On October 7, 2025 Cyteph Pty Ltd, a biotechnology company developing novel immunotherapies for difficult-to-treat cancers, reported that it has successfully completed recruitment for its first-in-human Phase I clinical trial of CYT-101 (Press release, Cyteph, OCT 7, 2025, View Source [SID1234656495]).

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CYT-101 is a novel off-the-shelf, HLA-matched CMV-specific T cell therapy for the treatment of glioblastoma multiforme (GBM) and other solid cancers. GBM is an aggressive brain cancer and one of the deadliest solid cancers in adults, with limited treatment options available.

The unique advantage of targeting CMV antigens on GBM cells is that they are detected on tumour cells while not found in surrounding healthy tissue. This characteristic allows for a highly targeted approach. By harnessing the power of allogeneic CMV-specific T cell therapy, CYT-101 has the potential to offer improved outcomes for GBM patients.

The Phase I study is being conducted in collaboration with Briz Brain & Spine and Newro Foundation and is evaluating the safety, tolerability, and preliminary signals of efficacy of CYT-101 in patients with recurrent GBM.

"We are pleased to have completed enrolment, reflecting the strong demand from clinical collaborators and patients for innovative treatment options for GBM," said Professor Rajiv Khanna, Chief Scientific Officer and Founder of Cyteph. "This milestone marks an important step forward in our mission to bring transformative therapies to patients with few existing options."

The Phase I trial follows participants through dose-escalation cohorts, with key readouts expected at the end of Q4 2025.

Results from this study will inform the design of subsequent clinical trials and support the continued development of CYT-101 as a novel treatment approach for glioblastoma and other high-unmet-need solid cancers.

"Completing recruitment is a critical milestone for any clinical program, and it underscores the dedication of our team, and the patients who make this research possible," said Professor David Walker, neurosurgeon and spinal surgeon at Briz Brain & Spine and lead clinical investigator for the CYT-101 clinical trial.

The CYT-101 Phase I clinical trial is funded through Australia’s national biotech incubator CUREator.

Cyteph is a spin-out biotechnology company from QIMR Berghofer, a leading medical research institute based in Brisbane, Australia.

On October 7, 2025 CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, reported that the results of CT071 (an autologous CAR T-cell product targeting GPRC5D) for the treatment of relapsed/refractory multiple myeloma (R/R MM) in an investigator-initiated trial (NCT05838131) have been published in The Lancet Haematology (Press release, Carsgen Therapeutics, OCT 7, 2025, View Source [SID1234656494]). The article was titled "GPRC5D-targeted CAR T-cell therapy (CT071) in patients with relapsed or refractory multiple myeloma: a first-in-human, single-centre, single-arm, phase 1 trial".

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This trial aimed to assess the safety, preliminary activity of CT071 in R/R MM. 20 patients received CT071 infusion. Patients had received a median of 5 prior lines of therapy (IQR 3.0-6.5); 19 (95%) were double-class refractory, 13 (65%) were triple-class refractory, 5 (25%) were penta-drug refractory, 10 (50%) had received autologous stem cell transplantation (ASCT), and 5 (25%) had relapsed after CAR T-cell therapies targeting BCMA or BCMA/CD19. Four (20%) patients had extramedullary disease (EMD), 14 (70%) had ≥1 high-risk cytogenetics and 19 (95%) had a Revised International Staging System (R-ISS) 2 or 3 disease at baseline.

No dose-limiting toxicities (DLTs) were observed. The recommended phase 2 dose was determined at 0.1×106 CAR T cells/kg. Cytokine release syndrome occurred in 12 patients (60%), all graded as 1 or 2. No Grade ≥3 cytokine release syndrome (CRS) occurred. One patient (5%) experienced Grade 3 immune effector cell-associated neurotoxicity syndrome (ICANS). No treatment-related deaths occurred.

With a median follow-up of 10.71 months (IQR 6.13-12.02), the objective response rate (ORR) was 100% (95%CI, 83.2-100). 10 (50%) patients achieved stringent complete response (sCR), 4 (20%) had very good partial response (VGPR) and 6 (30%) had partial response (PR). One patient with a large EMD (125 mm×99 mm at baseline) achieved a 67.6% reduction at month 10 with ongoing PR. All 5 patients previously treated with an anti-BCMA CAR T (n=1) or anti-BCMA/CD19 CAR T (n=4) responded; 2 achieved PR, 1 achieved VGPR and 2 achieved sCR. 18 of 20 (90%) evaluable patients achieved MRD negativity at 10−6 including all 10 with CR or sCR. Median time to MRD negativity was 29 days (IQR 29-29). Median duration of response (DoR), progression-free survival (PFS) and overall survival (OS) were not reached. The data cutoff for all analyses was December 9, 2024.

