Prelude Therapeutics Releases Preliminary Data on JAK2V617F Inhibitors
Prelude Therapeutics the first preclinical data on its JAK2V617F mutant selective JH2 inhibitors and additional preclinical data from its mCALR-targeted degrader antibody conjugate discovery program. Both oral presentations took place at the American Society of Hematology, ASH, 67th Annual Meeting in Orlando, FL. These presentations can be found at Publications - Prelude Therapeutics. Key highlights: First disclosure of PRT12396, a JAK2V617F-selective JH2 inhibitor demonstrates disease modifying potential in myeloproliferative neoplasms; PRT12396 has completed GLP toxicology studies and is on track for IND filing in the first quarter 2026; First disclosure of a mutant calreticulin targeted degrader antibody conjugate with a novel CDK9 degrader payload; JAK2V617F and mCALR are the two primary driver mutations responsible for disease progression and poor prognosis in the majority of MPN patients
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Oncolytics Biotech Secures FDA Approval with 33% Efficacy for New Drug
- Clinical Trial Breakthrough: Oncolytics Biotech's pelareorep achieves a 33% objective response rate in KRAS-mutant metastatic colorectal cancer patients, significantly surpassing the historical benchmark of 6-11%, indicating its potential in cancer treatment.
- Broad Market Outlook: The total addressable market for pelareorep in colorectal cancer is projected to reach $20 billion by 2033, highlighting the drug's significance in addressing unmet medical needs.
- Strategic Planning: The company plans to initiate a controlled study in second-line KRAS-mutant colorectal cancer following consultations with key opinion leaders and regulatory authorities, enhancing the analytical rigor of data to support potential regulatory submissions.
- Expert Endorsement: Dr. Sanjay Goel from Rutgers Cancer Institute emphasizes that a 33% response rate is highly unusual in this setting, underscoring the necessity for further studies and indicating the clinical value of the drug.

Oncolytics Biotech Secures FDA Approval with 33% Efficacy for Pelareorep in Colorectal Cancer
- Regulatory Shift: The FDA's move to require only one clinical trial for new drug approvals signifies a dramatic shift in regulatory pathways, potentially accelerating oncology breakthroughs and enhancing market opportunities for biotech firms.
- Promising Clinical Data: Oncolytics Biotech's pelareorep achieved a 33% objective response rate in KRAS-mutant metastatic colorectal cancer patients, significantly surpassing the historical benchmark of 6-11%, highlighting its potential in gastrointestinal tumors.
- Expansive Market Potential: The total addressable market for pelareorep in colorectal cancer is projected to reach $20 billion by 2033, indicating that the drug could become a transformational treatment option addressing unmet medical needs.
- Strategic Planning: Oncolytics plans to sponsor a controlled study in KRAS-mutant colorectal cancer following consultations with key opinion leaders and regulatory authorities, ensuring data control and transparency to support future regulatory submissions.









