On October 16, 2024 Matica Biotechnology, a leading Texas-based viral vector Contract Development and Manufacturing Organization (CDMO), reported a strategic partnership with the innovative biotech company, Mongoose Bio (Press release, Mongoose Bio, OCT 16, 2024, View Source [SID1234647239]). This partnership is focused on the full development and production of lentivirus for Mongoose Bio’s T cell receptor-engineered T cell (TCR-T) pipeline for cancer treatment.

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Under the terms of the agreement, Matica Bio will provide comprehensive services, including process development, analytical method development, and the manufacturing of non-clinical and clinical materials of the viral vector. The produced lentivirus vector will be used as an intermediate product in the manufacturing of the final TCR-T cell therapy.

This partnership holds significant meaning for Matica Bio, as it highlights Matica Bio’s role as a key CDMO player in Texas. By forming collaborative models with local biotech companies, hospitals, and institutions, Matica Bio is cementing its position as a leading partner in the region’s growing bio-ecosystem. Its strategic location further enhances opportunities for partnerships with innovative biotech companies in the growing Texas biocluster.

"We are honored to collaborate with a team that shares our dedication to improving patient outcomes and advancing the frontiers of cancer treatment," said Paul Kim, CEO of Matica Bio.

"We are pleased to be working with Matica Bio on viral vector manufacturing to advance our novel TCR-T therapies into the clinic," said Neil Warma, President and CEO of Mongoose Bio. "Our novel technology is based on over 20 years of research and development expertise and an extensive patent portfolio. It is particularly meaningful to collaborate with leading CDMOs, like Matica Bio, hospitals, and development companies in our goal of conducting global clinical trials to bring our cancer treatments to patients worldwide."

This partnership marks a significant step forward in the development of TCR-T cell therapies and reflects the strength of Texas’s growing biotech ecosystem.

On October 16, 2024 Remix Therapeutics (Remix), a clinical-stage biotechnology company developing small molecule therapies to modulate RNA processing and address underlying drivers of disease, reported that it will deliver a poster presentation demonstrating the therapeutic potential of REM-422, a potent, selective, oral small molecule MYB mRNA degrader for the treatment of acute myeloid leukemia (AML) and adenoid cystic carcinoma (ACC), at the upcoming 2024 EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics being held on October 23-25, 2024 in Barcelona, Spain (Press release, Remix Therapeutics, OCT 16, 2024, View Source [SID1234647238]).

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MYB is an oncogenic transcription factor that is dysregulated in human malignancies including ACC, where the majority of tumors contain a hallmark t(6:9) rearrangement resulting in a MYB::NFIB fusion oncogene. The poster presentation will include preclinical data from biophysical and cellular assays that demonstrate the mechanism of action of REM-422 in suppressing MYB mRNA and protein expression by promoting inclusion of a poison exon into the MYB mRNA transcript. In vivo studies in ACC patient-derived xenograft (PDX) mouse models harboring the MYB::NFIB fusion demonstrates that REM-422 induces tumor regressions, including in models that harbor co-occurring mutations in the Notch pathway, a profile that represents especially aggressive clinical cases of ACC. Anti-tumor activity of REM-422 in these models is associated with a reversal of gene transcriptional programs that are associated with ACC, as assessed by genome-wide RNAseq experiments.

"We’ve built an exciting package of preclinical data across various models that reinforces the therapeutic potential of REM-422 for the treatment of ACC and other MYB-dysregulated cancers," said Peter Smith, Ph.D., Co-Founder and Chief Executive Officer of Remix Therapeutics. "The preclinical data demonstrated that REM-422 monotherapy treatment leads to tumor regressions in PDX models of ACC and support clinical development in ACC patients."

REM-422 is currently being investigated as a potential treatment for adenoid cystic carcinoma (ACC) and AML/HR-MDS (High-Risk Myelodysplastic Syndromes) in two, phase 1 clinical trials.

Details for the poster presentation are as follows:

Title: REM-422, a potent, selective, oral small molecule mRNA degrader of the MYB oncogene, induces regressions in mouse patient-derived xenograft models of adenoid cystic carcinoma
Authors: M. Cameron1, S. Levin-Furtney1, A. Harney1, M. Thomas1, J. Maag1, B. Dunyak1, M. Shan1, S. Prajapati1, Y.A. Siu1, D. Nguyen1, S. Buonamici1, M. Seiler1, F. Vaillancourt1, P. Smith1, D. Reynolds1, C. Kung1.

