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Acuitas Therapeutics Unveils Next-Generation Lipid Nanoparticle Advancements at the 2025 mRNA Health Conference

On November 17, 2025 Acuitas Therapeutics, a global leader in lipid nanoparticle (LNP) delivery systems for the acceleration of partners’ clinical development, reported its Next-Generation LNP advancements, a suite of novel and enhanced technologies that expand the range of diseases treatable with mRNA-LNP medicines, at the 13th International mRNA Health Conference in Berlin. Also at the conference, the company highlighted additional preclinical data on its LNP formulations’ applicability in cancer vaccines, potency, and safety.

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"Commercial validation of our technology has provided both an important milestone of success and the impetus for continued advancement," said Dr. Thomas Madden, CEO of Acuitas Therapeutics. "Our research, presented at the mRNA Health Conference, is focused on two key goals: expanding the application of our technology into new therapeutic areas and enhancing the potency and safety of the platform itself, with novel LNP formulations and various improvement strategies. Underpinning both is our commitment to improving the translatability of preclinical data, which is essential for accelerating the journey of mRNA and personalized therapies from the laboratory bench to the clinic."

Next-Generation LNP for mRNA-based Therapeutics

At the conference, Acuitas’ Chief Scientific Officer, Dr. Ying Tam, showcased the company’s Next-Generation LNP advancements, a comprehensive approach that uses multiple technologies and strategies to improve all aspects of LNP utility and applicability – from potency, safety, extrahepatic targeting, to manufacturing.

The advancements were featured in an oral presentation titled "Next-Generation Lipid Nanoparticles for Clinical Development of mRNA-based Therapeutics." The presentation detailed Acuitas’ efforts in advancing mRNA-LNP beyond current clinical standards and broadening the range of diseases these therapies can treat. Key highlights of the presentation include:

Novel LNP candidates engineered for significantly improved potency, as high as a four-fold increase for some cases, in gene editing and vaccine applications.
Optimized lipid structures reduced liver exposure, leading to increased tolerability, lowered liver enzymes, while preserving therapeutic activity in mice.
DARPin-conjugated LNP candidates that achieved highly targeted delivery to immune cells (T-lymphocytes), with a long-circulating format further enhancing uptake efficiency and expression levels.
Mucous penetrant mRNA-LNP candidates capable of extrahepatic delivery to airway epithelial cells in cystic fibrosis lung models, enabling effective gene editing compared to control LNP.
An alternative LNP manufacturing approach, called pre-formed vesicles (PFV), with equivalent potency to standard benchmark manufacturing methods, offered significant improvements in cost, storage, distribution, and flexibility of LNP manufacturing, especially for personalized mRNA-LNP therapies.
Additional Posters Presented

In addition to its lead presentation, Acuitas also showcased three posters that elucidated the mechanics of LNP delivery and assessed its existing slate of lipids, as well as explored novel options for future formulations.

Applying Clinically Approved ALC-315 in Cancer Vaccines

Acuitas’ ALC-315 ionizable lipid — used in the Pfizer-BioNTech COVID-19 vaccine (COMIRNATY) — was assessed for its cancer vaccine development potential. The research directly compared Acuitas’ LNP to lipoplexes and evaluated modified mRNA against the unmodified mRNA predominantly used in current cancer vaccine trials. Key highlights of this data include:

Using LNP comprised of ALC-315, unmodified RNA induced a stronger antigen-specific CD8 T-cell response compared to a nucleoside-modified mRNA incorporating N1methylpseudouridine-encoding OVA payload as a model tumour antigen, while maintaining strong immunogenicity at one-tenth of the initially tested dose.
Using LNP comprised of ALC-315, mRNA delivered intramuscularly induced equal or superior cellular and humoral immunity compared to intravenously (IV) administered mRNA lipoplexes – an alternative mRNA cancer vaccine format in clinical development – despite mRNA lipoplexes being administered at four-fold higher doses and with more boosts.
Several potent novel proprietary lipids were identified that achieved equivalent cellular responses to ALC-315. Further assessment will be conducted to compare potency and activity using syngeneic neoantigen models.
Novel Lipids with Improved Activity for Prophylactic Vaccine Development

