Allogene Therapeutics Highlights Promising Phase 1 | U.S. Finance News
ALLO-316 reveals promising response charges in superior renal cell carcinoma, using Dagger technology for enhanced CAR T cell efficacy.Quiver AI AbstractAllogene Therapeutics has introduced promising knowledge from its Phase 1 TRAVERSE trial of ALLO-316, an allogeneic CAR T cell remedy focusing on CD70 for sufferers with superior or metastatic renal cell carcinoma (RCC). In the research, a single dose of ALLO-316 resulted in a 31% confirmed response price amongst sufferers with a CD70 tumor proportion rating of 50% or greater, with 4 of the 5 responders sustaining their responses, together with one affected person in remission for over 12 months. The trial demonstrated robust CAR T cell growth and tumor infiltration, facilitated by commonplace lymphodepletion strategies utilizing cyclophosphamide and fludarabine. The security profile of ALLO-316 was manageable, with probably the most common opposed occasions being hematologic in nature. These early outcomes spotlight the potential of ALLO-316 to deal with vital unmet medical wants in RCC sufferers who haven’t responded to present therapies.
Potential Positives
Potential Negatives
FAQWhat is ALLO-316 and its goal?ALLO-316 is an investigational AlloCAR T™ product focusing on CD70, developed to deal with sufferers with superior or metastatic renal cell carcinoma.What have been the principle findings of the Phase 1 TRAVERSE trial?The trial confirmed a 31% confirmed response price in sufferers handled with ALLO-316, with some sustaining response for over 12 months.How protected is ALLO-316 based mostly on scientific trial outcomes?The security profile was manageable, with no treatment-related Grade 5 occasions and common Grade ≥3 opposed occasions being hematologic in nature.What technology enhances ALLO-316’s efficacy?The Dagger® technology permits strong CAR T cell growth, enabling vital tumor infiltration and potential for sturdy remissions in stable tumors.What is the importance of the CD70 Tumor Proportion Score?A CD70 Tumor Proportion Score ≥50% in sufferers correlated with a 31% total response price, highlighting its significance in therapy outcomes.
Disclaimer: This is an AI-generated abstract of a press release distributed by GlobeNewswire. The model used to summarize this release might make errors. See the total release right here.
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Technology as a Next-Generation Allogeneic Platform
SOUTH SAN FRANCISCO, Calif., June 01, 2025 (GLOBE NEWSWIRE) — Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T
™
) merchandise for most cancers and autoimmune illness, introduced up to date knowledge from the Phase 1 TRAVERSE research of ALLO-316 in renal cell carcinoma (RCC) during an oral presentation on the 2025 ASCO Annual Meeting. The Phase 1 TRAVERSE trial enrolled sufferers with superior or metastatic renal cell RCC. Leveraging the proprietary Dagger
®
technology to allow strong CAR T cell growth, it stands as the primary and solely allogeneic CAR T product to show promise in treating stable tumors. The presentation centered on the Phase 1b growth cohort from the Phase 1 TRAVERSE research by which sufferers have been handled with a commonplace routine of cyclophosphamide and fludarabine adopted by a single dose of 80 million AlloCAR T
™
cells.
“ALLO-316 is showing clear evidence of targeted antitumor activity in patients who had failed most or all approved therapies for advanced or metastatic renal cell carcinoma,” mentioned Zachary Roberts, M.D., Ph.D., EVP, Research and Development and Chief Medical Officer at Allogene. “Our proprietary Dagger technology allows the use of a standard cyclophosphamide and fludarabine-based lymphodepletion regimen with a single dose of ALLO-316. Strong CAR T-cell kinetics and extensive infiltration of tumor tissue by CAR T cells are combining to generate deep and durable remissions. These are results that were previously considered out of reach for patients with advanced solid tumors.”
