On December 3, 2025 Quadriga BioSciences, a clinical-stage oncology company developing QBS72S (formerly QBS10072S) for the targeted treatment of cancer, reported positive Phase IIa interim clinical data presented at the 7th Quadrennial World Federation of Neuro-Oncology Societies and 30th Annual Meeting of the Society for Neuro-Oncology (WFNOS–SNO), held November 19–23, 2025, at the Hawaii Convention Center in Honolulu, Hawaii. In an oral session, data were presented from a single-arm, open-label study conducted by the Department of Neurosurgery at the Stanford University School of Medicine that evaluated the safety and efficacy of QBS72S, a novel chemotherapeutic designed to cross the blood–brain barrier via the L-type amino acid transporter 1 (LAT1). The results showed that QBS72S produced both radiographic and symptomatic improvement in breast cancer patients with leptomeningeal disease (LMD).

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"The Phase IIa results provide important early clinical signals that reinforce the potential of QBS72S to meaningfully impact outcomes for patients with LMD," said Gordon Ringold, Ph.D., CEO of Quadriga BioSciences. "Seeing radiographic stability alongside improvements in neurologic and physical symptoms, as well as survival beyond 12 months in 4 out of 10 patients, is very encouraging. These findings underscore the promise of our therapeutic approach and strengthen our commitment to advancing QBS72S as a treatment option for patients with LMD, for which there are no approved treatment alternatives."

LMD is a serious complication of advanced breast cancer in which cancer cells spread to the membranes surrounding the brain and spinal cord, leading to significant neurologic symptoms, rapid clinical decline, and a poor prognosis.

"Breast cancer is one of the most common solid tumors to spread to the brain, and LMD represents a serious and challenging complication for patients," said Ron Weitzman, M.D., CMO of Quadriga BioSciences "Available treatment options remain limited, in part due to challenges with drug delivery across the blood-brain barrier. The clinical findings presented at WFNOS–SNO suggest that QBS72S reaches the cancer cells and may offer meaningful benefit for patients with advanced metastatic disease. These data support continued evaluation of QBS72S as a targeted therapeutic candidate for LMD, an area of significant unmet need."

These results reinforce Quadriga Biosciences’ commitment to advancing QBS72S toward a potential therapeutic option for patients with leptomeningeal disease and other central nervous system manifestations of metastatic breast cancer.

Reference: Abstract ID: CTNI-71, Oral Presentation

Title: Interim analysis of a phase IIa trial of LAT1-targeted QBS72S in breast cancer leptomeningeal disease
Authors: Brandon Carlson-Clarke, Sahara Rout, Meaghan Roy-O’Reilly, Rukayat Taiwo, Paul M. Harary, Monica Granucci, Sophia B. Chernikova, Thy T.H. Trinh, Sophie Bertrand, Kate Therkelsen, Summer Han, Bo Gu, Gordon Ringold, Jaymes Holland, Ron Weitzman, Seema Nagpal, Melanie Hayden Gephart

About QBS72S
QBS72S is a novel, first-in-class chemotherapeutic agent that mimics an aromatic amino acid for cellular uptake by the amino acid transporter LAT1 (L-type amino acid transporter 1) thereby enabling the drug to cross the blood brain barrier (BBB) as well as to selectively target numerous types of rapidly growing cancer cells. Once inside the cell QBS72S causes double-stranded DNA breaks resulting in cell death. Most aggressive cancers express high LAT1, which is commonly associated with poor prognoses.1

About the Study
The Phase 2 open-label clinical trial is designed to assess the safety, tolerability and efficacy of QBS72S in patients with brain metastases from breast cancer. The study will recruit up to 35 patients with the primary objective of determining preliminary efficacy through overall response rate. Secondary endpoints include measurement of progression free survival, overall survival, duration of response, and adverse events.

Please refer to www.clinicaltrials.gov [NCT05305365] for additional clinical trial details.

(Press release, Quadriga BioSciences, DEC 3, 2025, View Source [SID1234661116])

On December 3, 2025 ImpriMed, a precision oncology CRO specializing in ex vivo drug sensitivity testing for hematologic malignancies, reported that it has been selected to present two significant research studies at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in Orlando, Florida, taking place December 6-10.

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"Being featured at ASH (Free ASH Whitepaper) is an important validation of our xCellSense platform for both pharma partners and clinicians," said Sungwon Lim, Chief Executive Officer of ImpriMed. "Our data demonstrates that ex vivo functional testing, combined with genomic profiling, can effectively predict which acute myeloid leukemia (AML) patients will respond to specific therapies. This powerful combination equips drug developers and physicians with the critical evidence needed to select the most effective treatments, design innovative clinical trials, and ultimately improve patient outcomes."

ImpriMed will present data from a prospective study integrating NGS-based genomic profiling with ex vivo drug sensitivity testing across a panel of 21 drugs in AML patients treated with standard-of-care regimens. The data demonstrate that ex vivo drug-sensitivity testing successfully stratified survival risk in AML patients and identified clinically meaningful genotype-drug associations. These results validate the platform’s utility for drug development applications, including lead candidate selection, patient enrichment strategies, and the development of companion diagnostics.