1Remix Therapeutics, Research, Watertown, USA.

Abstract Number: ENA24-0468
Session Date and Time: Wednesday, October 23, 2024 (11:00 AM – 8:00 PM)
Session Location: CCIB Exhibition Hall poster area, Barcelona, Spain

About REM-422

REM-422 is a first-in-class, potent, selective, and oral small molecule mRNA degrader that induces the reduction of MYB mRNA and subsequent protein expression. REM-422 functions by facilitating the incorporation of poison exons within the mRNA transcript, leading to nonsense-mediated decay (NMD) of the transcript. REM-422 addresses MYB dysregulation, a driver of oncogenesis, upstream of protein expression.

About ACC

Adenoid cystic carcinoma (ACC) is a rare cancer that commonly develops in glandular tissues in the head and neck. It is caused by genetic mutations, likely developed over a patient’s lifetime, with the majority of ACC cases linked to an overexpression of the MYB protein. Current treatment solutions include surgery, radiation therapy, and chemotherapy.

About AML/HR-MDS

Acute myeloid leukemia (AML), a rare cancer of the blood and bone marrow, is the most common type of acute leukemia in adults. AML is caused by genetic mutations within bone marrow cells, which in turn causes the production of leukemic white blood cells that crowd out healthy blood cells. This may cause problems with bleeding, infection, and anemia. Myelodysplastic Syndromes (MDS) are disorders of blood-forming units in the bone marrow. High-risk (HR)-MDS patients have a higher percentage of blast cells in the bone marrow and that, in many cases, progresses to AML. There are several approved agents to treat AML, however, many patients relapse after achieving a response, underscoring the need for new therapies.

On October 16, 2024 Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) reported thirteen abstract presentations featuring the Company’s ongoing theranostic development, medical technologies (MedTech), and research and innovation (R&I) programs at the 37th Annual Congress of the European Association of Nuclear Medicine (EANM) to be held in Hamburg from 19 – 23 October 2024 (Press release, Telix Pharmaceuticals, OCT 16, 2024, View Source [SID1234647237]).

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Telix’s extensive theranostic pipeline will be showcased in presentations covering: TLX250-CDx (Zircaix[1], 89Zr-girentuximab) kidney cancer imaging, including first real-world clinical experience; TLX101 (131I-iodofalan or 131I-IPA) glioblastoma therapy; TLX66 (90Y-besilesomab) bone marrow conditioning therapy; TLX252 (225Ac-girentuximab) carbonic anhydrase IX (CAIX)-targeted alpha therapy; and SENSEI, Lightpoint’s robotic-assisted gamma probe.

Dr. David N. Cade, Telix Group Chief Medical Officer, said, "We are pleased to be able to so comprehensively showcase our pipeline at EANM – the largest gathering of nuclear medicine professionals worldwide – with a sponsored symposium, and abstracts accepted across Telix’s late-stage theranostic programs in kidney and brain cancers, and in bone marrow conditioning. As in previous years, it is an honour for us to support the EANM Sanjiv Sam Gambhir Young Investigator Award. This is an exciting opportunity for a junior physician or scientist to further develop their career in radiopharmaceuticals, in memory of an extraordinary man and an inspiring educator."

We look forward to seeing delegates at Telix’s booth in Hall H, Stand H29 to discuss Telix’s industry leading theranostic pipeline in urologic oncology (prostate, kidney and bladder cancers), neuro-oncology (glioma), musculoskeletal oncology (sarcoma) and hematology, our associated medical devices, and opportunities for collaboration.

EANM presentation details are as follows:

Sponsored Symposium: Does size matter in targeted radionuclide therapies?

Chairperson: Professor Viktor Grünwald, University Hospital Essen, Essen, Germany.