“Patients diagnosed with advanced or metastatic renal cell carcinoma often face a median survival in months after exhausting standard therapies,” mentioned Samer A. Srour, MB ChB, MS, Associate Professor of Stem Cell Transplantation and Cellular Therapy at The University of Texas MD Anderson Cancer Center and lead investigator of the TRAVERSE trial. (*1*)
In the Phase 1b growth cohort, 22 sufferers whose tumors had progressed on a number of prior therapies have been handled with lymphodepletion and 20 have been handled with ALLO-316. All sufferers had tumors immune to immune checkpoint blockers and at the very least one tyrosine kinase inhibitor (TKI), 82% had ≥2+ prior TKI, and 41% had prior belzutifan. Sixteen of the ALLO-316 handled sufferers had a high CD70 Tumor Proportion Score (TPS >50%). The Phase 1b growth cohort evaluated the security and efficacy of ALLO-316 at DL2 (80M CAR T cells) following a commonplace FC lymphodepletion routine (fludarabine (30 mg/m
2
/day) and cyclophosphamide (500 mg/m
2
/day) for 3 days). The median time from enrollment to the beginning of remedy was 4 days.
A single dose of ALLO-316 stabilized or reversed illness development within the majority of sufferers. In the 16 sufferers with CD70 TPS ≥50%, the trial demonstrated a Confirmed Overall Response Rate (ORR) of 31% with 44% reaching a minimal of 30% discount in tumor burden. Of the 5 confirmed responders, 4 keep ongoing responses, with one in sustained remission for over 12 months. The median length of response (mDOR) has not but been reached, indicating the potential for long-term illness control.
CD70+ sufferers Phase 1b(N=20)
ORR (confirmed CR or PR per RECIST v1.1), n/N (%)
5/20 (25)
CD70 TPS ≥50percentCD70 TPS
5/16 (31)0/4 (0)
RECIST v1.1, Response Evaluation Criteria in Solid Tumors, model 1.1; TPS, tumor proportion rating
The security profile of ALLO-316 was manageable and in step with lymphodepletion and an lively CAR T product. The most frequent Grade ≥3 occasions have been hematologic and there have been no treatment-related Grade 5 occasions. The most common all-grade opposed occasions have been cytokine release syndrome (CRS) (68%; with no grade ≥3), neutropenia (68%), decreased white blood cell rely (68%), anemia (59%), and thrombocytopenia (55%). Immune effector cell-associated neurotoxicity syndrome (ICANS) was 18% (with no grade ≥3) and no graft-versus-host illness (GvHD) occurred. Improved recognition of IEC-HS signs led to analysis in 36% of sufferers with 2 sufferers (9%) experiencing a short-term Grade 3 (one) or Grade 4 (one affected person) occasion. Newly applied diagnostic and management algorithms considerably mitigated IEC-HS, with no related Grade 5 occasions.
TEAEs ≥20% incidence in Phase1b, n (%)
Phase 1b (N=22
a
)
All Grades
Grade ≥3
Neutropenia
15 (68)
15 (68)
White blood cell rely decreased
15 (68)
15 (68)
Anemia
13 (59)
9 (41)
Thrombocytopenia
12 (55)
6 (27)
Nausea
8 (36)
0
ALT elevated
7 (32)
2 (9)
Peripheral edema
7 (32)
0
Pyrexia
7 (32)
0
Arthralgia
6 (27)
0
AST elevated
6 (27)
2 (9)
Fatigue
5 (23)
0
Headache
5 (23)
0
AEs of Special Interest
Any Grade
Grade ≥3
CRS
15 (68)
0
Infection
10 (45)
8 (36)
IEC-HS
8 (36)
2 (9)
b
ICANS
4 (18)
0
Graft-versus-host illness
0
0
IEC-HS contains the popular phrases immune effector cell-associated HLH-like syndrome and Hemophagocytic lymphohistiocytosis.
a
Includes 2 sufferers who obtained LD however didn’t obtain ALLO-316
b
One affected person skilled G4 IEC-HS based mostly on GI bleeding with subsequent enchancment and 1 affected person skilled G3 IEC-HS based mostly on hypotension managed with out pressors with subsequent enchancment.
About ALLO-316 (TRAVERSE)
ALLO-316 is an AlloCAR T
™
investigational product focusing on CD70, which is very expressed in renal cell carcinoma (RCC). CD70 can also be selectively expressed in a number of cancers, creating the potential for ALLO-316 to be developed throughout a selection of each hematologic malignancies and stable tumors. The ongoing Phase 1 TRAVERSE trial is designed to judge the security, tolerability, and exercise of ALLO-316 in sufferers with superior or metastatic clear cell RCC. In October 2024 the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation based mostly on the potential of ALLO-316 to deal with the unmet need for sufferers with superior or metastatic RCC. The FDA beforehand granted Fast Track Designation (FTD) to ALLO-316 in March 2023. In April 2024, the Company introduced an award from the California Institute for Regenerative Medicine (CIRM) to help the continued TRAVERSE trial with ALLO-316 in RCC.
