On August 20, 2024 Adcendo ApS ("Adcendo") and Multitude Therapeutics Inc. ("Multitude") jointly reported that they have signed a licensing agreement for the development of a novel, highly differentiated antibody-drug conjugate (ADC) targeting Tissue Factor (TF) with the development code ADCE-T02 (Press release, ADCendo, AUG 20, 2024, View Source [SID1234646018]). Under this agreement, Adcendo will obtain the exclusive development and commercialization rights for the asset globally, except for the Greater China region (Mainland China, Hong Kong Special Administrative Region, Macao Special Administrative Region, and Taiwan) where Multitude will retain development and commercialization rights.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

According to the financial terms of the agreement, Multitude would receive upfront and milestone payments upon achieving development, regulatory, and commercial milestones totally over $1 billion, as well as single-digit to low double-digit tiered royalties on potential future product sales.

TF is a clinically validated ADC target that is highly expressed in indications such as non-small cell lung cancer, colorectal cancer, cervical cancer, oesophageal cancer, head and neck cancer, bladder cancer and certain gastrointestinal cancers, but its expression is limited in normal tissues.

ADCE-T02 is a highly differentiated anti-TF ADC, and the first ADC with a Topoisomerase I inhibitor-based linker/payload, to enter into clinical development in Australia, US and Europe. Its unique antibody design minimizes the impact on the coagulation pathway, while the T1000-exatecan linker-payload technology platform has been shown to amplify the bystander effect, improve linker stability, and has the potential to overcome potential resistance mechanisms. These differentiated features promise to translate into a superior therapeutic window, a better safety profile, enhanced response rates and longer response durations through reduced toxicity driven treatment terminations, interruptions or dose reductions.

Clinical Trial Notification for ADCE-T02 has been submitted in Australia, and an IND application in the United States is planned in the near future. The start of the Phase I study in Australia is expected in Q4 2024.

Michael Pehl, Chief Executive Officer of Adcendo, stated: "We are highly impressed by the deep science behind Multitude Therapeutics’ linker/payload platforms and are delighted about our licensing agreement on ADCE-T02, which perfectly complements our existing unique first-in-class ADC pipeline and allows Adcendo to become a clinical-stage biotech company in Q4 2024. TF is an excellent ADC target with ample opportunity in high unmet need indications, as was recently reported at the annual ASCO (Free ASCO Whitepaper) congress. The highly differentiated profile of ADCE-T02 will enable a full capture of the potential of this target and will hopefully bring tangible progress to cancer patients in need".

Dr. Xun Meng, Chief Executive Officer of Multitude, stated: "We are delighted to collaborate globally with Adcendo. The successful cooperation demonstrates that the T1000-exatecan linker-payload platform has played a significant role in multiple successful ADC pipelines. We look forward to Adcendo’s experienced global clinical development team bringing ADCE-T02 to cancer patients in need as soon as possible."

On August 20, 2024 BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical needs, reported a collaboration with Tempus, a technology company leading the adoption of AI to advance precision medicine and patient care, to advance the clinical development of BerGenBio’s selective AXL inhibitor bemcentinib in first line (1L) Non-Small Cell Lung Cancer (NSCLC) patients with STK11 mutations (STK11m) (Press release, BerGenBio, AUG 20, 2024, View Source [SID1234646019]). BerGenBio’s on-going BGBC016 Phase 1b/2a trial is designed to assess the benefit of adding bemcentinib to the current standard of care treatment (immunotherapy + doublet chemotherapy) in 1L STK11m patients, a population with poor outcomes and no specific therapies today.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The collaboration will provide BerGenBio with access to a tailored cohort of Tempus’ real-world clinical and molecular data that is intended to establish a synthetic control to provide a contextual benchmark for BerGenBio’s innovative study, which aims to address the urgent medical need for effective treatments in STK11m NSCLC patients. Tempus’ comprehensive, AI-enabled platform will enable BerGenBio to receive customized analyses of Tempus data and gain deeper insights into the genomic landscape and therapeutic responses of NSCLC patients with STK11m.

Upon conclusion of the BGBC016 study, the parties intend to present insights derived from the resulting data to appropriate regulatory agencies as a next step in the further development of bemcentinib.

Martin Olin, CEO of BerGenBio, expressed enthusiasm about the collaboration, stating, "We are excited to partner with Tempus to harness the power of their advanced technology in our mission to improve outcomes for NSCLC patients with STK11 mutations. By integrating Tempus’ platform into our study, we aim to enhance our understanding of the disease biology and treatment outcomes, ultimately driving our ability to accelerate further development of bemcentinib".

"We are excited to collaborate with BerGenBio to accelerate the development of precision therapies for STK11m NSCLC patients," said Kate Sasser, Chief Scientific Officer at Tempus. "Together, we aim to unlock new insights that will ultimately improve patient outcomes and redefine the standard of care in this challenging disease setting."