Why size matters: The relative benefits of antibodies vs. small molecules in oncology
Prof. Arturo Chiti, IRCCS San Raffaele Hospital, Milan, Italy
When small may be smart: The role of small molecules in neuro-oncology
Prof. Nathalie Albert, Ludwig-Maximilian’s-University of Munich, Munich, Germany
Where big may be best: The power of antibodies in onco-hematology
Prof. Stefano Fanti, University of Bologna, Bologna, Italy
How size will shape the future: The choice between antibodies and small molecules in uro-oncology
Prof. Karolien Goffin, University Hospital Leuven, Leuven, Belgium
Date & Time: Sunday, 20 October, 2024, 13:15 – 14:45 CEST
Location: Hall G1, Congress Center Hamburg
Abstract presentations

Title: Unravelling radiobiological and immunological mechanisms driving effective CAIX-TRT and ICI combination therapy
Presenter: S. Kleinendorst, RadboudUMC, Netherlands
Date and Time: 20-Oct-24, 08:00 – 09:30
Session: Cutting Edge Science Track – TROP Session: Dosimetry Committee: Preclinic and Radiobiology
Format: Oral
Location: Hall Y4-Y9
Presentation ID: OP-022

Title: Accuracy of personalised single time point dosimetry for bone marrow and liver dosimetry in TLX66 (90Y-Anti CD66) radioimmunotherapy
Presenter: A. Nautiyal, University Hospital Southampton, United Kingdom
Date and Time: 20-Oct-24, 15:00 – 16:30
Session: Cutting Edge Science Track – TROP Session: Dosimetry Committee: Dosimetry: A Question of Time
Format: Oral
Location: Hall Y4-Y9
Presentation ID: OP-158

Title: Tumour margin thickness inference for 99mTc radio-guided surgery using internal conversion electrons
Presenter: J. Moo, Telix
Date and Time: 21-Oct-24, 08:00 – 09:30
Session: Cutting Edge Science Track – TROP Session: Physics Committee: Data Corrections / Image Enhancement
Format: Oral
Location: Hall Y4-Y9
Presentation ID: OP-289

Title: Radiation protection considerations with TLX250-CDx (89Zr-girentuximab) PET/CT experience in France
Presenter: C. Morgat, Department of Nuclear Medicine, University Hospital of Bordeaux, France
Date and Time: 21-Oct-24, 15:00 – 16:30
Session: TROP Session: Radiation Protection Committee: Radiation Protection in Diagnostic Imaging Procedures
Format: Oral
Location: Hall Y1-Y3
Presentation ID: OP-452

Title: Correlation of tracer uptake in sentinel lymph nodes as measured on SPECT/CT and during intraoperative gamma tracing with the SENSEI drop in gamma probe: the UZ Leuven experience
Presenter: M. Manley, Nuclear Medicine, University Hospitals Leuven, Belgium
Date and Time: 22-Oct-24, 08:00 – 09:30
Session: Cutting Edge Science Track – TROP Session: Physics Committee: SPECT/CT Quantification
Format: Oral
Location: Hall Y4-Y9
Presentation ID: OP-543

Title: Development of 161Tb-DOTA-HYNIC-panPSMA for targeted radionuclide therapy of prostate Cancer
Presenter: C. Morgat, Department of Nuclear Medicine, University Hospital of Bordeaux, France
Date and Time: 22-Oct-24, 08:00 – 09:30
Session: M2M Track – TROP Session: Radiopharmaceutical Sciences + Translational Molecular Imaging & Therapy Committee: From Radionuclide to Clinical Translation
Format: Oral
Location: Hall X1-X4
Presentation ID: OP-532

Title: Feasibility and tolerability of TLX101 (¹³¹I-IPA) monotherapy in progressive and recurrent high grade gliomas; an ongoing single institution case series
Presenter: N. Tolboom, University Medical Centre Utrecht, Netherlands
Date and Time: 22-Oct-24, 16:45 – 18:15
Session: TROP Session: Neuroimaging Committee: Neuro-Oncology
Format: Oral
Location: Hall Y10-Y12
Presentation ID: OP-758

Title: The emerging role of TLX250-CDx (89Zr-girentuximab) PET/CT in accurate characterisation and staging of ccRCC: early experience with three patients
Presenter: F. Gelardi, Università Vita-Salute San Raffaele, Italy
Date and Time: 23-Oct-24, 08:00 – 09:30
Session: TROP Session: Case Report Session 2: You Won’t Believe the Things I’ve Seen!
Format: Oral
Location: Hall Y1-Y3
Presentation ID: OP-824