About CT071
CT071 is a CAR T-cell therapy candidate developed utilizing the proprietary CARcelerate platform targeting GPRC5D for the treatment of relapsed/refractory multiple myeloma (R/R MM) or plasma cell leukemia (PCL). Initiated trials include an investigator-initiated trial for R/R MM or PCL in China (NCT05838131), and an investigator-initiated trial for newly diagnosed multiple myeloma (NDMM) in China (NCT06407947).

On October 7, 2025 Blue Earth Therapeutics reported new modelling results demonstrating that front-loaded dosing of its radiohybrid lutetium labelled, PSMA targeted, investigational radioligand therapy Lutetium (177Lu) rhPSMA-10.1 Injection may increase cumulative tumour absorbed radiation dose without a proportional increase in normal organ exposure or total administered radioactivity (Press release, Blue Earth Therapeutics, OCT 7, 2025, View Source [SID1234656493]). These findings are being presented at the European Association of Nuclear Medicine (EANM) Annual Meeting (poster EPS-187) and have been used to shape the design of the Phase 2 portion of the Phase 1/2 clinical trial (NCT05413850). The model was built from patient data from the Phase 1 portion of the trial.

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In the Phase 1 study, tumor absorbed radiation doses in cycles 2 and 3 declined by 37% and 56% respectively from cycle 11. In contrast, healthy organ-absorbed doses remain broadly the same across cycles. In the model, maximum cumulative administered radioactivity was defined by the current limit of 23 Gy absorbed dose to kidneys. With the Phase 1 trial showing 0.30 Gy/GBq absorbed dose to the kidneys, administration of up to 60GBq or more was possible.

The model assessed three dosing scenarios, all with dosing at six-weekly intervals:

10 GBq in cycles 1 and 2, followed by five cycles of 7.4 GBq
14.8 GBq in cycles 1 and 2, followed by four cycles of 7.4 GBq
7.4 GBq in each of cycles 1-8 (flat dosing)
The model extrapolated the reductions in tumour-absorbed radiation doses across each of cycles 4-8 using data available from cycles 1-3 and predicted the cumulative tumour absorbed radiation dose for each dosing scenario. The results showed that the front-loaded regimens both increase tumour-absorbed radiation dose; by 15% for regimen #1 and by 34% for regimen #2 vs. a flat dosing regimen (#3).

Commenting on the results, Dr Dan Stevens, Blue Earth Therapeutics’ Chief Medical Officer, said, "There is increasing interest in exploring alternative dosing schedules for radiopharmaceutical therapies to try and optimise the potential for clinical benefit. We are taking observed data from our Phase 1 and attempting to apply this scientifically in testing different front-loading approaches in our ongoing Phase 2 study. The data collected should allow us to assess the potential benefit and any risks."

About metastatic prostate cancer
In 2025 it is estimated that there will be 50,055 new cases of metastatic prostate cancer in the United States (de novo diagnoses plus recurrence from earlier stage diagnoses).2 Five-year survival for newly diagnosed metastatic prostate cancer is low, 36.6%.3 While death rates from prostate cancer have declined over the past three decades3, there is still considerable room to improve patient outcomes.

About Radiohybrid Prostate–Specific Membrane Antigen (rhPSMA)
rhPSMA compounds are referred to as radiohybrid ("rh"), as each molecule possesses four distinct domains. The first consists of a Prostate–Specific Membrane Antigen–targeted receptor ligand. It is attached to two labelling moieties which may be radiolabeled with diagnostic isotopes such as 18F or 68Ga for PET imaging, or with therapeutic isotopes such as 177Lu or 225Ac for radioligand therapy, all of which are joined together by a modifiable linker which can be used to modulate important pharmacokinetic characteristics. Radiohybrid PSMA offers the potential for targeted treatment for men with prostate cancer and originated at the Technical University of Munich, Germany. Blue Earth Diagnostics acquired exclusive worldwide rights to rhPSMA diagnostic imaging technology from Scintomics GmbH in 2018, and therapeutic rights in 2020, and has sublicensed the therapeutic application to its sister company Blue Earth Therapeutics.

On October 7, 2025 TORL BioTherapeutics LLC (TORL), a clinical stage biotechnology company discovering and developing new antibody-based immunotherapies to improve and extend the lives of patients with cancer worldwide, reported closing of a $96 million Series C financing (Press release, TORL Biotherapeutics, OCT 7, 2025, View Source [SID1234656492]). Additionally, updated results from the ongoing Phase 1 study of the Company’s Claudin 6 (CLDN6) targeted antibody-drug conjugate (ADC) TORL-1-23 in patients with advanced cancer will be presented in poster sessions at the 2025 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress (ESMO 2025) in Berlin, Germany.

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"This financing ensures TORL is able to further the clinical development of TORL-1-23, our first- and potentially best-in-class Claudin 6 targeted ADC for women living with platinum-resistant ovarian cancer," said Mark J. Alles, Chairman and Chief Executive Officer of TORL BioTherapeutics. "We appreciate the support from our new and existing world-class life sciences investors who share our passion to discover and develop new targeted treatment options for patients with cancer."

