On Wednesday, Pyxis Oncology, Inc. PYXS launched preliminary knowledge from the continuing Section 1 scientific dose escalation examine evaluating PYX-201 in a number of strong tumors.
Amongst evaluable Head and Neck Squamous Cell Carcinoma (HNSCC) sufferers handled at an recognized dose vary of PYX-201 from 3.6 – 5.4 mg/kg (n=6), a confirmed 50% goal response price (ORR) was noticed, together with one confirmed full response (CR) and two confirmed partial responses (PR).
The corporate moreover introduced a Scientific Trial Collaboration Settlement with Merck & Co Inc MRK for a Pyxis Oncology-sponsored examine of PYX-201 together with Merck’s Keytruda (pembrolizumab) in sufferers with 1L and 2L HNSCC, HR+/HER2- breast most cancers, and triple-negative breast most cancers (TNBC) and sarcoma.
- PYX-201 and Keytruda mixture dose escalation and enlargement examine in 1L and 2L HNSCC with preliminary scientific knowledge readout anticipated within the second half of 2025.
- PYX-201 monotherapy examine in 2L and 3L HNSCC sufferers who’re platinum and PD-1 inhibitor skilled, with preliminary scientific knowledge readout anticipated within the second half of 2025.
- PYX-201 monotherapy examine in 2L and 3L HNSCC sufferers who’re EGFR and PD-1 inhibitor skilled, with preliminary scientific knowledge readout anticipated within the first half of 2026.
Exploratory PYX-201 Section 1 monotherapy enlargement cohorts are deliberate for ovarian most cancers, NSCLC, HR+/HER2 breast most cancers, TNBC, and sarcoma. Preliminary scientific knowledge are anticipated within the second half of 2025.
- The corporate additionally expects to provoke the PYX-201 and Keytruda mixture examine in HR+/HER2 breast most cancers, TNBC, and sarcoma, with preliminary scientific knowledge anticipated within the second half of 2025 and the primary half of 2026.
- Preclinical research of PYX-201 mixed with different brokers in ovarian most cancers and NSCLC will begin in 2025, adopted by scientific research with preliminary scientific knowledge anticipated in 2026.
PYX-201 demonstrated favorable preliminary tolerability profile knowledge with low incidence of dose discontinuation, interruptions, or delays as a result of treatment-related antagonistic occasions.
William Blair analysts notice that PYX-201 exhibits restricted effectiveness outdoors of head-and-neck most cancers, with solely 8.7% of sufferers (2 out of 23) responding to tolerable doses of three.6 mg/kg, 4.4 mg/kg, and 5.4 mg/kg.
“At this level, we’re not sure whether or not the three unconfirmed responses may finally be confirmed,” the analysts writes.
The analysts has decreased the likelihood of success for PYX-201 to 10% from 35%. The up to date truthful worth stands at $250 million or roughly $4.25 per share, comprising $1.77 per share from PYX-201 and $2.48 per share of money.
With no main stock-moving occasions anticipated till the second half of 2025, the analysts estimate the inventory will commerce round $2.80 per share quickly. William Blair says it contains $1.77 per share for PYX-201 and $1.07 for remaining money by late 2025.
William Blair downgrades Pyxis to Market Carry out, saying, “Since we view the head-and-neck most cancers outcomes as troublesome to distinguish, coupled with modest exercise in different strong tumor histologies.”
Worth Motion: PYXS inventory is down 42.15% to $2.21 throughout premarket buying and selling on Thursday.
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