Kari Edwards, Ph.D.

Honored to join the American Society of Clinical Oncology (ASCO) McKinsey & Company panel "The Rush to the Frontline: Treating Cancer Early." We explored how emerging technologies like liquid biopsies are changing the paradigm in early cancer detection and treatment — offering a less invasive, more scalable, and potentially more informative alternative to traditional diagnostics. Liquid biopsies using ctDNA, CTC, methylation patterns, immuno-phenotyping and exosomes are enabling earlier, more personalized interventions. But translating this promise into clinical practice requires more than innovation. Realizing their impact means overcoming challenges in standardization, access, and implementation — especially in community settings. #PrecisionOncology #CancerInnovation #ASCO2025

427

14 Comments

ICYMI: OneOncology and START Research are partnering to improve access to early-stage clinical trials. Beginning in July 2025, early phase clinical research capabilities will be integrated into Los Angeles Cancer Network in California,The The Center for Cancer and Blood Disorders Disorders in Texas, and Astera Cancer Care in New Jersey. These new START sites will join an existing partnership location at The Cancer & Hematology Centers in Michigan, marking an expansion of community-based early-phase research access under the OneOncology umbrella. https://lnkd.in/eJ3PXmPm

192

🚀 Weekly ADC Insights: Regulatory, Clinical & Corporate Updates. The ADC pipeline is deeper and more diverse than ever. With expanding indications, advanced platforms, and fresh capital—2025 may redefine. Here are the latest highlights you shouldn't miss 👇 Exhibit#1: Companies with ADC and latest updates 🎯 Regulatory Milestones 🏅 Daiichi Sankyo US: ENHERTU sNDA filed in Japan for HER2+ metastatic solid tumors (4 pivotal Ph2 trials). 🧪 Kelun-Biotech: FDA cleared IND for SKB518 in the U.S.; Ph1 ongoing in China. 🧪 Keymed Biosciences: NMPA approved IND for CDH17 ADC (GI cancers); strong preclinical safety & efficacy. 💼 Corporate Developments 💰 Daiichi Sankyo US / AstraZeneca: DATROWAY off to a solid start—¥1.4B (~$10M) sales in HR+/HER2– mBC. 💰 Synthetic Design Lab: Raised $20M to scale SYNTHBODY™, enabling 10x improved payload delivery. 🤝 1STBIO x Ligachembio Sciences: Strategic R&D/licensing deal for 2–4 novel ADC payloads. 🏭 LOTTE BIOLOGICS: Opened $100M ADC CDMO facility in NY; first clinical contract secured. 📅 AACR 2025 Highlights 🔬 Innovent Biologics: IBI3010, IBI3014, and IBI3022 data in solid and gynecologic tumors. 🔬 Pfizer/Nona Biosciences: Presented PF-08052666 (TOP1i ADC) with strong preclinical activity in solid tumor models. Ph1 ongoing 🔬 NextPoint Therapeutics, Inc.: Unveiled NPX125 (B7H7 ADC) showing potent tumor regression; IND expected mid-2026. 🔬 Cantargia AB: Highlighted anti-IL1RAP ADC with robust tumor inhibition. 🔬 Zai Lab: ZL-6201 (LRRC15 ADC) showed strong tumor suppression; IND planned for 2025. 🔬 Zymeworks Inc.: Shared preclinical results on ZW327 (Ly6E ADC) and a biparatopic PTK7 ADC with strong internalization and activity. 🔬 Elevation Oncology: EO-1022 (HER3 ADC) demonstrated improved stability and reduced toxicity 🔬 ADC Therapeutics: Highlighted three exatecan-based ADCs (CLDN6, PSMA, ASCT2) potent and well tolerated. 🔬 Mythic Therapeutics, Inc.: MYTX-011 (cMET ADC) showed efficacy across multiple xenograft models. 🔬 Innate Pharma: IPH4502 (Nectin-4 ADC) outperformed EV in resistant UC. 🔬 SOTIO Biotech: Presented SOT109 (CDH17 ADC) and SOT106 (LRRC15 ADC) with potential across CRC and sarcomas. 🔬 Acepodia: Introduced dual-payload ADC platform (AD2C) targeting GPC3 in HCC. 🔬 Kowa Pharma: Demonstrated superior efficacy of K-679 (ultra-high-DAR ADUC) in EGFR+ tumors. 🔬 Debiopharm: Showcased Debio 1562M (CD37 ADC) with potency in AML/MDS and AbYlink™ conjugate platform. 🔬 GlycoNex Inc. : GNX1021 (branched Lewis B/Y ADC) exhibited activity in gastric ca with high tumor selectivity. 🔬 Alphamab Oncology: Presented bispecific ADCs — JSKN021 (EGFR/HER3) and JSKN022 (PD-L1/ITGB6/8) — strong tumor inhibition. 🔬 Precision Biologics, Inc. : PB-223 ADC (core 2 O-glycan target) demonstrated preclinical efficacy. 💬 Which ADCs do you think are poised for breakout success in 2025? Let’s explore together! ⬇️ #ADCs #Oncology #Biotech #PrecisionMedicine #PhenomiqsInsights #WeeklyUpdate #AACR2025

