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Allogene Therapeutics to Present Updated ALLO-316 Clinical Results in Kidney Cancer in Oral Presentation and ALPHA3 Trial-in-Progress Poster for Cema-Cel at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting

On April 23, 2025 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer and autoimmune disease, reported that it will present updated data from the completed Phase 1 TRAVERSE trial of ALLO-316 in an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 29-June 2 in Chicago, Illinois (Press release, Allogene, APR 23, 2025, View Source [SID1234652047]). The trial evaluated ALLO-316 in patients with advanced or metastatic renal cell carcinoma (RCC) who had progressed following immune checkpoint inhibitor and VEGF-targeted therapies. In addition, a trial-in-progress poster is also being presented to highlight the ongoing pivotal Phase 2 ALPHA3 trial, which is evaluating cemacabtagene ansegedleucel (cema-cel) as part of first-line (1L) treatment for patients with large B-cell lymphoma (LBCL).

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ALLO-316 is an allogeneic, "off-the-shelf" CAR T product targeting CD70 and is the only allogeneic CAR T product to demonstrate potential in solid tumors. Data from the Phase 1 TRAVERSE trial previously showed a manageable safety profile and encouraging anti-tumor activity in heavily pretreated patients with advanced or metastatic CD70+ RCC. Enrollment is now complete in the Phase 1b expansion cohort, which evaluated the safety and efficacy of ALLO-316 at dose level 2 (80M CAR T cells) following a standard lymphodepletion regimen of cyclophosphamide and fludarabine.

The ALPHA3 trial is the first pivotal study to evaluate an allogeneic CAR T product as a consolidation strategy aimed at eradicating minimal residual disease (MRD) following 1L treatment in LBCL. It is assessing cema-cel in patients with MRD after standard 1L chemoimmunotherapy, such as R-CHOP, with the goal of improving 1L cure rates. The trial identifies patients at high risk for relapse after 1L treatment by utilizing Foresight CLARITY, powered by PhasED-Seq, a novel Investigational Use Only (IUO) test for MRD. This randomized trial will enroll approximately 240 patients and is designed to demonstrate a meaningful improvement in event free survival (EFS) in patients treated with cema-cel relative to patients who receive the current standard of care (observation).

Allogene Presentations at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting:

ALLO-316 in advanced clear cell renal cell carcinoma (ccRCC): Updated results from the phase 1 TRAVERSE study.
Presenter: Samer A. Srour, M.D., The University of Texas MD Anderson Cancer Center
Session Title: Oral Abstract Session – Genitourinary Cancer – Kidney and Bladder
Abstract: #4508
Location: Hall D2
Presentation Date and Time: Sunday, June 1, 9:45AM – 12:45PM CT

ALPHA3: A pivotal phase 2 study of first-line (1L) consolidation with cemacabtagene ansegedleucel (cema-cel) in patients (pts) with large B-cell lymphoma (LBCL) and minimal residual disease (MRD) after response to standard therapy.

Presenter: Jason Westin, MD, MS, FACP, The University of Texas MD Anderson Cancer Center
Session Title: Poster Session – Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia
Abstract: TPS7085
Poster Board: #267a
Location: Hall A
Poster Session Display Date and Time: Sunday, June 1, 9:00AM – 12:00PM CT

About Cemacabtagene Ansegedleucel (cema-cel)
Cemacabtagene ansegedleucel, or cema-cel, is a next generation anti-CD19 AlloCAR T investigational product for the treatment of large B cell lymphoma (LBCL). In June 2022, the U.S. Food and Drug Administration granted Regenerative Medicine Advanced Therapy (RMAT) designation to cema-cel in r/r LBCL. The ALPHA3 pivotal Phase 2 trial in first line (1L) consolidation for the treatment of LBCL launched in June 2024. Allogene has oncology rights to cema-cel in the US, EU and UK with options for rights in China and Japan.

About ALLO-316 (TRAVERSE)
ALLO-316 is an AlloCAR T investigational product targeting CD70, which is highly expressed in renal cell carcinoma (RCC). CD70 is also selectively expressed in several cancers, creating the potential for ALLO-316 to be developed across a variety of both hematologic malignancies and solid tumors. The ongoing Phase 1 TRAVERSE trial is designed to evaluate the safety, tolerability, and activity of ALLO-316 in patients with advanced or metastatic clear cell RCC. In October 2024 the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation based on the potential of ALLO-316 to address the unmet need for patients with advanced or metastatic CD70+ RCC. The FDA previously granted Fast Track Designation (FTD) to ALLO-316 in March 2023. In April 2024, the Company announced a $15 million award from the California Institute for Regenerative Medicine (CIRM) to support the ongoing TRAVERSE trial with ALLO-316 in RCC.

