Adam Kallel PhD

Lake N. Paul, PhD. is in San Diego at the Biotechnology Innovation Organization #BIO2024 conference meeting with colleagues & future clients. Connect with him in person to learn about how, as a Collaborative Research Organization, we are best positioned to support your analytical program. #aav #genetherapy #rarediseases #biophysics #STEM #STEMPhilly #biochemistry #celltherapy #bioanalysisllc #PhillyBusiness #phillyscience

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📢 In this recent article, authors evaluated the efficacy JPX-0700 and JPX-0750 as dual STAT3/5 inhibitors, reducing leukemic cell growth in AML/NKCL models. These compounds target STAT3/5 signaling, inducing cell death and growth arrest, and exhibit synergistic effects with approved chemotherapeutics. 👉

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In a recently published Perspective, Catherine Hutchings and Aaron Sato discuss phage display technology and its impact in the discovery of novel protein-based drugs. From the abstract: Areas covered In this perspective, the authors summarize the application of phage display for drug discovery and provide examples of protein-based drugs that have either been approved or are being developed in the clinic. The amenability of phage display to generate functional protein molecules to challenging targets and recent developments of strategies and techniques designed to harness the power of sampling diverse repertoires are highlighted. Expert opinion Phage display is now routinely combined with cutting-edge technologies to deep-mine antibody-based repertoires, peptide, or alternative scaffold libraries generating a wealth of data that can be leveraged, e.g. via artificial intelligence, to enable the potential for clinical success in the discovery and development of protein-based therapeutics. https://lnkd.in/ekeA5Z4j

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SOTIO’s innovative work on SOT201, a PD-1-targeting immunocytokine, was featured in a recent Drug Discovery World article. The article discusses data presented at Society for Immunotherapy of Cancer (SITC) Annual Meeting, which demonstrated SOT201’s promising ability to reinvigorate exhausted immune cells in both PD-1 sensitive and resistant tumor models. Read the full article here: https://bit.ly/4fRgCnW #CancerResearch #Biotechnology #SITC2024 #jsmePPF

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SDBN Feed: Candid Therapeutics unwraps three new collaborations to discover and develop T-cell engager antibodies https://lnkd.in/g4rKJTSk Candid Therapeutics, a new San Diego biotech bent on becoming a leader in the emerging T-cell engager space, has unwrapped three new research collaborations focusing on autoimmune diseases. Candid will partner with EpimAb Biotherapeutics, Nona [...]

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➡ Only 1.5 percent of cancer patients eligible for NTRK inhibitors received them. ⬅ In this analysis that assessed 4,250 patients with metastatic, refractory solid tumors over a two-year window, 800 had NTRK fusion-positive cancers, making them eligible for NTRK inhibitors.(1) Only 12 of the patients, however, received such therapies, despite studies demonstrating high response rates.(2) Another 346 patients – about 43 percent – received a different type of targeted therapy. The rest of the patients – more than 55 percent – received treatments that were not targeted to their tumors’ genotypes.    This data, presented by Diaceutics PLC at ASCO 2024, was recently covered in an article published by Precision Medicine Online. As the researchers and author noted, “...most patients with advanced NTRK fusion-positive solid tumors aren't getting the chance to benefit from available precision medicines designed to directly inhibit the molecular alteration driving their disease.” Clarified co-founder Howard McLeod, PharmD, FASCO, FCCP collaborated with the Diaceutics team on the analysis. As he and the research team noted, several factors contribute to the low rate of targeted therapy utilization found in this analysis. NTRK alterations are relatively rare. However, NCCN guidelines recommend profiling tumors for these genes (and others) in patients with advanced disease. As one study on TRK inhibitors stated, “The treatment of patients with NTRK fusion-positive cancers with a first-generation TRK inhibitor, such as larotrectinib or entrectinib, is associated with high response rates (>75%), regardless of tumour histology.” (3) Making these types of advanced, personalized treatment decisions, however, requires expertise and systems specific to precision oncology. As Dr. McLeod said, many oncology practices are not yet “set up to quickly adapt to new models of care." Learn more about the research >> https://lnkd.in/gncC9MjE This post is part of Clarified’s Journal Club series, where we share important studies in the field of precision medicine and discuss the findings. Please share your thoughts or clinical experiences on this topic in the comments – we’d welcome the chance to keep the dialogue going. Rajni Natesan, MD, MBA Lincoln Nadauld Howard McLeod Lisa Alderson Daniel Rotroff Susanne Munksted Peter Keeling Ken Ruppel #precisionmedicine #molecularprofiling #precisiononcology #oncology #journalclub #clarifiedprecisionmedicine 1. ASCO 2024 Abstract - Diaceutics PLC, as published in Precision Medicine Online https://lnkd.in/g7QBypEw 2. Cocco, E., et al. NTRK fusion-positive cancers and TRK inhibitor therapy. Nat Rev Clin Oncol. 2018 Dec;15(12):731-747. doi: 10.1038/s41571-018-0113-0.  3. Ibid.

