On June 23, 2025 Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that seek to overcome tumor immune evasion and drug resistance, reported the presentation of new preclinical data on its novel CAPTN-3 tri-specific antibody platform in a poster presentation at the 2025 Annual Congress of the European Association for Cancer Research (EACR 2025), that was held in Lisbon, Portugal from June 16-19, 2025 (Press release, Purple Biotech, JUN 23, 2025, View Source [SID1234654059]).

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"Purple’s proprietary CAPTN-3 platform of T-cell engagers enables the creation of a large number of antibodies to different targets, and by capping the anti-CD3 arm for conditional activation and adding an NK cell antibody arm, we are creating tri-specific antibodies that safely activate both the innate and adaptive immune systems," said Gil Efron, Purple Biotech CEO. "Our poster at EACR 2025 highlights the flexibility and efficiency of the platform."

The design of the CAPTN-3 lead product and other candidates in this platform includes an anti-NKG2A arm, which acts both as an NK cell antigen and as an immune checkpoint on both T cells and NK cells through its interaction with HLA-E, which is often upregulated in tumors to evade immune detection.

NKG2A expression identifies a subset of human gamma delta 2 T cells exerting the highest antitumor effector functions. Anti-NKG2A function is required to unleash the NKG2A+ gamma delta 2 T cell anti-cancer activity. Our data demonstrate that the NKG2A arm in CAPTN-3 TCE synergizes with the anti-CD3 arm to induce significant cytotoxic effects against solid tumor cells.

NKG2A is an immune checkpoint that plays an important role in the exhaustion of cytotoxic T cells in the tumor microenvironment (TME). The preclinical data demonstrate the potential of CAPTN-3 to re-invigorate exhausted T cells and efficiently kill solid tumor cells, largely attributed to the significant contribution of the unique anti-NKG2A arm.

These activities are further supported by the in-vivo data demonstrating that both the NKG2A and CD3 arms contribute to the sustained tumor regression observed in mice models. These results underscore the innovative design of CAPTN-3, highlighting the impact of the novel anti-NKG2A arm and its synergistic effect with the anti-CD3 arm.

The CAPTN-3 platform creates a tri-specific scaffold with three binding arms. In the variable region, one arm conditionally binds to CD3, only after the cap has been cleaved by proteases in the TME. The other variable region engages natural killer (NK) cells, activating the innate immune system to join activated T cells in the killing of tumor cells. The constant region of the tri-specific antibody targets tumor associated antigens (TAA) to recruit both NK and T cells to the tumor. Through activation of both the innate and adaptive immune systems, the CAPTN-3 platform can generate synergistic responses within the TME, without the risk of off-target cytokine release.

Key Highlights from the Poster Presentation:

● Robust In Vivo Anti-Tumor Activity: The lead CAPTN-3 tribody, IM1240 (capped-CD3×5T4×NKG2A), induced sustained tumor regression in a triple negative breast cancer (TNBC) xenograft model.

● Conditional, Tumor-Restricted Activation: The ‘capped’ CD3 arm remained inactive in serum samples of advanced cancer patients and healthy donors and is selectively unmasked by TME proteases, expanding the therapeutic window and reducing potential systemic NKG2A+NK cell depletion.

● Dual Innate and Adaptive Engagement: IM1240’s NKG2A checkpoint blockade arm synergizes with the CD3 engager to activate both innate and adaptive immune subsets, translating to potent cytotoxicity in vitro and in vivo. The poster demonstrates:

o Activation of the extremely high antitumor NKG2A+ gamma delta 2 T effector cells

o Reinvigoration of exhausted T cells against solid tumor cells

o The added value of IM1240 NKG2A arm to the in-vivo tumor suppression

● Plug & Play Flexibility: Additional CAPTN-3 tribodies, such as IM1060 (CD3×5T4×NKG2D) and IM1065 (CD3×EGFR×NKG2A), demonstrated significant tumor regression, underscoring the platform’s modularity and customizable capabilities.

● Superior efficacy versus combination of individual antibodies was demonstrated.

EACR 2025 poster details are as follows:

Abstract #: EACR25-1964

Title: "CAPTN-3: A novel platform of conditionally activated T cell and NK cell engagers"

Session Title: Immunotherapy

The poster is available in the Publications section on Purple Biotech’s website.

