On June 24, 2025 Accord Healthcare Limited (Accord) reported that the anti-PD-1 mAb, serplulimab, marketed as Hetronifly, has been approved by the MHRA to treat adults in the UK with extensive-stage small cell lung cancer (ES-SCLC), which has not previously been treated and has spread within the lungs or to other parts of the body (Press release, Accord Healthcare, JUN 24, 2025, View Source [SID1234654096]).

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This approval comes in the same week as the announcement in India, bringing the total number of countries and regions in which the medicine is approved to over 40 — including Europe, China, Indonesia, and Singapore. Accord Healthcare will lead commercialisation in both the UK and India on behalf of its parent company, Intas, and its commercial partner, Henlius.

Lung cancer remains the leading cause of cancer-related death globally. Small cell lung cancer (SCLC), one of the most aggressive subtypes, accounts for approximately 15% of all lung cancer cases and is associated with limited treatment options[1].

Julian Beach, Interim Executive Director of Healthcare Quality and Access at the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), commented: "As the first and only anti-PD-1 monoclonal antibody approved in the UK for small cell lung cancer, this marks an important new treatment option for patients with this aggressive type of lung cancer who currently have limited choices and face a poor prognosis."[2]

Henlius Biotech originally developed Serplulimab. In 2023, Henlius entered into a collaboration with Intas Pharmaceuticals, granting Intas exclusive rights to develop and commercialise the medicine in over 50 countries across Europe and India.

Welcoming the news, Paul Tredwell, Executive Vice-President EMENA, Accord Healthcare, said: "At Accord, we are dedicated to supporting patients with cancer. The MHRA’s approval of Hetronifly provides a new treatment option in the fight against extensive-stage small cell lung cancer — one of the most aggressive forms of lung cancer. This milestone reflects our ongoing commitment to providing novel specialty medicines for difficult-to-treat conditions."

Ping Cao, Chief Business Development Officer and Senior Vice President of Henlius said: "The approvals of serplulimab in the UK and India not only represent continued progress in our globalisation strategy but also reflect our concrete commitment to putting patients first. We are steadily expanding the global reach of the product, aiming to bring high-quality innovative therapies to more patients around the world."

In December 2022, serplulimab received orphan drug designation from the EC for the treatment of SCLC, this was recently reviewed by the committee and renewed.

ESMO has also scored serplulimab 4 out of 5 on their magnitude of clinical benefit scale (MCBS) in ES-SCLC.

About Serplulimab

Serplulimab (recombinant humanised anti-PD-1 monoclonal antibody injection)) is an anti-PD-1 mAb for the first-line treatment of SCLC and has been approved in China and several SEA countries. Serplulimab has been approved by the National Medicinal Products Administration (NMPA) in China for the treatment of squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC) and non-squamous non-small cell lung cancer (nsNSCLC). Serplulimab was granted orphan drug designations by the FDA and the EC for the treatment of SCLC, and its bridging head-to-head trial in the United States to compare serplulimab to standard of care atezolizumab (anti-PD-L1 mAb) for the first-line treatment of ES-SCLC is well under way.

The results of 4 pivotal trials of serplulimab were published in the Journal of the American Medical Association (JAMA), Nature Medicine, Cancer Cell and British Journal of Cancer, respectively. Furthermore, serplulimab was respectively recommended by the CSCO Guidelines for Small Cell Lung Cancer, the CSCO Guidelines for Non-Small Cell Lung Cancer, the CSCO Guidelines for Esophageal Cancer, the CSCO Clinical Practice Guidelines on Immune Checkpoint Inhibitor, the China Guidelines for Radiotherapy of Esophageal Cancer, and other definitive guides, providing valuable references for clinical diagnosis and treatment of tumours.

The approvals were primarily based on the results of the global phase 3 clinical study ASTRUM-005, which enrolled 585 patients across 128 trial sites worldwide. At the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, the results from the final analysis of ASTRUM-005 were presented, showing a median follow-up of 42.4 months and a 4-year overall survival (OS) rate of 21.9% (95% CI: 17.6–26.6%) for the serplulimab plus chemotherapy group. These results further confirm the long-term survival benefit of this immunotherapy-based regimen for patients with ES-SCLC.

About Lung Cancer

Lung cancer is the most common cancer worldwide in terms of incidence and mortality. According to GLOBOCAN 2022, there were over 2.48 million new cases of lung cancer globally in 2022, accounting for 12.4% of all new cancer cases.[1]

Small cell lung cancer (SCLC), which accounts for 15% to 20% of all lung cancers, is characterised by high malignancy, early metastasis, rapid progression, and poor prognosis.

Among SCLC patients, approximately 30% to 40% are diagnosed at a limited stage, while the remaining cases are in an extensive stage.

Within Europe, the prevalence of SCLC ranges from 1 to 5 per 10,000 people.

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 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 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 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.