On October 12, 2026 Kyowa Kirin International plc, a wholly owned subsidiary of Kyowa Kirin Co., Ltd. (TSE:4151, Kyowa Kirin), reported final results from the German MINT study evaluating mogamulizumab in patients with mycosis fungoides (MF) and Sézary Syndrome (SS). Presented at the European Organisation for Research and Treatment of Cancer Cutaneous Lymphoma Tumour Group (EORTC-CLTG) Annual Meeting 2026 in Berlin, Germany, the findings represent one of the largest real-world evaluations of mogamulizumab in Germany and add to the growing body of evidence supporting its use in routine clinical practice.1-3

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Conducted as a company-sponsored, multicentric, non-interventional, combined retro-prospective real-world study across 18 centres throughout Germany, MINT brought together cutaneous T‑cell lymphoma (CTCL) specialists to evaluate treatment outcomes with mogamulizumab in a real-world setting, with time-to-next-treatment (TTNT) as the study’s primary endpoint.1 The study captured a broad and heterogeneous patient population, including clinically relevant subgroups such as patients with large cell transformation (LCT) and folliculotropic mycosis fungoides (fMF), and stratified by disease stage and mogamulizumab-associated rash (MAR) status, providing insights that complement evidence generated through controlled clinical studies.1,4

MF and SS are forms of CTCL, a type of non-Hodgkin’s lymphoma that manifests on the skin,5 though the disease can also involve the blood, lymph nodes and visceral organs.6 Symptoms can include persistent, itchy and scaly rashes, changes in skin colour and patches, plaques and/or tumours.7 These visible and often difficult-to-hide symptoms can make everyday activities harder and significantly affect patients’ quality of life, including their work, relationships and social lives,8 and for some patients the disease can progress to affect long-term survival.9

"For patients living with mycosis fungoides and Sézary syndrome, understanding how treatments perform outside the controlled setting of clinical trials is critically important. The final MINT results demonstrate meaningful clinical outcomes across a broad patient population treated in routine practice and highlight the value of collaborative real-world research in helping clinicians make informed treatment decisions," said Professor Chalid Assaf, Director of the Department of Dermatology and Venereology, Helios Klinikum Krefeld, Health and Medical University Düsseldorf-Krefeld, Germany.

The final analysis included 109 patients, comprising 56 patients with MF and 53 patients with SS, with a median follow-up of 25.2 months.1 The majority of patients had advanced disease when they started treatment, with 83.5% at stage IIB or above.1 The study demonstrated durable treatment outcomes, reporting a median TTNT of 14.9 months, a best overall response rate of 62.4%, and an overall median progression-free survival of 20.2 months.1 Median overall survival was not estimable at the time of analysis due to the limited number of deaths observed, despite up to 71 months of follow-up in some cases.1

Looking more closely at treatment response in clinically relevant patient subgroups, exploratory analyses reported best overall response rates of 54.5% in patients with LCT (n=11; 95% CI: 23.4–83.3) and 50.0% in patients with fMF (n=12; 95% CI: 21.1–78.9). Additional exploratory analyses by disease stage showed best overall response rates of 50% in patients with early-stage disease (n=18; 95% CI: 26.0–74.0) and 64.8% in patients with advanced stage disease (n=91; 95% CI: 54.1–74.6).10 Disease control rate was also reported in patients with MAR (n=47), at 95.7%.4

TTNT is an important measure in real-world clinical practice as it reflects both disease control and the duration of clinical benefit before a patient requires an alternative treatment approach. The study reported a median TTNT of 12.0 months in patients with MF and 20.2 months in patients with SS.4 Patients also experienced improvements in quality of life, with median Skindex-29 scores improving by 38.5% from 49.1 at treatment initiation (n=21) to 30.2 at Month 12 (n=7).1

"MINT provides valuable real-world evidence from Germany on the use of mogamulizumab across the heterogeneous population of patients with mycosis fungoides and Sézary syndrome, including clinically relevant subgroups that are often underrepresented in clinical trials. By evaluating time-to-next-treatment as a clinically meaningful outcome, the study offers practical insights that can support CTCL specialists in making informed, individualised treatment decisions," said Dr. Azeem Danish, Medical Affairs Director, DACH, Kyowa Kirin.