Abstracts related to the EACR meeting will be published online following the presentation. For more information, please visit the EACR 2025 website.

On June 23, 2025 Oxcia reported that it has entered into an early research collaboration with LEO Pharma to explore OXC-101 in topical formulations for medical dermatology indications including psoriasis (Press release, Oxcia, JUN 23, 2025, View Source;utm_medium=rss&utm_campaign=oxcia-enters-a-research-collaboration-with-leo-pharma-to-explore-oxc-101-in-medical-dermatology [SID1234654058]).

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Oxcia is developing an oral product, OXC-101, mainly for treatments of cancer. In one of Oxcia’s clinical trials, a cancer patient with plaque psoriasis experienced significant improvement in the disease during OXC-101 treatment, indicating that OXC-101 might also have potential in skin diseases, as previously seen in pre-clinical models. OXC-101 is a mitotic MTH1 inhibitor with biological rationale also to treat skin diseases.

This collaboration, aimed at exploring OXC-101 for medical dermatology, aligns with Oxcia’s vision of extending the application of its technology platform beyond cancer. LEO Pharma’s proven expertise and long-standing success in developing dermatology treatments that deliver significant therapeutic advancements make them the ideal partner to help explore the potential of Oxcia’s OXC-101.

"We are very happy about the collaboration with LEO Pharma, a leading global dermatology company. Cancer cells and activated T cells have many similarities, i.e. increased oxidative stress and heightened levels of the enzyme MTH1, meaning that OXC-101 has potential also in auto-immune diseases. Together with Professor Helleday and Professor Enerbäck’s research groups, Oxcia have shown that OXC-101 has good effects in disease models for psoriasis and it is exciting that this is now further investigated. The patient that responded well on OXC-101 treatment is encouraging and we are looking forward to seeing the results of the continued development. At Oxcia, we also see the psoriasis project as a confirmation of the potential and versatility of the O2-DDR platform" says Ulrika Warpman Berglund, CEO of Oxcia.

On June 23, 2025 Lyell Immunopharma, Inc. (Nasdaq: LYEL), a clinical-stage company advancing next-generation CAR T-cell therapies for patients with cancer, reported that members of its senior management team will participate in the H.C. Wainwright "HCW@Home" Series taking place virtually on Wednesday, June 25, 2025, at 12:00 PM ET (Press release, Lyell Immunopharma, JUN 23, 2025, View Source [SID1234654057]).

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The discussion will highlight the positive new clinical data recently presented in an oral session at the International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland, on LYL314, Lyell’s lead product candidate, and the emerging landscape of next-generation dual targeting chimeric antigen receptor (CAR) T-cell therapy for patients with large B-cell lymphoma (LBCL). LYL314 is an autologous dual-targeting CD19/CD20 CAR T-cell product candidate with Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the U.S. Food and Drug Administration (FDA) that is in pivotal-stage development for patients with relapsed and/or refractory LBCL. LYL314 is designed to increase complete response rates and prolong the duration of the responses as compared to the approved CD19‑targeted CAR T-cell therapies for the treatment of LBCL.

Fireside chat details are as follows:

Lyell Speakers: Lynn Seely, MD, President and Chief Executive Officer and Charlie Newton, Chief Financial Officer
Date and Time: Wednesday, June 25, 2025, 12:00 PM to 1:00 PM ET
Webcast Link: Register here

A live webcast of the presentation can be accessed through the Investors section of the Company’s website at www.lyell.com. Following the live presentation, a replay of the webcast will be available on the Company’s website.

On June 23, 2025 Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported updated results from Part B of the DeFianCe study (NCT05480306), a Phase 2 study of sirexatamab (DKN-01), an anti-DKK1 monoclonal antibody, in combination with bevacizumab and chemotherapy (Sirexatamab Arm) compared to bevacizumab and chemotherapy (Control Arm) in patients with advanced microsatellite stable (MSS) colorectal cancer (CRC) who have received one prior systemic therapy for advanced disease (Press release, Leap Therapeutics, JUN 23, 2025, View Source [SID1234654056]). Due to the Company’s financial position, Leap’s Board of Directors is taking further steps to preserve capital and has initiated a process to explore strategic options to preserve and maximize shareholder value.