Additionally, the company will share findings on a quantitative ex vivo drug synergy analysis methodology using primary samples from AML patients. This innovative system enables pharmaceutical companies to identify synergistic drug combinations and accurately identify the patient subgroups most likely to benefit from combination therapy.

Oral Presentation Details:

Session: 803. Emerging Tools, Techniques, and Artificial Intelligence in Hematology
Date/Time: December 8, 2025, 3:15 PM – 3:30 PM
Publication Number: 939
Title: "Ex vivo drug sensitivity testing in Korean AML patients: Integration of functional and genomic profiles for predicting clinical response and survival"
Poster Presentation Details:

Session: 803. Emerging Tools, Techniques, and Artificial Intelligence in Hematology: Poster III
Date/Time: December 8, 2025, 6:00 PM – 8:00 PM
Publication Number: 6137
Title: "Quantitative ex vivo synergy profiling uncovers heterogeneous combination responses in AML primary samples"

(Press release, ImpriMed, DEC 3, 2025, View Source [SID1234661115])

On December 3, 2025 Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused clinical-stage biopharmaceutical company, reported a comprehensive update on its therapeutic pipeline. The Company detailed meaningful progress across HT-001, HT-KIT, HT-ALZ, and its newly launched GDNF-based metabolic program, while continuing to strengthen its global intellectual-property portfolio and expand strategic research partnerships.

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Pipeline Highlights

HT-001 (Topical Epidermal Growth Factor Inhibitor) – Phase 2 CLEER-001 Trial Advancing

Hoth continues to advance HT-001 in its Phase 2 CLEER-001 clinical trial targeting EGFR-inhibitor–associated rash, a significant unmet need in oncology supportive care.

Recent progress includes:

Strong safety profile to date with no dose-limiting toxicities observed.
Consistent improvement trends in rash severity and pruritus
Increased clinical-site engagement and favorable investigator feedback.
A further clinical update is anticipated in the coming months as enrollment continues to progress.

HT-KIT (Orphan Drug Designation for Mast Cell Diseases) – IND Preparation Underway

HT-KIT, Hoth’s targeted KIT-inhibitor program for mastocytosis and related mast-cell–driven diseases, continues to progress through IND-enabling activities.

Key accomplishments:

FDA Orphan Drug Designation already granted.
Compelling preclinical efficacy showing potent KIT inhibition and suppressed mast-cell activation.
IND-enabling toxicology studies moving toward completion.
Ongoing manufacturing scale-up and analytical characterization
Hoth expects to finalize its’ IND submission in 2026, followed by first-in-human studies.

HT-ALZ (Therapeutic for Alzheimer’s Disease) – Advancing Through GLP and PK Development.

HT-ALZ continues to deliver supportive data across absorption, distribution, and neuroinflammatory pathways.

Recent highlights:

GLP studies underway with positive PK, biodistribution, and CNS-penetration modeling
Regulatory-facing package expected to mature in 2026.
GDNF-Based Weight-Loss & Metabolic Program (VA Collaboration) – Newly Accelerated Initiative

Hoth’s newest program leverages GDNF (Glial-Derived Neurotrophic Factor) to target obesity, hepatic steatosis, and metabolic dysfunction, representing one of the largest and fastest-growing therapeutic markets globally.

Recent achievements:

Study preparations initiated with the Atlanta VA Medical Center
Mouse procurement completed; high-fat-diet regimen launches per approved VA protocols.
Aim 1 of the research program now underway, with early data expected in 2026.
Program supported by strong academic collaboration and growing IP protection.
Expanding Intellectual Property & Strategic Collaborations

Hoth continues to broaden its IP position through new filings and expanded protection around:

HT-001 dermatology and oncology-supportive-care mechanisms
HT-KIT mast-cell-disease formulations, methods, and manufacturing
HT-ALZ CNS-focused data and delivery systems
GDNF weight-loss and hepatic-function applications
The Company maintains collaborations with leading institutions, including the Atlanta VA Medical Center, academic neuroscience groups, and AI-assisted discovery platforms.

Upcoming Milestones

CLEER-001 Phase 2 HT-001 clinical data update
Completion of toxicology and IND filing for HT-KIT
GLP, BBB, and PK updates for HT-ALZ
VA metabolic program early findings
Management Commentary

Robb Knie, Chief Executive Officer of Hoth Therapeutics, commented:

"Our therapeutic pipeline has never been more focused or better positioned. With HT-001 advancing in the clinic, HT-KIT nearing IND submission, HT-ALZ progressing through GLP development, and our new GDNF program targeting one of the largest markets in medicine."

(Press release, Hoth Therapeutics, DEC 3, 2025, View Source [SID1234661114])

On December 3, 2025 ImmVira Group ("ImmVira" or the "Company") reported a poster presentation at the 26th Annual Meeting of the Society of Urologic Oncology (SUO 2025). The presentation featured the latest interim clinical data (as of September 19, 2025) for its lead HSV-1 oncolytic virus product. MVR-T3011, in high-risk BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) patients.

