UVA Cancer Center’s Post

✨ ACCENT Trial Update    #Amplia has today released an update on the ACCENT trial in pancreatic cancer.    Following the completion of the Phase 1b portion of the trial in November, a safe and well-tolerated dose of 400 mg narmafotinib once-a-day was identified. Response rates from the Phase 1b portion of the trial continue to be substantially better in terms of clinical response and duration on trial, when compared to treatment with chemotherapy alone. Recruitment for the Phase 2a stage of the trial is progressing well, with 11 patients currently enrolled in the Phase 2a cohort –  7 patients across Australian trial sites, and a further 4 pancreatic cancer patients in Korea.    The Phase 2a trial will initially enrol 26 patients and an interim analysis of efficacy will be conducted around Q3 2024.      Amplia CEO and MD, Dr Chris Burns, commented:     “The clinical responses we are seeing in patients is very promising and the duration on trial, given the aggressiveness of the disease in these patients, is also extremely encouraging.”    Read today’s ASX release 👉 https://lnkd.in/g78tsQyy     $ATX #ATX #ASX #pharma #biotech #innovation #cancertherapy #pancreaticcancer #clinicaltrial  

Immutep Limited is pleased to present its Q1 FY25 Quarterly Activities Report, showcasing robust progress in clinical trials, key regulatory milestones, and a solid cash position. Highlights include: - Positive feedback received from US FDA regarding the planned TACTI-004 Phase III in first-line non-small cell lung cancer successfully concluding regulatory preparations for the trial design - Efti in combination with MSD’s KEYTRUDA® reports positive efficacy and favourable safety in first-line head and neck cancer in TACTI-003 Phase IIb trial - First participant successfully dosed in the first-in-human Phase I trial of IMP761, a novel LAG-3 agonist antibody designed to treat autoimmune diseases Read the Quarterly Report: https://bit.ly/4f32nwh #biotechnology #LAG3 #immunotherapy #oncology

#ESMO24 Breast Cancer As ADC drug development advances, research into understanding the immunological mechanisms of ADCs continues, supported by biomarker analyses from various clinical datasets, although the data is based on limited clinical samples and requires cautious interpretation, accumulating research will enhance our understanding over time. It is crucial to explore whether ADCs induce immune responses directly or indirectly or show greater efficacy in tumors or stroma rich in immune cells—such as CD8+ T cells—for designing concurrent or sequential combination therapies. At ESMO24, studies like ICARUS-BREAST01, DAISY, and the exploratory biomarker analysis from DESTINY-Breast04 have provided insight into this journey. However, since these studies are limited to T-Dxd and HER3-Dxd, we cannot apply the findings universally to all ADCs. Different payloads and linker chemistries in other ADCs may yield different outcomes.

The recent Food & Drug Administration approval of Amtagvi by US-based Iovance Biotherapeutics is a groundbreaking milestone in cancer treatment. Specifically designed for metastatic melanoma patients who have exhausted standard treatments, Amtagvi employs TIL therapy, marking the first FDA-approved cellular treatment for solid tumours. Its fast-track approval, driven by promising results in a phase 2 clinical trial, signifies a potential paradigm shift with applications beyond melanoma. This innovative therapy, involving the extraction and replication of immune cells from a patient's tumour, represents a transformative advancement in cancer care. Despite potential side effects, experts emphasise its meaningful impact, particularly for patients who have exhausted conventional treatment options. For an in-depth exploration of Amtagvi's potential in cancer treatment, read the full story below: https://lnkd.in/eHbswTFk #molemap #fda #melanoma #cancertreatment

🔎 PROTEINA Case Study: Unveiling BCL2 PPI network 🔬 Discover our approach to investigating BCL2 PPI biomarkers to reveal the therapeutic impact of Venetoclax, the first FDA-approved BCL2 inhibitor, in transforming the treatment of hematologic malignancies. 📣 Takeaway: Assessing the efficacy of anti-cancer treatment has been always a primary objective for cancer drug developers. Our innovative SPID platform allows in-depth analysis of 47 distinct metrics including 20 different protein-protein interactions within the BCL2 family, providing a thorough quantitative assessment of apoptosis signaling from clinical samples of patients undergoing treatment. Check out the poster below to find out more about PROTEINA’s discovery, presented by our chief scientist, Byoungsan Choi at #AACR2024. Read a full abstract by clicking here: https://lnkd.in/gcJ7knrr   #PROTEINA #SPIDPlatform #CaseStudy #PPIBiomarker #BCL2Inhibitor #BCL2Family #MultipleMyeloma #Venetoclax  