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"Sirexatamab demonstrated a statistically significant benefit in patients with high levels of DKK1, no prior exposure to anti-VEGF therapy, or liver metastasis, with a positive trend on ORR and PFS in the full second-line CRC population. With the additional patient follow-up, we believe that the objectives of the DeFianCe study have been achieved. On behalf of everyone at Leap, I thank all the patients and physicians who have participated in our sirexatamab clinical trials," said Douglas E. Onsi, President and Chief Executive Officer of Leap. "However, due to current market conditions, we have decided to wind-down the DeFianCe clinical trial and further reduce internal expenses. In parallel, we have initiated a review of the full range of strategic alternatives to maximize shareholder value."

DeFianCe Study Update

In the updated analysis as of May 22, 2025, sirexatamab demonstrated a positive trend on overall response rate (ORR), by investigator assessment (IA) and blinded independent central review (BICR), and progression-free survival (PFS) in the full second-line CRC population, driven by the statistically significant benefit in patients with high levels of DKK1, no prior exposure to anti-VEGF therapy, or liver metastasis.

· Across the intent-to-treat population (n=188):

Sirexatamab Arm
(n=94) Control Arm
(n=94)
Median PFS 9.2 months 8.31 months HR 0.84
95% CI: 0.57, 1.22
p = 0.1749
ORR by IA 35.1% 26.6% p = 0.1009
ORR by BICR 33.0% 20.2% P = 0.0203
Remaining on study drug 21 15

· In patients with high DKK1 levels (upper quartile, n=44):

Sirexatamab Arm
(n=25) Control Arm
(n=19)
Median PFS 9.36 months 5.88 months HR 0.47
95% CI: 0.22, 1.01
p = 0.0237
ORR by IA 44.0% 15.8% p = 0.0149
ORR by BICR 40.0% 15.8% p = 0.0301
Median OS Not Yet Reached 9.66 months HR 0.19
95% CI: 0.05, 0.73
p = 0.0037
Remaining on study drug 7 1

· In patients with DKK1 levels above the median (upper median, n=88):

Sirexatamab Arm
(n=50) Control Arm
(n=38)
Median PFS 9.03 months 7.23 months HR 0.56
95% CI: 0.33, 0.94
p = 0.0146
ORR by IA 38.0% 23.7% p = 0.0706
ORR by BICR 40.0% 15.8% p = 0.0039
Median OS Not Yet Reached 14.39 months HR 0.48
95% CI: 0.2, 1.16
p = 0.0475
Remaining on study drug 12 3

· In patients who had not received prior anti-VEGF therapy (n=95):

Sirexatamab Arm
(n=49) Control Arm
(n=46)
Median PFS 11.2 months 8.34 months HR 0.61
95% CI: 0.35, 1.06
p = 0.0383
ORR by IA 55.1% 32.6% p = 0.0116
ORR by BICR 44.9% 26.1% p = 0.0252
Median OS Not Yet Reached Not Yet Reached HR 0.47
95% CI: 0.14, 1.6
p = 0.1069
Remaining on study drug 15 5

· In patients with liver metastases (n=138):

Sirexatamab Arm
(n=73) Control Arm
(n=65)
Median PFS 9.03 months 7.26 months HR 0.7
95% CI: 0.46, 1.06
p = 0.0443
ORR by IA 37.0% 27.7% p = 0.1203
ORR by BICR 30.1% 24.6% p = 0.233
Median OS Not Yet Reached 15.74 HR 0.69
95% CI: 0.33, 1.43
p = 0.1584
Remaining on study drug 14 6

Corporate Update

Leap is taking additional steps to reduce spending and preserve capital. Over the next two months as the DeFianCe study completes, the Company will implement a workforce reduction of approximately 75%. The total cash payments and costs related to this reduction in force, including severance payments, are estimated to be approximately $3.2 million. The majority of these costs will be recognized in the third quarter of 2025. The Company’s cash and cash equivalents totaled $32.7 million as of March 31, 2025.

