August 14, 2024 - 🧬 [nGram] Today’s Oncology Scoop: PanTher's FDA Clearance, Viracta's Positive Data, Financial Updates


  1. PanTher Therapeutics receives FDA clearance of IND application for phase 1b study of PTM-101 for the localized treatment of pancreatic cancer
    • PanTher Therapeutics has received FDA clearance for its IND application to proceed with a phase 1b clinical study of PTM-101.
    • The study will focus on patients with treatment-naive, borderline resectable, and locally advanced pancreatic ductal adenocarcinoma (PDAC).
    • PTM-101, developed using PanTher’s Sagittari platform, delivers high drug concentrations directly at the tumor site.
    • Earlier phase 1 data showed a >40% reduction in tumor volume in two out of three patients and a favorable safety profile.
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  2. Viracta Therapeutics announces positive data from the Phase 2 NAVAL-1 trial and regulatory progress
    • New combined Stage 1 and Stage 2 results from the Phase 2 NAVAL-1 trial show Nana-val’s substantial antitumor activity and well-tolerated safety profile in relapsed or refractory EBV-positive PTCL.
    • Productive FDA meeting provided clarity on the potential regulatory path for Nana-val in patients with relapsed or refractory EBV-positive PTCL.
    • Viracta plans to initiate a randomized controlled trial (RCT) of Nana-val in the second half of 2025, aiming for potential NDA filing in 2026.
    • Viracta will focus on the second-line EBV+ PTCL subpopulation in the ongoing NAVAL-1 trial’s expansion phase and has paused the EBV+ solid tumor program to prioritize resources.
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  3. Mural Oncology announces second quarter 2024 financial results and provides update on pipeline progress
    • Mural Oncology remains on track to report readouts from nemvaleukin alfa in two late-stage clinical trials in 1H 2025.
    • Presented clinical data from ARTISTRY-3 on less frequent dosing of nemvaleukin at ASCO annual meeting in June.
    • Candidate nominations for IL-18 and IL-12 programs expected later this year.
    • Cash, cash equivalents, and marketable securities are expected to fund operations into Q4 2025.
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  4. Predictive Oncology reports second quarter 2024 financial results and provides business update
    • Reported a net loss of $3.2 million on total revenue of $0.3 million for Q2 2024.
    • Entered the biomarker discovery market with promising results from an ovarian cancer study.
    • Implemented a cost savings initiative expected to reduce operating expenses by 20% annually.
    • Announced a new collaboration with the University of Michigan to evaluate pharmaceutically viable extracts.
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  5. Achilles Therapeutics reports second quarter 2024 financial results and recent business updates
    • Announced research collaboration with Arcturus Therapeutics to explore second-generation mRNA cancer vaccines.
    • Provided interim Phase I/IIa update on cNeT in advanced NSCLC and melanoma, showing improved persistence and engraftment in first EHC patients.
    • Cash position of $95.1 million supports operations through 2025.
    • Reported R&D expenses of $13.6 million and G&A expenses of $4.2 million for Q2 2024.
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  6. Apollomics reports first half 2024 financial results and highlights vebreltinib clinical progress
    • Reported $25.9 million in cash and cash equivalents as of June 30, 2024, with a cash runway into Q3 2025.
    • Vebreltinib showed a 43% objective response rate in the SPARTA Phase 2 trial for non-CNS MET fusion solid tumors.
    • Uproleselan Phase 3 study in China to be closed early due to negative results from GlycoMimetics' global study.
    • Net loss for H1 2024 was $35.2 million, including a $10 million impairment loss for the uproleselan intangible asset.
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