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Bristol Myers Squibb has queued a Phase 1 study of Orum Therapeutics’ ORM-6151 (BMS-986497), a first-in-class, anti-CD33 antibody-enabled GSPT1 degrader for the treatment of patients with acute myeloid leukemia or high-risk myelodysplastic syndromes. The study will enroll an estimated 35 patients and is due to start in late May 2024. Orum Therapeutics has developed a new class of ADC payloads, called neoDegraders, to specifically degrade intracellular target proteins within cancer cells via the E3 ubiquitin ligase pathway. Conjugated to antibodies, neoDegraders are designed to be delivered specifically to cancer cells and degrade the intracellular target protein and cause tumor cell death. https://lnkd.in/edTcDRFj

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The Quidel TriageTrue® High Sensitivity Troponin I Test, CE-marked in late 2018, demonstrates clinical performance akin to top central lab systems. Its assay-specific cutoffs for ESC 0–1 hour algorithm are validated and published in the ESC 2020 guidelines. Dr. Annemieke Dohmann discusses the benefits of the Triage MeterPro and TriageTrue® test in the clinical setting. QuidelOrtho #troponin #pointofcare #poct #clinicaldiagnostics #medicallaboratory #clinicallaboratory https://lnkd.in/ehKxtnv7

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Bristol Myers Squibb announces positive topline results from two pivotal Phase 3 trials evaluating Sotyktu (deucravacitinib) in adults with #psoriaticarthritis. POETYK PsA-1 and POETYK PsA-2 trials met primary endpoint, with significantly greater proportion of Sotyktu-treated patients achieving ACR20 response compared with placebo at Week 16. Additionally, the POETYK PsA-1 and POETYK PsA-2 trials met important secondary endpoints across PsA disease activity at Week 16. Detailed results will be presented at upcoming medical congresses.

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No lab space? We can help! 🧪 We know that advancing research doesn’t always come with unlimited resources. That’s why our contract research services are designed to provide the cutting-edge science you need—without the overhead. 💡 What We Offer: 🧬Human-Relevant Data: Leveraging our RepliGut® technology to deliver insights into drug absorption, metabolism, toxicity, and disease modeling. ✏️Customizable Studies: Tailored solutions to meet your specific research goals. 👩‍🔬Expert Support: Work with a team of scientists specializing in gastrointestinal biology. ⏱️Efficient Turnaround: Get high-quality, actionable results—fast. Let us take the lab work off your plate so you can focus on discovery. https://hubs.ly/Q031jvK-0

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🔬 A crucial discussion unfolded at #AAPSPharmSci360, as industry leaders tackled the FDA's transformative laboratory-developed test (LDT) proposed rule and its implications for biomarker testing at last month's conference in Salt Lake City.   The high-impact session, moderated by our Chief Scientific Officer, Dr. Lauren Stevenson, brought together expert perspectives from Stephen Piccoli (Sun Pharma), Patrice Hugo (IQVIA Laboratories), and Mark Ma (Rallybio).   The session revealed critical insights into the FDA's April 2024 LDT Final Rule, fundamentally reshaping how diagnostic and exploratory biomarker tests are regulated. Under this new framework, LDTs will transition from their current enforcement discretion policy to being regulated as medical devices.   The implications are significant: industry data suggests 200-400 clinical studies could face delays over the next three years, potentially affecting 30,000-45,000 patients. We're proud to see Immunologix Laboratories contributing to these vital industry discussions.   Read the full article by Bioanalysis Zone here: https://lnkd.in/eTvyRRgY   As a specialized bioanalytical CRO, we understand firsthand how these evolving regulations will reshape pharmaceutical development. Our expertise in this space allows us to offer strategic guidance to sponsors through:   💠 Sophisticated biomarker strategies coupled with depth of regulatory expertise 💠 Custom biomarker assay development and validation 💠 Method transfer and optimization for context of use 💠 PK/PD analysis This regulatory evolution presents both challenges and opportunities for our industry. As we look ahead, our scientific team remains committed to delivering innovative, compliant solutions that advance drug development programs and ultimately benefit patients.   Thank you to AAPS for facilitating these critical conversations that help shape the future of our industry!   #Bioanalysis #DrugDevelopment #Biomarkers #CRO #PharmaceuticalScience #RegulatoryScience #ImmunologixLabs

