After the safety and tolerability and preliminary antitumor activity of ONCT-534 have been assessed in Phase 1, Phase 2 will commence to further evaluate the safety and antitumor activity of ONCT-534 to support selecting an optimal dose. About Oncternal TherapeuticsOncternal Therapeutics is a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies for the treatment of patients with cancers that have critical unmet medical need. Oncternal pursues drug development targeting promising, yet untapped biological pathways implicated in cancer generation or progression, focusing on hematological malignancies and prostate cancer. ONCT-534 is an investigational dual-action androgen receptor inhibitor (DAARI) with demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR aberration. It is a potential treatment for patients with mCRPC with unmet medical need because of resistance to androgen receptor pathway inhibitors, including those with AR amplification, mutations in the AR ligand binding domain (LBD), or splice variants with loss of the AR LBD. Study ONCT-534-101 (NCT05917470) has completed enrollment in four dose cohorts and continues to enroll and dose patients for treatment with mCRPC. ONCT-808 is an investigational autologous chimeric antigen receptor T (CAR T) cell therapy that targets Receptor Tyrosine Kinase-Like Orphan Receptor 1 (ROR1) using the binding domain from zilovertamab. ONCT-808 has demonstrated activity in preclinical models against multiple hematological malignancies and solid tumors and has been shown to be specific for cancer cells expressing ROR1. Oncternal has developed a robust and reproducible manufacturing process that has the potential to reduce the time patients must wait for their individual CAR T therapy to be produced, compared with currently approved CAR T products. Oncternal has dosed patients under Study ONCT-808-101 (NCT05588440) with relapsed or refractory aggressive B-cell lymphoma, including patients who have failed previous CD19 CAR T treatment. Zilovertamab is an investigational monoclonal antibody designed to inhibit the function of ROR1. Zilovertamab has been evaluated in a Phase 1/2 Study CIRM-0001 (NCT03088878) in combination with ibrutinib for the treatment of patients with mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL) and marginal zone lymphoma (MZL), which resulted in 100% progression free survival (PFS) at 42 months in CLL patients expressing a p53 mutation/del(17p), a population underserved by current treatment options. Zilovertamab is also being evaluated in an investigator-initiated Phase 1b study of zilovertamab in combination with docetaxel in patients with metastatic castration-resistant prostate cancer (NCT05156905). More information on our company and programs is available at https://oncternal.com/. Forward-Looking InformationOncternal cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negatives of these terms or other similar expressions. These statements are based on Oncternal’s current beliefs and expectations. Forward-looking statements include statements regarding anticipated timing for study enrollment and announcing clinical data. Forward-looking statements are subject to risks and uncertainties inherent in Oncternal’s business, including risks associated with the clinical development and process for obtaining regulatory approval of Oncternal’s product candidates, such as potential delays in the commencement, enrollment and completion of clinical trials; the risk that interim results of a clinical trial do not predict final results and that one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, as follow-up on the outcome of any particular patient continues, and as more patient data become available; and other risks described in Oncternal’s filings with the U.S. Securities and Exchange Commission. All forward-looking statements in this press release are current only as of the date hereof and, except as required by applicable law, Oncternal undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Contact Information: InvestorsRichard Vincent 858-434-1113rvincent@oncternal.com MediaCorey Davis, Ph.D. LifeSci Advisors 212-915-2577 cdavis@lifesciadvisors.com

Phase 1Clinical ResultImmunotherapyCell Therapy

09 May 2024

·www.globenewswire.com

Oncternal Therapeutics Provides Business Update and Announces First Quarter 2024 Financial Results