Leap has initiated a process to explore strategic alternatives to preserve and maximize shareholder value, including leveraging its cash balance and exploring potential sale or partnership opportunities for sirexatamab and FL-501. The Company’s Board of Directors has approved the engagement of Raymond James & Associates, Inc. to serve as exclusive financial advisor to assist in the strategic evaluation process.

On June 23, 2025 The University of Cincinnati Cancer Center (UC), The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James) and Jabez Biosciences reported their partnering to open a new phase 1 clinical trial studying JBZ-001, a potential new treatment for acute myeloid leukemia (AML) (Press release, Jabez Biosciences, JUN 23, 2025, View Source [SID1234654054]).

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The trial is supported by a more than $3.4 million grant from the National Institutes of Health’s National Cancer Institute awarded to UC and OSUCCC – James. It also offers a new approach for research and industry partnerships that will benefit patients by improving efficiency for the therapeutic pipeline.

AML is diagnosed in more than 20,000 individuals per year in the U.S., with more than half of these patients estimated to die each year. This high mortality rate emphasizes the need for new treatments, and JBZ-001 has demonstrated best in class pharmaceutical properties with worldwide patent protection.

The development of the trial drug is unique, as it was initially developed as part of an undergraduate chemistry class at Hendrix College in Arkansas under the mentorship of Thomas Goodwin, PhD. The class was focused on developing small-molecule inhibitors of dihydroorotate dehydrogenase (DHODH), a critical pathway for cancer cell proliferation, using a novel synthesis method called the Suzuki reaction.

The project progressed when Goodwin approached John C. Byrd, MD, a Hendrix alumnus, board member and former student of his. Byrd, along with Erin Hertlein, PhD, and Ola Elgamal, PhD, performed preclinical testing of the drug at OSU before moving to UC in 2021.

In collaboration with the Drug Development Institute at OSU, many iterations of the initial compounds (originally referred to as the HOSU series for Hendrix and OSU) were tested until HOSU-53 was developed as the lead candidate for human therapy trials. HOSU-53 was licensed by Jabez Biosciences in 2024 and then became JBZ-001.

The development of JBZ-001 marks a significant milestone in Jabez Biosciences’ "bench-to-bedside" academic collaboration, with the compound receiving Investigational New Drug approval for first-in-human trials in solid tumors and non-Hodgkin lymphoma in 2024. A Phase 1 trial is currently underway at the OSUCCC – James.

"Jabez Biosciences is extremely proud and grateful to be partnering with the University of Cincinnati Cancer Center and The James Comprehensive Cancer Center at OSU in a new JBZ-001 phase 1 trial in AML," said Tamara Jovonovich, PhD, chief executive officer of Jabez Biosciences. "The excitement around this potential treatment is growing exponentially and this collaboration exemplifies the commitment each has to realizing the potential of JBZ-001 in oncology care."

The Phase 1 clinical study in AML will open at UC and OSU in 2026. This study aims to assess the safety, tolerability and preliminary efficacy of JBZ-001 in patients with AML. Co-principal investigators Byrd, Hertlein and OSU’s Alice Mims, MD, and Christopher Coss, PhD, will partner to define pharmacokinetic and pharmacodynamic exposure-response relationships in patients with AML treated with JBZ-001.

"We are excited to move JBZ-001 from the bench to the clinic," said Byrd, a University of Cincinnati Cancer Center physician-researcher and the Gordon and Helen Hughes Taylor Professor and Chair of the Department of Internal Medicine at the UC College of Medicine. "This three-institution collaboration has been phenomenal. We are grateful for the NCI support to do this trial."

Additional studies will be performed to study the specific mechanism(s) of action, and single cell sequencing technologies will explore potential resistance mechanisms.

"We are thrilled to work with UC and Jabez Biosciences to explore JBZ-001 as a potential new therapeutic option for patients with AML," said Mims, professor of internal medicine and co-leader of the OSUCCC – James Leukemia and Hematologic Malignancies Program. "Though there have been advances made in the past 10 years for new therapeutic options for patients with AML, most patients are still not cured of their disease. Novel treatments to improve patient outcomes remain a high need in these patient populations."

At UC, the trial will join more than 40 additional open trials for blood cancers operating at the Blood Cancer Healing Center. Other UC investigators involved with this study include Emily Curran, MD, and Shesh Rai, PhD.