About the ALPHA3 Trial
Over 60,000 patients are expected to be treated for LBCL annually in the US, the EU and the UK. While first line (1L) R-CHOP or other chemoimmunotherapy is effective for most patients, approximately 30% who initially respond will relapse and require subsequent treatment. The current standard of care (SOC) after 1L treatment has been simply to "watch and wait" to see if the disease relapses. The pivotal Phase 2 ALPHA3 study takes advantage of cema-cel as a one-time, "off-the-shelf" treatment that can be administered immediately upon discovery of MRD following six cycles of R-CHOP or other chemoimmunotherapy, positioning it to become the standard "7th cycle" of frontline treatment available to all eligible patients with MRD.

Alligator Bioscience announces initiation of HLX22 Phase 2 trial in breast cancer by Shanghai Henlius Biotech, Inc.

On April 23, 2025 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported that Shanghai Henlius Biotech, Inc. ("Henlius") has initiated a Phase 2 clinical trial with HLX22, an anti-HER2 monoclonal antibody originally developed by Alligator’s subsidiary, Atlas Therapeutics (Press release, Alligator Bioscience, APR 23, 2025, View Source [SID1234652046]). HLX22 is being developed by Henlius under a sublicense from AbClon, Inc., which had previously licensed the antibody from Alligator.

The Phase 2 study is being conducted in mainland China and is designed to evaluate HLX22 in combination with trastuzumab deruxtecan for the treatment of patients with locally advanced or metastatic breast cancer. The study aims to assess the efficacy and safety of the combination therapy.

Søren Bregenholt, CEO of Alligator, commented:
"Henlius’ progress with HLX22 underscores the continued clinical momentum behind this antibody. While Alligator is not directly involved in its development, we continue to monitor its progress with interest, as HLX22 may represent a potential future revenue stream for Alligator."
Under the terms of the license agreement, Alligator is entitled to 35% of AbClon’s revenue from its sublicense agreement with Henlius.

Adcentrx Therapeutics to Present First Clinical Data for ADRX-0706 Nectin-4 ADC at ASCO 2025

On April 23, 2025 Adcentrx Therapeutics ("Adcentrx"), a clinical-stage biotechnology company redefining Antibody-Drug Conjugate (ADC) therapies for cancer treatment and other life-threatening diseases, reported it will present the first clinical data for ADRX-0706 at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (May 30 – June 3, 2025) in Chicago, IL (Press release, Adcentrx Therapeutics, APR 23, 2025, View Source [SID1234652045]).

Adcentrx will deliver a poster presentation on ADRX-0706, a clinical-stage Nectin-4 ADC. The presentation will include interim clinical data from the Phase 1a portion of the ongoing trial (NCT06036121), demonstrating the best-in-class potential for ADRX-0706. The findings indicate a differentiated safety and pharmacokinetic profile, including a significantly lower incidence of critically meaningful adverse events such as peripheral neuropathy. Additionally, preliminary efficacy signals across different dose levels and tumor types provide strong clinical validation of Adcentrx’s ADC platform, including the i-Conjugation technology and novel auristatin payload AP052.

The first-in-human Phase 1a/b study is an open-label, two-part trial being conducted at sites in the U.S. and China. The completed Phase 1a portion consisted of a dose escalation of ADRX-0706 to evaluate initial safety and tolerability in patients with select advanced solid tumors, and to identify the recommended dose to be used in Phase 1b. This ongoing second portion of the study aims to further evaluate ADRX-0706’s safety and tolerability, preliminary efficacy, and optimal dose in urothelial, triple-negative breast and cervical cancers.

Details of the poster presentation at the ASCO (Free ASCO Whitepaper) Meeting are as follows:

Title: Preliminary results from a first-in-human phase 1 dose escalation trial of ADRX-0706, a next generation Nectin-4 ADC, in subjects with advanced solid tumors
Abstract Number: 3018
Session Date & Time: Monday, June 2, 1:30 p.m. – 4:30 p.m. CST
Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology

The full abstract will be published by ASCO (Free ASCO Whitepaper) in conjunction with the Meeting.

About i-Conjugation Technology

Adcentrx’s proprietary i-Conjugation technology platform is a core component in the design of the company’s ADCs. The platform utilizes protease-cleavable linkers and stable conjugation chemistry to enhance payload delivery. This advanced technology ensures a highly stable ADC with the desired linker-payload.

About ADRX-0706

ADRX-0706 is a fully proprietary ADC product candidate discovered by Adcentrx. The antibody component is a novel fully human IgG1 targeting Nectin-4, a cell surface adhesion protein with high expression in multiple solid tumors and limited expression in normal tissues. Nectin-4 is associated with poor disease prognosis and is a validated target for ADCs.