The investigators concluded that, in a real-world setting, mogamulizumab demonstrated a safety profile comparable to that observed in the pivotal Phase 3 MAVORIC study, while providing clinical benefits in treatment response and quality of life for patients with MF and SS.1,5 Grade 3 or higher treatment-related adverse events were reported in 38.5% of patients, most commonly drug eruption and lymphopenia.1 Serious treatment-related adverse events leading to discontinuation occurred in 22.0% of patients.1

Kyowa Kirin has supported the generation of real-world evidence in CTCL through collaborations with investigators and treatment centres across Europe. The MINT study contributes to a growing evidence base exploring outcomes in patients treated with mogamulizumab in routine clinical practice1-3 and reflects a shared commitment between investigators and industry to advancing understanding of rare cancers and improving care for patients living with CTCL.

About the MINT Study

MINT (Mogamulizumab In a Non-interventional study to evaluate the safety and outcome in mycosis fungoides and Sézary syndrome Treatment) is a German multicentric, non-interventional, retro-prospective real-world study evaluating the effectiveness and tolerability of mogamulizumab in patients with mycosis fungoides (MF) and Sézary Syndrome (SS). Data were collected from patient medical records across 18 study sites in Germany. The primary endpoint was time-to-next-treatment, with secondary endpoints including response rate, progression-free survival, overall survival, quality of life and tolerability.

(Press release, Kyowa Hakko Kirin, OCT 12, 2026, View Source [SID1234673338])

On October 12, 2026 Invenra Inc., a biotechnology company developing multispecific antibody therapeutics, reported the launch of its first 52 Views of Cancer, a playing card deck showcasing original artwork by people affected by cancer. Invenra is debuting the deck at the World ADC Conference in San Diego.

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The project links cancer journeys directly to researchers, clinicians, and drug developers. The launch also marks the company’s expansion into antibody-drug conjugate (ADC) asset discovery, using its powerful B-Body bispecific and T-Body trispecific antibody discovery platforms to create next-generation multispecific ADC assets for development with biopharma partners.

Art connects patients and researchers

Each of the deck’s 52 cards, along with the jokers and box cover, features original artwork contributed by a different cancer patient, survivor, or family member. Together, the works celebrate the creativity, resilience, and spirit of people whose lives have been touched by cancer.

"Through this project, we want to bring the experiences of people affected by cancer into the conversations shaping new cancer therapies," said Roland Green, Invenra CEO and founder. "The deck also introduces our work in antibody-drug conjugates. Invenra is developing ADCs for a wide variety of cancers, including ovarian, breast, lung, colon, neuroblastoma, osteosarcoma, rhabdomyosarcoma, Ewing’s sarcoma, diffuse midline glioma, and glioblastoma."

Invenra licensed the artwork and offered an honorarium to each featured artist. The artwork and accompanying stories are available on the 52 Views project website.

Invenra is sharing the decks at the conference and other major scientific and medical conferences, placing patients’ voices and perspectives directly in the hands of researchers, clinicians, and scientists working to cure the cancers these artists have experienced.

Advancing multispecific ADC discovery

The Invenra ADC discovery program combines its collection of antibody binders with proprietary multispecific platforms to develop candidates that enable access to broader patient populations with wider coverage by targeting multiple tumor targets.

Additionally, the company’s T-Body platform supports development of trispecific constructs incorporating HYPER-Internalization mechanisms, which can increase internalization, delivering more payload to cells while simultaneously targeting multiple pathways to reduce tumor escape routes.

On October 13, 2026, at the World ADC Conference, Bonnie Hammer, PhD, Invenra Executive Vice President of R&D, will present new preclinical data on the company’s ADC programs. In her talk, entitled From Bispecific to Trispecific Antibodies: Reimagining the Next Generation of ADCs, Hammer outlines a novel HER2 × HER2 × HER3 T-Body trispecific antibody, which combines three binders to target breast cancer.