Acuitas identified and validated six novel lipids that induce higher virus-specific immunogenicity compared to ALC-315. Key findings related to these novel lipids include:

The six novel lipid candidates induced equivalent neutralizing antibody titres at a five-fold lower dose than ALC-315.
The lipid candidates demonstrated favorable reactogenicity profiles comparable to ALC-315, while eliciting stronger cellular- and B-cell responses.
Innate immune responses induced by LNP correlated with their reactogenicity, but not with adaptive and innate immune responses.
Several lipid candidates achieved higher in vivo expression in secondary lymphoid organs and reduced liver expression compared to ALC-315.
Impact of Body Weight and Medications on mRNA-LNP Safety in Monkeys

As the industry continues using larger nonhuman primates in translational work, Acuitas sought to understand how body weight, premedications (steroid, H1 and H2 blockers), and concomitant medications (meloxicam) impact LNP activity and tolerability. The study was conducted in monkeys using an IV-administered mRNA-LNP encoding human IgG. Key highlights of this data include:

LNP tolerability is reduced in larger monkeys (>6 kg).
Premedications helped reduce the elevation of liver transaminases.
Premedications improved tolerability but reduced the level of IgG mRNA expression.
Platelet count decreases were greatest in large monkeys and monkeys given meloxicam.
More information on posters presented at the mRNA Health Conference and Vaccine R&D Conference can be found here.

(Press release, Acuitas Therapeutics, NOV 17, 2025, View Source [SID1234660039])

Anixa Biosciences Announces World Health Organization (WHO) Approval of International Non-Proprietary Name for its CAR-T Therapy, Marking a Key Milestone Toward Global Recognition and Future Commercialization

On November 17, 2025 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that the International Nonproprietary Names (INN) Expert Committee of the World Health Organization (WHO) approved "liraltagene autoleucel" for the non-proprietary name of the Company’s novel FSHR-targeted CAR-T therapy for recurrent ovarian cancer. The INN nomenclature scheme for CAR-T cell therapies follows a two-word structure describing the gene and cell component.

"The assignment of the non-proprietary name represents an important step in the development and potential future commercialization of our CAR-T therapy. The INN naming process meticulously evaluates proposed drug names for adherence to nomenclature guidelines and potential conflicts, followed by expert consensus and public review. With this INN approval, we have the ability to establish a universally recognized and conflict-free non-proprietary drug name for our CAR-T therapy," said Dr. Amit Kumar, Chairman and CEO of Anixa. "Looking ahead, we remain focused on the successful execution of our ongoing Phase 1 trial of liraltagene autoleucel for the treatment of ovarian cancer, and look forward to commencing the 5th dose cohort in the coming weeks. The Phase 1 study is being conducted in partnership with Moffitt Cancer Center."

Each INN name is unique and is used to identify active pharmaceutical ingredients. Each active substance that is to be marketed as a pharmaceutical must be granted a unique name of worldwide acceptability to ensure the clear identification, safe prescription and dispensing of medicines to patients. Anixa will transition to the use of liraltagene autoleucel, or lira-cel, in future communications.

Jose R. Conejo-Garcia, M.D., Ph.D., Professor of Immunology in the Department of Integrative Immunobiology at the Duke University School of Medicine and the co-inventor of Anixa’s CAR-T technology, stated, "It is gratifying to see this technology advance under Anixa’s guidance and through the work being performed at Moffitt Cancer Center. Receiving its non-proprietary name from the WHO is an exciting step in the process toward commercialization of this technology."

About liraltagene autoleucel
Liraltagene autoleucel, or lira-cel, is a follicle stimulating hormone receptor (FSHR)-mediated chimeric antigen receptor-T cell (CAR-T) technology that targets FSHR, which is exclusively expressed on normal ovarian cells, tumor vasculature, and certain cancer cells. Since the target is a hormone (chimeric endocrine) receptor, and the target-binding domain is derived from its natural ligand, this technology is also known as CER-T (chimeric endocrine receptor-T cell) therapy, a new type of CAR-T. Liraltagene autoleucel is currently being evaluated in a first-in-human trial (NCT05316129) that is enrolling adult women with recurrent ovarian cancer who have progressed after at least two prior therapies. The study is designed to evaluate safety, identify the maximum tolerated dose, and monitor clinical activity. Lira-cel is based on technology exclusively licensed to Anixa by The Wistar Institute.