Proceeds from this financing will advance CATALINA-2, the ongoing pivotal Phase 2 study of TORL-1-23 for CLDN6+ patients with platinum-resistant ovarian cancer (PROC) to pivotal data readout in 2027, and CATALINA-3, the confirmatory Phase 3 study of TORL-1-23 in CLDN6+ PROC initiating in 2026. In addition, funds will support registration-enabling Phase 2 and Phase 3 studies, as well as ongoing Phase 1 studies and IND-enabling work across TORL’s pipeline of novel high-value targets in solid tumors and hematologic malignancies.

Updated data from the TORL-1-23 Phase 1 study will be presented at ESMO (Free ESMO Whitepaper) 2025 (#1074P). In this ongoing study, patients with heavily pretreated CLDN6+ ovarian, testicular, endometrial, non-small cell lung and other cancers were enrolled across multiple dose cohorts. Emerging efficacy data from this study supported further evaluation of TORL-1-23 in larger, registrational studies.

In November 2024, TORL initiated CATALINA-2, a study designed to support accelerated registration of TORL-1-23 for CLDN6+ PROC. CATALINA-2 is a global, multi-institutional, randomized, open-label Phase 2 study of TORL-1-23 in women with CLDN6+ PROC who have received one to three prior lines of therapy. A CATALINA-2 Trial-in-Progress poster will be presented at ESMO (Free ESMO Whitepaper) 2025 (#1225TiP).

"The maturing clinical profile of TORL-1-23 continues to demonstrate the potential to improve treatment outcomes for patients with CLDN6+ platinum-resistant ovarian cancer, a defined subset of the disease with particularly poor prognosis," said Scientific Co-founder and Board Member Dennis Slamon, MD, PhD, Professor of Medicine, and Chief of the Division of Hematology/Oncology at UCLA’s David Geffen School of Medicine. "TORL-1-23 is the first of multiple high potential therapeutics to emerge from this unique academic-industry collaboration to redefine drug development from bench to bedside."

"TORL’s mission is to discover, develop and commercialize antibody-based therapeutics to improve and extend the lives of people with cancer worldwide," said Dave Licata,Co-founder, Board Member, President, and Chief Financial Officer. "Thanks to our dedicated employees and committed investors, we are well-positioned to advance the TORL-1-23 clinical program and our emerging pipeline across solid tumors and hematologic malignancies."

About Claudin 6

Claudin 6 (CLDN6) is overexpressed in several cancers with limited to no detectable expression observed in normal tissues, making it an ideal target for ADC development. CLDN6 is a transmembrane protein and member of a family of proteins important for cell-to-cell connectivity in normal tissues. CLDN6 expression normally occurs during embryonic and fetal development but not in adult tissues. Overexpression of CLDN6 occurs in specific malignancies and has been implicated in the pathogenesis of certain cancers including ovarian, non-small cell lung, endometrial and testicular malignancies. High expression correlates with shortened survival outcomes for patients with ovarian cancer.

About TORL-1-23

TORL-1-23 is a first- and potentially best-in-class clinical-stage ADC for the treatment of CLDN6+ solid tumors. TORL-1-23 has received Fast Track Designation from the U.S. Food and Drug Administration. TORL BioTherapeutics is currently enrolling the pivotal Phase 2 CATALINA-2 study of TORL-1-23 in women with CLDN6+ PROC. Further details can be found at View Source

About CATALINA-2

CATALINA-2 is a global, randomized, open-label Phase 2 study of novel CLDN6-targeted ADC TORL-1-23 in women with CLDN6+ PROC who have received one to three prior lines of therapy. The primary endpoint is objective response rate (ORR) per RECIST v1.1 by blinded independent central review. Secondary endpoints consist of duration of response, ORR by investigator assessment, progression-free survival, overall survival and safety. Further details can be found at View Source

On October 7, 2025 Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharmaceutical company focused on developing first-in-class therapeutics for dermatological, oncology, and Alzheimer’s, reported that Chief Executive Officer Robb Knie will be presenting at the upcoming BIO-Europe 2025 Conference, taking place November 3–5, 2025, in Vienna, Austria (Press release, Hoth Therapeutics, OCT 7, 2025, View Source [SID1234656491]).

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At the conference, Mr. Knie will highlight the Company’s two leading development programs:

HT-001 – a topical therapeutic designed to reduce rash and skin toxicity associated with cancer therapies, including EGFR inhibitors and radiotherapy.

HT-KIT – a precision oncology program targeting cancers driven by dysregulated KIT signaling.
"BIO-Europe is one of the premier global events for biopharma partnering and innovation," said Robb Knie, CEO of Hoth Therapeutics. "We look forward to sharing progress on our lead programs and engaging with potential collaborators who share our vision of developing breakthrough therapies for patients with high unmet needs."

Hoth’s presentation and partnering schedule will be available to registered attendees through the BIO-Europe partneringONE platform.