On August 20, 2024 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM") reported the official print publication of the data analysis from a long-term Early Access Program ("EAP") studying the company’s drug Ampligen (rintatolimod) for the treatment of advanced pancreatic ductal adenocarcinoma ("PDAC") (Press release, AIM ImmunoTech, AUG 20, 2024, View Source [SID1234646003]). The manuscript titled "Rintatolimod in Advanced Pancreatic Cancer enhances Anti-Tumor Immunity through Dendritic Cell-Mediated T Cell Responses," appears in the journal Clinical Cancer Research, one of oncology’s most prestigious journals.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Ampligen is a dsRNA product candidate that acts via the TLR-3 receptor present on several immune cells, epithelial cells and tumors. Researchers at the Erasmus University Medical Center ("Erasmus MC") found that Ampligen treatment in pancreatic cancer patients enhances peripheral immune activity at the transcriptomic and proteomic levels, particularly involving type 1 conventional dendritic cells (cDC1s) and T cells. Post-Ampligen, the increased peripheral abundance of BTLA+XCR1+ cDC1s and CD4+SELL+ T cells correlated with improved clinical outcomes. Patients with stable disease exhibited pronounced overexpression of genes related to DC and T cell activation. Notably, the expression of immune checkpoints PD-L1 and PD-L2 decreased post-Ampligen across all patients.

"We are grateful to the Erasmus team for their continued contributions to the advancement of Ampligen," said AIM Chief Executive Officer Thomas K. Equels "There remains a large and growing unmet need for safe and effective treatments for pancreatic cancer. This data continues to provide us with further insight into Ampligen’s ability to improve progression-free survival and overall survival and enables us to identify cancer patients who might benefit more from Ampligen treatment than they would from other known cancer treatments."

Prof. Casper H.J. van Eijck, MD, PhD, Pancreato-biliary Surgeon at Erasmus MC and co-author of the published paper, added, "We continue to be encouraged by this data which suggests Ampligen infusions modulate PD-L1 and PD-L2 expression in the tumor microenvironment, while at the same time they upregulate Ki67+CD4+ and Ki67+CD8+ T-cells. We continue to make progress in the ongoing DURIPANC trial, which looks at the combination effect of Ampligen and AstraZeneca’s durvalumab and look forward to continuing evaluation of its potential for the treatment of pancreatic cancer."

In addition to the published manuscript, further commentary discussing the potential of Ampligen and two other drugs, referencing findings from the journal article, were published. Key highlights from the additional commentary include:

Ampligen has been found to be also safely used through a systemic route.
Interesting increases in cDC1 numbers and cytokines governing T-cell activation and migration are found to be upregulated.
Researchers detected an important enrichment of B-cell numbers in peripheral blood from patients treated with Ampligen.
B-cells correlated with long-term (>1 year) survival in a previous study.
AIM is currently evaluating Ampligen as a therapy for metastatic pancreatic ductal adenocarcinoma in the Phase 1b/2 DURIPANC clinical study (NCT05927142) and as a therapy for locally advanced pancreatic adenocarcinoma in the Phase 2 AMP-270 clinical study (NCT05494697).

On August 20, 2024 EMulate Therapeutics, Inc. ("Emulate") reported the Open Journal of Biophysics (OJBIPHY), publisher of over 200 peer-reviewed open access journals, has accepted its manuscript, titled "Magnetic Field Emulations of Small Inhibitor RNA: Effects on Implanted GL261 Tumors in C57BL/6 Immune Competent Mice" for publication (Press release, EMulate Therapeutics, AUG 20, 2024, View Source [SID1234646020]). This submission supports independent results in an animal model of Glioblastoma Multiforme (GBM), recently published by Mukthavaram et al. (Bioelectron Med 2024 Vol. 10 Issue 1 Pages 10), which demonstrates the ability of EMulate’s second signal treatment offering, A2. GBM is a rare brain glioma that currently has no established treatment on the market and is categorized by the U.S. Food and Drug Administration (FDA) as a highly underserved orphan disease (affects fewer than 200,000 in the U.S.). View Source

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The paper demonstrates EMulate’s A2 signal treatment targets the established immune checkpoint inhibitor targets of CTLA-4 and PD-1, reducing the expression of these immune system receptors and inhibiting the growth of tumors in a validated mouse model of GBM. These results support the observed outcomes from a Phase I clinical trial (NCT02507102) demonstrating safety and possible efficacy against GBM in humans.

"The results of this pre-clinical animal model study continue to demonstrate the potential of our ulRFE technology in the treatment of cancers and other challenging diseases with high unmet medical needs. We strongly believe in the potential benefits of this treatment in patients afflicted by cancer with these genetic targets, which we intend to confirm in future clinical trials," stated Xavier Figueroa, Ph.D., EMulate’s SVP of Pre-Clinical Development.

On August 20, 2024 Delcath Systems, Inc. (Nasdaq: DCTH) (the "Company" or "Delcath"), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported that it will present data from its FOCUS Phase 3 study at the 2024 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting, which convenes from September 13-17, 2024, in Barcelona, Spain (Press release, Delcath Systems, AUG 20, 2024, View Source [SID1234646005]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Poster Presentation Details

Title: Subgroup Analysis of FOCUS Phase 3 Trial Efficacy Results
Date: September 14, 2024
Time: 9:00 am
Location: Hall 6
Poster number: 1127P

The presentation will highlight the efficacy of the Melphalan/Hepatic Delivery System (Melphalan/HDS) in patients across six subgroups with unresectable metastatic uveal melanoma (mUM).