Fourth dosing cohort at 300 mg per day is fully enrolled for the Phase 1/2 study with ONCT-534, our dual-action androgen receptor inhibitor (DAARI), for patients with advanced prostate cancer who are resistant to approved androgen receptor pathway inhibitors; initial data readout expected in the latter part of the second quarterPhase 1/2 study for ONCT-808, our ROR1-targeting autologous CAR T cell therapy, for patients with relapsed or refractory aggressive B-cell lymphoma, including patients that have failed prior CD19 CAR T treatment is open and enrolling patients; clinical data update expected in mid-2024Cash, cash equivalents and short-term investments totaled $27.0 million as of March 31, 2024; cash runway projected into Q1 2025Management to host webcast today at 5:00 pm ET SAN DIEGO, May 09, 2024 (GLOBE NEWSWIRE) -- Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, today provided a business update and reported first quarter 2024 financial results. “We are encouraged by the fast pace of execution for our clinical programs, and we are looking forward to important clinical data readouts in the coming months. Our Phase 1/2 study of ONCT-534 in patients with R/R mCRPC has advanced swiftly through the initial dose escalation cohorts and we are optimistic, based on preclinical data, that the 300 mg dose may be within the active dose range for antitumor activity. We believe that the novel mechanism of action of ONCT-534, which includes interaction with both the N-terminal and ligand-binding domains of the AR has the potential to address important unmet needs of prostate cancer patients who have progressed after treatment with approved AR pathway inhibitors,” said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. “Our ROR1 CAR T Phase 1/2 study is now open and enrolling patients after implementing protocol amendments. We continue to be encouraged by the initial response signals we observed, and we look forward to reporting additional clinical data in patients with relapsed or refractory aggressive B cell lymphoma, including those who have relapsed after CD19 CAR T treatment.” Recent Highlights In April 2024, we announced that the first patient had been dosed in the fourth cohort of our Phase 1/2 study of ONCT-534 for the treatment of patients with advanced prostate cancer who are relapsed or refractory to approved androgen receptor pathway inhibitors (ARPI). Patients in the fourth dosing cohort will receive 300 mg of ONCT-534 taken orally each day. The fourth cohort is now fully enrolled with three subjects treated.Our dose escalation/dose expansion Phase 1/2 Study ONCT-808-101, evaluating our ROR1-targeting autologous CAR T cell therapy, ONCT-808, for the treatment of patients with relapsed or refractory aggressive B-cell lymphoma, is open and enrolling patients. Protocol changes that include modified eligibility criteria, increased monitoring for early infection, and evaluating lower doses have now been implemented. Expected Upcoming Milestones ONCT-534, our dual-action androgen receptor inhibitor Initial clinical data update in the second quarter of 2024Additional clinical data readouts in the fourth quarter of 2024 ONCT-808, our autologous ROR1-targeted CAR T cell therapy Clinical data update in mid-2024Additional clinical data readouts in the fourth quarter of 2024 First Quarter 2024 Financial ResultsOur grant revenue was $0.6 million for the first quarter ended March 31, 2024. Our total operating expenses for the first quarter ended March 31, 2024 were $9.3 million, including $1.4 million in non-cash stock-based compensation expense. Research and development expenses for the quarter totaled $6.0 million, and general and administrative expenses for the quarter totaled $3.3 million. Net loss for the first quarter was $8.4 million, or a net loss of $2.83 per share, basic and diluted. As of March 31, 2024, we had approximately 3.0 million shares of common stock outstanding, $27.0 million in cash, cash equivalents and short-term investments and no debt. These funds are expected to be sufficient to fund our operations into the first quarter of 2025. About Oncternal TherapeuticsOncternal Therapeutics is a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies for the treatment of patients with cancers that have critical unmet medical need. Oncternal pursues drug development targeting promising, yet untapped biological pathways implicated in cancer generation or progression, focusing on hematological malignancies and prostate cancer. ONCT-534 is an investigational dual-action androgen receptor inhibitor (DAARI) with demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR aberration. It is a potential treatment for patients with mCRPC with unmet medical need because of resistance to androgen receptor pathway inhibitors, including those with AR amplification, mutations in the AR ligand binding domain (LBD), or splice variants with loss of the AR LBD. Study ONCT-534-101 (NCT05917470) has completed enrollment in three dose cohorts and continues to enroll and dose patients for treatment with mCRPC. ONCT-808 is an investigational autologous chimeric antigen receptor T (CAR T) cell therapy that targets Receptor Tyrosine Kinase-Like Orphan Receptor 1 (ROR1) using the binding domain from zilovertamab. ONCT-808 has demonstrated activity in preclinical models against multiple hematological malignancies and solid tumors and has been shown to be specific for cancer cells expressing ROR1. Oncternal has developed a robust and reproducible manufacturing process that has the potential to reduce the time patients must wait for their individual CAR T therapy to be produced, compared with currently approved CAR T products. Oncternal has dosed patients under Study ONCT-808-101 (NCT05588440) with relapsed or refractory aggressive B-cell lymphoma, including patients who have failed previous CD19 CAR T treatment. Zilovertamab is an investigational monoclonal antibody designed to inhibit the function of ROR1. Zilovertamab has been evaluated in a Phase 1/2 Study CIRM-0001 (NCT03088878) in combination with ibrutinib for the treatment of patients with mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL) and marginal zone lymphoma (MZL), which resulted in 100% progression free survival (PFS) at 42 months in CLL patients expressing a p53 mutation/del(17p), a population underserved by current treatment options. Zilovertamab is also being evaluated in an investigator-initiated Phase 1b study of zilovertamab in combination with docetaxel in patients with metastatic castration-resistant prostate cancer (NCT05156905). More information on our company and programs is available at https://oncternal.com/. Forward-Looking Information Oncternal cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negatives of these terms or other similar expressions. These statements are based on Oncternal’s current beliefs and expectations. Forward-looking statements include statements regarding Oncternal’s expected cash runway and statements regarding Oncternal’s development programs, including the anticipated timing for study enrollment and announcing clinical data. Forward-looking statements are subject to risks and uncertainties inherent in Oncternal’s business, including risks associated with the clinical development and process for obtaining regulatory approval of Oncternal’s product candidates, such as potential delays in the commencement, enrollment and completion of clinical trials; the risk that interim results of a clinical trial do not predict final results and that one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, as follow-up on the outcome of any particular patient continues, and as more patient data become available; and other risks described in Oncternal’s filings with the U.S. Securities and Exchange Commission. All forward-looking statements in this press release are current only as of the date hereof and, except as required by applicable law, Oncternal undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Contact Information: InvestorsRichard Vincent 858-434-1113rvincent@oncternal.com MediaCorey Davis, Ph.D.LifeSci Advisors212-915-2577cdavis@lifesciadvisors.com Oncternal Therapeutics, Inc.Condensed Consolidated Balance Sheets Data(in thousands) March 31,2024 December 31,2023 Cash, cash equivalents and short-term investments $27,027 $34,255 Total assets 29,141 36,729 Total liabilities 6,215 6,677 Accumulated deficit (206,167) (197,779)Total stockholders' equity 22,926 30,052 Oncternal Therapeutics, Inc.Condensed Consolidated Statements of Operations Data(in thousands, except per share data) Three Months EndedMarch 31, 2024 2023 Grant revenue $569 $203 Operating expenses: Research and development 6,059 9,031 General and administrative 3,289 3,315 Total operating expenses 9,348 12,346 Loss from operations (8,779) (12,143)Interest income 391 656 Net loss $(8,388) $(11,487)Net loss per share, basic and diluted $(2.83) $(3.93)Weighted-average shares outstanding, basic and diluted 2,959 2,926