"The preclinical data demonstrate the amazing potential of trispecific ADCs," said Hammer. "Invenra is exploring how trispecific targeting can improve payload delivery and address signaling pathways that may contribute to treatment resistance."

(Press release, Invenra, OCT 12, 2026, View Source [SID1234673337])

On October 12, 2026 Amphista Therapeutics Limited (‘Amphista’ or ‘the Company’), a leader in the discovery and development of non-cereblon / VHL targeted protein degradation (TPD) medicines, reported dosing of the first patient in a Phase 1 trial for its lead candidate, AMX-883. Initiated following authorization from the U.S. Food and Drug Administration in June 2026, the BRAMLIE trial will investigate the safety, pharmacokinetics, and preliminary efficacy of AMX-883 monotherapy in participants with AML and high-risk MDS1.

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BRAMLIE is expected to enroll approximately 54 patients across multiple sites. After establishing the monotherapy profile, a multi-center dose-escalation study would evaluate AMX-883 in combination with current standards of care in participants with relapsed/refractory AML as well as in earlier lines of therapy.

AML is an aggressive blood cancer causing ~130,000 deaths globally each year, with most patients receiving traditional cytotoxic chemotherapy. Although novel targeted agents can be effective, the use of these is restricted to specific mutations – and therefore target only a subset of AML patients – highlighting a need for broad-acting therapeutics.

Acting via a targeted protein degradation (TPD) mechanism, Amphista’s Targeted Glue degraders are highly selective small molecule therapeutics with properties optimized for human medicines. AMX-883 is a potent, selective, orally bioavailable Targeted Glue for BRD9 – a subunit of the chromatin remodeling complex involved in maintaining leukemic stemness and blocking of myeloid cell differentiation. Rapid BRD9 degradation is induced via AMX-883’s novel mechanism of action by which it recruits the E3 ligase DCAF16, enabling exceptional selectivity. Preclinically, AMX-883 has demonstrated activity across diverse AML subtypes, independent of mutation status2.

Dr Eytan Stein, Director, Program for Drug Development in Leukemia, Division of Hematologic Malignancies at Memorial Sloan Kettering Cancer Center, and Lead Investigator for this trial, said: "With a five-year survival rate of just 33%, and emerging resistance to standard-of-care treatments like venetoclax, AML is one of the most devastating blood cancers, and there is an urgent need for innovative new therapeutics. AMX-883 is the only BRD9 degrader currently in development, and I look forward to seeing what this clinical stage research will reveal."

Dr Louise Modis, Chief Executive Officer at Amphista, said: "The progression of our lead asset into the clinic marks a significant milestone for Amphista in our mission to transform the lives of patients with severe diseases. This study will help us better understand the potential of AMX-883, our lead Targeted Glue, and how it could establish an important new treatment pathway for patients facing this very difficult disease with high unmet medical need."

(Press release, Amphista Therapeutics, OCT 12, 2026, View Source [SID1234673336])

On October 12, 2026 Foresee Pharmaceuticals (TPEx: 6576), ("Foresee") reported that it was notified by its licensing partner, Changchun GeneScience Pharmaceutical Co., Ltd. ("GenSci"), that China’s National Medical Products Administration (NMPA) has approved the Marketing Authorization Application (MAA) for CAMCEVI 42 mg, a ready-to-use 6-month subcutaneous depot formulation of leuprolide mesylate, for the treatment of adult patients with advanced prostate cancer.

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Dr. Ben Chien, Ph.D., Chairman and Chief Executive Officer of Foresee Pharmaceuticals stated: "We are pleased that our partner GenSci will be launching CAMCEVI 42 mg in China. These efforts will significantly contribute to the growth of our global CAMCEVI franchise."