Title: Development of girentuximab as a theranostic tool in non-renal indications
Presenter: A. Ivashkevich, Telix
Date and Time: 23-Oct-24, 08:00 – 09:30
Session: e-Poster Presentations Session 13: Translational Molecular Imaging & Therapy Committee: Molecular Imaging & Therapy
Format: Oral ePoster
Location: Hall F
Presentation ID: EPS-270

Title: Preclinical evaluation of DNA damage response inhibitors and TLX252 (225Ac-DOTA-girentuximab) combination therapy
Presenter: Z. Cao, Olivia Newton-John Cancer Research Institute, Australia
Date and Time: 23-Oct-24, 08:00 – 09:30
Session: e-Poster Presentations Session 13: Translational Molecular Imaging & Therapy Committee: Molecular Imaging & Therapy
Format: Oral ePoster
Location: Hall F
Presentation ID: EPS-269

Title: Development of Kit-Composition for the Preparation of 99mTc-PSMA-GCK01 / RHN001-Dx
Presenter: J. Cardinale, University Hospital Duesseldorf, Germany
Session: D: Technical Studies -> D5 Radiopharmacy/Radiochemistry -> D57 Radiopharmaceutical Preparation and Quality Control
Format: e-Poster
Location: e-Poster Area
Presentation ID: EP-1037

Title: Development of 18F-labelled lactate for oxidative cancer imaging
Presenter: M. da Silva Morais, Pole of Pharmacology, Institut de Recherche Expérimentale et Clinique (IREC), Université catholique de Louvain (UCLouvain), Belgium
Session: D: Technical Studies -> D5 Radiopharmacy/Radiochemistry -> D55 Radiopharmacokinetics and Drug Development
Format: e-Poster
Location: e-Poster Area
Presentation ID: EP-1010

Title: Radiolabelling DOTA-HYNIC-panPSMA with actinium-225 for in vivo studies
Presenter: K. Attia, Telix
Session: D: Technical Studies -> D5 Radiopharmacy/Radiochemistry -> D53 New Radiopharmaceuticals – Therapy
Format: e-Poster
Location: e-Poster Area
Presentation ID: EP-0985

On October 16, 2024 Akeso Biopharma (9926.HK) (" Akeso", the "Company" ) reported positive results in progression-free survival (PFS) and overall survival (OS) from its Phase 3 clinical study (COMPASSION-16/AK104-303). This study evaluated the efficacy of its independently developed PD-1/CTLA-4 bispecific antibody, 开坦尼 (cadonilimab), in combination with or without platinum-based chemotherapy and bevacizumab, compared to placebo with platinum-based chemotherapy and bevacizumab for first-line treatment of persistent, recurrent, or metastatic cervical cancer (Press release, Akeso Biopharma, OCT 16, 2024, View Source [SID1234647236]). These findings were presented as a Late-Breaking Abstract (LBA) in an oral session at the 2024 annual global meeting of the International Gynecologic Cancer Society (IGCS 2024).

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The principal investigator of the study, Professor Wu Xiaohua from the Fudan University-affiliated Cancer Hospital, presented the results in an oral report, sharing these remarkable outcomes with global experts in gynecological oncology. Concurrently, the findings of the COMPASSION-16 study have been published in the medical journal The Lancet. This also highlights the study’s pivotal role in advancing the frontiers of international clinical cancer research and its potential role in cervical treatment options.

The COMPASSION-16 study shows that the cadonilimab regimen, with or without bevacizumab, demonstrates promising efficacy in treating persistent, recurrent, or metastatic cervical cancer, addressing a critical unmet need for patients without access to bevacizumab. Additionally, cadonilimab offers significant benefits for all patients, regardless of PD-L1 expression status. This study highlights the clinical value and commercialization potential of cadonilimab to advance standard treatment for advanced cervical cancer.

The primary endpoints of the COMPASSION-16 study were progression-free survival (PFS) and overall survival (OS) assessed by independent central imaging review (BICR) based on RECIST v1.1 criteria. A total of 445 patients were enrolled in the COMPASSION-16 study, with 27.9% of patients in the cadonilimab combined with chemotherapy ± bevacizumab treatment group having a CPS < 1, compared to 24.2% in the control group.