Cell TherapyPhase 1Financial StatementImmunotherapyPhase 2

02 May 2024

·www.globenewswire.com

Oncternal Therapeutics to Provide Business Update and Report First Quarter 2024 Financial Results

SAN DIEGO, May 02, 2024 (GLOBE NEWSWIRE) -- Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, today announced that it will report first quarter 2024 financial results after the U.S. financial markets close on Thursday, May 9, 2024. Oncternal’s management will host a webcast at 2:00 p.m. PT (5:00 p.m. ET) to provide a business update and discuss the Company’s financial results. The live webcast of the call will be available online at investor.oncternal.com and will be archived there for at least 30 days. About Oncternal TherapeuticsOncternal Therapeutics is a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies for the treatment of patients with cancers that have critical unmet medical need. Oncternal pursues drug development targeting promising, yet untapped biological pathways implicated in cancer generation or progression, focusing on hematological malignancies and prostate cancer. ONCT-534 is an investigational dual-action androgen receptor inhibitor (DAARI) with demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR aberration. It is a potential treatment for patients with mCRPC with unmet medical need because of resistance to androgen receptor pathway inhibitors, including those with AR amplification, mutations in the AR ligand binding domain (LBD), or splice variants with loss of the AR LBD. Study ONCT-534-101 (NCT05917470) has completed enrollment in three dose cohorts and continues to enroll and dose patients for treatment with mCRPC. ONCT-808 is an investigational autologous chimeric antigen receptor T (CAR T) cell therapy that targets Receptor Tyrosine Kinase-Like Orphan Receptor 1 (ROR1) using the binding domain from zilovertamab. ONCT-808 has demonstrated activity in preclinical models against multiple hematological malignancies and solid tumors and has been shown to be specific for cancer cells expressing ROR1. Oncternal has developed a robust and reproducible manufacturing process that has the potential to reduce the time patients must wait for their individual CAR T therapy to be produced, compared with currently approved CAR T products. Oncternal has dosed patients under Study ONCT-808-101 (NCT05588440) with relapsed or refractory aggressive B-cell lymphoma, including patients who have failed previous CD19 CAR T treatment. Zilovertamab is an investigational monoclonal antibody designed to inhibit the function of ROR1. Zilovertamab has been evaluated in a Phase 1/2 Study CIRM-0001 (NCT03088878) in combination with ibrutinib for the treatment of patients with mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL) and marginal zone lymphoma (MZL), which resulted in 100% progression free survival (PFS) at 42 months in CLL patients expressing a p53 mutation/del(17p), a population underserved by current treatment options. Zilovertamab is also being evaluated in an investigator-initiated Phase 1b study of zilovertamab in combination with docetaxel in patients with metastatic castration-resistant prostate cancer (NCT05156905). More information on our company and programs is available at https://oncternal.com/. Contact Information: InvestorsRichard Vincent 858-434-1113rvincent@oncternal.com MediaCorey Davis, Ph.D.LifeSci Advisors212-915-2577cdavis@lifesciadvisors.com