(Press release, Anixa Biosciences, NOV 17, 2025, View Source [SID1234660038])

Accession Therapeutics doses first patient in Phase 1 clinical trial of TROCEPT-01 (ATTR-01), a novel cancer immunotherapy

On November 17, 2025 Accession Therapeutics Limited, a biopharmaceutical company developing next generation cancer immunotherapies, reported it has dosed the first patient in its Phase I clinical trial evaluating TROCEPT-01 (ATTR-01), the company’s lead drug candidate from its proprietary TROCEPT platform technology. The patient has now completed the cycle of treatment. This milestone marks a major step forward in the development of a potentially transformative treatment for solid tumours.

TROCEPT-01 (ATTR-01) is a first-in-class, tumour-activated viral immunotherapy that, following systemic delivery, is designed to selectively generate a clinically validated checkpoint inhibitor within tumours. This approach, targeting αvβ6 integrin on epithelial tumours, optimises efficacy while minimising damage to healthy tissue. Preclinical studies have demonstrated strong anti-tumour activity across multiple solid tumour models, supporting its potential as a targeted therapy for aggressive cancers.

The ATTEST trial is an open label, dose-escalation and dose expansion study (View Source) designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of TROCEPT-01 (ATTR-01) in patients with advanced carcinomas who have had at least one prior treatment course. The trial is being conducted at leading clinical sites across the UK. Additional trial sites will be activated as the study progresses, including in Spain where there is established expertise in the treatment of solid tumours.

Professor Adel Samson, Professor of Cancer Medicine and Immunotherapy at Leeds University School of Medicine and lead Investigator in the ATTEST study, said:
"As a clinician, I am very excited about the potential of TROCEPT-01 (ATTR-01) and the TROCEPT platform to increase clinical response rates through high tumour-localised production of anti-cancer drugs. This program is targeted at solid tumours where there is significant need for better treatment outcomes".

Bent Jakobsen, PhD FMedSci, CEO of Accession Therapeutics, said:
"Dosing the first patient in our TROCEPT-01 clinical trial is a pivotal moment for Accession Therapeutics and a testament to the dedication of our team and collaborators. In TROCEPT, we have created a unique, highly versatile platform that enables novel drugs to be made inside cancer cells. The platform gives us multiple opportunities to generate valuable products to transform outcomes for cancer patients. TROCEPT-01 (ATTR-01) has the potential to expand the indications where checkpoint inhibitors have been successful."

Professor Hardev Pandha, FRCP, FRACP, PhD, Medical Director of Accession Therapeutics, added:
"TROCEPT-01 (ATTR-01) represents a novel approach to target hard-to-treat cancers, and we are excited to advance this promising therapy into clinical development. We anticipate the clinical data will show that the virus gets to the tumours when given systemically, and that the drug is produced within the tumours. Our goal in the ATTEST study is to establish a strong safety profile while identifying early signals of efficacy to benefit patients with limited treatment options."

(Press release, Accession Therapeutics, NOV 17, 2025, View Source [SID1234660037])

Biotheryx Announces Completion of Enrollment in Phase 1a Clinical Trial of BTX-9341 for the Treatment HR+/HER2- Breast Cancer

On November 17, 2025 Biotheryx, Inc., a biopharmaceutical company focused on the discovery and development of first-in-class protein degraders for cancer and inflammatory diseases, reported the completion of enrollment in the ongoing Phase 1a clinical trial of BTX-9341, a potent and selective CDK4/6 degrader, for the treatment of advanced and/or metastatic HR+/HER2- breast cancer in patients who have previously received CDK4/6 inhibitor therapy either in the adjuvant or metastatic setting.

The Phase 1a clinical trial began with dose escalation of BTX-9341 as a monotherapy, followed by a combination with fulvestrant. The primary objective of the Phase 1a trial is to assess safety, tolerability, pharmacokinetic and pharmacodynamic activity of BTX-9341 as a monotherapy and in combination with fulvestrant. Based on the recommended dose from Phase 1a, there will be a formal evaluation of efficacy in the dose expansion phase of the trial.