130

3 Comments

Great discussion today with ICON’s Simon Bruce and the other industry experts at the GLP-1-Based Therapeutics Summit: "Delving into clinical trial design to accurately assess GLP-1s in comorbidities of obesity". Learn more. https://ow.ly/y2li50VBrTh

128

Brian Finrow, co-founder and CEO of Lumen Bioscience, discusses his company’s platform technology for engineering spirulina to produce biologics, why it makes possible the pursuit of orally-delivered biologics for indications that were previously not practical, and the potential to make these advanced therapies affordable and accessible in parts of the world where people may not have widely enjoyed their benefits. https://lnkd.in/gjbjZYYZ

61

1 Comment

#News for #Investors and #Media: At #ASCO25, we’re unveiling new data from Arm C and D of our Phase 3 SEQUOIA study evaluating our BTK inhibitor in patients with treatment-naïve chronic lymphocytic leukemia (#CLL). These findings reinforce the potential of our BTK inhibitor as a frontline option in CLL/SLL. To learn more, read our latest press release: https://ow.ly/KXJg50W20bq #CancerResearch

161

CAR T vs. bispecific TCEs—what’s shaping the next wave of T-cell innovation in oncology? In this episode of ClearView Convos, Sam Ulin is joined by Kelsey Yardumian and David Konciak to unpack the evolving landscape of T-cell redirecting therapies. With multiple approvals primarily in hematologic malignancies, both modalities are redefining the oncology landscape—but diverge in key ways that impact clinical strategy, patient access, and commercialization.   As we head into ESMO - European Society for Medical Oncology this week, we’re excited to launch a new white paper that dives deeper into these distinctions. It explores how CAR T’s superior efficacy and one-time dosing potential stack up against the relatively safer profiles, logistical advantages, and broader accessibility of bispecific TCEs, which may be easier to administer and better suited for non-academic settings. The paper also highlights how innovation is driving convergence—CAR T is becoming safer and more scalable, while bispecific TCEs are closing the efficacy gap through combination approaches and engineering advances like logic gating.   Whether you're evaluating investment strategies or planning your next move in immuno-oncology, this conversation offers timely insights into the tradeoffs and opportunities ahead—including the push into solid tumors and even autoimmune disease. Watch the full-length episode: https://lnkd.in/eWMh8sjA Thank you to the additional white paper authors Justin Vandervelden and Michael Sugiyama – please find the link here: https://lnkd.in/eSer_87B #ESMO2025 #ClearViewConvos #clearviewhcp #cart #TCE #oncology

102

Today, Ignota Labs announced the acquisition of Kronos's clinical assets and unveiled our development pipeline with three promising assets. We're focused on rescuing assets that showed real therapeutic potential but stalled in development. Our drug turnaround process identifies what went wrong and how to fix it, so they can quickly reenter clinical trials for approval. The Kronos assets are a perfect example of this. While they didn't succeed in Phase 2 trials the first time around, we believe there's untapped value here that can make a real difference for patients. Really excited about what's ahead for our pipeline and the impact we can make together. Learn more about how we’re turning around promising but stalled drugs to bring safer treatments to patients faster: https://lnkd.in/ea2bqb3n #drugdiscovery #drugacquisition #pipeline