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#QUESTION: What challenges do toxicology labs face when it comes to reviewing individual sample data, and how can SCIEX OS help? As Luke Rodda, Chief Forensic Toxicologist and Director of the San Francisco Office of the Chief Medical Examiner discusses here, SCIEX OS software offers LOD flagging with decision rules that can help to speed up individual sample data review. Learn more about this in episode 3 of our Tox Chat Box video podcast series, “Streamline toxicology screening with software,” available now 👉 https://bit.ly/4elwC0y #Toxicology #SCIEXOS #software #ToxicologyLabs #ForensicScience #ToxChatBox #ToxicologyScreening #ForensicTesting #SCIEXforScience

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<!-- Content start --> South San Francisco, CA — July 3, 2024 — Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the Phase II/III SKYSCRAPER-06 study, evaluating tiragolumab plus Tecentriq® (atezolizumab) and chemotherapy versus pembrolizumab and chemotherapy as an initial (first-line) treatment for people with previously untreated, locally advanced unresectable or metastatic non-squamous non-small cell lung cancer (nSq NSCLC), did not meet its primary endpoints of progression-free survival (PFS) at its primary analysis with a hazard ratio (HR) of 1.27 [95% CI: 1.02,1.57] and overall survival (OS) at its first interim analysis with a HR of 1.33 [95% CI: 1.02, 1.73], which was immature. The combination of tiragolumab plus Tecentriq and chemotherapy showed reduced efficacy in both PFS and OS compared to the comparator arm in the intent-to-treat population, which includes Phase II and Phase III cohorts. The overall safety profile remains consistent with the safety profile previously observed for the combination of tiragolumab plus Tecentriq and chemotherapy, and no new or unexpected findings were identified. Based on these results, patients and investigators will be unblinded and we intend to halt the study. A communication will be sent to the investigators and results will be shared with health authorities and subsequently presented at an upcoming medical meeting. “These results are disappointing as it was our hope that this combination might yield improved outcomes for people living with metastatic non-squamous lung cancer,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “We are thankful to all of the patients and healthcare professionals involved in the study, and we will leverage the learnings to inform our scientific understanding of the anti-TIGIT pathway and new avenues in cancer research.” Ongoing Phase III studies are investigating treatment settings and indications distinct from SKYSCRAPER-06. Based on today’s results, we will evaluate any relevant changes needed to the ongoing tiragolumab program. About SKYSCRAPER-06 study SKYSCRAPER-06 is a global Phase II/III, randomized, placebo-controlled and double-blinded study evaluating tiragolumab plus Tecentriq® (atezolizumab) and chemotherapy as an initial (first-line) treatment versus pembrolizumab and chemotherapy in 542 people with non-squamous non-small cell lung cancer. Primary endpoints are overall survival (OS) and progression-free survival (PFS). About tiragolumab Tiragolumab is an investigational novel immune checkpoint inhibitor with an intact Fc region. Tiragolumab selectively binds to TIGIT, a novel inhibitory immune checkpoint which suppresses the immune response to cancer. Based on preclinical research, tiragolumab is thought to work as an immune amplifier with other cancer immunotherapies such as Tecentriq® (atezolizumab). The TIGIT pathway is distinct but

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Check out this great #article by Dan Shores highlighting key #IP considerations for #lipids, #polymers, and #LNPs! https://lnkd.in/eSvWZkmD #LNP #liposome #lipidnanoparticles #patent #patents #businessintelligence #celltherapy #genetherapy #innovation

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