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Onco-Summaries: Daily Oncology Updates at a Glance
- Oncofocus Team
- Jan 13
- 3 min read
12/01/2026
Novita Pharmaceuticals' NP-G2-044 received the FDA orphan drug designation for pancreatic cancer (Ref)
The US FDA granted the orphan drug designation to Novita Pharmaceuticals' NP-G2-044 (fascin inhibitor) for the treatment of pancreatic cancer.
Stewart Campbell, CEO, Novita Pharmaceuticals: "FDA Orphan Drug Designation for our fascin inhibitor represents an important regulatory milestone for Novita and validates the Company's scientific and clinical approach in the fight against pancreatic cancer, as it remains one of the most lethal solid tumors with limited therapeutic progress over decades. Fascin inhibition offers a novel approach with the potential to enhance anti-tumor immune activity and improve outcomes for patients with this devastating disease, and we look forward to continuing advancement of NP-G2-044 to address the high unmet need."
Novita's Phase 2 trial of NP-G2-044 as monotherapy and combination therapy in patients with advanced or metastatic solid tumor malignancies is currently ongoing
Eureka Therapeutics' ECT204 received the FDA RMAT designation for hepatocellular carcinoma (Ref)
The US FDA granted the Regenerative Medicine Advanced Therapy (RMAT) designation to Eureka Therapeutics' ECT204 (GPC3-targeting CAR T-cell therapy) for the treatment of patients with advanced hepatocellular carcinoma.
The designation is based on data from the completed Phase 1 cohort and additional data from the ongoing Phase 1/2 ARYA-3 trial of ECT204 in adult patients with GPC3-positive advanced HCC
Dr. Cheng Liu, Founder and CEO, Eureka Therapeutics: “This represents an important inflection point for Eureka and for cell therapy in solid tumors. ARTEMIS was designed to overcome the limitations of conventional CAR T-cell therapies in solid tumors, and early clinical observations with ECT204 in liver cancer reinforce our belief that the ARTEMIS architecture can meaningfully expand the therapeutic reach of cell therapy.”
Summit Therapeutics submitted a BLA seeking approval for ivonescimab + chemo in 2L+ EGFRm NSCLC (Ref)
Summit Therapeutics has submitted a Biologics License Application (BLA) to the US FDA seeking approval for Akeso & Summit's ivonescimab (PD-1 x VEGF BsAb) + chemotherapy in second-line or later treatment of patients with EGFR-mutated locally advanced or metastatic non-squamous NSCLC.
The BLA submission was based on results from the global Phase 3 HARMONi trial
The BLA was submitted during the Q4'25, and a decision from the agency is anticipated by Q4'26
Robert W. Duggan and Dr. Maky Zanganeh, Co-Chief Executive Officers of Summit: “This BLA submission, the first for ivonescimab, marks a critical milestone for Summit, our global clinical development plan, and the many patients with EGFRm NSCLC in need of better therapeutics options. As we continue to support and expand ivonescimab’s rapid development via our growing set of global Phase III trials and clinical collaborations, we look forward to the potential first U.S. approval for ivonescimab in this difficult to treat setting.”
AbbVie acquires ex-China rights to RemeGen's RC148 in a ~$5.6B deal (Ref)
AbbVie & RemeGen announced an exclusive licensing agreement for the development, manufacturing and commercialization of RemeGen's RC148 (PD-1 x VEGF BsAb).
RC148 is currently being developed by RemeGen as a monotherapy and in combination regimens across multiple advanced solid tumors
Under the terms of the agreement, AbbVie will receive exclusive rights to develop, manufacture, and commercialize RC148 outside of the Greater China territory
RemeGen will receive an upfront payment of USD $650 million and is eligible to receive up to USD $4.95 billion in aggregate development, regulatory, and commercial milestone payments, along with tiered, double-digit royalties on net sales outside the Greater China territory
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