The ADRX-0706 antibody is linked to a proprietary tubulin inhibitor payload, AP052, through Adcentrx’s innovative i-Conjugation technology using a cleavable linker and stable conjugation chemistry. This novel platform technology enables a highly stable ADC with a drug-antibody ratio of eight (DAR 8) with a substantially expanded therapeutic window as demonstrated in preclinical studies.

ADRX-0706 has a favorable pharmacokinetic and safety profile in preclinical models and has demonstrated significant efficacy across a variety of tumor indications in vitro and in vivo. ADRX-0706 is currently being evaluated in a Phase 1a/b clinical trial.
For more information about the ADRX-0706 Phase 1a/b clinical trial, please refer to the Study ID NCT06036121 on ClinicalTrials.gov.

Adcendo ApS to Present Data on its Clinical Stage ADCs ADCE-T02 and ADCE-D01 at the 2025 American Association for Cancer Research (AACR) Annual Meeting

On April 23, 2025 Adcendo ApS ("Adcendo"), a biotech company focused on the development of first and best-in-class ADCs for the treatment of cancers with high unmet medical need, reported it will be presenting data on its two novel ADC programs ADCE-T02, targeting Tissue Factor, and ADCE-D01, targeting uPARAP, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, held in Chicago, Illinois, from April 25th to April 30th, 2025 (Press release, ADCendo, APR 23, 2025, View Source [SID1234652044]).

ADCE-T02 is a potential best-in-class Topo-1 inhibitor-based ADC targeting Tissue Factor (TF). Tissue Factor is clinically validated target overexpressed in a broad range of solid tumors, with limited expression in normal tissues. ADCE-T02 is composed of a next-generation TF targeting antibody conjugated to an exatecan-based T-1000 payload, a clinically validated linker-payload technology. ADCE-T02 shows strong anti-tumor activity in a wide range of solid tumor models and is well tolerated in non-human primate toxicology studies with no evidence of toxicity from earlier generation TF ADCs. A phase 1 clinical trial in advanced solid tumors is ongoing in both Australia and the United States. Australian recruitment is underway and enrollment in the United States will be initiated in the near future [NCT06597721].

ADCE-D01 is a first-in-class ADC targeting uPARAP conjugated to the Topo-1 inhibitor payload P-1021. uPARAP is a novel endocytic ADC target that is overexpressed in tumors of mesenchymal origin, such as sarcomas, while exhibiting restricted expression in normal tissues. ADCE-D01 is composed of a first-in-class uPARAP-targeting antibody conjugated to an optimized, clinically validated linker payload technology, selected for its superior efficacy and tolerability. Preclinically, ADCE-D01 shows strong anti-tumor activity in a range of mesenchymal tumor models including soft tissue sarcoma and is well tolerated in non-human primate toxicology studies with a favorable safety profile and no evidence of target-specific toxicity. A phase 1 clinical trial in advanced soft tissue sarcomas is enrolling in the United States and is under regulatory review in the European Union [NCT06797999].

Dominik Mumberg, PhD, Chief Scientific Officer at Adcendo, said: "We are excited to share the promising preclinical data for ADCE-T02 and ADCE-D01 demonstrating strong anti-tumor activity across a broad range of epithelial and mesenchymal tumor models with highly favourable tolerability profiles. We look forward to advancing both programs in our phase 1 Tiffany-01 and ADCElerate1 trials to help cancer patients in need of novel therapeutic options."

Details of the poster presentations are as follows:

Date & Time: April 29th, 9.00am – 12.00pm CT
Session Title: Antibodies and Antibody-Drug Conjugates
Poster Section: 36

Board Number: 14, Abstract number: 4778
Presentation title: ADCE-T02: A first-in-class topoisomerase-1 inhibitor-based antibody drug conjugate against tissue factor demonstrates excellent preclinical efficacy and tolerability
Authors: T. T. Poulsen1, Y. Zhang2, J. Zhang2, H. Shi2, S. Liu3, X. Meng2, M. Gillberg1, D. Mumberg1
1 Adcendo ApS, Copenhagen, Denmark. 2 Multitude Therapeutics, Shanghai, China. 3 Multitude Therapeutics, Redwood City, CA, USA

Board Number: 20, Abstract number: 4784
Presentation title: ADCE-D01: a first in class antibody-drug conjugate against urokinase plasminogen activator receptor-associated protein (uPARAP) demonstrates excellent preclinical efficacy and tolerability
Authors: J. Wardman1, A. Bie1, C. Côme1, P. Barkholt1, S. van Putten1, C. Løkke1, I. Gregersen1, J. Lange1, M. Gilberg1, K. Bannister1, M. Krogh-Madsen1, T. T. Poulsen1, C. Nielsen1, L. Engelholm2, N. Behrendt2, C. Lynch1, P. Hemmingsen1, D. Mumberg1
1 Adcendo ApS, Copenhagen, Denmark. 2 The Finsen Laboratory, Rigshospitalet/BRIC, Copenhagen University, Copenhagen, Denmark

Abstracts are available in an online itinerary planner (ADCE-T02 abstract; ADCE-D01 abstract), and will be available in an online only supplement to the AACR (Free AACR Whitepaper) journal Cancer Research one month after the conference. Electronic posters will be made available for registered conference participants from April 25th, 2025, through the conference web portal.

