On June 18, 2025 QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) and GENCURIX, Inc. (KOSDAQ: 229000) reported a new partnership to develop oncology assays for use on the QIAcuityDx platform, a high-performance digital PCR system designed for clinical diagnostics (Press release, Qiagen, JUN 18, 2025, View Source [SID1234653980]).

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GENCURIX is the first development partner under QIAGEN’s QIAcuityDx Partnering Program. This important advancement marks a significant step towards establishing a broad menu of in vitro diagnostic (IVD) assays on the QIAcuityDx Four platform, increasing access to digital PCR diagnostics.

The new partnership combines QIAGEN’s QIAcuityDx digital PCR platform to advance sensitive, cost-effective oncology diagnostics with GENCURIX’s expertise in multiplex assay development. The aim is to enable the creation of oncology IVD assays for both tissue and liquid biopsy applications, with flexible commercialization options and global reach through QIAGEN’s Partnering Program.

"The QIAcuityDx Partnering Program is designed to enable the generation of a broad menu of IVD assays on the platform," said Jonathan Arnold, Vice President and Head, Partnering for Precision Diagnostics at QIAGEN. "The first partnership in this program with GENCURIX is an exciting moment, giving our oncology testing customers access to high-quality IVD assays that complement other established methods such as qPCR and NGS. We look forward to working with GENCURIX within this promising partner program."

"This strategic partnership with QIAGEN represents a major inflection point for expanding our oncology molecular diagnostic technologies into the global market," said Sang Rae Cho, CEO at GENCURIX. "We are confident that the synergy between our diagnostic content and QIAGEN’s platform will lead to global-standard precision cancer diagnostic solutions."

The QIAcuityDx Partnering Program aims to support third-party assay development on QIAcuityDx, which is a member of the QIAcuity family of digital PCR systems that reached at the end of 2024 more than 2,700 cumulative placements since launch. These menu initiatives for clinical applications will leverage this installed base as well as build on the 2024 milestone of launching more than 130 new assays for QIAcuity for research applications, and complemented by the extensive menu of custom assays available on QIAGEN’s GeneGlobe platform at geneglobe.qiagen.com.

GENCURIX will apply its proven expertise in complex, multiplex IVD assay development to create oncology tests The QIAcuityDx Four platform delivers a scalable and high-performance digital PCR solution for clinical laboratories. As global adoption of digital PCR grows, it is increasingly recognized as a complementary method to qPCR and NGS—particularly in oncology, infectious diseases, and rare genetic disorders. Through the QIAcuityDx Partnering Program, QIAGEN is opening its platform to third-party developers, encouraging innovation in order to offer laboratories a continuously expanding range of validated diagnostic tests.

GENCURIX will begin developing multiple oncology assays and pursue IVD regulatory approvals. GENCURIX, as the legal manufacturer of the assays, will be fully responsible for obtaining and maintaining all necessary regulatory approvals and certifications. Upon approval, the assays will be marketed through QIAGEN’s global commercial infrastructure as part of the QIAcuityDx Partnering Program, ensuring streamlined access for laboratories worldwide.

By enabling third-party development, QIAGEN is addressing the growing demand for broader access to high-precision and cost-efficient diagnostic assays. The collaboration with GENCURIX represents the first step in building a robust and innovative assay ecosystem for the QIAcuityDx platform, backed by QIAGEN’s distribution capabilities and technical support.

For more information about the QIAcuityDx Partnering Program please visit: www.qiagen.com/us/applications/digital-pcr-mdx/partnering.

On June 18, 2025 Oxford Vacmedix (OVM) reported that patient recruitment in the ongoing Phase 1 trial of OVM-200 has been completed (Press release, Oxford Vacmedix, JUN 18, 2025, https://oxfordvacmedix.com/patient-recruitment-completed-in-ovm-200-phase-1-trial/?utm_source=rss&utm_medium=rss&utm_campaign=patient-recruitment-completed-in-ovm-200-phase-1-trial [SID1234653979]). 24 patients have been recruited in Phase 1b bringing the total recruitment, including Phase 1a, to 36 patients in the trial. All current patients in Phase 1b are being treated with new extended dosing of OVM-200, that was first suggested by the clinical investigators in the trial, following the excellent safety record seen in Phase 1a. The new regime allows up to 11 vaccinations of OVM-200 over a six-month period and has been approved by the UK Medicines and Healthcare products Regulatory Agency (MHRA). OVM-200 is a new cancer vaccine developed using OVM’s novel recombinant overlapping peptide (ROP) platform. It targets survivin, a protein overexpressed by cancer cells, which prevents them being attacked by the body’s immune system.

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The Phase I trial of OVM-200 is focused on safety and on establishing an immune response in patients with three tumour types – non small cell lung cancer (NSCLC), prostate cancer and ovarian cancer. It is being run at four sites in the UK including the Sarah Cannon Institute and University College London Hospital (UCL), the Churchill hospital of the Oxford University Hospitals Foundation Trust (OUHFT) and the Christie NHS Foundation Trust in Manchester. The first part of the trial , Phase 1a, has been completed and has shown both excellent safety and a strong immune response. The Chief Investigator for the trial is Professor Martin Forster, based at UCL Cancer Institute. This trial is the first time any ROP based vaccine has been tested in the clinic.

William Finch, CEO of Oxford Vacmedix, said:

We are delighted to have completed recruitment in the OVM-200 Phase 1 trial in such a short time after implementing the extended dosing protocol. This demonstrates both confidence in our novel technology and the huge unmet need that there is for effective new immunotherapies. We look forward to seeing the results in these critically ill patients.

Professor Martin Forster, Chief Investigator at University College London Hospital, added:

We are very pleased to see the progress of the trial. The results from Phase 1a showed excellent safety and a strong immune response. We are hoping that extended dosing will produce a very durable immune response for our patients and maximise the potential benefits of this new form of immunotherapy.

On June 18, 2025 Neogap Therapeutics, a Swedish clinical-stage biotechnology company developing personalised immunotherapy for cancer, reported it will participate in this year’s Neoantigen Summit Europe in Amsterdam (Press release, Neogap Therapeutics, JUN 18, 2025, View Source,c4165752 [SID1234653978]). Ola Nilsson, Head of Neoantigen Production, Development & Clinical Processing at Neogap, is an invited expert speaker and will present the company’s personalised cell therapy pTTL and its EpiTCer technology.

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pTTL (personalised tumour-trained lymphocytes) is a personalised cell therapy based on the patient’s own T cells, extracted from regional lymph nodes and trained to recognise tumour-specific neoantigens. The treatment is currently being evaluated in an ongoing Phase I/IIa clinical trial in patients with advanced colorectal cancer.

EpiTCer, Neogap’s proprietary technology, plays a central role in the development of pTTL. By mimicking natural antigen presentation, it delivers selected neoantigens to the immune system. It is also used to develop potency assays – functional tests that assess the therapy’s ability to trigger a tumour-directed immune response.

"The EpiTCer technology is very powerful, as it not only enables efficient delivery of neoantigens to the immune system and selective expansion of tumour-specific T cells, but also provides us with the tools to functionally assess the potency of our therapy. This combination makes Neogap’s approach unique within cell therapy," says Ola Nilsson, Head of Neoantigen Production, Development & Clinical Processing at Neogap Therapeutics.

"Neoantigen Summit is a key international forum for demonstrating how we bridge technological innovation with clinical application – and to contribute our perspectives to the global conversation on the future of cancer treatment."

Neoantigen Summit Europe is a leading international conference focused on neoantigen-based therapies, bringing together researchers, clinicians and industry leaders from around the world.

The conference will be held in Amsterdam on 24–26 June 2025. Ola Nilsson is scheduled to speak on 26 June at 11:30. For registration and program details, visit the event website: https://neoantigen-summit.com/.