104

4 Comments

New research from Prime Therapeutics highlights long-term trends in GLP-1 use for obesity. Pat Gleason, PharmD, BCPS, FCCP, FAMCP, shares insights from Prime’s third year of real-world GLP-1 data. The findings show a continued decline in therapy persistence over time, with slightly higher rates among individuals using high-potency GLP-1 drugs. Read the full analysis: https://bit.ly/3HZw3yF

69

3 Comments

First half-day at #DIA2025 a success. Attended the #RWE Panel: Moving From Last to First? Key insights below. Great Panel Nancy A. Dreyer 👏 At the #DIA Global conference, a standout session on Real-World Evidence (RWE) spotlighted the global momentum behind making fit-for-purpose real-world data (RWD) central to regulatory, reimbursement, and clinical decision-making. 🔍 Highlights from the panel: Patrice Verpillat(EMA) shared how DARWIN EU—a federated network now spanning 30+ partners—is transforming evidence generation across the EU. EMA’s RWE-supported decisions now include RSV humanitarian use, pediatric myositis feasibility, and NSCLC therapy effectiveness aligned with trial data. Rich Gliklich (OM1) emphasized the role of #AI in unlocking unstructured data and enabling traceable, auditable RWE pipelines. From AI-based phenotyping to digital signatures for regulatory traceability, the future of prospective studies is increasingly hybrid and scalable. Brian Bradbury (Amgen) advocated for RWE as a first option, not a last resort. His case studies—from Prolia in Taiwan and China to Erenumab in the U.S.—show how robust design and transparency build global trust in RWE for both effectiveness and safety. Themes that stood out: ✅ Data must be FFP—Fit-for-Purpose ✅ AI unlocks scale and granularity ✅ Transparency builds confidence in evolving methodologies ✅ RWE can (and should) drive decisions before clinical trials The convergence is clear: high-quality RWD, supported by rigorous methods and digital trust, is becoming core infrastructure for tomorrow’s healthcare. Let’s make RWE the first option, not the fallback. #RealWorldEvidence #RWD #AIinHealthcare #DIA2025 #RegulatoryScience #DigitalHealth #DataIntegrity #FutureOfMedicine

20

3 Comments

Clinical Trialblazers is now officially live with not one, but TWO episodes! 🎧 In Episode 1, Michael Bailey, President & CEO of Aveo Oncology, shares his expert insights on the evolving world of oncology trials and their crucial impact on patient care. And in Episode 2, Robert Blum, President & CEO of Cytokinetics, takes us on his journey from the biology classroom to leading a biopharmaceutical company. He also dives deep into his leadership values and how to overcome failure. These conversations are a must-listen for anyone passionate about biotech, leadership and the future of medicine. Tune in now and subscribe wherever you get your podcasts: https://lnkd.in/eDGYaZTn #ClinicalTrialblazers

15

Bristol Myers Squibb is expanding its radiopharma portfolio with a $350 million upfront investment, and up to $1.35 billion in potential milestones, through a new partnership between RayzeBio and Philochem. The collaboration centers on OncoACP3, a small-molecule radiotherapeutic targeting ACP3, a novel biomarker that is highly expressed in prostate cancer and may be more abundant than PSMA, the current leading target. OncoACP3 is designed to carry both Lutetium-177 and Actinium-225, the two most common isotopes in radiopharma. This agreement marks a strategic move by BMS to differentiate its pipeline in an increasingly competitive prostate cancer space, where major players like Novartis, AstraZeneca, and Eli Lilly are advancing PSMA-directed assets. By pursuing an alternative pathway, BMS signals its intention to broaden therapeutic options and reshape the radiopharma landscape. Pending approvals, the deal is expected to close in Q3 2025.

129

2 Comments

Vertex Pharmaceuticals has dropped its AAV gene therapy research, impacting partnerships with Affinia Therapeutics and tRNA therapy startup Tevard Biosciences, and raising questions about its CRISPR therapies for muscular dystrophy. Read more in my scoop for Endpoints News - https://lnkd.in/eTqekvrA #AAV #GeneTherapy #GeneEditing #CRISPR #tRNA #tRNAtherapy #musculardystrophy #Duchenne #Duchennemusculardystrophy #DMD #raredisease

105

2 Comments