The study results indicate that the cadonilimab regimen significantly prolonged survival in the overall population, substantially decreasing the risk of disease progression and the risk of death.

In the intention-to-treat (ITT) population, the median overall survival (OS) for the cadonilimab regimen has not yet been reached, while the control group exhibited a median OS of 22.8 months (the hazard ratio [HR] 0.64, P=0.0011). The 12-month OS rates were 83.1% for the cadonilimab group compared to 73.7% for the control group, and the 24-month OS rates were 62.6% and 48.4%, respectively.
In the ITT population, the median progression-free survival (PFS) for the cadonilimab regimen was 12.7 months, compared to 8.1 months in the control group (HR 0.62, P<0.0001). The 12-month PFS rates were 51.1% and 35% , respectively. As the follow-up time extended (as of April 30, 2024), the benefits of the cadonilimab regimen became increasingly evident, with updated median PFS rates of 13.3 months and 8.2 months (HR 0.62).
Regardless of whether it is combined with bevacizumab, the cadonilimab regimen shows a significant improvement in overall survival (OS).

In the absence of bevacizumab, the cadonilimab regimen is associated with a 50% reduction in the risk of death compared to the control group (OS HR 0.5), thereby effectively addressing the clinical need for patients who are ineligible for bevacizumab.
Regardless of PD-L1 expression levels, cadonilimab regimen significantly reduces the risk across the entire patient population.

In the CPS < 1 cohort, the cadonilimab regimen was associated with a 23% reduction in the risk of death (OS HR 0.77). In the CPS ≥ 1 cohort, there was a 31% reduction in the risk of death.(OS HR 0.69). Notably, in the CPS ≥ 10 cohort, the regimen led to a 32% reduction in the risk of death (OS HR 0.68).
The cadonilimab regimen exhibits a high and sustained antitumor response.

The objective response rate (ORR) for the cadonilimab group was 82.9%, compared to 68.6% in the control group. The complete response (CR) rates were 35.6% and 22.9%, respectively. The median duration of response (DOR) was 13.2 months in the cadonilimab group, compared to 8.2 months in the control group.
The combination of cadonilimab with chemotherapy ± bevacizumab has a manageable safety profile, with no new safety signals identified.

On October 16, 2024 Pillar Biosciences, Inc., the leader in Decision Medicine, reported an expansion of their existing partnership with Illumina, through which a broader portfolio of Pillar’s oncoReveal NGS panels will now be offered directly by Illumina (Press release, Pillar Biosciences, OCT 16, 2024, View Source [SID1234647235]). Several of Pillar’s oncology panels will be available as part of the validated libraries on the MiSeq i100 Series sequencing platform, which launched last week.

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The additional research-use-only (RUO) oncology NGS panels manufactured by Pillar Biosciences and available directly through Illumina will include:

Liquid Biopsy Tumor Profiling:

oncoReveal Core LBx
oncoReveal Essential LBx
oncoReveal Fusion LBx
Solid Tumor Profiling:

oncoReveal Multicancer RNA Fusion (18-Driver gene RNA panel)
oncoReveal Solid Tumor v2 (48-gene DNA panel)
These panels are enabled on the MiSeq and NextSeq 550 Systems. Pillar Biosciences panels that are enabled on the newly launched Illumina MiSeq i100 Series include:

oncoReveal Essential MPN
oncoReveal Myeloid
oncoReveal Multi-Cancer with CNV and Fusion Panel
oncoReveal BRCA1 & BRCA2 plus CNV Panel
"As part of Illumina’s commitment to address our customers’ total workflow, we are pleased to bring more oncology assays from Pillar Biosciences into our product lineup, including the new MiSeq i100 Series," said Angela Ryan, Vice President, Product Management at Illumina.

"We are excited about the commercial progress generated through our collaboration with Illumina over the past 18 months. By expanding their oncology offering with rapid, high-quality targeted genomic content we can ensure more customers have a full suite of NGS solutions to fulfill their genomic profiling needs," said Dan Harma, Chief Commercial Officer at Pillar Biosciences. "Pillar and Illumina’s NGS solutions are complementary and have very specific technical benefits. These can be utilized together efficiently. We look forward to working together to better enable our customers and further driving localized NGS services."