About antibody-drug conjugates (ADCs):

ADCs are a class of highly potent biopharmaceutical drug composed of a targeting antibody linked to a biologically active drug or cytotoxic compound. ADCs combine the unique and very sensitive targeting capabilities of antibodies, with the potent effects of the conjugated cytotoxic drugs, allowing sensitive discrimination between healthy and cancer tissues.

EUROPEAN MEDICINES AGENCY (EMA) HAS GRANTED ORPHAN DRUG DESIGNATION IN THE EUROPEAN UNION FOR AB8939 IN THE TREATMENT OF ACUTE MYELOID LEUKEMIA

On April 23, 2025 AB Science SA (Euronext – FR0010557264 – AB) reported that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) granted orphan drug status to AB8939 for the treatment of acute myeloid leukemia (AML) (Press release, AB Science, APR 23, 2025, View Source [SID1234652043]).

AB8939 had already obtained orphan drug designation from the US Food and Drug Administration (FDA) in AML.

Granting of this orphan drug status in the EU is a significant milestone because it means that the COMP considered that AB8939 offers a significant benefit to people suffering from this condition in addition to existing treatments.

Indeed, the criteria to obtain orphan drug designation at EMA differ from those at FDA and are very stringent for the following reasons :

-There must be no satisfactory method of diagnosis, prevention or treatment of the condition or, if such a method exists, the medicinal product must offer a significant benefit to patients. -Because the application is based on an assumption of significant benefit, a comparison with authorized treatments is required.

-Significant benefit means that a medicine produces a clinically relevant advantage or makes a major contribution to patient care, as compared with existing methods to treat the condition. Thus, orphan designation is given to a product that will improve patients’ current treatment, having considered what else is available.

-To follow the spirit of the orphan legislation, which makes it clear that an orphan application may bemade at any stage of the development, significant benefit will be based on the available evidence at the stage of designation.

In support of the significant benefit of AB8939 in AML, AB Science has released preclinical data from mouse models demonstrating a significant benefit of AB8939 treatment over current therapies, such as cytarabine, azacitidine (Vidaza) and venetoclax (Venclexta). This included:

-Efficacy on resistant cells: AB8939 manages to have an effect on the cancer cells (blasts) of AML patients, even when these cells are resistant to other drugs such as vincristine or cytarabine. For example, 45% of vincristine-resistant cells and 66% of cytarabine-resistant cells still respond to AB8939, including in severe cases with complex genetic mutations (MECOM, TP53).

-Convincing results in xenograft models derived from refractory AML patients: In these mouse models which mimick human AML, AB8939 reduces tumors and prolongs survival, even when cells areresistant to cytarabine. -Additive effect with reference treatments: When used with other treatments (cytarabine, Vidaza or venetoclax), AB8939 further improves results. For example, with venetoclax, it eliminates cancer cells in the blood, spleen and bone marrow, without serious side effects

-Furthermore, unlike venetoclax, AB8939 does not cause blood toxicity (hematotoxicity) and appears to act synergistically with other treatments, reinforcing its efficacy.

AB Science also presented preliminary efficacy and safety data from phase 1 of AB8939 as a monotherapy, with a 3-day treatment cycle (stage 1 of phase 1) and a 14-day treatment cycle (stage 2 of phase 1).

Professor Olivier Hermine, President of AB Science’s Scientific Committee, member of the French Academy of Sciences and Head of the Hematology Department at Necker Hospital, commented: "This designation testifies to the potential of AB8939 for the treatment of AML. Indeed, AB8939 has shown activity as a monotherapy on Ara-C-resistant patient lines, including in unfavorable genetic situations (MECOM, TP53 mutations) that have resisted all treatments administered to date, as well as a synergistic effect with the reference treatments Vidaza and Venclexta. The ongoing Phase 1 trial will now evaluate the combination of AB8939 with these reference treatments in refractory patients".

About AB8939

AB8939 is a new synthetic molecule which jointly targets cancer cells, by destabilizing the microtubules essential for cell division, and cancer stem cells, by inhibiting enzymes (ALDH1A1 and ALDH2) essential for maintaining their physiological state and survival. The molecule ‘1-{4-[2-(5-ethoxymethyl-2-methylphenylamino)-oxazol-5-yl]phenyl}imidazolidin-2-one’ is the chemical name of AB8939. The intellectual property of AB8939 is 100% owned by AB Science.