Cell TherapyPhase 1ImmunotherapyClinical ResultFinancial Statement

100 Deals associated with Zilovertamab

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
B-Cell Lymphoma	Phase 3	-	Oncternal Therapeutics, Inc.	01 Mar 2023
Mantle cell lymphoma refractory	Phase 3	-	Oncternal Therapeutics, Inc.	01 Mar 2023
Mantle-Cell Lymphoma	Phase 3	US	University of California	04 Jan 2022
Mantle-Cell Lymphoma	Phase 3	US	Oncternal Therapeutics, Inc.	04 Jan 2022
Chronic Lymphocytic Leukemia	Phase 2	US	University of California San Diego	06 Aug 2020
Chronic Lymphocytic Leukemia	Phase 2	US	Oncternal Therapeutics, Inc.	06 Aug 2020
Castration-Resistant Prostatic Cancer	Phase 1	US	Oncternal Therapeutics, Inc.	14 Jul 2022
Metastatic castration-resistant prostate cancer	Phase 1	US	University of California San Diego	16 Jun 2022
Locally Advanced Unresectable Breast Carcinoma	Phase 1	US	Oncternal Therapeutics, Inc.	15 Aug 2018

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03088878 (CIRM-0001, GlobeNewswire) Manual	Phase 1/2	Mantle-Cell Lymphoma \| Chronic Lymphocytic Leukemia \| Marginal Zone B-Cell Lymphoma TP53	-	Zilovertamab (CLL)	acrnnwxtbn(cccgwdewre) = vhedmxodfc ftxpcdmxnb (efttqnpmhd )	Positive	29 Feb 2024
ICML2023	Phase 1/2	Mantle-Cell Lymphoma \| Chronic Lymphocytic Leukemia \| Marginal Zone B-Cell Lymphoma TP53 mut/del(17p)	99	Zilovertamab 600 mg IV q4wks + Ibrutinib 420 mg (CLL) or 560 mg (MCL) daily	tikyhgrvxo(ckigzjbudh) = 9.4% of all pts treated gytmnfmdcz (lbaisqjviz ) View more	Positive	09 Jun 2023
NCT03088878 (ASCO2022)	Phase 1/2	Mantle-Cell Lymphoma \| Chronic Lymphocytic Leukemia	102	Zilovertamab	lyaukzsxgp(gswkdempxn) = snrfmwwymq doaaptvrpt (zijyntcjrt ) View more	-	02 Jun 2022
NCT03088878 (ASCO2021)	Phase 1/2	Mantle-Cell Lymphoma \| Chronic Lymphocytic Leukemia	102	Cirmtuzumab	abmcxotyfu(znehsbnnxf) = jzzitkmfhm mrbnqdvfbn (axniskzjik ) View more	-	28 May 2021
NCT02222688 (CTgov)	Phase 1	Chronic Lymphocytic Leukemia	26	cirmtuzumab (Cirmtuzumab 0.015 - 0.03 mg/kg)	swvawffytp(tvgqrtbwwc) = mbeiiokmhf onmngqfdpm (wvjsphrgiv, hgjijykohc - gcbjpqxocx) View more	-	13 Aug 2020
NCT02222688 (CTgov)	Phase 1	Chronic Lymphocytic Leukemia	26	cirmtuzumab (Cirmtuzumab 0.06 - 0.12 - 0.24 mg/kg)	swvawffytp(tvgqrtbwwc) = mqyzjgcjps onmngqfdpm (wvjsphrgiv, uwzljucedu - qebgdrtcss) View more	-	13 Aug 2020
NCT03088878 (ASCO2020)	Phase 2	Mantle-Cell Lymphoma \| Chronic Lymphocytic Leukemia	46	Cirmtuzumab + Ibrutinib	gcldbijfch(ixagleofme) = only grade 1/ 2 AEs were reported as possibly related to Cirm alone, whereas the safety profile attributed to Ibr or Ibr / Cirm was similar to published data, with no new or unexpected events gjhaluowsu (hifjrklhdo )	Positive	25 May 2020
NCT02776917 (AACR2020) Manual	Phase 1	Locally advanced breast cancer HER2 Positive \| ROR1 Positive	15	paclitaxel +cirmtuzumab	tgpqnjdcwg(hkplqpbdyd) = none ipzwlepybk (asbjbvdwyw ) View more	Positive	15 Feb 2020
ASCO2019	Phase 1/2	Chronic Lymphocytic Leukemia	-	Cirmtuzumab	kyhxwhcqls(qyqldydpzb) = 1 atrial fibrillation event usduauxtcu (hxyyxzdmfd ) View more	Positive	26 May 2019

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Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis

Zilovertamab

Overview

Basic Info

Gene Sequence

Related

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation