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Transgene CompletesInitial Patient Screening in Phase II Part of TG4050 Trial
in Operable Head and Neck Cancer

On June 18, 2025 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, reported the completion of initial patient screening in the randomized multicenter Phase II part of its Phase I/II clinical trial with TG4050, an individualized neoantigen therapeutic vaccine, as a single agent in the adjuvant treatment of HPV-negative squamous head and neck cancers (NCT04183166) (Press release, Transgene, JUN 18, 2025, View Source [SID1234653982]). TG4050, Transgene’s lead asset, is based on its proprietary myvac platform and powered by NEC’s cutting-edge AI capabilities designed to optimize antigen selection for individual patients.

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All patients treated with TG4050 in the Phase I part of the trial remained disease-free after a minimum of two years of follow-up, confirming clinical proof of principle. Translational data showed sustained T cell responses at 24 months in these patients. The results, which met all trial endpoints including safety, feasibility, immune activation and disease-free survival (DFS, defined as survival without recurrence or death for any cause), were presented in an oral presentation at the recent American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (ASCO 2025) annual meeting.

Transgene expects to complete randomization of all patients in the Phase II part by the end of 2025, following a second screening of patients conducted after surgery and adjuvant (chemo)radiotherapy. These screenings represent key steps during which patients are evaluated to determine whether they meet the eligibility criteria to participate in the clinical trial. In total, approximately 80 patients with a complete response to adjuvant therapy are anticipated to be enrolled and subsequently randomized in the Phase I/II trial. First immunogenicity data from the Phase II part of the trial are expected to be available in H2 2026, and preliminary efficacy data are expected in H2 2027.

Dr. Emmanuelle Dochy, MD, Chief Medical Officer of Transgene added: "Timely completion of first patient screening of the Phase II part of our Phase I/II trial is an important milestone for Transgene and brings us one step closer to providing a new treatment option for patients living with operable squamous head and neck cancer. With meaningful data readouts expected over the next two years, we are preparing to deliver important data for TG4050 and at the same time explore its wider potential. We are grateful to the patients, their families, investigators, and clinical staff whose commitment made this achievement possible."

Dr. Alessandro Riva, CEO of Transgene commented: "The positive results from the Phase I part of our TG4050 trial support the strong potential of our myvac platform. The successful completion of the first screening of the randomized Phase II part in less than a year and ahead of schedule underscores the investigators’ commitment to rapidly advance the development of TG4050. In the ongoing Phase II part of the trial, we have been able to scale efficiently, strengthen our manufacturing capabilities and operate with the agility needed to lead in a highly competitive and fast-moving environment.

The myvac individualized cancer vaccine platform can be applied across a range of solid tumors where in many cases a significant unmet medical need remains. Consequently, Transgene is starting initial preparations for a new Phase I trial in a second, undisclosed indication in an early treatment setting, with the aim to initiate the trial in Q4 2025."

Quince Therapeutics Announces Closing of Up to $22 Million Private Placement of Securities

On June 18, 2025 Quince Therapeutics, Inc. (Nasdaq: QNCX) ("Quince" or the "Company"), a late-stage biotechnology company dedicated to unlocking the power of a patient’s own biology for the treatment of rare diseases, reported the closing of its previously announced sale and issuance to certain institutional and accredited investors, of its common stock (or pre-funded warrants in lieu thereof), and accompanying common warrants ("Warrants") that resulted in approximately $11.5 million in upfront proceeds and potential additional proceeds of up to $10.4 million if the accompanying Warrants are exercised in full for cash, before deducting placement agent fees and other private placement expenses (Press release, Quince Therapeutics, JUN 18, 2025, View Source [SID1234653981]).

The private placement priced at a premium and was led by healthcare-focused institutional investor Nantahala Capital with participation from existing Quince stockholders including ADAR1 Capital Management, along with members of Quince’s senior management.

Dirk Thye, M.D., Quince’s Chief Executive Officer and Chief Medical Officer, said, "We are pleased to secure additional financing that allows us to complete enrollment of our pivotal Phase 3 NEAT clinical trial and extend our cash runway beyond topline results. This transaction reflects a significant commitment from high caliber healthcare investors who believe in our technology platform and Phase 3 asset, eDSP. Success in our lead indication of Ataxia-Telangiectasia (A-T) would demonstrate our ability to deliver corticosteroid efficacy without toxicity and would expand opportunities for pursuing additional indications for both rare and non-rare diseases."

Quince intends to use the net proceeds of this offering for working capital and general corporate purposes, including funding the ongoing enrollment of the Company’s pivotal Phase 3 NEAT (Neurological Effects of eDSP on Subjects with A-T; NCT06193200/IEDAT-04-2022) clinical trial in A-T, research and development expenses, general and administrative expenses and capital expenditures. The net upfront proceeds from the private placement, combined with Quince’s current cash, cash equivalents, and short-term investments of $31.6 million as of March 31, 2025, are expected to fund the Company’s operations into the second quarter of 2026, or the second half of 2026 if the Warrants are exercised in full for cash. In addition, the Company expects to use proceeds to continue to expand and accelerate its development pipeline by funding new program expansion into Duchenne muscular dystrophy and other high priority rare disease indications for its lead asset eDSP.

The Company continues to make meaningful progress in enrolling participants in its pivotal Phase 3 NEAT clinical trial. Key highlights to date include:

A total of 95 participants have been enrolled, including 77 participants in the six to nine year-old primary analysis population and 18 participants aged 10 years or older.
All 39 NEAT participants to date have elected to transition to the NEAT open label extension (OLE) study (NCT06664853/IEDAT-04-2022). Participants who complete the full treatment period, complete study assessments, and provide informed consent are eligible to transition to the OLE study.
Quince expects to report topline results from the Phase 3 NEAT clinical trial in the first quarter of 2026. Assuming positive study results, the Company plans to submit a New Drug Application to the U.S. Food and Drug Administration (FDA) in the second half of 2026.
Quince was granted FDA Fast Track designation for the Company’s eDSP System for the treatment of patients with A-T based on the potential for eDSP to address a high unmet medical need.
NEAT is an international, multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the neurological effects of Quince’s lead asset, eDSP (dexamethasone sodium phosphate [DSP] encapsulated in autologous red blood cells; previously referred to as EryDex) in patients with A-T.
Participants are randomized (1:1) between eDSP or placebo and treatment consists of six infusions scheduled once every 21 to 30 days. The primary efficacy endpoint will be measured by the change from baseline to last efficacy visit in the rescored modified International Cooperative Ataxia Rating Scale (RmICARS) compared to placebo.
About the Private Placement

At the closing, the Company issued to the investors an aggregate of 6,671,928 shares of common stock, 2,000,000 pre-funded warrants and accompanying Warrants to purchase an aggregate of 8,671,928 shares of common stock (or pre-funded warrants in lieu thereof), at a combined purchase price of $1.325 per share (or $1.324 per pre-funded warrant) and accompanying Warrant (representing a 10% premium over the $1.20 closing price per share of the Company’s common stock on June 11, 2025). The accompanying Warrants have an exercise price of $1.20 per share and are exercisable immediately. The Warrants will expire five years from the date of issuance.

Citizens Capital Markets acted as the lead placement agent for the private placement. Maxim Group LLC and Brookline Capital Markets, a division of Arcadia Securities, LLC, acted as co-placement agents for the private placement.

The securities issued in connection with the private placement described above were offered in a private placement and were not registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state or other applicable jurisdictions’ securities laws, and were not offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws.

This news release does not constitute an offer to sell or the solicitation of an offer to buy the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

QIAGEN and GENCURIX Announce QIAcuity Digital PCR IVD Assay Development Partnership

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]).

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.

Patient recruitment completed in OVM-200 Phase 1 trial

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.

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.

Neogap to present at Neoantigen Summit Europe 2025

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.

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/.