"Completing enrollment in the Phase 1a trial for BTX-9341 marks a significant step forward in advancing a very promising first-in-class treatment option for patients with HR+/HER2- breast cancer who have received prior CDK4/6 inhibitor therapy." said Dr. Leah Fung, Chief Executive Officer of Biotheryx. "We are deeply grateful to the patients, investigators, and our team who made this possible as we continue to work together towards the common goal of improving patient lives."

About BTX-9341

BTX-9341 is a first-in-class, oral degrader of CDK4/6, important targets for a range of cancers and clinically validated in HR+/HER2- breast cancer. In preclinical breast cancer models, BTX-9341 demonstrated superiority to CDK4/6 inhibitors through potent and highly selective catalytic degradation of CDK4 and CDK6, robust inhibition of Cyclin E and CDK2 transcription, cell cycle arrest and ultimately superior in vivo efficacy in breast cancer xenografts. Beyond this increased efficacy potential, BTX-9341 is differentiated from CDK4/6 inhibitor approaches through the ability to overcome key resistance mechanisms that limit the impact of inhibitors in second line HR+/HER2- breast cancer.

(Press release, BioTheryX, NOV 17, 2025, View Source;breast-cancer-302616179.html [SID1234660036])

Lunit and Labcorp Announce Strategic Collaboration to Advance AI-Powered Digital Pathology Research

On November 17, 2025 Lunit, a leading provider of AI for cancer diagnostics and precision oncology, and Labcorp, a global leader of innovative and comprehensive laboratory services, reported a collaborative initiative to accelerate innovation in digital pathology (DP) and artificial intelligence (AI) for oncology research and clinical care.

The collaboration aims to leverage Labcorp’s extensive clinical and pathology expertise alongside Lunit’s cutting-edge AI algorithms to transform how tumor microenvironments are analyzed and interpreted. By combining high-resolution whole-slide imaging with AI-powered spatial profiling, the collaboration seeks to generate new insights that can enhance biomarker discovery and guide precision immuno-oncology strategies.

First Collaborative Studies Presented at SITC (Free SITC Whitepaper) and AMP

The first outcome of the collaboration was showcased at two leading scientific conferences:

Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper): Study demonstrated how AI-based spatial profiling and machine learning can identify immune-active subtypes of non-small cell lung cancer (NSCLC) tumors with the MET exon 14 skipping mutation, which are associated with improved immunotherapy outcomes. Using Lunit SCOPE IO, researchers analyzed more than 370 pathology slides to characterize immune phenotypes across different types of MET alterations, including exon 14 skipping, amplification, or no mutation (wildtype). Immune gene expression analysis further validated the AI-defined immune phenotypes and revealed key immune response pathways driving the inflamed phenotype, underscoring the predictive power of AI-based spatial profiling in MET-mutated NSCLC.
Association for Molecular Pathology (AMP): Study highlighted distinct tumor-immune microenvironments linked to different MET alterations in NSCLC, revealing immune-desert phenotypes in MET-amplified tumors, and inflamed phenotypes in those with MET exon 14 skipping tumors.
"Collaborating with Labcorp, one of the most respected leaders in diagnostics and clinical research, marks an important step toward expanding the real-world use of AI in oncology. These early studies show how AI can reveal meaningful, predictive biomarkers hidden within pathology slides," said Brandon Suh, CEO of Lunit. "It’s a clear example of how digital pathology and AI can work hand in hand to advance precision oncology understanding, bridging discovery research and real-world clinical care."

"Our collaboration with Lunit aims to turn complex pathology data into meaningful insights," said Shakti Ramkissoon, M.D., Ph.D., MBA, vice president and medical lead for oncology at Labcorp. "These studies demonstrate how AI-powered digital pathology can reveal patterns within tumors—ultimately helping to guide treatment decisions, inform biomarker development, and pave the way for more personalized cancer care."

Labcorp and Lunit plan to further broaden their collaboration by applying digital pathology AI to additional cancer types and genomic correlations.

(Press release, LabCorp, NOV 17, 2025, View Source [SID1234660035])