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The patients were enrolled and treated with intravesical MVR-T3011 at two dose levels: 2×109 PFU and 1×1010 PFU in this study. There were a total of 26 patients with papillary (16 patients at the dosage level of 2×109 PFU, 10 patients at the dosage level of 1×1010 PFU), and a total of 12 patients with carcinoma in situ (CIS) (7 patients at the dosage level of 2×109 PFU, 5 patients at the dosage level of 1×1010 PFU) enrolled in this trial. Data from the patients demonstrated a promising efficacy profile:

Among 16 evaluable patients with BCG-unresponsive papillary who received MVR-T3011 at a dose of 2×109 PFU, the 3-month, 6-month, 9-month and 12-month recurrence-free survival (RFS) rates were 87.1%, 80.4%, 80.4% and 71.4%, respectively. Among 6 evaluable patients who received MVR-T3011 at a dose of 1×1010 PFU, 100% of patients remained recurrence free at Month 3 and Month 6.
As of the same date, among 7 evaluable patients with BCG-unresponsive CIS (with or without Ta/T1) who received MVR-T3011 at doses of 2×109 PFU, the CR at any time, 3-month and 6-month CRR was 71.4%, and among 5 evaluable patients with BCG-unresponsive CIS (with or without Ta/T1) who received MVR-T3011 at doses of 1×1010 PFU, the CR at any time, 3-month and 6-month CRR was 100%.
Consistent with previous clinical findings, MVR-T3011 continued to demonstrate a favorable safety and tolerability profile in the latest study. Most treatment-emergent adverse events (TEAEs) were at Grades 1 or 2. Only five Grade 3 TEAEs were reported, two of which were treatment-related adverse events (TRAEs) and were consistent with reactions commonly associated with catheterization procedures. No Grade 3 or above TEAEs and no dose-limiting toxicities (DLT) occurred.

According to Frost & Sullivan, bladder cancer is one of the top 10 most common solid tumors globally by incidence and often requires prolonged treatment and surveillance spanning 5-10 years. NMIBC is a main type of bladder cancer, representing approximately 75% of all newly diagnosed bladder cancer cases. The current standard of care for high-risk NMIBC is Bacillus Calmette-Guerin (BCG). However, the availability of BCG is significantly limited by global supply shortages. In the U.S., BCG supply meets less than 30% of the total demand. These significant unmet medical needs highlight a clear opportunity for novel immunotherapies such as oncolytic viruses, which hold considerable potential as a new mechanism of action in this underserved market.

"We are highly encouraged by the interim efficacy data from the study, especially the high CR and RFS rate for both BCG-unresponsive CIS and papillary patients at 1×1010 PFU," said Dr. Grace Zhou, Chairwoman and CEO of ImmVira. "We have initiated a phase II trial for BCG-unresponsive high-risk NMIBC in the U.S. in June 2025 and are progressing a global multi-regional clinical trial (MRCT) inclusive of China. We believe MVR-T3011 could emerge as the new generation of therapy for patients with high-risk, BCG-unresponsive NMIBC."

About MVR-T3011

MVR-T3011, represents a breakthrough in HSV-1-based oncolytic immunotherapy. Its proprietary "3-in-1" design unites a replication-competent, tumor-lytic HSV-1 backbone with anti-PD-(L)1 antibody and IL-12, enabling it simultaneously to lyse tumor cells and stimulate innate and adaptive immunity. MVR-T3011 has demonstrated its adaptability and feasibility across multiple routes of administration including intratumoral, intracavitary and intravenous administrations. MVR-T3011 is the world’s first HSV-1-based oncolytic immunotherapy that has completed a phase I trial via systemic intravenous dosing under the FDA regulatory regime.

(Press release, Immvira, DEC 3, 2025, View Source [SID1234661113])

On December 3, 2025 TransThera Sciences Nanjing, Inc. (the "TransThera") reported that Tinengotinib tablets have been included in the List of Products for Priority Review by the Center for Drug Evaluation ("CDE") of the National Medical Products Administration ("NMPA") of the PRC, with the proposed indication for the treatment of adults with unresectable advanced or metastatic cholangiocarcinoma (CCA) who have received at least one prior systemic treatment and FGFR inhibitor treatment. Previously, Tinengotinib has been granted Breakthrough Therapy Designation by the NMPA for the treatment of CCA.

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Disclaimer: This article serves as a press release by TransThera to disclose the company’s latest developments. It is not intended as a product promotion advertisement and does not constitute the company’s investment advice.

About Tinengotinib

Tinengotinib is an internally discovered, registrational clinical stage, multi-kinase inhibitor that exerts antitumor effects by targeting FGFRs/VEGFRs, Aurora kinases and Janus kinases (JAK). Ongoing clinical trials in the US and China have revealed the potential of Tinengotinib to be efficacious in various solid tumors. It was granted the Orphan Drug Designation (ODD) and Fast Track Designation (FTD) by the FDA for the treatment of CCA, the Breakthrough Therapy Designation (BTD) by the NMPA in China, the Orphan Drug Designation (ODD) for the treatment of biliary tract cancer by the EMA.

(Press release, TransThera Biosciences, DEC 3, 2025, View Source [SID1234661112])