June 13, 2024 - 🧬 [nGram] Today’s Oncology Scoop: MSK's Pancreatic Cancer Breakthrough, Innovent's FDA Fast Track, Immorta Bio's Lung Cancer Success

  1. Precision targeting of TF in pancreatic cancer signals ADC drug innovations
    • The 2024 ASCO Annual Meeting highlighted MRG004A, a novel ADC designed to treat advanced solid tumors with high TF expression.
    • TF is significantly elevated in various cancers, particularly pancreatic cancer, and is linked to poor prognosis and metastasis.
    • The Phase I/II study evaluated the efficacy and safety of MRG004A in patients with solid tumors, with a focus on pancreatic cancer.
    • Sixty-three patients were enrolled, with significant anti-tumor activity observed in pancreatic cancer patients.
    • MRG004A demonstrated a manageable toxicity profile and striking antitumor activity across multiple tumor types with high TF expression.
    • Further evaluation of MRG004A is warranted, particularly in TF-overexpressed solid tumors.
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  2. Innovent receives fast track designation from the U.S. FDA for IBI343 as monotherapy for advanced pancreatic cancer
    • Innovent Biologics announced that the U.S. FDA granted Fast Track Designation to IBI343 for advanced unresectable or metastatic pancreatic ductal adenocarcinoma (PDAC).
    • IBI343 targets CLDN18.2 and has shown a 40% overall response rate in a Phase 1 trial for advanced PDAC patients who have received at least one prior line of treatment.
    • Fast Track Designation facilitates the rapid review and development of drugs that address unmet medical needs.
    • IBI343 has previously received FDA approval for its IND application for the treatment of PDAC.
    • The National Medical Products Administration (NMPA) of China has also granted breakthrough therapy designation to IBI343 for claudin 18.2–positive gastric or gastroesophageal junction adenocarcinoma.
    • Innovent plans to continue clinical trials to confirm the efficacy and safety of IBI343 and explore its use in combination therapies and other solid tumors.
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  3. Immorta Bio reports successful inhibition of lung cancer growth by senolytic immunotherapy product SenoVax
    • Immorta Bio announced positive preclinical findings for its senescent cell-killing immunotherapeutic product, SenoVax, in non-small cell lung cancer.
    • The results showed successful induction of immunity to senescent cells surrounding lung cancer cells and reproducible regression of established tumors.
    • SenoVax was administered without other cancer-killing therapeutics, highlighting its potency.
    • The company plans to file an Investigational New Drug (IND) application with the FDA to initiate treatment of advanced lung cancer patients.
    • Immorta Bio is in the late phase of preclinical development and focuses on longevity therapeutics platforms, including Cellular Rejuvenation and Senolytic Immunotherapy.
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  4. Agenus’ novel immunotherapy shows promise against colorectal cancer
    • Agenus published results in Nature Medicine on a novel immunotherapy for microsatellite stable metastatic colorectal cancer (MSS mCRC).
    • The Phase 1 trial involved 148 heavily pretreated MSS mCRC patients, with 77 patients without active liver metastases showing a 22% Objective Response Rate (ORR).
    • Updated results as of March 1, 2024, showed an ORR of 23% with a median follow-up of 13.6 months and a median overall survival (OS) of 21.2 months.
    • No treatment-related deaths were reported, and side effects were manageable.
    • A randomized Phase 2 study has completed enrollment, with a Phase 3 trial planned for later this year.
    • The combination of botensilimab (BOT) and balstilimab (BAL) could represent a significant advancement in the treatment of MSS mCRC.
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  5. Ensem Therapeutics achieves milestone with CDK2 inhibitor entering clinical trials
    • Ensem Therapeutics' partner BeiGene has dosed the first five patients in a Phase 1 trial for BG-68501.
    • BG-68501 is a small molecule CDK2 inhibitor aimed at treating solid tumors.
    • The trial targets advanced or metastatic solid tumors, including HR+/HER2- breast cancer and small cell lung cancer.
    • This milestone triggers a payment from BeiGene, which licensed BG-68501 from Ensem in November 2023.
    • BG-68501 is the first clinical stage compound from Ensem’s Kinetic Ensemble platform.
    • Ensem plans to nominate two additional development candidates in 2024.
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  6. Pancreatic cancer on the rise: how biotech firms are developing groundbreaking treatments
    • A study by the National Cancer Institute reveals Generation X is experiencing higher rates of pancreatic cancer compared to previous generations.