On June 18, 2025 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat cancers and viral infections, reported it has received a written response from the Office of Oncologic Diseases – Pediatric Oncology, of the U.S. Food and Drug Administration (FDA) regarding the Company’s Initial Pediatric Study Plan (iPSP), which was submitted after a June 2024 end-of-phase 1/2 meeting (Press release, Moleculin, JUN 18, 2025, View Source [SID1234653977]). The FDA has agreed to a single pediatric approval study in which Annamycin (also known as naxtarubicin) in combination with Cytarabine (also known as "Ara-C" and for which the combination of Annamycin and Ara-C is referred to as "AnnAraC") will be evaluated as second line therapy in pediatric patients with relapsed/refractory acute myeloid leukemia (R/R AML), a form of cancer.

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"We continue to be encouraged by the potential of Annamycin to change the game when it comes to the most prevalent cancer therapies in use today. This is particularly important in pediatric oncology, where about 60% of children with cancer are treated with anthracyclines that present a high risk of causing heart damage. An independent expert’s review of study data has shown no cardiotoxicity to date in 84 adult patients treated with Annamycin, which is why we’re excited about moving forward in young children with cancer. Receiving this written feedback from FDA is a crucial step in the development of Annamycin for pediatric use and provides us with helpful insight as we continue to prepare for the launch of a pediatric trial, planned for the second half of 2027," said Walter Klemp, Chairman and CEO of Moleculin. "As our team works to address and implement FDA’s feedback on our iPSP, we remain focused on the successful execution of our ongoing MIRACLE trial of AnnAraC in adult patients with R/R AML and look forward to initial data from that trial later this year."

As part of the iPSP, Moleculin proposed a single-arm study evaluating pharmacokinetics (PK), efficacy, and safety of AnnAraC in patients between 2 and 16 years of age. The FDA response calls for including patients from 6 months of age and older, with no minimum number of patients between 6 months and 2 years old. FDA also clarified that drug concentration exposure and safety profile that are comparable would allow extrapolation from efficacy in adults. Importantly, FDA said Moleculin would be able to start the pediatric trial before having the full two years of follow-up data from the adult trial.

Moleculin is in the process of updating its iPSP to incorporate FDA’s recommendations and intends to submit the revised plan to FDA later this quarter. Moleculin expects to initiate pediatric clinical study in the second half of 2027.

The Company is currently evaluating AnnAraC for the treatment of adult patients with R/R AML in the pivotal, adaptive Phase 3 MIRACLE trial (MB-108). This "MIRACLE" trial (derived from Moleculin R/R AML AnnAraC Clinical Evaluation) is a global trial, including sites in the US, Europe and the Middle East. Patient dosing has commenced, and the initial data readout is on track for the second half of 2025. For more information about the MIRACLE trial, visit clinicaltrials.gov and reference identifier NCT06788756

FDA has granted Annamycin Fast Track Status and Orphan Drug Designation for treating relapsed or refractory acute myeloid leukemia, and an additional Orphan Drug Designation for treating soft tissue sarcoma. The European Medicines Agency (EMA) has also granted Orphan Drug Designation for the treatment of relapsed or refractory acute myeloid leukemia.

On June 18, 2025 Merck reported the first patient has been dosed in the IDeate-Prostate01 phase 3 trial evaluating the efficacy and safety of investigational ifinatamab deruxtecan (I-DXd) versus docetaxel in patients with metastatic castration-resistant prostate cancer (mCRPC) with disease progression during or after treatment with an androgen receptor pathway inhibitor (Press release, Merck & Co, JUN 18, 2025, View Source [SID1234653976]).

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Ifinatamab deruxtecan is a specifically engineered, potential first-in-class B7-H3 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed by Daiichi Sankyo and Merck (NYSE: MRK), known as MSD outside of the United States and Canada.

While localized prostate cancer has a five-year survival rate of more than 90%, survival decreases to 31% in the advanced or metastatic stage.1 Current standard of care for patients with mCRPC includes treatment with androgen receptor pathway inhibitors followed by taxane-based chemotherapy.2-5 However, due to poor prognosis associated with previously treated mCRPC, many patients do not receive subsequent therapy, reinforcing the need for new approaches to improve outcomes.6

"Despite the emergence of new therapies, the current treatment landscape for patients with metastatic castration-resistant prostate cancer is challenging, and there is a need for new treatments," said Mark Rutstein, MD, Head, Therapeutic Area Oncology Development, Daiichi Sankyo. "Following the promising results seen in our earlier phase trial, IDeate-Prostate01 has been initiated to evaluate whether ifinatamab deruxtecan may replace standard taxane-based chemotherapy as a potential treatment strategy in patients with metastatic castration-resistant prostate cancer with disease progression during or after treatment with androgen receptor pathway inhibitors."