About Allogene Therapeutics
Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T
™
) merchandise for most cancers and autoimmune illness. Led by a management crew with vital expertise in cell remedy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell product candidates with the aim of delivering available cell remedy on-demand, more reliably, and at higher scale to more sufferers. For more data, please go to
www.allogene.com
, and observe @AllogeneTx on X and LinkedIn.
Cautionary Note on Forward-Looking Statements for Allogene
This press release comprises forward-looking statements for functions of the protected harbor provisions of the Private Securities Litigation Reform Act of 1995. This press release might, in some circumstances, use phrases equivalent to “develop,” “potential,” “expect,” “can,” “enable,” “showing,” “generate,” “may,” “could,” “designed to,” “promise,” “hope,” “ongoing,” “indicating,” “mitigate,” “evaluate,” “pioneer,” “goal” or “will,” together with different types thereof, or different phrases that convey uncertainty of future occasions or outcomes to determine these forward-looking statements. Forward-looking statements embrace statements concerning intentions, beliefs, projections, outlook, analyses or present expectations regarding, amongst different issues: the potential of ALLO-316 to deal with sufferers with superior or metastatic RCC or to supply significant scientific benefit in sufferers with superior RCC; the potential for ALLO-316 to be developed throughout a selection of each hematologic malignancies and stable tumors and to generate deep and sturdy remissions; the potential that ALLO-316 can cut back tumor burden, control illness, and ship sturdy responses; the design and potential advantages of our Dagger technology; whether or not the Dagger® technology will develop into the next-generation allogeneic platform; ALLO-316 and the Dagger technology’s potential to allow strong CAR T cell growth and persistence and tumor infiltration; the potential of ALLO-316 to deal with the unmet need in stable tumors or offer hope to sufferers who’ve exhausted different choices; the transformative potential of our AlloCAR T™ in stable tumors; the potential benefits of the RMAT and Fast Track designation; and our potential to ship cell remedy on-demand, more reliably, and at higher scale to more sufferers. Various elements might trigger materials variations between Allogene’s expectations and precise outcomes, together with, dangers and uncertainties associated to: the restricted nature of our Phase 1 knowledge from our scientific trials and the extent to which such knowledge might or is probably not validated in any future scientific trials; the extent to which the Food and Drug Administration disagrees with our scientific or regulatory plans or the import of our scientific outcomes, which might trigger future delays to our scientific trials or require extra scientific trials; we might encounter difficulties enrolling sufferers in our scientific trials; we might not have the ability to display the security and efficacy of our product candidates in our scientific trials, which might stop or delay regulatory approval and commercialization; RMAT and Fast Track designations might not result in a sooner development or regulatory review or approval course of and it doesn’t increase the probability that our product candidates will obtain advertising approval and the designations will be revoked if the factors for eligibility stop to be met; and challenges with manufacturing or optimizing manufacturing of our product candidates. These and different dangers are mentioned in higher element in Allogene’s filings with the Securities and Exchange Commission (SEC), together with with out limitation beneath the “Risk Factors” heading in its Quarterly Report on Form 10-Q for the yr ended March 31, 2025. Any forward-looking statements which can be made on this press release communicate solely as of the date of this press release. Allogene assumes no obligation to replace the forward-looking statements whether or not as a end result of new data, future occasions or in any other case, after the date of this press release.
AlloCAR T
™
and Dagger
®
are logos of Allogene Therapeutics, Inc.
Allogene’s investigational AlloCAR T
™
oncology merchandise make the most of Cellectis applied sciences. The anti-CD70 AlloCAR T program is licensed completely from Cellectis by Allogene and Allogene holds world development and industrial rights to this AlloCAR T
™
program.
Allogene Media/Investor Contact:
Christine CassianoEVP, Chief Corporate Affairs & Brand Strategy Officer
[email protected]
This article was initially printed on Quiver News, learn the total story.
The views and opinions expressed herein are the views and opinions of the writer and don’t essentially replicate these of Nasdaq, Inc.
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