📢 New approvals by EMA and FDA 1️⃣ The CHMP of the EMA has recommended granting marketing authorisation to erdafitinib, an FGFR inhibitor, for patients with unresectable or metastatic urothelial carcinoma with FGFR3 alterations after PD(L)1 inhibition. This approval is supported by the THOR trial results, demonstrating a longer OS than docetaxel or vinflunine monotherapy. However, the restricted choice of therapeutic agents in the control arm and an imbalance in patient dropout may affect the relevance of these findings. Read more: https://lnkd.in/ddN2mA4A 2️⃣Additionally, the FDA has granted accelerated approval to adagrasib in combination with cetuximab for KRAS G12C-mutated colorectal cancer post-chemotherapy. The response rate was 34%. Controlled data is needed for regular approval. Learn more about this approval here: https://lnkd.in/gCXife_Z #Oncology #CancerResearch #FDAApproval #EMAApproval #UrothelialCarcinoma #ColorectalCancer #ClinicalTrials #Trialing

Congratulations to Pierre Fabre Laboratories! The company announced that the first patient has been dosed with PFL-002/VERT-002, a monoclonal antibody acting as a degrader of c-MET, in a Phase 1/2 first-in-human dose-escalation, dose-optimization and dose-expansion trial, for patients with non-small cell lung cancer harboring MET alterations. The PFL-002/VERT-002 trial is an open label, multi-center study that aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary clinical efficacy of PFL-002/VERT-002 as a monotherapy for patients with MET-dependent tumors, including those emerging with acquired resistance to other treatments. #mabs https://lnkd.in/e8NCCfiw

📄 [Press Release] – MaaT Pharma Provides a Business Update and Highlights Key Milestones Expected in 2024 ▪ Positive efficacy and safety data of MaaT013 in aGvHD in the Early Access Program presented at the EBMT 2024 annual meeting with 63% GI-ORR at D28, a 49% one year and 42% 18 months Overall Survival (OS) in patients similar to those included in the ARES Phase 3 clinical trial. ▪ Primary endpoint readout, GI-ORR at D28, of the ARES Phase 3 clinical trial in aGvHD expected for mid Q4-2024. ▪ Production of batches of MaaT013 destined for clinical supply in the US. ▪ Participation in a randomized multicenter investigator-sponsored Phase 2 trial evaluating MaaT033 concomitant to anti-PD1 treatment in advanced lung cancer patients. This trial is sponsored by Institut Gustave Roussy, steering cutting-edge research in the microbiome field, as part of the IMMUNOLIFE program, a consortium including researchers and biotech companies. ▪ Completion of patient recruitment for the Phase 1 clinical trial IASO, evaluating MaaT033 for patients with Amyotrophic Lateral Sclerosis. 👉see press release: https://lnkd.in/eN7CZEHM #GvHD #MaaT013 #MaaT033 #Microbiome #Microbiota #LungCancer #Oncology #Cancer

Alligator Bioscience AB to present positive phase 2 Mitazalimab data in pancreatic cancer at 2024 ASCO annual meeting OPTIMIZE-1 study results showed confirmed ORR of 40.4%, unconfirmed ORR of 50.9% and DCR of 79% in 57 evaluable patients with chemotherapy-naïve mPDAC The encouraging duration of response (median 12.5 months) and overall survival (median 14.3 months) support continued development of mitazalimab in a randomized confirmatory Phase 3 trial. Biomarker analysis demonstrates correlation of mitazalimab-induced immune activation with clinical outcomes. Updated results from a longer, 18-month survival follow-up in OPTIMIZE-1 expected at end of June 2024 #biotech #medicine #cancer #investorrelations #communications #aktier #shares

In less than 8 months, the EU #HTA Regulation will become a reality: all new #cancer #medicines and advanced therapy medicinal products will be jointly assessed at the EU level. A recent report commissioned by the EFPIA Oncology Platform simulated the new joint clinical assessment on 3 cancer medicines that were approved in recent years. It shows that the proposed methods do not always fit the specificities of medicines for cancer and novel therapies that use genes, tissues and cells. If applied from 2025, this approach would hamper access to some of the most cutting-edge products in the research pipeline. Join us for a discussion on how we can work together to ensure that EU HTA can facilitate faster access for patients together with: - Antonella Cardone, CEO, Cancer Patients Europe - Robin Doeswijk, Head of European Affairs, European Hematology Association - Tanja Podkonjak, Head of Access Intelligence and Readiness, Takeda 🗓 4 June 2024 🕛 12:30-14:00 📍 Online ✏ Register here: https://lnkd.in/g4b8Nx-P