    • Oncolytics Biotech presented two abstracts at the 2024 ASCO Annual Meeting on their novel immunotherapy, pelareorep.
    • The GOBLET study's cohort 5 will examine pelareorep combined with mFOLFIRINOX, with and without atezolizumab, in metastatic pancreatic ductal adenocarcinoma (PDAC).
    • Verastem's Phase 1/2 trial of avutometinib plus defactinib showed an 83% overall response rate in patients with metastatic pancreatic cancer.
    • Candel Therapeutics' phase 2 trial of CAN-2409 demonstrated a median overall survival of 28.8 months in borderline resectable pancreatic cancer patients.
    • FibroGen and Regeneron announced a supply agreement to evaluate FG-3165 and LIBTAYO in select solid tumors, with upcoming data releases expected in mid-2024.
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  7. Sirnaomics demonstrates strong antitumor activity of its novel oligonucleotide-chemodrug conjugate
    • Sirnaomics published a major advancement of its novel Oligonucleotide-Chemodrug Conjugate (ODC) agent in the Journal of Oncology Research and Therapy.
    • The ODC demonstrated potent antitumor activity in multiple tumor cell lines and a pancreatic tumor model in mice.
    • The ODC construct contained chemically modified bases to improve stability, enhancing potency and efficacy against CHK1 gene expression.
    • In vitro tests showed potent antitumor activities of gemcitabine containing CHK1 specific siRNA in Pancreatic, NSCLC, TNBC, and Ovarian cell culture models.
    • The construct also provided efficacy against a pancreatic tumor in a xenograft model in mice, using Sirnaomics' proprietary polypeptide nanoparticle formulation.
    • Sirnaomics plans to pursue delivery using this construct coupled to an antibody against markers upregulated in the tumor, forming the foundation of Antibody Oligonucleotide-Drug Conjugates (AODC).
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  8. Zumutor Biologics announces dosing of first patient with ZM008, a first-in-class anti LLT1 antibody
    • Zumutor Biologics has dosed the first patient in its Phase 1 clinical trial for ZM008, targeting advanced solid tumors.
    • The trial (NCT06451497) is an open-label, multicenter, dose escalation study evaluating ZM008 alone and in combination with pembrolizumab.
    • ZM008 is a fully human IgG1 monoclonal antibody that disrupts LLT1-CD161 interactions, aiming to convert 'cold' tumors into 'hot' tumors.
    • The trial will assess safety, pharmacokinetics, maximum tolerated dose, pharmacodynamic biomarkers, and initial antitumor activity.
    • Patients with various solid tumors, including NSCLC, TNBC, HNSCC, prostate cancer, CRC, and HGSOC, will be enrolled.
    • ZM008 will be administered intravenously every three weeks, with multiple visits required for lab tests and safety evaluations.
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  9. PDS Biotech provides data update from ongoing VERSATILE-002 phase 2 clinical trial in head and neck cancer
    • PDS Biotechnology provided an update on the VERSATILE-002 Phase 2 clinical trial for HPV16-positive head and neck squamous cell cancer (HNSCC).
    • The trial evaluates the combination of Versamune® HPV and KEYTRUDA® (pembrolizumab) in immune checkpoint inhibitor (ICI) naïve patients.
    • As of May 17, 2024, the median overall survival (mOS) remains at 30 months with a 95% confidence interval lower limit of 19.7 months.
    • 27 patients are still alive and awaiting their next clinical assessment, while 18 patients have died.
    • Full data from the May 17, 2024 data cut are expected to be announced in Q3 2024.
    • PDS Biotech plans a three-arm registrational trial for first-line treatment of HPV16-positive recurrent/metastatic HNSCC, including double and triple combination therapies.
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  10. Velocity Clinical Research partners with Luminis Health, moves into oncology in the U.S.
    • Velocity Clinical Research and Luminis Health announce a partnership to conduct clinical research within Luminis Health’s organization.
    • Velocity will take over the operation of Luminis Health’s existing clinical research capabilities, aiming to increase efficiencies and cost savings.
    • The partnership marks Velocity’s significant entry into oncology in the United States.
    • Velocity will establish integrated research sites within Luminis Health locations, providing staff and management experience in clinical trial operations and patient recruitment.
    • The collaboration aims to bring more clinical trial opportunities to Maryland residents, promoting health equity and diversity in clinical research.
    • Velocity has other partnerships in the pipeline to expand its oncology remit, bringing more clinical trial opportunities to cancer patients.
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