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DRUG:

NY-303

i
Other names: NY-303, CYT-303
Associations
Trials
Company:
CytoLynx Therap, NAYA Bio
Drug class:
GPC-3 inhibitor, Natural cytotoxicity triggering receptor 1 agonist
Associations
Trials
over1year
Derivation and Preclinical Characterization of CYT-303, a Novel NKp46-NK Cell Engager Targeting GPC3. (PubMed, Cells)
In vivo, CYT-303 showed no toxicity or cytokine release in cynomolgus monkeys up to the highest dose (60 mg/kg), administered weekly by intravenous infusion for 28 days. These results demonstrate the potential of CYT-303 to be a safe and effective therapy against HCC.
Preclinical • Journal
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GPC3 (Glypican 3)
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GPC3 expression
|
NY-303
over1year
CYT-303 FLEX-NKTM engager dose response efficacy mechanisms in HCC tumor model and safety in cynomolgus monkey toxicology studies support clinical evaluation in hepato-cellular carcinoma (AACR 2023)
CYT-303 efficacious doses identified in the HCC model together with safety in cynomolgus monkeys and planned human pharmacokinetic modeling studies support clinical evaluation of CYT-303 in first in human HCC clinical trials.
Preclinical
|
GPC3 (Glypican 3)
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GPC3 expression
|
NY-303
over1year
Improved anti-tumor immune functions of iPSC-derived NK cells with TGFβR2 knock-out and/or IL-15 knock-in by TALEN® editing for use alone or in combination with GPC3 Flex-NKTM bispecific antibody (AACR 2023)
This work demonstrates that KI of IL-15 and KO of TGFβR2 is a promising strategy for TALEN®-engineered iNK cell therapies to overcome the immunosuppressive TME and mount a potent and persistent anti-tumor immune response. The data also provide a solid foundation for combining these edited iNK cells with CYT-303 to address the immunosuppressive TME towards a cure for HCC.
Combination therapy
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GPC3 (Glypican 3) • TGFBR2 (Transforming Growth Factor Beta Receptor 2) • TGFB1 (Transforming Growth Factor Beta 1) • IL15 (Interleukin 15) • NKG2D (killer cell lectin like receptor K1)
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GPC3 expression
|
NY-303
over2years
Glypican-3 (GPC3) and NKp46 directed FLEX-NK engager antibody (CYT-303) recruits natural killer (NK) cells to tumors in a preclinical hepatocellular carcinoma (HCC) mouse model (ESMO 2022)
Conclusions Pharmacologically active CYT-303 doses were identified. CYT-303 can help recruit NK cells to the tumor site to achieve tumor growth inhibition.
Preclinical
|
AFP (Alpha-fetoprotein) • GPC3 (Glypican 3) • IL15 (Interleukin 15)
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GPC3 expression
|
NY-303
over2years
Preclinical characterization of FLEX-NKTM tetravalent NKp46 engager directed against GPC3 (CYT-303) alone or in combination with iPSC derived Natural Killer cells (iNKs) against hepatocellular carcinoma (HCC) (AACR 2022)
CYT-303 greatly enhanced the cytotoxic activity of iNKs and cytolysis of Hep3B tumor cells in-vitro. CYT-303 and iNK cells, alone or in combination, demonstrate anti-tumor activity against HCC that warrants clinical development.
Preclinical • Combination therapy
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GPC3 (Glypican 3) • NCAM1 (Neural cell adhesion molecule 1) • NKG2D (killer cell lectin like receptor K1)
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GPC3 expression
|
NY-303