CAMCEVI is exclusively licensed to GenSci for commercialization in China across all current and pipeline indications, including advanced prostate cancer, central precocious puberty (CPP), and premenopausal breast cancer.

In addition to the NMPA’s approval of CAMCEVI 42 mg for advanced prostate cancer described above, GenSci submitted a supplemental New Drug Application (sNDA) in May 2026 for leuprolide mesylate injectable emulsion for the additional indication of premenopausal breast cancer, which has been accepted by the NMPA for substantive review.

About CAMCEVI 42 mg

CAMCEVI 42 mg is a sustained-release, ready-to-use, 6-month subcutaneous formulation of leuprolide mesylate, a gonadotropin-releasing hormone (GnRH) agonist, offering a less-frequent, ready-to-use dosing alternative to existing therapies.

It is approved for the treatment of adult patients with advanced prostate cancer in the United States (since May 2021), the European Union (since May 2022), and other markets, and, as announced today, in China. Product labeling may differ by country; please refer to the locally approved prescribing information.

(Press release, Foresee Pharmaceuticals, OCT 12, 2026, View Source [SID1234673335])

On October 12, 2026 Lunit (KRX: 328130), a leading provider of AI for cancer diagnostics and precision oncology, reported a strategic collaboration with Discovery Life Sciences (Discovery), a global leader in biospecimens and specialty laboratory services, to expand the adoption of the Lunit SCOPE suite, the company’s AI-powered pathology platform, across biopharmaceutical research.

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Discovery brings more than 25 years of assay expertise and has delivered biomarker services for more than 2,000 clinical trial programs while currently supporting over 350 active trial programs through its end-to-end specialty laboratory services across the drug development lifecycle.

Through the collaboration, Discovery and Lunit will work together with biopharma clients to apply the Lunit SCOPE suite within Discovery’s biomarker and tissue analysis workflows, tailoring AI-powered pathology to each program’s design. By pairing Discovery’s global biospecimen network and specialty laboratory expertise with Lunit’s AI-powered image analysis on client programs, the companies aim to provide pharmaceutical and biotechnology companies with standardized, quantitative tissue insights that support clinical research, translational studies, and drug development. The collaboration is expected to broaden global access to Lunit’s AI-powered pathology platform for biopharmaceutical researchers and organizations.

The companies also plan to expand AI-enabled tissue analysis services that help researchers generate deeper biological insights, improve the reproducibility of tissue-based analysis, and accelerate evidence generation throughout the drug development process.

In addition, Lunit will participate in Discovery Life Sciences’ Bridging Biomarker Breakthroughs to Bedsides (B4 Tour) on October 14 in South San Francisco. Yoojoo Lim, Medical Director at Lunit Oncology, will speak in an expert session and join the panel discussion, "AI in Biomarkers: What’s Working, What’s Next."

"AI-powered pathology only delivers on its promise when the tissue and the workflow behind it are consistent. Because we source the biospecimens and perform the tissue processing and pathology in our own laboratories, we can apply the Lunit SCOPE suite to reliably prepared samples and give our biopharma partners tissue data they can trust across their programs," said Anna Juncker-Jensen, PhD, Vice President of Scientific Affairs, Discovery Life Sciences.

"As biopharmaceutical companies increasingly seek quantitative and reproducible biomarkers to guide drug development, AI-powered pathology is becoming an essential part of modern translational research," said Brandon Suh, CEO of Lunit. "Through our collaboration with Discovery Life Sciences, we aim to bring the Lunit SCOPE suite to more biopharma researchers worldwide, enabling standardized tissue analysis that accelerates biomarker research and ultimately supports the development of next-generation therapies."

Through this collaboration, biopharma partners gain access to the Lunit SCOPE suite within Discovery’s end-to-end tissue workflows, from specimen sourcing through molecular pathology and quantitative readout, all performed in Discovery’s own laboratories. Integrating AI at the point of analysis gives researchers standardized, reproducible tissue data across their biomarker and translational programs.

(Press release, Lunit, OCT 12, 2026, View Source [SID1234673334])