"IDeate-Prostate01 marks the initiation of the third pivotal trial in the ifinatamab deruxtecan development program and reinforces our commitment to addressing critical unmet needs for patients," said Marjorie Green, MD, Senior Vice President and Head of Oncology, Global Clinical Development, Merck Research Laboratories. "Our continued progress in the exploration of this potential first-in-class B7-H3 antibody drug conjugate in collaboration with Daiichi Sankyo, speaks to our pursuit of novel science in the hopes of making a difference for patients in need of new options."

The initiation of IDeate-Prostate01 is based on results from the IDeate-PanTumor01 phase 1/2 trial previously presented at the 2022 and 2023 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congresses where ifinatamab deruxtecan showed promising responses in heavily pretreated patients with mCRPC.

About the IDeate-Prostate01 Trial

IDeate-Prostate01 is a multicenter, open-label, randomized phase 3 trial evaluating the safety and efficacy of ifinatamab deruxtecan (12 mg/kg) versus docetaxel (75 mg/m2) plus corticosteroid in patients with mCRPC. Eligible patients must have received prior treatment with one or two androgen receptor pathway inhibitors and experienced disease progression during or after at least eight weeks of treatment.

The dual primary endpoints of IDeate-Prostate01 are overall survival and radiographic progression-free survival. Secondary endpoints include objective response rate, time to first subsequent therapy, duration of response, time to pain progression, time to prostate-specific antigen (PSA) progression, PSA response, time to first symptomatic skeletal-related event and safety.

IDeate-Prostate01 will enroll approximately 1,440 patients across Asia, Europe, North America and Oceania. For more information, please visit ClinicalTrials.gov.

About Metastatic Castration-Resistant Prostate Cancer

Prostate cancer is the second most common cancer in men, and the fifth leading cause of cancer death in men worldwide.7 Nearly 1.5 million prostate cancer cases were diagnosed in 2022, with approximately 400,000 deaths globally.7

While localized prostate cancer has a five-year survival rate of more than 90%, survival decreases to 31% in advanced or metastatic stage.1 Approximately 10% to 20% of early-stage prostate cancer cases progress to metastatic disease within five years of treatment on hormonal therapies such as androgen deprivation therapy.8,9 Current standard of care for patients with mCRPC includes treatment with androgen receptor pathway inhibitors followed by taxane-based chemotherapy. However, due to poor prognosis associated with previously treated mCRPC, many patients do not receive subsequent therapy, reinforcing the need for new approaches to improve outcomes.6

About B7-H3

B7-H3 is a transmembrane protein that belongs to the B7 family of proteins, which bind to the CD28 family of receptors that includes PD-1.10,11 B7-H3 is overexpressed in a wide range of cancer types, including mCRPC and its overexpression has been shown to correlate with poor prognosis, making B7-H3 a promising therapeutic target.12-15 There are currently no B7-H3 directed medicines approved for the treatment of any cancer.

About Ifinatamab Deruxtecan

Ifinatamab deruxtecan (I-DXd) is an investigational potential first-in-class B7-H3 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, ifinatamab deruxtecan is comprised of a humanized anti-B7-H3 IgG1 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

Ifinatamab deruxtecan has been granted orphan drug designation by the U.S. Food and Drug Administration, European Commission, Japan Ministry of Health, Labour and Welfare and Taiwan Food and Drug Administration for the treatment of small cell lung cancer.

About the Ifinatamab Deruxtecan Clinical Development Program

A comprehensive global clinical development program is underway evaluating the efficacy and safety of ifinatamab deruxtecan across multiple B7-H3 targetable cancers. Trials in combination with other anticancer treatments also are underway.